Pfizer

Gastrointestinal symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-07 vomiting, nausea Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Em... Read more
Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
76 2021-01-17 flatulence, diarrhea Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . ... Read more
Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.
76 2021-01-20 nausea dizziness, headache, nausea
76 2021-01-21 nausea high fever 102, fatigue, no energy, aches in muscles in joints, nauseous
76 2021-01-22 abdominal pain, vomiting fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, +... Read more
fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, + non st elevation MI
76 2021-01-23 nausea injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lou... Read more
injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is
76 2021-01-25 diarrhea Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection si... Read more
Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
76 2021-01-25 difficulty swallowing, nausea Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minute... Read more
Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine. After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous. Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow. Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.
76 2021-01-25 nausea s/p vaccine c/o dizziness, nausea, unsteady
76 2021-01-26 decreased appetite Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness fo... Read more
Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness for 48 hours and slept for most of the day. 2nd Day pain at site and headache continued. Treated with Acetaminophen. Extreme sleepiness slept for most of the day. Sore throat,cough and nasal congestion and drip, and metallic taste in mouth. Loss of appetite. Loss of hearing and appetite. I woke up at night at 1:00 a.m. with severe nasal discharge and had to sit upright for 2 hours till it abated a little. Day 3 Pain at site continued as did nasal congestion and discharge. Loss of appetite and hearing also continued. I still have nasal congestion and discharge on my 3rd week and also the loss of appetite and hearing loss. The loss of hearing has improved very minutely.
76 2021-01-26 decreased appetite Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me) Jan 27, 2021 1:30... Read more
Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me) Jan 27, 2021 1:30 am woke up feeling hot and perspiring (really unusual for me, but I did not think much about it at the time) 3:00 pm - mild headache ( unusual for me, but I did not take anything for it) 5:00 pm felt mildly unwell and felt mildly chilled 5:30 pm, took temperature - 99.5 - and did not want anything to eat - no nausea, just not hungry. 8:30 pm, took temperature - 100.2, ate some mild cheese and fruit (pear) and coca-cola to settle my stomach a little
76 2021-01-26 nausea headache; nausea; This is a spontaneous report from a contactable consumer. A 76-year-old female pat... Read more
headache; nausea; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 14Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression and anxiety from an unknown date and unknown if ongoing. Concomitant medication included alprazolam (ALPRAZOLAM), melatonin (MELATONIN), escitalopram (ESCITALOPRAM). The patient experienced headache and nausea on 16Jan2021 19:00. The outcome of the event was recovering.
76 2021-01-27 diarrhea, vomiting Unsteady - 2 staff members accompanied resident to ambulate, resident was immediately lowered to sit... Read more
Unsteady - 2 staff members accompanied resident to ambulate, resident was immediately lowered to sitting position in chair as resident experienced a change in LOC- approx. 5 sec. T- 99.3 O2 at 90% and pulse 44. Regained orientation X 2, began vomiting and diarrhea,. 911 transported to hospital, Family aware
76 2021-01-28 abdominal discomfort I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out ... Read more
I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out of bed. I tried to get out bed and couldn't my husband had to come help me. I could barely walk because I hurt so bad. He helped me to the bathroom and then to my chair in the living room. It hurt so bad I couldn't stay long. My husband helped me back to bed, I stayed in bed all day besides when I needed to go to the bedroom. Today I am shaky, my stomach is bothering me, I can walk today but I real tired and shaky and have to come right back to my chair to sit down. I am better then I was yesterday. If I don't feel better by noon I will call my doctor.
76 2021-01-28 nausea Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monit... Read more
Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.
76 2021-01-28 nausea Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 o... Read more
Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN). The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot. The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00. No treatment was received for the events. The outcome of the events was recovering.
76 2021-01-30 diarrhea, nausea Nausea and diarrhea plus headache
76 2021-01-31 gastrointestinal pain, diarrhea loose stools; gut hurting; Headache; This is a spontaneous report from a contactable consumer report... Read more
loose stools; gut hurting; Headache; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 10:30 arm right way high at single dose for covid-19 immunisation. Her 2nd dose is schedules for 09Feb2021. She states that the Lot and Expiry were not written, it just says (Name) for healthcare professional or clinical site. This was her first dose for the Covid 19 vaccine she received, it says Pfizer. Medical history included stomach ulcer, Resection of Small Intestines, 18 months ago, it was complete right side resection of the small intestine, it was pre colon cancer and they took out 10 inches, AFib, It was discovered almost exactly a year ago (from 2020), Graves' disease, headaches. Concomitant drug included rivaroxaban (XARELTO) for Atrial fibrillation and a blood pressure medication. The patient previously received Flu shot in Sep2020 at 75 year old for immunization and shingles shot in 2020 for immunization. The last 2 vaccines she got were shingles and Flu shot, and this last year 2020, for the first time in her life she had a little bit of a reaction, it was in particular, the shingles shot, she felt unwell. The reaction she was speaking of with the shingles shot earlier was that she just felt unwell, but not severe. It was for about a day. She has no name and no Lot number for the Flu shot and Shingles shot, what ever the Flu shot was for 2020, she got it in Sep2020. She went to drug store, the shingles shot was the new 2 shot shingles or something like that, in which it is also 2 doses. She only had trouble the 1st time, it was the little reaction and next time there was no reaction or vice versa, but nothing severe. She kept thinking, she was a worry wart. She thought that she must have Covid 19. Her daughter laughed at her and said that she did not have covid because she did not have the correct symptoms for covid, but she has to ask it would not help her if she was going to die. Her husband and her had the first dose Friday at like 10:30AM, she Lives an hour away from the site. She had not felt one thing in her arm, no soreness no puffiness, no redness. She was having trouble with her Gut hurting and she was running to the bathroom with loose stools. She did not have a temperature and she does not have any aches and pain. It was diarrhea but not watery, there was some form to it. The gut symptoms started on the same day, possibly in the evening, about 19:00 at night. The Loose stools also started on the 15Jan2021 around the same time. During the night, last night, more so in the middle of the night, her gut really started to feel better, but she has had 2 bowel movements this morning, but it was still very soft. The Loose stools are still on going, but she felt better this morning. She didn't feel "sicky." She felt she was going to live. She has never had a fever. She did have a headache on 15Jan2021, especially when she was worrying. Lab data included investigation: She had physical for the year in Nov2020. Outcome of the event loose stools, headache was resolving. Outcome of the event gut hurting was recovered on 18Jan2021. Information on the Lot/Batch number has been requested.
76 2021-01-31 nausea Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the fa... Read more
Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker
76 2021-02-01 abdominal discomfort, nausea, vomiting 76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulo... Read more
76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.
76 2021-02-01 nausea Body Chills; body aches; nausea; This is a spontaneous report from a contactable consumer (patient).... Read more
Body Chills; body aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9261, expiration date unspecified), via an unspecified route of administration on 16Jan2021 08:30 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19, prior vaccination. The patient was not pregnant. Concomitant medications were not reported. Patient had other medications in two weeks. The patient previously took codeine (reported as codine) and experienced allergies. On an unspecified date, the patient experienced body chills, body aches and nausea. There were no treatment for the events. There were no other vaccine in four weeks and patient was not Covid tested post vaccination. Outcome of events was recovered in Jan2021.
76 2021-02-03 nausea, decreased appetite Patient developed chills, nausea, headache, body aches, loss of appetite. She went to the emergency ... Read more
Patient developed chills, nausea, headache, body aches, loss of appetite. She went to the emergency room and received Benadryl and a bolus of normal saline, She is feeling back to her baseline today,
76 2021-02-03 vomiting, diarrhea I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and st... Read more
I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.
76 2021-02-04 abdominal pain upper, nausea Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout bod... Read more
Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.
76 2021-02-04 diarrhea diarrhea for 2 wks starting night of Pfizer covid vaccine admin
76 2021-02-04 nausea Felt nauseous Tired
76 2021-02-04 nausea not feeling well/general malaise/feeling sick; feeling really bad; a bad headache; feeling sick and ... Read more
not feeling well/general malaise/feeling sick; feeling really bad; a bad headache; feeling sick and nauseated/nausea; worried it will not go away; frustrated; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiry date unknown), via an unspecified route of administration in the right arm, on 11Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she had her first vaccine on 11Jan2021. On 19Jan2021, the patient was feeling really bad, had a bad headache, general malaise and was feeling sick and nauseated. She was not feeling well and has not been feeling well the last 3 days. She thought the side effect would be right after getting the vaccine however hers started on 19Jan2021 (2 days ago). She stated she had an awful headache which she still has and had nausea. She wanted to know if it was normal to have happened this far away from receiving the vaccine, this amount of time from the vaccine. The patient reported that she is not quite as bad now, but she still feels it. The patient was worried it will not go away (Jan2021). The patient became frustrated and stated that she was just trying to find out if what she was feeling was normal. The patient also thought she had COVID and took a test in Jan2021 but she did not have COVID (negative). The outcome of the events "not feeling well/general malaise/feeling sick", "feeling really bad", "a bad headache" and "feeling sick and nauseated/nausea" was recovering; and the outcome of "worried it will not go away" and "frustrated" was unknown.
76 2021-02-04 nausea I have been really nauseous and dizzy most of the day; I have been really nauseous and dizzy most of... Read more
I have been really nauseous and dizzy most of the day; I have been really nauseous and dizzy most of the day; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELT284), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included being diabetic, glaucoma. Concomitant medications were not reported. Patient stated that she had the vaccine on Tuesday (19Jan2021) she was reading over the 'notary' the side effects to be expected and that list one here it say, it could be an allergic reaction but it says that would happen after few hours after the injection but she got it on Tuesday, yesterday (20Jan2021) she was fine. On 21Jan2021, she had been really nauseous and dizzy most of the day, patient wondered whether that was something that she should expect you know would happen because the list here says dizziness and weakness is one of the side effects so is that just something that last for a while and then go away or she should be concerned about. 09Feb2021 is the date that would be for her second shot. Outcome of the events was unknown.
76 2021-02-05 nausea, vomiting Nausea with vomiting and dizziness; vomiting was constant when it began @ 2100. patient then came to... Read more
Nausea with vomiting and dizziness; vomiting was constant when it began @ 2100. patient then came to er, received fluids dizziness and nausea decreased in ER
76 2021-02-06 blood in stool, diarrhea Diahrrea - ongoing
76 2021-02-07 nausea Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutchin... Read more
Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.
76 2021-02-07 nausea Headache, nausea, fever, chills, aches all over, extremely tired. Slept for about10 hours and took... Read more
Headache, nausea, fever, chills, aches all over, extremely tired. Slept for about10 hours and took 2 Tylenol. Fever disappeared and nausea got better after about 12 hours Still have some fatigue that is not normal for me.
76 2021-02-07 nausea headache, nausea, severe myalgia -cervical/thoracic; pt had to take Tylenol and when that didn't wo... Read more
headache, nausea, severe myalgia -cervical/thoracic; pt had to take Tylenol and when that didn't work she had to take hydrocodone to get some relief.
76 2021-02-08 nausea fever, fatigue, nausea, muscle aches
76 2021-02-08 nausea Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12... Read more
Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours
76 2021-02-09 abdominal discomfort Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" o... Read more
Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" or my intestines) were on fire. I didn't have diarrhea, but the feeling was very intense and I had to go to bed. I took Pepto Bismal, hoping it would alleviate the awful feeling. It wasn't like any other stomach or intestinal upset I've ever had. It literally felt as though my insides were "on fire", inflamed. The feeling persisted for 2 days and then went away. During that time, I just ate tea and toast and hoped that I wouldn't see any blood in my stool. It was very frightening.
76 2021-02-10 nausea slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for on... Read more
slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for one day then a tapering off for about 3 days, Took Tylenol 500mg 2 every 6 hrs for a few days, ONDANSETRON 4mg 1every 8 hrs as needed for nausea
76 2021-02-11 abdominal pain upper pt states that she developed terrible stomach cramps, chills and change in stools. She says so far... Read more
pt states that she developed terrible stomach cramps, chills and change in stools. She says so far today she is no longer having the stomach cramps.
76 2021-02-11 vomiting Within 20 minutes I started vomiting
76 2021-02-12 abdominal discomfort, abdominal pain Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elb... Read more
Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain. My blood pressure rose to 160; however, there was no fever, cough or shortness of breath. This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning. Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening. I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.
76 2021-02-13 nausea extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensi... Read more
extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensitive to light and eye balls aching and still are ,temperature 3rd day morning 100.2 never checked on 2nd day. Shot in the arm hurt 1 st day where a 1st doze shot did not hurt till next day, nausea, weakness all over and joints hurt. I took1/2 of 2 percocets 1half every 3 hours for 12 hours and that helped with headache and teeth..tylenol did not help headache and I never have headaches. I thought I was dying. I spoke to friends who have had 2nd dose and most experienced some but not all and many nothing after 2nd dose.
76 2021-02-14 abdominal discomfort, nausea, vomiting She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdom... Read more
She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdominal and chest discomfort. She was taken to ED. Her vital signs remained stable. All work-up for cardiac event was negative. This was determined to be a vaccine reaction leading to nausea with 1 episode of emesis.
76 2021-02-14 nausea Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient)... Read more
Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 26Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included arthritis, blood pressure and allergies. Relevant concomitant medications included atorvastatin, furosemide and metoprolol. On 27Jan2021, the patient woke up in the morning the room was spinning and she was so dizzy she couldn't even get up. She remained dizzy for quite a while - she was not sure if she should receive the next dose. She also had nausea. The patient was not treated for the events. Pre and post vaccination COVID tests were not performed. The patient had recovered from the events on unknown date in 2021. Information about Lot/Batch number has been requested.
76 2021-02-15 diarrhea, nausea Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhe... Read more
Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhea was better on 2/14 bug then on 2/15 pt started to feel chest pressure. pt admitted to hospital on 2/15 noted to have NSTEMI and plt=68. Thrombocytopenia is new for pt. on 2/16 plt=79. pt has been on ibrance for years for hx of breast ca- has never had thrombocytopenia related to the ibrance.
76 2021-02-15 difficulty swallowing Lethargy, confusion, unsteady gait. Decreased O2 saturation, difficulty swallowing.
76 2021-02-16 nausea Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS e... Read more
Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS evaluated patient on-site and administered 4mg Ondansetron PO. Patient was hypertensive (156/84) in transport to Emergency Department. Patient remained hypertensive in ED. Discharged from ED with diagnoses of dizziness, nausea, resolved, secondary to vaccination.
76 2021-02-16 nausea she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hea... Read more
she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm. Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.
76 2021-02-17 difficulty swallowing The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd nigh... Read more
The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning, had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat. When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest. Then on the third night, last night, all the same pain but the headache had disappeared. Today, 2/18/21 she is still having the same symptoms. The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area. She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM. The Benadryl triggers her tinnitus so is limited with that. Her daughter is trying to find OTC medicine for the ear. She has not called her doctor as they are trying to treat it with OTC medicines. For additional information call her daughter: who takes care of all her medical information.
76 2021-02-17 nausea, decreased appetite A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm a... Read more
A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm ached but not too much but my body ached all over like you get with the flu which I've never had. I was like that for 2 days. I didn't want to eat or do anything. Then I tried to keep eating a little & drinking anything water, coffee,& tea hot & iced . On the 3rd day I felt better not well but better.
76 2021-02-17 nausea, vomiting Patient received second dose of Pfizer vaccine on 02/12. On 02/13 she experienced extreme vertigo. ... Read more
Patient received second dose of Pfizer vaccine on 02/12. On 02/13 she experienced extreme vertigo. Hx of same but this is worse than her usual. She continues to experience this although it has improved over the days since. She reports nausea starting 02/15 or 02/16 and vomited one time yesterday 02/17. She is experiencing intermittent chills but no fever, highest temp was 97.6.
76 2021-02-17 profuse anal bleeding Rectal Bleeding; This is a spontaneous report from a contactable consumer (patient). A 76-year-old f... Read more
Rectal Bleeding; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, lot number: EN5318, expiration date not reported), via an unspecified route of administration on the right arm on 02Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included osteoporosis and allergic reaction to penicillin. The patient is not pregnant. The patient has no prior COVID vaccination. There was no other vaccine given within four weeks. Concomitant medication included atorvastatin, calcium, magnesium. The patient experienced rectal bleeding on 03Feb2021 09:00. Patient reported that she had her first shot yesterday morning and today when she went to the bathroom she has rectal bleeding, bright red blood, which is not normal for her. The patient was not tested for COVID post vaccination. Outcome of the event was unknown.
76 2021-02-19 nausea Fever- (100.7) started 14 hours after vaccine and lasted 24 hours Nausiated- started 14 hours after ... Read more
Fever- (100.7) started 14 hours after vaccine and lasted 24 hours Nausiated- started 14 hours after vaccine and lasted 48 hours Extreme Fatigue- started 14 hours after vaccine and lasted 48 hours
76 2021-02-24 diarrhea, nausea pt states that after she got the covid vax and within 10 minutes she started getting light headed so... Read more
pt states that after she got the covid vax and within 10 minutes she started getting light headed so she sat down. After sitting about 10 minutes she felt better but felt like she was having a mild vertigo episode. After she got home , she ate and laid down where she was having another dizzy spell or vertigo episode and was also nauseated. She woke up next day, she got up but felt drained so went back to bed. Through out the night the next night she had chills, nausea, runny nose and bad vertigo episodes. She woke up w/ diarrhea and more vertigo. Pt had an appt w/ her physical therapist today 2/25/2021. They did a procedure to treat her vertigo. She is still having nauseated, having chills and vertigo episodes at this time. Pt states she is going to contact her PCP today.
76 2021-02-24 nausea patient reported feeling faint, got lightheaded, dizzy, nauseated
76 2021-02-25 abdominal pain, nausea, abdominal distension, decreased appetite Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms ov... Read more
Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms over the next two days (fatigue, nausea, anorexia). 2/2/21 awoke with abdominal pain and distension. Presented to MHN ED 2/2/21 @ 1100 for workup and initially declined admission and went home. Was called and asked to return for admission and further workup, admitted to MHN 2/2/21 @ 1750. Fever, myalgias, headache. CT abd/pelvis "There is mild diffuse mesenteric edema surrounding the abdominal aorta and proximal branches. Additionally, there is mild bowel wall thickening involving the stomach without discrete mass. This is nonspecific and may represent infectious versus inflammatory changes." Per provider note "flu-like sx over the weekend that easily coincide with the timing of the COVID Pfizer vaccine. In addition, I wonder if her CT scan findings might also be related to the vaccine." Discharged home the next day.
76 2021-02-25 decreased appetite Received shot at approximately noon and within a few hours, began not feeling well and by that night... Read more
Received shot at approximately noon and within a few hours, began not feeling well and by that night developed fever 102 with loss of appetite, chills, weakness, unable to stand - her legs developed spasms and jerking. The next day, temp continued to climb up to 102.6 with continued issues with spasms and jerking to lower extremities. Did not seek medical care but did take natural herbs and nutritional supplements to treat. Symptoms have lessened each day but were persistent for 10 days post vaccination. Has a hx of CLL diagnosed in 2008 and WBC runs persistently high.
76 2021-02-25 difficulty swallowing Shortness of breath, difficulty swallowing, coughing. BP 230/98
76 2021-02-26 difficulty swallowing, nausea Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems... Read more
Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking
76 2021-02-27 nausea Severe dizziness & nausea. Needed help standing & walking. B/P normal for her. Went to bed & slept ... Read more
Severe dizziness & nausea. Needed help standing & walking. B/P normal for her. Went to bed & slept for about 4 hrs. Just mild dizziness on waking. That resolved in a few hrs. No symptoms since then.
76 2021-02-27 vomiting Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to vi... Read more
Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes
76 2021-02-28 abdominal pain upper Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great de... Read more
Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.
76 2021-02-28 nausea Body aches, fever, chills, sore arm, inability to walk after first dose. Second dose more severe sym... Read more
Body aches, fever, chills, sore arm, inability to walk after first dose. Second dose more severe symptoms. Headache, nausea, fatigue.
76 2021-03-01 appendicitis, abdominal pain appendicitis; intense abdominal pain; This is a spontaneous report from a contactable consumer (pati... Read more
appendicitis; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:45 (03:45 PM) at a single dose as Covid vaccine. Medical history included gastrointestinal distress at the time of incident. The patient had no known allergies. Concomitant medications included cyanocobalamin (B12), calcium, levothyroxine sodium (LEVOXYL), lisinopril, and ergocalciferol (VIT D). The patient developed intense abdominal pain on 08Feb2021 10:00 AM. She went to the ER on 09Feb2021 and a CT scan on 09Feb2021 which revealed that she had appendicitis on 08Feb2021 10:00 AM. The patient was hospitalized for the events from 09Feb2021 to 13Feb2021 (4 days of hospitalization). Treatment for the events included intravenous antibiotics. The patient had no Covid prior to vaccination. Additional lab data included Covid test type post vaccination Nasal Swab with negative result on 09Feb2021 (Covid tested post vaccination). The outcome of the events was recovering. Information on the lot/batch number has been requested.
76 2021-03-02 nausea head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; ligh... Read more
head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; light-headed and dizzy; Sweating; Chills; seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together; Not hearing correctly; not wanting to eat; She was beginning to feel dehydrated; shaking; equilibrium was off; sleeping for hours; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization. Medical history included pre-diabetic, thyroid (disorder), and cholesterol (abnormal). Concomitant medications included levothyroxine from unspecified date to 31Jan2021 as thyroid medication and rosuvastatin for cholesterol. The patient previously took first dose of bnt162b2 (lot number: PFREL1283, expiry date: 30Apr2021) on 08Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization and experienced Injection arm pain, a little more drowsy than normal, and more tired. On 29Jan2021, the patient experienced sleeping for hours. On 30Jan2021, the patient experienced when she woke up, she thought she was headed for the emergency room (ER) as she had pain in all of her joints. At first, it was only her fingers which lasted for five minutes or so where she couldn't move her fingers, she felt numb, she was very nauseous. she couldn't hold down food, she never threw up though, she felt unstable. If she drank water, she would immediately be going to the bathroom, she was beginning to feel dehydrated. She just couldn't hold it when she had to go to the bathroom. Then, the finger pain went to her joints in her elbows and knees. On 30Jan2021, she was also light-headed and dizzy, she was not wanting to eat, she tried to eat dry toast. She was nauseous in her stomach, but she didn't throw up. She experienced sweating and chills. On late Saturday evening of 30Jan2021, she also had an issue, a very mild case, of not hearing correctly but it was not a ringing in her ear, it was like her equilibrium was off. She ended up putting a little bit of liquid ear drops in her right ear, and that seemed to help it. Right now she feels like she has recovered from everything. When unstable, it didn't seem to last too long, she is in bed most of the time. By the time she got up to eat, she was fine. But then she lapsed into chills and shaking. The patient also experienced she seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together (30Jan2021). She can remember stuff now and it only lasted that day. On 31Jan2021, her head hurt. Therapeutic measure was taken as a result of the event a very mild case, of not hearing correctly. Outcome of events felt unstable, light-headed and dizzy, memory impairment was recovered on 30Jan2021. Outcome of the events arthralgia, felt numb, nauseous, head hurt, sweating, chills; not hearing correctly, not wanting to eat, dehydration, shaking and equilibrium was off was recovered on 31Jan2021. Outcome of event sleeping for hours was recovering.
76 2021-03-03 nausea, vomiting She developed nausea, vomiting that has persisted from 2/11/21 (first visit to see me) until today 3... Read more
She developed nausea, vomiting that has persisted from 2/11/21 (first visit to see me) until today 3/4/2021 (second visit)
76 2021-03-03 nausea Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe... Read more
Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.
76 2021-03-03 vomiting, nausea not feeling good; chills; fever, which she thought was a 100.1; headache; nausea; started throwing u... Read more
not feeling good; chills; fever, which she thought was a 100.1; headache; nausea; started throwing up; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, NDC/UPC number and expiry date were unknown), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) on an unspecified date for COVID-19 immunization. Relevant medical history included heart problem, for which the patient did take "medicine," but it was not specified. All day on 01Feb2021, the patient was not feeling good; she had chills all day and then she had a fever, which she thought was a 100.1; and she had a headache; she had nausea and she started throwing up. The patient did not receive any treatment for the events. The outcome of all the events was unknown.
76 2021-03-04 nausea on 2/16/21 began to have chills in late afternoon persisting into evening. oral Temperature at b... Read more
on 2/16/21 began to have chills in late afternoon persisting into evening. oral Temperature at bedtime averaged 99.6 persisted with decreasing chills by 2/28/21 Please note that received 2nd dose of pfizer on 3/1 and symptoms of chills, inc temperature returned along with nausea thru most of the day on 3/3/21
76 2021-03-06 abdominal discomfort, vomiting Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throw... Read more
Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throwing up ,
76 2021-03-07 vomiting, nausea, diarrhea, abdominal pain Pfizer-BioNTech Covid-19 Vaccine EUA 2 2/2 days post vacine nausea, sore throat, vomiting, abdomina... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA 2 2/2 days post vacine nausea, sore throat, vomiting, abdominal cramps, headache, loose stools, fatigue. Continued for 10 days. Two weeks After 2nd pfizer vaccine, above symptoms once again (no vomiting) and continuing. Basically sick for 5 weeks to date.
76 2021-03-08 nausea Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third d... Read more
Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third day after, and became extremely hot the morning of the fourth day after the vaccine and again on the seventh day after the vaccine. The nauseous, headaches, and irritable bowels subsided by fourth day after the vaccine. Did not receive any treatment.
76 2021-03-09 decreased appetite Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching beh... Read more
Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching behind eyes, especially right eye which lingered until about day 7, headache on right side for about last 4 of the 7 days, some discomfort in right armpit and tenderness of right breast nipple. No treatment except fluids and bed rest for first 3 days. By day 6 I felt myself again.
76 2021-03-09 nausea, vomiting Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkale... Read more
Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.
76 2021-03-09 nausea headache, body aches, fever, fatigue, nausea, trouble sleeping, still happening 3/10
76 2021-03-09 nausea Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evalua... Read more
Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evaluated the patient on-site. Patient was found to have orthostatic hypotension, hypoglycemia, and was near-syncopal. EMS administered 400mL of normal saline and 15g oral glucose. EMS transported the patient to Emergency Department. In the ED, the patient was hypertensive (163/73). EKG demonstrated NSR, rate 67 bpm, no ST-T changes, no ectopy, normal PR & QRS intervals. CBC/CMP was unremarkable. Patient noted improvement and was discharged with a diagnosis of a probable vasovagal event.
76 2021-03-10 abdominal pain upper, profuse anal bleeding, diarrhea, nausea nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the va... Read more
nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown. Information about lot/batch number has been requested.
76 2021-03-10 diarrhea, abdominal discomfort Started with upset stomach and achey body late afternoon on Friday (1 week after 1st shot). Then dev... Read more
Started with upset stomach and achey body late afternoon on Friday (1 week after 1st shot). Then developed diarrhea at the same time extreme fatigue. Diarrhea only lasted about 1 day, but fatigue ( which demanded many naps) and achey body lasted until Monday night. Woke up Tuesday feeling stronger, but still had lower back ache and tiredness - not extreme fatigue, but still so very tired - fewer naps. Today is Thursday and I am still quite tired, lower sore back ache. Never had a fever.
76 2021-03-10 nausea, vomiting blood DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three day... Read more
DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three days later on Sunday, February 21, 2021, after being admitted to the intensive care unit at Hospital. After developing an adverse reaction that started with nausea and then got progressively worse, including vomiting blood, Mom was rushed to the emergency room where she was tested for Covid-19 due to hospital policy (neg. result) and admitted to the intensive care unit. Mother died on Sunday, February 21, 2021. NOTE: Mother was doing well with her heart and renal conditions until she received the second dose of the Pfizer Covid-19 vaccine on February 18, 2021, directly or indirectly causing her death three days later on February 21, 2021. It is unfortunate that we are all advised (sometimes ill advised), particularly those with underlying conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of covid vaccines was rushed and thus the Pfizer and Moderna Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, My Mother is DEAD! Sadly, there are probably more unreported deaths caused by the vaccine. While you have immunity from liability, you still have a moral obligation to collect data and advise accordingly. My goal is to save lives by sharing my mother?s personal experience and death after receiving the vaccine with everyone I know through every available resource. It is unconscionable that I have to shoulder the burden of getting the facts out about your vaccine so that individuals with underlying conditions can make a proper, informed decision about getting vaccinated. Sadly, I receive over 100 questions a day via social media from individuals inquiring about whether or not they or their loved ones should opt for the vaccine. I am not a medical professional?this is your job! Until you assume responsibility, I will continue advising anyone with heart and/or renal conditions to stay away from any and all covid vaccinations. Instead of the massive all call for vaccinations, we need further information and data from additional studies that will give more insight as to when the vaccine can cause more harm than good, as in My Mother?s case.
76 2021-03-14 decreased appetite Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 2... Read more
Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 21st. ON THE 22nd I WOKE UP TO A SEVERE NOSE BLEED THAT I COULD NOT STOP! I NEVER RECALL HAVING A NOSE BLEED IN MY LIFE! I HAD MY SECOND SHOT ON FRIDAY, MARCH 12, AND WHILE SITTING WATCHING TV MY NOSE STARTED BLEEDING AGAIN EXCEPT, NOT SO PROFUSELY! It seem very strange to me that this would happen days after having the Covid vaccine
76 2021-03-14 diarrhea Chills Fever Severe diarrhea for 6 weeks Dehydration Pleurisy Esophagus inflammation Lethargy
76 2021-03-14 nausea, abdominal pain Patient presented to the emergency room with chief complaint of right side abdominal pain and and n... Read more
Patient presented to the emergency room with chief complaint of right side abdominal pain and and nausea. Primary problems were found to be right ureteral stone and urinary tract infection. Patient was admitted on 3/13/21 and while doing rapid COVID-19 testing on 3/13/21, was found to be positive. Patient denies any contact with COVID-19 and presented with no symptoms to suggest COVID-19 illness. Patient denied any fever, headache, loss of senses of taste or smell, muscle aches, fatigue, vomiting, constipation, or diarrhea.
76 2021-03-14 nausea, decreased appetite Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a sponta... Read more
Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing). Information regarding lot/batch number has been requested.
76 2021-03-14 nausea tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report f... Read more
tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.
76 2021-03-14 nausea Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in th... Read more
Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in the form of hives and itching on lower extremities and slightly on lower side of upper arms. (No adverse reaction to first shot)
76 2021-03-15 decreased appetite Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes.... Read more
Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.
76 2021-03-15 vomiting seizure like activity of upper extremities. slumped over in chair vomited pale in color
76 2021-03-16 diarrhea generalized weakness, subjective chills, fever, diarrhea
76 2021-03-18 decreased appetite Hallucigenic, stop eating, chronic forgetfulness, behavior change,
76 2021-03-18 diarrhea, diarrhea with profuse bleeding, nausea diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a cha... Read more
diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.
76 2021-03-21 decreased appetite, nausea, diarrhea, abdominal pain Visited PCP on 3/8/21 with reports of nausea, fatigue, and anorexia following COVID-19 vaccine. Repo... Read more
Visited PCP on 3/8/21 with reports of nausea, fatigue, and anorexia following COVID-19 vaccine. Reports body aches, nausea without vomiting, abdominal pain, diarrhea, runny/stuffy nose. Presented to ED on 3/9/21 and reported shortness of breath started 2/28/21. Had COVID positive contact on 2/24. Required supplemental oxygen on presentation. Admitted to ICU on 3/14/21 until present.
76 2021-03-21 difficulty swallowing EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw... Read more
EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw her PCP who diagnosed her with Bell's Palsy. She was prescribed acyclovir and prednisone. 4 days after the vaccine, she began to feel dry eyes, and difficulty swallowing. She was advised that symptoms will improve with time and steroids and to return to the ED if she experiences voice changed or cannot tolerate liquids.
76 2021-03-21 nausea Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea... Read more
Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness
76 2021-03-23 nausea, diarrhea Nauseous, diarrhea, chills, aches, headaches, sinus, could not turn off my brain. Awake till 3 am.
76 2021-03-23 vomiting, indigestion 1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she wa... Read more
1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.
76 2021-03-24 abdominal pain upper Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pai... Read more
Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.
76 2021-03-26 nausea Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injecti... Read more
Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injection. Feeling generally bad all over, aching muscles, much like the symptoms of the covid 19 but only lasted a day and a half. I had covid in December through the new year and it last 3 1/2 weeks.
76 2021-03-28 abdominal pain upper, nausea Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago... Read more
Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago), nausea, stomach pain, bilateral ankle swelling, drainage in back of throat, right ear is clogged), Pt was admitted to hospital for AMS last month, uncertain underlying cause. Over past few days shes gotten more weak, possibly more confused, more back pain, and lost voice, some congestion and ear congestion. Her son is managing medication. She has SOB and nausea too. No vomiting or diarrhea. Symptoms worsening. No sick exposures, 1st covid shot 2 days ago
76 2021-03-28 diarrhea, vomiting, decreased appetite COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS F... Read more
COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS FOLLOWING 2ND DOSE OF VACCINE; SYPTOMS INCLUDE DIARRHEA, ANOREXIA, WEAKNESS, VOMITING, COUGH, SHORTNESS OF BREATH
76 2021-03-30 diarrhea, flatulence severe gas; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-ye... Read more
severe gas; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, in Arm Left on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced severe gas and diarrhea on 13Feb2021 with outcome of not recovered. The patient reported that severe gas started on 13Feb2021. It would last about an hour and then she would go to the bathroom and have diarrhea. Severe gas and diarrhea have been intermittent, and they continued throughout. The patient received the second dose on 02Mar2021 (Lot EN6205) in left arm and about 4 days later she had the same gas effect. The patient mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she was basically a vegetarian that ate well and did not normally have diarrhea issues.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269680 same patient, different dose/AE
76 2021-03-30 diarrhea Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spon... Read more
Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
76 2021-03-30 nausea she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was fe... Read more
she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.
76 2021-03-31 abdominal discomfort sick to stomach, generalized weakness
76 2021-04-02 nausea nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in m... Read more
nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.
76 2021-04-04 decreased appetite Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees)... Read more
Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees) up through my thighs to my hips, pretty much 24/7. Chills, loss of apatite and some foods taste strange. have been unable to sleep through the night because of the pain.I do think that the antibiotic did not mix with the second shot even though the medical staff cleared me at the COVID clinic that I could have the shot.
76 2021-04-05 diarrhea Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note... Read more
Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.
76 2021-04-05 nausea Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially... Read more
Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea
76 2021-04-06 diarrhea Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A... Read more
Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.
76 2021-04-07 decreased appetite, nausea Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about ... Read more
Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about it; sleeplessness; headache; recurring chills; allover muscle & joint pains, nausea, appetite loss -- lost 6 lbs. in 6 days; blurred vision, dizziness. On the 5th day was able to eat cheese sandwich; only chicken noodle soup & crackers & tea & toast prior to that. Finally on the 8th day began to feel normal.
76 2021-04-08 diarrhea Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head ... Read more
Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head cold. On Tues. his job told him to get a COVID test. He went in Wed. and the rapid test was positive. I went down hill. I had headache, chills, sore all over, sore throat, coughing, shortness of breath, sore tongue, diarrhea, didn't have fever. Was up Thursday night because of shortness of breath. Called Doctors office and was told to go to walk in clinic and someone would come out and get me. Was seen by PA I think. Not a doctor. They only did a rapid test and it was negative. She didn't do the second test and send it off. I have found two people who had the rapid rest and results were negative that the results s Results sent in from second test came back positive. She prescribed Prednisone which helped. I was sick for over two weeks and still struggling with fatigue, aching , sore throat and shortness of breath.
76 2021-04-16 abdominal discomfort, nausea headache; feeling sick in her stomach.; Nausea; This is a spontaneous report from a contactable fema... Read more
headache; feeling sick in her stomach.; Nausea; This is a spontaneous report from a contactable female consumer reported for herself. A 76-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) at single dose on 13Feb2021 13:50 via an unknown route in left arm for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL0142) on 23Jan2021 at 13:30 injection to left arm for Covid-19 immunization and reported that she did not have any problems with the first dose of the Pfizer-BioNTech COVID-19 Vaccine except for her arm was really sore and heavy the next day (on 24Jan2021 13:50) which lasted about 2-3 days until she recovered completely from event, and flu shot around Sep2020 for immunization. She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm was really sore and heavy, but also reported that she had no history of adverse events or reactions to prior vaccinations. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Family Medical History Relevant to events was none. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient experienced headaches and nausea on 15Feb2021, approximately 2 days after second dose administered. She reported headache lasting more than 7 days. The clinical course was reported as follows: Having headaches off and on, had not been a constant day and night thing. It kind of comes and goes. The past weekend (as of 15Mar2021), on 14Mar2021 it was really bothering her. She took a Tylenol on 14Mar2021 after she got back from church and last night took 2 Benadryl and that seemed to help. That was the first time she has taken Tylenol for events. She had just been letting headache wear itself out. Regarding nausea, it was further described as sick to her stomach. Outcome of Headaches was not resolved. Seriousness for headaches was unspecified. No visit to Emergency Room/Physician Office required, not hospitalized. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected. Follow-Up (13Apr2021): Follow-up attempts are completed. No further information is expected.
76 2021-04-17 indigestion BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous repo... Read more
BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient). A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The outcome of events were recovered. No follow-up attempts are needed. No further information is expected.
76 2021-04-23 nausea Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contac... Read more
Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on the left arm 13Feb2021 at 2:15pm as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. Patient other vaccines within 2 weeks prior to the COVID vaccine included tamsulosin hydrochloride (FLOMAX), ondansetron (ZOFRAN), furosemide, oxycontin and oxycodone. The patient's medical history included bladder issues, celiac disease and allergy (reported as known allergies Yes 17 rxs). On 13Feb2021 at 11pm, the patient started to feel dizzy and nauseous in the evening received shot. The patient reported that the symptoms got progressively more pronounced. It was reported that patient did not receive any treatment for events. The outcome of the events was not resolved.
76 2021-04-24 nausea Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; N... Read more
Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-04-24 nausea Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than mor... Read more
Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than morphine. Was released and sent home to which the pain got so bad when the med wore off that the following morning I was in the ER again. I also had a fever of 102.3 and a rash (red bumps all over my chest, stomach, back of neck and shoulder back area, nausea, chills. this lasted exactly for 5 days and then was gone.
76 2021-04-25 decreased appetite She got her vaccine, started with a headache, severe and then it went to chills, then started with a... Read more
She got her vaccine, started with a headache, severe and then it went to chills, then started with a low grade fever of 99.1. She was cold, shaking, then was tired, joint and muscles aching, and not wanting to move, just wanting to sleep. No appetite. She took a baby aspirin, the headache subsided but returned when the aspirin wore off. She was out of it from Saturday to Sunday morning. The headache was so severe and she took some Tylenol. During the night she sweated so much that everything was drenched. She had to get up and change her clothes again as she was wet from the chills, and urinating a lot possibly due to the water intake. She feels much better than she did yesterday and Saturday but still having headaches, and not wanting the 2nd vaccine. She did have COVID in July of 2020 and hospitalized 3 times during that time-frame. She does not want to experience the same reaction. She has an APT with her PCP coming up in May. She was also diagnosed with the regular flu in January and feels that she has the same symptoms if not worse than what she had experienced in the past. She did have dizziness a lot and had to use her walker to steady herself first.
76 2021-04-25 vomiting This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/202... Read more
This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/2021 and was admitted on 4/13/2021 with hortness of breath, abnormal lab, and returned to ED on 4/16/2021 and admitted on 4/17/2021 with vomiting, elevated troponin, dehydration and returned on 4/23/2021 and admitted on 4/24/2021 with rapid heart rate and acute respiratory failure and died on 4/24/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
76 2021-04-28 nausea, retching On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the na... Read more
On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER . They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.
76 2021-04-28 vomiting she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was ch... Read more
she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.
76 2021-04-29 decreased appetite March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced t... Read more
March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose. I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever. Also my ears felt they were blocked. I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did. I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.
76 2021-04-29 diarrhea Started with loose stools on 2/25/21- 2 days after receiving 2nd dose, has had many blood tests done... Read more
Started with loose stools on 2/25/21- 2 days after receiving 2nd dose, has had many blood tests done, colonoscopy, x-rays & CT scan ordered. Continues with liquid-diarrhea stools
76 2021-04-30 nausea, vomiting, difficulty swallowing 4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting sub... Read more
4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting subsided. 4/15/21 Vertigo, nausea, difficulty swallowing. 4/16/21 Completely unable to swallow. Taken to ER. Upper esophageal sphincter spasm resulting in inability to swallow. 4/27/21 Laryngospasms began intermittently progressing to continuous on 4/28/21 severely compromising ability to breathe. Intubated and placed on ventilator.
76 2021-05-05 nausea Chills for 5 hours, Fever 100.9, Headache, Achy body, Nausea. Still had fever of 99.0 24 hours l... Read more
Chills for 5 hours, Fever 100.9, Headache, Achy body, Nausea. Still had fever of 99.0 24 hours later. This same thing happened with the 1st shot, but not as intense and as long as this 2nd shot.
76 2021-05-06 diarrhea, abdominal pain Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on... Read more
Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21
76 2021-05-07 profuse gastrointestinal bleeding This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 ... Read more
This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 and was admitted on 4/6/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified GI Bleed
76 2021-05-07 nausea She had no pain from the initial shot but then that night she stated she felt horrible, aches and pa... Read more
She had no pain from the initial shot but then that night she stated she felt horrible, aches and pains and her cough worsened. a week later she said that the symptoms were just as bad, she was extremely tired also. Nauseated as well. She did not believe that she had a fever.
76 2021-05-10 nausea Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally... Read more
Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect. No follow-up attempts are needed. No further information is expected.
76 2021-05-11 diarrhea, nausea injection site became red swollen and firm and warm within 24 hours of injection; injection site bec... Read more
injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.
76 2021-05-14 vomiting blood Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She... Read more
Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours.
76 2021-05-21 nausea Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical hi... Read more
Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.
76 2021-05-26 nausea, decreased appetite not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/... Read more
not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
76 2021-05-27 diarrhea 1 week later: Fever 102 several days diahhrea
76 2021-05-28 abdominal discomfort, retching, nausea weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Na... Read more
weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.
76 2021-05-28 abdominal pain upper, loss of appetite very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anyt... Read more
very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anything; mouth was very dry; achy body and lower back/felt aches and pains; achy body and lower back; went through was some kind of flu; it was hard to sleep at first; kids are watching over her, clean up stuff and doing laundry and all that; Arm hurt; discomfort; feet hurt; she could not walk; felt weak/she could not push herself up, her arm and legs would not push her up; more off balance/balance got worse; could not almost stand up; terrible stomach pains at went up and down her stomach; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Apr2021 (lot number: ER8731), as 1st dose, single dose, at age 76 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included a flu shot for immunization and experienced hives after. In the evening of 29Apr2021, when the patient was about to go to bed, she experienced terrible stomach pains at went up and down her stomach. She almost called the ambulance. For the next 14 days (dates unspecified), she was very exhausted, was sleeping a lot/sleeping all the time causing the bottom of her neck area to ache, she was not able to eat anything for 2 days (I would just have 'brock' and cheese and crackers something easy), her mouth was very dry she had to keep hydrating, had an achy body and lower back, felt aches and pains, her feet hurt she could not walk, felt weak which made her more off balance/balance got worse (pending clarification) causing her to use a walker just to be careful. The patient stated that what she went through was some kind of flu which knocked her out, she was sleeping all the time and mentioned that it was hard to sleep at first. At one time (unknown date), as she woke up from her nap, she could not push herself up, her arm and legs would not push her up and had to be assisted by her grandson. The patient could not almost stand up. The patient reported that her kids are watching over her, clean up stuff and doing laundry and all that. The patient also experienced discomfort and her arm hurt on an unspecified date. On 13May2021, she had her first real small meal. She stated that she avoided taking medications until she gave in and took Tylenol for "bottom neck area to ache", "achy body and lower back/felt aches and pains", "feet hurt", "arm hurt", and discomfort. She stated, "I was very happy after getting the shot, I felt very good but after some days I felt like I was going to die here, should I call the ambulance, what going on with my stomach, and that's was shocking for me." The patient asked if what she experienced was normal and if she should get the second dose. The patient was recovering from the events (reported as "she was coming out of it"). Follow-up attempts are needed. Further information is expected.
76 2021-05-28 decreased appetite head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous repor... Read more
head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201; expiration date: unknown), via an unspecified route of administration, administered in left arm on 01Mar2021 11:15 (at the age of 76-year-old) as a single dose for covid-19 immunisation. The vaccine was administered at Public Health facility. The patient had no known allergies. Medical history included controlled high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 08Feb2021 11:15 (at the age of 76-year-old) at a 1st dose, single dose for covid-19 immunisation. Concomitant medications included lisinopril (LISINOPRIL); naproxen sodium (SYNFLEX DS); ascorbic acid, betacarotene, biotin, boron, calcium carbonate, calcium pantothenate, calcium phosphate, chromium picolinate, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, lycopene, magnesium oxide, manganese sulfate, nickel, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium metavanadate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (SENTRY SENIOR). On 01Mar2021 at 08:00 PM, the patient experienced headache, chills, fatigue and weakness. These symptoms lasted through the following day and the majority of the second day. The patient had no appetite but drank water. The morning of the third day the patient was back to normal, no more symptoms. No treatment received for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had any other vaccine in four weeks. The outcome of the events were recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
76 2021-05-29 diarrhea, decreased appetite began with headache and chills during the night and the next day continued headache, chills, tired, ... Read more
began with headache and chills during the night and the next day continued headache, chills, tired, loose stool decreased appetite. The second day after injection was better but not normal and the third, fourth, fifth, and sixth days were mainly headaches with minor chills. The most persistent event has been waking with headaches each morning. Goody's headache powder helped but then they returned. Sixth day just felt tired along with the headache. Normal appetite has not returned.
76 2021-06-03 nausea she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is... Read more
she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-06-03 nausea Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in... Read more
Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in drivers seat, c/o nausea immediately after receiving vaccine. EMS standby staff on scene. Pt stated she had received vaccine approx 30 minutes prior to EMS arrival and began to feel ill <15 minutes later at which time standby EMS crew were alerted and in turn alerted transport. Pt has extensive list of allergies, including many antibiotics. Pt was A&OX4, pink warm and dry w/ good ABCs/PMS upon EMS arrival. Pt had no apparent life threats/injuries, was PEARL, equal lung sounds. Upon being placed in ambulance pt began to complain of dull ex pressure 2/10. 3 lead displayed sinus rhythm w/ PVCs which pt stated was her normal per pt cardiologist and that she was medicated for same with herbal medication.12 lead obtained, no elevation or depression noted, PVCs still noted, otherwise unremarkable. R-IV access attempted x2, good flash vein blew. 3 and 12 lead obtained to rule out cardiac involvement and monitor for changes. Given reference pt statement of positive ex pressure. Zofran considered, Medic was already at hospital when last IV was unsuccessful, PO zofran not given. No further interventions. Pt moved to stairchair via stand and pivot with assistance, secured via straps and moved to stretcher, pt placed in stretcher via stand and pivot with assitance, covered for comfort, secured via straps/siderails and moved to ambulance without incident. Pt and pt vitals monitored for duration of routine transport. Pt report called for prior to arrival. Upon arrival pt offloaded and moved to bed in ER via sheet draw without assistance. Pt care report given and pt care transferred to ER RN. Medic checked back in service. 76-year-old presenting with nausea and general malaise. Symptoms started about 15 minutes after receiving her COVID-19 vaccine around 2:30 PM. She has been nauseous but had no vomiting. Slight central chest discomfort with palpitations. Also feeling somewhat dizzy. She did not receive any medications. EMS was called and brought her to the ED. Denies any itchy skin, abdominal discomfort, sensation of throat swelling or pain. No wheezing or difficulty breathing. She has had anaphylaxis to medications in the past but she is unsure exactly which ones except for codeine. 76-year-old presenting with possible reaction to the Pfizer COVID-19 vaccine. Constellation of symptoms are not consistent with anaphylaxis but may represent a different type of allergic reaction. Will give Zofran for nausea, Benadryl, and observe. Basic labs and EKG. KG My interpretation of EKG Normal sinus rhythm. Normal axis and intervals. No acute ST elevations or depressions. Reexamination/Reevaluation Patient was observed for over an hour without any progression of symptoms. Her nausea improved with Zofran. No episodes of vomiting in the ED. Discharged with plan to follow-up with her PCP, continue symptom management at home. Diagnosis/Disposition Nausea without vomiting atient Instructions Continue your regular medications as prescribed. Use Zofran 4 mg every 8 hours as needed for nausea. Follow-up with your doctor within the next 1 to 2 days for recheck. Return to the ED if you develop severe difficulty breathing, severe chest pain, intractable nausea and vomiting or have other concerns. RX Given ondansetron: 1 tab, PO/SL, TID, nausea/vomiting, # 10 tab, 0 Refil(s)
76 2021-06-07 hunger She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a ... Read more
She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-08 nausea Patient developed chills, fatigue, nausea, and a generalized rash (inflammed and red).
76 2021-06-09 vomiting Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 t... Read more
Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge
76 2021-06-14 nausea A few days after I got the shot I started having night sweats, nausea. The night sweats went away un... Read more
A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.
76 2021-06-16 abdominal pain upper Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering ... Read more
Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. The patient has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.
76 2021-06-24 flatulence It was the worst last Friday night/ feels it in both breasts. It is getting worse; had subtle gas pa... Read more
It was the worst last Friday night/ feels it in both breasts. It is getting worse; had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder/ feels like the gallbladder pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 07:30 (at the age of 76 year) as single dose for covid-19 immunisation at hospital. Medical history included ongoing Atrial fibrillation, thyroid problem and asthma. Patient had gallbladder concerns from twenty years ago. Gallbladder removed years ago. Patient's family history includes heart problems and diabetes. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, digoxin (DIGOXIN) taken for atrial fibrillation, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, levothyroxine sodium (SYNTHROID) taken for thyroid disorder, metoprolol tartrate (METOPROLOL TARTRATE) taken for atrial fibrillation, prednisone (PREDNISONE) taken for asthma and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing and Potassium. Patient was not received any other vaccine prior four weeks of vaccination. She states two weeks ago on Friday she got her first dose vaccine COVID 19 vaccine on 22Jan2021 0730 AM in the left arm. Reports a week later on 29Jan2021 she had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder too. She added it feels like gas pains and it feels like the gallbladder pain she had when she had her gallbladder removed years ago. She added did not feel it every day It was the worst last Friday night. And she also feels it in both breasts It is getting worse. States she didn't have this until she got the shot, she was going to call her doctor, but she thought Pfizer would have more information about other people reporting this. She was scheduled to receive the second dose on 17Feb2021 at 07:00AM. Seriousness reported as non-serious by reporter. The outcome of the events was reported as not resolved and unknown for It was the worst last Friday night/ feels it in both breasts. It was getting worse. Follow-up attempts are completed. No further information is expected.
76 2021-06-24 nausea She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this ... Read more
She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this weekend; Memory issues; Confusion; Weakness in her legs; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Nausea; Not feeling right, very tired; Not feeling right, very tired; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 16:30 (Batch/Lot number was not reported) (at the age of 76-year-old) as single for covid-19 immunisation. The patient medical history included digestive system, blood thinner, acid, high blood pressure, diverticulitis she went into the hospital in 12Nov2020 or 13Nov2020 for an emergency for diverticulitis and then while she was there, she was sleeping and when she woke up, she had atrial fibrillation. They did the electric shock to get her heart back without sedation and that had an effect on her. Mentions she had another episode of atrial fibrillation about three years before, but it went back on its own. She was also diagnosed with diabetes mellitus at this hospitalization on an unknown date in 2020. Concomitant medications included famotidine for acid at 40mg twice a day via oral, lisinopril at 5 mg via oral for twice a day taken for high blood pressure, metformin at 500 mg daily via oral taken for diabetes mellitus, metoprolol at 25 mg daily via oral taken for blood pressure measurement, lactobacillus acidophilus (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]) daily (expiration date: Jul2022, Lot number: WHD204) for digestive system, rivaroxaban (XARELTO) since on an unknown date at 220 mg daily via oral taken for blood thinner. The vaccination facility was a medical centre. The vaccine was not administered at (name) facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect product. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient states she just wanted to report an experience after the vaccine. On 27Jan2021 (Wednesday) she went to the place for vaccination. It went very smoothly, and she didn't feel anything. The patient mentioned that she thought maybe it was her medicine and stopped taking her over the counter probiotic. The patient had problems, so she stopped this a couple of days before for the over-the-counter probiotic she stopped. On an unspecified date, in hindsight she thought some of the effects she was experiencing might be related to the vaccine. She was not sure if she was allergic to her usual medications or not. On 28Jan2021, the patient reports she had a lot of nausea; and not feeling right as in very tired. She didn't connect it to the vaccine. She thought maybe it was her medicine and stopped taking her over the counter probiotic. On 31Jan2021, she reported that weakness in her legs, pain in the back of her head, neck and above the ear and up to her skull. On 01Feb2021, she had worst memory issues and confusion. On an unknown date, she stated that she had had a lot of trouble with confusion doing her check book and questioning things that she did not do usually, and she also has dizziness and feeling like pitching forward like vertigo. On an unspecified date, the patient reported dizziness got much worse this weekend. She was supposed to get the next dose on 17Feb2021. The patient visited physician office. The outcome of the events the dizziness got much worse this weekend, she is pitching forward like vertigo was unknown. The outcome of the events pain in the back of her head, neck and above the ear and up to her skull was resolving whereas other events was not resolved. Follow-up attempts are completed. No further information is expected.
76 2021-06-29 abdominal discomfort felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report... Read more
felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered. Follow-up attempts completed. No further information expected.
76 2021-06-29 abdominal discomfort Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; This is a spontaneous report from... Read more
Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products that included sulphur drugs. Concomitant medications included Tylenol started on unknown date within 2 weeks of vaccination for unknown indication. The patient previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 27Feb2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine which are not specified. The patient experienced chills, muscle and joint aches, upset stomach and tiredness on 21Mar2021. The patient did not receive any treatment for events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events chills, muscle and joint aches, upset stomach and tiredness were not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
76 2021-06-30 vomiting secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse ... Read more
secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30
76 2021-07-05 vomiting, diarrhea diarrhea and throwing up after breakfast/ antimodium
76 2021-07-07 frequent bowel movements, flatulence, vomiting, nausea My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I h... Read more
My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I had swollen glands under my jaw. 1)The morning after the shot I awoke to severe nausea and vomiting and had to get prescription anti-nausea meds. 2) A few days later my bowels went wild with lots of rumbling and gas and frequent bowel movements. 3) The swollen glands in my jaw cycled between getting better and then worse, and I had and bouts of feeling unwell and fatigued. I went from sleeping 7-8 hours per night before the vaccine to sleeping 9-10 hours a night. Some days I was fine. Then I would have a bad day. One day I was fine in the morning then crashed after noon -- like when I had mononucleosis at 17.
76 2021-07-13 diarrhea tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable con... Read more
tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
76 2021-07-17 diarrhea, nausea Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; ... Read more
Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.
76 2021-07-17 nausea Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 da... Read more
Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected
76 2021-07-19 abdominal pain upper, nausea, vomiting headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new bli... Read more
headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
76 2021-07-23 indigestion, nausea, diarrhea Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, Diarrhea, Heart Burn. Heartburn. Diarrhea beginning Sat... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, Diarrhea, Heart Burn. Heartburn. Diarrhea beginning Saturday, July 24 around 6:30 AM.
77 2021-01-20 decreased appetite sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (... Read more
sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (enough to go to bed), stayed in bed all afternoon, got up for dinner (couldn't eat normal amount) and went back to bed and slept all night. Woke up ok on January 21 but still have light fatigue.
77 2021-01-22 diarrhea 10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have ... Read more
10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have a BM, arriving home had diarrhea then tremors of both hands, fast heart, and extreme tiredness
77 2021-01-24 diarrhea, nausea About 20 minutes after the injection I started to feel like I was going to vomit, got nauseated and ... Read more
About 20 minutes after the injection I started to feel like I was going to vomit, got nauseated and dizzy.. I had left the site after the 15 minute wait, and since I read that Nausea was one of the side effects, I thought it would go away. I waited another 30 minutes in my car at a parking lot outside the hospital in case I really couldn't drive home. I did drive home , but have been feeling the same nausea every day and some dizziness and diarrhea for the past 11 days. I called my doctor and she said to take it easy, drink fluids, eat light and that I could get the second shot. I am not sure if this is just a reaction or a severe allergic reaction and I need advice and feedback on that issue.
77 2021-01-24 nausea, vomiting Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shakin... Read more
Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shaking for 12 hours. Urine is now colorless instead of yellow-orange. I have had no treatment. Urine remains colorless, but other symptoms are almost resolved.
77 2021-01-25 abdominal pain upper epigastric pain 4/10 with elevated blood pressure 170/72, HR 75
77 2021-01-25 diarrhea admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Dia... Read more
admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21
77 2021-01-26 difficulty swallowing tightness in throat, chest discomfort, felt throat was closing off, difficulty swallowing
77 2021-01-26 difficulty swallowing Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the mor... Read more
Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...
77 2021-01-28 nausea Nausea, achy body pain and shoulder site
77 2021-01-29 diarrhea, nausea Dizziness, Chills, Diarrhea Nausea Weakness, Tiredness
77 2021-01-31 nausea 10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; moni... Read more
10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; monitoring sats & b/p. 1103 - Nausea - gone! good V/S. Stayed with patient, V/S equalized and pt slowly got better.
77 2021-02-03 diarrhea, abdominal discomfort Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach w... Read more
Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.
77 2021-02-03 diarrhea Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant 77-... Read more
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: CO87750), via an unspecified route of administration, in the left arm on 20Jan2021 at 10:45 AM (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included ongoing arthritis, congestive heart failure, open heart surgery in 2010. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced diarrhea. The patient reported "this morning" she had diarrhea. She had it again within the hour. The clinical outcome of diarrhea was not recovered.
77 2021-02-03 nausea, diarrhea, vomiting About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was goin... Read more
About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; then I felt dizzy; About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; diarrhea; This is a spontaneous report from a contactable consumer (patient) A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL324) on 14Jan2021 at 10:00 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included GERD, disc disease, meningioma, diverticulitis, panic attack and allergy to Macrodantin, Levaquin and Bactrim. Concomitant medications included metoprolol, atorvastatin, omeprazole and alprazolam. On 14Jan2021 about 20 minutes after the vaccine was administered patient felt a wave of nausea and felt like she was going to vomit, then she felt dizzy. Patient waited another 30 minutes before driving home hoping it would subside. Patient informed she have been nauseated, dizzy and had diarrhea on and off for 9 days. She didn't called her doctor yet or notified anyone at the site hoping it would pass, as she knew that nausea was one of the side effects. The patient was not treated for the events. At the time of the reporting the patient had not yet recovered from the event.
77 2021-02-03 nausea Patient immediately felt dizzy, lightheaded, faint after received vaccine, also experienced nausea. ... Read more
Patient immediately felt dizzy, lightheaded, faint after received vaccine, also experienced nausea. Monitored for approx 1 hr until patient felt better/ "back to normal." Vitals signs remained stable and SaO2 WNL throughout observation period. Patient was transported in w/c from waiting area to observation bay and laid on gurney, bottle of water provided, snacks provided. Pt remained A&O throughout observation period. Husband present.
77 2021-02-03 nausea Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4t... Read more
Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.
77 2021-02-03 vomiting, diarrhea Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours fol... Read more
Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours following vaccination; This is a spontaneous report from a contactable consumer (patient reported for herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration at the left arm on 20Jan2021 at 16:00 (04:00 PM) at single dose for Covid-19 immunization, administered in a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included prior malignancy s/p chemo and targeted therapy (last dose approximately 3 years ago). The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe vomiting and diarrhea 2 hours following vaccination on 20Jan2021 at 18:30 (06:30 PM). Therapeutic measures were taken as a result of the events which included ondansetron, oral fluids, and lorazepam. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
77 2021-02-04 decreased appetite Flu like symptoms, chest heaviness, anorexia, cough...symptoms have resolved as of 1/29/21
77 2021-02-07 nausea, diarrhea Nausea and diarrhea.
77 2021-02-07 nausea sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fin... Read more
sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fine 24 hrs later
77 2021-02-09 abdominal discomfort Upset stomach; This is a spontaneous report from a contactable consumer(patient). A 77-year-old fema... Read more
Upset stomach; This is a spontaneous report from a contactable consumer(patient). A 77-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 25Jan2021 at single dose, left arm for covid-19 immunization. Medical history included hysterectomy from 1993, breast cancer from 28Feb1988 to an unknown date, she had three stents put in on 07Jan2021. Additional Information for Other Conditions reported as they did a mastectomy and had had a prosthesis for 30 years; they took out 18 lymph nodes and still suffers from her right arm being; she had right breast cancer. She shrunk before the vaccine. She had a hysterectomy and breast cancer and could not take any hormones. She guessed that was the reason why she shrunk. She was 5'3" or 5'4" and used to be 5'6". The patient's concomitant medications were not reported. The patient took the shot this morning(25Jan2021). She had an upset stomach on 25Jan2021. She messed her pants. She had three stents put in on the 07Jan2021. This was prior to the vaccine. She ate potato soup a little while before. This was her first dose. Treatment reported as none. The outcome of the event was unknown.
77 2021-02-09 difficulty swallowing "I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinki... Read more
"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN
77 2021-02-09 nausea By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally s... Read more
By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally sick. I felt tired, headachy, nauseous. I rested and felt worse and worse. I soon began chilling -- couldn't get warm. After a couple hours, I took my temp and it registered 101.1. I went to bed feeling quite unwell. When I awoke the next morning, I felt pretty good and felt fine all the next day.
77 2021-02-10 decreased appetite, nausea dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection... Read more
dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.
77 2021-02-10 vomiting, nausea chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, j... Read more
chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.
77 2021-02-12 diarrhea One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place.... Read more
One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.
77 2021-02-13 decreased appetite Maybe this is not what is qualified as "adverse", but i have not been able to get out of bed, eat, ... Read more
Maybe this is not what is qualified as "adverse", but i have not been able to get out of bed, eat, or do anything but sleep for 2 days. Runny nose and stuffed up sinuses, low grade temp not above 100.5. Muscle aches It is now almost 6 pm Sunday. I think I can eat some soup now. Temp is gone I think I'm recovering.
77 2021-02-13 nausea 02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, m... Read more
02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, my eyes seem to have new floaters, and I felt strange in my head. 10:00pm the symptoms continued, but when I got in bed I had terrible nauseau so bad that I couldn't sleep. The next morning my symptoms continued but did not worsen, and then I got so dizzy that I was stumbling. This all continued for three days. On 02/09/21 my symptoms subsided, and I felt normal again
77 2021-02-13 vomiting, diarrhea Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms las... Read more
Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms lasted for 24 hours and then I was feeling bad and in bed for 3 days. I took Tylenol for symptoms. I called my doctor and was advised to take Tylenol.
77 2021-02-16 diarrhea Diarrhea , fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14
77 2021-02-17 nausea, vomiting Fever, splitting headache, nausea, vomiting
77 2021-02-17 nausea Severe flu-like symptoms--headache, achy body, queasy stomach, extreme fatigue lasting for two days... Read more
Severe flu-like symptoms--headache, achy body, queasy stomach, extreme fatigue lasting for two days keeping patient bedfast.
77 2021-02-17 nausea Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine... Read more
Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine, Metachlopramide in ER. Persistent sxs of virtigo, decrease hearing, nausea resolving over several days treated with meclizine, ativan, phenergan, Virtigo improved but still persisting when moving quickly or looking up or down Left frontal discomfort and sinus congestion; hearing returned to near baseline after 10d Steroid 5d dose pack and Augmentin started 2/13 Still unsteady (untrustworthy gait), excess fatigue and fatigability, wt loss, head pain Has not had fever
77 2021-02-17 vomiting, nausea, diarrhea This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patien... Read more
This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 28Jan2021 13:30 at a single dose for covid-19 immunization. Medical history included diabetes type 2 and neuropathy (reported as neuropothy). The patient experienced Upper and middle back severe pain, nausea, vomiting, diarrhea; all on 01Feb2021 04:00 AM. The outcome of the events was unknown. Information on the lot/batch number has been requested.
77 2021-02-20 nausea, abdominal pain, abdominal pain upper, vomiting RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF... Read more
RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA AND VOMITING. DAIGNOSED WITH EPIGASTRIC ABDOMINAL PAIN, ATYPICAL CHEST PAIN, URINARY TRACT INFECTION WITH OUT HEMATURIA, AND HIATAL HERNIA. DISCHARGED HOME WITH INSTRUCTIONS FOR FOLLOW UP APPOINTMNET WITH PCP, GI, GENERAL SURGERY, AND CARDIOLOGY.
77 2021-02-21 nausea, vomiting, abdominal pain started having nausea, vomiting, abdominal pain after 2nd vaccine. Went to urgent care, then sent t... Read more
started having nausea, vomiting, abdominal pain after 2nd vaccine. Went to urgent care, then sent to ER and admitted to hospital on 2/22/21
77 2021-02-22 difficulty swallowing Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching... Read more
Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.
77 2021-02-23 abdominal discomfort 2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last unti... Read more
2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication
77 2021-02-23 nausea, diarrhea, vomiting Severe Diarrhea, vomiting, nausea, Severe weakness, Chills. Put on Ondansetron, the BRAT diet, and ... Read more
Severe Diarrhea, vomiting, nausea, Severe weakness, Chills. Put on Ondansetron, the BRAT diet, and Pedialyte. Vomiting lasted 2 days, Nausea lasted 5 days, Diarrhea lasted off and on for 14 days, weakness lessened by lasted for 12 days, chills lasted for 14 days
77 2021-02-23 nausea At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken t... Read more
At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis. Had slight nausea, shakiness, weakness, little dizzy, headache. Treatment: observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour. Considered going to ER but continued to feel better as time passed and went home. BP was at 167/66 when leaving. Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63. 2/22/2021 BP 123/66/61. Continue to have headaches.
77 2021-02-24 diarrhea, vomiting, nausea Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diar... Read more
Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diarrhea. She started getting ill after receiving her second dose of the Pfizer Covid vaccine. Admitted to hospital for 2 day stay.
77 2021-02-26 nausea Shaking, chills, fever (101), headache, slight nausea, arm pain. Took Tylenol. Night sweat the f... Read more
Shaking, chills, fever (101), headache, slight nausea, arm pain. Took Tylenol. Night sweat the following night. Event lasted 24 hours. Fine the following day, 2/27/21.
77 2021-02-27 nausea chills, nausea,metallic taste, half an hour after shot felt sick and had chills bad taste in mouth. ... Read more
chills, nausea,metallic taste, half an hour after shot felt sick and had chills bad taste in mouth. lasted that day and next day. felt fine after that
77 2021-02-28 vomiting Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up bla... Read more
Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up black liquid. Could not take care of self for 2 and one-half days. Very weak for 4 days. I was sick with the 1st vaccine for a day one-half with chills and fever but nothing compared to the 2nd one. I will not taken another Pfizer vaccine ever.
77 2021-03-02 diarrhea She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is hav... Read more
She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is having chills occasionally; She feels totally exhausted; she has felt so stupid; she doesn't feel well enough; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 27Jan2021 13:50 at single dose for COVID-19 immunization. The patient received the vaccine due to her age and she was due for it. Medical history included fractured ankle. Pateint's height was five two and shrinking. She is on (networking site) with people she went to high school with and they are all getting the shot at same time because of their age. They were all saying they have had no side effects and no symptoms. There were no concomitant medications. The patient read the information they gave her after the shot. Now, she knows why she has felt so stupid. It was all the stuff on the list. On 28Jan2021 about 19:00, she had a day and a half of diarrhea and she was having chills occasionally. On 28Jan2021, she felt totally exhausted. A little bit of everything. She was not nauseous. On 29Jan2021, she has been able to eat, but nothing tasted that great. Even when her son got her what she wanted it still did not taste great. She is coming off a fractured ankle and she is going to have cancel therapy because she doesn't feel well enough to do that. She got the first vaccine on 27Jan2021. It will be a week on Wednesday. On Thursday and Friday she had diarrhea. Serious quantity of Pepto Bismol kept that at bay. The exhaustion has only improved a little. It was good for her to get up and move. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event diarrhea was recovered on 29Jan2021; events chills and exhausted was recovering; event 'she has been able to eat, but nothing taste that great' was not recovered; and unknown outcome for the other events.
77 2021-03-02 nausea Patient developed h/a 8/10right after injection he was observed and felt nauseous. ER MD came and sa... Read more
Patient developed h/a 8/10right after injection he was observed and felt nauseous. ER MD came and saw patient x2 patient allowed to go home. H/A better he stayed 1.5hours. he was transported by wheelchair to vehicle
77 2021-03-02 nausea became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under w... Read more
became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.
77 2021-03-02 nausea dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anast... Read more
dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anastrozole; breast cancer stage 1/taking anastrozole; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ELV5318, expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included stage 3 kidney disease, breast cancer stage 1 and blood pressure abnormal (reported as 'blood pressure') all from an unknown date and all ongoing. Concomitant medication included anastrozole (manufacturer unknown) for breast cancer, levothyroxine (manufacturer unknown) for kidney disease and amlodipine (manufacturer unknown) for blood pressure. The patient has breast cancer stage 1 and was taking anastrozole. The patient got the vaccine on 30Jan2021 and did not have any side effects 22 hours later, on the day of the report, 31Jan2021. The patient was grocery shopping and became very dizzy and thought she has to keep this together. The patient then just broke out into a sweat and managed to get herself home. She was feeling a little nauseous and she got the chills and then it (unspecified) was pretty much over in about 2-3 hours. The patient was scheduled for the second dose on 20Feb2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.
77 2021-03-02 vomiting, nausea Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital ... Read more
Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days
77 2021-03-02 vomiting walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very ... Read more
walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.
77 2021-03-03 nausea they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a m... Read more
they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.
77 2021-03-04 abdominal pain upper Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generali... Read more
Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.
77 2021-03-07 nausea injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills... Read more
injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
77 2021-03-08 abdominal pain upper, diarrhea, nausea ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her ... Read more
ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems
77 2021-03-10 decreased appetite The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did d... Read more
The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did drink and slept a lot, also extreme fatigue, headache. Neck and up the back of head was very painful. Had muscle pain throughout. Feels really good today.
77 2021-03-10 decreased appetite Bedridden for 11 days with pain, headache, chills, loss of appetite, Extreme fatigue, Raynaud?s. Bl... Read more
Bedridden for 11 days with pain, headache, chills, loss of appetite, Extreme fatigue, Raynaud?s. Blood test on 12th day revealed high sed rate and abnormally high platelets ( twice normal)
77 2021-03-10 diarrhea Fever and diarrhea since 3/4. Tested positive for COVID on 3/7 and was admitted as an inpatient.
77 2021-03-11 profuse anal bleeding On 3/11/2021 the patient presented to the ED for rectal bleeding after a bowel movement and rectal p... Read more
On 3/11/2021 the patient presented to the ED for rectal bleeding after a bowel movement and rectal pain. The patient had apparent external hemorrhoids. The patient denied diarrhea.
77 2021-03-14 diarrhea, vomiting Diarrhea and extreme vomiting
77 2021-03-14 nausea dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a... Read more
dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events. No follow-up attempts are possible. No further information was provided.
77 2021-03-15 nausea Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pa... Read more
Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pain radiating to base of skull and shoulders. Fatigue. Chills. Nausea. Headache. Had repeat PCR Covid test at facility. Negative. Naproxen for approx 10 days of no benefit. Heel pain, shoulder/neck pain, fatigue, chills, nausea and headache continued. Saw FNP BC March 8, 2021. Symptoms continued through March 16.
77 2021-03-16 abdominal pain upper Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report fr... Read more
Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine; lot number: EL9269; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration on 07Feb2021 at a single dose for covid-19 immunisation. Medical history included prediabetes and slight blood pressure or something (blood pressure abnormal). Concomitant medication included hydrochlorothiazide and unspecified medication (reported as she takes all kind of medications), all on an unspecified dates and indication. The patient received her first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter inquired for his wife because her body now. They had the second shot on 07Feb2021 (Sunday) and he wonder how many days it takes after the shot to have side effects. She has rash all over her body her back and front on Feb2021 so he wonders if the shot could cause that. They had the vaccine given to them in a hospital. The reporter mentioned that she just a blood test (unknown results) on the 8th Monday (08Feb2021). She went to the ER (emergency room) in the same hospital. They did the whole work/lab work (unknown results) because she had some pain in her stomach on Feb2021. The outcome of the events was unknown.
77 2021-03-17 constipation Constipation Shortness of Breath Death
77 2021-03-17 gastrointestinal pain, abdominal distension One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The ne... Read more
One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.
77 2021-03-17 nausea On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body... Read more
On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.
77 2021-03-17 nausea Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly ... Read more
Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly hypertensive. No EMS report was filed. The patient did proceed to Emergency Department for follow-up. In the ED, the patient was hypertensive (153/69) and stated they continued to be nauseous. The physician administered 4mg IV Odansetron and 1L IV saline. Labs were unremarkable. The patient reported feeling improved after treatment and was discharged with a diagnosis of Side effect of vaccination.
77 2021-03-18 diarrhea Woke up to go to bathroom about 3:50 am and couldn't get out of bed. I was completely off balance.... Read more
Woke up to go to bathroom about 3:50 am and couldn't get out of bed. I was completely off balance. I tried to walk and couldn't. Sat down again but had to do so I hung on to the bed, walls, and doors to steady myself to get to bathroom. Had a little diarrhea. Managed to take 2 Tylenol and drank lots of water. I held on to everything again and got back to bed but sat up instead of laying down. I still had diarrhea so I held on to every thing again and took one Anti-Diarrhea pill. Went back to bed sitting up and tried to sleep. Got up around 8 am and felt better but still a little woozy.
77 2021-03-19 diarrhea March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like ... Read more
March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like a faucet turned on ? running down my face. March 13 - Saturday morning, I started coughing c chest congestion, and had Phlegm rattling in my chest, started sneezing very frequently/ some diarrhea. Otherwise, I felt fine. March 14 - Sunday morning, I started wheezing slightly, coughing more and sneezing frequently. Felt fine. Went shopping. Nose ran so much in store, had to run to the store to get paper towels to catch it. Later, when I carried a heavy bag of groceries from one car 12 feet to another, noticed I was very exhausted and had to rest about 15 minutes before driving home. Wheezing more. Monday, March 15, I took my B/P meds at 1:00am and my blood pressure was way up x 4 (160?s/ 70?s) p58-64, at 2:08am ? B/P was 183/92) so I took my PRN Clonidine and ate all the high Potassium foods I had in the house. By 3:40am my B/P was 120/66 but went back up later with coughing. I felt fine but tired. A little after 4am, I carried a bag of apples and a bag of oranges up my stairs and was totally exhausted ? I felt the energy draining out of me, and so was out of breath I dropped the bags on the floor and sat hyperventilating to get enough air in my lungs until I could breathe normally ? for 40 minutes - it felt like fluid building in my lungs. I started massaging my abdomen like crazy and coughing until it subsided ? considering whether I should go to E.R. My breathing did get some better But I sure did not exert myself. Just picking up my computer was taking my energy. Still coughing and getting rid of some phlegm. This was very scary and I was on the verge of going to the E.R. at 4:45am - I called the E.R. who said I probably could wait for a urgent care to open or talk to Dr.?s office. My breathing was some better. By 6:10am I was so tired I fell asleep. At 10am my B/P was 138/77 p53. Still very weak, coughing, wheezing, and trying to get rid of phlegm. I had no other symptoms. I called my Dr. who got me in a urgent care in her building at 3pm. That evening I started Postural Drainage which helped in getting rid of the phlegm. I have continued that still. March 16 ? I ?chatted? my doctor to let her know all that was going on. She scheduled me to see the Respiratory office in her building on the next day. I was feeling much better ? little nasal dripping, lungs felt better, March 17 ? Wednesday ? went to Respiratory appt but declined treatment because I felt so much better. More energy, better lungs than Tuesday, wheezing gone, less phlegm, still some coughing ? which is okay with me. I think this is a severe enough reaction that I should not have the second dose ? which is known to be more severe than the first.
77 2021-03-20 vomiting, decreased appetite, abdominal discomfort She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and a... Read more
She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.
77 2021-03-21 decreased appetite "Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt st... Read more
"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care
77 2021-03-21 indigestion Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indiges... Read more
Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.
77 2021-03-24 retching, nausea severe pain emanating from injection site; traveled upward over shoulder; continued up right side of... Read more
severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.
77 2021-03-25 decreased appetite, vomiting Vomitting, loss of appetite, very tired and disoriented 3/21/2021. Very low appetite 3/21/2021 - 3/2... Read more
Vomitting, loss of appetite, very tired and disoriented 3/21/2021. Very low appetite 3/21/2021 - 3/26/2021
77 2021-03-29 abdominal discomfort, diarrhea 12 hours after fits vac red blood blister on nose; flattened next day but came back at about 36 hrs.... Read more
12 hours after fits vac red blood blister on nose; flattened next day but came back at about 36 hrs. Chest rash 36 hours after vac and last through night. 12 hrs after 2nd vac stomach upset and lose bowels; 2nd, 3rd and 4th day much fatigue sleeping 14 hours out of 24 hrs; went away after 4th day.
77 2021-03-30 diarrhea had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contact... Read more
had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced diarrhea last night and cramping most of the night. Additional Context included, caller states that she got the COVID vaccination. Caller states that she did not know what she was getting until after she got the injection and this paper they gave her. Caller states that her daughter had called and said that there was clinic, and the lady from the clinic called and scheduled an appointment for the caller. Caller had no other vaccines on the same day as the COVID vaccine. The outcome of the event was unknown. Follow-up nformation on the lot/batch number has been requested.
77 2021-03-31 diarrhea, vomiting vomiting, diarrhea, sinus
77 2021-03-31 diarrhea On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Re... Read more
On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Resolved without treatment.
77 2021-04-01 diarrhea weakness, diarrhea
77 2021-04-09 nausea sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept mos... Read more
sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative. The outcome of events was recovering. No follow up attempts are possible. No further information is expected.
77 2021-04-10 diarrhea Diarrhea for one week.
77 2021-04-15 nausea Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, ... Read more
Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, moderate to light for 4 more days Weakness 5 days Dizzy, foggy condition for 5 days These symptoms were simultaneous for close to a week Not inclined to get booster in 12 months
77 2021-04-16 gastrointestinal pain site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report fr... Read more
site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 10Feb2021 at 11:45(at the age of 77-year-old ) as a single dose for COVID-19 immunization. Patient medical history included asthma, some mild arthritis, osteopenia. Concomitant medications included Mometasone Furoate(ASMANEX) (MANUFACTURER UNKNOWN), Esomeprazole sodium (NEXIUM) (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), (FLUTICASONE), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, on the 2nd and 3rd day, the patient experienced site pain, tiredness, headache. On the 6th day, the patient experienced chills without fever, tiredness, unwell/sourgut, headache. The outcome of the events was Recovered on an unknown date.
77 2021-04-17 frequent bowel movements, blood in stool Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have ... Read more
Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.
77 2021-04-17 nausea she and they thought she was having a heart attack; she must have passed out because she didn't reme... Read more
she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.
77 2021-04-24 diarrhea 3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine ... Read more
3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21
77 2021-04-24 nausea Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Te... Read more
Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown. No follow-up attempts are possible; No further information is expected.
77 2021-04-25 profuse gastrointestinal bleeding gi bleed, anemia, bilateral interstitial pneumonia with scars
77 2021-04-29 diarrhea Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was ... Read more
Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.
77 2021-05-01 difficulty swallowing 4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swo... Read more
4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swollen lympth node on the left side of jaw. MD stated there was an infection and prescribed Augmentin for 14 days. 4/23/21: back to fast med. Still has no healed and was prescribed Doxycycline for `14 days 4/26/21: Patient developed a vaginal itch and raw legs * Stated had a headache during this whole duration
77 2021-05-04 nausea Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontan... Read more
Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.
77 2021-05-07 abdominal discomfort abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous rep... Read more
abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 08:30 (Lot Number: EL9265) at single dose for COVID-19 immunization. Medical history included hypertension and irritable bowel syndrome (IBS), Shellfish allergy. Patient didn't have COVID prior vaccination. Concomitant medications included metoprolol succinate ER 25mg taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. After the shot on 01Feb2021, there was abdominal discomfort within 15 minutes. 3 itchy bumps also appeared in the left breast area. No treatment was received for the events. The outcome of the events was not recovered. COVID was not tested post vaccination.
77 2021-05-10 abdominal distension Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotch... Read more
Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-05-12 nausea Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdome... Read more
Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdomena nd chest
77 2021-05-13 nausea headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Di... Read more
headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Dizzy; This is a spontaneous report was received from a contactable consumer or other non hcp. A 77-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergy to gluten. Concomitant medications included vitamin b complex (vitamin b), zinc (zinc), vitamin c [ascorbic acid] (vitamin c [ascorbic acid]), colecalciferol (vitamin d [colecalciferol]), bifidobacterium lactis (Probiotic [bifidobacterium lactis]). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. Follow up attempts are completed. No further information is expected.
77 2021-05-14 nausea Extremely sleepy; nausea; headaches; This is a spontaneous report from a contactable consumer. This ... Read more
Extremely sleepy; nausea; headaches; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EN6201) as SINGLE D0SE for covid-19 immunisation. Medical history included diabetes mellitus, rheumatoid arthritis, pulmonary hypertension, fibromyalgia, dermatitis contact, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication; macitentan (MACITENTAN) taken for an unspecified indication; rosuvastatin calcium (ROSUVAS) taken for an unspecified indication, start and stop date were not reported. The patient previously took betadine [povidone-iodine] and experienced drug hypersensitivity, spironolactone and experienced drug hypersensitivity. On 08Feb2021 15:00 the patient experienced extremely sleepy, nausea, headaches. Extremely sleepy into the 3rd week now. Sleep night and day naps. Used 5 night hours, no day naps. 3rd week. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.
77 2021-05-17 diarrhea Severe diarrhea after the vaccine on day 1 and day 2 following administration. Felt better on day 3.... Read more
Severe diarrhea after the vaccine on day 1 and day 2 following administration. Felt better on day 3.; This is a spontaneous report from a contactable consumer (other-HCP). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 12Feb2021 12:45 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 21Jan2021 10:00 as 1st single dose (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included AFib. The concomitant medication included rivaroxaban (XARELTO). The vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive prior COVID-19 vaccination. Patient was not tested for COVID-19 post vaccination. On 13Feb2021, patient experienced severe diarrhea after the vaccine on day 1 and day 2 following administration and felt better on day 3. Patient was not given any treatment for the adverse event. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
77 2021-05-17 nausea feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up... Read more
feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.
77 2021-05-18 diarrhea Office Visit 3/27/2021 T, PA-C COVID-19 Dx Cough ? Diarrhea ? Fatigue ? Covid-19 Screening Reason... Read more
Office Visit 3/27/2021 T, PA-C COVID-19 Dx Cough ? Diarrhea ? Fatigue ? Covid-19 Screening Reason for Visit Progress Notes , PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/27/2021 ? ? Signed Cosigned by: MD at 3/28/2021 9:14 AM Expand AllCollapse All MDM Nontoxic-appearing 77-year-old female presents with 5 days of URI symptoms. Rapid Covid testing house was positive. Patient has had 1 dose of Pfizer SARS-CoV-2 vaccine and is due for his second and final in 1 week. Patient was given strict supportive care and isolation instructions. She is to follow-up with her PCP today when she leaves to discuss monoclonal antibody infusion. ED precautions reviewed in detail with patient. 1. COVID-19 was seen today for cough, diarrhea, fatigue and covid-19 screening. Diagnoses and all orders for this visit: COVID-19 - POCT COVID-19 Antigen RN Registered Nurse Progress Notes Signed Encounter Date: 3/30/2021 Signed Hide copied text Hover for details Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions
77 2021-05-19 diarrhea in the last hour that she has had a headache and diarrhea twice; in the last hour that she has had a... Read more
in the last hour that she has had a headache and diarrhea twice; in the last hour that she has had a headache and diarrhea twice; This is a spontaneous report from a contactable consumer (patient) reporting about herself. A 77-year-old female patient (77 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration Date: 2021), via an unspecified route of administration, in left arm on 28Jan2021 at 13:40 as (0.3 ML) single dose for COVID-19 immunisation. The patient's medical history stated that she dropped weight before the vaccine. She usually had diarrhoea that it depended on what she ate. In the last hour following vaccination (28Jan2021, afternoon), the patient experienced a dull headache and diarrhoea twice. She stated that sometimes it was normal to have diarrhoea for her, but she did not know the reason as it started so bad that afternoon. The patient said that she took Pepto-Bismol (unspecified formulation) for her diarrhoea that she normally used to take, as treatment medication. The outcome of the event headache was reported as recovering while the outcome of the event diarrhoea was reported as unknown. Information on the lot/batch number has been requested.
77 2021-05-19 nausea Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consume... Read more
Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 77-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unknown route of administration on 09Mar2021 at 03:00 PM (at the age of 77-years) for COVID-19 immunisation. On 09Mar2021 at unknown time, the patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not provided) via an unknown route of administration for COVID-19 immunisation. Medical history includes osteoarthritis. The patient was allergic to darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient experienced nausea, severe fatigue, vertigo and sore arm on 09Mar2021 at 03:00 PM, which were intense for 24 hours then intermittent for 6 days. No therapeutic measures were taken as a result of these events. On an unknown date, the patient was recovered from the events nausea, severe fatigue, vertigo and sore arm. Information about lot/batch number cannot be obtained. No further information is expected.
77 2021-05-23 nausea, diarrhea She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight... Read more
She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight nausea for a few days and then it stopped. She is having these symptoms again, and is having this for the third time which started a few days ago with the same reactoin, plus muscle weakness, just feeling sick like, crappy feeling.
77 2021-05-26 diarrhea ear feel like they were popping/ears pop when she swallows; Sore throat; Throat was swollen; fever; ... Read more
ear feel like they were popping/ears pop when she swallows; Sore throat; Throat was swollen; fever; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9261, Expiration Date was not reported), via an unspecified route of administration on 25Jan2021 (at the age of 77-year-old) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, breast cancer female (Breast cancer with lymph node removal) from 2012 to an unknown date, lymphadenectomy (Breast cancer with lymph node removal), type 2 diabetes mellitus, blood pressure abnormal. Concomitant medications included metformin hcl (METFORMIN HCL, 500mg) taken for type 2 diabetes mellitus from 2006 and ongoing; simvastatin (SIMVASTATIN, 20mg) taken for blood pressure abnormal from an unspecified start date and ongoing. It was reported that, patient got the Pfizer COVID-19 vaccine on 25Jan2021 and on the next day (26Jan2021), she had a fever (101.1F), diarrhea, and chills. It reminded her of her having COIVD-19 back in Sep2021. She said she took some Tylenol and She put compresses on her forehead and neck, then her temperature went down to 99F. She didn't have chills. She did have diarrhea on Tuesday as well, her temperature remained on 99F and caller had no fever since then but on Wednesday (27Jan2021), She was fine on Wednesday. Then on Thursday, her throat was sore. Her throat was still sore when she swallows. She has not had trouble breathing, her throat was swollen and her ear feel like they were popping. Her ears will pop when she swallows. She said it was uncomfortable. It was just annoying. She checks her temp, pulse, and o2 intake every day. They are good. She heard them say something about 3 when they were talking about the dose. She had COVID back in Sep2020. It was a mild case. She had diarrhea and a temp. That was it. She wasn't sure if she could get it again, or if she could carry it and give it to someone. That was why she decided to get it. She also had breast cancer, and her lymph nodes removed in 2012. She was due for her second shot 16Feb2021. She taught school for 32 years. She has a doctor's appointment tomorrow (04Feb2021) and will have some bloodwork done. She said she monitored her pulse (heart rate was on 70s) and oxygen level (94 or 97) and said they were good. She wanted to know recommendations for the second dose considering this AE. The patient underwent lab tests and procedures which included body temperature was 99 on an unspecified date, body temperature was 101.1 on 26Jan2021 , body temperature was 99 on 27Jan2021, heart rate: 70s/good on an unspecified date (She said she monitored her pulse (heart rate was on 70s/She checks her temp, pulse, and o2 intake every day. They are good) , oxygen saturation: 94or 97/good on an unspecified date (oxygen level (94 or 97) and said they were good/She checks her temp, pulse, and o2 intake every day. They are good), sars-cov-2 test: positive on Sep2020. Therapeutic measures were taken as a result of fever (pyrexia). The case was non serious. The outcome for the event fever was recovered on 27Jan2021, for events chills and diarrhoea was recovered on 26Jan2021, not recovered for events ear feel like they were popping/ears pop when she swallows, Sore throat and unknown for other events. Follow-up attempts are completed. No further information is expected
77 2021-05-26 nausea Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills... Read more
Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21. Seemed to then improve but then became lightheaded and dizzy. Came to emergency room 5/2/21 at 1000. BP stable at 136/69, O2 sat 99% on room air. No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits). Chest Xray was normal. EKG showed atrial fibrillation with rapid ventricular rate in the 150s. She was given IV diltiazem and her heart rate was controlled. She was admitted to the hospital for observation and conversion from IV to PO diltiazem. She declined oral anticoagulation. She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.
77 2021-05-28 nausea tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consume... Read more
tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, nausea and whole body was twitching. The outcome of the events was unknown. This Follow-up is being submitted to notify that lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed. No further information is expected.
77 2021-05-31 profuse gastrointestinal bleeding major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old fema... Read more
major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack. she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown. No further information expected.
77 2021-05-31 nausea she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contact... Read more
she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 77-year-old patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Feb2021 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Jan2021 as 1st dose (at the age of 77-years-old) for COVID-19 immunization. Patient had no other vaccines on the same day as her COVID vaccine. Patient medical history and concomitant medications were not reported. Patient woke up this morning (03Feb2021) with nausea and a real bad headache and wanted to know if she can take Tylenol but she is wondering if it is contraindicated with the product. Patient stated that the first dose did not do anything to her like this second dose has done. Patient further stated that she believes her symptoms are listed on her fact handout sheet as known side effects of the product. Patient lab data and procedures included patient weight as 265 or 270 pounds, she believes she might have gained weight during the pandemic. The outcome of the events was unknown. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 77-year-old female consumer reported that included patient's complete age, description about the adverse event with the onset date.
77 2021-05-31 vomiting, abdominal discomfort, nausea nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spon... Read more
nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
77 2021-06-01 decreased appetite, nausea a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose... Read more
a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
77 2021-06-02 abdominal discomfort, flatulence This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269), via intramuscular route, administered in Arm Left on 09Feb2021 10:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was 77-years-old at the time of vaccination. Time the vaccination was given was 10:30. The patient medical history included diabetes from 2012 to an unknown date, high blood pressure from 2012 to an unknown date and thyroid problems. Family medical history: All of family have high blood pressure and thyroid problems, thyroid surgery on 2012. No concomitant medications prior to Vaccinations (within 4 weeks). On 11Feb2021, Patient reported that she felt that there was lots of gas in her stomach after she had the 1st dose - She described it that there are lots of gases in her stomach and once she goes to the bathroom it suddenly disappears. She never had gas like this. The gas fell down in her stomach all of a sudden. If she has gas, she takes pills or something. This is like more progressive. She doesn't hardly have any irritation in bottom of stomach. She never had it. She would like to know if her stomach problems are a side effect from the vaccine. No relevant test. Events were assessed as non-serious. The outcome of event was not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
77 2021-06-02 diarrhea Slight fever -- 100.9; extremely tired; diarrhea; This is a spontaneous report from a contactable co... Read more
Slight fever -- 100.9; extremely tired; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Pfizer and expiration date: not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 09:45 (at the age of 77 years) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications (No other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and not covid tested post vaccination. No known allergies. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection, Batch/Lot Number: EN6201 and expiration date: not reported), via an unspecified route of administration, administered in arm left on 06Feb2021 09:15 (at the age of 77 years) as single dose for covid-19 immunisation. The patient experienced slight fever - 100.9, was extremely tired and had diarrhea on 28Feb2021 at 06:00. No treatment given for any event. The patient's lab data included fever: 100.9. The Outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.
77 2021-06-09 abdominal pain upper, difficulty swallowing Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; h... Read more
Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; her eyes were red and irritated when she was in for her treatment; Her vision was blurry; white circle around the cornea; difficulty swallowing; exhausting; end of her fingers and toes are still hurting and feel frozen; end of her fingers and toes are still hurting and feel frozen; slow abnormal blink. Very slow blink; Neuropathy felt worse; Neuropathy felt worse; Her eyes were extremely sensitive to light./She couldn't open her eyes; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; Left arm hurting; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Lot number: EN6201), via an unspecified route of administration, administered in arm left on 19Feb2021 09:30 (at the age of 77-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included multiple myeloma from 2017, fibromyalgia, Raynaud's phenomenon, neuropathy all was ongoing; Bone and blood transplant 3 years ago in 2018, pain, sleep disorder, herpes, cancer, dry eyes, and fungus from the pneumonia. Concomitant medications included ongoing gabapentin, started over 3 and a half years ago (unspecified date) for neuropathy; lorazepam for pain and to sleep; ongoing acyclovir for herpes; ongoing omeprazole (PRILOSEC); ongoing fexofenadine hydrochloride (ALLEGRA); ongoing glucosamine; ongoing cyanocobalamin (VIT B12); ongoing daratumumab taken for cancer treatment; ongoing vitamins; MSN (Did not confirm what MSN was), stuff for bones and for her fibromyalgia. The patient previously received the first dose of (BNT162B2, Lot Number: EL9264) administered in left arm on 29Jan2021 09:30 as single dose for COVID-19 immunization. The patient had a reaction to the second vaccine. The patient experienced left arm hurting on 19Feb2021. She did not feel first one at all. The second one hurt. Arm still hurts when gets up in the morning and reaches for something. She can still feel it. Two (2) days after the second vaccine on 21Feb2021, neuropathy felt worse; her eyes were extremely sensitive to light. She sat inside with shutters closed. She was very sensitive to light. She went outside to walk, wore sunglasses and large brimmed hat. At times she had to stop. She couldn't open her eyes. She felt more on her left side. She had to pull the brim down. She was also getting muscle spasms in right arm and under right breast and going across her stomach and in legs at times. It was more in her arm and stomach areas. She was getting in in legs also. Her eyes are still a little sensitive but not bad. Her doctors wanted her to go off her neuropathy medication. They also talked about replacing the Gabapentin with other medications, but it was explained they all have side effects. She had been taking 2 pills and went down to 1 pill. Neuropathy got worse. They did not think the Gabapentin was part of it. Confirmed with caller that neuropathy medication was Gabapentin. They did not think pill had anything to do with it. Caller stated that she had been on it for at least 4 years. She had been afraid to start on something else. She said everything had something. Caller reported that she has been back on 2 pills of Gabapentin for 3 weeks now. On unspecified date, the end of her fingers and toes are still hurting and feel frozen. At her next appointment, she wanted to know if can go on 3 pills and then cut back. She had it for 4 years, but it got worse. This was under control, the neuropathy, and now all of this threw it out of control. Caller stated that everything calmed down about 9 days later. She had problem with her eyes, she did not have to sit inside in the dark. The neuropathy was there but not quite as painful. After going down to 1 pill of Gabapentin, it got worse. In the past she had dry eyes. She went to 3 different doctors and had different eye drops. They mentioned that her blink was not normal. They put plugs in and for about year, her eyes didn't bother her. At her first appointment, she checked her eyes. She ordered permanent plugs for her eyes for her dry eyes. She had slow abnormal blink on 21Feb2021. Very slow blink. It was causing eyes to be dry. They had suspicion that it was Benign Essential Blepharospasm on unspecified date. She wanted her to stop taking the Gabapentin as side effect is loss of muscle. On unspecified date, her eyes were red and irritated when she was in for her treatment. She was having hard time in there. Her next appointment was 19Mar2021. Caller said her first appointment was 09Mar2021 and she put in plugs. Her vision was blurry. PRIVACY felt she definitely had Benign Essential Blepharospasm. She talked to other doctors and it was agreed this is what she had. The only cure for Benign Essential Blepharospasm is these little Botox injections in her eye. Caller stated on 23Mar2021 she went back. Her eyes were getting worse. She had abnormal blinking problems opening and closing her eyes. She injected Botox on top. Her vision was clear and her blink was back to normal. This only lasted for half an hour. At the visit she saw white circle around the cornea. Caller stated the cure didn't work. Next visit was 30Mar2021. Her eyes were getting worse and worse, mainly only the whites of her eyes were showing. She was having trouble keeping her eyes open. Caller said that a few years ago she got up 3 times in the middle of the night and it took a minute or two to get her eyes open. Her fear was that she couldn't get her eyes open. Caller stated that it was exhausting to keep her eyes open. She got medicine drops to keep her eyes open. 06Apr2021 the white circle around her cornea was getting smaller. It was still blurry. It was burning, but it was a pinch better. She had more control over the muscle. The drops were Apraclonidine ophthalmic drops. At this point her eyes were barely open. Mostly saw whites of eyes. Barely color. Caller stated that she started 2 pills of Gabapentin. On 19Apr2021 white around cornea gone. She had blurry days but also clear ones. They ordered MRI (Magnetic resonance imaging). Her blink was still abnormally slow. When she tried to read or watch TV, it strained her eyes. 02May2021 MRI was done. She saw PRIVACY 03May2021 for treatment and he already had MRI results. MRI normal. They talked about Gabapentin and said he did not believe it was that. Caller says she told him that she had gone back on it. She was getting more muscle control. She continued to use ointment that they had given to her. She told her not to drive. She used the ointment twice daily. It was Erythromycin 5mg. She put in in her eyes twice daily. On 07May2021 appointment PRIVACY said vision was 20/30. It was 20/50 when it was bad. The white circle in her eyes was slightly back. Seeing improvement. On 21May2021 was last appointment. PRIVACY checked her vision and it was 20/25. Caller said she was dancing around. She looked so much better. Her blink was more normal. PRIVACY confirmed that all of the problems were from the second dose. Caller stated that her friend knew a scientist that said that if it was from vaccine, it would take at least 3 months to get normal. It is getting more normal, her eyes. She is driving. Once in awhile it gets a little blurry but mostly pretty clear. It is nothing like before. She could only read one line and texting she knew where it was. She mainly sat around with her eyes closed resting them. Her biggest fear was they would close and not open. Treatment for the events slow abnormal blink, Benign Essential Blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea included Eye plugs, Apraclonidine ophthalmic drops, Botox on eyes, Erythromycin Ointment. She had transplant 3 years ago, bone and blood for Multiple Myeloma. Her doctors researched the chemotherapy she had for the transplant to see if it had anything to do with this. Caller than gave more information regarding the transplant. She had pneumonia. She was supposed to have transplant. There was a shadow on her lung. She had CT scan on unspecified date. She had to cancel her transplant. Something was in the lung. They did a biopsy on her lung (unspecified date). During the biopsy, they pulled her arm down hard. That is when the neuropathy started. She had fungus from the pneumonia. It took 3 months to heal the fungus. Cancer was back up higher than the first time. When it was down low enough, she had the transplant. Caller stated that day or two after blood test for Myasthenia Gravis, she had difficulty swallowing. She looked at internet. She thinks it was just nerves and trying to keep her eyes open. It was exhausting. She called a girl to come stay with her and it went away. When she looked at the internet, she got shook up. The events neuropathy felt worse, extremely sensitive to light, slow abnormal blink, benign essential blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea, muscle spasms in right arm and under right breast and going across her stomach and in legs at times resulted in physician office visit. The patient underwent laboratory test which included Blood test for Myasthenia Gravis in 30Mar2021 with negative result, MRI eyes on 02May2021 with normal result. The outcome of the events neuropathy felt worse, slow abnormal blink, Benign Essential Blepharospasm was not recovered; the events left arm hurting, eyes were extremely sensitive to light was recovering; the outcome of white circle around the cornea recovered on 19Apr2021; and the outcome of the remaining events was unknown.
77 2021-06-09 nausea, vomiting weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some diffic... Read more
weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown. Information about batch/lot number has been requested.
77 2021-06-11 diarrhea Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (da... Read more
Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)
77 2021-06-15 vomiting, diarrhea, nausea This is a spontaneous report from contactable consumer reporting for herself. A 77-year-old female p... Read more
This is a spontaneous report from contactable consumer reporting for herself. A 77-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 12Mar2021 at 10:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included COPD, Lupus, Contrast media allergy. The patient received first dose of BNT162B2 (UEN 6201) on 19Feb2021 at 14:00 on left arm. Concomitant medications included metoprolol, prednisone, amlodipine. On 13Mar2021 at 02:00 the patient experienced pyrexia, nausea, vomiting, diarrhea. No Treatment was received for the event. At the time of the reporting the patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.
77 2021-06-16 abdominal discomfort she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also ver... Read more
she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.
77 2021-06-16 diarrhea 2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lo... Read more
2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired
77 2021-06-16 indigestion Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it starte... Read more
Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; she did not get a good night of sleep; exhausted; too I was very aware of my stomach, now feel the tommy again and burning is getting less; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via unspecified route of administration on 25May2021 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. The concomitant medication was not reported. Patient reported that in May2021 after the first dose of the vaccine patient was exhausted for 5 full days, her arm never hurt but she was very aware of her stomach and for 5 days she had to seat still and that finally past. On 10Jun2021 all of the sudden the skin on her left leg started to feel like a had a sunburn, it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn, she tried to put the Aspercreme on it thinking that her take care of this terrible feeling but that did not help it made it worse so she washed it off. This all started off around 9:30 pm last night she finally got in bed around 10 pm. Patient was trying to sleep with her leg outside of the covers because it felt like it needed to be cooled down, she had AC on and fan. "she did not get a good night of sleep because she kept feeling her leg and did not know what else to do for it. "This morning she was very tired of course from last night, very aware of her stomach again which happen along of getting the first shot for those 5 days and she was exhausted and then too she was very aware of her stomach, now feel the tommy again and burning was getting less, but she had no clue was this was something anybody has reported. Patient was highly sensitive to medications. Patient never get any type of immunizations prior to this since she was a child. in a week she will be 78 years old, she was due for her second shot on 15Jun2021.The outcome of the event exhaustion was recovered, stomach burning sensation was recovering and sunburn, burning sensation, tingling sensation, feeling abnormal, sleep disorder was unknown. Information on Lot/Batch number has been requested.
77 2021-06-18 abdominal discomfort, diarrhea Diarrhea; Upset stomach; Low gradefever; This is a spontaneous report from a contactable consumer, t... Read more
Diarrhea; Upset stomach; Low gradefever; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6208), via unspecified route of administration in left arm on 16Mar2021 at 11:45 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), depression and fractured arm and leg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: em9810), via unspecified route of administration and in left arm on 05Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient had no known allergies. Concomitant medications included LIPITOR, gabapentin (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and blood pressure medications (unspecified); all for unknown indications from an unknown date. Prior to vaccination, the patient had no symptoms associated with COVID-19. Since vaccination, the patient was not tested COVID-19 positive. On 16Mar2021 at 15:00, the patient experienced diarrhea, upset stomach and low grade fever. Therapeutic measures were taken as a result of diarrhea, upset stomach and low grade fever and included treatment with IMODIUM AD and TYLENOL from an unknown date. The clinical outcome of diarrhea, upset stomach and low grade fever were not resolved. No follow-up attempts are possible. No further information is available.
77 2021-06-29 diarrhea, abdominal pain upper cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactabl... Read more
cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 08:45 (at the age of 77-year-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, hypertension, restless legs and low thyroid. Concomitant medications included levetiractan (MANUFACTURER UNKNOWN), ropinirole (MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN) and valsartan (MANUFACTURER UNKNOWN) taken within last two weeks of vaccination for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00 AM, the patient experienced chills, aches in joints, cramps in stomach, and diarrhoea. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, aches in joints, cramps in stomach, and diarrhoea was recovering. No follow-up attempts are possible. No further information is expected.
77 2021-06-29 diarrhea Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient... Read more
Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
77 2021-06-29 nausea little nausea; This is a spontaneous report from a contactable Other HCP and contactable consumer (p... Read more
little nausea; This is a spontaneous report from a contactable Other HCP and contactable consumer (patient). A 77-year-old female reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 04Feb2021 (at the age of 77 years), as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experience little nausea. The outcome of the event was unknown. No additional information/details provided. Information on the lot/ batch number has been requested. Follow-up attempts completed. No further information expected
77 2021-07-13 diarrhea Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-o... Read more
Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-07-15 vomiting, abdominal pain upper, nausea Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of ... Read more
Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.
77 2021-07-19 decreased appetite loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a co... Read more
loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patients son). This consumer reported for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) (age at vaccination was reported as 77 years) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number not reported) as single dose for covid-19 immunization. Patient's Medical History including any illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. The patient experienced loss of appetite, loss of taste, headaches, fatigue on an unspecified date. Additional context reported as report that his 78-year-old mother experienced side effects after administration of the fist dose of Pfizer Covid-19 Vaccine. The patient has already gone to the physician for the management of the symptoms. The patient was dosed with first dose of Pfizer Covid-19 Vaccine less than 2 weeks ago but does not have the actual date of administration or the Pfizer Covid-19 Vaccine Lot and things like that. The patient underwent lab tests and procedures which included chest x-ray: not have pneumonia on 09Jul2021. She does not have pneumonia. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested
77 2021-07-21 vomiting, nausea Nausea, vomiting, black tarry stools,
77 2021-07-27 nausea she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her ... Read more
she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her heart started racing; Just didn't feel good; Tired; Felt queasy; Dizziness; blood sugar was low; Sore Left Arm; This is the spontaneous report from a contactable consumer. This 77-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201 and expiry date: 31-May-2021) via an unspecified route of administration on 24-Feb-2021 at 08:15 in left arm (77-year-old), as dose 2, single for COVID-19 immunization. Medical history included of the patient included a dental surgery. When she got up in the morning her face was real puffy and she thought she looked like the Pillsbury dough boy. Both cheeks were swollen. This surgery was to remove a tooth. She stated that she took her premedication before her oral surgeon appointment. She previously had a kidney replacement and a shoulder replacement. She always takes pain meds before she does any dental work. She had blood pressure measurement, depression, knee arthroplasty, shoulder arthroplasty, thyroid atrophy, renal failure, coronary arterial stent insertion, hypothyroidism and steroid therapy. Concomitant medications of the patient included sertraline taken for antidepressant therapy, levothyroxine taken for hypothyroidism, potassium citrate taken for renal failure, atorvastatin taken for coronary arterial stent insertion, hydrochlorothiazide taken for blood pressure measurement, prednisone taken for steroid therapy from 27Jan2021 to an unspecified stop date; amoxicillin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265 and expiry date 31May2021) via an unspecified route of administration on 02Feb2021 in left arm (77-year-old), as dose 1, single for COVID-19 immunization and had no problems. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. On 25Feb2021 the patient experienced sore left arm. On 28Feb2021 the patient did not feel good, tiredness, felt queasy, dizziness and blood sugar was low. So she had some orange juice and went about her day to grocery shop, so she laid down to take a nap and then felt okay. On 01Mar2021 she could not breathe very good and her heart started racing. Caller reported that she did not get clammy and that was why she did not feel it was hypoglycemia. She has not had that for years as she watched and made sure she does not eat too many carbs. She was tired and took a 3 hours nap. Caller states the whole time she just did not feel herself, but she just went on and pushed things aside as she had a life to live. She did not relate it to the vaccine at first. She got out her information paper and she had all of the symptoms that were on the paper besides the rash. The patient did not require emergency room and physician office visit. On an unknown date in 2021 breathing difficult, Heart racing, Feeling unwell, Tired, Felt queasy, Dizziness, blood sugar was low recovered. On 27Feb2021 sore left arm recovered. Caller would like to know if it is typical to experience side effects four days after receiving a dose of the Pfizer vaccine. Caller stated that she was home when she experienced the side effects and felt like a wet noodle and just wanted to lay down and did not seek medical attention. Caller did not clarify what the other number was that she had called and was directed to Pfizer DSU, but stated she had not made any reports previously. Caller does not have an email for her doctor at this time. She said she has not called him. She felt sick yesterday. Her cousin wanted her to go to the hospital but she said she can not do it as she could not breath good and just wanted to lie down. She was so weak. Caller mentioned that she was a little chubby, but she exercises and moves around a lot. Caller stated that she was not feeling good but went on because she has a life to live and go on with things. Caller stated she was taking Prednisone when she received her second Covid vaccination and she wondered if that had anything to do with her reaction. The patient took Excedrin Migraine for headache took Saturday, caller was unaware of dose she took. She stated that it was just over the counter. The Excedrin Migraine expiration date 21Dec and Lot SP2W, but she stated that she usually just takes Tylenol. Caller Mentioned taking normal vitamins daily and I Caps, she stated she feels like she does well for her age, and then restated that she does Damn well for her age. Caller states her family has heart disease issues during Vaccine supplemental form but continued to stated that she does not feel that was relevant to this report. Follow-up attempts were completed. No further information was expected.
77 2021-07-27 vomiting, nausea Nausea and vomitting, dizzy
77 2021-07-28 nausea Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all o... Read more
Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
78 2021-01-03 retching "Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoreti... Read more
"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site
78 2021-01-05 diarrhea After vaccine administration, pt experienced severe diarrhea with incontinence.
78 2021-01-09 nausea Tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, nausea, weakness
78 2021-01-11 diarrhea After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine admin... Read more
After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine administration, pt experienced severe diarrhea with incontinence.; This is a spontaneous report from a non-contactable pharmacist. A 78-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5730, intramuscular from 16Dec2020 to 16Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccine administration on 16Dec2020, The patient experienced severe diarrhea with incontinence. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
78 2021-01-14 nausea, vomiting Fever 102, chills, nausea, vomiting, body aches 24+ hours
78 2021-01-14 nausea Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, tempera... Read more
Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6
78 2021-01-21 abdominal pain CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chill... Read more
CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chills, throat swelling during night, feeling as id needles pricking entire body for an hour or so around 2 or 3 am. Better next day exvept tired and weak. Ok since then.
78 2021-01-23 difficulty swallowing 1037am Reports Difficulty Swallowing 1043 Benadryl 25mg and Oxygen mask 1058am Patient reported res... Read more
1037am Reports Difficulty Swallowing 1043 Benadryl 25mg and Oxygen mask 1058am Patient reported resolution of symptoms. Patient escorted and ER precautions given.
78 2021-01-25 nausea Slight nausea; This is a spontaneous report from a contactable consumer (patient). A 78-years-old fe... Read more
Slight nausea; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3248), via an unspecified route of administration on the left arm, on 13Jan2021 at 10:15, at a single dose for Covid-19 immunization. Medical history included vertebral artery occlusion. The patient did not receive other vaccines in four weeks. Concomitant medications included metoprolol, amlodipine, tramadol, and hydrochlorothiazide. The patient previously took oxycodone hydrochloride;paracetamol (PERCOCET), acetylsalicylic acid;oxycodone hydrochloride (PERCODAN) and hydrocodone and experienced allergies. On 13Jan2021, at 11:30, the patient experienced slight nausea. The patient did not receive any treatment for the event. Outcome of the event was not recovered.
78 2021-01-27 abdominal pain upper started the 2nd day after the shot. I was slight head head, stomach, achy all over. This week i have... Read more
started the 2nd day after the shot. I was slight head head, stomach, achy all over. This week i have just started to feel better
78 2021-01-27 vomiting, GERD Persistent acid reflux (unusual for me)( didn't respond to TUMS) followed by severe but short term v... Read more
Persistent acid reflux (unusual for me)( didn't respond to TUMS) followed by severe but short term vomiting lasting about 5+ minutes. I feel fine now (30 minutes later) Last thing I ate before vaccination was 2 pieces of toast with butter and a banana for breakfast eight hours earlier than the vomiting..
78 2021-01-28 diarrhea Diarrhea. Administered Immodium. Controlled by 12 PM
78 2021-01-28 nausea felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fas... Read more
felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
78 2021-01-30 nausea Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, naus... Read more
Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.
78 2021-01-30 nausea Flu-like symptoms while in bed. Fever, sweating, nausea, fatigue which lasted from midnight till mor... Read more
Flu-like symptoms while in bed. Fever, sweating, nausea, fatigue which lasted from midnight till morning.
78 2021-01-31 abdominal pain upper Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles... Read more
Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles and arches. Stomach pain, and feeling lethargic. I took Tylenol but i think that disturbed my stomach. Still having soreness in my legs and ankles and still don't have energy today.
78 2021-01-31 anal incontinence Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid... Read more
Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.
78 2021-01-31 diarrhea I felt fine the day of the vaccine but I woke up at 3:45 AM. I was so cold that I was shaking, I ac... Read more
I felt fine the day of the vaccine but I woke up at 3:45 AM. I was so cold that I was shaking, I ached all over. When I got up my temperature was 102 and in stayed between 101.5 and just over 102 for about 30 hours. I also had cold like symptoms, a cough and diarrhea. It wasn't until 48 hours after the shot that my temperature was normal.
78 2021-02-01 nausea not feeling well that day; The next morning I was tired because I didnt get good sleep the night bef... Read more
not feeling well that day; The next morning I was tired because I didnt get good sleep the night before; severe chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283; expiration date: unknown), intramuscularly left deltoid on 12Jan2021 10:50 at a single dose for prevention (covid-19 immunization). Medical history included cystitis interstitial and headache. There were no concomitant medications. The patient didn't receive other vaccines in the last 4 weeks. The patient reported that she had her first dose on 12Jan2021 around 10am and she experienced severe chills where she could not get warm and nausea the night of 13Jan2021, about 10pm. It lasted approximately 8 hours. She probably had a temperature, but she was shaking so much, she did not check. She could not get warm. The next day, she was tired, and probably because she could not sleep the night before. The tiredness was back to normal on 14Jan2021 at 8pm. She was awake the whole night until 8am. The chills stopped and she was very, very tired. Around 8pm on 14Jan2021, she felt like her normal self and it was amazing. She was not feeling well that day (unspecified date). She is due for her second dose on 02Feb2021. She added that she had severe chill ("couldn't get warm") and nausea then the next morning, she was tired because she didn't get good sleep the night before and then felt like herself the following day. The nausea stopped 8 hours afterwards. The tiredness was back to normal on 14Jan2021 at 8pm. She mentioned that she was treated for interstitial cystitis before she took the vaccine. She began to experience a headache prior to receiving the vaccination and called the hotline to see if it was COVID. They did not want to test her since she did not have any other symptoms. She got tested for COVID on 18Jan2021, and it came back negative. She inquired if she can take 25mg of diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) prior to her receiving her second dose to prevent side effects. Treatment was received by the patient. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovered on 14Jan2021 20:00.
78 2021-02-03 nausea Nausea most of the day; This is a spontaneous report from a contactable consumer (patient). A 78-yea... Read more
Nausea most of the day; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 18:45 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertension and stress. The patient has no known allergies. Concomitant medications included atorvastatin, ezetimibe, amlodipine, and irbesartan. On 17Jan2021 at 13:00, the patient experienced nausea most of the day. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the event. The patient recovered from nausea in Jan2021. Information on the batch/lot number has been requested.
78 2021-02-04 retching 3rd day became very dizzy, dry heaves. Dizziness continues for 2 weeks now, gradually improving in ... Read more
3rd day became very dizzy, dry heaves. Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.
78 2021-02-05 anal incontinence Anal incontinence, sudden for about 2 hours
78 2021-02-05 difficulty swallowing Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 ... Read more
Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 mg of benedryl, and after 15 more minutes, she continued to have the same symptoms, and in addition was breathing more labored, was having a harder time swallowing, and complaining of feeling dizzy and a headache. She then received an Epi Pen, was placed on oxygen, used her Xopenex inhaler, and EMS was called. She was then transferred to the ED for continued monitoring.
78 2021-02-05 nausea Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea.... Read more
Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea. These symptoms have continued to the present, 2/6/2021.
78 2021-02-06 diarrhea, vomiting Chills/ Diarrhea/Throwing up/ aches Very sick/ Head ache
78 2021-02-07 nausea At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 th... Read more
At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 that morning. Sat. afternoon I was feeling much better.
78 2021-02-07 nausea Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low ... Read more
Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low grade fever continue for three more days, rash appears on my neck, back and front of my body. Doctor insist I get a Covid 19 test. It came back negative. This was my first pfizer vaccine.
78 2021-02-09 diarrhea Headache, body aches, diarrhea
78 2021-02-09 nausea Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, cou... Read more
Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, could hardly walk and had to walk with a cane and hold onto wall. Just plain pain all over, I felt nauseated but never threw up. I took anti-nausea pills and pain pills.
78 2021-02-09 vomiting, diarrhea Vomiting , diarrhea, bad headache, tiredness, sweating
78 2021-02-10 diarrhea, blood in stool, abdominal pain hrs post vaccine, pt began expereincing severe abdominal cramping, diarrhea and bloody stools.
78 2021-02-12 nausea Severe headache, severe nausea, elevated temp 101.9, severe body aches...In bed all day, so sick jus... Read more
Severe headache, severe nausea, elevated temp 101.9, severe body aches...In bed all day, so sick just like I was so very sick when I had covid-19. 2 /13/21 woke up feeling normal.
78 2021-02-12 vomiting, nausea Vomiting 4 times after feeling nauseous and weak with head and body aches for 2 days
78 2021-02-13 nausea NAUSEA AFTER 15 MIN OF VACCINATION; GAVE SNACK; FEELING BETTER.
78 2021-02-14 nausea Severe chills, total body aches, nausea, headache, low grade fever 99.7. Pain at injection site. Let... Read more
Severe chills, total body aches, nausea, headache, low grade fever 99.7. Pain at injection site. Lethargic very sleepy
78 2021-02-15 difficulty swallowing Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's pal... Read more
Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's palsy in the past. She started with right sided facial droop and was choking with swallowing.
78 2021-02-15 nausea Vertigo, nauseous, sweaty Symptoms lasted 3 to 4 hours. Not like orthostatic hypotension when bp is ... Read more
Vertigo, nauseous, sweaty Symptoms lasted 3 to 4 hours. Not like orthostatic hypotension when bp is low. Did not stop when sitting. Did not vomit but felt very sick. Hope it doesn't happen again.
78 2021-02-16 diarrhea, vomiting, abdominal pain upper Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after... Read more
Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after receiving shot, 8:00 pm, Saturday, Feb 13, developed stomach cramps. Over the next 4/5 hours, diarrhea, vomiting, cramps, chills. Felt very hot at times, but never ran a fever. Sunday, February 14, felt tired and weak, periodic cramps. No nausea or diarrhea. Monday, February 15, more energy, some cramps, By
78 2021-02-17 diarrhea This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. ... Read more
This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 25Jan2021 at 13:00 (at 78 years) at single dose for COVID-19 immunization. The patient medical history included anxiety, headache, dry eye and low potassium, each from an unknown date and unknown if ongoing. The patient's concomitant medication included potassium oral at 10 meq daily for low potassium, cholecalciferol (D3) oral at 2000 iU once a day to help with bones, fish oil oral at 1200 mg once a day, alprazolam at 0.5 mg as needed (take one three times a day) for anxiety, clonazepam oral at 0.5 mg once a day for anxiety, nortriptyline HCl oral at 10 mg once a day, paracetamol (TYLENOL) at 500 mg as needed for headache, estradiol (SYSTEN) ophthalmic one drop as needed, all from an unknown date and ongoing. The patient experienced one or two hours after the vaccine (on 25Jan2021), she went to talk, she couldn't get her sentence straight. She knew what she wanted to say but she couldn't say it. Her first thought was that she was having a stroke and it really scared her. She became very tired and went to sleep, when she woke up, she was talking straight but she was still really tired. The next morning (on 26Jan2021) she had diarrhea three time and after that she felt better. The patient outcome of speech disorder and diarrhea was recovered on 26Jan2021 and the outcome of tiredness was recovering. The information on the batch number has been requested.
78 2021-02-18 nausea, abdominal pain, abdominal pain lower, vomiting RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRA... Read more
RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRAMP/ACHY PAIN) IN RIGHT LOWER QUADRANT X5 DAYS. DIAGNOSED WITH ACUTE ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT AND NON-INTRACTABLE VOMITING WITH NAUSEA. DISCHARGED FROM ED AND INSTRUCTED TO FOLLOW UP WITH PCP.
78 2021-02-18 vomiting, nausea, abdominal pain lower 1st Vaccine 2/14/21; same day onset RLQ ABD pain with nausea and vomiting; seen at ED on 2/19/21 for... Read more
1st Vaccine 2/14/21; same day onset RLQ ABD pain with nausea and vomiting; seen at ED on 2/19/21 for ongoing symptoms; d/c'd home from ED same day to follow up with primary care as outpatient. Dx in ED: 1. Acute abdominal pain in right lower quadrant 2. Non-intractable vomiting with nausea, unspecified vomiting type
78 2021-02-19 nausea, abdominal pain, decreased appetite, diarrhea Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unabl... Read more
Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unable to sleep due to abdominal pain, considered calling ambulance. In morning, diarrhea, nausea, poor appetite. Now 2:30 pm. , pretty much recovered
78 2021-02-21 nausea On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and ... Read more
On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).
78 2021-02-21 vomiting, diarrhea, nausea Approx. 6 h after injection, chills; followed by headache, nausea, aching, vomiting and diarrhea. Du... Read more
Approx. 6 h after injection, chills; followed by headache, nausea, aching, vomiting and diarrhea. Duration approx. 24 h.
78 2021-02-23 abdominal discomfort, nausea Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This ... Read more
Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.
78 2021-02-23 decreased appetite she was "Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; D... Read more
she was "Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; Did not want supper; This is a spontaneous report received from a non-contactable consumer (patient herself). A 78-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Not available), via an unspecified route of administration on 23Jan2021 to 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported that on Monday (2 days post-vaccine on 25Jan2021) she was "Just not feeling myself - nothing, she can even describe in detail, just vaguely not myself. Did not want supper so had scrambled eggs and toast and went to bed early. Woke up feeling fine. She hardly ever felt other than fine and she could not think of anything other than the vaccine on Saturday that was unusual. On Sunday, she felt fine and today she feel fine". Treatment was not received for the events. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.
78 2021-02-24 abdominal pain Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left ... Read more
Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
78 2021-02-24 decreased appetite, nausea chills, dizzyness, nausea, fatigue, light headed, loss of appetite
78 2021-02-27 decreased appetite Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, ... Read more
Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, very weak...stayed in bed for approx 30 hours 2nd dosage: approx 4 hours after shot; bad headache, no appetite, very weak lasted longer still in bed on following Sunday 2/28 (shot on 2/25) headache would come and go; was told to make sure someone stayed with me since I had had reaction with first shot and warned me thatif I had reaction to 1 would have for 2nd...No one to stay
78 2021-02-27 vomiting blood, faeces discoloured RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21 COMPLAINING OF H... Read more
RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21 COMPLAINING OF HEMATEMESIS AND BLOCK COLORED STOOL. ANTICOAGULATED ON ASPIRIN AND PLAVIX. DIAGNOSED WITH UPPER GI BLEED AND ADMITTED TO HOSPITAL ON 02/27/21.
78 2021-02-28 diarrhea lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; ... Read more
lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
78 2021-02-28 nausea, diarrhea she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report f... Read more
she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.
78 2021-02-28 nausea Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredn... Read more
Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.
78 2021-03-01 diarrhea Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guill... Read more
Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guillian barre s/p COVID vaccine. The patient tells me that she was in her normal state of health, and she received her 1st dose of the COVID-19 vaccineseen 7 days ago. Subsequent to that, the next day she developed chills, fatigue that continued for approximately 2 days. She states that 3 days ago, she woke up and was unable to lift her legs or get herself out of bed on her own. She felt weak in her proximal lower extremities and her trunk. She denied any bandlike sensations or paresthesias. She cannot tell me that she developed any distal lower extremity weakness initially but felt that it was the acute onset. She needed some help her out of bed when she was upright, she was able to use her walker to slowly get to the factor. She may have had some urinary incontinence, she does complain of diarrhea now. Denies any tingling sensation, no bulbar symptoms. This is a 78-year-old female who we were asked to evaluate for possible Guillain-Barre syndrome. She had acute onset of lower much greater than upper extremity weakness without any definite ascending features, of relevance, is that she received the COVID-19 vaccine 3 days prior to the onset of her symptoms. She did exhibit flu-like symptoms prior to this. Given that she does not have any specific area of intrathecal enhancement to suggest Guillain-Barre or other areas of radiculitis, I think it is reasonable to proceed with lumbar puncture to look for any other source. --Given the findings on the MRI cervical and lumbar spine including enhancement of the bilateral sacral S1 region, I would like Neurosurgery to further evaluate. -- would likely benefit from CT chest abdomen pelvis to rule out any underlying occult malignancy particularly if workup remains unremarkable. -- continue supportive care, monitor for shortness of breath, new vital capacities Patient remains admitted to the hospital with continued weakness at the time of this report
78 2021-03-02 decreased appetite Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, bu... Read more
Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, but unable to sleep. Nine days after 2nd shot still having the same symptoms.
78 2021-03-02 nausea, retching Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming d... Read more
Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on 23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered. Information about lot/batch number has been requested.
78 2021-03-03 nausea 2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke... Read more
2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke with pulmonologist on 3/1/21 and he advised me to start a 5 day regimen of 40 mg. prednisone. I am on day 3 and breathing has been better, not back to normal.
78 2021-03-04 nausea Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the n... Read more
Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.
78 2021-03-05 nausea Fatigue,Nausea, headache, chills for 26 hours
78 2021-03-07 nausea, decreased appetite, diarrhea 3/1 tired and diarrhea 3/2 I was ok. 3/3 I had chills all day and I was dizzy. I was also nauseous ... Read more
3/1 tired and diarrhea 3/2 I was ok. 3/3 I had chills all day and I was dizzy. I was also nauseous in the mornings. 3/4 I had no nausea and no diarrhea but I had no appetite and food made me gag. still had chills and extremely dizzy. felt the same until 3/7 the chills went away. 3/8 I was and am still dizzy and I had soft stools and no appetite.
78 2021-03-08 decreased appetite, diarrhea Mild diarrhea, loss of appetite, back ache, and hip ache. All were mild and lasted two to six days.... Read more
Mild diarrhea, loss of appetite, back ache, and hip ache. All were mild and lasted two to six days. This happened only after shot number two.
78 2021-03-08 loss of appetite, nausea Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well,... Read more
Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.
78 2021-03-10 vomiting, nausea, loss of appetite LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The followi... Read more
LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.
78 2021-03-13 vomiting, abdominal pain upper, diarrhea, nausea I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinate... Read more
I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.
78 2021-03-14 nausea, GERD Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous... Read more
Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering. No follow-up attempts are possible. No further information was provided.
78 2021-03-15 vomiting, diarrhea, nausea 03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomit... Read more
03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomiting. The patient was admitted for GI evaluation who stated that the nausea, vomiting, and chronic diarrhea, could be from gastroparesis and diabetic diarrhea versus IBS. The patient was discharged the next day with outpatient follow up with her primary gastroenterologist.
78 2021-03-18 diarrhea episode of diarrhea; This is a spontaneous report from a contactable consumer. A 78-year-old non-pre... Read more
episode of diarrhea; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease (GERDS) and hypertension from an unknown date and unknown if ongoing. The patient had other concomitant medications received within 2 weeks of vaccination, reported as 'many'. The second night after vaccination (unspecified date), the patient suddenly had an episode of diarrhea, could not get to the toilet in time. There was no treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
78 2021-03-20 nausea Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; ... Read more
Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
78 2021-03-21 abdominal discomfort, diarrhea, nausea Patient is a 78 yr/o female who IBS, HDL, GERD, gastroparesis, anxiety, depression presents to the E... Read more
Patient is a 78 yr/o female who IBS, HDL, GERD, gastroparesis, anxiety, depression presents to the Emergency Department complaining of fever and generalized body ache onset 3 AM this morning. She attributes it to the second Covid shot that she received yesterday. She progressively started experiencing abdominal discomfort which she attributes to gastroparesis. Reports she took Tylenol at 1 PM for body ache with no relief. She also took Zofran for nausea. She had associated diarrhea without any hematochezia. Denies chest pain but has shortness of breath. She did not check her temperature at home. States she had a fever upon arrival to the emergency department. She denies dysuria, hematuria, flank pain. Patient has a history of COVID-19 infection in April 2020.
78 2021-03-21 nausea, abdominal discomfort, diarrhea FEVER, GENERALIZED BODY ACHES, ABDOMINAL DISCOMFORT, NAUSEA, DIARRHEA
78 2021-03-21 nausea I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nau... Read more
I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again. However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared. I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had. Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.
78 2021-03-22 decreased appetite vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient c... Read more
vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.
78 2021-03-22 nausea, abdominal discomfort metallic taste in mouth and nausea. Was asked to wait an extra 15 minutes and give pretzels and wate... Read more
metallic taste in mouth and nausea. Was asked to wait an extra 15 minutes and give pretzels and water. Felt a little better and wnt home. Nausea continued for 5days u with discomfort at the pit of my stomach, then I started with multiple bowel movements for the past 3 days.
78 2021-03-23 nausea my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontane... Read more
my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV. After about 15 minutes she called 911 and was taken to hospital. All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
78 2021-03-24 nausea I just started coughing and they told me to go to the emergency room so I did you know; arm got real... Read more
I just started coughing and they told me to go to the emergency room so I did you know; arm got real sore; Fever; feel nauseous; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; I have been so off-center; This is a spontaneous report received from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 10mar2021 (formulation: Solution for injection, lot number: EIV6202) via an unspecified route of administration at single dose for covid 19 immunisation. The patient medical history included ongoing tubular dysfunction, migraine and patient had the vestibular Dysfunction from 40 years, ongoing migraine headache. The patient historical vaccine included BNT162B2 (formulation: Solution for injection, lot number: EL9267), (first dose) via an unspecified route of administration on 17feb2021 at single dose for covid 19 immunisation and took Flu shot for immunization. The patient had regular flu shot a few years ago it was mentioned that doctor told get a Benadryl an hour before my shot which I did and she was in the hospital for 5 hours on a Breathing machine. Concomitant medications included rizatriptan benzoate (MAXALT) at 10 mg, as needed for migraine. Consumer stated, "I had Tubular Dysfunction been diagnosed many years ago and I live with dizzy every day In Mar2021. I have tried everything to get rid of it and nothing is working. This is going on for Probably 40 years may be more anyway (Intent: History). I had my second vaccine on 10Mar2021 and on the first day, my doctor told me since I had the reaction to the regular Flu shot a few years ago my doctor told me get a Benadryl an hour before my shot which I did and the first day everything was wonderful. I was so happy you know no reaction, I didn't have any. The first time I got the flu shot I was in the hospital for 5 hours on a Breathing machine, it was beautiful. I thought I was free and then the next day my arm got real sore and I expected that and I expected to have a fever I expected to feel nauseous and all but the dizziness set in and just got progressively worse and it will be a week tomorrow since the vaccine still I was dizzy In Mar2021. I have been so off-center In Mar2021. Sunday I could hardly do over I was just so sick with the dizziness and yesterday the same thing and this morning I thought I will get over maybe today will be a good day and it's the same. I called my neurologist and he said that any pre-existing condition can be exaggerated by the vaccine while the system is building up his anti-bodies so I expected but is this going to go away, this thing, is this going to go away and reported just so beside myself, I just can't live like this anymore everyday you know this is beyond dizzy." tried taking, I do have a prescription for it starts with M wait a minute it hasn't helped but I tried it , if it doesn't help for the first time I won't take it again but I have a prescription for Meclizine 25 mg Tablets. Consumer stated, "I spoke to somebody earlier and told me to call this number and tell you that what's going with me. Tomorrow will be one week, since I had my second Covid shot and the first day, I got it everything was fine. The second day I was feeling a little off and I thought okay will they told me that I would feel little, may be not sick-sick but not feeling good and then the second day after that Friday. I got it on Wednesday and by Friday, I have a pre-existing condition and it is called Vestibular Dysfunction. Consumer stated, "I had the Vestibular Dysfunction from 40 years. So, I live with dizzy all the time. But by Friday, it is just unbelievable dizzy, Saturday was worse, Sunday was even worse, yesterday was little bit better. Today, I am still shaking and dizzy and Tomorrow will be one week since I have the shot and I read that stuff happened in the first week and I was wondering, have you had the other people with the same problem, Consumer further added, "It is not an inconvenience, this is horrible way to live. I feel dizzy all the time, this is horrible. Was I told that I should talk to you about, can the shot exacerbate a bad situation like this, they told me to call you, now I getting no help at all can anybody tell me." Consumer stated, "Nothing I have no recollection of any of that no, I just started coughing and they told me to go to the emergency room so I did you know In Mar2021. The patient has received treatment with Meclizine 25 mg tablets. The outcome of the events was reported as unknown.
78 2021-03-25 diarrhea, vomiting, nausea extreme vertigo, vomiting, diarrhea - lasted about an hour. This was repeated the following night, ... Read more
extreme vertigo, vomiting, diarrhea - lasted about an hour. This was repeated the following night, about 3:00 am. Since then I have had several more vertigo incidents with vomiting and diarrhea, and I have some dizziness and nausea on a regular basis
78 2021-03-25 nausea she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would driv... Read more
she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.
78 2021-03-27 decreased appetite A week later, flu like symptoms: slight fever ( 99-100)r joint and muscle aches and pains, fatigue, ... Read more
A week later, flu like symptoms: slight fever ( 99-100)r joint and muscle aches and pains, fatigue, poor appetite, chills intermittent sharp pain jabs throughout body and head. Rx: one dose of extra str. Tylenol, inc. fluids and sleep/ rest. Feel better tonight: took a shower after 3 days and am able to eat better.
78 2021-03-30 decreased appetite, nausea cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no ... Read more
cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-03-30 decreased appetite caller doesn't feel great; Headache; was exhausted/she was so worn out, she just felt zapped; had ch... Read more
caller doesn't feel great; Headache; was exhausted/she was so worn out, she just felt zapped; had chills; fever of 100; overall a feeling like she had the flu; had no appetite; felt sluggish; she slept most of the day; This is a spontaneous report from a contactable consumer. A 78-year-old female (pregnancy unknown) patient receive second dose in series of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN5318), via unknown route of administration on Right arm on 03Feb2021 09:00 (the day of vaccination), at single dose for covid-19 immunisation. The patient's medical history includes High blood pressure, and historical vaccine Caller had the First Dose on 13Jan2021 and it was Lot number EL3302. Caller had the Second Dose on 03Feb2021, and it was Lot number: EN5318. Caller reports that she got both doses via injection into the right arm. Concomitant medications were not reported. It was reported that caller states that she would like to talk about side effects from the COVID vaccine. Caller had the first dose of the product on 13Jan2021 and the second dose, this past Wednesday at 09 AM. Caller states that she was fine the whole rest of that day but then she woke up at 3 AM the next day and everything had changed. Caller states that she had a headache, she was exhausted, had chills, a fever of 100, it was overall a feeling like she had the flu. Caller is wondering if these are known side effects of the product because the caller's husband also got the vaccine, and he did not have any of these symptoms. Caller states that her primary care doctor is her Gynecologist and he is not aware that the caller even had the vaccine because she only goes to him once a year. Caller confirms the product was not prescribed to her by anyone in particular. Caller states that she had just read about the product and saw stuff on TV and thought that because of her age she should get it. Caller states that her brother in law is a physician and he told the caller to get the product. Caller states that her brother in law got the shot too and after his first shot he was fine but he had a few symptoms after the second shot, where he was feeling like he had the flu but he did not have as many symptoms as the caller had. Caller states that she got through the whole day of the day she had the injection and everything was great until 3 AM the next morning and she woke up with all the side effects. Caller states that she was so worn out, she just felt zapped, she had no appetite, a dull headache, she slept most of the day, fever of 100, and overall she felt sluggish. Now today, caller doesn't feel great, but she has no symptoms, she is just washed out. Caller states that she just guesses she did not know to expect that from the product. Caller states that she had heard there were some side effects and some people get them more than others but her husband did not get a single one. Caller is also wondering if the side effects will just go away on their own. Caller had no other vaccines on the same days as her doses of the COVID vaccines. Caller states that she has not had any bloodwork done in a while.
78 2021-03-30 diarrhea Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Uri... Read more
Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Urinating like crazy/had to urinate non-stop; Sick; Swelling on her right eyelid; Pain down her neck; Everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 19Jan2021 (at the age of 78-years-old) at a single dose for covid-19 immunisation. Medical history included mastectomy (she had a mastectomy before, so she has no lymph nodes, she doesn't let them touch her left arm. She says this was done 26 years ago when she was 52), arthritis (she has bad arthritis in her back), Blood pressure high (she takes a high blood pressure medication), High cholesterol (she takes a high cholesterol medication) and eye surgeries (she has had all kinds of eye surgeries before this). The patient's concomitant medications were not reported. The patient experienced swelling on her right ear, symptoms of the flu/side effects like the flu, diarrhea/bad diarrhea, urinating like crazy/had to urinate non-stop, sick, swelling on her right eyelid, pain down her neck, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side on an unspecified date in 2021. The patient stated that she had a lot of side effects and she talked to her doctor who said to go ahead and get the second dose. She says she had no fever, but had all the rest of the side effects, such as swelling of her neck, ear, and eye, which all went away fast. She says she was sick almost 4 days, and her doctor said side effects shouldn't last that long, so she called to get advice about whether to get second shot or not. She says her appointment for her second shot is the 09Feb2021, she would like to know if it is safe for her to get. She says her side effects started in the evening, the swelling of her right ear didn't last, it went away. She says during the night she woke up and had to urinate non-stop that started that night a day later. She says that lasted the next day, then the day after, until Saturday she felt better. She says she had all side effects like the flu, then later bad diarrhea too. She says she finally took something for diarrhea (no further information provided about this) and took Tylenol. she doesn't see the expiration on that bottle, she thinks it is good for 2021. She says that she doesn't see too good. She clarifies that they Tylenol she had took before, with no issues, and her not seeing too good had nothing do with the vaccine, she has had all kinds of eye surgeries before this. She says her right ear was swollen, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side. She says that the pain started about a day later Pfizer COVID-19 vaccine. Caller says that she called her doctor today, that was the first time she did that, she was trying to wait and see, and her doctor said normally side effects don't last that long, so he has her worried. She says if she does not take the vaccine she will not be protected, but if she does, she may have worse side effects. Therapeutic measures were taken as a result of diarrhea/bad diarrhea. The patient recovered from the event swelling on her right ear on an unspecified date in 2021, outcome of the event Urinating like crazy/had to urinate non-stop was recovering, while outcome of other events was unknown.
78 2021-03-30 nausea her immune system since has not been the same and has been very deprived; her immune system since ha... Read more
her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.
78 2021-03-30 nausea Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old no... Read more
Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: unknown), via unspecified route of administration on Left arm on 28Jan2021 09:45 at single dose for covid-19 immunisation. The patient's medical history included High Blood pressure, Obesity. The patient's concomitant medications were not reported. It was reported that patient experienced Fever, Nausea, and headaches after vaccine on 24Jan2021 08:00 AM. Other medications the patient received within 2 weeks of vaccination are blood Pressure Medication The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Not recovered". Ethnicity information is available. Information on the lot/batch number has been requested.
78 2021-03-31 blood in stool, diarrhea ADR began 6 days after the second dose. Caller states she spoke to PMD when she developed the diarr... Read more
ADR began 6 days after the second dose. Caller states she spoke to PMD when she developed the diarrhea with blood beginning about 6 days after 2nd dose of vaccine. The MD recommended Urgent care , but urgent care recommended ED and patient went to the hospital. Went to ED Saw ED MD Diagnosed with diverticulitis and treated with IV fluids in ED and 10 day course of Flagyl that she began on 2/27 . CT scan incidental finding: Pneumonia Diverticulitis s/sx - mainly diarrhea with blood but perhaps slight Abd tenderness or cramps all of which abated while on Flagyl, but recurred after Flaygl stopped and then persisted until yesterday. She received trimethopril/sulfamethathoxazole for the pneumonia. which she took concurrently with the Flagyl Patient was not admitted to hospital. S/sx cleared completely 3/30. Patient had Diarrhea so bad she thought it was C.Diff, but tested negative for this - results just came in today. Note: Unable to obtain patient's date of birth. Patient is 78 years old.
78 2021-03-31 loss of appetite rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thro... Read more
rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
78 2021-03-31 nausea Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat... Read more
Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.
78 2021-04-02 decreased appetite rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a c... Read more
rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EM9809) via unspecified route of administration on 09Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller and his wife received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday, he experienced a little of body aches that disappeared; however, his wife experienced a severe reaction: ongoing chills from 10feb2021, ongoing sweating from 10feb2021, ongoing headache from 10feb2021, from 10feb2021 to 11feb2021 experienced fever, ongoing body aches from 10feb2021 and today she broke out in rash on the front of her body from 11Feb2021 and ongoing no appetite from 10feb2021. They would like to know if there are any recommendations on what to do. Calling about the Covid 19 Vaccine. States that he and his wife had their 2nd doses of the vaccine on Tuesday afternoon. He had very little side effects; just body aches. But his wife woke up the first night after getting the shot with chills, fever, sweats, headache, and body aches. Today she is feeling a little better; her temperature this morning was 99.2, and she had a really bad headache. When she got in the shower, she noticed that she had a rash on her body; it doesn't itch. States that she has a little appetite today, which is good because she didn't eat at all yesterday. Asks, what does he need to do, if anything at all? States that he went on the Pfizer website and the side effects were listed there, one of the bad ones was a rash, so he would like to speak with Medical Information. Caller does not have the full contact information to provide for the prescribing physician. States that she got the shot about 2:15-2:30pm and the aide effects started about 12 hours later. States that she goes from being hot to cold to lukewarm, so the chills come and go. Her fever is gone, her temperature is now 97.5. The headache was really bad this morning, but she only feels a little pressure now. The rash is on her back and legs, but it has gotten better in the last hour. States that her appetite has improved; she just ate some breakfast. The lot number on the card is difficult to read due to the handwriting. Caller states that by comparing her card to his card, they think the Lot number is either EU9809 or EM9809. Caller later states that after looking at if for longer he really thinks it's EM9809. The outcome of the events for "Chills", and "Sweating" was "Not Recovered", for "Fever" was "Recovered", and for "Headache", "Body aches", "Rash", "No appetite" was "Recovering". Follow-up attempts are completed. No further information is expected.
78 2021-04-02 decreased appetite Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many ... Read more
Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.
78 2021-04-03 nausea felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a... Read more
felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via antibodies test on an unspecified date with positive result. On an unspecified date, a day after receiving the vaccine, the patient developed a fever and said that she felt paralyzed and nauseous. The patient needed to go to the hospital in order to recover and tested positive for antibodies. The outcome of events, fever, felt paralyzed and nauseous was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
78 2021-04-04 nausea Pt @ 1745 began to feel dizzy, nauseous, and lightheaded, cold. Water and snack given BP 153/71, H... Read more
Pt @ 1745 began to feel dizzy, nauseous, and lightheaded, cold. Water and snack given BP 153/71, HR 62. @ 1802 symptoms resolved, pt able to return home.
78 2021-04-05 diarrhea, decreased appetite **Please note that the same adverse reaction (diarrhea) occurred after each of my two Covid -19 vacc... Read more
**Please note that the same adverse reaction (diarrhea) occurred after each of my two Covid -19 vaccinations. See separate VAERS form for the second incidence.** I had my first Covid-19 vaccination shot on 1/11/2021. About five days later (1/16/2021), I awoke with an episode of diarrhea. This continued for about 10 days, until 1/25/21. On most days, these episodes were first thing in the morning only (on waking), but some days had more episodes, with some in the middle of the night. I had loss of appetite but no vomiting or fever and only slight weight loss. [I had started the antibiotic Sulfamethoxazole ? TMP SS in December 2020 and wondered if this might be a cause, but I checked with my urologist and we agreed that I had likely taken it for too long for it to be an issue.] **Please note that diarrhea started again on 2/2/2021, the morning after my second Covid shot. See separate VAERS form for this incidence.**
78 2021-04-05 diarrhea, indigestion **Please note that this form continues the story of diarrhea after my first Covid shot (1/11/2021). ... Read more
**Please note that this form continues the story of diarrhea after my first Covid shot (1/11/2021). See earlier VAERS form for the first incidence.** I had my second Covid-19 shot on 2/1/2021. The following morning, I awoke with diarrhea, and this continued for nearly three months, with a brief gap from 2/11 to 2/14. At first, my stool was lumpy, with mucus, but it gradually turned quite watery. It was also clear by eye that I was having trouble digesting higher fiber foods (salads, fruit & vegetable skins, et al.), so I worked to keep to a lower fiber, bland diet. Episodes of diarrhea varied with the day, but they usually occurred first thing in the morning, with some additional episodes during the day or in the middle of the night. By the end of this period, I had lost about eight pounds.
78 2021-04-06 nausea Nausea; chills; low-grade fever (99.8)
78 2021-04-07 difficulty swallowing Difficulty Swallowing
78 2021-04-07 nausea, vomiting, abdominal pain, abdominal pain upper, indigestion Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had aci... Read more
Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:
78 2021-04-08 nausea, diarrhea About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The s... Read more
About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The stomach issues resolved after a couple of days, but the severe itching continued and is especially bad wherever my clothing comes in contact with my skin. Over the next several weeks, I tried hydrocortisone cream, Benadryl gel, Benadryl tablets, Calamine lotion, corn starch, menthol itch cream, but nothing has helped for very long. I don't have much of a rash...just a bit of raised redness when the itching is particularly bad. I have been miserable with it. I visited my neurologist for Botox injections and asked her about it and she said she thinks I'm having a histamine reaction to the Covid vaccine. The severity of the itching is getting slightly better, but it's now been almost 6 weeks of unrelenting itching. I'm not taking Benadryl 3 times a day.
78 2021-04-09 difficulty swallowing it began working up her arm with arm pain and chest pain which persisted and she went to the hospita... Read more
it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; blood pressure went up to 198/203; still has tiredness; difficulty swallowing like her throat is still tight; difficulty swallowing like her throat is still tight; short of breath; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 11:00, single dose for covid-19 immunisation. Medical history included silent heart attack, ongoing Barrett's oesophagus from 2008, fall she had over two months (2021), eye surgery on an unknown date. She does not get any shots and can't have shots even for the flu shot because she had problems with two flu shots she had; states she had a problem with each one of the flu shots and does not know the names of the flu shots and has no lot numbers to provide for them; states she had the flu shots in the early 1990's and worked in healthcare and had to have them and they told her back then if she wanted to work she had to have the flu shots and then she got sick with both of the flu shots and they said they guessed they would not force her to have the flu shots. The patient's concomitant medications were not reported. Patient had the first dose administered and then about 14 hours after (12Mar2021) that she had no problems until it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours. She does not know what to do about getting the 2nd dose of the vaccine and was at her cardiologist's this week and he said he is not familiar with the Pfizer vaccine causing chest pain; caller states she has a history of silent heart attacks. She still has tiredness and difficulty swallowing like her throat is still tight and they told her to mention if she does go for the second dose of the vaccine to mention that she had this situation.The chest pain and arm pain began 12Mar2021 and the arm pain is in her right arm where the vaccine was administered and the arm pain and chest pain have resolved; states the arm pain and chest pain stopped and she thinks that lasted about an hour and a half and she called a family member to take her to the hospital; states about 2:30am that same day she was admitted the morning of 12Mar2021 and was discharged on 13Mar2021. They ran every test known to the patient and for a while her blood pressure went up to 198/203 in the emergency room (12Mar2021) and she is not on any medication; caller states she does have Crestor but has not started on it and has not taken it yet. The tiredness and difficulty swallowing like her throat is still tight began the same time she was having the chest pain and she is not having any chest pain or anything like that right now but the tiredness and difficulty swallowing like her throat is still tight is still ongoing; states she did go get cardiac clearance to make sure which was this past week and she does not feel well and like for her the tiredness is bugging her. The tiredness and difficulty swallowing are better but she knows they are there and she tries to swallow something and is like boy her throat is still tight. They did an ultrasound in her left leg because she was limping from a fall she had over two months ago but still has a sore ankle from that and they sent her down for the ultrasound and a CT looking for blood clots in her lungs because she was short of breath (12Mar2021); caller states she thinks they were running everything they could to rule out things; states everything was negative for the CT and ultrasound and she believes the CT and ultrasound were done on 12Mar2021. She has no idea when she was diagnosed with silent heart attacks but they kept asking her about this when she went in for eye surgery and asked her when she had a heart attack and she said she had never had one and they said yes she had and she never knew. She just set up a HCP appointment after the reported events with a gastroenterologist because she has Barrett's and because of the esophagus she did not know if it flared up by the Pfizer vaccine and that caused the pain because the two pains of the heart and esophagus mimic each other with pain going up into the jaw so they were ruling out which one it was; states she went out as an atypical chest pain and called the cardiologist and went in and went over her records from the hospital with the cardiologist. She does not know what caused what in terms of the pain. The outcome of the event blood pressure increased was unknown, chest pain and pain in arm was recovered, other events was recovering.
78 2021-04-09 nausea Extremely sick with vertigo, nausea, headache, runny nose, mild fever. Sicker than I've ever been in... Read more
Extremely sick with vertigo, nausea, headache, runny nose, mild fever. Sicker than I've ever been in my life. Couldn't even stand up.
78 2021-04-12 diarrhea, abdominal pain upper Diarrhea, fever, stomach pain for 7 days. She died on the seventh day.
78 2021-04-14 vomiting, nausea After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizzines... Read more
After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.
78 2021-04-15 nausea injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; Th... Read more
injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; This is a spontaneous report received from a contactable consumer or other non hcp reporting for herself. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 19:15 at a single dose for COVID-19 immunization. Medical history included hypertension and thyroidectomy. Concomitant medications included sertraline, pravastatin, cranberry and losartan potassium.T he patient experienced injection site pain, tiredness, joint pain, slight fever, chills, nausea and feeling unwell on 29Jan2021. The patient underwent lab tests and procedures which included body temperature as less than 100 Fahrenheit on 29Jan2021. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.
78 2021-04-18 diarrhea Diarrhea for one week.
78 2021-04-21 abdominal pain, anal incontinence On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I... Read more
On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I was light headed, had abdominal cramping pain, bowel emptying and possibly fainted. I was transported by EMTs to the ER and was later diagnosed with inflamitory bowel by a CT scan. I took antibiotics and was feeling fine. My gastroenterologist performed a colonoscopy on 3/24/21 and the findings were that I was healed and tissue samples were normal. 3/25/21 I had an annual physical and was told I was in good health. Later that afternoon I began feeling light headed upon standing. In the night I called my health insurance hotline because my blood oxygen meter was beeping continuously. The Dr. on call told me to go by ambulance to the ER. When sitting or lying down, I felt fine and all the tests at the ER for my heart and my vital signs were good. A few hours later, they did a hest Xray and then a CT scan of my lungs which showed a saddle embulism. I had also thought I had bruised my knee if and when I fainted on 2/18 and 1o hours later a blood lot was found by ultrasound of my left knee. I was given blood thinners in the ER and then in ICU where I spent the next night. I am now taking Eleris. I was also given pantoprozole for GERD coughing the next day. I continue to have periods of abdominal ramping/pain, light headedness in waves and pressure in my head. I have disontinued the stomach medication with some feeling better with the lightheadedness.
78 2021-04-21 indigestion, nausea Pt developed HA, dizziness, and nausea about 10 minutes after vaccine. Denies chest pain, palpitatio... Read more
Pt developed HA, dizziness, and nausea about 10 minutes after vaccine. Denies chest pain, palpitations, SOB, but does endorse "indigestion"." Hx HTN, took all BP meds this AM. BP in clinic 203/84 and 186/81. Pt taken to ER.
78 2021-04-23 nausea severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; He... Read more
severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication. The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable. No follow-up attempts are possible. No further information is expected.
78 2021-04-24 nausea nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting ... Read more
nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.
78 2021-04-26 vomiting Adverse events: unstable, too dizzy to walk, through-up, double vision. Treatment: wait for the sym... Read more
Adverse events: unstable, too dizzy to walk, through-up, double vision. Treatment: wait for the symptoms to pass.. The symptoms have lessened but are still with me.
78 2021-04-27 diarrhea, abdominal pain urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood ... Read more
urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment
78 2021-04-27 difficulty swallowing, vomiting tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of abou... Read more
tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events. Information on the lot/batch number has been requested.
78 2021-04-28 nausea I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gathe... Read more
I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gather myself to be at an appointment after the event. I was very disoriented upon waking. I could not gather my thoughts and memories. Things like: I knew I was in a city , but didn?t know where the city was in the world; and other things like that. It was as though I had stepped out of my life and didn?t remember enough to step back in. It only lasted maybe 5 min, but was completly disconcerting & disarming. I?ve never had a similar event. And it came after another disarming 10 min bout of dizziness / sense of off-balancedness and a very slight nausea the night before. It too, was arresting because I had had no alcohol to drink for months. I felt continually better during the early morning and didn?t think about it much during the rest of the day.
78 2021-04-28 vomiting, nausea hurting on right side of face, in and around R ear; hurting on right side of face, in and around R e... Read more
hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.
78 2021-04-29 diarrhea Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second ... Read more
Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second COVID-19 vaccine injection. Although I am predisposed to heart arrhythmia having been diagnosed with super ventricular tachycardia in late teen years, then atrial fibrillation starting at age 60, I was getting an episode of a-fib only once every 3-4 months following an ablation procedure. This was different as I had several episodes in a day on two different days. They subsided only following the taking of propafenone.
78 2021-05-02 decreased appetite, abdominal pain Patient experienced an arthritis flare after the 1st dose, and this became much more intense after t... Read more
Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.
78 2021-05-10 gastrointestinal disorder intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, j... Read more
intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered
78 2021-05-18 diarrhea, nausea cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A... Read more
cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A contactable 78-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on left arm on 04Feb2021 at single dose for COVID-19 immunization. The medical history of the patient included high blood pressure (Caller mentioned this was diagnosed in her late 50s or early 60s, and she was 78 now). She also had history of irritable bowel disease and hiatal hernia which was diagnosed years ago. She said that she did not had any other recent vaccinations or started any new medications. However she takes high blood pressure pills and stomach medicines and a medication for her bowels. It was reported that she had cataract in Feb2021 for which she underwent cataract surgery on 18Feb2021 taking eye drops- Prolensa every morning for 1 and half week. On an unknown date in Feb2021, she was nauseated and had diarrhea. She says she got the shot 04Feb2021 then a few days later she had diarrhea. She mentioned that she was scheduled to get the second shot today i.e. 26Feb2021 Friday, and her son saw on tv some people can get diarrhea, which she did not know before. She said that she had not gotten a temperature, and her BP was fine. She mentioned that she had irritable bowel disease anyway, and usually when she has that it clears in a week. She says that she would like to know if it is safe for her to get the second shot. On an unknown date in Feb2021, she experienced nervousness and it will have repercussions. She said that her son said there was some program on TV that listed all those things, some that were not in the paperwork she got. She had been nauseated or had diarrhea, and she called before, and some people get diarrhea, and she was supposed to check and see if she should get second shot. The outcome of all the events was unknown. Caller mentioned that she called her provider, but they were not going to get back to her in an hour and a half before she would go to get the second dose. She says she got the first dose of the vaccine at (Pharmacy) and says that she thought her diarrhea was better and then it came back the day before yesterday. She mentioned that her vaccine card was handwritten, and she could not read the writing on it. She says it mentioned (Clinic site) and that the handwriting was horrible on the card, and she could not tell if the LOT was E129EG. She says NDC/EXP were not provided on the card. The caller said that she has either got to get the shot or cancel this one, but if she cancels this one she does not know when she would be able to get second since the appointments are all booked up in (State). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
78 2021-05-25 decreased appetite back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt... Read more
back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; so dizzy I could not stand up; no appetite; brain fog; I shuffle very short distances and very slowly trying to avoid a fall.; toes and bottoms of feet were also totally numb; This is a spontaneous report from a contactable other health professional (patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration, in the right arm, on 15Mar2021 08:45 (lot number: EN 6207), at the age of 78, at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at the hospital. Patient medical history was not reported. Concomitant medications included losartan, hydrochlorothiazid and fexofenadine hydrochloride (ALLEGRA) for unspecified indications. The patient previously received first dose of bnt162b2 via unspecified route of administration, in the right arm, on 23Feb2021 14:30 (02:30 pm) (lot number: EN 5318) for COVID-19 immunization. On 15Mar2021 11:15, exactly 2 and a half hours after receiving the second dose of vaccine, patient tried to stand up but experienced back was so stiff; it was extremely difficult to stand. When patient was in a standing position, an electric bolt of pain shot in her left groin and down the right of her left thigh and into her left knee on down inside the left calf, left ankle and left toe; all on 15Mar2021 11:15. The pain has been constant and the most horrible pain she have ever suffered, as reported. It was reported that patient have never had this type of episode before in her life, which causes her to believe it has been a side effect of the 2nd dose of the vaccine. The pain continues to this day, at the time of reporting. Patient also experienced being so dizzy, she could not stand up; no appetite and brain fog on 15Mar2021 11:15. Before the shot, patient reported she can walk 50 blocks daily for the past 10 years. After 15Mar2021 (on unspecified date in Mar2021) she shuffles very short distances and very slowly trying to avoid a fall. Her toes and bottoms of feet were also totally numb when she wakes up each morning, since unspecified date in Mar2021. Treatment was received for the events (unspecified medications) on 28Apr2021 and physical therapy. Patient went off the medications the doctors gave her on 28Apr2021, choosing to tolerate the pain. The pain to this day, somewhat diminished. The events resulted to a Doctor or other healthcare professional office/clinic visit. Events were assessed as serious, disability. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events, musculoskeletal pain, dyssastia, groin pain, pain in extremity, arthralgia, postural dizziness, hypoesthesia, feeling abnormal cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
78 2021-05-25 diarrhea diarrhea; Tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer spons... Read more
diarrhea; Tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 78-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 25Feb2021 in left arm as 1st dose, single for COVID-19 immunization. Medical history included allergic to soy and dairy products, allergic to naproxen, diabetes, high blood pressure, supplementation therapy. Patient previously took and statins and developed joint pain. Concomitant medications included metformin 500mg 2 tablets in the morning and 1 tablet at night for diabetes, lisinopril 20mg twice a day by mouth for high blood pressure, vitamin d3 at 50mcg once a day by mouth as supplementation therapy. It was reported that metformin, ER > She said that she thinks she is over medicated. No further details provided. Vitamin D3, extra strength. stated that they put white writing on a white label. 31Jan2022, Lot 20123519, natures way. Patient was calling about the Covid-19 vaccine. She said that she had a reaction she believes. She said that she had the shot between 10-1030 today (25Feb2021) and left the facility and was home by about 1130 and all of a sudden she had a overwhelming diarrhea attack with no warning or anything. She did not eat anything to cause it. She said that she is afraid to take the next shot. She said that she had allergies to Statins and Naproxen and they make her throw up. Patient clarified that Statins gave her joint pain, but she does not remember what the drug names are. There was another drug that she got muscle cramps and joint pain, but she was unable to provide that information. She can not take Zetia and had a reaction. She said that she always throws up from pain killers. Patient had no NDC, lot, or expiration date for any of the above mentioned medications. It was samples that the doctors gave her. She said that some of them made her joints locked up and the others caused muscles cramps. No further details provided. She said that she was tired and did not sleep last night. Patient said that she shrunk. Patient said that it was just one episode of diarrhea at this time. She said that she was also very tired. She was tired for about a hour and it went away,. She is still a little tired, not the overwhelming tiredness she had earlier. She said that she was doing a puzzle and could not even focus on it. She had to lay her head down on the table to rest. She said that there was a little bit of pain when they stuck the needle in her arm, but no pain since. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
78 2021-05-31 diarrhea I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back... Read more
I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back home and I had extreme fatigued for a whole month and my husband would have to wake me up three times a day to feed me, I have severe head aches, my kidney level functioning drop to above 50, then the second month I would sleep 3 3 hour nap for the day, I could not get my stamina back. I went about 2 days later to the doctor. She did some blood tests, I have had 4 of them, and all of them have been fine. Now is month 4 and I am slowly recovering, my heart doctor gave me Colchicine and I have been on that for 5 days. I have to get up 7 times in the night to go to the bathroom for diarrhea. In the 29th of June I will have an ECHO cardiogram.
78 2021-05-31 nausea Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction... Read more
Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.
78 2021-06-04 GERD her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was s... Read more
her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was still burning; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 78-years-old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included macular degeneration. The patient's concomitant medications were not reported. Historical vaccine included tetanus vaccine on an unspecified date for immunisation. She got her first dose of the Pfizer Covid 19 vaccine on 25Feb2021 and thought she was having a reaction. She called her doctor and he said go get some Benadryl to make sure your throat doesn't get swollen. She went out and bought Benadryl and she took the Benadryl every six hours. Her doctor said don't get the second dose of the Covid 19 vaccine because these side effects she had are a warning and the second dose might not be helpful for her. The patient reported that she stayed at the facility that gave her the Covid 19 vaccine for 20 minutes and her husband was waiting for her. When she was driving away from the facility her tongue felt burned and then her mouth was burning and then her throat was burning on an unspecified date. She does have acid reflux but this wasn't like any acid reflux she's ever had. She got home and she drank some cool water but everything was still burning. By then it was almost supper time so she took 20 mg of Pepcid. Her mouth burned throughout her meal. She called her doctor again and he asked her if her mouth was swollen and she told him she didn't know. She took more Benadryl. One of her daughter's told her that the Covid 19 virus was so bad that she should get her second dose of the Covid 19 vaccine no matter how bad her reaction was. Her doctor told her not to get the second Covid 19 vaccine. She assumed it was a done deal. She wasn't going to get the second dose. She was supposed to get her second dose on 17Mar2021. She had gone to the doctor a couple times and each time he told her, do not get the second Covid 19 vaccine. He showed her the Pfizer Covid 19 vaccine print out with side effects. When her mouth started burning after she got the first Covid 19 vaccine her husband did ask her if she wanted to turn around and go back to the facility where she got the vaccine but she told him no. Now she's missed her second Covid 19 vaccine on 17Mar2021 because she thought that what her doctor told her was the final word. She was afraid to get the second Covid 19 vaccine and she wants to listen to her doctor because he knows what's best. During this Covid 19 virus time she was also diagnosed with Macular Degeneration. That's keeping her from driving and she's lost even more of her independence. She's heard if she gets the Covid 19 virus it can attack her eyes. Every time she hears the words fully vaccinated it makes her want to cry. She's worried that people won't want to be near her because she's not fully vaccinated. Her husband had both of his Covid 19 vaccines and he had no side effects. Her husband gets every vaccine on the market and never has any side effects. As far as she's concerned she feels like a pariah because no one will want to be around her because she's not fully vaccinated. Therapeutic measures were taken as a result of all events. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (02Jun2021): No follow-up attempts are completed; information about lot/batch number cannot be obtained.
78 2021-06-07 abdominal pain, retching, nausea, decreased appetite very serious extreme anxiety; nausea, severe nausea, where she couldn't eat; Severe Headache; Abdomi... Read more
very serious extreme anxiety; nausea, severe nausea, where she couldn't eat; Severe Headache; Abdominal pain; Dry heaves; she had a morbid feeling; feeling of doom; lost 13 pounds; hypothyroid went to hyperthyroid; Aversion to Food; Anorexia; nausea, severe nausea, where she couldn't eat; This is a spontaneous report from a contactable Nurse (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 10:50 (Batch/Lot Number: EJ1686; Expiration Date: 20Mar2021) as 2ND DOSE, SINGLE, vaccinated at the age of 78 years old for covid-19 immunisation. Patient received the first dose on 21Dec2020. Medical history included ongoing hypothyroidism Diagnosed 20 years ago, ongoing colitis, ongoing proctitis, ongoing diverticulum, ongoing gastrointestinal pain, and breast cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. Caller states she was told by a couple of doctors that she needed to report this. Caller states her first vaccine was 21Dec2021 and then her second dose was on 11Jan2021. Caller states four days after the second dose, she wound up in the ER with severe headache, abdominal pain, dry heaves and she had a morbid feeling. Caller states after that, she saw her doctor and for two months she had problems with nausea, severe nausea, where she couldn't eat, lost 13 pounds, hypothyroid went to hyperthyroid, very serious extreme anxiety, which she is still battling. Caller states the Endocrinologist felt it could've been associated with the vaccine. Caller states the ER ran tests and abdominal scans and all they showed were the usual things she knew she had, nothing new. Caller states she asked the ER doctors, and they said they didn't know if it was related and when she asked Endocrinology, they said they don't know for sure. Caller states her Primary doctor said it could be related, anytime a person has a vaccination, if they are immunocompromised or have inflammation, it can possibly trigger this and events occur. Caller states she had dry heaves, an aversion to food, lost weight, and had terrible anxiety, all four days after vaccine. Caller states after the first vaccine, she was fine. Caller states after the second vaccine, she woke up that morning four days after, it was acute, this had never happened before and she had a feeling of doom and dry heaving. Caller states it took her two months, before she started to eat and put the weight back on. Caller states the nausea is gone and she is able to eat and put weight back on. Caller states she still has extreme anxiety and she is seeing a doctor for that and is being medicated so it is persisting by improved with medicaiton. Caller repeats, this all happened four days after her second injection. Caller states no one knows that much about the vaccine but they said something that this reaction should be reported. Caller states the nausea and other GI issues lasted for about two months, but she can't give actual dates of when it recovered. Caller states she doesn't know dates of when the other side effects recovered, but they only thing she still has is the anxiety. Seriousness: Caller states the Nausea was disabling, she couldn't eat at all, she had to drink ensure and boost. Caller states the rest were medically significant. She was worked on by her PCP and Endocrinologist, and they adjusted her thyroid medication to bring back down her levels, and she is sure that is part of the reason for her anxiety and anorexia. Caller states before she had hypothyroid. Treatment: Suppositories, Zofran, Reglan, Anxiety Medication, Adjustment of the thyroid medication Synthroid. States when she lost an extreme amount of weight, her thyroxin increased, so they dropped her dose to the normal range. Causality: Caller states she feels it is related because it was an acute onset and rare for her, even though she is older, she is healthy. Caller states she has had breast cancer but nothing that stopped her from working. Caller states it is hard to know, but she thinks it is related. Caller states her one son was home and called and said mom looks like she is going to pass out and she is not an alarmist and usually would say no, but she said yes, he better make sure that she gets to the ER, she felt impending doom, with abrupt onset. Tests: Caller states they did an Endoscopy and Colonoscopy because of her abdominal pain and they found colitis and proctitis and every, itis, a person can think of along with diverticulosis and inflamed gut, but she already had those, they were not caused by the vaccine, she had them in the past. Outcome of anxiety was recovering, of others was recovered in Jan2021.; Sender's Comments: Based on the temporal relationship between events anxiety, nausea, headache, abdominal pain, retching, malaise, weight decreased, hyperthyroidism, decreased appetite, eating disorder and company suspect BNT162B2, the causal relationship cannot be denied. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
78 2021-06-07 nausea Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report fro... Read more
Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving. Follow-up attempts are completed. No further information is expected.
78 2021-06-08 abdominal pain She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her ... Read more
She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; Feeling that her shoulder is killing her.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; she also have a sharp pain in her belly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 30Apr2021 as a single dose for covid-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route on an unspecified date. The patient's medical history included diabetes. The patient's concomitant medications were not reported as single dose. It was reported that the patient felt that her shoulder was killing her. The patient stated that the pain was up to her neck and does not let her raise her arm. The patient also stated that she also had a sharp pain in her belly which did not had it ever before all on 19May2021. The patient also stated that she was also a diabetic and has high eye pressure. Patient called her doctor this morning and could not find him so she she left a message. Patient did not want to go to the ER and she wanted to know why she was having these adverse reactions after 20 days of taking the vaccine. The patient was explained about the reports of muscle pain and pain in the injection site, the possible duration and being more intense after the second dose. The patient was recommended to consult her physician to determine the cause of her pain. Therapeutic measures were not taken as result of AE. The outcome of the events was unknown. Information on lot number/batch number was requested.
78 2021-06-09 decreased appetite Had spinal surgery 5/16 and was at an inpatient rehab facility until 6/3 where discharged and then r... Read more
Had spinal surgery 5/16 and was at an inpatient rehab facility until 6/3 where discharged and then readmitted back to Hospital on 6/4 due to spinal complications. She was then discharged on 6/9/2021 to home. Thus case was readmitted due to spinal surgery complications, not due to to COVID.
78 2021-06-16 nausea Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy... Read more
Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.
78 2021-06-24 nausea nausea; tired/every day since receiving the product, she has had extreme fatigue; This is a spontane... Read more
nausea; tired/every day since receiving the product, she has had extreme fatigue; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 78-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medicine. Patient had no other vaccines on the same day as the COVID vaccine. On 03Feb2021, the next day after receiving Pfizer COVID vaccine, the patient was very tired. On the third day, the patient became even more tired. Patient also had nausea, but that comes and goes. Fatigue does not go away and every day since receiving the product, she had extreme fatigue. Patient had been on high blood pressure medications for a long time, so she thought that could have done it. The clinical outcome of the event was tired/every day since receiving the product, she has had extreme fatigue was not resolved and the clinical outcome of the event nausea was unknown. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
78 2021-06-29 abdominal distension, diarrhea, flatulence neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of... Read more
neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
78 2021-06-29 decreased appetite, abdominal discomfort, diarrhea feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; ... Read more
feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; weak; This is spontaneous report from contactable consumer. This consumer (patient) reported that a 78-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot Number: EW0170), (at the age of 78-years-old) via an unspecified route of administration on 28Apr2021 at 15:00 (Wednesday afternoon) on right arm as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after received shot she had been sick ever since. She has been taking two Tylenol every six hours. On 28Apr2021, the patient feels lightheaded when she gets up, fever and chills at night, headache, stomach upset, could not eat up until today and stated that she ate jello, diarrhea, stated that she did not known if she can drive or not that she was weak, aches all over and that the other day when she had the headache that Tylenol would not take it away. Stated that she was okay when she got it and it took 4 hours to get sick. Stated that she could not even drive. Stated that she had Covid on 28Jan2021 and waited 90 days to get the shot. The patient treated herself by using cold packs. The outcome of adverse events feels lightheaded, stomach upset, diarrhea, weak and aches all over was not recovered. On 29Apr2021, fever, chills were recovered. On 30Apr2021, headache was recovered. The outcome of adverse event could not eat was unknown. No follow-up attempts are needed. No further information is expected.
78 2021-06-29 diarrhea, flatulence gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneo... Read more
gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
78 2021-06-29 GERD Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she exp... Read more
Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
78 2021-06-30 difficulty swallowing, abdominal pain upper dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose ... Read more
dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.
78 2021-07-06 nausea, diarrhea, abdominal pain Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Pos... Read more
Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Positive 7/6/21 7/6/21: The patient presents to ED with diarrhea and Pt is 78 y/o female who presents to the ED complaining of chronic diarrhea onset since March that worsened over the last two weeks. Pt has had a cough as well. Pt has had a previous colonoscopy, but was told by GI that it was "too soon to have another." Pt denies any recent antibiotics, recent sick contacts, or recent travel. Pt states she is diabetic and her sugars have been 112 in the morning and 150 in the evening. Pt denies any abdominal surgery. Pt admits to cough, nausea and back pain, but denies vomiting, bloody stools, fevers, chest pain, shortness of breath, and abdominal pain aside from a pain that occasionally radiates down to her pelvic which she does not have currently. Pt denies a bowel movement today. Pt admits to both Covid-19 vaccine doses in March. Pt received the Pfizer vaccine.. The onset was chronic. The course/duration of symptoms is worsening. The character is not bloody. Risk factors consist of not recent antibiotic use, not infectious exposure and no recent travel. Associated symptoms: abdominal pain, nausea, cough, denies vomiting, denies fever, denies chest pain and denies shortness of breath. Patient seen examined emergency department for chief complaint of diarrhea that has been present for several weeks. Patient has seen her GI doctor. She states that stool cultures were obtained. Stool cultures reviewed, which demonstrated all negative stool cultures. Due to patient's persistent diarrhea, workup was obtained to rule out acute dehydration verses AKI verses electrolyte abnormality. Workup obtained demonstrates no acute findings. Patient was updated results. On reexamination, patient states he has had no episodes of diarrhea in the ED. This juncture, I believe patient is stable for discharge home with close follow-up with GI. Patient is agreeable. Return precautions are discussed, including change in mental status, decreased urinary output, or any other concerns..
78 2021-07-06 nausea, vomiting Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started... Read more
Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.
78 2021-07-06 vomiting, nausea Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ... Read more
Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.
78 2021-07-08 indigestion severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneo... Read more
severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date. No follow-up attempts are needed; Information about lot number cannot be obtained.
78 2021-07-12 abdominal pain upper hives, vertigo, dizziness, knee pain, paralysis of knees down. severe stomach pain.
78 2021-07-19 difficulty swallowing Patient started to have trouble breathing around February 10th. She also complained that she couldn'... Read more
Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.
78 2021-07-27 nausea, decreased appetite, diarrhea and really horrible radiating pain down both of her legs, front and back.; She also said there was n... Read more
and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/ weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
78 2021-07-27 nausea, diarrhea high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was ... Read more
high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.
79 2021-01-04 vomiting, nausea pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, ... Read more
pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
79 2021-01-08 diarrhea Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minu... Read more
Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.
79 2021-01-12 nausea, diarrhea dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (pat... Read more
dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient non-pregnant received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13246), via an unspecified route of administration on 06Jan2021 13:00 at single dose in right arm for covid-19 immunization. Medical history included arthritis. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. The patient experienced dizziness, weakness, nausea, diarrhea on 07Jan2021. The patient was not received any treatment. The outcome of the events was not recovered.
79 2021-01-12 vomiting Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hour... Read more
Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hours later another seizure at the home, with emesis, Sent to hospital at 2pm. Focal Status elepticus. Seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED. Seizure during the CT scan.
79 2021-01-14 abdominal pain upper Started getting headache within minutes of shot. Bad body aches for about 12 hours. Everything a... Read more
Started getting headache within minutes of shot. Bad body aches for about 12 hours. Everything ached and couldn't get comfortable to sit, stand, lay down. Stomach cramps that doubled me over lasted for a few hours. Last 4 hours could barely walk. Husband had to help walk me to the bathroom. Chills and shaking and could not warm up after the 1st hour through the rest of the night! Everything started going away about 1:00 in the afternoon and felt better at 2:00.
79 2021-01-17 nausea, decreased appetite She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nause... Read more
She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it. She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day. It looks like it would get better by now, but it hasn't. She never runs a temperature, but she has now (unspecified date). She is still freezing to death on unspecified date. She usually has a good appetite. Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
79 2021-01-18 nausea Tired, headaches, muscle pains, chills, stiff neck, overall unwell feeling, joint pain, nauseous
79 2021-01-21 diarrhea Terrible diarrhea
79 2021-01-23 nausea, vomiting, decreased appetite Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/... Read more
Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/throwing up Fever No appetite
79 2021-01-23 nausea She experienced nausea that was treated with ondansetron.
79 2021-01-25 retching Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my tee... Read more
Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.
79 2021-01-26 difficulty swallowing WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE,... Read more
WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.
79 2021-01-26 nausea Nausea, dizziness
79 2021-01-27 diarrhea slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache;... Read more
slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine. Information on the batch/lot number has been requested.
79 2021-01-27 nausea Extreme dizziness some nausea headache loss of balance
79 2021-01-30 nausea Chills and nausea
79 2021-01-31 nausea Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated bl... Read more
Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.
79 2021-01-31 nausea Little nauseous; This is a spontaneous report from a contactable consumer. A 79-year-old female pati... Read more
Little nauseous; This is a spontaneous report from a contactable consumer. A 79-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus, hyponatraemia, Macrocytic anemia, Bad back and visual impairment. There were no concomitant medications. The patient previously took tylenol and tramadol for back pain. The patient experienced little nauseous on an unspecified date. The outcome of the event was unknown. Information on the batch number/lot number has been requested.
79 2021-02-02 diarrhea, abdominal discomfort urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going... Read more
urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient
79 2021-02-02 vomiting, nausea, diarrhea Felt fine the day of event, during the night she felt like she had a heavy head, but when she woke u... Read more
Felt fine the day of event, during the night she felt like she had a heavy head, but when she woke up around 8:00 and she realized that something was very wrong, she could not sit up due to nausea and the room spinning. She texted her daughter who is a nurse and got there about 1:00 PM, she was still in bed. When she tried to sit her up she felt like she was going to throw up. She put her legs over to the side of the bed, and she felt like somebody was pushing her with her daughter over a cliff, in a tornado and on a Ferris wheel. She started vomiting and having diarrhea. She had heard about an epley maneuver and after a time she sat her up again and still had the previous feeling of going off a mountain in a tornado. She did the epley maneuver and tilter her head to the left and was still very dizzy but not as bad. She then tilted her head to the right and it was not as bad. Things started to settle down and eventually she was able to get up, still nauseated but 90% better. She was able to go to the restroom with her daughter's help. She stayed in the bed all that day and finally in the evening was abler to keep food down. She limited her distance to the bed to the bathroom. Her doctor was notified and called in some nausea and vertigo medicine (meclizine), which he did and only took 2 doses of that. The next morning she went up and down the stairs to make sure she was able to. She was very, very cautious but each day has been better. On 2/2/21 she called and got an APT with ENT but will not see him in a couple of weeks. They are going to send a therapist tomorrow to evaluate her for the vertigo. She is scheduled for the 2nd vaccine on 2/11/21. Saw her internist today and he evaluated her and did 2 blood tests and sent the referral for the therapist to come tomorrow.
79 2021-02-02 vomiting vomited x 2 later that day
79 2021-02-04 diarrhea, abdominal pain, GERD diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat... Read more
diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown. Information on the lot/batch number has been requested.
79 2021-02-04 nausea, abdominal pain Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (fel... Read more
Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (felt paralyzed), fever (100.5) 12-15 hours after shot, nausea and moderate abdominal cramping morning after shot, extreme fatigue for 1 week following shot
79 2021-02-04 vomiting, abdominal discomfort Stomach uncomfortable; Vomiting; Had cough that would not quit; This is a spontaneous report from a ... Read more
Stomach uncomfortable; Vomiting; Had cough that would not quit; This is a spontaneous report from a contactable consumer (patient). This 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL3246), via an unspecified route of administration on 21Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. Patient took COVID 19 vaccine was because of her age group and risks. The patient experienced stomach uncomfortable, vomiting and had cough that would not quit, all on 21Jan2021. Clinical course reported as follow: patient stated she had yesterday that got first COVID vaccine. Stated that she had it at 9:00PM. Stated that she was fine until 3:30. Stated that her stomach was uncomfortable. Stated that at 7:00 she started vomiting for 4-5 hours. Had a cough that would not quit that started at 7PM. Patient stated that her stomach and cough resolved at midnight. Stated that she recovered completely from both. No treatment received. Outcome of the events was recovered on 21Jan2021. No investigation assessment.
79 2021-02-05 decreased appetite Soreness at the site in injection. Couldn't sleep that entire night. Woke up with sweats and chill... Read more
Soreness at the site in injection. Couldn't sleep that entire night. Woke up with sweats and chills. Felt absolutely exhausted the following day with little to no appetite. Slept soundly (unusual for me) that night and felt absolutely fine the next day.
79 2021-02-07 abdominal pain soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is... Read more
soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular at single dose for COVID-19 immunisation on 20Jan2021, at 05:30 PM. The patient did not receive other vaccine same date. Relevant history included apnea, depression, high blood pressure, reflux, 2 strokes, restless legs and allergies with Clarithromycin, compazine, Hydrocodone; kiwi, peppers. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination. Relevant concomitant medications in two weeks includes amlodipine, atorvastatin, duloxetine, plus more. The patient did not receive other vaccine in four weeks of vaccination. The patient experienced soreness at site, swelling at site, fatigue (slept for 12 hours next night); abdominal pain (may be unrelated) since 20Jan2021 at 08:00 PM. The events reported as non-serious. Treatment therapy included Acetaminophen. Outcome of events was resolved. Information about lot/batch number has been requested.
79 2021-02-07 diarrhea Patient reported fever 101.9F for atleast 24hrs after vaccination, fatigue, diarrhea, chills, and he... Read more
Patient reported fever 101.9F for atleast 24hrs after vaccination, fatigue, diarrhea, chills, and headache
79 2021-02-07 nausea Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a ... Read more
Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program Pfizer First Connect. A 79-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. Medical history included gastroparesis. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), mirtazapine, calcium, colecalciferol (VITAMIN D). It was reported that the patient got the vaccine on the 13Jan2021. Wednesday and Thursday night, she was fine. On Friday (15Jan2021), she started getting nausea and chills. Then Saturday she was ok again. Then Sunday the nausea came back. She had had nausea since then. It comes in waves. When it is kind of mild, she doesn't feel so bad. This morning it has been bad. It makes her tired when the nausea gets like this. It may subside during the day. When she firsts get nausea, she gets hot flash. The patient's arm got a tad sore, but only a little. The outcome of the event chills was recovered on an unspecified date, nausea was not recovered while unknown for the other event.
79 2021-02-08 difficulty swallowing About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriente... Read more
About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.
79 2021-02-09 diarrhea, abdominal pain upper Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became ho... Read more
Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.
79 2021-02-09 nausea Dizziness and nausea began overnight on Feb 4-5, continuing throughout the day on Feb 5. Went to ER ... Read more
Dizziness and nausea began overnight on Feb 4-5, continuing throughout the day on Feb 5. Went to ER for treatment the evening of Feb. 5. IV fluids administered to treat mild dehydration. Symptoms eased temporarily, then increased on Feb 6. As of today (Feb 10), symptoms have steadily improved, but not yet fully recovered.
79 2021-02-09 vomiting, diarrhea, nausea Client reports developing shingles after vaccination on right side of face and has right eye involve... Read more
Client reports developing shingles after vaccination on right side of face and has right eye involvement. Client reports started with runny nose and watery eyes on 2-1-2021. Was recommended to get COVID-19 testing which was completed on 2-2-2021 and results returned negative. Client was given prescriptions for amoxicillin and prednisone dose pack on 2-2-2021 by COVID testing site practitioner. Client then developed nausea, vomiting and diarrhea after starting amoxicillin and stopped taking it. She spoke with her MD who placed her on another ATB, which she has not taken. On 2-4-2021, she went to the ER as recommended by her PCP for dehydration. The ER noted eye swelling and that she had increased eye pressure after running some tests. She saw her eye doctor on 2-5-2021 and is scheduled for an MRI and MRA on 2-11-2021 and will follow-up with eye doctor on 2-12-2021 as well.
79 2021-02-11 nausea Chills and fever. It was only 99 and later in the day it was 99.5 and nausea. Weakness.
79 2021-02-11 nausea Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness... Read more
Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness.
79 2021-02-11 nausea slight nausea off and on for about a week, rashes on arms and back -- no treatment -- nausea still p... Read more
slight nausea off and on for about a week, rashes on arms and back -- no treatment -- nausea still present occasionally
79 2021-02-12 diarrhea Headache coughing fever diarrhea sweats mucus
79 2021-02-14 nausea Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Sys... Read more
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
79 2021-02-15 nausea Severe dizziness and nausea since Saturday 2/13/2021 . Called doctor who prescribed medication. Nau... Read more
Severe dizziness and nausea since Saturday 2/13/2021 . Called doctor who prescribed medication. Nausea has abated, but dizziness is still an issue. This is the fourth day.
79 2021-02-18 nausea Feeling very ill and listless. Bad nausea with no vomiting.
79 2021-02-24 nausea, abdominal pain upper Headache, stomach cramps, dizziness, shaking, fatique, joint pain, nausea
79 2021-02-24 nausea injection site soreness, tired, chills, nausea, headache
79 2021-02-25 decreased appetite day after shot--fatigue, headache, body aches, no appetite, no energy
79 2021-02-27 nausea Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted ... Read more
Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted about 24 hours.
79 2021-02-28 diarrhea, vomiting 2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild co... Read more
2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild cognitive impairment) 2/28 - vomiting and diarrhea
79 2021-03-01 difficulty swallowing Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital fo... Read more
Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.
79 2021-03-01 nausea tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during... Read more
tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment
79 2021-03-02 stomatitis, vomiting, abdominal discomfort nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; ... Read more
nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.
79 2021-03-03 decreased appetite Achy body, backache, neck ache, weak, low appetite, losing weight, no energy
79 2021-03-04 decreased appetite At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I... Read more
At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I knew I wasn't feeling well. I wan not hungry and as a result only had a cup of tomato soup with cracker that day. Later in the evening I had a cup of warm milk. Periodically I would have chills and muscle aches especially in my legs. I went to bed early and am much better today. I am also getting my appetite back.
79 2021-03-05 vomiting, nausea Dizzy, nausea and vomiting 11:00 AM
79 2021-03-06 diarrhea, abdominal discomfort At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a ... Read more
At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.
79 2021-03-09 nausea 1120 Rec'd vaccine; while checked on, no complaints At 1140, let nurse know with further questioning... Read more
1120 Rec'd vaccine; while checked on, no complaints At 1140, let nurse know with further questioning, upon sitting after vaccine, slight nausea and lightheadedness, headachedenied issues with shortness of breath, no swelling of lips, no apparent hives/itching, slightly improved. Notes walked quite a far way from parking lot; would now like wheelchair ride back . BP 120/70 ; HR 52-58 notes on metoprolol; p ox 96%. Monitored another 10-15 minutes, took sips water; felt ready to go. Knows to seek medical attention if further symptoms. Encourage to follow up with MD re: tiredness, low pulse; notes it is normal for her in 50s/60s.
79 2021-03-10 nausea, vomiting Pt's daughter called around 4:30pm on 3/11/21 (day 2 post vaccination on 3/9/21) reporting that pt w... Read more
Pt's daughter called around 4:30pm on 3/11/21 (day 2 post vaccination on 3/9/21) reporting that pt woke up feeling nauseous all day & vomited profusely at 4:00pm. Advised to stay hydrated and take nausea medication patient had at home & to call back with any changes. If not improved in 6-12 hours, advised to call physician for evaluation.
79 2021-03-11 nausea severely cold, short of breath, exhaustion, muscle pain, nausea, fast heart rate, dizzy, weak
79 2021-03-12 painful swallowing Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when sh... Read more
Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.
79 2021-03-14 diarrhea, abdominal pain fatigue, diarrhea, body aches, chills, sore throat, runny nose, headache, abdominal pain lasting for... Read more
fatigue, diarrhea, body aches, chills, sore throat, runny nose, headache, abdominal pain lasting for 2 weeks and not improving
79 2021-03-15 nausea Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old fe... Read more
Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration on 02Feb2021 at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing stage 4 lung cancer from Dec2019 and chemo from Apr2020. The patient had no concomitant medications. On 02Feb2021, the patient experienced nausea and chills. The patient reported that she had her first Pfizer shot on 02Feb2021. She had just a few problems in the middle of night afterwards- nausea and chills. That night she had nausea and chills. It lasted for about 30 minutes. She just laid in bed. She was fine after that and was fine the next morning. Outcome of the events was recovered on 02Feb2021. Information on the Lot/Batch Number has been requested.
79 2021-03-15 nausea nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling ... Read more
nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc. The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.
79 2021-03-15 nausea sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in add... Read more
sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media
79 2021-03-16 GERD Chills; acid reflux; This is a spontaneous report from a contactable consumer. A 79-years-old female... Read more
Chills; acid reflux; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 05Feb2021 as single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 14Jan2021 (lot number: EK9231) for COVID-19 immunization. The patient mentioned that she had to go to the doctor with acid reflux on 06Feb2021. She was taking some medication for the acid reflux and it was getting better. On 12Feb2021, the patient was having some chills. The patient was feeling a little bit better because she took a Tylenol. The outcome of the events was recovering.
79 2021-03-16 nausea, flatulence, diarrhea, vomiting After 4 1/2 days, I developed retching and diarrhea. Day 2, the retching stopped, but, I had mild n... Read more
After 4 1/2 days, I developed retching and diarrhea. Day 2, the retching stopped, but, I had mild nausea for 26 days. Still, after 31 days, I continue to have mild diarrhea and intestinal mucus, and enough intestinal flatulence to fill a hot air balloon.
79 2021-03-16 nausea, vomiting nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to per... Read more
nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities, took bonine and tylenol
79 2021-03-17 decreased appetite Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, ... Read more
Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.
79 2021-03-18 diarrhea Body hurts everywhere, major diarrhea and going many times a day that stool looks mainly clear no si... Read more
Body hurts everywhere, major diarrhea and going many times a day that stool looks mainly clear no signs of blood. Lots 4 lbs in three days
79 2021-03-21 nausea, vomiting On 3/11 pt reported severe n/v to pharmacy - called back 3/12 to state sx resolved. On 3/22 pt call... Read more
On 3/11 pt reported severe n/v to pharmacy - called back 3/12 to state sx resolved. On 3/22 pt called back stating sx started again 3/13 and lasted thru the week. Pt currently in emergency room post fall on 3/21 and getting fluids for severe dehydration
79 2021-03-21 nausea I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed ... Read more
I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021. Information on the lot/batch number has been requested.
79 2021-03-22 decreased appetite, vomiting It started with a feeling as though I was getting a sore throat. I took an Emergen-C drink and wen... Read more
It started with a feeling as though I was getting a sore throat. I took an Emergen-C drink and went to bed at normal time. I also had more drainage than normal from my head. During night I felt a fierce sore throat. Next day, sinus headache, slight sore throat, additional drainage from head. Last meal that day was lunch. Going to bed, I vomited. Next day, sinus headache, drainage, cough and yellow phlegm from lungs--a cough. Took Tylenol during these times. Vomited before bed. Next day I took Alka-Seltzer Plus Cold meds in a.m. and again in afternoon. Felt better. Ribs very sore from coughing. Appetite began returning. Congestion much improved. Following day (today) still congested but improved. No meds so far today.
79 2021-03-23 diarrhea Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart ... Read more
Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.
79 2021-03-23 diarrhea Heavy Head; Tired; Chills; Diarrhea Symptoms; This is a spontaneous report from a contactable consum... Read more
Heavy Head; Tired; Chills; Diarrhea Symptoms; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Jan2021 15:00 (lot number El 9269) and on 12Feb2021 17:30 (lot number EL9262), respectively, both via an unspecified route of administration in the left arm (at the age of 79-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: allergies to penicillium and sulphur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: atorvastatin, multivitamin, "vitamin C K E calcium". The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 09:00, 4 days after the first dose, the patient experienced heavy head, tired, chills and diarrhea symptoms, lasted about 6 hours. The patient had to take 2 antidiarrhea pills. Seven days after the second dose, the patient experienced the same symptoms for the same amount of time. The patient did not receive treatment for heavy head, tired, chills. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
79 2021-03-23 vomiting, nausea First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. F... Read more
First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.
79 2021-03-25 nausea Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day... Read more
Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,
79 2021-03-25 nausea bad memory, weak, extreme nausea, hallucinating,
79 2021-03-25 vomiting Initial rash on forehead after first injection. After second dose several weeks later she immediatel... Read more
Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.
79 2021-03-27 diarrhea She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contacta... Read more
She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via unspecified route of administration on 01Mar2021 at 14:00 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient called to report that her second dose is due on 25Mar2021 (24 days after the first dose) and wanted to know if this is ok to do. She stated that she had 20 hours of diarrhea yesterday (10Mar2021) and today (11Mar2021), she has not had a bowel movement. The events did not result to emergency room/ physician clinic visit. The outcome of the event 20 hours of diarrhea was recovered on 11Mar2021 while the other event was unknown.
79 2021-03-28 decreased appetite, nausea Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - ... Read more
Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)
79 2021-03-29 nausea presented with chest pain onset around 1800 this evening. She describes it as "an elephant sitting o... Read more
presented with chest pain onset around 1800 this evening. She describes it as "an elephant sitting on [her] chest" that began suddenly and was constant until she received pain medicine in the ED. She had associated shortness of breath and nausea. She did receive her COVID-19 vaccine today. She denies fever, chills, cough, vomiting, abdominal pain, diarrhea, constipation, urinary sx.
79 2021-03-29 vomiting HEADACHE,SLEEPY AND VOITING 2 DAYS.
79 2021-03-30 abdominal pain, diarrhea belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch... Read more
belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263 ), dose 1 administered in Arm Left on 29Jan2021 11:15 as single for covid-19 immunisation. Medical history included breast cancer from 1984 and it was fully recoverd and cured. The patient's concomitant medications were not reported. It was reported that On 29Jan2021 03:00 PM after 3 hours of vaccination patient experienced felt belly cramps, watery bowel. Felt tired, had nap. Much better evening. No pain or red at injection site just little tender to touch. It was reported that all the events were recovered.
79 2021-03-30 nausea not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is... Read more
not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.
79 2021-03-30 vomiting, diarrhea This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.
79 2021-04-01 vomiting delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spont... Read more
delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant). No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
79 2021-04-03 diarrhea my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I cou... Read more
my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I could not walk, it was like I was drunk; pulse rate was like 116; O2 stat was like 98 percent; headache; diarrhea; short of breath when I walk up to the stairs; blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's; This is a spontaneous report from a contactable Nurse (Patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included High cholesterol. Concomitant medication(s) included rosuvastatin (40, not clarified further); aspirin [acetylsalicylic acid] (ASPIRIN) (81, not clarified further); zinc (50, not clarified further); alendronate sodium (Generic Fosamax) and Multivitamin. Historical Vaccine included First dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and experienced sore arm (The sore arm went away, it descended in about 12 hours and gracely went away), got really tired and itching (It started itching, okay no problem). The patient experienced my arm is a little bit sore on an unspecified date, shivering on an unspecified date, I was so cold on an unspecified date, I ached all over on an unspecified date, I am getting the flu on an unspecified date, I could not walk, it was like I was drunk on an unspecified date, pulse rate was like 116 on an unspecified date, O2 stat was like 98 percent on an unspecified date, headache on an unspecified date, diarrhea on an unspecified date, short of breath when I walk up to the stairs on an unspecified date, blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's on an unspecified date; all (non-serious). Reporter (Nurse) stated "I had my first Pfizer vaccine on Friday, I think 22Jan2021 and the only thing I have was the sore arm and got really tired okay and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching, okay no problem. I had my second vaccine this past Friday at about 8 O'clock between 8:15 in the morning. As the day went on I felt my arm is a little bit sore, no problem. Okay I went to bed and about 3 O'clock in the morning, I woke up and I was shivering, I was so cold and I ached all over and I said okay I am getting the flu, went back to sleep, by the time I got up in the morning about 6 o'clock the aching was gone but I could not walk, it was like I was drunk. I have a little dog and she was barking to go out and it was like 0 here so I sat there for a minute and I left her out and she started barking, to bring her back and I could not walk, I kept walking into the walls and my house was just this dark, I thought it's so dark in my house so I got my little dog back in, sat down and again and I thought what, maybe I will take my blood pressure, so I did and it was 66 over 48 so I though okay, so I started drinking, I thought I got to eat, I got to drink, so I get that, my pressure came up to 80 over 62 or something, my pulse rate was like 116, my O2 stat was like 98 percent so that was not a problem. So, I ate and drink, as the day went on the pressure came up to like about 103, gradually last night by the time I went to bed, the only thing I had was a little bit of headache, I did not thought enough to take anything for, when I went to bed, my pressure was like 120, the systolic was 120 and diastolic was like 70 something, this morning when I got up my pressure was in the 90's. I was not taking any blood pressure medication, I mean I have but doctor took me off long time ago, I did not I mean I have no aches, I have no pains, I have nothing just a little bit of headache, not even enough to bother me, every now and then I think about it, I also, I mean I thought I have got to the bathroom, I had diarrhea terribly, something, I did not know if any of this is from the vaccine. I have not called my primary, I thought I called him tomorrow I mean I am fine, I am little short of breath when I walk up to the stairs but that is nothing unusual." Causality: Reporter stated "I don't know, I am thinking it does I never had anything like this before but you know I don't know, I don' know, I am just reporting it, I am 79 so I don't know how much this is, I don't know." When probed from where reporter got the vaccine, Reporter stated "I got it the first one at (Institute name)." LOT# of COVID-19 Vaccine administered on 22Jan2021: Reporter stated "You know it's not on my little card, just the LOT# of second one is on here. The first vaccine was 22Jan2021, the second one was 12Feb2021." Reporter provided the LOT# as EM9809 for second shot of COVID-19 Vaccine administered on 12Feb2021 and did not have LOT# of the first vaccine administered on 22Jan2021. Date of side effects: Reporter stated "I think when I started having difficulty was the morning of 13Feb2021." (Not clarified further). Still experiencing side effects: Reporter stated, "No, finally last, I felt yesterday I felt like I kind of had the flu, I have got to get the flu, but it was not enough to stop me, I kept going, I went to work, I did all my stuff, this morning I got up I felt fine." (Not clarified further). Treatment: Reporter stated: No, did not take anything, no. Other medications: Reporter stated "the generic 10 mg." (Not clarified further). Reporter stated "No I was just going to report this, like I said I don't know if this is a problem or not. I have never had anything like this before, I thought this is something you needed to know." Reason of delay: Daily spike of incoming calls due to COVID-19 Vaccine. The outcome of all events was unknown except for event I ached all over, outcome was recovered on an unspecified date.
79 2021-04-06 abdominal discomfort 79 y/o female complain of headache and "empty feeling in stomach." Vital signs checked by onsite EM... Read more
79 y/o female complain of headache and "empty feeling in stomach." Vital signs checked by onsite EMS. B/P 140/82, P 70. Client monitored for 35 minutes. Reported symptoms "better". Encouraged to follow up with ER or PCP if needed. Verbalized understanding.
79 2021-04-06 diarrhea suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tire... Read more
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.
79 2021-04-08 vomiting Pt had fever 102; stiff neck; blinding headache; vomit for 14 hours
79 2021-04-09 diarrhea headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredn... Read more
headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: May2021) on 27Jan2021 15:20-15:30 (at the age of 79-year-old) intramuscularly administered in Arm Left as single dose for prevention. The patient medical history were not reported and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. Vaccination facility type was reported as hospital and not a military facility. The patient called for information about if her symptoms could be related to the administration of the Pfizer's COVID-19 vaccine. The patient reported that she has massive diarrhea (08:30), projectile vomiting (10:00), fever (10:00), pretty serious muscle aches (11:00), tiredness (07:30), headache (13:00) and chills (08:30) on 10Feb2021. Events fever, Pretty serious muscle aches and tiredness were reported as worsened. The patient reported that she was administered with the first dose of the vaccine 2 weeks ago and she was feeling fine starting with the symptoms today (10Feb2021). The patient reported that she thought it was possible that she has been infected of COVID-19 virus. The patient reported that she considered herself a healthy 79-year-old woman. Received call from the patient regarding the Pfizer COVID 19 vaccine. She had the first vaccine two weeks ago today (10Feb2021). She was having massive Diarrhea, Chills, projectile vomiting, fatigue, muscle aches and fever. She started out with her normal body temp of 97.3 and this morning it was 98.2. She took it an hour later, and it was 98.4 and then it was 100 and now it was 100.2. That was why she was calling. She would like to know if these were side effects. She said she cannot think. She filled out two forms on the second day after the shot. It came up on her email and it listed the symptoms and said have you had any today. She was kind of fatigued today (10Feb2021). A week later she had pretty serious muscle aches and one more thing. The diarrhea was one massive one this morning and it got rid of everything. It was liquid. She has not had one since. Projectile vomiting was twice within 10 minutes of each other. It happened pretty fast at 09:30-10:00 this morning. She has not eaten anything at all. Muscle aches started at 10:00. The tiredness started before diarrhea and was progressively getting worse. Headache started an hour to hour and a half ago. Chills started at 08:00 and were worse for 2 hours and then got better. She could take off gloves and scarf around her neck but does not have chills now. Outcome of the events massive diarrhea, projectile vomiting and chills was reported as recovering. Outcome of the events fever, pretty serious muscle aches, tiredness and headache was reported as not recovered.
79 2021-04-09 nausea nausea, headache, pain in MCP joints of both hand - like trigger fingers. Lasted 4 hours.
79 2021-04-10 vomiting, diarrhea Vomiting and diarrhea two hours after shot. Foggy head for 4 days. Severe joint pain for for 3 days... Read more
Vomiting and diarrhea two hours after shot. Foggy head for 4 days. Severe joint pain for for 3 days. All ended 04/02/21 except for fatigue which has been ongoing.
79 2021-04-12 decreased appetite she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't wan... Read more
she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered. Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.
79 2021-04-17 decreased appetite about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below sit... Read more
about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown. No follow-up attempts are needed. No further information is expected.
79 2021-04-23 nausea immediate headache; extreme tiredness; dizziness; nausea; This is a spontaneous report from a contac... Read more
immediate headache; extreme tiredness; dizziness; nausea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry were not provided), via an unspecified route of administration, in right arm, on 06Feb2021 at 01:00 AM, as a single dose for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks prior to COVID vaccination. Patient's medical history included known allergy. Patient received unspecified medications within 2 weeks of vaccination. It was reported that on 06Feb2021 at 01:00 AM, the patient experienced immediate headache followed by extreme tiredness, and dizziness. Patient also had nausea after 3 days which lasted several days. Patient did not have COVID-19 prior vaccination and since the vaccination, the patient was not tested for COVID-19. No treatment was given to the patient for the events. Outcome of the events was recovered on an unknown date in Feb2021. Information on the lot/batch number has been requested.
79 2021-04-24 decreased appetite Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking;... Read more
Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.
79 2021-04-26 abdominal discomfort Exhaustion, fever/chills, upset stomach, headache - may have triggered fib - afib led to ICU on 4/22... Read more
Exhaustion, fever/chills, upset stomach, headache - may have triggered fib - afib led to ICU on 4/22/2021.
79 2021-04-26 diarrhea 1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sigh... Read more
1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.
79 2021-04-27 abdominal pain upper excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report fr... Read more
excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Right arm on 06Feb2021 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing Verbatim: Diabetes. Concomitant medications included metformin taken for diabetes mellitus from 2000 and ongoing insulin glargine (LANTUS) taken for diabetes mellitus from 2011 and ongoing. On Feb2021 the patient experienced numbness in hands, numbness in arms and on 24Feb2021 when she was in the kitchen she had excruciating cramps in her stomach. The patient would receive the second dose this Saturday. The clinical outcome of the events was not recovered except excruciating cramps in stomach was recovered on 24Feb2021.
79 2021-04-28 vomiting, diarrhea hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eye... Read more
hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown. Information on lot number/batch number has been requested.
79 2021-05-02 profuse gastrointestinal bleeding, abdominal pain upper, colitis Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hosp... Read more
Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena. 1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI 2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21. 3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup. 6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy. 7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB. 8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP 10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen. 11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol. 12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.
79 2021-05-04 nausea patient felt lightheaded and nauseous suddenly on the morning after the 2nd covid vaccine. she trie... Read more
patient felt lightheaded and nauseous suddenly on the morning after the 2nd covid vaccine. she tried to lower herself to the floor, but blacked out and hit her head, requiring staples. she is still experiencing extreme fatigue, which is unusual for her. she is highly functional at baseline.
79 2021-05-05 abdominal pain This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was a... Read more
This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was admitted on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
79 2021-05-06 nausea Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid v... Read more
Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date: Jul2018. Concomitant medications were not reported. On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy. She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated. States she does not know if that ties in with the vaccine or not. She states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021. The outcome of the events of not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown. .
79 2021-05-09 diarrhea Cough SOB Muscle or body aches, New loss of taste or smell, Congestion or runny nose and Diarrhea
79 2021-05-10 vomiting vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redne... Read more
vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
79 2021-05-13 diarrhea, vomiting, nausea Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: ... Read more
Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved
79 2021-05-18 nausea ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis wit... Read more
ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.
79 2021-05-25 diarrhea tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; ne... Read more
tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient). A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep. Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
79 2021-05-28 abdominal discomfort, diarrhea red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report... Read more
red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 79-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose of the vaccine she had side effects that included red blood bleeding during the 3-4 days that she had gastrointestinal upset, diarrhea, chills, and headache. The patient stated, the bleeding stopped, and she was doing better now but she was just upset and concerned with the bleeding. She did not know if she should receive the second dose. She would like to know should she receive the second dose after having this side effect. The Pfizer team responded as the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The Pfizer team referred patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events red blood bleeding was recovering, and the outcome of the events gastrointestinal upset, diarrhea, chills, and headache was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.
79 2021-05-28 decreased appetite sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneou... Read more
sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 22Feb2021 12:00 (at the age of 79-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, acid reflux and shell fish allergy. The patient's concomitant medications were not reported. On 24Feb2021 at 12:00 chills, fever, no appetite, weak, fatigue, sleepy and wanting to sleep all day. The patient did not receive any treatment for the events. The patient did not have COVID prior vaccination. She was not COVID tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
79 2021-05-28 nausea a few little chills; I started shaking violently from chills; severe muscle pains all through my bac... Read more
a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.
79 2021-05-28 nausea no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100... Read more
no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
79 2021-06-01 diarrhea, nausea, vomiting She got her vaccine, she had no symptoms. The following day had very little soreness and nothing el... Read more
She got her vaccine, she had no symptoms. The following day had very little soreness and nothing else. Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy. She did not have skin feeling funny like with regular flu, but mostly all intestinal. She changed her clothes and then was shivering and could not get warm, and had hard shaking chills. She slept very little and has had it continuous since the vaccine. She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat. Over the past week and a half has had the cold chills less, but has awakened moist. She is having the diarrhea and GI issues less, but feels nauseous at times during the day. She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before. It is not debilitating as much but still tired a lot.
79 2021-06-01 profuse gastrointestinal bleeding Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type
79 2021-06-01 nausea nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-... Read more
nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-year-old female consumer (Patient) reported that she started to receive BNT162B2 (BNT162B2, formulation: Solution for injection, vaccinated at the age of 79-year-old) via unknown route of administration from 21Jan2021 16:00 to 21Jan2021 16:00 at single dose daily for covid-19 immunization. Patient's medical history was reported that, I have allergy to penicillin and sulfur but this was 50 years. Felt like my throat and ears were closing. Concomitant medications were not reported. It was reported that caller she received the first dose of the Pfizer vaccination on 21Jan2021 at around 4 in the afternoon. She had a bad reaction. She drove 1 hour and 45 minutes away and she was fine that night. Caller stated, "The next morning, I was nauseous. I couldn't sit up. I had to call my daughter to help me sit up. When I tried to sit up. it was like it was I had to push (myself and my daughter) up a mountain in a tornado. I couldn't control my body even if you tried. It was a very severe reaction if not vertigo. It was awful. spinning widely, nauseous. I called the doctor and he prescribed some vertigo medication/nausea medication. We tried an Epley maneuver for vertigo. spinning uncontrollably. which ear it was in. did the epley maneuver itself. I couldn't bend down. The last week or so I've been cautious but ok, tried to seen ENT and I have a therapist to help me do that Epley maneuver again. I don't want to set off anything. I don't know if you had any reports of any like that? I'm due to get my next shot 11Feb2021 and I have to drive 2 hours again and will have to drive home again. I'm most concerned and my doctor feels I need to get the second dose too. I reported to VAERS. The outcome of events was "unknown". Information on lot/ Batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
79 2021-06-07 abdominal pain upper I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completel... Read more
I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
79 2021-06-07 diarrhea Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder w... Read more
Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder was sore; This is spontaneous report received from a contactable consumer (patient sister, Caregiver). This is report 1 of 2. This report is in regard to the reporter's sister. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, NDC number: Unknown, Expiry Date: Unknown), via unspecified route of administration on an unspecified date (about two months ago) as 2nd dose single for covid-19 immunization. The patient had History with Oral lichen planus From an Unspecified date and unknown if ongoing). Concomitant medications were not reported. Patient did not have any other product. Reporter stated that, she doesn't know the specific day of vaccination. It has caused diarrhea to the patient that has persisted for 8 weeks. GI doc gave Lomotil, and it helped a little bit. She has had to change her diet and cut out vegetables because it made the diarrhea worse. Patient was very depressed. Patient wanted to know if It was reported earlier and why would it cause the ongoing diarrhea. Patient had seen that that it causes sometimes severe diarrhea, but it didn't say how long it will last. Patient was concerning about if someone need to take an immunosuppressive medication to stop the diarrhea. She was afraid her doctor is going to tell her she needs to take an immunosuppressant medication. It also had stated like, if the Pfizer aware that people have to take medications that shut down the immune system. Upon follow up on 27May2021, reporter stated that, patient was very depressed (on unspecified date) about it. She had a tendency of having autoimmune problems, that she had oral lichen planus, sometimes called burning mouth syndrome. Her doctor diagnosed her with oral lichen planus, which is an autoimmune reaction to bell peppers, she was eating a lot of bell peppers. patient has a hyper immune system. She did not take any type of autoimmune medications no Humira or immunosuppressive medications. Patient took the COVID-19 vaccine 8 weeks ago and patient developed the diarrhea by the 4th day after the vaccine. Patient had never had diarrhea her entire life. Patient went into shock. Her sister's diarrhea was still ongoing. The gastro doctor gave her sister Lomotil and the Lomotil was working to a point, it prevents the worst of the diarrhea. Her stool was coming out very loose. Reporter did not have the NDC number, lot number and expiry date for the Lomotil, stating it was a prescription, chemical name called atropine or something (as reporter). Patient changed her diet and was becoming depressed. Normally, her sister is a person very concerned for her health and she would have a plant-based diet with multiple vegetables, and now her sister can't do that. patient felt her life depends on having a healthy diet. Patient had vaccinated at pharmacy or something, reporter was concerned that, patient got a good vaccination that was not corrupt in any way. Reporter was urging patient to get the vaccine because she travels and goes to a different country and this and that. So, she could be able to travel. patient has a hyperactive immune system, it appears so anyway. Reporter was using her own words when she uses the term hyperactive immune system, so this may not be medically accurate. Her sister has oral lichen planus which is a bad problem. patient was eating a lot of bell peppers. Bell peppers produce an immune reaction, because they contain a chemical called solanine. patient was eating a lot of bell peppers because the internet said they were healthy and contained a lot of vitamin A. she got an immune reaction to the bell peppers, and the immune reaction produced sores under her sister's tongue, very painful sores. Patient had side effects happen three or four days later after the vaccine- it started as diarrhea and she thought it would stop. Patient's shoulder was sore. reporter mentioned she doesn't know when patient's soreness began and ended. The soreness did completely go away for patient. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Event Did not require any visit to emergency Room or Physician Office. Prior Vaccinations within 4 weeks of the suspect vaccine and events following prior vaccinations were none. Patient's Family Medical History was related to the autoimmune stuff, clarified as the oral lichen planus. Patient had oral lichen planus and was previously treated with steroids. The oral lichen planus started with sores under her sister's tongue. Her sister was treated twice with steroids. Patient said the steroids were successful. Patient's sores were treated with a steroid once and then the sore returned so she went back to the same doctor, and the doctor treated her again with steroids. The second time, the sores went away. At that point, this condition was called burning mouth syndrome, which is on the internet, it was a known condition that is very painful. The doctor diagnosed it as burning mouth syndrome. The diarrhea her sister is experiencing was causing a psychological effect. Reporter stated that, there was no warnings of if a person who has an overactive immune system shouldn't take the COVID vaccine, there was no kind of warning. Reporter seriousness for all the events were Unspecified. Outcome of all the events were unknown. Information on the lot/batch number has been requested.
79 2021-06-09 profuse anal bleeding rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable co... Read more
rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day. She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.
79 2021-06-10 nausea, vomiting Patient had previously been feeling short of breath for about a month. She received the 2nd Pfizer c... Read more
Patient had previously been feeling short of breath for about a month. She received the 2nd Pfizer covid vaccine dose on 6/9 and felt nauseous the next two days. She came to the ED on 6/10 with nausea, vomiting, and lethargy. Found to be hypotensive, bradycardic, and in 3rd degree heart block. Suspect patient was already in heart failure and might have developed myocarditis after receiving the vaccine which could have exacerbated her heart failure.
79 2021-06-14 vomiting Two weeks after first shot was dizzy,. One night after second vaccine dizzyness and emesis lasted f... Read more
Two weeks after first shot was dizzy,. One night after second vaccine dizzyness and emesis lasted for one day
79 2021-06-20 nausea COMPLAINED OF FEELING NAUSEOUS. DRANK WATER AND OBSERVED.
79 2021-06-21 vomiting, abdominal pain upper, nausea Extreme Stomach Pain; Vomiting; Really sick; Nausea; This is a spontaneous report from a contactable... Read more
Extreme Stomach Pain; Vomiting; Really sick; Nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 79-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on Wednesday (19May2021) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a COVID-19 test on 29Apr2021 with a result of negative. The patient previously received dose 1 of BNT162B2 on 28Apr2021 for COVID-19 immunization. On 22May2021, the patient experienced extreme stomach, vomiting, and nausea. She was really sick. The patient received treatment with bismuth salicylate (PEPTOBISMOL) 2 tablets to try to stop nausea. The outcomes of extreme stomach pain, vomiting, really sick, and nausea were unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
79 2021-06-24 abdominal pain upper headache; low temperature, temperature was 97 degrees and went up 101 at one point; stomach cramps; ... Read more
headache; low temperature, temperature was 97 degrees and went up 101 at one point; stomach cramps; bad backache; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EN5318, expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 22Jan2021 at 16:00-16:30 hours as dose 1, single dose (at the age of 79-years-old) for COVID-19 immunisation. The patient had no medical history and relevant family medical history. There were no concomitant medications or other products used by the patient. Patient had no other vaccinations within four weeks prior to the first administration date of the vaccine. On 24Jan2021 at 07:30 hours, patient had bad backache, stomach cramps and low grade temperature. Patient stated that she was in bed for three days with a bad backache, stomach cramps and low temperature, temperature was 97 degrees and went up 101 at one point. Patient stated that on the information sheet paperwork that it stated that if she had a reaction with that one that she should not get the second vaccine, so patient wanted to know what to do. On 26Jan2021, at 10:00 hours, patient had a headache the last day. Patient took Tylenol, as treatment. Patient had no emergency room and physician office visit. No relevant lab tests were performed. The outcome of all the events was resolved on 26Jan2021. Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
79 2021-06-24 decreased appetite, diarrhea loss of apatite/can't eat anything- everything tastes like soap; diarrhea; fatigue; body aches; diff... Read more
loss of apatite/can't eat anything- everything tastes like soap; diarrhea; fatigue; body aches; difficulty breathing; congestion; feel sick; chills; cough; headache; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that: A 79-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ENG198, Expiration date: Unknown), via an unspecified route of administration with a needle into left upper arm on 06Mar2021 at 9:30 (at the age of 79-years) as (exact dose unknown) single dose for covid-19 immunization. The patient medial history included ongoing neuropathy pain, ongoing asthma (diagnosed when she was a kid), ongoing bladder problem/bladder infections (she kept getting bladder infections; went to a bladder specialist 6 months prior), ongoing high blood pressure (diagnosed for many years), ongoing arthritis (diagnosed for many years) and knee replacement in 2008. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect, was not administered additional vaccines on the same date of the Pfizer vaccine, and did not receive any prior vaccinations within 4 weeks of Pfizer vaccine. The patient had no family history relevant to the adverse events. Concomitant medications included gabapentin (been taking that for years) from an unspecified date to ongoing for neuropathy pain, losartan potassium (been taking this for years) from an unspecified date to ongoing for high blood pressure, nitrofurantoin (MACRODANTIN) (about 6 months) from an unspecified date to ongoing for bladder infections, beclometasone dipropionate (QVAR REDIHALER) (been taking this for years) from an unspecified date to ongoing for asthma, Serevent Diskus (been taking this for years) from an unspecified date to ongoing for asthma, estradiol vaginal cream usp (about 6 months) for "bladder" (bladder disorder), and ibuprofen (if she needs it, but she doesn't always need it). The patient stated she was taking her usual medications-allergy medications, high blood pressure medicine and estrogen. The patient's historical vaccines included shingles vaccine in 2019 with sore arm as the reaction, pneumonia vaccine in 2019 with sore arm as the reaction and tetanus vaccine in 2019 with sore arm as the reaction. She did not have NDC/LOT/Expiration number of the historical vaccines. On 19Mar2021, the patient began to feel sick. She reported the following symptoms: chills, cough, headache, difficulty breathing and congestion starting on 19Mar2021 around noon time, fatigue and body aches starting on 20Mar2021 gradually throughout the day, and loss of appetite/ "can't eat anything- everything tastes like soap" gradually throughout the day and diarrhea starting on 21Mar2021. She thought it was going away, but it didn't. She stated that when the chills first started, she couldn't even hold her hand still, but that had improved. She stated that everything tasted like soap on the third day of the symptoms' onset on 21Mar2021. She stated that she made herself eat a little, but she just couldn't. She stated that she drank as much water as she could. She stated that the taste of soap was there before, but she didn't recognize it for what it was until it started to get worse. She stated that she needed to get her glasses to read the writing on her vaccination record card. She started that she did not want to get the second dose on Saturday, 27Mar2021. The patient inquired what she should do. She stated that to be able to talk on the phone, she had to take paracetamol (TYLENOL) 650 mg, and she had taken one tablet. The patient did not require emergency room or Physician office visit due to the events. She thought it would go away, so she didn't go see her doctor. Treatment received for the events included paracetamol (TYLENOL) 650 mg. The patient had undergone no investigations or relevant tests. The outcome of the event fatigue and loss of appetite was worsened. The outcome of the events difficulty breathing, body aches and diarrhea was not recovered. The outcome of the event chills, cough, headache and congestion was recovering. The outcome of the event "feel sick" was unknown. No follow-up attempts are possible. No further information is expected.
79 2021-06-29 diarrhea Diarrhea; This is a spontaneous report from a contactable consumer (reported for herself). A 79-year... Read more
Diarrhea; This is a spontaneous report from a contactable consumer (reported for herself). A 79-year-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Feb2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing irritable bowel syndrome (she has had it for years, probably about 30 years ago and it doesn't go away) and ongoing arthritis (she has arthritis so before she goes to bed every night, she takes 2 Advil). Concomitant medication included Advil (2 Advil every night) for arthritis. The reporter stated that, she got first dose on last Thursday, it was her first shot, she was supposed to get the next one in 3 weeks. She was reading on the internet before the day of vaccination at night that if they take Advil, it would reduce the effect of taking the vaccine. The reporter didn't get any information like that when they got the vaccine. She had arthritis so before she goes to bed every night, she takes 2 Advil, does that effect the vaccine and if so what percentage of the efficacy was affected. The reporter said she had another question. Her and her husband both didn't know they shouldn't take headache medicines and her husband gets migraines and the day before the vaccine he took an excedrin and she took advil every night so they both were wondering and also the day after the vaccine, they did not feel bad the first day but the next day they had diarrhea. Caller said she had Irritable bowel syndrome so she sometimes had diarrhea, but her husband never had diarrhea and they both had diarrhea the day after. The reporter stated that the diarrhea was gone now for both of them but in the information the hospital gave with the possible side effects, that wasn't mentioned at all there was a bunch of different things but not diarrhea. The reporter stated that she had IBS but her husband didn't have that was why they thought it may have been the vaccine. She had that problem all the time with IBS so never know if it was with the IBS or not. The outcome of the event was resolved. Description of Product Complaint: Description of complaint: Caller is calling about the Pfizer COVID 19 vaccine she got last Thursday, it was her first shot, she is supposed to get the next one in 3 weeks. She was reading on the internet last night that if they take Advil, it would reduce the effect of taking the vaccine. They didn't get any information like that when they got the vaccine. She has arthritis so before she goes to bed every night, she takes 2 Advil, does that effect the vaccine and if so what percentage of the efficacy is effected. She says she has another question. Her and her husband both didn't know they shouldn't take headache medicines and her husband gets migraines and the day before the vaccine he took an Excedrin and she takes Advil every night so they both were wondering about that. Caller does not have their vaccine record cards with her at the time of the call. She is not able to provide NDC lot expiration for either of their vaccinations. She confirms her and her husband both received the Pfizer COVID 19 vaccine. Product strength and count size dispensed: Additional lot numbers: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact? Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
79 2021-06-30 decreased appetite This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.
79 2021-06-30 indigestion Heart burn complaint later into the night and into the current date/time. My mom has not had heartbu... Read more
Heart burn complaint later into the night and into the current date/time. My mom has not had heartburn problems in the past.
79 2021-06-30 vomiting, nausea felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feelin... Read more
felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.
79 2021-07-01 difficulty swallowing Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swa... Read more
Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swallow; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization.Medical history included gastrointestinal issues and high blood pressure. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination was high blood pressure meds, pain meds.On 04Mar2021, the patient was not eating, unable to eat without choking. Couldn't swallow. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Duration of hospitalization was 30. The patient had not yet recovered from the event.
79 2021-07-05 nausea, diarrhea Chills, fever, dehydration, intense bone pain, intense fatigue diarrhea, nausea, then pneumonia, the... Read more
Chills, fever, dehydration, intense bone pain, intense fatigue diarrhea, nausea, then pneumonia, then pleural effusion, then extreme hypothyroidism, then multiple episodes of elevated pulse/heartbeat. Over a 2 month period.
79 2021-07-08 stomatitis Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering ... Read more
Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering around eyes,burning itchy peeling rash neck,chest,around ears,burning itchy rash fingers to shoulder. On going progressive to present date. Prednisone finally prescribed at Hospital emergency. 40 mg. Per day for 5 days. Dr. is lowering the dosage. The first three weeks are prescribed 40 then 20 on going to 20 and an appointment July 22 to decide on the dosage to continue. I have photos documenting every horrible symptom. I was advised to do that.
79 2021-07-12 nausea she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like ... Read more
she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.
79 2021-07-12 nausea Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneou... Read more
Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneous report received from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included prediabetes and rheumatoid arthritis. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unspecified date. The patient previously received penicillin and sulphonamide and experienced an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021, the patient experienced tiredness, some achiness and muscle aches. On 12Mar2021, the patient reported that the muscle aches were more tense and uncomfortable. On an unspecified date in Mar2021, the patient experienced queasiness. Therapeutic measures included intake of VICKS flu syrup for the adverse events experienced. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tiredness, aches, muscle aches and queasiness were resolved on 13Mar2021. No follow-up attempts are needed. No further information is expected.
79 2021-07-17 nausea gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and... Read more
gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and sweating; She states the nausea was slight after the first dose but more so after second shot.; headache; not feeling well; no energy; She states after the second shot, her tiredness is worse; She stated after the second shot, her tiredness was worse; Blood pressure high; Fever; Nose bleeds; Severe Chest Pain, fluttering feeling, feels little things; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 13Mar2021 at 10:15 (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation at "PRIVACY" where doctor offices older buildings are. "PRIVACY" now has brand new office, old used for shot and doctors. Medical history included diverticulitis from 2016 and ongoing (she changed her diet. No greasy, no fried, no spicy foods. 2017 attack, 2018 or 2019. Stated that she has felt fine ever since), booster from an unknown date and unknown if ongoing (She stated about 5-6 years ago, she had boosters from childhood shots, every booster. Never had the shingles shot. She stated she has never had a reaction from any of it). Historical vaccine included A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at "PRIVACY" where her doctor was located, her office was upstairs (the nurses had people spaced downstairs) and experienced a lot of face redness, severe chills, nausea. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she stated that about a week before the second vaccine she was not sleeping well but she had started to feel better but then she got the second dose and that was a whammy. She stated that when she got the first shot, it kept her awake, like she drank 20 cups of coffee, but after 24 hours, she was just exhausted. She has always been energetic and none of that anymore. She stated after the second shot, her tiredness was worse. She gets exhausted doing nothing. She stated that it was on and off nausea where some mornings felt ok, others she felt nauseated. She does not know if it was the blood pressure pill or not, she was not used to taking any meds. She would probably call the doctor "today" and tell them. She was not used to not feeling well. The patient stated that on 17Mar2021, she got a nosebleed, but she was able to control it and had fever. She called her doctor and told her about the chest pain and nosebleed. She stated the nausea was slight after the first dose but more so after second shot. She was more aware of not wanting to eat and feeling nauseous. She was being cautious because it was so profuse on "Sunday" 21Mar2021 and her blood pressure was so high. "Now", she was on a blood pressure pill and she hopes she does not have another nosebleed. She stated that it was a fluttering feeling, and she can feel little things. It was started testing her blood pressure when it went up on the 17Mar2021. It was 122 and 131. Then on 20Mar2021, it was 174/77 in the "evening" and on 21Mar2021, it really shot up and she went to the hospital and there it was 197/93. She stated that on the 17Mar2021, she was not feeling well and on 18Mar2021, she called her doctor and they told her to stay hydrated and take her blood pressure. She stated then on 21Mar2021, it got really bad. She stated with the medication since the 21Mar2021 "Sunday". On 22Mar2021, it was 156/91 and 128. It was 107/64 "yesterday" and "now" 117/75. She stated that it seems to be back down where it usually has been, more towards lower rather than the higher reading. She has never experienced high blood pressure. She stated that the ER (emergency room) doctor said her problem was high blood pressure and you have had for years but she states she has not. She stated in 2016, she went to the hospital for a diverticulitis attack and then it went back low again at doctor office. In 2017, she went to the ER (emergency room) with diverticulitis. She stated the ER (emergency room) doctor was looking at the blood pressures from times when she was in the ER (emergency room) in 2016, 2017, and 2018 or 2019. She stated that after the ER (emergency room), she always maintained her blood pressure, but he put her on a blood pressure pill, but she was questioning it because she has always maintained low BP. She has never had high blood pressure in her life, it always runs low. On 21Mar2021, emergency room doctor said her blood work for her age looks very good and she really was very healthy. She was thinking, then why was she there. Stated her blood work looked very good and she looked very healthy. The patient was received the treatment in ER (emergency room), Amlodipine, talked to nurse yesterday afternoon and she asked how she was feeling, not like feeling bad, no energy. They gave it to her IV (intravenous) to bring her blood pressure down on "Sunday" (21Mar2021). " Physician office: Followed Up with Phone Calls, 06Apr2021 she has a follow-up appointment ". The patient underwent lab tests and procedures which included blood pressure: 174/77 (unknown units) on 20Mar2021, 197/93 (unknown units) on 21Mar2021, 156/91 (unknown units) on 22Mar2021, 107/64 (unknown units) on 23Mar2021, 117/75 (unknown units) on 24Mar2021. The outcome of fever was resolved on 17Mar2021, nose bleeds was resolved on 21Mar2021; Severe Chest Pain, fluttering feeling, feels little things, Blood pressure high, her tiredness worse, Nausea aggravated was not resolved; gets hot and then cold and sweating, headache, not feeling well, no energy, was unknown No follow-up attempts are possible. No further information is expected.
79 2021-07-22 nausea Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a sp... Read more
Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
79 2021-07-27 diarrhea constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 79-year-... Read more
constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 19Feb2021 at 17:30 (at the age of 79-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on an unspecified date ; as a single dose for COVID-19 immunisation. Medical history included arthritis, two hip replacement, two knee replacement, shots in hands and feet every three months and low kidney function. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 11:00 the patient experienced constant diarrhea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea and included treatment with unspecified antibiotic prescribed by the doctor. The clinical outcome of the event constant diarrhea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
79 2021-07-28 nausea freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the g... Read more
freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown. No follow-up attempts are needed. No further information is expected.
80 2021-01-05 diarrhea, abdominal pain upper, abdominal pain she started to get very sick, which continued to worsen until nowwhen she feels like she is improvin... Read more
she started to get very sick, which continued to worsen until nowwhen she feels like she is improving; had stomach and abdominal pains; had stomach and abdominal pains/stomach is still very sensitive; loose stool; she was very tired; Pain or little discomfort in the arm she received the injection; Pain or little discomfort in the arm she received the injection; This is a spontaneous report from a contactable consumer (Patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9896), via an unspecified route of administration to very top of right arm on 22Dec2020 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included glaucoma she had drops to take for, mostly she just has problem with her joints and her back with her age. She did not have any diseases or anything; she was not diabetic, nothing like that. There were no concomitant medications. She was administered her first dose of COVID-19 Vaccine on 22Dec2020. She reported that the pain or little discomfort she had in the arm she received the injection in disappeared by 25Dec2020. But on 24Dec2020 she started to get very sick, which continued to worsen until now when she felt like she was improving. She did not know if these events could have something to do with the COVID-19 Vaccine. Pain or little discomfort in the arm she received the injection: Right arm. Everyone warned her that the site would hurt, so she was really glad when it totally went away on 25Dec2020 and thought that it was over; any issues from the injection. Very sick: this event started to get bad on 24Dec2020, she was very tired and not very hungry, she had stomach and abdominal pains and loose stool; 25Dec2020 those symptoms were worse. It was Christmas so she cooked and thought at first maybe she got carried away baking pies; because that evening she started to have pain and did not each much. 26Dec2020 it was worse; she said she was going to work on 27Dec2020; it was terrible because she was stuck for 12 hours trying to work while very sick. She called off of work 28Dec2020 and 29Dec2020. Since then she has stayed home and still has pain but she took her ranitidine delayed release 100mg twice daily as needed for stomach pain as given to her by her doctor, and is now down to just once daily. She did not know what she would have done without the ranitidine. She did not have any more abdominal pain, but her stomach was still very sensitive. She was tired but thought she was going to be ok. She was scared to get the second scheduled dose of COVID-19 Vaccine because she thought the side effects will be more severe with the booster shot. She just needed to rest and stay home which she has been doing. She has not had any fever. She has not notified her family doctor of these events. There was nothing she did on Christmas that she could think of other than she drank a glass of champagne because she did not know her stomach was going to be so bad. The outcome of the events Pain or little discomfort in the arm she received the injection was recovered on 25Dec2020, the outcome of event sickness was recovering, the outcome of the event Abdominal pain was recovered on an unknown date in Dec2020, the outcome of event stomach pain was not recovered, the outcome of the other events was unknown.
80 2021-01-17 nausea Patient c/o severe nausea. RN offered pt a seat near the bathroom. Pt sat down and waited until naus... Read more
Patient c/o severe nausea. RN offered pt a seat near the bathroom. Pt sat down and waited until nausea decreased. RN gave pt a bottle of water and she drank about 60ml. After about 10 minutes, pt stated she was still nauseous but felt slightly better. RN ensured pt that she could stay as long as she needed to and until her symptoms subsided. Pt and family member agreed that they were comfortable enough to head home. RN instructed pt to notify healthcare worker of her episode of nausea before she received the second dose of the covid-19 vaccine.
80 2021-01-18 nausea EXTREME NAUSEA, HEADACHE, BODY ACHES, NO FEVER
80 2021-01-20 vomiting, nausea On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was e... Read more
On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.
80 2021-01-22 abdominal pain lower, abdominal pain Abdominal Pain similar to a diverticulosis attack except on the lower right quadrant. After discuss... Read more
Abdominal Pain similar to a diverticulosis attack except on the lower right quadrant. After discussion and physical exam (no other tests) with Doctor, we decided to treat with an antibiotic (AMOX_CLAV 875-125 MG Tablet) and see if I got better. One day later, pain has subsided.
80 2021-01-23 painful swallowing rights side of neck and throat sore felt like punched sore to swallow
80 2021-01-24 diarrhea severe diarrhea
80 2021-01-24 nausea waves of heat in hands, arms, chest up into head . 3x per day. feel tired and naesous afterwards. st... Read more
waves of heat in hands, arms, chest up into head . 3x per day. feel tired and naesous afterwards. still happening after one week
80 2021-01-26 abdominal pain upper, diarrhea High fever 101.7 for two days. Extreme shakes all night on the25th. Advil taken every four hours. ... Read more
High fever 101.7 for two days. Extreme shakes all night on the25th. Advil taken every four hours. Stomach cramps and loose bowels the next day.
80 2021-01-28 flatulence, abdominal distension, diarrhea I had terrible bloating and gas January 22, all day diarrhea January 25 and gas all this week which... Read more
I had terrible bloating and gas January 22, all day diarrhea January 25 and gas all this week which is only helped by heating pad on stomach and when ready to exit standing to release gas from bowels, plus have had to take the simethicone 6 to 7 times per day.
80 2021-01-28 nausea, vomiting Onset of vertigo with nausea, vomiting
80 2021-01-30 diarrhea Almost uncontrollable shaking, 2.3 degree increase in temperature, really bad diarrhea . Symptoms... Read more
Almost uncontrollable shaking, 2.3 degree increase in temperature, really bad diarrhea . Symptoms lasted around 12 hours, temperature came down in a day and I took Tylenol
80 2021-01-31 nausea, abdominal pain Dull Headache coming and going. Nausea starting on Sunday, January 31, continuing on Monday, Februar... Read more
Dull Headache coming and going. Nausea starting on Sunday, January 31, continuing on Monday, February 1. Pain in lower abdomen.
80 2021-01-31 nausea day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Sat... Read more
day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Saturday i got nausea.
80 2021-02-01 decreased appetite I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red a... Read more
I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red and itchy. Overall I feel fatigued and lost my appetite. In addition when I had CoVID in September I experienced difficulty falling or staying asleep. I experienced that last night again. I am very tired but unable to fall asleep.
80 2021-02-01 vomiting Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vo... Read more
Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.
80 2021-02-03 abdominal discomfort, diarrhea, nausea Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and ch... Read more
Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and chest felt like they were on fire; Freezing and could not warm up; She was very crampy; nauseous; Left arm soreness; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 19Jan2021 (at the age of 80-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 19Jan2021, the patient started not feeling right- her stomach was bothering her, diarrhea, her face turned red, face and chest felt like they were on fire then freezing and could not warm up, she was very crampy, nauseous and left arm soreness. The outcome of the events stomach discomfort, diarrhea, feeling hot, feeling cold, very crampy and nauseous was recovered on 19Jan2021. The outcome of the event face turned red was unknown. The outcome of the event left arm soreness was not recovered.
80 2021-02-03 abdominal pain EMT and PHN responded to Pt hunched over, C/o sudden onset of abdominal cramping and pain, 7/10, and... Read more
EMT and PHN responded to Pt hunched over, C/o sudden onset of abdominal cramping and pain, 7/10, and throbbing HA 7/10 pain. Denies dizziness, nausea, itchiness, swelling. Vitals taken at 1:53 pm: BP 510/88, HR 60. Pt request to go to bathroom, ambulated self with steady gait to restroom. Pt assisted by son, in bathroom. NO BM, reports pain comes and goes from 7/10 to 3/10.. Pt walked back to reclining chair in vaccination observation area. Vitals recheck at 2:13: BP 156/90, HR 52, 28 respirations., reports no change in pain or HA. Pt wincing and bending over, 9-1-1 activated, EMS on scene at 2:20 pm. Pt refused ED transport/and care, Pt walked off site with son, states will go to clinic ASAP.
80 2021-02-03 diarrhea, vomiting, nausea Nausea, diarrhea, nausea, throwing up.
80 2021-02-03 indigestion, GERD Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her ch... Read more
Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.
80 2021-02-03 indigestion DEVELOPED CHEST PAIN AND INDIGESTION.
80 2021-02-03 nausea Headache, Nausea, Fatigue
80 2021-02-07 vomiting, diarrhea, nausea 2 hours after shot felt nauseous. 6 hours after shot had vomiting and diarrhea. Repetitive vomitin... Read more
2 hours after shot felt nauseous. 6 hours after shot had vomiting and diarrhea. Repetitive vomiting 14 hours and diarrhea and malaise for 36 hours.
80 2021-02-08 abdominal pain Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the da... Read more
Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the day. She went to the ED and was hospitalized. Abdominal pain complaints increased and continued, she decompensated rapidly, was intubated and subsequently died 3 days later. Imaging results showed, progressive ovarian cancer in the bowels. Blood culture revealed that she had E.Coli in her blood. It is thought that this is NOT related to the vaccine.
80 2021-02-09 decreased appetite The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit... Read more
The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.
80 2021-02-09 diarrhea extreme diahrea weakness anto diahrea med dicyclomine still have diaerhea
80 2021-02-09 vomiting, hunger Became dizzy when she bent over to tie her shoe. Came to lie down for dizziness to pass. Reported ... Read more
Became dizzy when she bent over to tie her shoe. Came to lie down for dizziness to pass. Reported a headache and being hungry. Juice and trail mix given. Later went to the restroom and vomited a small amount per client. Rested further, reported her headache improved and wanted to go home. Was informed we would like for her to get a ride home. She did not want to and declined to stay for further observation. b/p 138/76 pulse 72. Informed to seek medical help for further problems.
80 2021-02-10 difficulty swallowing I am a well 80 year old woman. I have no preexisting medical conditions. I take no prescribed drug... Read more
I am a well 80 year old woman. I have no preexisting medical conditions. I take no prescribed drugs or over the counter medications. I had no side effects for shot one. The second day after shot two I had a very very severe headaches for 22 hours. When I tried to drink water , it came right back up. I could not keep anything down for the same 22 hours. I am now fine.
80 2021-02-10 vomiting, nausea chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be trea... Read more
chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21
80 2021-02-11 nausea Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache,... Read more
Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache, having a hard time raising the arm, it's very sore, nauseated, lasted 1 day.
80 2021-02-20 decreased appetite First shot no problems. Second day after second shot, fatigue, could not get warm, redness and heat ... Read more
First shot no problems. Second day after second shot, fatigue, could not get warm, redness and heat at the injection site. Diminished appetite. Body aches. Third and fourth day after shot redness and itching at injection site
80 2021-02-21 abdominal discomfort, diarrhea, nausea, loss of appetite Extreme stomach distress: Nausea, diarrhea, stomach unsettled/growling, afraid to eat. Gradually b... Read more
Extreme stomach distress: Nausea, diarrhea, stomach unsettled/growling, afraid to eat. Gradually better by 02/21/2021 (light eating all day) and feeling pretty well today (02/22/2021)
80 2021-02-22 decreased appetite Slight headache, chills, loss of appetite. Gone in 24 hours
80 2021-02-22 difficulty swallowing 0920, reporteed thickness in back of tonge,c/o trouble swollowing, able to drink water, 126/72, hr8... Read more
0920, reporteed thickness in back of tonge,c/o trouble swollowing, able to drink water, 126/72, hr83, 02 sat 96% RA, rr 16 Called rapid response, NP assessed and rec ER, pt refused. 0940 Benedry 50 mg po given. Refused ER again, Agrreded to monitor until 11am Checked out At 11:10. Denied other symptoms.
80 2021-02-23 nausea pt states that she had a left arm and mild body aches for a couple of days after getting the covid v... Read more
pt states that she had a left arm and mild body aches for a couple of days after getting the covid vax. Three or four days later she started getting dizzy and nauseated. She says she feels hungry even after she eats. Pt states the dizziness comes and goes and is normally in the morning. She doesn't feel right and feels unsafe when she walks like she may fall. Pt contacted her PCP on 2/23/2021 and they just told her to see if the symptoms went away and the FU if they did not.
80 2021-02-23 vomiting, diarrhea, nausea On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to h... Read more
On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to hospital and found to have a troponin of 72 and coronary angiogram done. Endomyocardial biopsy revealed myocyte damage and mixed inflammatory infiltrate concerning for myocarditis. Patient ultimately has started to recover with treatment of methylpred 1 gram x 3 days.
80 2021-02-25 decreased appetite, vomiting, nausea Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report f... Read more
Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested.
80 2021-02-25 vomiting, nausea Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine ... Read more
Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever. Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM. Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.
80 2021-02-26 diarrhea, nausea, decreased appetite No adverse events following the first dose on 02.05.2021 The second dose on 02.26.2021 : fever - hig... Read more
No adverse events following the first dose on 02.05.2021 The second dose on 02.26.2021 : fever - highest 101.2 degrees; slight headache; nausea; deltoid pain; anorexia; loose stools; fatigue I was pleased to have a reaction suggesting to me that some immune response was being generated.
80 2021-02-28 abdominal distension, vomiting, diarrhea Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. Sh... Read more
Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.
80 2021-02-28 vomiting first vaccine 2/4/21 el9265 first vaccine , second was 2/25/21 en6200 - second vaccine headache, vo... Read more
first vaccine 2/4/21 el9265 first vaccine , second was 2/25/21 en6200 - second vaccine headache, vomited ice to headache and arm, food and fluids very difficult to understand caller , shaky voice ( dystonia)
80 2021-03-02 decreased appetite Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't... Read more
Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.
80 2021-03-02 decreased appetite Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; havi... Read more
Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown. No follow-up activities are needed. No further information is expected.
80 2021-03-03 vomiting, nausea Had shot on Thursday 2/25/21. Friday didn't feel well-laid around all day. Saturday was so dizzy I ... Read more
Had shot on Thursday 2/25/21. Friday didn't feel well-laid around all day. Saturday was so dizzy I had to hold on to walls and furniture to walk around house. Sunday was still dizzy and nauseous so I ate a sandwich and 3 or 4 tums. All came up and I continued to vomit throughout the day. Could not even keep water down. Monday I had someone bring Ginger Ale. Nausea gone, but still very dizzy. Never had a temperature but continue to be dizzy. I am a very active 80. Clean my own house and Mow my yard. I play bridge 2 or 3 times a week and walk my 2 Yorkie Dogs several times a week and never have been dizzy before.
80 2021-03-04 nausea Fever of 102 to 103, nausea, headache and fatigue for 24 hours
80 2021-03-04 vomiting, diarrhea Vomiting, Diarrhea
80 2021-03-07 profuse gastrointestinal bleeding, nausea Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing short... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose. Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.
80 2021-03-07 nausea, vomiting, diarrhea On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very so... Read more
On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very sore. The next 2 days t he same as late afternoon on the day of injection. 2/20/2021 woke up feeling fine. 2/21, 2/22 back to feeling nauseous and dizzy with the injection arm hurting a lot. 2/22, 2,24, 2/25 were fairly good days. But 2/26 woke up at 3:30 a.m. feeling very, very nauseous and then vomiting violently and again at 6:30a.m. and 8:30a.m. (along with a bad case of diarrhea. Was nauseous for the next 3 days and could not move my left arm above my elbow.
80 2021-03-07 nausea On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- ... Read more
On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- muscus membrane swelling mainly -- not much phlegm to be cleared out - settled down about an hour later without taking any medications. Starting on 3/7/21 - Sore & stiff muscles in both arms - aching joints and muscles in legs also, stiff neck and waves of nausea that come and go. - also very groggy & fatigued On 3/8/21 - Woke up more aching, swollen glands under left arm and headache starting - took only Tylenol for the headache . Rest of symptoms still in effect. Stayed home from work to take it easy. Hoping things will pass by tomorrow or Wednesday
80 2021-03-08 diarrhea symptoms, Shortness of air, sat 93% room air, cough, headache, diarrhea. exposure to positive family... Read more
symptoms, Shortness of air, sat 93% room air, cough, headache, diarrhea. exposure to positive family member approx. two weeks prior to office visit on 03/01/2021, was scheduled for Monoclonal antibody treatment.
80 2021-03-08 nausea Symptoms: nausea, scratchy throat Outcomes: improved with PO Benadryl and extended monitoring
80 2021-03-09 gastrointestinal pain, nausea severe joint pain, GI pain and nausea
80 2021-03-10 nausea On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and... Read more
On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and went to the hospital. They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?. While I was there the blood pressure went up over 200 to 214/81. I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets. After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64. Today I am still taking meclizine as prescribed and am still slightly dizzy. I do not know if this was related to the vaccine or not.
80 2021-03-11 vomiting, nausea Received vaccine on 2/17 at local health department clinic and presented to the reporting person's f... Read more
Received vaccine on 2/17 at local health department clinic and presented to the reporting person's facility ED on 2/24/21 with a 4 day h/o N/V and headache. patient was provided symptomatic treatment and discharged to home.
80 2021-03-14 nausea, vomiting, diarrhea Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea;... Read more
Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered. Information regarding lot/batch number has been requested.
80 2021-03-14 nausea Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after v... Read more
Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after vaccine. Never reached out for treatment.
80 2021-03-15 abdominal pain bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmac... Read more
bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
80 2021-03-17 nausea Severe pain on right side back of skull, headache, blurred vision , nausea, fatigue
80 2021-03-21 nausea, diarrhea, abdominal pain Abdominal pain, nausea, diarrhea, fever to 103, lactic acidosis to 3.9,
80 2021-03-22 difficulty swallowing Patient reported swelling on back of the neck about 5 minutes after receiving vaccine, was given Ben... Read more
Patient reported swelling on back of the neck about 5 minutes after receiving vaccine, was given Benadryl 25mg. Several minutes later reported difficulty swallowing and was administered 0.3mg of epinephrine. Daughter called 911, patient reported feeling better after emergency response arrival.
80 2021-03-23 difficulty swallowing Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.
80 2021-03-25 abdominal pain, vomiting, nausea The following reaction signs/symptoms were observed: abdominal pain, nausea and other dizziness with... Read more
The following reaction signs/symptoms were observed: abdominal pain, nausea and other dizziness with vomiting Emergency response notified: EMS (911) EpiPen administered by RN as per standing order?: No Required VAERS reporting completed?: No Report given to EMS (911) EMT evaluated her Found her to be stable enough to wait at parking lot until symptoms resolved. She stayed in lot with daughter on phone until 115 when she reports her symptoms resolved and was able to drive home RN took vitals
80 2021-03-30 diarrhea she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a s... Read more
she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.
80 2021-03-30 nausea reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient expe... Read more
reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient experienced light headedness, dizzy and icky feeling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 80-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6204, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included hypertension, caller says she has had hypertension prior to getting vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 as single dose for covid-19 immunisation. There was no family history relevant to adverse events. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 13Mar2021, patient experienced light headedness, dizzy and icky feeling, on 15Mar2021, experienced blood pressure jumping/blood pressure shot up and on an unspecified date patient experienced nausea and headache. Caller says she has had hypertension prior to getting vaccine. Caller got her 2nd dose, "last Wednesday on 10Mar2021". Caller says she had no issues until Saturday/Sunday. Caller experienced: nausea, light headedness, icky feeling, headache. Caller says she has never had a "continuous headache before". Caller had a pre-existing appointment with doctor that Monday after. During appointment, caller had systolic blood pressure reading of 205. Caller says the doctor "gave me a little orangeish coloured pill, she was monitored after that in office." Caller says she was told to go to emergency room from doctor office. Caller had EKG and blood work done at emergency room and sent home to continue to monitor blood pressure and follow up with her doctor. Caller is asking, "has anyone else reported Blood Pressure jumping". Caller also says, "I know people have headache and nausea, how long does that usual last" Caller asking how long her headache might last. Dizzy/Lightheaded/Icky feeling: She said that she still has a kind of a funny headache. She said that she is never really sick and can't even remember having a cold. Caller said that her blood pressure is currently in the 140's and 150's systolic. She said that it has been high for a number of years, but it has never been as high as 205 that she can recall. Caller said that her blood pressure dropped while she was at the hospital and she was discharged from the emergency room. The caller was not admitted to the hospital. Caller does not remember the diastolic number from her blood pressure. The patient underwent lab tests and procedures on 13Mar2021, which included blood pressure measurement: systolic was 205. The outcome of the events light headedness, dizzy, icky feeling and blood pressure jumping/blood pressure shot up were recovering and nausea, headache were unknown.
80 2021-04-03 nausea Off balance; Slight nausea; Slight headache; Not feeling well; This is as spontaneous report receive... Read more
Off balance; Slight nausea; Slight headache; Not feeling well; This is as spontaneous report received from a contactable consumer (patient herself) of 80-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route of administration on 12Feb2021 at 09:15 AM as a single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medications included losartan, Norvasc (amlodipine besilate), ezetimibe. The patient did not receive other vaccines in four weeks. Prior to vaccination patient did not have COVID-19 and was not tested post vaccination. On 13Feb2021 at 04:30 AM, the patient experienced off balance, slight nausea, slight headache and not feeling well. NO treatment was received for events occured. Outcome of events was recovering. Information on the lot/batch number has been requested.
80 2021-04-04 diarrhea March 27,28,29 Severe diarrhea, foggy head. March 29 Altered mental status, symptoms of stroke, los... Read more
March 27,28,29 Severe diarrhea, foggy head. March 29 Altered mental status, symptoms of stroke, loss of memory for short period of time, diarrhea,headache-recurrent. Low sodium levels
80 2021-04-07 nausea chills and nausea for about 6 hours on following day
80 2021-04-09 nausea March 21 was supposed to be the "end" of the final period after my 2nd shot -- On March 21st I start... Read more
March 21 was supposed to be the "end" of the final period after my 2nd shot -- On March 21st I started developing aching muscles, joints and neck and waves of nausea along with intermittent muscle wekness & extreme fatigue. It became worse on the 22nd & 23rd so for safety on the 24th I had a "nasal Covid-19 test" done at a Urgent Care facility to determine if I had possibly contracted the Covid-19 virus. The test came back 'negative' -- I did not have an active case of Covid. The symptoms I was experiencing finally calmed down about Friday - the 26th and by Sunday, they were over. It was almost like a further delayed adverse reaction to my final March 6th 2nd dosage shot although the muscle & joint aches and fatigue were worse than just after the 2nd shot?
80 2021-04-10 diarrhea Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills,... Read more
Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills, but no fever.
80 2021-04-15 nausea high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contac... Read more
high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contacted the patient , patient has been feeing much better for some time , no issues now
80 2021-04-20 abdominal pain worsening abdominal pain x 2 weeks which has subsided went to ER on 3/23/21 and received pain patch... Read more
worsening abdominal pain x 2 weeks which has subsided went to ER on 3/23/21 and received pain patch, tylenol and intravenous muscle relaxer, CAT scan was done on lumbar and abdomen, results were negative. No longer has signs and symptoms at this time.
80 2021-04-23 blood in stool, diarrhea, vomiting Vomiting, fever, Diarrhea, headache, and blood in stool
80 2021-04-24 abdominal distension, nausea, gastrointestinal pain, abdominal pain body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely wal... Read more
body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; Nausea; by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating; bloating; could still void but it was pressure tying to go/severe pain and abdominal pain was causing pain to void; couldn't eat or anything; intestinal cramping/severe gut, lower abdominal, intestinal pain; This is a spontaneous report from a contactable consumer via An 80-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in arm on 04Apr2021 15:00 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Ehlers-Danlos syndrome (states she was diagnosed about 40 years ago), Allergies, lung collapses (due to Ehlers-Danlos syndrome), preemie, no fusion in her eyes (States she sees out of one eye most of the time), does not retain sodium and potassium (related to Ehlers-Danlos syndrome), egg allergy. The patient previous received pneumonia and shingles vaccine for immunization and was fine, the first dose of the bnt162b2 via an unspecified route of administration in arm on unspecified date as single dose for covid-19 immunisation and fine. Concomitant medication included potassium as does not retain potassium; spironolactone; a list of medications. Her mom got her 2nd dose on Sunday and is in the process of needing to report that. She ended up with severe gut, lower abdominal, intestinal pain and bloating along with other normal things. States she saw her doctor yesterday and he believes it could be caused by the Propylene Glycol in the vaccine. Her mother received her shot at 3pm on 4Apr2021 and does not know which arm. Her symptoms started around 8:30 with body aches everywhere, a severe headache, her bones and joints were hurting so bad she couldn't barely walk much, she made it to the bathroom and that was it, and nausea. Caller states by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating. States her mom could still void but it was pressure tying to go and caused severe pain and abdominal pain was causing pain to void. Caller provides that her mom continues the same until Tuesday morning and then the intestinal cramping and bloating is still continuing now and it's more primarily her lower left area as of Wednesday. She has a big history of Ehlers-Danlos syndrome and her doctor that she met with yesterday feels this is probably from the propylene glycol component that caused the flare up, as she usually doesn't have this and he is hoping it will calm down in about a week. Her mom also couldn't eat or anything until Tuesday. She was down all of Sunday night and Monday for about 36 hours. Stated the voiding is somewhat better but not much better and the rest of the symptoms are consolidated and persisting. Reporter stated her mom can't go without her medications. Her mom did a virtual doctor visit and will follow up later this week. Her mother got the second dose of the vaccine and had severe intestinal pain, headache, joint pain, nausea, abdominal pain. The outcome of the event Dysuria was recovering, Unable to eat was recovered on 06Apr2021, other events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
80 2021-04-30 nausea, vomiting, abdominal discomfort, diarrhea soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; naus... Read more
soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered. No follow-up attempts are needed. No further information is expected.
80 2021-05-03 abdominal distension, abdominal pain, diarrhea Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swol... Read more
Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swollen area on left side of intestines. Shingles like pain in abdominal skin and flesh.
80 2021-05-04 diarrhea feeling very, very dizzy/dizziness; diarrhea; This is a spontaneous report received from a contacta... Read more
feeling very, very dizzy/dizziness; diarrhea; This is a spontaneous report received from a contactable consumer. A 80-year-old female consumer (patient) received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), (Batch/lot number: EL3249) on 20Jan2021 at single dose for COVID-19 immunisation. The medical history of the patient included genito arthritis and asthma. The concomitant medication was not provided. On 20-JAN-2021 patient was feeling very, very dizzy and diarrhea. Patient was concerned about diarrhea as she got a shot 20Jan2021 and on 27Jan2021 she was still experiencing diarrhea. The patient took the vaccine on last Wednesday and had side effects or dizziness and 2 days later I started with diarrhea which is going on now. Patient did not received any treatment. Patient had some blood work done. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
80 2021-05-10 nausea, decreased appetite hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt lik... Read more
hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt like they were asleep; so sick; Hurt all over; not moving too fast; I do not want food; I have not eaten, taken a shower or anything; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Feb2021 09:45 (at the age of 80-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency, atrial fibrillation. The patient got her shot last Tuesday morning at 9:45 and had been real sick after this. The patient had a bad reaction to it. Well after patient got the shot it was in the. And it said if she was on blood thinner (Unspecified Medications) or 'immune disorder' (not clarified further) she know and she was both of those and was just wondering what to expect and today from elbow. On unspecified date of Feb2021 , her arms felt like they were asleep and then now it was from elbow bit down and her hands got real cold. Now she had not ran a fever and she had not vomited, but she did not want food. She had hurt all over and she had been nauseated (on unspecified date of Feb2021) but not vomited. She had not eaten, taken a shower or anything, and she had been so sick (on unspecified date of Feb2021). Well let her see if she could see a pen that writes. She was not moving too fast (on unspecified date of Feb2021). She wanted to know if this was going to affect her blood, the thickness or the firmness. Since Tuesday, 09Feb2021, patient hands were tingly and so cold. The patient had felt terrible everyday. She had other relatives that got some aches and fatigue , but nothing like what she had. The patient was not currently not taking any immunosuppressant drugs. Patient was enquiring that was it ok to get her 2nd Pfizer vaccine vaccine dose in 4 weeks. The patient also enquiring about was it a problem, with getting the vaccine, if she take Blood thinners, she had atrial Fib and used to get a lot of blood clots. And was there any problem with being immunocompromised and getting the vaccine. Outcome of the events was unknown. Information on batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
80 2021-05-12 vomiting shortness of breath, vomiting, dizziness and fatigue
80 2021-05-13 abdominal pain Hypo-osmolality and hyponatremia Acute kidney failure, unspecified abdominal pain
80 2021-05-13 diarrhea, decreased appetite weakness diarrhea poor appetite fever chills shortness of breath
80 2021-05-13 nausea Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was dia... Read more
Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she presented to our emergency department with persistence of the above symptoms and hypoxia to the 70s on room air and again tested positive for COVID. Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7 days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%. However on 5/13 she acutely desaturated and was found pulseless. Patient was DNR/DNI so was pronounced dead.
80 2021-05-15 vomiting Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfi... Read more
Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.
80 2021-05-25 diarrhea, vomiting, nausea cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so ... Read more
cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so weak.; felt that she needed to lay down because she was so tired; felt like she had the full blown (COVID-19) Virus; regurgitating; nausea hit her like 'bang'; little bit of diarrhea; Weakness; felt deathly ill for a month; vomited up the Cephalexin 500mg; lost 25 lbs. in a month and a half.; very acute bronchitis that hit her after her first COVID-19 Vaccine; coughed and coughed for about 2-1/2 weeks; thought she had whooping cough; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 at 15:30 at the age of 80 years old (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included uterine cancer (uterine cancer at 28 years old, had surgery for the uterine cancer); renal cancer (kidney cancer battled for 8-1/2 years. did not want another surgery, doctors did liquid cobalt treatments); nasal cavity cancer (had surgery to remove the cancer on nose about 7-8 years ago. had big hole taken out of her big Irish Cherokee nose. Thought the cancer was from her cat always hitting her with its claw on that side of her nose), bronchitis ( all her life) , radiotherapy (liquid cobalt treatments) , arthritis in back , kidney infection, pertussis, cytogenetic abnormality (missing half of a chromosome). Concomitant medication included estrogen nos (ESTROGEN NOS) 0.06 mg, 1x/day half of the pill in the morning, taking estrogen since she was 48 years old, meloxicam (MELOXICAM) 15 mg, 1x/day half of the pill at night for three years for arthritis in her back, cefalexin (CEPHALEXINE) taken for kidney infection, start and stop date were not reported. The patient previously took B12 shot every month (no additional information provided. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No other vaccines were given within 4 weeks. The patient experienced felt like she had the full blown (COVID-19) Virus, regurgitating, nausea hit her like 'bang', little bit of diarrhea, Weakness, felt deathly ill for a month on 28Mar2021; lost 25 lbs. in a month and a half, very acute bronchitis that hit her after her first COVID-19 Vaccine, coughed and coughed for about 2-1/2 weeks, thought she had whooping cough, vomited up the Cephalexin 500mg on Mar2021; felt that she needed to lay down because she was so tired, couldn't vacuum because she was so weak on 09Mar2021, cut her left thumb right across the top with a cat food can lid on 10Mar2021 Treatment was given for cut on left thumb received 7 stitches in her left thumb on 10May2021 and bronchitis. Relevant Tests were reported as None. The clinical course was reported by the patient as follows patient received her first COVID-19 Vaccine dose on 28Mar2021 at about 3:30PM, and by 6:30PM, she felt like she had the full blown (COVID-19) virus. She stated started regurgitating. The nausea hit her like 'bang' and she had a little bit of diarrhea, and was really weak. She felt deathly ill for a month. Today (10May2021) was one of the first days she got dressed, and was up for the whole day. She said some days, she could not get up for more than an hour or two, and then she would have to go back to bed because she was so weak. Her doctor told her since the second COVID-19 Vaccine dose was supposed to be a little rougher than the first COVID-19 Vaccine dose, he didn't want her to get the second COVID-19 Vaccine dose. She said she was 80 years old, and had always been very self-sufficient. Stated she beat cancer 3 times. The patient called her physician, and her doctor wanted her to go to the hospital but didn't want to go. The doctor told her to take Cephalexin 500mg for 2-1/2 weeks, and then drop down to 1 Cephalexin 200mg nightly. Caller mentioned she kept Cephalexin 200mg and Cephalexin 500mg on hand in case she had symptoms of a kidney infection because she lived in a mountain town, and wasn't close to her doctors office. Since she had a history' kidney cancer she had more kidney infections'. Patient would take Cephalexin 500mg if she was hit hard with a kidney infection, and she would take Cephalexin 200mg is the kidney infection symptoms were just starting. Patient vomited up the Cephalexin 500mg. She said she lived on ginger ale and water. She stated she lost 25 lbs. in a month and a half. She said she was trying to gain back some of her weight now. No further details provided. Patient developed a very acute bronchitis that hit her after her first COVID-19 Vaccine. She clarified she coughed and coughed for about 2-1/2 weeks. She said she thought she had whooping cough, and had no way to stop the coughing. She could not vacuum because she was so weak. She said she went outside yesterday, and was outside for 20 minutes. She said she felt so weak, she went inside and laid down on her couch. She said she fell asleep for 4 hours. She said her weakness was like nothing she ever experienced before. Felt energetic and would start to do something, and then felt that she needed to lay down because she was so tired. She said she would go lay down, and then wake up 4 hours later. She doesn't think she was positive for the COVID-19 Virus. No further details provided. Patient stated she cut her (left) thumb (right across the top with a cat food can lid) this morning. She said the clinic in the valley, put 7 stitches in her left thumb today. The clinical outcome of the events Regurgitating, Nausea, Diarrhea, Vomited recovered; weakness, Ill feeling, Acute bronchitis, cough was recovering, while the remaining events was unknown. Follow up attempts are needed. Further information has been requested.
80 2021-05-26 nausea feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle o... Read more
feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.
80 2021-05-27 diarrhea, abdominal discomfort Swelling and peeling of lips, peeling and soreness inside mouth, Diarrhea, upset stomach ache, dizz... Read more
Swelling and peeling of lips, peeling and soreness inside mouth, Diarrhea, upset stomach ache, dizziness
80 2021-05-31 abdominal pain upper big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain i... Read more
big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain in the back and stomach/hurts in front of her upper stomach; broke out in rash all over her body; This is a spontaneous report from a contactable consumer or other Non-health care professional. An 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as 2ND DOSE, SINGLE for indication of COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. The following 4 days patient was fine and after that she described her side effects as big itching in the body, pain in the back and stomach - She went to Hospital and doctors were not able to give any treatment recommendations. She wants to consult with Pfizer about her condition and seek for recommendations. patient broke out in rash all over her body and she was concerned about it. Patient stated that she had a strong itching for three days. Reported that hurts upper back and front of upper stomach. Has insurance and no one answered what she needs. Stated that she is in the shower every half hour. Stated that the itching is bad and she wanted to know what to do. Stated that she is healthy and has no problems and she had the vaccine a week ago and did not have any symptoms until three days ago when the itching started very hard then her back thing and then her stomach thing. Stated that she had no symptoms from the first one. Patient had taken her second dose of vaccine a week ago and did not have any symptoms until three days ago when she experienced, strong itching (pruritis), hurts in her upper back/front of her upper stomach (abdominal pain upper), rash all over her body. Stated that she called Medical Information before and they did nothing. Case number not provided. Outcome of events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
80 2021-05-31 difficulty swallowing throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous ... Read more
throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH, Solution for injection) (Lot no: 5318) via unspecified route of administration at right arm on 29Jan2021 at 16:30 as single dose for COVID-19 Immunization. Medical history included high blood pressure and high cholesterol. Concomitant medications included Lisinopril, Amlodipine, Pravastatin, ergocalciferol (Vit. D). On 29Jan2021 after 15 minutes of receiving first dose the patient felt that her throat was very tight and although she can swallow, it was difficult to do so. This lasted between 10 to 15 minutes and gradually subsided and did not return afterward. Since the vaccination, the patient had not been tested positive for Covid-19. No other therapeutic measures were taken. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since vaccination. The clinical outcome for the events throat felt very tight, difficult to swallow was recovered on 29Jan2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added; Postal Code added; Patient's Ethnic Group captured. Patient's Age/Units captured as 80 years per event's onset=29Jan2021. For Relevant Med History: Verbatim "Blood pressure high" updated as "high blood pressure" per source reported. For suspect vaccine: Indication "COVID-19 immunization" captured twice, removed one. All Con-Meds were re-coded to remove from "Obtain Drug Country/Drug Authorization Country" since both fields should be Blank for con-med per SOP. 6. For all events: "Treatment Received?" captured as "No" per verbatim "if treatment ae: No"; Onset updated from "29Jan2021 00:00" to "29Jan2021 16:45" per source reported. Event term "difficult to swallow" updated as "although I could swallow, it felt difficult to do so" per source reported. "None" removed from Concomitant Therapy field since con-meds already coded in Product tab. Initial missed information "administration date=29Jan2021, administration time=04:30 PM", "adverse event start date: 29Jan2021, adverse event start time: 04:45 PM", "known allergies: No"
80 2021-05-31 nausea her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness... Read more
her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown. No follow-up attempts are needed. No further information is expected.
80 2021-06-08 abdominal pain upper, diarrhea severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed wit... Read more
severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath
80 2021-06-09 vomiting Constant throwing up and went into a stroke; Constant throwing up and went into a stroke; This is a ... Read more
Constant throwing up and went into a stroke; Constant throwing up and went into a stroke; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO151), at the age of 80 years old, in right arm on 02Apr2021 12:45 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced constant throwing up and went into a stroke on 01May2021 10:00. The patient was hospitalized due to the events. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of constant throwing up and went into a stroke. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
80 2021-06-10 nausea Recommended dose is 0.3 mL. Actually 0.5 mL dose was given but it was the same supplier. Client repo... Read more
Recommended dose is 0.3 mL. Actually 0.5 mL dose was given but it was the same supplier. Client reports "feeling nausea like I did with the first dose". This was at 4:20 PM on 6/11/21. PHN discussed and client knows to stay hydrated, she is drinking clear soda. She will rest and try to eat a little. PHN discussed COVID s/s and advised client to seek care at ER is symptoms worsen or seem different from the s/s with her first dose.
80 2021-06-17 diarrhea, vomiting low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash... Read more
low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash on the right side of hrash on inner thigh of one leger belly/rash on inner thigh of one leg; diarrhea; vomiting/Throwing up; This is spontaneous report from a contactable consumer (patient husband). This report is regarding his wife. A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: PHFEEL9263, Expiration date: Unknown), via an intramuscular route in the left arm on 28Jan2021 Thursday at 12:00 PM, as 1 ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history included cancer; however, she is cancer-free right now. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Jan2021 until 23:00 or midnight patient was fine, and the patient had experienced heavy 20 minutes being in the bathroom throwing up and having diarrhoea and in the morning rash on the right side of her abdomen about the size of a saucer and inner thigh and on 02Feb2021, a low grade fever (99.7 degree Fahrenheit). Her temperature never went higher than 99.7 degrees. Patient wanted to know if can expect these side effects from the second dose and could they be worse. The patient underwent lab test and procedure which included regular CBC (like whole bloodwork) on 01Feb2021, Monday. She doesn't have any test results to include. The clinical outcome of fever has subsided and outcome for the event rash on the right side of her abdomen and inner thigh of one leg was recovering, outcome for diarrhoea and throwing up was unknown. Follow-up attempts are completed. No further information is expected.
80 2021-06-22 diarrhea, nausea Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metal... Read more
Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
80 2021-06-24 burping Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; State... Read more
Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
80 2021-06-24 retching, abdominal pain upper neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heav... Read more
neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown. Follow-up attempts are completed. No further information is expected.
80 2021-06-29 nausea dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient).... Read more
dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient). A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN5318) via an unspecified route of administration on 06Feb2021 11:45 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure had this for years, ongoing high cholesterol, ongoing allergies had for at least 20 years, perennial allergy from an unknown date and unknown if ongoing she has perineal allergies. also, she has an allergy to penicillins and erythromycin with penicillin being an anaphylaxis reaction. Caller has no NDC, Lot, or Expiry for any of the products which caused these reactions, this was a long time ago, cancer from an unknown date and unknown if ongoing, swine flu from an unknown date and unknown if ongoing AE(s) following prior vaccinations: In the 1970's with the swine flu, she was given the vaccine and right after she felt like she was going to pass out. EMS gave her oxygen, and she was fine. No NDC, Lot, manufacturer, or expiry. Concomitant medications included lisinopril (LISINOPRIL) 40 mg taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. No prior Vaccinations within 4 weeks. On 06Feb2021, less than 48 hours ago the patient experienced after she had the first shot, she has had a headache and mild nausea for 2 days. On 08Feb2021, this morning she has been very dizzy and so she was wondering if this was normal; she didn't see it on the side effect list, but I am not having weakness or anything really bad and asked if this dizziness could be from the COVID-19 vaccine. When she eats, she feels sick to her stomach, in regard to the nausea. She gets a flu shot every year and has never had a problem. The clinical outcome of the events was not resolved. Follow-up attempts completed. No further information expected.
80 2021-07-01 vomiting sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the p... Read more
sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) into left arm on 19Mar2021 at 10:30 (at the age of 80-years-old) as single dose for COVID-19 immunisation. The patient's medical history included open heart surgery. The patient's concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), levothyroxine 100 mcg (MANUFACTURER UNKNOWN) for and multivitamins (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had an allergy towards amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been diagnosed with COVID-19. On 20Mar2021 at 07:00, the patient experienced sore arm, tiredness, throw up and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, tiredness, throw up and headache was recovered on an unknown date. No follow-up attempts possible. No further information expected.
80 2021-07-05 vomiting, nausea Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: ... Read more
Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: dysgeusia at onset followed by vomiting 3 days pater precipitating a trip to er and subsequent rx for ondansetron
80 2021-07-08 abdominal pain lower, nausea I was having side effects during the vaccine a headache and then nausea, throat soreness, face redne... Read more
I was having side effects during the vaccine a headache and then nausea, throat soreness, face redness, neck redness, rash on chest. Pain in lower abdomen. Pressure around left ankle.
80 2021-07-13 diarrhea, nausea Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; T... Read more
Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021. No follow-up attempts are possible. No further information is expected.
80 2021-07-17 colitis Admitted for colitis
80 2021-07-21 diarrhea, vomiting Sweating, dizziness, vomiting and diarrhea a week later after getting the vaccine
80 2021-07-25 diarrhea Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the ... Read more
Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the touch, as if nerves inflamed. Doctor suspected shingles, but no blisters appeared. Pain stopped after five days. Swelling lasted a couple of weeks. Irritated nerve sensation in trunk persists,
80 2021-07-27 diarrhea, gastrointestinal disorder, burping, abdominal discomfort, indigestion both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; w... Read more
both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.
80 2021-07-28 diarrhea Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80... Read more
Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm on 07Apr2021 (at the age of 80-year-old) at dose 2, single for covid-19 immunisation. Medical history included hysterectomy (Additional Information: Done when the caller was 31 years old). Concomitant medication included omeprazole (OMEPRAZOLE) at 20 mg; lisinopril (LISINOPRIL) at 20 mg once a day taken for blood pressure measurement; acetylsalicylic acid (ASPIRIN 81) at 81 mg once a day; calcium (CALCIUM) at once a day; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The reporter was taking 20 mg of the Omeprazole and then her doctor increased it when the diarrhea started. Lot, NDC, and expiration date unknown. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, on 17Mar2021 (at the age of 80-year-old) at dose 1, single for covid-19 immunisation. No reaction on previous exposure to vaccine. On 09Apr2021 the patient experienced diarrhea. Adverse event led to physician office visit. The reporter is calling about the Pfizer covid vaccine. On 17Mar2021 the reporter had her first shot and everything was fine afterwards. On 07Apr2021 the reporter had her second dose, she was in at the time. 2 days after the second shot the reporter got diarrhea when they were leaving to come back and it wasn't very pleasant. The reporter had the diarrhea for 4.5 weeks. The reporter went to her doctor after having the diarrhea for 2 weeks and the doctor started her on rice and all sorts of things, some diet. The reporter was sticking to the diet and it didn't do any good. The reporter doctor referred the reporter to the colonoscopy doctor. The reporter had the colonoscopy last Friday and they found nothing. The reporter felt like the diarrhea came from the shot. The diarrhea left after 4.5 weeks and then 2 weeks after that, the caller had the colonoscopy. Event: The caller clarifies and confirms that before the colonoscopy the diarrhea has stopped probably a week and a half prior. First Dose: Received 17Mar2021, lot EP7534, unknown expiration date and NDC. Second Dose: Received 07Apr2021, lot EW0151, unknown expiration date and NDC. Investigation: The reporter had routine blood work done a couple of days ago and said it was fine. The reporter would not get a booster shot if we offered it because she doesn't want to go through this again. The patient underwent lab tests and procedures which included Blood work: normal on an unspecified date, colonoscopy: normal on 18Jun2021. Description of Product Complaint: The reporter was taking 20 mg of the Omeprazole and then her doctor increased it to 40mg when the diarrhea started. Lot, NDC, and expiration date unknown. Outcome of the event was resolved on an unspecified date in 2021.
80 2021-07-28 diarrhea Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animal... Read more
Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .
81 2021-01-07 nausea, diarrhea Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient h... Read more
Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient herself). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 30Dec2020 at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included sertraline, levothyroxine and furosemide. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. Age at vaccination was 81-year-old. No other vaccine was received in four weeks. On 01Jan2021 at 12:00 AM, the patient had nausea, diarrhea and mild headache. The outcome of the events was unknown. Information on the lot/batch number has been requested.
81 2021-01-10 nausea Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient... Read more
Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure increased. Concomitant medication included sertraline (UNKNOWN MANUFACTURER) for high blood pressure. On an unspecified date the patient experienced dizzy, nauseous and was unable to breath. The patient still had those symptoms and was wondering if it was normal and how much longer will these symptoms be. The outcome of the events was not resolved. Information about lot/batch number has been requested.
81 2021-01-18 nausea 12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fev... Read more
12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away
81 2021-01-20 nausea Resident became hypotensive, chest pain, low O2 SAT, diaphoretic, body aches, fatigue and chills on ... Read more
Resident became hypotensive, chest pain, low O2 SAT, diaphoretic, body aches, fatigue and chills on 1/14/21. Second episode on 1/15/21 of nausea, body aches and lethargy.
81 2021-01-21 nausea, vomiting pt. has had 4 days of nausea with vomiting, fatigue, change in stool consistency.
81 2021-01-25 decreased appetite Fever, lethargic, loss of appetite, redness and sore below the vaccination site on left arm.
81 2021-01-25 nausea weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a sponta... Read more
weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.
81 2021-01-26 nausea, abdominal discomfort fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth... Read more
fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.
81 2021-01-28 abdominal pain upper, diarrhea, diarrhea with profuse bleeding She was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started p... Read more
She was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots; She kept getting pains; Bad stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date unknown), via an unspecified route of administration, on 14Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date. Concomitant medication included atorvastatin, losartan, alprazolam, mirtazapine, and several medications because of her age and she has hypertension. The patient had her vaccine on 14Dec2020 at about 10 o'clock and a couple of hours later she began getting really bad stomach cramps and had diarrhea for most of the day and about 11 o'clock of 14Dec2020 she reported she was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots. Treatment for the events include Some Pepto-Bismol (as reported). The outcome of the event "bad stomach cramps" was not recovered, and for other events was unknown.
81 2021-01-31 diarrhea Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / cont... Read more
Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / continuing cough
81 2021-02-01 nausea shoulder pain, dizzy, nausea
81 2021-02-01 nausea arm below the injection site was swollen, red and hot; it was about 2 inches down below injection si... Read more
arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; nauseous/nauseated; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, on 13Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) and diabetes and cancer surgery. The patient has unspecified concomitant medications ("she takes many"). The patient experienced being nauseous/nauseated when she got up this morning (25Jan2021). And her arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site. The patient underwent unspecified lab tests and procedures on Dec2020, results were also unknown. Patient took Tylenol as treatment to the events. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
81 2021-02-02 abdominal pain, abdominal discomfort Dull abdominal pain, all-over achiness, fatigue on day after 2nd vaccination. Around 2 a.m. (36 hour... Read more
Dull abdominal pain, all-over achiness, fatigue on day after 2nd vaccination. Around 2 a.m. (36 hours after vaccination), severe stabbing pains radiating from colon up through ribs on left side. Only shallow breathing possible; any more than that brought unbearable pain. Took 10 mg. of Bentyl and another 10 mg about an hour later. Pain subsided in less than an hour after 2nd dose. Discomfort & occasional sudden pain in abdomen, along with achiness, through the next day. Continued to take Benadryl. Dr. reachable by phone only said this probably not a repeat of the diverticulitis I have had several times over the past 15 years but simply spastic colon. By 3rd day, only mild abdominal distress & mild fatigue. I do not know whether this experience is related to the vaccine at all. I had no difficulties after the 1st Covid vaccine.
81 2021-02-03 nausea Following the vaccine, the patient reported feeling "loopy" and a "little nauseous" about 20 minutes... Read more
Following the vaccine, the patient reported feeling "loopy" and a "little nauseous" about 20 minutes after vaccine was given, and attributed this to likely not having eaten earlier. The patient was found not to be diabetic and was given some crackers, juice and water. She was offered to go to a private room for further monitoring, but declined. Her condition did not improve, so she was taken to a private room for monitoring and observation at about 2:30PM. Vitals were taken, she was still feeling poorly and had very high blood pressure (>200 systolic). She declined the ED. At 2:40PM, her blood pressure did not decrease, so the ED was called to take her in, and she agreed.
81 2021-02-03 nausea Dizziness, Nauseous, Fast heartbeat (AFIB)
81 2021-02-03 nausea Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within norma... Read more
Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within normal limits (BP, glucose, O2 Sat, HR). I administered a Benadryl 50mg IM injection to the patient, and the hospital staff later gave her a dose of Zofran as she felt nauseous. Since then the patient seems to be reacting well to treatment.
81 2021-02-03 vomiting, diarrhea 3 hours of Vomiting and Diarrhea for aprox 48 hours
81 2021-02-04 abdominal distension, indigestion, flatulence Muscle aches, indigestion, gas and bloating, ELEVATED BLOOD PRESSURE and Rapid Pulse
81 2021-02-04 frequent bowel movements, nausea the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent st... Read more
the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.
81 2021-02-07 vomiting, frequent bowel movements Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few se... Read more
Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.
81 2021-02-08 abdominal distension, abdominal pain, nausea I am an RN and know that side effects are usually headache, elevated temp, and fatigue. I had the te... Read more
I am an RN and know that side effects are usually headache, elevated temp, and fatigue. I had the temp (not much as I take Tylenol for arthritis tid) and fatigue but my other symptoms were gastrointestinal. Epigastric distention, abdominal pain and nausea. It was over in approx. 12 hours. I had similar but more severe symptoms last April that I thought were food poisoning. Now I wonder if they were COVID-19 related.
81 2021-02-08 diarrhea Diarrhea 12 hours post vaccine and ended within 24 hours.
81 2021-02-10 diarrhea experiencing severe diarrhea have been taking non diarrhea tablets it clears it up for about a day a... Read more
experiencing severe diarrhea have been taking non diarrhea tablets it clears it up for about a day and the diarrhea returns. Im experiencing dehydration as well.
81 2021-02-10 nausea Awakened at about 1:00 A.M with painful arm. Pain has continued until now. Also chills and naus... Read more
Awakened at about 1:00 A.M with painful arm. Pain has continued until now. Also chills and nausea. Fever reached 100, subsequently dropping to 98.
81 2021-02-14 diarrhea My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms w... Read more
My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms were more prevalent( thirst, frequent urination, dry mouth, diarrhea)
81 2021-02-15 nausea Severe dizziness, nausea, weakness, racing heart
81 2021-02-17 abdominal discomfort, diarrhea FLU LIKE SYMPTOMS: CHILLS, BODY ACHES, HEAD ACHE, STOMACH PROBLEMS, DIARREA LASTED 3-4 DAYS. TOOK... Read more
FLU LIKE SYMPTOMS: CHILLS, BODY ACHES, HEAD ACHE, STOMACH PROBLEMS, DIARREA LASTED 3-4 DAYS. TOOK OTC FOR DIARREA - TYLENOL FOR BODY DISCOMFORT. SLEPT FOR MOST OF THESE DAYS .
81 2021-02-18 retching, vomiting Started upon rising from sleep on morning after vaccine. Very dizzy, needed help to bathroom, began... Read more
Started upon rising from sleep on morning after vaccine. Very dizzy, needed help to bathroom, began dry heaving, did not feel sick to my stomach. Dry heaved 3 different times, then vomited 2 times. Still Dizzy. My roommate called ambulance and I had just finished vomiting as they arrived. My blood pressure was 227/70. They monitored me for a while until my blood pressure was at 160/72. I opted not to be taken to the hospital at that time. I ate a slice of toast, which stayed down, them took my morning medications. They also stayed down. I had liquids all day and some crackers. Was dizzy all day. Blood pressure before retiring was 150/74. Slept well last night and am still a little dizzy yet today, but appetite has returned. Blood pressure is now 135/74. which is about my normal.
81 2021-02-22 diarrhea with profuse bleeding diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood... Read more
diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood coming from her anal area; feel heaviness, she just feels that heaviness.; she lost weight; This is a spontaneous report from a contactable consumer (patient). A 81-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EM9809) (at the age of 81-years-old), via an unspecified route of administration on 06Feb2021 between 12:30 and 1PM as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was a doctor's office and administered anatomically located on the right arm. The patient medical history included: She has been diagnosed years ago 10 years ago, which was since she smoked with COPD and she is on breathing medication, but she has not had it due to getting in a donut hole with insurance and she cannot afford it, her hands also won't let her use it, She hasn't had it for 2 months. Arthritis. She has had no other vaccines on the same day or in the past 4 weeks, she had the flu shot back in Oct2020. Family Medical History: Her dad had heart problems and cancer. Her brother had cancer. Her mother had heart conditions. Concomitant medications included: Acetaminophen and Naproxen sodium. She was taking a lot of acetaminophen and Naproxen sodium for arthritis pain, but she has not had any since Friday night 05Feb2021. She did not want to take anything before the shot. She hasn't been weighed in a while, she lost weight. On 06Feb2021, at 8 o clock on the night, she experienced bright red blood coming from her anal area; then, she had diarrhea and it was just all bright red fresh blood, it was fresh new blood not dark at all. Today she is still having bright red blood with diarrhea; the blood seems like it is decreasing, it's being colored by diarrhea. She felt maybe in so many years is like when you have a period at times and feel heaviness, she just feels that heaviness. Caller reports that she does have a standing appointment with her provider tomorrow. The clinical outcome of the events bloody diarrhea and anal bleeding was not recovered, heaviness and weight decreased was unknown. She is scheduled for the second dose on 10Feb2021.
81 2021-02-23 diarrhea, vomiting check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; fel... Read more
check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.
81 2021-02-24 difficulty swallowing Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.
81 2021-02-26 diarrhea Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after rec... Read more
Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after receiving her second Pfizer COVID-19 vaccine on 2/26/21
81 2021-02-28 abdominal pain upper, diarrhea SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOUR... Read more
SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.
81 2021-03-01 difficulty swallowing Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals... Read more
Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60
81 2021-03-01 nausea blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contac... Read more
blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin. The patient experienced death cause: heart problems on 20Jan2021, blood clot on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems
81 2021-03-03 diarrhea, retching She went to the living room and fell and couldn't get up; She went to the living room and fell and c... Read more
She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered
81 2021-03-14 vomiting, nausea, decreased appetite headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then i... Read more
headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then it ran straight to my back; suffering pain; arm was real sore /pain in the left arm/her arm felt like it was going to fall off; sick as a dog; She was very upset; nausea; her back still hurts to move/it ran all way over to my back; didn't feel like eating; sneeze; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she was administered with the first dose of the vaccine on 26Jan2021, and she has been feeling sick as a dog since she got it. The patient wanted to know about the ingredients used in the formulation of the Pfizer's COVID-19 vaccine. It was reported that patient had been suffering pain on 26Jan2021. The patient took pain pills for the pain. On 26Jan2021, the patient arm was real sore, her arm felt like it was going to fall off/pain in the left arm and on 27Jan2021, the patient experienced hurting in her head/ headaches. The patient reported that she would not have taken the vaccine if she had known her arm would hurt like that. On 27Jan2021, she started having sharp pain across her shoulders, through her shoulder blade to the middle of the back . She tried a heat pad, ice packs and the pain just keep shooting and she believes she had a fever with it. She threw up. She was very upset with all of this and mentions that her husband had passed away. It was reported that patient took pain medication referring to Robaxin 500mg and it didn't work. She also took Methocarbamol 500mg and it helped a little but not a lot. Adds she called the paramedics. The paramedics examined her and told her they had been to the Navy hospital several times and it was very crowded and they advised her to take Tylenol. She took the Tylenol 325mg and she went to sleep but when she woke up she still had the real sharp pains. She thinks the Tylenol helped some. She also took Ibuprofen via oral route at a dose of 400mg as needed per the instruction of the paramedics at. Mentions her symptoms were improved but her back still hurts to move on an unknown date in 2021. She has not eaten except to take medicine. She didn't feel like eating on an unknown date in 2021. She was scheduled to receive the second dose on 16Feb2021 but wanted to refuse because she heard it is even worse than the first time. The patient reported that she experienced sneeze on an unknown date in 2021. The patient reported ‘top of my arm swollen and then it ran straight to my back and I cannot get no relief on 26Jan2021; I really get sick with pain I mean with pain, it ran all way over to my back (as reported). It was reported that Pain is so bad; I have been in pain; I have been laying, it's hurt me so bad (as reported). The patient also experienced nausea on an unknown date in 2021. The patient was suggested to rest until feel fine. The patient called the ambulance but they (staff) confirmed no need of emergency room and want the patient to rest until she was fine. They told her not to get up and she don't want to get up either. Therapeutic measures were taken for suffering pain, pain across her shoulder, headaches/her head hurt, her back still hurts to move/it ran all way over to my back, top of my arm swollen/her arm was real sore and pain in the lefts arm/her arm felt like it was going to fall off. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events pain, sick as a dog, nausea, her back still hurts to move/it ran all way over to my back, didn't feel like eating, sneeze, she was very upset, arm was real sore /pain in the left arm/her arm felt like it was going to fall off was unknown while for other events was recovering.
81 2021-03-17 nausea About 4 days after receiving vaccine, started to get a headache which lasted for about 1 week. Also... Read more
About 4 days after receiving vaccine, started to get a headache which lasted for about 1 week. Also felt like I was coming down with something. Felt nauseous at times but had no vomiting. Spent about 2 days in my recliner because of overall feeling of unwell ness.
81 2021-03-18 diarrhea, vomiting Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details:... Read more
Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea. Still a little weak today (3-18-21).
81 2021-03-21 vomiting, nausea Nauseous, vomiting and headache. Off and on since 2:00 P.M. into night.
81 2021-03-21 vomiting severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundi... Read more
severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundiced; This is a spontaneous report from a non-contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), dose 2 intramuscular, administered in arm right on 19Feb2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia. The patient's concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose at 81 years of age, intramuscular in the right arm on 28Jan2021 for COVID-19 immunisation. The patient was not pregnant. The patient had not received other vaccines in four weeks. The patient had no COVID prior to vaccination nor was she tested post vaccination. She had no known allergies. The patient experienced a severe ulcerative colitis flare up starting within 24 hours of the 2nd vaccine. Initially, as a exceptionally private and stubborn person, she did not report her progressing symptoms to her family and only after she "felt as if she was actively dying" did she reach out for help (01Mar2021). Additional symptoms included severe burning pain across her lower abdomen, vomiting greater than 7 times, persistent diarrhea, gray skin pallor and she appeared slightly jaundiced. Patient refused repeated offers from daughters to be taken to hospital. On 01Mar2021, contact was made with her gastroenterologist and in the morning of 02Mar2021, she was restarted on her UC treatment, which was oral budesonide (unsure of dose). Outcome was improving. She was now able to intake food and liquids and her UC symptoms are resolving. She was up and active again. The events started on 20Feb2021 with outcome of recovering. Therapeutic measures were taken as a result of the events. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
81 2021-03-24 vomiting dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daug... Read more
dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daughter. Pt rcvd Covid vaccine 2nd dose yesterday. patient having protracted vomiting/dizziness. pt does get medication for dizziness regularly and has history of stress induced vomit. pt not feeling well. Daughter able to provide some of the information regarding vaccine but very nervous and d/c as soon as EMS arrived. Agency had recommended to have EMS evaluated and transport as needed. Adv pt should f/u w/PCP ASAP. Adv to call back if any questions. Adv daughter that she may get call back from PIC/Covid Hotline.
81 2021-03-30 abdominal pain upper Patient presented and was admitted through the ED for complaint of epigastric abdominal pain onset t... Read more
Patient presented and was admitted through the ED for complaint of epigastric abdominal pain onset this morning that has since resolved, as well as complaint of shortness of breath, fatigue that is persistent. She had HD but stopped 10-15 minutes into HD with noted severe bradycardia. Diagnosis on admission - 3rd degree heart block. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine.
81 2021-03-30 nausea light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report fro... Read more
light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.
81 2021-03-31 vomiting Severe dizziness with vomiting
81 2021-04-01 diarrhea Day 2 following vaccination-headache, severe diarrhea, vomiting Day 3- mild diarrhea, general feelin... Read more
Day 2 following vaccination-headache, severe diarrhea, vomiting Day 3- mild diarrhea, general feeling of feeling ill, fatigue Day 4- symptoms had nearly resolved
81 2021-04-02 nausea, vomiting, diarrhea got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm;... Read more
got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose. Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm. Information on the lot/batch number has been requested.
81 2021-04-02 stomatitis mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were ... Read more
mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were puffy; random itchiness; increased fatigue; Irritation roof of mouth; tongue was raw, red, and puffy; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 04Feb2021 13:00 as SINGLE DOSE for COVID-19 immunization. Medical history included restless legs syndrome, multiple allergies, disability (handicapped for 7 years), osteoarthritis, drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took ampicillin and experienced rash, ampicillin and experienced drug hypersensitivity. After 1.5 hours after vaccination, the patient experienced headache, random itchiness, increased fatigue, irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021, mucous membranes inside her nose were burning, on 05Feb2021. The patient stated some side effects including: the inside of her cheek became puffy, the roof of her mouth became irritated, her tongue became raw and puffy and red, the mucous membranes became irritated, and she had burning inside her nostrils. The roof of her mouth and inside of cheeks is diminished but it is not gone and has been 6 days. The caller stated she has multiple allergies and chemical sensitivities and asked if this is a common side effect in sensitive people. She stated she has not taken any allergy medicine. The caller stated she also had a headache that lasted the rest of the day, soreness in the arm, random itchiness that began an hour and half after and continued to next day then began to disappear, intense fatigue for 3 days, her restless leg was increased through yesterday, for several days she felt out of sorts, didn't feel like herself, she can't put her finger on it but she felt off, she had increased joint and muscle pain a day and a half later, and has heard that whatever side effects you experience they will be more intense after the second dose. The patient stated that the facility didn't give them a vaccine card, NDC/LOT/EXP: Unknown. She says that they gave her some copied pages and a date for her next dose appointment which is 25Feb2021. She says that her first dose was injected in her left arm on 04Feb2021 at 01:00PM. She says that 1.5 hours after her first dose she had a headache and itchiness. She says that the itchiness was random and minor, and went away by the next day with no treatment. She says then she also had increased fatigue that day, which lasted for three days. She says later on Thursday, the day she got the vaccine, the inside of her cheeks were puffy, the roof of her mouth was irritated, and her tongue was raw, red, and puffy. She says she did no treatment for this, though she does have Benadryl in her house, she is so sensitive to Benadryl (UPC/LOT/EXP: Unknown) because she has restless legs syndrome, it makes it worse. Caller says she did not take the Benadryl. Caller says she is handicapped and has difficulty standing with restless legs syndrome. She says that those symptoms diminished, but have not gone, it has been 6 days already which is why she looked at the information from Pfizer. She says that the mucous membranes inside her nose on the following day were like burning, and she couldn't use her regular nasal wash that she uses. No further details provided about nasal wash. She says that was subsiding, and the thing that has been the most aggravating right now are the feelings in her mouth, which are not listed on normal side effects, which is why she called to find out if they could be side effects, and find out if it could be her immune system working. The patient stated she has had previous allergic reactions 7 years ago, when her allergist wanted to immunize her to Ampicillin allergy, which she is allergic to all major antibiotics, and when she had that she had a thick tongue and a puffy roof of her mouth and irritated tongue. She says that her allergist wrote a note saying they felt this was her immune system reacting. She says that the allergist was trying to help her with desensitization for her allergies, and she wanted to know if something like this happens with this COVID-19 vaccine, if a number of sensitive people that are sensitive to medications have reactions like this to it. She says that she thought she would call here before calling her general practitioner. Ampicillin NDC/LOT/EXP: Unknown. She says she is allergic to Ampicillin and Penicillin, she took Ampicillin 30 years ago and had a rash, and is allergic to everything else. She says that she was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient stated she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient stated she has so many allergies that she can't tell what they all are, she has multiple allergies and chemical sensitivities that she doesn't know what they are. She says there are inert ingredients in some medications too, she is difficult to prescribe for, as well as some things have multiple fillers but those have never been identified as to what is bothering her, so she just tries different manufacturers to see which don't bother her after she takes them. She says she is an unusual case. The patient says that she is handicapped and has had restless legs syndrome which she has had for a number of years. And handicapped 7 years, and she needs two hip replacements. She says she has end stage osteoarthritis, documented as provided. She says when her allergies and chemical sensitivities become active, with her restless legs syndrome it is difficult to stand, it makes her restless legs syndrome worse. The outcome of the event random itchiness was recovered and the outcome of all other events was unknown. Information on the lot/batch number has been requested.
81 2021-04-04 decreased appetite, diarrhea Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for incre... Read more
Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for increased fatigue and decreased appetite which began 3d after vaccine. In ER she tested + for covid and CXR was unremarkable, pt was discharged home. Patient returns to ER for increasing shortness of breath causing her to increase her home 02 to 3L and then ultimately 4L prior to EMS arriving. She notes she is dizzy and fatigued. She denies chest pain, n/v, but did have 1 episode of diarrhea PTA. This morning patient requiring 5L NC 02 and ID asked to evaluate for recommendations. Remdesivir withheld as symptom onsent > 2 weeks ago. Tocilizumab 8 mg/kg and dexamethasone 6 mg daily initiated.
81 2021-04-04 nausea, diarrhea 81 years old woman with PMH of Anemia, CAD s/p CABG, Carotid stenions, CHF with EF 30%, COPD, DM, HL... Read more
81 years old woman with PMH of Anemia, CAD s/p CABG, Carotid stenions, CHF with EF 30%, COPD, DM, HLD, HTN, who presented to the ED with chief complaint of increase SOB over the last 5-6 days. The SOB got worse with exertion. Pt stated that she was using O2 only at the weekend but now she required O2 all the time. The associated symptoms wheezing, SOB, productive cough with yellow sputum, nausea, chills, fever, and diarrhea. Pt stated that she been having 6 episodes of diarrhea per days. Pt denied having any vomiting, chest pain, abd pain. Pt stated that she tested positive for Covid on 3/23/21. Per chart review, patient had 1st COVID 19 vaccine on 03/04/2021, tested positive for COVID 19 on 03/24/2021.
81 2021-04-07 nausea break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; p... Read more
break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.
81 2021-04-10 diarrhea Pt reports diarrhea, nasal congestion, cough with green phlegm since Friday 4/9/21.
81 2021-04-12 decreased appetite 3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremit... Read more
3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremities. Often trembly with complete lack of appetite (lost 6 pound in 2 weeks). Only wanted to sit or lie down- unable to go for daily walk (no strength). No fever or respiratory symptoms. This extreme condition lasted for approx. 10 weeks, during which time I saw my doctors five times for diagnosis or assistance. They could find no reason for my sudden symptoms except for adverse reaction to the vaccine, and were unable to assist. I mostly sat and laid around for 10/11 weeks , after which my symptoms improved gradually, and I am feeling better at this time.
81 2021-04-12 profuse gastrointestinal bleeding Jan 13 first dose received...Jan 30th collapsed at night by herself. Was able to get up and go back... Read more
Jan 13 first dose received...Jan 30th collapsed at night by herself. Was able to get up and go back to bed. Next day was taken to urgent care and sent by emergency to hospital. Suffered large blood clot in the leg that broke off and traveled to the lungs. Acute saddle pulmonary embolism with acute cor polmonale. Was put on blood thinners and released from hospital on 2/2. As soon as we got home from the hospital she suffered from a massive gastrointestinal intestinal bleed and had to be rushed back to the hospital. Two days later while still in the hospital she suffered a mild heart attack and had a stent inserted.
81 2021-04-13 decreased appetite Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept a... Read more
Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept all day. Body was hot to touch. Lasted for 24 hours.
81 2021-04-15 decreased appetite, nausea Patient diagnosed with COVID-19 infection on 3/31/21, chest xray at that time unremarkable. Patient... Read more
Patient diagnosed with COVID-19 infection on 3/31/21, chest xray at that time unremarkable. Patient presented to outlying hospital on 4/4/21 with worsening cough and nausea. D-dimers were elevated and CT chest showed scattered airspace opacities. Prescriptions for antibiotics and patient discharged from ED. Patient again presented to outlying ED on 4/6/21 with worsening shortness of breath and nausea and poor appetite. Patient was hypoxic saturating 86% on room air and was requiring 3L to maintain oxygen saturation. Repeat chest x-ray showed mild-to-moderate bilateral airspace opacities. Patient was admitted to outlying hospital on 4/6/21. Patient transferred to this hospital on 4/9/21 with severe diffuse bilateral pulmonary infiltrates on CT chest and worsening COVID-19 infection. Patient was treated with oxygen, antibiotics, remdesivir, and steroids. Patient was discharged to home with new home oxygen.
81 2021-04-16 nausea, vomiting tired; Chills; temperature going up and down many times, the most it went to was 100.5F then went to... Read more
tired; Chills; temperature going up and down many times, the most it went to was 100.5F then went to normal; puking/throwing up; Nauseous; Headache; This is a spontaneous report received from contactable Nurse. A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262 and expiration date: 31May2021), via an unspecified route of administration at the left arm on 17Feb2021 at single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot: Lot 1283) on 27Jan2021 for COVID-19 immunization. The patient's medical history included immune system disorder. Concomitant medications included promethazine (PHENERGAN) and loratadine (IMMUNIX). It was reported that patient experienced the headache a couple days after second dose. The patient first got tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal. The patient kept taking tylenol for 4 days then after she was nauseous and kept puking. The patient took ondansetron and stopped puking and reported sometimes it works sometimes it doesn't get in system fast enough and then the patient had dry eating and hydrated. The patient feels nauseous and sick still and still has a headache. It was reported that the patient called the doctor wanting a refill on her Phenergan, but the doctor told her no and said that she has to call Pfizer. It was reported that she doesn't understand why the doctor would say that when he knows Pfizer has nothing to do with her receiving her Phenergan. It was stated that he doesn't understand, this is not a new medication for her, she's just getting a refill for something that she's had before. The doctor said that they couldn't do anything. Outcome of puking was reported as recovered and outcome of tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal and nauseous was reported as unknown. Follow-up information has been requested and pending to receive.
81 2021-04-18 nausea, vomiting Rash/Allergic reaction all over body, nausea, vomiting, dehydration, UTI, acute kidney injury
81 2021-04-19 abdominal pain Rash, abdominal pain
81 2021-04-21 nausea Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled sp... Read more
Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled speech
81 2021-04-21 vomiting, vomiting blood 8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died. No ot... Read more
8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died. No other symptoms of sickness leading up to this.
81 2021-04-23 decreased appetite, nausea Nausea, cold chills, sweats, loos of appetite and memory.
81 2021-04-24 profuse gastrointestinal bleeding This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient)... Read more
This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.
81 2021-04-26 vomiting After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like... Read more
After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like symptoms for approximately 3 days, and unusual bowel movements not diarrhea, not constipated, but not normal and painful. After second dose had similar reaction bowel issues are still bad and very painful (to the point of vomiting during bowel movements due to pain). She saw her primary care doctor and was Rx'd a cream. This has caused her to decrease her eating. This did not help and she was having loss of visual acuity and started not being able to speak properly so went to the ED for concern over Strokes. had 2 MRIs, and determined not to be having a stroke so was released to home. Sxs seemed to resolve ( like a spell) . Was still having bowel issues and she also developed a rash from the neck to the groin. So she went to a specialist. The Rash cleared after about 3 days. Specialist advised that the sxs were all due to the COVID Vaccine. Flank pain under the right ribs has also been present, this is not improving, it is a dull pain that seems to be worsening ( the bowel seems to be about back to normal now) She is planning on speaking with her PCP about the right flank pain.
81 2021-05-07 diarrhea This 81 year old received the Covid shot on 2/2/21 and went to the ED on 3/2/21 with the fo... Read more
This 81 year old received the Covid shot on 2/2/21 and went to the ED on 3/2/21 with the following diagnoses listed below. U07.1 - COVID-19 DIARRHEA FEVER
81 2021-05-10 vomiting Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-... Read more
Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: Unknown; Expiry Date: Unknown) dose 1 intramuscular, administered in Arm Left on 06Feb2021 16:00 as SINGLE DOSE for COVID19 immunization. Medical history included If covid prior vaccination: Yes. Concomitant medications included apixaban (ELIQUIS); propranolol; chlorthalidone; pravastatin sodium for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive post vaccination. The patient experienced on 06Feb2021 16:00 profuse vomiting, chills, dryness. The patient did not receive any treatment for adverse event. The outcome of the events were unknown.
81 2021-05-12 anal incontinence, vomiting ears went dead with no sound to be heard, went to walk felt like could not control body, was swayin... Read more
ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
81 2021-05-12 difficulty swallowing ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acu... Read more
ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Principal problem Discharge Summary Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/6/2021 Length of Stay: 3 Days Discharge Date: 4/9/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Yes Type 2 diabetes mellitus (CMS/HCC) Yes Obesity Yes Hypothyroidism Yes Chronic combined systolic and diastolic heart failure (CMS/HCC) Yes Benign essential hypertension Yes 81-year-old female presented to the hospital with a complaint of fever and cough COVID-19 - now saturating well on room air and Afebrile Complaining of sore throat and difficulty in swallowing- now resolving Back pain improving Episode of diaphoresis and blurry vision -now resolved Home Or Self Care CODE STATUS: DNR (Do Not Resuscitate) Active Issues Requiring Follow-up Follow-up with PCP for further care as outpatient. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture- 2 SETS Preliminary result Blood culture- 2 SETS Preliminary result Hospital Course HPI: See H&P Hospital Course: Patient presented to the hospital with a complaint of fever and cough. She was admitted for COVID-19 with respiratory failure. Since she was saturating below 94%, she was started on remdesivir on admission. Oxygen was given for supportive care. She received albuterol inhaler, Mucinex, Tessalon Perles and Decadron. In addition she complained of some sore throat and received Chloraseptic spray along with lozenges. She had an episode of diaphoresis and change in vision during the hospitalization. There were no events on the monitor and the CT of the head was negative. The symptoms resolved. She also complained of insomnia back pain for which he received melatonin and Lidoderm patch respectively. She is feeling much better and has been saturating well on room air above 95% for the past 2 days. I will continue with the albuterol inhaler, Decadron and Mucinex as outpatient for few more days. She is asked to follow-up with her PCP for further care as outpatient. ED to Hosp-Admission Discharged 4/13/2021 - 4/16/2021 (3 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/13/2021 Length of Stay: 1 Days Discharge Date: 4/16/2021 Admission Diagnosis Hospital Problems POA Type 2 diabetes mellitus (CMS/HCC) Yes Hypothyroidism Yes Hyperlipidemia due to type 2 diabetes mellitus (CMS/HCC) Yes Gastroesophageal reflux disease Yes Problem List Resolved POA Resolved Problems Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) 4/17/2021 Yes * (Principal) Weakness 4/17/2021 Yes Generalized weakness 4/17/2021 Yes Home Under Care Of Organized Home Health Service CODE STATUS: Prior Active Issues Requiring Follow-up Test Results Pending at Discharge Hospital Course HPI: See H&P admit report. Hospital Course: Patient was admitted secondary to weakness and hypoxia she recently did have a bout of COVID-19 and had been discharged home and has been set up for remote outpatient monitoring as per protocol. She returns for ongoing weakness. Patient was continued on Decadron and was seen by physical therapy and Occupational Therapy. The patient slowly continued to improve and was now back to baseline functioning. She may be discharged home and follow-up with PCP as advised as she is no longer on oxygen. She is to complete the dexamethasone dose as she had previously been taking to complete a course. Home health had been previously set up at her previous admission.
81 2021-05-19 abdominal distension, diarrhea Office Visit 5/4/2021 screening laboratory testing for COVID-19 virus +1 more Dx Cough ? Diarrhea ?... Read more
Office Visit 5/4/2021 screening laboratory testing for COVID-19 virus +1 more Dx Cough ? Diarrhea ? Fatigue Reason for Visit ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Last attending Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM Note: Document: 08/22/19 - Consults Rheumatology Paroxysmal atrial fibrillation (CMS/HCC) Yes Atrial fibrillation with RVR (CMS/HCC) Yes Esophageal stricture Yes Hospital Course HPI: patient is an 81 y.o. female with pmh of COPD and HTN presented to the ER with complaint of palpitations. She reports since her second covid short on 4/29, she's been feeling "ill." she states she's been having diarrhea, chills, fatigue, and cough. In the ER, she was found to be in afib with RVR. She was given a one time dose of cardizem but then spontaneously converted to NSR. She is not hypoxic but admits to increased cough and occasional dyspnea. CTA was done in the ER due to elevated D dimer. Pulm embolism was ruled out, however, she was found to have bilateral infiltrates concerning for viral pna Hospital Course: Please send details from consultation note from hematology gastroenterology 81-year-old Caucasian female she had a history of COPD hypertension she was admitted through the emergency room on May 6 with a chief complaint of palpitation chest discomfort. She was found to have A. fib with RVR with underlying history of paroxysmal atrial fibrillation. Patient was admitted and atrial fibrillation is rate controlled in maintain with increase his Lopressor. ACS is ruled out by cardiac enzyme patient was found to have a COVID-19 pneumonia fortunately patient oxygen saturation remained good continue having mild cough. And initially she was not started any dexamethasone or any antiviral remdesivir. But over the time patient actually having mild wheezing shortness of breath but oxygen saturation remained stable so then dexamethasone was started. Heart rate was pretty controlled with current medication Lopressor anticoagulation did not start since patient was found to have a severe thrombocytopenia. Patient was seen by hematologist recommend to bone marrow biopsy thought that the sudden drop possible from infectious source. So then that point Heparin Olympic Eliquis was not started. Over the time patient platelet count back to normal platelet count 1 75,000 Eliquis started 2 days ago. Since she looked tolerating Eliquis heart rate is well controlled after adding dexamethasone she is underlying history of COPD her wheezing is much improved and she is currently on DuoNeb. In the history of asthma without status asthmaticus patient will be discharged home with continue current medication Decadron for 5 more days started Eliquis 5 mg 2 times daily since she is tolerating and platelet count is normal I recommend to check CBC for platelet count in 5 days. This patient will benefit to see hematologist outpatient although she refused to do a bone marrow biopsy. She is having chronic low back pain and currently on narcotics recommend to follow-up with PCP to change his narcotic medication.. Initially she had a CTA chest done which was normal although D-dimer was mildly elevated negative for pulmonary embolism and a mild infiltration concerning viral pneumonia so bacterial antibiotic was not started. Stable to be discharged home she was having intermittent low-grade fever for almost like 5 to 10 days. The fever is totally gone now. She is clinically stable new medication is adjusting increase Lopressor 50 mg 2 times daily. Eliquis 5 mg p.o. twice daily and she is going to go home with Decadron only for 5 days.. Patient also have underlying history of chronic dysphagia patient was seen by gastroenterology recommend to follow-up outpatient in 2 to 3 weeks Follow-up PCP in 5 days, follow-up with hematology as scheduled
81 2021-05-20 decreased appetite, abdominal pain, diarrhea Cough Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches,... Read more
Cough Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches, cough. Had 2nd covid shot 4/29/21. ? Diarrhea ? Fatigue Patient is a 81 y.o. female HPI Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 10 days ago. Sinus pain and pressure No Fever/ chills Yes Headache Yes Body aches No Cough Yes Sob No Sore throat No Nausea/ vomiting/ diarrhea. Yes Loss of taste or smell Yes Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. yes Patient felt sick before receiving her second COVID 19 vaccine on 4/29. She states her and her husband were also exposed to someone at church who tested positive x 5 days ago and they were not wearing masks. She does use her rescue inhaler as needed for her cough. ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Hospital MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/17/2021 DOB: Admission Date: 5/5/2021 PCP: DO Length of Stay: 10 Days Discharging provider: MD Discharge Date: 5/17/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM by LPN Note: Document: 08/22/19 - Consults Rheumatology - Paroxysmal atrial fibrillation Yes Atrial fibrillation with RVR Yes Esophageal stricture Yes
81 2021-05-24 indigestion, abdominal pain, nausea nauseous; terrible abdominal cramps; indigestion; This is a spontaneous report from a contactable co... Read more
nauseous; terrible abdominal cramps; indigestion; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization administered in Hospital. Medical history included hypersensitivity, compromised immune status, respiratory disorder. There were no concomitant medications. The patient reported, she got the 1st dose of the vaccine yesterday and woke up today with terrible intestinal cramps, indigestion on 29Jan2021 15:30 and is nauseous on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for nauseous was unknown and for the other events it was not recovered. Follow-up attempts are completed. No further information is expected
81 2021-05-25 vomiting Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she starte... Read more
Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival
81 2021-06-03 stomatitis My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically ... Read more
My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically significant; Inflamed gums; Abscessed teeth on her lower jaw; some kind of side reaction; My gums and the roof of my mouth (Incomplete sentence)/my gums were so raw, I couldn't brush my teeth; My mouth became all inflamed; I have a very hard time hearing you; Equilibrium affected; But I am still deaf in my right ear; This is a spontaneous report from a contactable Nurse (patient). An 81-year-old female nurse received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0169; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 12May2021 20:00 (at the age of 81-year-old) at a 2nd dose, single for COVID-19 immunization. Medical history included macular degeneration (diagnosed about 3-5 years ago), low thyroid hormone (seems like she's had forever), high cholesterol just beyond normal (has had for years), banana, avocado, and kiwi allergy (stated all are interrelated because they are cousins to the rubber tree plant. Also, healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is metamucil); psyllium allergy (patient had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight), flu (every flu shot she received, she has gotten the flu and only takes periodically. She had to take in 2016 and 2015. It had been 5-10 years before that, and another 5-10 years before that), latex allergy (since the 1980's), shingles (having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. Stated it was a mild case. Patient gets the shingles vaccine and gets the shingles, gets the flu vaccine and gets the flu), atrial tachycardia from 2015 to an unknown date, anaphylactic reaction to a metapower bar from 2015 to an unknown date (about 7 minutes after eating the bar, she went into a severe reaction). Concomitant medications included levothyroxine tablet at a dose of 50 ug, 1x/day, vitamin B complex and akurit (not clarified hence not captured in tab). The patient previously took first dose of BNT162B2 (Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), administered in arm left on 21Apr2021 09:00 for COVID-19 immunization and experienced deaf in my right ear, I woke up with pressure in both of my ears, I could not hear and arm soreness. The patient drug history included synthroid from an unknown date to ongoing (started about 15 years ago) for low thyroid hormone, simvastatin from an unknown date to ongoing (started about a year ago) for cholesterol is slightly elevated, ocuvite preservision from an unknown date to ongoing (taking about 3 years. Macular degeneration has not changed or gotten worse in 3 years) for macular degeneration age related, vitamin D3 (taking for 3 years) for bone health from an unspecified date to ongoing, calcium with magnesium (it has calcium citrate. Been taking a long time. 5-10 years) to prevent osteoporosis, glucosamine chondroitin (taking since late 1990s. About 20 years) for joint health from an unspecified date to ongoing, vitamin C (about 3 years ago. started with the Ocuvite. Eye doctor though it was a good idea to take together), multivitamin (taking since 1995 or 1996. about 25 years) for general health; metoprolol ER for atrial tachycardia from Jan2016 to an unspecified date, baby aspirin from Jan2016 to ongoing (81 mg daily, cardiologist thought it would be a good idea). The patient reported, she received first Pfizer vaccine on 21Apr2021 and equilibrium affected and on 28Apr2021 she could not hear in her right ear and the day before on 27Apr2021 it was like she woke up with pressure in both of her ears. It sounded like heck like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and she was still deaf in her right ear. She got second vaccine on 12May2021 and on 16May2021 and 17May2021 her gums and the roof of my mouth became all inflamed and her teeth were so sore she felt like she had an abscessed tooth. My gums were so raw, couldn't brush my teeth. So she gargle with some peroxide and some saline and then her teeth were sore like you have an abscess teeth on lower jaw. And then that went away within two days. Pressure in both ears has subsided, but then confirms it is a lasting effect comes and goes a little bit from 27Apr2021 to ongoing. First the doctor put her on valacyclovir and methylprednisone 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Started 05May2021 for 7 days. And then last week he started me on the dexamethasone injections through tympanic membrane into her middle ear last Thursday, 20May2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help, she will have an MRI. States cortisone decreases irritation and inflammation. Adds she is pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events I am still deaf in my right ear, I have a very hard time hearing you was not recovered; equilibrium affected, some kind of side reaction was unknown; my teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw, inflamed gums, abscessed teeth on her lower jaw, my gums and the roof of my mouth (incomplete sentence)/my gums were so raw, I couldn't brush my teeth, my mouth became all inflamed was recovered on an unspecified date in 2021. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, unilateral deafness, non infective gingivitis, tooth abcess, toothache, balance disorder cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate
81 2021-06-07 abdominal pain upper slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach... Read more
slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach, like hurting; stomach felt warm; could taste shot; Felt terrible; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm on 06Mar2021 at 09:15 (Batch/Lot Number: EN6200) at the age of 81-year-old as second dose single for COVID-19 immunisation. Medical history included ongoing restless legs syndrome, sinus and nose run. She takes a blood pressure medicine and she has restless leg syndrome that she takes a medicine for. She had a regular check up in Dec2020. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL9269), via an unspecified route of administration, on 13Feb2021 at the age of 81-year-old, as first dose single, for COVID-19 immunization and the patient experienced no adverse events. On 06Mar2021 at 17:30 the patient experienced problems with stomach, like hurting, stomach felt warm, could taste shot and on 07Mar2021 experienced slept all day, very tired, mouth and throat was dry. The patient reported when they gave her the shot she tasted it and then about 17:30 on 06Mar2021 she started having problems with her stomach. Her stomach started hurting. Then it felt like when you put your hand on your stomach like putting your hand on your head for a fever that it felt warm. She felt terrible. On 07Mar2021 she slept all day and she didn't feel like going to work on 08Mar2021 and she's not one that misses work. She only weighs less than 85 pounds, she did not know if her weight had something to do with that. Her husband took the COVID-19 vaccine and he didn't have any side effects. She told her doctor that she wasn't going to get the COVID-19 vaccine until he did. And he got it. It's not like her to sleep all day. She reported her mouth was dry as it could be, like she had cotton in her mouth. She's never sick, she doesn't miss days at work. Is there anything she can take? Her daughter had said people do get sick and it lasts about 24 hours and then they feel better. She took aspirin clarified as Dollar General Pain Relief 500mg, she took 3 at one time. She takes Dollar General Pain Relief when she has a bad headache. She doesn't usually have headaches. She reports the Dollar General Pain Relief did help. Expired 2019 she didn't even see that, that's how much she doesn't use them. She sees AO561 on bottle. She usually does and goes and goes, she's usually doing something. She woke up on 07Mar2021 and her mouth was dry, she has sinus, but her nose usually runs. Clarified nose did has not run since getting the COVID-19 vaccine. Her stomach was better on 08Mar2021 but her throat was still dry. At least her stomach was not hurting. She felt better last night (07Mar2021). She's feeling better and decided take one more day off to not overdo it. She reported that her stomach felt real warm like her stomach had a fever but she did not have a fever and her stomach is fine now. The events did not require emergency room visit or physician office visit. Outcome of mouth and throat was dry was not recovered, outcome of problems with stomach, like hurting and stomach felt warm was recovered in Mar2021, felt terrible was recovering, while outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
81 2021-06-17 abdominal discomfort, nausea Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ... Read more
Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose. No follow-up attempts are needed. No further information is expected.
81 2021-06-20 abdominal pain, vomiting I was very sick and had abdominal pain on the right with vomiting one month after the second dose of... Read more
I was very sick and had abdominal pain on the right with vomiting one month after the second dose of the vaccine. I went to Urgent care and I was sent home. It was bad pain and it reoccurred. I have had the Shingles vaccine and I had the Shingles, and I was given medication because I had the Shingles. It was an Anti-viral which I took for ten days. Two weeks later I had a temperature of 103 and abdominal pain. I was admitted on 05/24/2021 and I had my Gall Bladder removed and the Gallstones removed the next day. I have had Gallstones for years, but I have not had problems.
81 2021-06-22 decreased appetite, nausea Painful ribs ,profound fatigue,- frontal headaches, muscle pain, chills , loss of apatite .joint pai... Read more
Painful ribs ,profound fatigue,- frontal headaches, muscle pain, chills , loss of apatite .joint pain , nausea .
81 2021-06-24 nausea blood pressure went up very high, It went up to about 180, 190 even 200 over 80; Anxiety; Headache; ... Read more
blood pressure went up very high, It went up to about 180, 190 even 200 over 80; Anxiety; Headache; slightly nauseous; This is a spontaneous report from a contactable consumer reported for herself. An 81-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EL9264; expiration date: unknown), via an unspecified route of administration in left arm on 05Feb2021 (at the age of 81-Year-old) as single dose for Covid-19 immunization. The patient medical history included cholesterol and taking medication for cholesterol. The patient stated, she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266; formulation: solution for injection; expiration date: unknown) via unspecified route of administration on 26Feb2021 as single dose for Covid-19 immunization. The patient stated this was the story. She received her two doses of the Pfizer vaccine and the last one received was two and half week ago. Now it's two and half week later and found that number one, after the first dose about 8 days later (unknown date in Feb2021), her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician. So, the physician put her on some blood pressure medication, and she got better and then had second vaccine. After that the same thing happen about a week later. Her blood pressure went very high, and she suffered because of it with a lot of anxiety. She wanted to know something about that the blood pressure goes really very high. It was still not regular; it was very irregular. Also, the other thing she wanted to talk about was that when she received the first dose, she had a headache and was slightly nauseous on unknown date in 2021. When she went for the second dose, she did not even look when she was putting a needle in her arm so, felt that the needle went in but shortly after heard her say oh jeez and she know she put it right in her arm, she thought might be she was bleeding, she did not have a look, ended up with a bandage over it and that was it, other day she see it did not have any blood on it. So, one of her friend told her that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm (Further clarification was unknown, hence split was not made) and she was wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took yesterday a test for antibody and that came out negative. The caller wanted to know that if she had antibody now with the two doses. Also asked does the blood pressure go up very high after the two doses. The patient underwent lab tests included antibody test with results shows no antibodies on unknown date, blood pressure (It went up to about 180, 190 even 200 over 80) on unknown date in Feb2021. On an unknown date, the blood pressure was between a 140-150. The patient received treatment included Losartan 75 mg. The adverse events resulted in physician office visit. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289470 same patient/drug, different dose/event
81 2021-06-29 abdominal pain upper Chills; Tiredness; Pain stomach; This is a spontaneous report from a contactable consumer. A 81-year... Read more
Chills; Tiredness; Pain stomach; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration, in right arm on 02Feb2021 11:30 (at the age of 81-years-old) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 12Jan2021 at 9:30am as 1st dose, single for covid-19 immunisation. No additional vaccines administered on same date of the pfizer suspect. Patient explained that it had been a week since getting her second shot and she went through the chills (on 03Feb2021) and muscle aches, but the acute tiredness is still on going. Caller clarified that there were no muscle aches. She explained she did have pains in the stomach (on 02Feb2021). This started 6 hours after the second dose and lasted about 8 hours. Acute tiredness this started Wednesday (on 03Feb2021) and had gotten worse. It is now a little better but still ongoing and exhausted. Adverse event did not require a visit to emergency room or physician office. Outcome of the event fatigue was recovering, pain stomach recovered on 03Feb2021 and chills recovered on 04Feb2021. Follow-up attempts completed. No further information expected.
81 2021-07-09 decreased appetite, nausea Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the we... Read more
Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the weeks leading up to diagnoses patient was feeling extreme lethargy, nauseous, lack of appetite and general extreme discomfort.
81 2021-07-11 nausea ALTERED MENTAL STATUS, SHAKING, NAUSEA, ELEVATED BP
81 2021-07-22 nausea 82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladde... Read more
82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.
82 2021-01-04 vomiting Patient vomited one time, 1 hour after administration, observed by nursing staff, Patient had no oth... Read more
Patient vomited one time, 1 hour after administration, observed by nursing staff, Patient had no other complaints or signs prior to vomiting, patient monitored for additional 15 minutes, and did not develop any other symptoms.
82 2021-01-11 vomiting first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021... Read more
first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.
82 2021-01-15 vomiting Patient awoke at approximately 1:50 AM experiencing sever chilling with rigors. Vomited once . Took... Read more
Patient awoke at approximately 1:50 AM experiencing sever chilling with rigors. Vomited once . Took temperature, wrapped in blanket and took two Tylonol tabs with water. Episode lasted approximately 40 minutes. Has experienced no further episodes and temperature has remained normal.
82 2021-01-20 diarrhea, vomiting vomitting, diarrhea, hypotension, bradycardia 2 hours after the vaccine was given treatment: placing... Read more
vomitting, diarrhea, hypotension, bradycardia 2 hours after the vaccine was given treatment: placing the patient in trendelenburg position until BP improved after 1 hr
82 2021-01-20 nausea, abdominal discomfort Patient experienced tingling lips, shaking, tremor and stomach upset and nausea
82 2021-01-20 nausea Nausea for 10 days Feeling tired 10 days
82 2021-01-21 vomiting, nausea, diarrhea Nausea, diarrhea, vomiting, fever, malaise, soreness at injection site
82 2021-01-26 nausea, vomiting Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Hypotension; symptoms lasted 1 day
82 2021-01-26 vomiting, nausea This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vacci... Read more
This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.
82 2021-01-27 nausea pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt state... Read more
pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt stated in bed next day since she was unsteady on her feet and had 101 fever. Pt called PCP to let them know and will FU with regular scheduled appt.
82 2021-01-27 vomiting, diarrhea @ 1830 developed diarrhea, dizzy and vomited. Lips were tingling and swelling
82 2021-01-30 nausea Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2... Read more
Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2021 and had 2 falls, second fall resident became lost consciousness while ambulating and abruptly feel to the ground . Paramedics were called and transported her to ER evaluation.
82 2021-01-31 difficulty swallowing Slight ache at injection site....lasted about 2 days Woke up Friday am...approx. 15 hrs. after injec... Read more
Slight ache at injection site....lasted about 2 days Woke up Friday am...approx. 15 hrs. after injection...with large swollen area in throat under right side of chin...presumably a lymph gland, which is sore to the touch and uncomfortable when swallowing. Has not gone away yet. Seeing my Doctor tomorrow.
82 2021-01-31 retching, vomiting, nausea Vaccine shot #1 was received in shoulder on Monday 1/25 around mid-day. At mid-day the day after (1... Read more
Vaccine shot #1 was received in shoulder on Monday 1/25 around mid-day. At mid-day the day after (1/26), patient began to feel nauseated. By 9pm she was vomiting, but dry heaves because she had not eaten all day. Vomiting resolved a bit after midnight. Some residual nausea until noon 1/27.
82 2021-02-01 diarrhea, vomiting, colitis got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomitin... Read more
got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.
82 2021-02-01 diarrhea Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female ... Read more
Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 05Jan2021 at 13:30, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes, arthritis, vitamin D, bones, gums, eye, joint pain lubrication, hair and nail growth and strength, control sugar, atrial fibrillation (Afib), heart, supplement, cholesterol, liver clean, and gastro problem. The patient's concomitant medications included apixaban (ELIQUIS) for Afib from 2019 (a year and three-fourths), metoprolol for heart from 2019 (a year and three-fourths), metformin hydrochloride (METFORMIN ER) for diabetes, berberine to control sugar, biotin from 2011 (for 10 years) for hair and nail growth and strength, Silybum marianum (MILK THISTLE) to make liver clean (two or three years), hyaluronic acid for joint pain lubrication, niacinamide for diabetes, chondroitin sulfate/ glucosamine sulfate (GLUCOSAMINE CHONDROITIN) for bones, Monascus purpureus (RED YEAST RICE) for cholesterol, colecalciferol (VITAMIN D3; UPC Number: 3373900373, Lot Number: 3162111, and Expiration Date: Jun2024) for vitamin D, probiotics for gastro problem, betacarotene for eye, ubidecarenone (COENZYME Q10) for gums, calcium/ magnesium (CALCIUM MAGNESIUM) for bones, and unspecified multivitamins as supplement and OSTEOPHASE for arthritis; all were ongoing. The patient her first dose of COVID-19 vaccine dose on 05Jan2021. The patient had experienced diarrhea ever since 09Jan2021 and is still continuing until today. The patient experienced a sudden onset of diarrhea and it has continued on and off since then; it is persisting or worse. She has seen a gastroenterologist, but they don't have any answers, sent stool cultures in Jan2021 but no results yet. The patient was asking if this is a documented adverse event. The patient is scheduled on 26Jan2021 for the second dose. With this experience, the patient was asking what to do with the second dose- if she should get the second shot. The patient had not recovered from the event.
82 2021-02-01 nausea blue finger tips--red spots on upper legs that turned black the next day--100 degree fever-nausea-he... Read more
blue finger tips--red spots on upper legs that turned black the next day--100 degree fever-nausea-headache--upper legs swelled up and was discolored for a few days
82 2021-02-01 vomiting, nausea Severe headache, nausea and vomiting lasting two days. Rx. Small sips of Gator Aid, Recovered after ... Read more
Severe headache, nausea and vomiting lasting two days. Rx. Small sips of Gator Aid, Recovered after two days.
82 2021-02-03 nausea, vomiting Fever 101.8 HR 121 tachycardia SP02 85% RA Chills Nausea/Emesis x 4
82 2021-02-04 nausea Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old... Read more
Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization, fish oil, lactobacillus casei (RESTORA RX), via an unspecified route of administration from 21Jan2021 08:30 to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was calling in regards to the Covid Vaccine. She had the shot(covid vaccine) on 20Jan2021 at about 10 or 10:15AM. After her First dose, She had a doctor appointment at 11:20, 20Jan2021, the doctor put her on a new medicine, the Restora RX was in capsule form, she started that on 21Jan2021 at 8:30AM. She was nervous. She was nauseous on 21Jan2021 at about 8:30AM. She was a little nauseous and was basically trying to find out which one was causing it, the vaccine or the new medication. The name of the new medication was "Restora Rx". The action taken in response to the event for fish oil, lactobacillus casei was unknown. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
82 2021-02-07 abdominal discomfort Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite pro... Read more
Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite problem.
82 2021-02-07 vomiting, nausea Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her... Read more
Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her second pfizer covid vaccine.
82 2021-02-08 abdominal pain upper 12 hours after receiving vaccine I woke with severe stabbing pain in stomach, moving up left side w... Read more
12 hours after receiving vaccine I woke with severe stabbing pain in stomach, moving up left side went to ER about 48 hours later, diagnosed Shingles, slight rash on left side above breast around to left back shoulder I continue to have shingles
82 2021-02-08 difficulty swallowing, nausea Started feeling achy around 11:00 PM. Took Tylenol. Was achy all day Wednesday and took Tylenol ev... Read more
Started feeling achy around 11:00 PM. Took Tylenol. Was achy all day Wednesday and took Tylenol every 4-6 hours. Woke up Thursday morning and couldn't get out of bed. I was dizzy and nauseous. I got up 3 times to use the bathroom and couldn't even swallow water until 9:30 PM. I had 1/2 cup soup and water that evening. Thursday I was only slightly dizzy but was able to eat and drink. I didn't feel well enough to leave my house until Sunday. Today is a week since the second dose and I'm almost back to normal, but still tired. FYI, I did have COVID last March. I was quite sick but not hospitalized. I received phone calls every other day from the DOH during the almost 3 weeks I was in isolation at home. I gave plasma 3 times after recovering.
82 2021-02-09 nausea Client verbalized feeling nauseous and weak. Client was evaluated by rescue and released to go home... Read more
Client verbalized feeling nauseous and weak. Client was evaluated by rescue and released to go home at 10 am.
82 2021-02-11 diarrhea, nausea Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme ... Read more
Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme diarrhea (may be due to antibiotic) very slight soreness as injection cite. This lasted for 48+ hours. Did not feel myself for 72 hours.
82 2021-02-15 diarrhea Pfizer-BioNTech COVID-19 Vaccine EUA The first symptoms to appear at approximately 8:00 pm on Feb. ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The first symptoms to appear at approximately 8:00 pm on Feb. 9th the day of my mom?s vaccine were headache and diarrhea. The following day, 2/10 she seemed to feel better and went on with her day. The night of 2/10 she awoke coughing and wheezing. She called 911 at approximately 4:45 am on 2/11. They transported her to hospital.
82 2021-02-21 abdominal discomfort, diarrhea, abdominal pain upper Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next d... Read more
Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.
82 2021-02-21 abdominal pain upper, diarrhea Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not... Read more
Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not so much vertigo but like i was floating. yesterday i ate lunch and very quickly after i got diarrhea very suddenly and i felt i emptied my entre body This morning i have had pain in my stomach but seems to be subsiding as the day goes on.
82 2021-02-23 difficulty swallowing sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affect... Read more
sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affects her ear and swallowing; it was shooting pain up into her skull and the top of her head; neck pain on the left side; her skin on the left side of her neck is sore to touch; This is a spontaneous report from a contactable nurse (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiration date was not reported) (at 82 years of age), via an unspecified route of administration in the left arm on 06Feb2021 15:40 at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. There were no concomitant medications. The patient did not take any other vaccinations within four weeks prior to the first administration date of the vaccine. She had no adverse events prior vaccinations and no illness at time of vaccination. The patient received her 1st dose on Saturday (06Feb2021). On Sunday (07Feb2021), she had neck pain on the left side, which was the same as she got the vaccine, and it was shooting pain up into her skull and the top of her head. She stated that her skin on the left side of her neck was sore to touch on 07Feb2021. Sometimes it affects her ear and swallowing on 09Feb2021. She stated that he looked in her throat and it looked okay. She wanted to know if this was from the vaccine. She stated that the shooting pain was killing her today. She had been using Bengay, heat, and Tylenol which lasts about 8hrs. States that the pain woke her up last night, so she took 2 Tylenol Arthritis. Her 2nd dose of the vaccine is scheduled for 27Feb2021. Her husband kept saying it was from the shot, but she doesn't know. She asked if it was then what is she going to do with the 2nd one? The patient did not go to the emergency room nor visit a physician's office for the events. The outcome of the event neck pain was not recovered while recovering for other events. The events neck pain on the left side, skin on the left side of her neck is sore to touch, and sometimes the pain in her neck affects her ear and swallowing are reported as medically significant events.
82 2021-02-24 decreased appetite, abdominal discomfort Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is ... Read more
Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is continuing. Intestinal upset which is continuing.
82 2021-02-25 nausea some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneo... Read more
some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient). An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation. Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension. Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot. However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved. Information on Lot/Batch number has been requested.
82 2021-02-28 diarrhea About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i ... Read more
About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i have not gotten back yet, joint pain, tiredness, fever. I have been so thirsty i have been drinking a ton of water. i had all the symptoms of covid . I had covid in November and symptoms were worse .
82 2021-03-02 decreased appetite Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; ... Read more
Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered. Information on the lot/batch number has been requested.
82 2021-03-02 nausea, vomiting nauseated; vomited and cannot keep anything down; This is a spontaneous report from a contactable co... Read more
nauseated; vomited and cannot keep anything down; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 30Jan2021 14:40 at a single dose for covid-19 immunisation. Medical history included diabetes mellitus diagnosed 40 years ago. There were no concomitant medications and no prior vaccinations within 4 weeks. The patient was nauseated and vomited and cannot keep anything down starting on 31Jan2021 to the date of report. Events did not require emergency room nor physician's office visit and no treatment was received. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
82 2021-03-04 gastrointestinal disorder, nausea, vomiting, difficulty swallowing Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA.... Read more
Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021.
82 2021-03-04 nausea, abdominal pain upper, decreased appetite Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely rest... Read more
Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely restored to previous level February 25, 2021: Received first dose of Pfizer Covid Vaccine and noted a small red spot and small bump on the arm at the injection site February 26, 2021: Noted the following symptoms; Took Tylenol ? Arm swelling with the bump getting painful and redness expanding ? Very weak and body aching ? Chills and fever ? Headache and nausea February 27, 2021: Noted these symptoms: Took Tylenol ? Felt like I had the virus all over again with every bone aching ? Headache with fever of 100.5. ? Chills with shaking ? Loss of appetite ? Swelling in the arm growing larger with the bump feeling hard and more painful February 28, 2021: Noted these symptoms: ? Stomach hurt and thirsty took some Tums and drank water to relieve it ? Arm very red swollen and painful from shoulder to elbow. Pain in the bump close to level 10. Took pictures ? Still limited appetite ? Body aches ? Night sweats March 1, 2021: Noted these symptoms ? Arm still red, swollen and painful but area away from the bump becoming itchy tried ice but not very helpful ? Chills, fever and body aches dissipating ? Night sweats ? Thirsty ? Able to take a short walk outside March 2, 2021: Noted these symptoms: ? Woke up drenched in sweat ? Still very thirsty ? Labored breathing when we took a walk ? Tried heat and cold on arm which was still painful but the pain level had come down between 8 and 9 ? Saw Dr. who prescribed Traumeel to reduce the redness and swelling in my arm and told me she would do more research but at this point not to take the second dose of the vaccine after hearing my symptoms March 3, 2021: Noted these changes ? Arm still swollen and red with the bump still painful but closer to a 6 or 7. ? Saw my chiropractor, who gently massaged my body back into alignment and showed me some massages for my arm ? Was able to take a walk and the breathing was improved
82 2021-03-06 diarrhea Symptoms began as very tired, a bit of soreness with mild flu-like symptoms with a bit of soreness a... Read more
Symptoms began as very tired, a bit of soreness with mild flu-like symptoms with a bit of soreness at site for 3-5 days. Some diarrhea which is still prevalent to this date (03-07-2021) . Am counter acting diarrhea with an OTC anti-diarrheal medicine. The adverse symptoms I experienced did not seem necessary to follow-up as listed in item No. 21
82 2021-03-07 nausea, vomiting Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to... Read more
Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke.
82 2021-03-14 stomatitis had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a ... Read more
had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a contactable consumer reporting for herself. An 82-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypertension, blood pressure abnormal, blood cholesterol increased, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included triamterene (TRIAMTERENE), verapamil (VERAPAMIL), levothyroxine (LEVOTHYROXINE), atorvastatin (ATORVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Caller stated that she had her first Pfizer vaccine on 08Jan and was scheduled for her second one tomorrow. Stated that the next day in the evening that she had a reaction in her mouth that broke out in tiny sores. Stated that she went to her dental appointment and was prescribed Triamcinolone Acetonide paste and it went away. Wanted to know if this is anything that has been reported before she gets the second one. Clarified it as Pfizer Covid 19 vaccine. Is in her 80s. Stated that she also had facial flushing in 15 minutes of the vaccine that went away in 30 minutes. Concomitant Medication: Stated that she was on her regular medication. Littles sores in the roof of my mouth, dentist checked and said that sometimes vaccine can trigger like you have had cold sores or canker sores in the past. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email.Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Ethnicity: Consumer stated, "(Withheld) with some (withheld). Consumer confirmed vaccine name as COVID-19 Vaccine When probed for the expiration date, consumer stated, "No, but I am having a second one tomorrow. I was given at (Institute name). Other medical conditions: Consumer stated, "I have thyroid." (Not clarified further). When probed for the treatment, consumer stated, "The only treatment I had is the dentist prescribed a paste that I dab on, that I put in my mouth, but it took care of the problem I used it about five days. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, "She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email. Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Consumer confirmed vaccine name as COVID-19 Vaccine. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer was provided with Pfizer Medical Information Department's number as (Phone number withheld) and was informed to press option 3 and call from 8 AM to 11 PM, Mon to Sun as per EST. Outcome of the events was recovered. The reporter considered the events as non-serious.
82 2021-03-15 abdominal pain, diarrhea king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spon... Read more
king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.
82 2021-03-15 indigestion 3-9-21 1PM PT C/O 'LIGHT BURNING IN STOMACH & MILD HEADACHE' A/O, PINK, W/D, RESP REG WITH EASE. N... Read more
3-9-21 1PM PT C/O 'LIGHT BURNING IN STOMACH & MILD HEADACHE' A/O, PINK, W/D, RESP REG WITH EASE. NO SOB, NO NAUSEA, NO DIAPHORESIS. 1:05PM 'FEELS BETTER NOW'. NO ACUTE OR OBVIOUS DISTRESS. 1:10PM AMBULATORY TO EXIT- GAIT STEADY. NO DISTRESS NOTED. 3-10-21 9:30AM PT STATES'FEELS BETTER- SYMPTOMS RESOLVED'.
82 2021-03-18 nausea A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extrem... Read more
A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
82 2021-03-18 nausea woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; b... Read more
woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested.
82 2021-03-20 diarrhea tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous rep... Read more
tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.
82 2021-03-20 nausea she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she... Read more
she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she has been very nauseous. She said she was nauseous all day Thursday, 04Feb2021; Chills; Shaking; She clarified she is always cold, but her coldness seems to be worse at night.; This is a spontaneous report from a contactable consumer. A 82-Year-old female consumer receive second dose of COVID-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot no: EL9262, formulation; solution for injection), via an unspecified route of administration on 03Feb2021, 10:30AM as single dose at arm left for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot no: EL1284) on Jan2021 for covid-19 immunisation. The patients' Medical history included Partial knee replacement on 16Nov2020, ongoing Diabetes and Spinal stenosis. The patients concomitant medication was not reported.On 03 Feb 2021, the patient had been freezing since receiving her second COVID-19 Vaccine dose, she was nauseous all day , had chills and was shaking. The patient took Extra Strength Tylenol 500mg. the outcome of event shaking was not recovered, chills and nausea was recovered on 03 Feb 2021.
82 2021-03-22 vomiting, decreased appetite dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left a... Read more
dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
82 2021-03-26 vomiting, nausea nausea, vomiting, patient waited 15 minutes, resolved, patient released.
82 2021-03-28 abdominal discomfort Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then ... Read more
Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then to upper body. This happens every night about one hour after sleep. I have no fever. But I feel like I am in an oven. Subsides about one hour later but extreme tinnitus continues. During the day I feel hot but not the same intensity of the nightly attacks. Never had this before. I had a second shot on 2/26 and on that night it was very severe. Still suffering to this date. Primary doctor does not know what I have. Blood work negative except for two positive Ana antibody tests.
82 2021-03-30 nausea nauseous/ queasy/ Terribly nauseous; tired/ fatigue; slept right through the night; This is a sponta... Read more
nauseous/ queasy/ Terribly nauseous; tired/ fatigue; slept right through the night; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 31Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetic, thyroid disorder from an unknown date and unknown if ongoing Thyroid medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; (OCUVITE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced nauseous/ queasy/ terribly nauseous, tired/ fatigue, slept right through the night. The patient underwent lab tests and procedures which included weight fluctuation: 112, 110, 111 on It's about 112 pounds, once day it's 110, 111 it depends on (incomprehensible word). The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown. Information on the lot/batch number has been requested.
82 2021-04-03 diarrhea 4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 1... Read more
4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 10+ days, diarrhea for 3 days starting 1 week after shot,
82 2021-04-05 vomiting, abdominal distension Side effects started day 2 after vaccine administration. Pt started with fever, vomiting, abdominal ... Read more
Side effects started day 2 after vaccine administration. Pt started with fever, vomiting, abdominal distension, spot where she had previous hernia surgery was bothering her. She spent a whole day in bed and then felt better. Just follow home care treatment.
82 2021-04-10 vomiting, abdominal pain, nausea Pt states hx of anxiety and was throwing up with abdominal painprior to arrival as well. Given 4 mg ... Read more
Pt states hx of anxiety and was throwing up with abdominal painprior to arrival as well. Given 4 mg SL zofran with mild relief of nausea, abdominal pain persisted: Pt presents with nausea/vomiting which she attributes to anxiety. States she has had severe anxiety about getting vaccine and has been vomiting with abdominal pian throughout the day. She is noted to be extremely hypertensive today, denies hx of hypertension. She was given 4 mg SL zofran with resolution of nausea however abdominal pain and hypertension did not resolve. Of note, pt has a hx of Whipple procedure Nov 2019 and reports she has had intermittent abdominal pain since that time. Report called and pt escorted via wheelchair to the ER
82 2021-04-13 difficulty swallowing COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination ... Read more
COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness. But the last few days have been very painful. I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful. Since Saturday my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse. Additionally I ache all over and feel like a very bad case of the flu. I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour. Now I'm using Advil, which helps for several hours. Is there anything I can do to get relief. This is the 8th day....and it seems to be getting worse instead of better.
82 2021-04-14 abdominal pain blood in urine abdominal pain R31.9 - Hematuria R31.0 - Gross hematuria N32.89 - Bladder mass R10.2 ... Read more
blood in urine abdominal pain R31.9 - Hematuria R31.0 - Gross hematuria N32.89 - Bladder mass R10.2 - Suprapubic pain, acute
82 2021-04-14 vomiting Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but ... Read more
Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but found her on bathroom floor when I woke up. Transported to local hospital & transported to Neuro icu at major hospital. Now in nursing home with rehab. Unable to assist yet with much therapy. Impaired vision, can't feed herself or sit unattended. Very groggy & sleepy. Never lost consciousness.
82 2021-04-16 nausea This all happened after the second shot I felt nothing except a sore arm after the first shot. I im... Read more
This all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous. Nausea continued for days--intermittently for 3 weeks. Severe headache, muscle and joint pains, fatigue. Very very cold the fist night. slight fever. In the morning my nightgown was soaking wet. Headache persisted for a few days. Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.
82 2021-04-22 retching Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less ... Read more
Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80. Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale. Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER. Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.
82 2021-04-23 abdominal pain upper, diarrhea vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous rep... Read more
vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
82 2021-04-24 nausea, abdominal pain upper Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a con... Read more
Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
82 2021-04-26 decreased appetite chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; ve... Read more
chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021. The patient was recovering from all the events.
82 2021-04-28 diarrhea with profuse bleeding Bloody diarrhea
82 2021-04-28 nausea Pt presented to the emergency room 4/19/21 in the evening c/o the sudden onset of severe dizziness, ... Read more
Pt presented to the emergency room 4/19/21 in the evening c/o the sudden onset of severe dizziness, light-headedness, nausea and diaphoresis. She received her second covid 19 vaccination at 10am earlier that day. pt was brought in via ambulance. she had a past history of vertigo but felt this incident was very different than her past episodes. she denied any problems with the first vaccine dose. she was admitted with a near syncopal episode and observed overnight in the hospital on telemetry. she was discharged home the following day feeling better with improvement in the dizziness. orthostatic blood pressures were negative.
82 2021-04-30 abdominal pain upper, diarrhea stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient... Read more
stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of the Pfizer Covid Vaccine (BNT162B2) on 16Mar2021 (lot number: EP7534) at 82-years-old for COVID-19 immunization and had sore arm from first vaccine. The patient experienced sore arm from second vaccine on 06Apr2021 and stomach pains and diarrhea on 08Apr2021 at 17:00. The reporter stated she had the second dose of the vaccine on Tuesday (06Apr2021). On Thursday (08Apr2021) she got severe stomach pains and had diarrhea for an hour and half straight. Later that morning it happened, and at 3:30, 4:30 and between 6:00 and 7:00. It happened 6 times and just poured out of her. She had been ok since that. It was really bad. She asked if this is a side effect of the vaccine. The events didn't require a visit to Emergency Room or Physician Office. The patient called physician this morning. Treatment of the event sore arm included Arm Tylenol. The outcome of the event sore arm was recovered on 08Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
82 2021-04-30 diarrhea, abdominal discomfort could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Mu... Read more
could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Muscle ache; felt bad; Sore throat; bled after her injection; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 between 15:30-16:00 (at the age of 82-years-old) as a single dose for COVID-19 immunization; apixaban (ELIQUIS) via an unspecified route of administration at 5 mg twice a day from an unspecified date in 2018 and ongoing as a blood thinner/for the heart. Medical history included diabetes (started a couple of years before 2018), arthritis, lupus since 2020 (started just 6 months ago), high cholesterol, heart disease, all ongoing; as well as aortic valve replacement and pacemaker in 2016; she had all 3 types of arthritis: osteo, rheumatoid, and the one with the rashes, she has had aches and pains for a long time; arthritis pain; heart surgery in 2016; COVID-19 in the last part of Jul2020 to the first 2-3 weeks in Aug2020 (and then tested negative on 19Aug2020) with the following symptoms: bad headache, muscle aches, diarrhea, loss of smell and taste, "just about everything" for almost 4 weeks, autoimmune disease, diuretic and muscle relaxant therapy. Ongoing concomitant medications included glimepiride for diabetes from 2014, potassium tablet as a diuretic from 2016, furosemide as a diuretic from 2016, metoprolol for the heart from 2016, atorvastatin for cholesterol, hydrocodone for pain, tizanidine as a muscle relaxant, cinnamomum verum (CINNAMON) capsule, ascorbic acid (VITAMIN C), fish oil, ubidecarenone (COQ-10), vitamin D3, paracetamol (TYLENOL ARTHRITIS PAIN) tablet for arthritis pain, and an unspecified multivitamin. There were no additional vaccines administered on the same date or 4 weeks prior to BNT162B2. On25Mar2021, the patient bled after her injection, the blood started running down her arm when they pulled the needle out. The patient experienced sore throat on 25Mar2021 at 22:00, which was not excruciating, and the patient did not take anything for it. After waking the next morning, the sore throat was gone. The patient took paracetamol daily in the morning, and she wasn't sure if that was why her sore throat went away or not. She stated that when she had COVID disease the paracetamol didn't help her sore throat or headache at that time. The patient then started to have muscle ache on 26Mar2021 and a slight fever, never over 98 degrees, and she felt bad. The patient's normal temperature was around 97 degrees. The patient experienced a slight headache on 27Mar2021, diarrhea for 1 day and stomach upset on 27Mar2021 and then diarrhea again on 31Mar2021 for 1 day. The patient didn't take anything for the diarrhea, it was not that severe. The muscle aches continued in the upper part of legs, thighs, upper arms to her elbows. The patient had never had a hurting like that in her muscles and on an unspecified date, the patient could hardly walk since it was hurting so bad. On an unspecified date, the patient's arm was very sore. The events did not require an emergency room or physician office visit. The patient did call her doctor because she was hurting so bad who informed her that he had heard of other people who had the disease were having a reaction to the first vaccine. The action taken in response to the events for apixaban was dose not changed. The clinical outcome of sore throat was resolved on 26Mar2021 (duration 1 day), muscle ache was resolved on 03Apr2021 (duration 8 days), slight headache was resolved on 04Apr2021 (duration 8 days), diarrhea occurring on 27Mar2021 was resolved on 28Mar2021 and diarrhea occurring on 31Mar2021 was resolved on 01Apr2021, slight fever was resolved on 26Mar2021 (duration 1 day), stomach was upset was resolved on an unspecified date, and of could hardly walk, arm was very sore, bled after her injection, felt bad was unknown. No follow-up attempts are possible. No further information is expected.
82 2021-05-06 diarrhea Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy a... Read more
Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy and lightheaded for everyday since shot. Added 5/7 some days super duper tired Pfizer 03/13/ 2021 left arm. No medicine, has arthritis,
82 2021-05-06 nausea Patient is an 82 y/o female with PMHx of HTN, HLD, COPD, CAD s/p CABG, AFlutter post CABG who presen... Read more
Patient is an 82 y/o female with PMHx of HTN, HLD, COPD, CAD s/p CABG, AFlutter post CABG who presented to the ED c/o generalized malaise, nausea, diaphoresis, dizziness, and a HA after her first Pfizer COVID vaccine on 4/22/21.She presented in Aflutter with RVR. She converted to sinus rhythm s/p IV Diltiazaem. She was evaluated by Cardiology and cleared for discharge on Multaq, diltiazem, carvedilol, ASA, and Eliquis. Echo showed LVEF 65%. Mild MR. Moderate TR. Her symptoms resolved on the day of discharge. She is to follow up with Cardiology.
82 2021-05-07 decreased appetite, abdominal pain upper Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain... Read more
Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain; This is a spontaneous report from a contactable consumer. An 82-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 05Feb2021 at 12:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medication included lisinopril. On 05Feb2021 at 21:00 patient started experiencing headache, stomach cramps, pain in legs and weakness, not hungry, arm pain. The patient did not received treatment for the events. At the time of the reporting the patient had not yet recovered from the events. Follow-up attempts are completed. No further information is expected.
82 2021-05-10 diarrhea This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE, solution for injection, Lot Number: ER8737; Expiration Date: Jul2021, NDC number: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 82-year-old) at single dose for COVID-19 immunisation. Medical history included had headaches most of her life, she knew it was her cervical spine because of bone spurs, arthritis, and bulging disc; she has also had change in vision, she was coming down the road from seeing her cardiologist and was looking down the road, out of right eye the road continued straight, but out of her left eye it looked like the road was turning off to the left, it was actually going straight, her eye doctor had told her that her eyes were no longer compatible, she was having five prisms put in her glasses, the neurologist was concerned, the eye thing started four or five months ago; she had shrunk to 4 foot 10 inches or 4 foot 11 inches, she used to be 5 foot 2 inches and shrunk because she had osteoporosis. The patient's concomitant medications were not reported. Patient reported that she had diarrhea one day in Apr2021. She started coughing some yesterday (14Apr2021). Then she was coughing more a little later. That was not what she would normally do. 14Apr2021, she was moving her winter clothes out to her summer clothes. She worked for three to four hours. Then she got so sore and was hurting all over. She felt the same this morning (15Apr2021). She was wondering if muscle aches could be a part of it. She was really hurting last night (14Apr2021) all over. She woke up this morning and felt sore. She was better now. It was from the waist up to the rib cage and all the way around. It was general, all over. She felt so badly last night (14Apr2021) and didn't feel great this morning. Another reason she was calling was because she saw her neurologist three days before and he scheduled her for an MRI of her head and brain. She had the appointment for the MRI on the 21Apr2021. She had been told that particular test was a magnet test and not radiation. She wanted to make sure there was nothing in the vaccine. They were not sure what the vaccine was going to do. They were not sure what was dealing with. Diarrhea started a couple of days before in Apr2021 when she was out of town, just for one day. It had stopped, she had recovered completely from the diarrhea. Coughing started on 14Apr2021. It was kind of a deeper cough. She had a little coughing 15Apr2021, but mainly body aches that started late 14Apr2021. She hobbled around and went to bed and got up to go to the bathroom and was having a hard time walking because she was so sore on 14Apr2021. The soreness was all over the body. She was having the MRI on her brain and head because she had been having headaches in Apr2021. She has had headaches most of her life. She had seen him (neurologist) several years before. She knew it was her cervical spine because of bone spurs, arthritis, and bulging disc. The doctor said that was the reason for a headache, but this was a different headache. It extended from behind her eye on the left side to the back of her head. It came on suddenly and she would have it for two to three days. Then that side of the head when she was turning in the left direction was sore and hurts. The headaches that felt different had been on and off for the past several months. She would have them for 3 days running and then maybe get a reprieve. She didn't want to take the second vaccine and had that on top of each other with the MRI. She wondered if she could take the second vaccine a little later. She was not comfortable getting it around the same time of the MRI. The outcome of the event diarrhea was recovered in Apr2021, sore was recovering, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
82 2021-05-10 diarrhea Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Di... Read more
Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
82 2021-05-11 profuse gastrointestinal bleeding K92.2 - Gastrointestinal hemorrhage, unspecified
82 2021-05-17 nausea Lite nausea and tired the next day; Lite nausea and tired the next day; This is a spontaneous report... Read more
Lite nausea and tired the next day; Lite nausea and tired the next day; This is a spontaneous report from a contactable consumer. An 82-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration in right arm on 29Jan2021 01:45 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on other medications. The patient was not diagnosed with COVID-19, prior to vaccination. On 29Jan2021 at 7:00 pm, the patient experienced Lite nausea and tired the next day. The patient has not been tested for COVID-19 Since the vaccination. There was no treatment received for adverse events. The outcome of events was recovered. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
82 2021-05-24 nausea Dizzy, head pressure, increased sleepiness, headache, nausea, congestion, ringing in ears, chest pai... Read more
Dizzy, head pressure, increased sleepiness, headache, nausea, congestion, ringing in ears, chest pain
82 2021-05-25 GERD Encounter Details Date Type Department Care Team Description 04/22/2021 - 04/29/2021 Hospital Encou... Read more
Encounter Details Date Type Department Care Team Description 04/22/2021 - 04/29/2021 Hospital Encounter Acute respiratory failure with hypoxia (Primary Dx); Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present; Pneumonia due to COVID-19 virus; Pneumonia due to 2019-nCoV; Simple chronic bronchitis Details of the Hospital Course: Patient is a 82 y.o. female with COPD follows with the respiratory disease specialist outpatient, history of mediastinal mass s/p VATS procedure done by Dr. in June 2011, pathology came back benign thymoma, she subsequently developed a slowly growing posterior mediastinal recurrence that was resected by Dr. in June 2016 and was felt to represent "recurrent/metastatic thymoma?type AB", with surgical margins < 1 mm; she declined postoperative XRT, last seen by Dr. in April 2020 recommended repeat CT in 1 year for evaluation who presented to the ER on 04/22/2021 with complaints of shortness of breath, found to be hypoxic on room air with pulse ox of 87% and found to be positive for covid 19 (of note: patient received her first COVID 19 vaccination mid April). Chest xray showed radiographic evidence of pneumonia in RLL but without evidence of acute PE on CT scan. Patient was requiring 15 L of supplemental oxygen to maintain oxygen saturations and so was placed on high flow nc with better response 4/23 remained on HFNC 4/24 BCx from 4.22.21 growing out gram positive cocci in 1/2 bottles 4/26 HFNC at 50% and 45L 4/27 off HFNC and on 6 L NC/ awaiting PT evaluation 4/28 per, OT assessment -- pt dropped into 70's on 6L 02 with short walk to bathroom and toileting tasks. cues for rest and PLB needed to increase 02 into 80s. with a seated rest break over 5 mins 02 increased to 88% on 6L COVID pneumonia (first dose of Pfizer vaccine mid April) S/P remdesivir X 5 days, now on day 8/10 decadron but will go home on oral decadron Acute hypoxic respiratory failure slowly improving (not on home oxygen therapy) now off HFNC, was on 10 L oxymask. Patient's pulse ox this morning at rest on 4 L was 86% but improved to 92% on 5 L NC -will need 5L home oxygen therapy at discharge (new) -discussed the need to follow up with Dr or PCP to wean off supplemental oxygen. Patient agreeable with this plan Transaminitis levels trending downwards. History of thymoma s/p VATS 2011 -outpatient follow up Positive blood culture on admission, contaminant in 1 of 2 blood culture bottles. Repeat blood cultures showed no growth. Not on antibiotics Associated attestation - 04/22/2021 3:39 PM EDT Formatting of this note might be different from the original. Patient seen and examined. Current status reviewed with resident staff. I have reviewed pertinent physician documentation, laboratory and radiographic data. I have initiated therapies based upon this reviewed In brief 82-year-old woman with history of COPD, mediastinal mass status post VATS with benign thymoma with local recurrence presented with respiratory tract symptoms since 6 days prior to admission COVID testing is positive. In the emergency room she was noted be hypoxemic requiring 15 L of supplemental oxygen to maintain oxygen saturations. She is currently on high-flow feels much improved. I concur with exam as per Pulmonary fellow. Laboratories and imaging reviewed in detail. Impression COVID-19 infection COVID-19 pneumonia Severe hypoxemic respiratory failure requiring high-flow oxygen Thrombocytopenia which is new since 2016 and a poor prognostic sign History of benign thymoma with local recurrence COPD with exacerbation Doubt bacterial pneumonia Recommendation: Remdesavir 5 days Corticosteroids. Optimum dosing induration of corticosteroids has yet to be fully defined. Decadron 6 mg daily is reasonable however if develops progressive disease in the next 24 hr would escalate corticosteroids and would also add IL 6 inhibitor Additional minerals and vitamin supple role is unclear but probably benign If thrombocytopenia worsens may need alternative anticoagulation. Would check venous Dopplers Supplemental oxygen for saturations greater than 88% Daily PPI unless anticoagulation intensified then would go to q.12 hours Would favor discontinuing antibiotics
82 2021-05-28 diarrhea She has not eaten anything; Diarrhea; This is a spontaneous report from a contactable consumer (pati... Read more
She has not eaten anything; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received through Pfizer sponsored program. A 82-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via, an intramuscular route of administration, administrated in left arm on 22Jan2021 at 10:00AM as 1ST dose, single for COVID-19 immunization. The patient medical history included as diabetes. The patient concomitant medications included as Metformin two tablets in the morning, and one tablet at night by mouth taken for diabetes. On 27Jan2021 patient experienced with diarrhea and patient was calling about the Pfizer Covid vaccine. Everything was fine. Patient had the corona virus first shot on 22Jan2021. On 27Jan2021, the patient experienced diarrhea. On an unspecified date, the patient patient had not eaten anything today. Patient had diarrhea for a day or two. Patient called her doctor for an appointment and Patient was told that diarrhea was a sign of the coronavirus and that patient should go to urgent care. Patient was asking if this was true. patient was confused and in shock, now patient was scared patient may have coronavirus. patient was told that even though patient had the shot could still have the coronavirus. Patient had diarrhea once or twice. patient not had any diarrhea today but patient had not eaten anything today. Patient had to go back 13Feb2021 for the second shot. Patient was not given a card and patient cannot provide lot, ndc, or expiration date. Patient called the doctor and they said no they wouldn't see her because that is a sign of the coronavirus and wants to know if that is true since she already had the first shot. No further details provided. Unable to provide an email address. Declines report and wants to speak to someone about this. The outcome of the event resolved on 29Jan2021 and outcome of remaining event was unknown. Information about lot/batch number has been requested.
82 2021-05-31 diarrhea fever of 101; joint pain; diarrhea; This is a spontaneous report from a contactable consumer. An 82-... Read more
fever of 101; joint pain; diarrhea; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via intramuscular route of administration on 26Jan2021 at 10:00 (at the age of 82-year-old) as first dose, single in left arm (shoulder) for COVID-19 immunization. The patient's medical history included breast cancer. Concomitant medications were not reported. Patient was healthy before vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at night, on the day of vaccination, the patient had diarrhea. On Wednesday she felt fine. On 28Jan2021 Thursday, the patient experienced joint pain, on only her thigh in the left leg and noticed fever which was at 100.1 on 31Jan2021, Sunday morning. Patient took aspirin and it went down. On 01Feb2021, her temperature was normal and was 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 100.1 Fahrenheit on 31Jan2021, body temperature: 97.5 Fahrenheit on 01Feb2021, which was normal. The clinical outcome of the event joint pain was recovering and outcome of all other events was recovered. Follow-up attempts are completed. No further information is expected.
82 2021-06-02 diarrhea, constipation Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps... Read more
Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps in both legs, muscle aches in all parts of body. Each symptom was not severe except muscle cramps. Muscle aches and shortness of breath still happening.
82 2021-06-02 profuse anal bleeding "hemorrhaging out" from her rectum/this time was the worst; "hemorrhaging out" from her rectum/this ... Read more
"hemorrhaging out" from her rectum/this time was the worst; "hemorrhaging out" from her rectum/this time was the worst; received second bnt162b2 on 21Jan2021; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer. An 82-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included rheumatic fever when she was 3 years old, open heart surgery for valve repair in Feb1982, open heart surgery for mitral valve replacement with artificial valve in 1993, type 2 diabetes started coming on by 2000 but it was not adequately addressed and treated until probably 2005, Heart failure maybe had it since at least 2000 and it got worse, sepsis from an infection, lymphedema from 2011 (that was treated with a black box antibiotic which ended up destroying the balance in her brain and then she was no longer able to drive, walk without a walker or assistance from someone, and that's when the heart really became more serious with the heart failure in 2011), high blood pressure. Height: Caller says her mother may have shrunk a little bit with age. Weight: 145 to 148 pounds. Caller says for her mother's medical conditions she had rheumatic fever at age 3 and she was hospitalized for almost 3 years in a trial when they didn't have a treatment. They finally put her in the Hospital for 6 months and gave her penicillin shots every week and she was told to have no physical activity until she was 18 years old and then they stopped the penicillin shots and they didn't anticipate that she would live long. So she has always had trauma from that to her heart. Concomitant medication included warfarin sodium (COUMADIN) from 1982 and ongoing for blood thinner. The patient previously received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 for covid-19 immunisation. Caller reported that while she has had hemorrhoids in her history and has unaddressed issues found in a colonoscopy, on 09May2021 in the morning her mother experienced "hemorrhaging out" from her rectum causing her to be admitted to the hospital. Reporting that she was just released on 17May2021. Caller vocalizes concern that, because her mother required blood transfusions during her hospitalization, the vaccine efficacy may have been affected and she asks if given her mothers situation, she should get an additional dose of the vaccine? During this call she mentioned that both of her parents received both doses of the vaccine and experienced none of the common side effects. Caller states that her mother was hemorrhaging blood and when she was at the hospital they immediately got her on blood. The caller is unsure if the blood was originally received in the ambulance or in the hospital. When she got to the hospital her hemoglobin was 8 and they did a blood transfusion and she got 2 bags of blood. Event Details: On 09May2021, her mother began hemorrhaging at that point and she had tried to go to the bathroom because she felt like she was going to leak more and when she had went to the bathroom, which is not a long distance maybe about 6 feet, at the entrance of the bathroom her mother described it as she couldn't hold it and blood poured out of her. This has been an ongoing issue that her mother has neglected to take care of by getting a colonoscopy for the past 4 years and she has been bleeding all this time but never to this extent. The caller didn't think that her father realizes how close she was to death. Caller confirmed that her mother has been bleeding since before the COVID vaccine but it was nowhere near as bad as this, this time was the worst. For the past month or so her Coumadin levels have been going up and down and her bloodwork was not coming back right away and her primary care provider, mentioned above, hasn't done much for this. For the caller and her mother it is very discouraging. If her mother saw the heart doctor then all of this probably could have been prevented and if the blood thinner was working correctly. They have dealt with all of that at Hospital but her mother puts things off, she is stubborn. The caller thinks that the lengthy hospital stay and being so close to death maybe scared her mother a bit. The only thought was that her mother's blood thinner hasn't been balanced correctly for the past month and that was something that was concerning but her doctor, wasn't taking it very seriously. Her mother has been on Coumadin for a long time and when they did see her and did the bloodwork it showed that her blood thinner was extremely too high and that would explain why this episode of bleeding was so much worse than the previous ones. The outcome of the events was unknown. Information on the lot/batch number has been requested.
82 2021-06-04 nausea I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; C... Read more
I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; Chills; This is a spontaneous report from a contactable consumer (Patient). An 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 82-years-old) as a first dose, single dose for covid-19 immunisation. The medical history included intolerant of iodine, shellfish, slight high blood pressure and known allergies: Comparing. The concomitant medication included 2 mult, levothyroxine sodium, losartan, HCTZ and pravastatin. The patient previously took morphine, demerol, darvocet, oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergy for all of them. The patient not received other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient reported, she had the first shot of the vaccine on 4th which was Thursday of March 10.30, 10:45 in the morning or 10:45. She had 100.2 temperature and seem to get temperature at night, chills, fatigue, nauseous and headache, lightheaded. It's getting better, took an Advil yesterday one and day before one, helps the fever, the temperature. Her second shot is scheduled for the 25th of March. Just want to know what to do. The patient not received treatment for the other events. The patient did not have COVID tested post vaccination. The outcome of the events chills, light-headed was unknown and the outcome of the events fever, fatigue, headache, and nausea was recovering. No follow-up attempts are needed. No further information is expected.
82 2021-06-06 diarrhea Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD,... Read more
Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD, nocturnal use of 3 liters oxygen, dementia, eliquis for hx dvt, esophageal stricture who presents today from clinic secondary to hypoxia. History obtained from daughter bedside and chart review as patient has dementia. Patient began feeling ill one week ago. Complains of cough, congestion, wheezing, shortness of breath, mild wheezing, chest discomfort with coughing, fatigue, and decreased energy. She has had one episode of loose stool. Denies fevers, chills, loss of taste/smell. She was evaluated by pulmonology on 5/25 and noted to have oxygen desaturation. She was recommended to go to the ED for further evaluation however patient refused and preferred home treatment. She was prescribed Augmentin for possible aspiration pneumonia as well as prednisone taper. Patient reportedly felt some mild improvement since starting treatment however continued to require use of 3 liters of oxygen during day and night rather than just at night. She followed up with clinic today where she continued to have oxygen desaturation despite supplemental oxygen and chest xray noted new infiltrate. She was again recommended to go to the ED for further evaluation and management at which time patient agreed.
82 2021-06-06 nausea Dizziness, headache, nausea, congestion, fever, weakness, shortness of breath,
82 2021-06-07 nausea Felt like crap; Sore throat; Tired; Achy; Nausea; This is a spontaneous report from a contactable co... Read more
Felt like crap; Sore throat; Tired; Achy; Nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH CPVID-19 VACCINE; solution for injection; lot number was not provided), via an unspecified route of administration on 01Mar2021 (at the age of 82-years-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included direct exposure to granddaughter who tested positive for COVID-19 in Apr2021. The patient's concomitant medications were not reported. The patient previously received the 1st dose of BNT162B2 (lot number was not provided) on an unspecified date for COVID-19 immunization. In Mar2021 (3-4 days after the vaccination), the patient experienced side effects. She felt like crap, sore throat, tired, achy, and nausea. The patient mentioned that she was fine on the first few days. The patient reported that her granddaughter, who was 10, had tested positive for COVD-19 in Apr2021. The patient has been around her granddaughter who tested positive for COVID-19. The patient wanted to know if she's immune since she has had both doses of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
82 2021-06-09 diarrhea bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as wor... Read more
bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as worsened.; it started from the top of her neck and her balance was off, she felt "fuzzy-headed"; She has been experiencing periods of tiredness where she does not want to do anything; increased forgetfulness in addition to her intermittent light headedness; increased forgetfulness in addition to her intermittent light headedness; Was cold; diarrhea; her knees hurt her; chills; mild fever; her arm was hurting; Arm was just a teensy bit sore at the injection site; Felt a little like balance was off; So tired I don't want to do anything; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199, Expiration date: Jun2021), via an unspecified route on 13Mar2021 (age at the time 82-year-old) as 2nd dose, single dose in the left arm for covid-19 immunization. The patient medical history included osteoarthritis, fibromyalgia (reported that she was diagnosed with fibromyalgia close to 20 years ago, between 15-20 years ago). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route on 20Feb2021 at 10:00 (age at the time 82-year-old) as 1st dose, single dose in the left arm for covid-19 immunization. On 13Mar2021, the patient experienced armed was hurting, armed was just a teensy bit sore at the injection site, and the next day, on 14Mar2021 she had diarrhea and her knees hurt her and had chills and mild fever, was cold and felt a little liked balance was off. Patient reported that the next day, 15Mar2021, she was fine, on 16Mar2021 it started from the top of her neck and her balance was off, she felt fuzzy-headed, fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she doesn't wanted to do anything. Patient experienced periods of tiredness where she did not want to do anything was reported as worsened and reporting increased forgetfulness in addition to her intermittent light headedness. Patient reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. She reported that she was a senior, and most seniors had a problem where they couldn't remember a word then blinked and could've thought of it. She reported that the thing that bothers her was that her problem remembering words was getting worse and the problem remembering words had gotten worse from her baseline after she received the covid-19 vaccine, but it had stayed the same since originally worsening from baseline. Patient reported that the difficulty remembering words worsened around the same time that her fuzzy or lightheaded feeling began, and temperature was 99. 7. Patient explained that her armed did tended to hurt a little and that she received her shot in the affected armed and she was not sure if the diarrhea lasted the second day or not, but it resolved completely. she had a teeny problem with her knees and the covid-19 vaccine really nailed it. She reported that since she received the second dosed of the covid-19 vaccine, her knees had been terrible. She reported that what's really bothering her now was her knees. She reported that her knees were hurting so bad that she could've hardly walked. It was reported that patient visited to physician office. The outcome of the events diarrhea was resolved on Mar2021, armed was hurting was resolved on 14Mar2021, chills, mild fever, cold was resolved on 15Mar2021, felt a little liked balance was off was resolving, her knees hurt, so tired I did not want to be done anything was not recovered and other events was unknown. Information on lot/batch number was available. Additional information had been requested.
82 2021-06-10 decreased appetite, nausea The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The fol... Read more
The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.
82 2021-06-15 nausea Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am... Read more
Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.
82 2021-06-18 abdominal discomfort fatigue; mild stomach issue; This is a spontaneous report from a contactable consumer (patient). An ... Read more
fatigue; mild stomach issue; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 01Feb2021 at 09:40 (at the age of 82 year) as SINGLE DOSE for covid-19 immunisation. The patient medical history reported as none and relevant tests reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication from 01Feb2021 to 04Feb2021. Patient was not received any other vaccine prior four weeks of vaccination. Patient received second dose on 22Feb2021 at 9:40 AM (batch no: EN5318) for COVID-19 immunisation at Hospital and experienced fatigue and neck pain. In 2021 the patient experienced fatigue and mild stomach issue for 3 days. She explains that on Monday she got her first dose. Today she was talking with some and it was mentioned that she had gotten a steroids injection the Friday before the shot was given and that might not have been a good idea. Caller would like to know if we have any information regarding this. It was administered on 10Feb2021, but the lot was left blank. It was explained the steroid shot was before getting the vaccine. Therapeutic measures were not taken as a result of the events. The outcome of the events fatigue and mild stomach issue was recovered in 2021. No follow-up attempts are possible. No further information is expected.
82 2021-06-21 nausea, abdominal pain upper Nausea, extreme fatigue, chills, stomach ache and joint pain.
82 2021-06-24 profuse gastrointestinal bleeding Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/2... Read more
Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/29/21 with a GI bleed, patient asymptomatic for COVID s/s but was tested following hospital admission policies and had a positive PCR test on 05/29/2021. Patient reports her husband was positive for COVID a few weeks prior. Patient treated for GI bleed and d/c'd home on 05/30/2021. She returned to the hospital same day within a few hours reporting dizziness, syncopal episode, and slurred speech per medic. Admitted again with a-fib with RVR. No fever or cough, did report some shortness of breath at home. Discharged on 06/04/21, then readmitted for a-fib with RVR again, discharged home with homecare on 06/14/21.
82 2021-06-24 nausea Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; ... Read more
Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.
82 2021-06-29 diarrhea She had more severe diarrhea; This is a spontaneous report from a contactable consumer. A an 82-year... Read more
She had more severe diarrhea; This is a spontaneous report from a contactable consumer. A an 82-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: E29269, NDC number and Expiry Date: Unknown) dose 1 via an unspecified route of administration, administered in the Upper Left Arm on 18Feb2021 (at the age of 82 years old) as a DOSE 1, SINGLE for covid-19 immunisation (it is her best hope for not catching Covid). Patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing Diagnosis date, Reporter stated, "Late 90s, I don't know", hypothyroidism from 1985 to an unknown date, glaucoma from 1988 to an unknown date. Patient also had atrial fibrillation, cardiovascular disorder, urinary incontinence and blood cholesterol abnormal, all from an unknown date and unknown if ongoing. For Other Conditions Diagnosis date was stated by Reporter as, May be 2011 (unspecified).Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus, 6 Units, three times a day before each meal, insulin glargine (LANTUS) taken for diabetes mellitus 8 Units at bed time, atenolol taken for cardiovascular disorder, 50 mg twice a day, dabigatran etexilate mesilate (PRADAXA) taken for atrial fibrillation, 150 mg, twice a day, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, 25 mg, once every other day, losartan taken for an unspecified indication, 100 mg once a day, levothyroxine sodium (SYNTHROID) taken for hypothyroidism, One day 50 mcg and other day 75 mcg, simvastatin taken for blood cholesterol abnormal, 10 mg, once a day, metformin hydrochloride (METFORMIN ER) taken for diabetes mellitus, 500 mg, once a day, brimonidine tartrate, brinzolamide (SIMBRINZA) taken for an unspecified indication, Twice a day and travoprost taken for an unspecified indication, Once a day. All concomitant medications were started on an unspecified date and unknown if was ongoing. The patient experienced she had more severe diarrhea on an unspecified date. She had more severe diarrhea was reported as worsened. Patient had the Pfizer Covid vaccine on the 18Feb that was her first one and she has had problems like diarrhea and her gastro tract (Incomplete sentence). She pretty much had it on and off. Today (date unspecified) she has had more severe diarrhea than before in those days before. She was wondering if that could be attributed to the Covid vaccine." Patient took an antidiarrheal after the last one in the afternoon (date unknown). This was an over the counter, it is called Loperamide HCL soft gelatin capsule, 2 mg and she took 2 of them but they are expired, the expiration date was Jul2020. That all the patient had at home. Outcome of the event was Not Resolved. No follow-up attempts are possible. No further information is expected.
82 2021-07-02 diarrhea Heart attack; Arterial occlusion/artery was blocked; Fluid loss; Acute haemorrhagic ulcerative colit... Read more
Heart attack; Arterial occlusion/artery was blocked; Fluid loss; Acute haemorrhagic ulcerative colitis; Diarrhea; Bowel obstruction; Hemorrhoids; Postoperative pain; Groin hernia; Lower extremity mass/big lump on her groin; This is a solicited report based on the information received by Pfizer from manufacturer control number: 21K-163-3910536-00). A contactable consumer (patient) reported that an 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Feb2021 (Batch/Lot number was not reported), at the age of 82-year-old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (1 in 2 wk) (40MG/0.4ML) for rheumatoid arthritis and ulcerative colitis. Medical history included ulcerative colitis, control unspecified blood condition and heart issues. Concomitant medications included sulfasalazine taken for colitis ulcerative, start and stop date were not reported; prednisone taken for colitis ulcerative, start and stop date were not reported; folic acid taken for control unspecified blood condition, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for heart issues, start and stop date were not reported; isosorbide taken for heart issues, start and stop date were not reported; losartan potassium (COZAAR) taken for heart issues, start and stop date were not reported; metoprolol taken for heart issues, start and stop date were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old, in Jan2021 for covid-19 immunization. The patient experienced heart attack on 19Apr2021, groin hernia in Mar2021, lower extremity mass in Mar2021, acute haemorrhagic ulcerative colitis on 13Apr2021, diarrhea on 13Apr2021, bowel obstruction on Apr2021, fluid loss on 13Apr2021, arterial occlusion on 19Apr2021, hemorrhoids in Apr2021, postoperative pain in Apr2021. The patient hospitalized from 18Apr2021 to 25Apr2021 due to these events. It was reported that the patient with events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids and artery was blocked and non-serious possible hemorrhoids and postoperative pain with Humira 40mg/0.4ml (Adalimumab). In Mar2021, the patient experienced groin hernia and big lump on groin. In Apr2021, the patient experienced blockage in bowels, possible hemorrhoids and postoperative pain. On 13Apr2021, the patient experienced bleeding a lot as a complication of ulcerative colitis, diarrhea and loss of fluids. On 19Apr2021, the patient experienced heart attack and artery was blocked. On 19Apr2021, the heart attack and artery was blocked resolved. On 20Apr2021, the diarrhea resolved. On 25Apr2021, the bleeding a lot as a complication of ulcerative colitis resolved. In Apr2021, the groin hernia, big lump on groin, blockage in bowels, loss of fluids, possible hemorrhoids and postoperative pain resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. Unknown stool softener also considered as suspect. In Mar2021, patient felt a big lump on her groin that was determined by physician as a hernia through physical examination and not an imaging test. On 09Apr2021 she had an outpatient surgery due to hernia in her groin. When she took acetaminophen as prescribed she had a blockage in her bowels and took unspecified stool softener which caused terrible diarrhea. On 16Apr2021 she went to the emergency room due to the diarrhea and had loss of fluids and just went home even when advised not to go home. On 18Apr2021 she was continued having diarrhea, she went back to the emergency room and had unspecified blood test that confirmed she was having a heart attack while on emergency room due to not taking her medications for the heart because was told not to take any medication while having diarrhea which she also temporarily interrupted her Humira while having diarrhea. Physician advised to admit patient to the hospital as she was told she was having a heart attack. On 19Apr2021, she had another stent because the artery was blocked from her previous stent. On 25Apr2021 she was discharged. She believed that her hospitalization was prolonged to nine days (as reported) due to she was bleeding a lot as a complication of ulcerative Colitis. She had a shot of covid 19 vaccine before at least one symptom happened therefore covid 19 vaccine was considered as co suspect product. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On Jan2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Feb2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with acetaminophen. The patient underwent other lab tests and procedures which included blood test: heart attack on 18Apr2021, laboratory test with unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events heart attack, Arterial occlusion/artery was blocked, Postoperative pain was recovered on 19Apr2021. The outcome of the event groin hernia, Lower extremity mass/big lump on her groin, Bowel obstruction, Fluid loss, Hemorrhoids was recovered in Apr2021; of the event Acute haemorrhagic ulcerative colitis was recovered on 25Apr2021; of the event Diarrhea was recovered on 20Apr2021. The reporter's causality for the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Manufacturer opinion is that there is no reasonable possibility that the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain are related to humira 40mg/0.4ml(adalimumab). No follow-up attempts are possible, information about lot/batch number cannot be obtained.
82 2021-07-19 abdominal discomfort Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off th... Read more
Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off the wall; Swelling of the face; Mouth was swollen, just her face and her lips were real swollen; Mouth was swollen, just her face and her lips were real swollen; Tiredness; Had a bowel movement, it was white-looking and smelled like a chemical; Urinating cloudy and with a chemical smell; her eyes were so foggy; Running from nose; Coughing; Having trouble thinking; This is a spontaneous report received from a contactable consumer or other non hcp. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported; Expiration Date: Feb2022) via an unspecified route of administration in Arm Right on 05Mar2021 13:20 (age at vaccination 82years old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure measurement. The patient's concomitant medications were not reported. The patient experienced running from nose, coughing, her eyes were so foggy, urinating cloudy and with a chemical smell on 05Mar2021, blood pressure and heart rate off the wall, swelling of the face, mouth was swollen, just her face and her lips were real swollen, weak, tiredness, had a bowel movement, it was white-looking and smelled like a chemical on 06Mar2021, having trouble thinking on Mar2021, blurred eyes on an unspecified date. She has never reported the side effects that she had, and her daughter told her should have done that. She found her papers and now she is 82 and she got her first shot on 05Mar2021. Patient reported as she felt fine then she got up to leave and her nose started running and it was just like water was pouring out and she made it up to the front and had Kleenexes in her pocket, then started coughing violently, her nose was running violently and trying to come out of her mouth, and she sat down on the chair there and she thought it will pass. she walked out to look for the person that took her out there and she saw exactly where they parked, and her eyes were so foggy she could hardly even see the car. She felt okay then the next day, she got up and her mouth was swollen, just her face and her lips were real swollen. However, her whole face was swollen. she didn't read the side effects to it and thought oh well, it's just some-thing. The next day her blood pressure was going off the wall, her heart rate was horrible, she called the doctor, they wanted her to go to the hospital. The doctor told her to take Benadryl, and Benadryl bothers her, and she said that made her worse. It made her worse. She further clarified made her worse as, it made her heart worse, dizzy and lethargic and she was already tired anyway. she would have been better off not taking it. Her heart rate, which is always normal or very good, and it was like it was going ninety miles an hour. she would get it to slow down then it would feel like it was going 90 miles an hour for a few days then she was really weak and her mind, which at her age she has a very good mind, they tested that, she was having trouble thinking. she guesses she would call it foggy. she wanted to sit down and pay bills, but she couldn't even concentrate. Her question is she had the first shot but now she's afraid to get the second shot because of what it did the first time around. she's afraid it will do double; they say it's a worse reaction. The card that she had, she said that her nose was running so bad, she shoved the card in her purse and looked in her purse later and she can't even find that card. She will say she can't get the flu shot because in the past, she had a very bad reaction from the flu shot, she was questioning whether to get this vaccine or not. It wasn't a live vaccine. she is scared to death of the virus and her kids wanted her to get it now, hurry, hurry, and she thought she would try it. Since she has reactions to suspect product, she's concerned about getting the second one. That was 10 years or more that she had the bad reaction. She is a person that her body is very sensitive. Her doctor has trouble getting medicines she can take. She has a bad back, she has tired every painkiller there is and she can't take any of them, they are worse than the pain. She has trouble seeing too. She keeps every-thing up, they don't give as many papers and it changes every week. She doesn't know how the people in the medical profession can take it, she imagines they change things on them overnight. She has macular. She couldn't understand with that shot why she could see whenever she went in and after she got the shot then everything was fogged when she came outside, but she knows it still wasn't as bad as getting the virus. She's still weak, but she's gotten better. They said she could leave, her nose started running and she started coughing. The girl said is she okay and thought she was, and she made it out then started coughing violently and that water was almost drowning her. She sat down in the chair, and it finally calmed down and got in the car, kept wiping that water with paper towels in her car and coughing and by the time she got home it was slowed down. She is more tired than usual, and her eyes haven't cleared up as good as they should. She doesn't know what that happened, it just came out of there and thought well god what has happened to her eyes. She has an appointment with the Optometrist at the end of April. Another thing she forgot, they are going to think she's looney, she started urinating that evening and she thought, this is not good, something was going on with her kidneys, because it was cloudy-like and had a chemical smell and then the next morning, she still smelled the same thing and her bowels were the same way, just smelled this chemical. That evening her urine was like that and the next morning she noticed it was like that into the next day, whatever was in there had to come out and then her urine and things cleared up. Started on 05Mar2021, that evening, when she urinated before she went to bed it was cloudy and had this chemical smell, maybe it was something she ate or something. The next morning, she urinated a lot and it was cloudy and the bowel movement, it was white-looking and smelled like the chemical and cleared up. She has recovered completely after whatever was in there got out the next day. She states she was okay after she did all that, she cleared up. The clinical outcome of the event blurred eyes was unknown, another events week, her eyes were so foggy, having trouble thinking, tiredness was recovering, and event running from nose, coughing recovered on 05Mar2021, blood pressure and heart rate off the wall was recovered on 09Mar2021, swelling of the face, mouth was swollen, just her face and her lips were real swollen was recovered on an unspecified date Mar2021, urinating cloudy and with a chemical smell and had a bowel movement, it was white-looking and smelled like a chemical was recovered on 06Mar2021. Therapeutic measures were taken as a result of swelling of the face (swelling face), mouth was swollen, just her face and her lips were real swollen (mouth swelling), mouth was swollen, just her face and her lips were real swollen (lip swelling). Information on Lot/Batch number was available. Additional information has been requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
82 2021-07-21 diarrhea, nausea Nausea, diarrhea began morning after 2nd Pfizer shot on February 25,2021 Today's date is July 22,202... Read more
Nausea, diarrhea began morning after 2nd Pfizer shot on February 25,2021 Today's date is July 22,2021 (5 months of symptoms)
82 2021-07-28 vomiting, diarrhea all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very ... Read more
all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering. No follow-up attempts are needed. No further information is expected.
83 2021-01-03 diarrhea, nausea Patient reporting sore arm, diarrhea and nausea every once in a while since 1/2/2021.
83 2021-01-03 vomiting Chills, Vomitting
83 2021-01-11 vomiting On phone follow-up after vaccine patient noted that she fainted and vomited ~1.5 days after vaccine.... Read more
On phone follow-up after vaccine patient noted that she fainted and vomited ~1.5 days after vaccine. Event occurred in the public. EMS was called but patient declined transport to ER facility. Patient said she felt fine after event and no further issues after episode. Patient has had no further follow-up with another health care provider for event.
83 2021-01-11 vomiting Patient on phone call follow-up noted that she fainted and vomited about ~1.5 days after vaccine adm... Read more
Patient on phone call follow-up noted that she fainted and vomited about ~1.5 days after vaccine administration. Patient was in a public area and EMS was called. Patient noted she felt fine after event and refused transport to another facility. No other issues noted after this episode per patient.
83 2021-01-13 nausea 83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient re... Read more
83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling "blah", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death
83 2021-01-18 nausea At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nause... Read more
At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nausea. Patient states that she had a headache on arrival and took her bp meds this morning. Patient released by EMS to home with friend on site.
83 2021-01-24 nausea Patient within 10 minutes experienced nausea, lightheadedness, and dizziness. Patient went to ED. re... Read more
Patient within 10 minutes experienced nausea, lightheadedness, and dizziness. Patient went to ED. received hydration and ondansetron 4 mg. Discharged from ED.
83 2021-01-25 nausea severe nausea, weakness, rigors, shortness of breath
83 2021-01-27 vomiting, diarrhea One day after vaccine fever to 102, severe vomiting, diarrhea. All lasted three days.
83 2021-01-28 nausea, vomiting Resident complain of not feeling well. Upon entering her room, she was jittering, witnessed some unc... Read more
Resident complain of not feeling well. Upon entering her room, she was jittering, witnessed some uncontrollable movement nausea and vomited once. she called her son and said that she had the second covid shot yesterday and since then she is not feeling well. VS stable, no fever, MD called, resident currently in bed alert and oriented x 3, no change in mental status.
83 2021-01-31 nausea swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the ... Read more
swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.
83 2021-01-31 nausea Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 ... Read more
Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 pt reported feeling "cold, nauseous" and reported feeling "every side effect on the handout." Staff provided juice and graham cracker and assessed vitals. Vitals within patient's baseline. Pt then reported "back pain" and described ita s "squeezing" Staff performed 12 lead EKG. EKG results within patient's baseline. Pt kept for another 10 mins and observed. Staff advised pt to contact doctor and go to ER if symptoms persist. Pt reported feeling better and comfortable with going home. Pt went home after a total of 45 minutes of observation with daughter.
83 2021-02-02 gastrointestinal disorder 5 cold sores, red blotch on cheek, fever, fatigued, gastro distress, Woke up the next day, 1/23/21 ... Read more
5 cold sores, red blotch on cheek, fever, fatigued, gastro distress, Woke up the next day, 1/23/21 with these events. All was gone the next day except the cold sores which are now healed.
83 2021-02-03 diarrhea, vomiting Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minute... Read more
Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minutes after not having one in years. We gave fluids. Gave Zofran. Comfort measures. Pt passed at midnight. Was completely fine one day before. Had minimal issues with COVID though did have a pneumonia that was treated w ATB early on and resolved.
83 2021-02-04 nausea Symptoms started 12 hrs. after vaccination including, 100.7 temperature, nausea, headache, fatigue,... Read more
Symptoms started 12 hrs. after vaccination including, 100.7 temperature, nausea, headache, fatigue, pain in left upper arm, dry cough. Temperature 98.6 at 8am 02/05 all symptoms have subsided except malaise.
83 2021-02-04 vomiting Chills; fever of a 102; I threw up; This is a spontaneous report from a contactable consumer (patien... Read more
Chills; fever of a 102; I threw up; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included COVID. The patient's concomitant medications were none. After vaccination, the patient had terrible side effects, she thought she had COVID again. She had chills, fever of a 102 and she threw up that lasted a day. Her test was on the 17Jan2021 (also reported as 17Nov2021). Will that be anything that interfere with the shot? The patient received paracetamol (TYLENOL) for treatment. The outcome of event 'threw up' was recovered in Jan2021; of rest events was unknown.
83 2021-02-08 GERD, abdominal pain upper, burping pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awa... Read more
pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.
83 2021-02-09 diarrhea Within 5-minutes of vaccination, the patient reported having diarrhea. EMS monitored the patient's c... Read more
Within 5-minutes of vaccination, the patient reported having diarrhea. EMS monitored the patient's condition on-site.
83 2021-02-13 difficulty swallowing RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFIC... Read more
RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFICULTY SWALLOWING, SORE THROAT, SOA, WEAKNESS/TINGLING IN BLE. ADMITTED ON 02/13/21 FOR DIAGNOSIS OF WEAKNESS, HYPOKALEMIA, CARDIAC ENZYMES ELEVATED, CHF, AND LEUKOCYTOSIS.
83 2021-02-15 diarrhea Fever Muscle aches Headache Diarrhea
83 2021-02-21 diarrhea Diarrhea
83 2021-02-23 abdominal pain upper, retching I woke up with stomach pain and diarrhea and dry heaves. I took some tums and sparkling water. I hav... Read more
I woke up with stomach pain and diarrhea and dry heaves. I took some tums and sparkling water. I have flu like symptoms and chills. I have congestion.
83 2021-02-24 diarrhea Severe diarrhea / Resolved with rest, increased fluid intake and temporary change in diet / Lasted o... Read more
Severe diarrhea / Resolved with rest, increased fluid intake and temporary change in diet / Lasted one day
83 2021-02-24 nausea, diarrhea Injection pain, tired, chills, joint pain, nausea, and didn't feel well. I had diarrhea. I had COVID... Read more
Injection pain, tired, chills, joint pain, nausea, and didn't feel well. I had diarrhea. I had COVID in November and the symptoms were pretty much the same. Feeling much better today.
83 2021-02-28 nausea chills, fatigue, injection site swelling, nausea
83 2021-03-02 decreased appetite fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is ... Read more
fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.
83 2021-03-02 diarrhea, nausea diarrhea; injection site pain; tiredness; headache; muscle pain; chills with elevated temp; chills w... Read more
diarrhea; injection site pain; tiredness; headache; muscle pain; chills with elevated temp; chills with elevated temp; joint pain; injection site swelling and redness; injection site swelling and redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 28Jan2021 at 08:00 AM (at age of 83 years old) at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included stage 3 kidney, prediabetes, and allergies to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received unspecified concomitant medications (patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took hypromellose (GENTEAL; reported as "gen-teal") and experienced allergy. On 29Jan2021 at 02:00 AM, the patient experienced diarrhea, injection site pain, tiredness, headache, muscle pain, chills with elevated temp, joint pain, injection site swelling and redness, nausea, and feeling unwell. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the events was recovering.
83 2021-03-06 difficulty swallowing Contacted by caregiver. Patient spiked temperature of 103 deg at about midnight. Unable to bring fev... Read more
Contacted by caregiver. Patient spiked temperature of 103 deg at about midnight. Unable to bring fever down. Patient is diabetic and unable to take fluids and eat according to caregiver. Blood sugar elevated but unable to provide value. Patient does not have local primary care provider. Recommended ER visit to evaluate based on health conditions and symptoms
83 2021-03-06 nausea Mild lightheadedness after injection, observed 15" + 15"more. Ok then, drove home. Usual sore arm ... Read more
Mild lightheadedness after injection, observed 15" + 15"more. Ok then, drove home. Usual sore arm x 2 days, mild nausea, malaise, a little dizziness/light headed off and on x day 2-4. Ok till day 6, woke up with itching and red injection site. Continued increasing itching and redness next two days-- this is day 8 following injection. Still red, itchy, tender area on skin around injection site -- size approximately 2 cm across and 4cm long. Itching feels deeper than skin level, soreness around shoulder joint. No noticeable swelling of lymph nodes. Looked online and appears same as "Covid vaccine arm" reports I read, occurring with both Moderna and Pfizer at times.
83 2021-03-07 decreased appetite visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown... Read more
visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown sputum, dyspnea, fever/chills, poor appetite, body aches since roughly 7-10 days ago which would be about the time of her 2ND COVID Vaccine. Also had visits on 2/23,3/01 for similar complaints. Tested negative for SARS COV-2 through PCR on 3/1/21. tested positive on 3/7/21 through PCR.
83 2021-03-09 nausea headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spon... Read more
headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.
83 2021-03-11 vomiting, nausea Extreme nausea and vomiting for 14 hours plus some chilling
83 2021-03-14 nausea, decreased appetite 6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so ... Read more
6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so sore I could not move it without excruciating pain. Began forcing fluids as symptoms persisted. Slept almost all of the following two days and nights. Now 3 days have passed, much better now but no appetite, still forcing water and juice. Worse than any flu I have ever had! This was my 2nd shot. After my first shot I had slight fatigue and a sore arm only.
83 2021-03-15 nausea Client had Nausea and dizziness for 3-4 days: then on the 3rd or 4th day client blacked out. Clien... Read more
Client had Nausea and dizziness for 3-4 days: then on the 3rd or 4th day client blacked out. Client informed by her Physician that she had a concussion. On 3-16-2021 on a follow-up call it was reported by her son that she is now fine.
83 2021-03-17 vomiting, nausea, diarrhea Caller c/o of N/V/D beginning today every hour for 4 hrs., denies fever, shortness of breath, chest ... Read more
Caller c/o of N/V/D beginning today every hour for 4 hrs., denies fever, shortness of breath, chest pain. Caller has no other symptoms, will attempt to drink water & eat bland foods. Advised to contact PCP if symptoms do not resolve. Spoke with caller, feeling much better, symptoms resolved, eating and drinking well -KLC
83 2021-03-18 flatulence, constipation My mother called me when she was going to get her second vaccination. She was alive and well and liv... Read more
My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.
83 2021-03-18 nausea, abdominal pain lower Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back... Read more
Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
83 2021-03-21 abdominal distension Daughter of patient states that mother has bloated stomach since last covid vaccination. Denies any ... Read more
Daughter of patient states that mother has bloated stomach since last covid vaccination. Denies any pain, vomiting, blood in stool, tenderness, or hardening of stomach. Patient has hx of constipation. Patient has taken Beano and modified diet for alleviation of symptom with no effect. An appointment with provider is scheduled on 3/23/21. Will follow up with patient on 3/24/21.
83 2021-03-23 loss of appetite, abdominal pain upper, difficulty swallowing progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal p... Read more
progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal pain; inability to eat; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 14Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history included right partial nephrectomy for renal cell carcinoma (RCC) in the remote past, hypertension, obstructive sleep apnea, hypothyroidism, morbid obesity, motion sickness, unspecified allergy as the patient cannot tolerate anything but paracetamol (TYLENOL), acute on chronic respiratory failure secondary to centrilobular emphysema. Ongoing concomitant medications included levothyroxine sodium (LEVOXYL) tablet, meclizine hcl tablet for motion relief and hydrochlorothiazide/ triamterene (DYAZIDE) capsule. The patient previously took paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) on 22Jan2021 (at the age of 83-years-old) in the left arm and experienced difficulty breathing, ground glass opaque lung problem, weak, nausea, "pain on rt.side waist around to back, down to lower belly", slight temp almost 100. On an unspecified date in Feb2021, the patient presented to the hospital with progressive shortness of breath and inability to eat for two days. The patient reportedly received the second dose of BNT162B2 four days prior to coming to the emergency room (ER). In the ER, the patient reported severe asthenia, mild upper abdominal pain and dysphagia, all as of an unspecified date. The patient underwent a CTA in the ER, on Feb2021, which showed no acute pulmonary embolism, or no ground glass infiltrates. The patient was admitted to the hospital on 21Feb2021 at 17:51 for management of worsening shortness of breath. Due to the patient's acute on chronic respiratory failure secondary to centrilobular emphysema and obesity, hypoventilation (as of an unspecified date in Feb2021) was further complicated by obstructive sleep apnea, thus, the patient was admitted to "MedSurg". The patient did not present with COVID-19 or COPD. The BMP was 226 at the time of admission. The patient was started on supplemental oxygen and additionally started on CPAP at night. She was seen by a pulmonologist who recommended Salmeterol Xinaf/ fluticasone (ADVAIR). Pulmonology also recommended to work-up any underlying unaddressed coronary artery disease contributing to the patient's shortness of breath. The patient underwent an echocardiogram on Feb2021 with regadenoson (LEXISCAN) for her shortness of breath which was within normal limits. As the patient additionally reported dysphagia at the time of admission, she was evaluated by a speech and swallow evaluation specialist as well as a gastroenterologist. A GI swallow series was recommended which the patient underwent on Feb2021 and was found to have no active signs of oropharyngeal or esophageal dysphagia. The patient additionally underwent a physical exam on 24Feb2021 at 08:00 with the following results. Vital signs: Temp: 98.2, Pulse: 69, Resp: 17, B/P (MAP): 98/62 (74), Pulse Ox: 96, O2 Delivery: Nasal cannula, O2 flow rate:2.00. HEENT: Pupils equal round reactive light accommodation, no lymphadenopathy noted, neck vens were apple. CVS: S1-S2 normal, no appreciable murmur rub or gallop noted. Respiratory: Good Inspiratory effort, good air entry bilaterally, no rhonchi, Rales or wheezes heard. Gl: Abdomen soft, nontender nondistended, bowel sounds heard, no organomegaly detected. Extremities: Bilateral lower extremities Shaw no edema, bilateral dorsalis pedis 2+, skin appeared intact. Neurological: Patient alert and oriented x3, strength 5x5 in all 4 extremities, no signs of focal neurological deficits. Skin: No clear breakdown or rashes noted. The patient was being discharged home on 24Feb2021 at 08:04 with a CPAP machine. The patient was prescribed Cefuroxime axetil (CEFTIN) 250mg Tablet orally twice a day; Salmeterol Xinaf/ fluticasone (ADVAIR) 250-50 diskus 1 puff twice a day for progressive shortness of breath and hypoventilation. The patient had been advised to follow-up with a pulmonologist for an outpatient pulmonary function test. The clinical outcome of progressive shortness of breath, hypoventilation, inability to eat, dysphagia, severe asthenia and mild upper abdominal pain was unknown. The reporting physician considered that BNT162B2 had no causal effect on the events reported. Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the HCP reporter, the reported events do not appear to be related to the subject vaccine. The events likely represent intercurrent medical conditions, possibly associated with the patient's history of emphysema. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
83 2021-03-23 nausea, diarrhea, loss of appetite 83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc withou... Read more
83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc without treatment who presented to ED 03/15/21 via EMS complaining of generalized weakness. She had felt well and had been in her usual state of health, and was able to cook and enjoy a turkey dinner with 5 individuals on 03/07/21, but on 03/08/21 she began to develop progressive generalized weakness up to the point where she remained in bed for several days. She could not support herself when attempting to rise from bed. She noted poor PO intake with nausea, no vomiting. Loose stools for several days, no noted stool blood. Did endorse waves of lightheadedness and had fallen backwards three times in the prior week, reportedly due to poor balance when standing. She was unable to elaborate regarding the falls but admitted to hitting her head at least once, unable to say if she lost consciousness or if she felt presyncopal symptoms before falling. She had initially presented on 03/12/21 to ED for evaluation, workup negative, labs and imaging normal. CT brain found no acute process. She was sent home with arrangements for home PT. She returned to ED 03/15/21 when symptoms had not improved. In the ED she was found to be afebrile, significantly hypertensive, mildly tachycardic, + orthostatic vital signs. Labs significant for heme occult positive stool, proBNP 397, WBC 10.1, H/H 13.4/39.9, PLT 493, UA neg for infection. COVID neg. CXR found slightly increased interstitial markings. MRI brain found no acute intracranial abnormality. She was evaluated by PT and found to be unsafe to DC home as she could not ambulate without leaning backward and to the right and needed 1-2 assist. She was admitted to HM service for further management. She has remained consistently afebrile. She continues to experience significant gait instability, cognitive slowing, and difficulty with finger-to-nose testing with noted dysmetria, no focal weakness.
83 2021-03-24 nausea Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS e... Read more
Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS evaluated the patient on-site. The patient stated they were currently taking Augmentin for a UTI. Patient was hypertensive (162/82) with a FSBG of 84 mg/dl. EKG demonstrated NSR, rate 99bpm, no ST elevation. EMS administered 250mL IV saline en-route to Emergency Department. In the ED, the patient reported lightheadedness, nausea, dry mouth, left arm injection site pain, and feeling like her throat was closing. Patient remained slightly hypertensive (144/81). Physician administered 1L IV saline bolus and 10mg IV Decadron. The patient was discharged with diagnoses of Dizziness and Vaccination reaction.
83 2021-03-28 abdominal pain, nausea Fever; Abdominal Pain; Nausea; Malaise
83 2021-03-31 diarrhea tiredness; diarrhea; chills; coughing; This is a spontaneous report from a contactable consumer (pat... Read more
tiredness; diarrhea; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 83 years of age, via an unspecified route of administration on 29Jan2021 at single dose, for COVID-19 immunization. The patient medical history was not reported. Patient taking other medication which were not reported. On 29Jan2021, the patient experienced diarrhea, chills, coughing and tiredness. The events were considered as non-serious. Patient was taking cough drops for coughing. The outcome of the events was recovering. Information on the Lot/Batch Number has been requested.
83 2021-04-04 decreased appetite, vomiting, abdominal pain upper, nausea 3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuo... Read more
3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuously in back last two (2) days. Nauseated, weak bladder every hour or so. No appetite. 1st Covid shot 3-27.
83 2021-04-16 diarrhea Terrible diarrhea; patient feels awkward and she going to die; acting very puny; bit of lethargic; T... Read more
Terrible diarrhea; patient feels awkward and she going to die; acting very puny; bit of lethargic; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma. The patient's concomitant medications were not reported. On an unspecified date, reporter mentioned patient got terrible diarrhea, patient feels awkward and she going to die, she was acting very puny and bit of lethargic. Reporter wanted to know if it was something that could be bothering her four days after or three days after she had the treatment. Reporter also wanted to know if it could be because of the vaccination and how much should they worry about it. Outcome of the events was unknown. No follow-up attempts possible. No further information expected.
83 2021-04-19 vomiting, diarrhea, nausea, abdominal pain Patient admitted to hospital through ED on 4/19 due to intractable N/V/D with abdominal pain, cough ... Read more
Patient admitted to hospital through ED on 4/19 due to intractable N/V/D with abdominal pain, cough and fatigue. PCR testing upon admission + for COVID-19. This patient has had two doses of Pfizer COVID-19 vaccine, dates: 01/30/2021 and 02/17/2021
83 2021-04-22 nausea 5 minutes post vaccine, started feeling warm burning sensation all over, stayed on site for 60 minut... Read more
5 minutes post vaccine, started feeling warm burning sensation all over, stayed on site for 60 minutes. Was briefly shaky and weak, recovered enough to drive home after waiting. Nausea started later that evening and has been on and off since date of the vaccine. Patient describes warm burning sensation from waist up nightly since vaccine, also has hot/cold flashes followed by fatigue next day. Reports headache for several days following vaccine. Patient reports similar burning sensation has happened with other medications in the past including the 2019-2020 flu shot and antibiotics (unsure what types). Patient reports that the flu shot reaction was possibly a neomycin hypersensitivity, did not know specific type of flu shot.
83 2021-04-24 nausea, diarrhea, decreased appetite Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time ... Read more
Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time - depressed , excessive sweating on the left side of face and neck - excessive phlegm production as well as left eye buringin
83 2021-04-25 diarrhea, vomiting, nausea Patient c/o nausea, vomiting, diarrhea and dyspnea for 2 days. Resident of assisted living facilit... Read more
Patient c/o nausea, vomiting, diarrhea and dyspnea for 2 days. Resident of assisted living facility, presented to emergency department of local hospital where she was admitted for COVID pneumonia.
83 2021-04-25 profuse gastrointestinal bleeding This 83 year old female received the Covid shot on 1/28/21 while under hospice care and went to th... Read more
This 83 year old female received the Covid shot on 1/28/21 while under hospice care and went to the ED and admitted 2/4/21 and again on 3/3/21 and again on 3/25/21 and 4/15/21 died on 4/24/21. GI bleed, duodenal ulcer with hemorrhage, SIRS (systemic inflammatory response syndrome, shortness of breath, acute heart failure, acute respiratory failure, cough, pleural effusion. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
83 2021-04-30 decreased appetite Fever; lack of appetite/ lost her appetite, she is having a hard time eating and very rarely felt li... Read more
Fever; lack of appetite/ lost her appetite, she is having a hard time eating and very rarely felt like eating anything; weight loss/ lost 8 pounds; Headaches; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 11Feb2021 at 17:00-18:00 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 03Mar2021 at 12:00, both as single dose for COVID-19 immunization. The patient's medical history included flu vaccination for years and pneumonia vaccine. Concomitant medication(s) included Vitamin D 2000. On 25Feb2021, patient had headaches starting 2.5 weeks after her first shot. On 15Mar2021, patient experienced weight loss/ lost 8 pounds, patient also stated she was between 129-130 pounds when this started. On 15Mar2021, patient experienced lack of appetite/ lost her appetite, she was having a hard time eating and very rarely felt like eating anything. Patient also stated that she used to enjoy breakfast and lunch but then she was forcing them down, sometimes she could eat dinner. On an unspecified date, patient experienced fever. Patient mentioned that one night she felt like mashed potatoes and so her husband made her mashed potatoes and she ate a lot of them. Also mentioned that she forced herself to eat because she knows she had to. Patient was not losing anymore weight but she was not putting any back on like she thought she should be either. In the evening, she tried to eat pasta or potatoes. Patient mentioned that she had been to the doctor on 10Mar2021 and he gave her a B12 shot for her lack of appetite and said if she doesn't improve, to come back; she had been to the doctor twice. Patient stated that she lived on Tylenol and started taking it every 7-8 hours then down to every 4 hours because she needed relief. Her temperature would go from 97.1 to 99. Patient reported that no fever now and the highest it got was 99.8 and as soon as she took Tylenol, her temperature would go down. Patient wanted to know if anyone else has had this reaction. Outcome of the fever was recovered on an unspecified date, headache was recovered on 14Mar2021 while the events; lost her appetite and weight loss was not recovered. No follow-up attempts are needed. No further information is expected.
83 2021-04-30 decreased appetite lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse... Read more
lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; stopped talking; Cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen); it burned when she peed; blood in her urine; wanted to sleep/getting worse with sleeping; was shutting down; she was dehydrated because her urine was dark; urine was dark; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; arm was sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in the left arm, on 24Feb2021, as single dose, for COVID-19 immunisation. Medical history included mild asthma, dementia (moments like putting things in the wrong place and being forgetful) and was confused. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) received at age 83 years, on 03Feb2021, for COVID-19 immunisation. On 24Feb2021, after the second vaccinations, the patient's arm was sore. On 06Mar2021, the patient began just feeling bad, was having like a terrible time, having a hard time, was really not feeling good; was more confused; lethargic; had trouble getting her up, was having to do everything for her, feed her, bathe her; couldn't walk and lost her appetite. On 09Mar2021, the patient was shutting down. On the same day at 18:30, the patient had gone in the bathroom and said it burned when she peed. So, the patient was taken to urgent care so it would not get out of hand. At the urgent care, they said she has a UTI, there was blood in her urine so they gave her Cipro but they cultured her urine and it grew no bacteria but there was still blood in her urine and she was getting worse with sleeping and she didn't even get up to eat. The patient was also dehydrated and her urine was dark. The events dehydrated, urine was dark, it burned when she peed, blood in her urine required emergency visit on 16Mar2021. The reporter thought the patient was going to die. On 16Mar2021, in the ER, they did blood work (unknown result), chest xray which showed she had a spot where her lung was starting to collapse (they said it was a tiny place, from not getting up and moving around, they said it would correct itself) and the patient's potassium, Vitamin D and Vitamin B12 were low. They did a CT scan of the head and chest to look for stroke or seizure and there was nothing. They blamed it on her dementia that had suddenly progressed. The patient was hospitalized from 16Mar2021 to 18Mar2021. On 12Mar2021, the patient experienced cellulitis in her arm. The reporter clarified that the cellulitis was further down her arm, around her wrist hand area. Her wrist was huge, hot, red, and her hand was swollen. On 24Mar2021, the patient followed up with the family doctor because the hospital wanted her to follow up with a GYN because they didn't feel it was urinary at all. When the reporter took the patient in to see the doctor, she couldn't walk in, she had to roll her in a wheelchair, she had stopped talking again. On 26Mar2021, the doctor sent the patient to the emergency room (unspecified reason) and they kept her. They said her said lactic acid was high. She was admitted on 26Mar2021 and discharged on 29Mar2021. On 29Mar2021, the patient's potassium was 3.3 and her lactic acid level was back to 2. The patient was recovering from lactic acid was high; potassium, Vitamin D and Vitamin B12 were low; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; was shutting down; stopped talking. The patient recovered from cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen) in Mar2021; and arm was sore on 29Mar2021. The outcome of events spot where her lung was starting to collapse, dementia had suddenly progressed; she was dehydrated because her urine was dark; it burned when she peed; blood in her urine; and wanted to sleep/getting worse with sleeping was unknown.
83 2021-04-30 vomiting, nausea Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw ... Read more
Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Tired; Muscle pain in my left thigh; This is a spontaneous report from a contactable consumer (the patient). A 83-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN5318 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 30Jan2021 (age at the vaccination 83-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications include hydroxychloroquine, methotrexate. The patient received first shot on the 30Jan, and I was okay until 01Feb, and I woke, and I got nauseated and threw up and then later in the day the same thing happened to me. I nauseated and threw up and I had muscle pain in my left thigh. The next day, I was just extremely tired, and I didn't do any more throwing up because I do have Rheumatoid Arthritis and I was already compromised, I wonder should I take the 2nd shot which I due to have on 22Feb. Patient just took Tylenol for the pain in my leg and nothing else, I didn't want to start up again by taking something. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
83 2021-05-02 vomiting, diarrhea, nausea PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM... Read more
PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM AIR AND RESPIRATORY OF RATE OF 40. PATIENT TESTED POSITIVE FOR COVID 19 AND WAS HOSPITALIZED, LATER PLACED IN ICU
83 2021-05-03 vomiting 7 day post shot 2: sore feet - could not stand up 9 days post shot 2: vomiting, lethargy, severe c... Read more
7 day post shot 2: sore feet - could not stand up 9 days post shot 2: vomiting, lethargy, severe chest pains, lymphopenia, low magnesium, low glucose, mildly elevated troponin
83 2021-05-04 loss of appetite Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) ... Read more
Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16). Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake. Found to be febrile, hypotensive w/increased confusion. Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia. Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
83 2021-05-10 nausea, diarrhea sore throat, cough, nausea, diarrhea, and feeling icky all over. COVID monoclonal antibodies
83 2021-05-17 vomiting Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp o... Read more
Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
83 2021-05-24 diarrhea Approximately 1 week prior to admission patient developed increased bruising and a few minor episode... Read more
Approximately 1 week prior to admission patient developed increased bruising and a few minor episodes of epistaxis. She also experienced 1 day of diarrhea which was followed by 4 days of significant fatigue with subsequent improvement. Labs performed by PCP 5/21/2021 showed platelet count of 2000 and when labs resulted on 5/22/2021 patient was instructed to present to the emergency department where her count was repeated and was less than 2000. Patient is receiving 4-day course of IV immune globulin 20 g and prednisone 1 mg/kg (60 mg) daily for 2-3 weeks Patient received 1 unit platelet transfusion in emergency department on 5/22/2021 COVID-19 vaccination could have precipitated relapse of ITP
83 2021-06-01 decreased appetite, flatulence gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees)... Read more
gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
83 2021-06-02 diarrhea Explosive diarrhoea; This is a spontaneous report from a contactable consumer (patient) received via... Read more
Explosive diarrhoea; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 83-years-old female patient received first dose bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN9581), via an unspecified route of administration, administered in arm left on 08Feb2021 12:30 (at an age of 83-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 88 mcg, daily for thyroid mediciene; alendronate sodium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 88 mcg, daily for bone building. On 23Feb2021, the patient experienced explosive diarrhoea. The female consumer reports receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine on 08Feb2021. Two weeks later, she started experiencing severe diarrhea, which is continuing. She asked if this explosive diarrhea could be a delayed side effect of the vaccine, if this has been reported with the vaccine. she guessed that is the place that she got it where they sent them through like a herd of elephants, unknown if she is going to get the second dose or not relative to these events. The clinical outcome of the explosive diarrhea was not recovered. Follow-up attempts are completed. No further information is expected.
83 2021-06-02 profuse gastrointestinal bleeding GIB and bradycardia treatment of pantoprazole drip and transfusion
83 2021-06-03 vomiting, diarrhea, abdominal pain eyes were showing bright silver snowflakes; severe abdominal pain; diarrhea; vomited3x in 15 min; Th... Read more
eyes were showing bright silver snowflakes; severe abdominal pain; diarrhea; vomited3x in 15 min; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 24Feb2021 14:00 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, kidney stones (controlled), penicillin allergy, allergy to antibiotics, allergy to trees, allergy to grass and sulfa and cataracts and surg to replace retina 6 years ago (as reported). Concomitant medications included simvastatin, metoprolol, amlodipinum, lisinopril and paracetamol (TYLENOL),all taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 15:00 the patient experienced severe abdominal pain followed by diarrhea and vomited 3x in 15 min. On 26Feb2021 16:30 the patient had eye problem: she was not able to see because her eyes were showing bright silver snowflakes. Lasted about 15 minutes. Tearing and water made it go away. The patient did not received treatment for the other events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The events were resolved on an unspecified date. No follow-up attempts are possible. No further information is expected.
83 2021-06-07 vomiting downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was ar... Read more
downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet. Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week. Went to ER and was kept overnight. Was told sodium was low and she was sent home. Now her arm is blue and her vision is decreasing. Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.
83 2021-06-09 difficulty swallowing Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning ... Read more
Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning of May patient started to become OCD with her purse and wallet, on 5/12 she put ravioli that was to be boiled into the microwave and started a fire. After she did so, she realized it was wrong and said "how stupid" "why did I do that". I proceeded to make dinner for her and her meals for the next day, I advised her that I was going to take her to the hospital on Friday 5/14 for a Mental Health check as she began to decline. She returned home from but had her stay with me didn't trust her to stay alone. I followed up with her CP, Neurologist and Cardiologist, during her visits she struggled with words but was aware something was wrong as she stated "i just want the old me back". From 5/15 thru 6/1 her mental health only worsened, she had no cognitive functions (phone, tv, computer) unable to eat on her own and shower. We placed her in a Memory Care Facility on 6/2, she fell the next day and was hospitalized with a broken hip, she is now in rehab. The current reports are she is not eating well, put on a puree diet since she is having swallowing issues, cannot talk and attention span is minimal, The PET Scan determined Alzheimer's with Picks Disease. She showed absolutely no signs of decline prior to the 2nd vaccine.
83 2021-06-24 loss of appetite, nausea, vomiting, vomiting blood, GERD, decreased appetite Pt was vaccinated on 3/9/21 and 4/6/21 with Pfizer vaccines. Prior to her recent hospitalization she... Read more
Pt was vaccinated on 3/9/21 and 4/6/21 with Pfizer vaccines. Prior to her recent hospitalization she or the daughter had no knowledge of her severe hiatal hernia but she did admit to early satiety and poor po intake for a few months. Patient is an 84-year-old female with a past medical history significant for hypertension, hyperlipidemia, recurrent urinary tract infections who presented to the emergency room on 6/1/2021 due to some dysuria, frequency, nausea, vomiting and increased confusion. She denied any fever or chills or any abdominal pain but did report some acid reflux symptoms and poor appetite. she was ultimately admitted with a suspected urinary tract infection. She was also profoundly electrolyte depleted with hypokalemia, hypomagnesemia and hyponatremia due to poor p.o. intake. She was started on IV fluids and electrolyte repletion was also started on Rocephin based on her old cultures and subsequently admitted. Patient's urine and blood cultures ultimately produce no growth and a urinary tract infection was ruled out. She was found the day after admission with a large amount of black emesis covering her sheets. When questioned patient reported that she had been vomiting during the night. Stool OB was ultimately positive. Her DVT prophylactic heparin was discontinued. She was started on IV Protonix. CT of the abdomen pelvis was ordered. CT revealed nearly the entire stomach was above the left hemidiaphragm with air-fluid levels but there was no significant distention seen. The case was discussed with our general surgical team and the decision was made to transfer the patient to a higher level of care for a GI/EGD evaluation .She was transferred on 6/3/21. She was ultimately discharged on 6/7/21 home after being found to have a gastric volvulous. On 6/21 she returned for Robotic-assisted laparoscopic repair of a giant hiatal hernia with Bilateral placement of pleural pigtail catheters as both pleural linings were densely adhesed to the hernia sac. The plan was to discharge her home on 6/25/21.
83 2021-06-27 GERD It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daught... Read more
It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daughter's and I had no reaction. I came home and slept fine. After 7 days, I got hot spells and I keep taking my temperature. Sometimes it varies from 98.7-97.9. I started getting headaches and a lump in my neck after 3 weeks. I saw an ENT and he said these symptoms would go away. I was coughing and I asked my doctor to get a CAT scan. I had inflammation on my chest. It was last week that my PCP told me to see a pulmonary doctor. The disk that she had given him was not clear and that he couldn't determine anything. I have told my doctor about the weird headaches and acid reflux that I have been getting.
83 2021-06-29 nausea, diarrhea, abdominal pain upper, abdominal discomfort Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia,... Read more
Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia, back muscle pain, unusual dreams, hallucinations. Symptoms on and off to varying degrees for a month, especially muscle pain. Fatigue was constant.
83 2021-07-04 nausea, vomiting Patient with development of nausea and non bloody emesis x1, Patient observed for 30 min post emesis... Read more
Patient with development of nausea and non bloody emesis x1, Patient observed for 30 min post emesis without return of symptoms . ER precautions given .Patient without symptoms at time of discharge.
83 2021-07-06 difficulty swallowing Loss of voice, difficulty swallowing, rapid muscle mass deterioration, eventual death on 5/21/2021 f... Read more
Loss of voice, difficulty swallowing, rapid muscle mass deterioration, eventual death on 5/21/2021 from acute respiratory failure, and slight pneumonia.
83 2021-07-11 difficulty swallowing Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). ... Read more
Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). Unexplained physical and mental fatique, wants to sleep all the time. Trouble walking up and down stairs or around curves. Chronic joint and muscle pain. Restless legs. Trouble with swallowing. Cold intolorance. Sleep disorders. Low endurance. Memory and concentration problems.
83 2021-07-12 nausea I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed... Read more
I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed from the waist down, hospitalized, and had a very slow recovery. This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.) Little was known at that time. I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected. Currently the muscles going down the back of my lower leg and around the ankle are affected. Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI. I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing. My breathing was erratic for a few days and I felt nauseous for 2 weeks. I have not had the second covid shot.
83 2021-07-14 nausea, vomiting, decreased appetite ACCORDING TO THE PATIENT'S AND SON'S NARRATIVE, SHE EXPERIENCED BRAIN FOG AND NAUSEA AND VOMITTING I... Read more
ACCORDING TO THE PATIENT'S AND SON'S NARRATIVE, SHE EXPERIENCED BRAIN FOG AND NAUSEA AND VOMITTING IMMEDIATELY AFTER HER FIRST DOSE. SHE CAME BACK FOR HER 2ND DOSE AND SAID HER SYMPTOMS JUST GOT WORSE. THE IMMUNIZING RPH SAID THAT SHE ASKED THE PT HOW WAS HER FIRST DOSE AND SHE SAID THAT EVERYTHING WAS OK AND DIDN'T HAVE ANY PROBLEMS. WHEN SHE CAME TODAY, SHE SAID THAT SHE WAS JUST DISCHARGED FROM THE HOSPITAL AND STAYED THERE FOR 2 MONTHS. THEY TOOK OUT HER GALL BLADDER AND SAID IT STILL DIDN'T FIX THE PROBLEM. THE SON SAID THAT NOW SHE CAN'T EAT NORMAL NOW AND CAN ONLY EAT A TABLESPOON OR SO NOWADAYS AND STILL FEEL VERY SICK.
83 2021-07-14 vomiting 9 pm chills 4am found myself about to hit the floor was not aware of fall until I was about a foot ... Read more
9 pm chills 4am found myself about to hit the floor was not aware of fall until I was about a foot from hitting floor Tried to get back in bed but felt like I had no knees or lower legs laid on floor for unknown time Unsure How I got back in bed but I was and need to throw up. With no use of legs throw up on floor 9 am tried to go to toilet but again fell as still had no use of legs. So did so on the floor.. removed wet pants Slept from 9:30 am until 5 pm. Friend came over and helped me get up. Had 70% of leg use back. Ate a cracker and drank water and went back to bed at 7 pm and slept til 9 am Now it is 2 days after shot and finally have leg control but sweaty All this time for the 3 days had body aches and head ach. Took 5 days before I was back to normal
83 2021-07-17 decreased appetite, nausea Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were wat... Read more
Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were watering; Pain in lymph nodes in neck when touched; Loss of appetite; Felt like heart was going to go through her head; Heart was racing; Felt like her throat was closing up a little bit; This is a spontaneous report from a contactable consumer (Patient). A 83-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (age at vaccination: 83-yesr-old) as single dose for covid-19 immunization. (Vaccination facility: Clinic). Medical history included bursitis, arthritis, High blood pressure, High cholesterol all from an unknown date and unknown if ongoing, body aches many years at least from 10 years ago. Concomitant medication included ubidecarenone (COQ-10) taken for myalgia (started shortly after she started taking the cholesterol medication and she found out she was having body aches many years at least 10 years ago), acetylsalicylic acid (ASPIRIN CHILDREN) taken for cardiac disorder (started since long time ago probably 15 years or better), LISINOPRIL taken for blood pressure measurement (stated since many years), SIMVASTATIN taken for blood cholesterol increased (from same time as the lisinopril, at least 10 many years). Vaccine not Administered at Facility. It was reported that patient stated she and her husband received their second dose of the Covid shot clarified to be the Pfizer Covid 19 vaccine. She stated that she got almost every symptom on the list. Later that both she and her husband experienced fatigue. reported that she broke her hip a few years ago and that her husband told her that she did better after breaking hip than after receiving the Covid 19 vaccine. She reported that she does not usually experience any side effects after vaccinations stating that she normally sails right through the flu shot. She stated she just retired from a full time job in the first part of February, and if she had still been working she wouldnt have been able to go to work. Patient reported that within 12 hours of receiving the Covid-19 vaccine she was woke up in middle of night around 2 AM with her heart was racing she felt like she was going to have a heart attack, and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. She stated it could have been her heart or her blood pressure that she felt like she was speeding. She also reported that she was running a fever had chills pain and a splitting headache. She stated that within 48 hours the worst had passed. headache improved after the first night but that for a few days after she would get a shot up the back of her neck into her head. She reported that it was quickly resolve on its own. fatigue was worse after the second dose and they are both still experiencing fatigue. She was stated that she feels that the fatigue has improved but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. She is still having some lightheadedness if she stands up too quickly, she has to take a moment to balance herself before she proceeds, this was began after receiving the Covid 19 vaccine. She stated she was Felt like her throat was closing up a little bit, she did not feel that it was emergent or life threatening that she thought it was related to her swollen lymph nodes. she noticed pain around her breasts when she put her bra on mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. She was unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05 Mar 2021. She reported that the pain gradually diminished. She stated that it didnt bother her, she was noticed it when getting dressed. She stated she was just slightly nauseated but that she didnt throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later around 06Mar2021 or 07Mar2021. Reported that the watering eyes have cleared up. She stated that it resolved quickly maybe a day or two after they began on 04 or 05Mar2021. She also reported had Pain in lymph nodes of neck she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry but her stomach just didnt feel like it had the room for food. She reported that the loss of appetite resolved a few days later around 06 or 07Mar2021. Received treatment with Tylenol she stated during the 48 hours after symptoms began she stayed in bed and slept. She reported that she was get up to get a drink or take Tylenol just a couple a day and was drank water. She reported that she drank lots of fluids. She stated that she was get up would take something and then go right back to sleep. Tylenol helped a little bit Tylenol doesn't do a whole lot but it's better than nothing. Adverse event not resulted in Physician Office visit or ER visit. The outcome for the event Fatigue and Lightheadedness was resolving, for events Loss of appetite, Eyes were watering, Nauseated outcome was resolved on Mar2021, for events Felt like heart was going to go through her head, Heart was racing outcome was reported as resolved on 03Mar2021 and for events Fever, Chills, Splitting headache, Felt like her throat was closing up a little bit outcome was resolved on 05Mar2021, and for remaining events outcome was resolved on unspecified date. Follow-up attempts are completed. No further information expected.
83 2021-07-17 difficulty swallowing Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her se... Read more
Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home. Patient received treatment for events (labored breathing, chest pressure, fatigue, chest felt very tight, wheezing, pains all over, neck pain. The outcome of events Labored breathing, chest pressure, fatigue, chest felt very tight, Wheezing was not recovered, the outcome of events she is not planning to get her second vaccine, got very sick, pains all over, headache, neck pain, arm pain, bone pain, because has vertigo besides this and she can't swallow was unknown.
83 2021-07-19 nausea, decreased appetite, abdominal discomfort Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upse... Read more
Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upset; Lightheadedness; Loss of appetite; Felt like her throat was closing up a little bit; Eyes were watering; Pain in lymph nodes in neck when touched; NAUSEATED; Fatigue; Felt like heart was going to go through her head; Heart was racing; fever; Chills; Splitting headache; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EM98089, Expiration date: Unknown), dose 2 via an unspecified route of administration in Arm Left on 02Mar2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient medical history included bursitis, arthritis Verbatim: Arthritis, hypertension, ongoing blood cholesterol increased. The patient also received first dose on bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 09Feb2021 as dose 1, singe for covid-19 immunisation. The patient concomitant medications included ubidecarenone (coq-10) taken for myalgia, start and stop date were not reported; acetylsalicylic acid (aspirin children) taken for an unspecified indication, start and stop date were not reported; lisinopril (lisinopril) taken for blood pressure measurement, start and stop date were not reported; simvastatin (simvastatin) taken for blood cholesterol increased, The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Caller reported that within 12 hours of receiving the Covid-19 vaccine, she woke up in middle of night around 2 AM with her heart racing, she felt like she was going to have a heart attack and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. Caller reported that it could have been her heart or her blood pressure, that she felt like she was speeding. Caller reported that she was running a fever, had chills, pain, and a splitting headache. She stated that within 48 hours the worst had passed. Caller stated that the headache improved after the first night, but that for a few days after she would get a shot up the back of her neck into her head. She reported that it would quickly resolve on its own and also that both she and her husband experienced fatigue after receiving the first dose of the Covid-19 vaccine, but that the fatigue was worse after the second dose and they are both still experiencing fatigue. Caller stated that she feels that the fatigue has improved, but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. she was still having some light-headedness if she stands up too quickly. She reported that she has to take a moment to balance herself before she proceeds. She stated that this began after receiving the Covid-19 vaccine. Felt like her throat was closing up a little bit: Caller reported that she did not feel that it was emergent or life threatening, that she thought it was related to her swollen lymph nodes. Caller reported that she noticed pain around her breasts when she put her bra on, mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. Caller stated she is unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05Mar2021. She reported that the pain gradually diminished. She stated that it didn't bother her, that she just happened to notice it when getting dressed. she was just slightly nauseated but that she didn't throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later, around 06Mar2021 or 07Mar2021, went along with throat feeling like it was closing up. Caller reported that the watering eyes have cleared up. She stated that it resolved quickly, maybe a day or two after they began on 04 or 05Mar2021. she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Caller reported that the loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry, but her stomach just didn't feel like it had the room for food. She reported that the loss of appetite resolved a few days later, around 06 or 07Mar2021. Caller reported that during the 48 hours after symptoms began, she stayed in bed and slept. She reported that she would get up to get a drink or take Tylenol, just a couple a day, and would drink water. She reported that she drank lots of fluids. She stated that she would get up, would take something, and then go right back to sleep. Tylenol helped a little bit, Tylenol did not do a whole lot, but it's better than nothing. Tylenol: UPC/lot/expiry not provided. Caller stated that she was not supposed to take ibuprofen, saying the reason was something to do with blood pressure or something. She reported that if the AEs she experienced had gotten severe, she would have called her doctor and had them check it out or at least asked advice. She stated that because symptoms began resolving after 48 hours, she thought it was ok. She reported that she is going to the doctor in May for a routine check-up, and they will inform her if anything has changed. The outcome of events was fatigue was resolving and outcome of other events Felt like heart was going to go through her head, fever, Chills, Splitting headache, Felt like her throat was closing up a little bit was resolved on 05Mar2021, Heart was racing on 03-MAR-2021. Outcome of events Loss of appetite, Lightheadedness, Eyes were watering, Pain in lymph nodes in neck when touched, High cholesterol, stomach felt a little queasy or upset on an unspecified date. Outcome of Bursitis, High blood pressure was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
83 2021-07-20 diarrhea, nausea nausea; loose stools; aching; This is a spontaneous report from a contactable healthcare professiona... Read more
nausea; loose stools; aching; This is a spontaneous report from a contactable healthcare professional, the patient. A 83-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 25Mar2021 at 12:00 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high cholesterol and hypertension (HTN). Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (SERTRAL) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 26Mar2021 at 14:00, the patient experienced nausea, loose stools and aching. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events nausea, loose stools and aching were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
83 2021-07-21 abdominal pain upper she experience a burning sensation that right side where she got the injection, the sensation went u... Read more
she experience a burning sensation that right side where she got the injection, the sensation went up her neck and into her throat.; She states that she had an odd taste in her mouth, but it was not metallic, just a funny taste in her mouth; Her stomach cramped up a little bit as well.; muscle pain in the back of her neck that did last for a couple of days; A little bit of pain in the left breast; Pain in arm; She states that a couple dats after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair) the pain in her hip wasn't there.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN0186, Expiration date: unknown), dose 1, via an intramuscular route of administration, administered in Arm Right on 23Jun2021, (at the age of 83-year-old), as dose 1, single for covid-19 immunisation. Patient medical history included ongoing Arthritis (she had arthritis as a teenager but did not know it. She reported that she was diagnosed with arthritis years ago in her late 40's), ongoing Heart condition (she has a heart murmur and she believes that she was born with it),ongoing High cholesterol (she was diagnosed with high cholesterol many years ago and she cannot remember when), ongoing Hypoglycemia (she was diagnosed years ago), ongoing Macular degeneration (the macular degeneration began years ago and that is why she is now legally blind), ongoing Asthma (she was diagnosed years ago and it goes along with the allergies), Cancer (she reported that she had cancer surgery on her left breast), Diverticulitis, lumpectomy in the late 1990s, Covid-19, ongoing Osteoporosis (she was diagnosed with osteoporosis years ago), Colon resection in the 2000's and guesstimate around 2011. Patient reported that her last surgery was for diverticulitis in the 2000's, she wants to guestimate around 2011. She reported that her diverticulitis has been pretty good since the surgery. She reported that once in a while she has a little discomfort. She reported that she was not sure if the diverticulitis was causing the pain in her hip area as that is where the colon resection was done. She reported that she was not sure if was arthritis or osteoporosis or the other stuff. Family Medical History Relevant to AE(s) was none. She has allergies to strong odors and stuff like that and some foods like berries, strawberries, and chocolate cause her to break out in pimples and a rash and allergy to pollock, the fish. She has allergy to unspecified medications caused her to break out with hives really bad. She had most allergies to NSAIDs medications. The patient concomitant medications were not reported. The patient historical drugs included Lescol, Zocor, Lobid, Lipitor, Celebrex, salicylate, Darvocet, clarithromycin, erythromycin, Lyrica, Crestor, Zoloft, Zyrtec, Vicodin, Limbrel, and Vioxx and experienced allergies. She reported that she carries a list with her of her medication allergies so that she is not prescribed anything she is allergic to. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. On 23Jun2021, within the first 5 minutes of receiving the Covid-19 vaccine, the patient experienced a burning sensation that right side where she got the injection, the sensation went up into her neck and throat, felt odd taste, Her stomach cramped up a little bit as well, muscle pain in the back of her neck that did last for a couple of days, A little bit of pain in the left breast and Pain in arm and Pain in left hip is not there within a day or day and a half of receiving the Covid-19 vaccine, She states that a couple days after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair on an unspecified date in Jun2021. The clinical course of the events as follows: She reported that within 10 minutes while waiting, she first experienced a burning sensation on the right side where she got the Covid-19 vaccine injection. Caller reported that the burning sensation went up into her neck and throat, also felt an odd taste that she could not distinguish, not a metallic taste, but kind of a funny feeling with her throat, an odd feeling, she reported that a couple of minutes later, she felt cramping in her stomach and later on in the afternoon, a couple hours later, she had real severe muscle pain in the back of her neck, severe muscle pain in the back of her neck lasted quite a while, for a couple of days, pain in her arm developed the evening of 23Jun2021 and she felt it for a day and a half. She stated that they say that the arm pain was normal but the other things she was not quite sure about. she did feel a little bit of pain in her left breast, she had cancer surgery on her left breast and that the pain was probably in the lymph node area. Caller inquired if these are just normal side effects for people to get and not to worry about the second Covid-19 injection. She reported that the burning sensation, odd taste in her mouth, and funny feeling in her throat only stayed a little while. Muscle pain in back of neck lasted 2-3 days, little bit of pain in the left breast lasted 2-3 days, cramping in stomach lasted a couple of days. Pain in left hip is not there: she reported that she has a lot of senior problems and one of them is that she has arthritis from head to toe. Caller reported that in her left knee and hip on the inside of the hip area, she has severe pain. She reported that she has minimal walking ability and uses a wheelchair but uses a walker in the house when she has good days. She reported that within a day or day and a half of receiving the Covid-19 vaccine, she got up to walk to the kitchen and the pain in her left hip was not there and reported that it was really weird, and she was grateful of course, but her left hip is still ok. She reported that when she was on her feet and walking, she does not have the severe pain that used to put her off her feet. She reported that when she was laying down in bed and stretching, she feels severe pain, but walking around it's better. She reported that the pain in her left hip was not there when she was walking and that used to be when it was the worst. She reported that her second dose of the Covid-19 vaccine would be due for 14Jul2021. She reported that she knows that the vaccine is still experimental and that there are side effects, but it was better to take chances on the Covid-19 vaccine than to get Covid. She reported that one of her distant family members that got Covid got really sick, and they were young. She reported that she just wanted to make sure that these side effects would not prevent her from getting the second dose of the Covid-19 vaccine. She reported that the side effects were not severe but were annoying. The events did not require a visit to Emergency Room and Physician Office. Relevant Tests were none. No Investigation Assessment was done. she said that she had not heard of those side effects and it was nothing severe and not to worry. She reported that the girl instructed her that if she did have an allergy, she had to wait 6 hours to take an allergy pill. the outcome of the events burning sensation that right side where she got the injection, the sensation went up her neck and into her throat, felt odd taste was resolved on 23Jun2021, the outcome of events Cramping in stomach, muscle pain in the back of her neck that did last for a couple of days, little bit of pain in the left breast and Pain in arm was resolved on an unspecified date in Jun2021, while outcome of other events were unknown.
83 2021-07-25 blood in stool Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakn... Read more
Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakness, fatigue, bloody stool. Also reports having chills and has a mild cough. Patient has COPD.
83 2021-07-28 vomiting, diarrhea, nausea Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and... Read more
Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and vomiting; diagnosed with bronchial pneumonia; This is a spontaneous report from a Pfizer Sponsored Program. Information was received from a contactable nurse (the patient). A 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 (Batch/Lot Number: EL6204) as single dose for covid-19 immunisation (Age at vaccination 83 years) . Medical history included mycobacterium avium complex infection. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medications included multivitamin (MULTIVITAMIN) taken for an unspecified indication from 19Mar2021 12:30 to 19Mar2021 12:30; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with bronchial pneumonia (medically significant) on Mar2021 with outcome of recovered , lost 5 pounds (non-serious) on an unspecified date with outcome of recovered , headaches (non-serious) on Mar2021 with outcome of recovered , nausea and vomiting (non-serious) on Mar2021 with outcome of recovered , one bout of diarrhea (non-serious) on an unspecified date with outcome of recovered , night sweats so bad (non-serious) on Mar2021 with outcome of recovered. Therapeutic measures were taken as a result of diagnosed with bronchial pneumonia and included antibiotics, albuterol and cough medicine. Course of the event. Caller states that she then had a sore throat and nasopharynx and throat felt like she was breathing fire. It got worse and worse. Caller states that within 48 hours of receiving the vaccine, she also began coughing and coughing. She had headaches, nausea, vomiting, one bout of diarrhea, and night sweats so bad that she had to change her pillow and bedding and was soaked from the waist up. Caller adds she was diagnosed with bronchial pneumonia. She had an appointment with a pulmonologist doctor and was seen at the clinic. They did x-rays, cat scans, and she was unable to do a breathing test because she could not quit coughing. Caller does not have additional details. Gave her antibiotics for 21 days, a nebulizer of albuterol and saline and they gave her cough medicine. It was the same cough medicine with codeine. She spent 6 days just at the clinic with tests in the doctor and came home from the train. Caller adds she was not admitted. This all stretched out over 3 weeks and gradually increased. Follow up information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
84 2021-01-22 flatulence About 5 hrs after had terrible stomach gas pains for several hours. Had terrible chills and became v... Read more
About 5 hrs after had terrible stomach gas pains for several hours. Had terrible chills and became very woozy. Still chilled and woozy at 12 hrs after shot
84 2021-01-25 nausea ON 1/19/21 DEVELOPED NAUSEA. FOLLOWED UP WITH PCP.
84 2021-01-26 diarrhea, nausea Tiredness started about 1:30 pm 1/26/21 - by evening 1/26/21 felt nauseated - didn't eat evening mea... Read more
Tiredness started about 1:30 pm 1/26/21 - by evening 1/26/21 felt nauseated - didn't eat evening meal - 1/27/21 - 9:00 am Diarrhea started - very severe until about noon. By 6:00 pm 1/27/21 was feeling better.
84 2021-01-28 nausea Shivers, nausea
84 2021-01-31 diarrhea Severe diarrhea
84 2021-01-31 diarrhea headache off and on, severe coldness and some chills, diahrrea for 48 hours
84 2021-02-01 vomiting, abdominal discomfort Two days, 1/29 ,after shot, vomiting and fatigue, emergency room visit on 1/31 , additional ER visi... Read more
Two days, 1/29 ,after shot, vomiting and fatigue, emergency room visit on 1/31 , additional ER visit on 2/01. Continual slight stomach upset but general fatigue and weakness still prevalent.
84 2021-02-02 nausea Pt states she is feeling nauseous. Pt seated and vital signs obtained 120/78, rr 18, hr 60, 96% on r... Read more
Pt states she is feeling nauseous. Pt seated and vital signs obtained 120/78, rr 18, hr 60, 96% on room air. Sips of water given. Pt offered to receiv additional medical attention, pt refused. States the water helped and no longer feeling nauseous. Son is accompanying pt and will be driving her home advised son to monitor pt and symtpoms to look for. Son verbalized understanding.
84 2021-02-02 vomiting The next morning after the vaccine she reports multiple episodes of emesis and feeling "crappy"
84 2021-02-03 abdominal pain upper Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all ... Read more
Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all aches were gone
84 2021-02-03 nausea Chills, weakness, light headed, slight nausea , slight arm pain at injection sight. Only treatment ... Read more
Chills, weakness, light headed, slight nausea , slight arm pain at injection sight. Only treatment was go to bed
84 2021-02-05 abdominal pain upper stomach cramps, extreme tiredness
84 2021-02-07 diarrhea 48 hours after vaccination 2/4/21, diarrhea, followed by extreme, dizziness/lightheadedness, all day... Read more
48 hours after vaccination 2/4/21, diarrhea, followed by extreme, dizziness/lightheadedness, all day., starting 9:30am,2/6/21 Lightheadedness ongoing( day of reporting)2/7/21
84 2021-02-07 nausea, vomiting Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakn... Read more
Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakness and one episode of vomiting/nausea surrounding her Covid vaccination this afternoon. On exam patient appears mildly anxious, has no evidence of allergic reaction, lungs are clear and equal bilaterally. Patient is resting comfortably, speaking in complete sentences. Shortly after physical exam patient was noted to have oxygen saturation of 90 to 92%, subsequently placed on 2 L nasal cannula. Will obtain CBC, CMP, chest x-ray, EKG. We will also give patient 500 cc of fluid and 4 mg of Zofran for control of nausea and vomiting. We will continue to monitor patient. No leukocytosis, no AKI, electrolytes within normal limits, chest x-ray without evidence of underlying pneumonia or pneumothorax. I have reevaluated patient, patient has been reporting a ongoing headache for which she has a history of and takes Fioricet, requesting Fioricet. Will order Fioricet. We attempted to take patient off of her oxygen however when taken off the oxygen she drops to 88% on room air. Patient reports ongoing generalized weakness and nausea which has required an additional 4 mg Zofran. Given that patient has been monitored for couple of hours and has had ongoing nausea and vomiting, generalized weakness in the setting of hypoxia when taken off of oxygen will obtain troponins and admit patient to the hospital for obs. I have spoken to Dr. who has accepted patient to observation with telemetry for further management. Patient was informed of admission status, with no further questions at this time.
84 2021-02-07 nausea Tired; dizzy; nauseated; shivery; could not even stay awake; This is a spontaneous report from a con... Read more
Tired; dizzy; nauseated; shivery; could not even stay awake; This is a spontaneous report from a contactable nurse. This 84-year-old female nurse (Patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunication on 14Jan2021. Relevant history included Atrial fibrillation, Rheumatic heart disease several years ago and needed a pacemaker, getting shingles and ongoing, Congestive heart failure, she got really bad 2.5 years ago after she got the flu and it affected her flu. Relevant concomitant drugs were unknown. The patient stated she got the vaccine on 14Jan2021 (a week ago). She got really tired, stated she slept 9 hours, she was dizzy, nauseated and shivery which started yesterday or the night before, she was really tired for about 3 days after the vaccine, could not even stay awake. Exact dates were not provided. The symptoms were somewhat improved. She took some meclizine and it helped some. She wanted to know if these were side effects of the vaccine. Outcome of events was resolving. Information on the lot/batch number has been requested.
84 2021-02-07 nausea Fever, headache, nausea, weakness, dizziness
84 2021-02-08 indigestion Pt felt a chest and stomach burning about 10 minutes, throat tightness, and tingling around her mout... Read more
Pt felt a chest and stomach burning about 10 minutes, throat tightness, and tingling around her mouth
84 2021-02-09 nausea Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency depar... Read more
Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>
84 2021-02-10 diarrhea diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female ... Read more
diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunisation, lot number: EL9261. Medical history included blood pressure high, thyroid gland disorder and thyroid surgery (patient had her thyroid surgery, they took a part out). Concomitant medications included rosuvastatin, losartan for blood pressure high and levothyroxine sodium (SYNTHROID) for thyroid disorder. It was reported that patient got the vaccine on 25Jan2021 and she was doing good, but on 27Jan2021 morning she got the diarrhea. Patient did not take anything for diarrhea. Due date for the next shot: 22Feb2021. Patient stated that she did not got to the doctor she went to Hospital (as reported). Patient had not recovered from the event.
84 2021-02-10 nausea fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her ... Read more
fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her arm; felt like she could pass out; didn't know who she was, she just kept walking and walking; funny feelings; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date not reported), via an unspecified route of administration on the right upper arm on 21Jan2021 17:00 at single dose for covid-19 immunization. Medical history included oral cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received flu vaccine for immunization and reported that it made her sick for 10 days 4 or 5 years ago. The patient previously took Tylenol (takes 1 instead of 2, Everything she takes half the recommended dose). The patient experienced fast heartbeat, increased BP, weakness, dizziness, nausea and headache on an unspecified date in Jan2021. It was further reported that she had a fast heart beat, her blood pressure went real high, she was dizzy and weak. This was while she was there and being watched for the 15 minutes by a nurse. She is 84 years old and doesn't take any medication; she did have oral cancer but with no chemo as it had not spread and this was 2 years ago. It was explained that the patient didn't feel good about it but she drove home. When she got home she was confused and felt like she could pass out. She walked through the house didn't know who she was, she just kept walking and walking. It was a strange feeling that lasted 15-20 minutes. She called her son late in the afternoon and told him to check on her to make sure she made it through the night. She still had funny feelings over the next few days but at this point she only has the dizziness that happens occasionally. She notes also that her blood pressure was checked at home by her and was higher than normal the first few days after but is now normal. Over the next day she had a headache and a little nausea, but it was not severe. She also mentions having a little soreness in her arm but not bad. She did read about the side effects and states she had the elevated heart rate, increase in blood pressure and dizziness right after getting it. The patient wonders could she ask for smaller dose, she only weighs about 110lb. When she spoke with her doctor she was told that the COVID virus is worse than what she experienced after the vaccine. She has not been to the doctor since getting the vaccine, she just talked to them. The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: fast on Jan2021. The patient was recovering from dizziness, the outcome of nausea was unknown and the patient recovered from the rest of the events on an unspecified date in Jan2021.
84 2021-02-17 difficulty swallowing Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
84 2021-02-21 anal incontinence, difficulty swallowing, decreased appetite 1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of men... Read more
1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am
84 2021-02-21 vomiting, nausea Severe headache. Nausea. Vomiting. Tired. Difficulty concentrating.
84 2021-02-24 abdominal distension Nasal congestion, chills no fever, exhaustion, pain at injection site. Palpitations and arrythmla. ... Read more
Nasal congestion, chills no fever, exhaustion, pain at injection site. Palpitations and arrythmla. Tylenol and bismuth subsalicylate for bloating and chest pain.
84 2021-02-25 nausea pressure all in her head and all over her body; pressure all in her head and all over her body; Feel... Read more
pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.
84 2021-02-27 difficulty swallowing Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite cli... Read more
Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite clinic for Assisted Living Facility. Received 2nd dose Pfizer-BioNTech vaccine Lot EN5318 Exp 05/2021 on 02/08/2021 during CVS onsite clinic for Assisted Living Facility. On 02/10/2021 during routine employment screening, tested positive for COVID-19. On 02/12/2021 reported generalized malaise, otherwise denied symptoms. On 02/21/2021 employer notified by family friend that patient was treated at Medical Center on 02/20/2021 secondary to sudden onset difficulty swallowing, impaired speech, and facial droop. Employer later notified patient was then admitted to the ICU at aforementioned hospital secondary to dx of CVA.
84 2021-02-28 nausea Nausea, 1 am through the night. Still nauseated today 3/1/21
84 2021-03-02 nausea Systemic: Nausea-Mild
84 2021-03-04 diarrhea, nausea nausea and diahhrea
84 2021-03-04 nausea, diarrhea she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness;... Read more
she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness; Weakness; Nausea/felt sick to her stomach; Diarrhea; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER VACCINE SHOT; lot number: EL3248; expiration date: unknown) at vaccination age of 84-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:20 at a single dose for covid-19 immunization. Medical history included open heart surgery, diabetic/diabetes, high blood pressure, bone and joint problems, and her bones were already hurting for a long time before. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. Familial history included all of her family that has passed, died of diabetes or cancer. Concomitant medications included unspecified other blood pressure medication and nifedipine for blood pressure. The patient did not receive other vaccination within 4 weeks. The patient reported that she took the shot on 29Jan2021 and she stayed for the 15 minutes, but she didn't have any feeling about it. A little more than an hour later (29Jan2021), she had a slight headache, then she got tired and felt like she needed to lay down. She did lay down and slept 9 hours. The patient reported that she felt her blood pressure was up and so she checked, it was at 179 [unspecified unit]. It was at that point she called her children and told them she was not doing well. She does feel this is under control at this point. The next morning (30Jan2021), she had dizziness, weakness, felt sick to her stomach, and had a slight headache. She clarified that the sick to her stomach feeling was nausea and diarrhea both started on 30Jan2021. It had resolved as of 31Jan2021. She mentioned that she feels better but the tiredness is still going on today. It is explained that her blood pressure was up and her sugar was down on 30Jan2021, she is a diabetic. She takes blood pressure medication, but it wasn't bringing it down at first. She explained that when she took her blood sugar it was 70 [unspecified unit] something on 30Jan2021. Her normal is 120-121 [unspecified unit] (unspecified date) and that is where she likes to keep it so that was a problem. She has had to eat sweets to get it up, but it won't stay up. She reported that the tiredness, dizziness, and headache are still going on right now. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. She feels they should ask more questions or have the doctor send a recommendation over or information about a person. The outcome of the events headache was not recovered, as for the events dizziness and tiredness were recovering while the outcome of the events nausea and diarrhea were recovered on 31Jan2021. The outcome of the other events was unknown.
84 2021-03-04 nausea 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and f... Read more
2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2, PERL, BP 120/82, HR 88 regular, RR 18. Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline). ABDM soft, non tender. Breath sounds clear bilaterally. 1100 IV NS 1L, 30 mg Toradol IV given. Temp 99.2-102.0 variable throughout the day. Severe HA. Tylenol and Motrin alternated q 4hr. 2/24 Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above. 2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above. Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue. Pt states "do not feel myself"
84 2021-03-04 nausea This is an 84 year old patient who presented for her initial dose of the Pfizer/BionTech COVID-19 va... Read more
This is an 84 year old patient who presented for her initial dose of the Pfizer/BionTech COVID-19 vaccine. About 10-15 minutes after receiving the dose, she experienced a burning sensation in her upper mid-chest, felt dizzy, felt nauseous. She also said that she initially had dyspnea, but denied cough or wheezing (she denies a prior history of chronic respiratory disease, such as asthma). She said that her throat began to feel tight, and she was administered epinephrine at the immunization point of distribution (at the gym). She was then transferred via EMS to the ER for further evaluation. She denied experiencing cutaneous symptoms. She denied vomiting, diarrhea, syncope. She states that she has an allergy to sulfa drugs (she develops hives) and has an allergy to penicillin (she states that she passed out after receiving a penicillin shot as a teenager, but did not have any other systemic symptoms).
84 2021-03-05 decreased appetite She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 time... Read more
She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 times and ended up on hospice
84 2021-03-07 diarrhea The day after the second COVID-19 Pfizer vaccine, the patient has bee experiencing persistent diarrh... Read more
The day after the second COVID-19 Pfizer vaccine, the patient has bee experiencing persistent diarrhea. Patient denies melena, but admits fatigue, frank red blood, and intermittent cramps. A full work-up is in process and no definitive diagnosis has been found as on 03/08/2021. However patient has bee stable and no hospital admission has been required as of 3/8/2021.
84 2021-03-08 diarrhea diarrhea
84 2021-03-08 diarrhea Diarrhea
84 2021-03-09 decreased appetite Patient reported losing her "taste buds" and also did not feel hungry and was tired around 3 days af... Read more
Patient reported losing her "taste buds" and also did not feel hungry and was tired around 3 days after her second dose of the Pfizer-BioNTech COVID-19 vaccination. Patient said this has now resolved but did not state exactly when it resolved.
84 2021-03-15 abdominal pain, nausea 3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints ... Read more
3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints of back pain, nausea, and abdominal pain. Patient approximately 1 week ago was bending over to pick something up and fell to the floor landing on her coccyx, and has had increased low back pain since that time. Patient does have a history of congestive heart failure and atrial fibrillation. Patient states that she had noticed increasing lower extremity edema and mild shortness of breath with exertion. The patient states that her back pain escalated and she was unable to stand or walk on her own. Patient was then brought to the ER for further evaluation per EMS. The patient did have a CT of the abdomen and pelvis which showed no definite acute intra-abdominal/pelvic abnormality, and mild acute during L2 superior endplate compression fracture with approximately 4 mm of displacement into the spinal canal. Patient also had a CT of the lumbar spine without contrast which showed acute appearing mild L2 superior endplate compression fracture with approximately 2 mm of displacement to the spinal canal, and multilevel degenerative disc disease. This morning upon entering the room the patient was standing with assistance of a walker and hospital staff. Patient tolerated fair. Patient does complain of severe pain with standing and movement. Patient does have 3+ pitting edema to bilateral lower extremities. Denies numbness or tingling to lower extremities. Bilateral lower extremity pulses are 1+ 1+, with CMS being less than 3 sec and skin is pink warm and dry. Patient's EKG in the emergency room did show atrial fibrillation with RVR with a rate of 137. Patient was given Cardizem IV in the emergency room, and then was started on Cardizem CD 100 80 mg p.o. daily. Patient's rate is controlled at between 92 and 96 beats per minute and continues to show atrial fibrillation on the telemetry. No shortness of breath is noted at this time. Patient did also have lab work drawn in the emergency room CBC: White count is 9.4, hemoglobin 14.4, hematocrit was 43.7, with a platelet count of 261. Patient's CMP showed a BUN of 21, creatinine 1.2, potassium was normal at 4.6, and her GFR was noted at 41. Patient also had a BMP drawn which was noted at 322. Patient also had a urinalysis performed which shows negative for leukocytes, nitrate negative. Patient was admitted to medical inpatient as it is deemed that she will need longer than a 2 midnight stay for cardiac monitoring and will work with physical therapy and occupational therapy for gait training and strengthening with relation to the compression fracture of her L2 fracture, and pain control.
84 2021-03-16 abdominal pain Within approximately 5 minutes of observation post vaccination, patient suddenly became unresponsive... Read more
Within approximately 5 minutes of observation post vaccination, patient suddenly became unresponsive to questions asked by her granddaughter, no respiratory distress. After 3-4 minutes, she was responsive and alert , oriented to person, place and time. Then after a few more minutes, was unresponsive again with her BP 70s/ 40s HR 48 complaining of abdominal pain and "feeling warm ". She was then transferred to the Emergency Department.
84 2021-03-20 vomiting, diarrhea diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient herself) A 84-... Read more
diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient herself) A 84-years-old non female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201 ; Expiration Date: 30Jun2021 ) dose 1 intramuscular, administered in Arm Left on 07Feb2021 as SINGLE DOSE for covid-19 immunisation .Medical history included hypertension from an unknown date and unknown if ongoing , irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for hypertension from an unspecified start date and ongoing.The patient experienced diarrhea on 08Feb2021 02:00 and vomiting on 08Feb2021 02:00 with outcome of recovered. She did stop vomiting, but vomited about 4 times and the diarrhea kept up for a little while and then stopped.The events were considered as non-serious by consumer. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.
84 2021-03-22 decreased appetite, nausea, vomiting For 6 weeks she has had been nauseous, throwing up, -0- energy (like a limp dish rag--hard to sit up... Read more
For 6 weeks she has had been nauseous, throwing up, -0- energy (like a limp dish rag--hard to sit up or hold her head up), severe chills, loss of appetite (lost 20 pounds)
84 2021-03-23 abdominal discomfort Developed sensation over dermatome of abdomen within 1 hr of 1st dose of Pfizer vaccine. Increased ... Read more
Developed sensation over dermatome of abdomen within 1 hr of 1st dose of Pfizer vaccine. Increased pain over 3 days. Eruption of herpes zoster rash on 3/22 with confirmation by provider on 3/23.
84 2021-03-24 gastrointestinal disorder got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous rep... Read more
got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient's daughter) that an 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 (at the age of 84 years) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was daughter, her mom (patient) got 1st dose on 04Feb2021, then patient got covid (tested positive) on 23Feb2021, patient had GI (gastrointestinal) issues and weak in Ferb2021. Patient took antiviral treatment and had to be in hospital in 2021. Patient was currently out of hospital, recovered, and in rehab place. Caller was asking for information about 2nd dose past 21 days. Caller was asking if her mother should restart the series. The case was reported as non-serious. Outcome of events was recovered in 2021. Information about batch/lot number has been requested.
84 2021-03-28 difficulty swallowing Systemic: Tachycardia-Medium, Additional Details: Difficulty swallowing
84 2021-03-28 blood in stool Bloody stool
84 2021-03-29 diarrhea Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no a... Read more
Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available.
84 2021-04-01 decreased appetite 3/25 temp 99.1, change in condition form sent to dr. 3/26 Res continues to be lethargic this AM s... Read more
3/25 temp 99.1, change in condition form sent to dr. 3/26 Res continues to be lethargic this AM shift. Res does nothing to participate with cares, transfers or eating. Denies any pain or SOB when asked. Difficult to have res to keep eyes open. Appetite very poor, even with full assist provided- sent to ER- admitted to hospital dx of UTI/hypernatremia 3/29 retn to nursing home and3/30 admit to hospice
84 2021-04-09 nausea extremely ill; extreme fatigue; nausea; muscle aches; He is afraid she has COVID; have achy arm; Thi... Read more
extremely ill; extreme fatigue; nausea; muscle aches; He is afraid she has COVID; have achy arm; This is a spontaneous report from a contactable consumer (patient reported herself). A 84-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3949, NDC number: Unknown, Expiry Date: May2021) intramuscularly given very high in the top of left arm on 04Feb2021 9:20 AM at 0.3 ml single dose for Covid-19 immunization. The patient's medical history included fractured skull (five years ago), shingles (two years ago) and bleeding ulcers. Concomitant medications were not reported. Patient had the first dose of PFIZER-BIONTECH COVID-19 VACCINE last 04Feb2021 at 9:20 AM - Same day 6:00 PM started to have achy arm - After a few days developed symptoms like extremely ill, extreme fatigue, nausea, muscle aches. DSU potential duplicate AE Report E transmit - According to the patient she had already reported the side effects and transferred to our department. On 04Feb2021, the patient experienced arm started to ache like hell. Tiredness, muscle pain, nausea and feeling horribly ill. It was reported that, "she was having some symptoms. She got her vaccination on the 04Feb2021 and developed the symptoms yesterday. Her doctor was very alarmed that it was not just usual symptoms that go along with the vaccine because of the length of time between when she got it and when she developed symptoms. He was afraid she had COVID. She needed to know if that was normal so she could get back to him. Caller clarified that she meant side effects. She wanted to know whether it was normal to have gotten the vaccine on 04Feb2021 and not develop side effects until 09Feb2021. The vaccination was given in the morning at 9:20 AM and she did not have any symptoms until 6:00 PM that evening. Her arm started to ache like hell. That one showed up then, but cleared up in a couple of days. The arm got better and better. The other set of side effects started yesterday which was tiredness, muscle pain, nausea, and feeling horribly ill. She felt awful and did not want to go to a hospital if it was not necessary. HCP information included she had only seen him a couple of times. She had a long term doctor that retired and she got shifted over to him. They did not have a good relationship she must say. His whole group was associated with where she got the vaccine. They were all virtual now. She had been on lock down for a year. She did not have the doctor's address, phone number, or email. Tiredness, muscle pain, nausea, and feeling horribly ill: started yesterday morning when she got up between 4:30 AM and 5:00 AM. She was so woozy and thought it was left over sleep. She felt unwell all day. She had felt unwell today, but not as bad as yesterday. She had to get vaccination card out of hand bag and needs her glasses to read the small numbers. First dose was given on 04Feb2021. She had appointment on 25Feb2021 for second dose. Healthcare Provider who gave the vaccine was Hospital. They called her on the third at 5:00 PM to see if she could come the next day for the vaccine. They did a good job. Her brother was a retired anesthesiology and she called him this morning and he said to go to the hospital or testing center. Then he agreed that she should call Pfizer. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect were none. She did not get her flu shot in anticipation of getting the COVID vaccine. Her brother and his granddaughter were both anesthesiologist. They get work up about not being able to breathe and ventilators. They gave advice. She was glad her brother approved for her to call Pfizer to find out. She wanted to believe it was side effects. She had been on lock down. Her brother said she could have been exposed at the vaccine site. Caller stated everyone had on a mask. She was not obese. She was not sure if it is relevant, but she would tell it anyway. She fractured her skull 5 years ago and was in Hospital because it was bleeding. That had resolved. She was in ICU and then six weeks of acute rehab. She had a bad case of shingles two years ago which led to bleeding ulcers. Again she went to the hospital, but she was scoped they found ulcers and treated. She went back for scope again and it had all healed up". Outcome of the event have achy arm was recovering whereas other events was unknown.
84 2021-04-12 colitis developed a small Pulmonary embolism in Lung; Colitis; This is a spontaneous report from a non-conta... Read more
developed a small Pulmonary embolism in Lung; Colitis; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 84-year-old non pregnant patient female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9264 and expiration date was not reported), via unspecified route of administration in left arm on 11Mar2021 at 09:00, at single dose for COVID-19 immunization. The patient's medical history included Myeloma and concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201 and expiration date was not reported), via unspecified route of administration in right arm on 18Feb2021 at 09:30, at single dose for COVID-19 immunization. On 25Mar2021 at 09:30 AM patient developed a small Pulmonary embolism in Lung and Colitis, 10 days after second dose of Pfizer vaccine. The patient had received the treatment medication for the adverse event. The seriousness of the event considered as serious due to hospitalization of the patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and after vaccination was not tested for COVID-19. The outcome of the events small Pulmonary embolism in Lung and Colitis was recovering. Information on Lot/Batch number was available. Additional information has been requested
84 2021-04-12 diverticulitis Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the fir... Read more
Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the first dose; spinal nerve damage/Spinal nerve pain; Legs are burning hot now; Pain felt in calf and thigh; Bone density test/Ultra sound bad; This is a spontaneous report from a contactable consumer(patient). An 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 01Feb2021 11:30 (Batch/Lot Number: EN5318) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included angina from 2002 and ongoing, She says she has angina, and if she would have beating problems can she take a Nitro, cholesterol, depression from 2008 to an unknown date, blood pressure, anxiety from 2018 to an unknown date, arthritis from 1998 and ongoing Illness/AE: Arthritis Onset Date: 1998-2002 Stop Date: Ongoing , hypertension from 2002 and ongoing, blood cholesterol increased from 2002 and ongoing, ongoing urinary tract infection On and off, coronary artery disease from 2005 to an unknown date On and off, Family medical history included Mother coronary artery disease Died on 18Oct1967 and Father 1936 other. Concomitant medications included amlodipine taken for blood pressure abnormal from 2017 to an unspecified stop date; atorvastatin taken for blood cholesterol abnormal from 2002 to an unspecified stop date; bupropion taken for depression from 2008 to an unspecified stop date; buspirone taken for anxiety from 2008 to an unspecified stop date; carvedilol taken for blood pressure abnormal from 2002 to an unspecified stop date, 2x a day carvedilol 12.5. On an unspecified date, the patient experienced diverticulitis arteries, had a blood clot after ultrasound, sore arm/feel sore arms after the first dose, spinal nerve damage/spinal nerve pain, legs are burning hot now, pain felt in calf and thigh, bone density test/ultrasound bad. The patient underwent lab tests and procedures which included blood test: unknown results, computerized tomogram: diverticulitis arteries- On and off, investigation: unknown results. Comments: Going to pain clinic. On always, ultrasound scan: bad on Comments: Ultrasound bad, urine analysis: unknown results on comments: on and off. Treatment received for the events sore arm/feel sore arms after the first dose and spinal nerve damage/spinal nerve pain. Outcome of all events was unknown Follow-up (29Mar2021): This is a follow-up report combining information from duplicate reports 2021138557 and 2021162095. The current and all subsequent information will be reported under manufacturer report number 2021162095.
84 2021-04-14 decreased appetite Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented t... Read more
Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented to the ED for workup, diagnosed with a UTI and discharged home. The patient presented to the ED again on 4/11/2021 with ongoing altered mental status, tremors and anorexia. Family reports no improvement in patient's symptoms since onset (4/6/21). Patient now having difficulty finding words, shakiness on ambulation, hallucinations and tremors. Denies urinary symptoms, repeat urine culture was benign. Patient remains hospitalized as of this report (4/15/21) with fluctuating symptoms, Serial head CTs and lab studies also benign. Unclear etiology of symptoms.
84 2021-04-24 diarrhea Diarrhea; Exhaustion; This is a spontaneous report from a contactable consumer. A 84-year-old femal... Read more
Diarrhea; Exhaustion; This is a spontaneous report from a contactable consumer. A 84-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications was not reported. the patient had vaccine on 10Feb202 and had minor symptoms 2 days after the shot and then had total exhaustion for 3 days now and had diarrhea. The outcome of event diarrhea was not recovered, whereas outcome of event exhaustion was unknown. No follow-up attempts are possible. No further information is expected.
84 2021-04-24 vomiting, nausea Nauseous; laying down on couch, then on bed, sitting on toilet, had bowel movements.; Then VOMITING ... Read more
Nauseous; laying down on couch, then on bed, sitting on toilet, had bowel movements.; Then VOMITING started.14 times at HOME, 3 more times in ER.; This is a spontaneous report from a contactable nurse. A 84-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Exp6202), dose 1 intramuscular, administered in LEFT ARM ON 24FEB2021 AT 13:30 AS SINGLE DOSE FOR COVID-19 immunisation. Medical history included arthritis, sciatica, sinusitis, allergic sinusitis, surgery. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested prior and post vaccination. 25Feb2021 01:00 PM, she had nauseous, laying down on couch, then on bed, sitting on toilet, had bowel movements. then vomiting started. 14 times at home, 3 more times in ER. The event assessed as non-serious. Therapeutic measures of GI Cocktail with Lidocaine, Carafate. RX: Ondansetron HCL 4 MG were taken for all events. Outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
84 2021-04-26 decreased appetite Exactly 72 hours after Pfizer shot, pt had loss of appetite and severe fatigue (she barely had enoug... Read more
Exactly 72 hours after Pfizer shot, pt had loss of appetite and severe fatigue (she barely had enough energy to walk to her bathroom). She is slowly recovering; still experiencing loss of appetite and fatigue. Her son and doctor are not certain if the COVID vaccine caused these adverse effects.
84 2021-04-29 vomiting, nausea Vasovagal syncope, followed by nausea/vomiting, declined transport to ER
84 2021-05-05 abdominal pain, diarrhea symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hos... Read more
symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness
84 2021-05-12 abdominal discomfort I was having palpitations; the feeling was in upper part of stomach; I had difficulty breathing; The... Read more
I was having palpitations; the feeling was in upper part of stomach; I had difficulty breathing; The initial case was missing the following minimum criteria: No Adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Consumer (patient) A 84-years-old female patient (weight reported as '140' only) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (at the age of 84) as single dose for covid-19 immunisation; denosumab (PROLIA), via an unspecified route of administration from 2019 and ongoing, cyclic, twice a year for osteoporosis. Medical history included osteoporosis. The patient's concomitant medications were not reported. The patient experienced palpitations, the feeling was in upper part of stomach (not in heart), difficulty breathing, all on 07Feb2021 at 20:00. No treatment received or hospital admission required. By bedtime she was able to fall asleep and awoke in the morning on 08Feb2021 and was fine. The events outcome was recovered on 08Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
84 2021-05-12 vomiting, GERD tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; thr... Read more
tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; throwing up; loss of sleep; lightheaded and dizzy; She experienced soreness on her arm after the first shot; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 14:30 (Batch/Lot Number: EL9269) as 1st dose, single for covid-19 immunisation. Medical history included ongoing shingles (but got the shot anyway), ongoing acid reflux (been years and years and years ago, way back in 1990s or so maybe later than that), high blood pressure from 2001 and ongoing, dry eye, macular degeneration, CPO because she was a smoker, 4 bypass surgery, allergic to a blood pressure medicine, blood thinner therapy, and bad sinuses. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) taken for gastrooesophageal reflux disease, start and stop date were not reported; amlodipine taken for hypertension from 2001 and ongoing; albuterol sulfate taken for ex-tobacco user, pulmonary oedema, start and stop date were not reported; krill oil taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; aspirin taken for anticoagulant therapy, start and stop date were not reported; ciclosporin (RESTASIS) taken for dry eye, start and stop date were not reported. She experienced soreness on her arm after the first shot. Patient have acid reflux anyway and it seemed like it come up and it was worse than before, she was pretty sick last night on 15Mar2021 throwing up and still feeling pretty bad today from loss of sleep. Her nose was dripping and her head was all lightheaded, was dizzy and she was sick to her stomach. She sat in her recliner until about 3AM. Patient did not know if this was from the shot or what, but it was terrible. These things were not really ongoing on 16Mar2021, but she feels tired on 16Mar2021 from the loss of sleep on 15Mar2021. She took her antihistamine and her blood pressure pills and she was alright now, just tired from no rest. She reported that she was scheduled for her second dose of the product on 31Mar2021 at 150PM. Patient had blood work done at her last physical on 20Jan2020, and she reports that was all good. Outcome of the events was unknown.
84 2021-05-14 diarrhea, vomiting weakness, lightheaded, vomiting and diarrhea, cold, cough, fatigue, congestion or runny nose Imodiu... Read more
weakness, lightheaded, vomiting and diarrhea, cold, cough, fatigue, congestion or runny nose Imodium peppermint tea push fluid Zofran
84 2021-05-17 diarrhea Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This i... Read more
Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This is a spontaneous report from a contactable consumer (patient). A 84-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Feb2021 at 01:30 as 1st dose, single for COVID-19 immunization. The patient medical history included UTI and known allergies: Penicillin. The concomitant medication included fluoxetine, pravastatin and levothyroxine received in two weeks. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced feeling ill, tiredness, headache, muscle pain, chills, joint pain, confused and diarrhea. Body, headache and tiredness through to Sunday afternoon. On Monday, the patient was still feeling dizzy. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
84 2021-05-18 diarrhea 6 weeks after her second Pfizer vaccine, my mom was sitting at the kitchen table after eating breakf... Read more
6 weeks after her second Pfizer vaccine, my mom was sitting at the kitchen table after eating breakfast when she had a syncopal episode (she was unresponsive and lost consciousness for a few minutes). I called 911, and when the paramedics came, her blood pressure was very low and she was sweating heavily. She was very weak and couldn't stand up. She had a similar episode 10 days earlier while having a bowel movement (and also experience diarrhea at that time). She was taken to the ER and was admitted to the hospital for 2 days where testing was done.
84 2021-05-18 nausea she seems to have a cold with a runny nose; full of phlegm; Adds now she seems to have a cold with a... Read more
she seems to have a cold with a runny nose; full of phlegm; Adds now she seems to have a cold with a runny nose; feeling tired/she is tired; extreme chills and freezing; she cut her lip in two places from her teeth chattering; Uncontrollable shaking/worst part was the chills, almost like a seizure'; she had extreme chills and freezing for 3 hours starting when she went to bed.; She started to feel nausea later on Monday; stiff neck on the right side of the back of her neck the day after the vaccine; headachy; Adds hers were like a fast flu; she was so sick she had to get back in bed yesterday; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old female patient re-ceived first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247; Expiration Date: unknown), via an unspecified route of administration, administered in arm left on 21Jan2021 16:00 (at the age of 84-year-old) at a 1st dose, single for COVID-19 immuniza-tion. Medical history included thyroid disorder. No medical history (including any illness at time of vac-cination) was reported. None of the patient family medical history was reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. Concomitant medication includ-ed levothyroxine sodium (SYNTHROID) at a dose of 0.88 mg 1x/day (.088 mg; take once daily by mouth) via oral route of administration taken for thyroid disorder. Consumer states she received the Pfizer COVID 19 vaccine 21Jan2021 at 1600PM in the left arm. The effects didn't come until Tuesday night when she went to bed. The patient experienced worst part was the chills, almost like a seizure, headachy, she was so sick she had to get back in bed yesterday, hers were like a fast flu on an unspeci-fied date in Jan2021, she seemed to have a stiff neck on the right side of the back of her neck the day after the vaccine on 21Jan2021, she started to feel nausea later on Monday on 25Jan2021 and she had extreme chills and freezing for 3 hours starting when she went to bed on 26Jan2021. Adds she took two Advil, put on sweats and took a heating pad into bed then she was able to fall asleep. She cut her lip in two places from her teeth chattering and uncontrollable shaking Tuesday night on 26Jan2021. When she put the heavy clothes on and took that Advil the chills stopped, and she slept for four hours. she is tired on 27Jan2021, she seems to have a cold with a runny nose and full of phlegm on 28Jan2021. The patient received Advil as a treatment medication to the events extreme chills and freezing. The events were reported as non-serious. Outcome of the events she seems to have a cold with a runny nose, full of phlegm was not recovered; headachy, adds hers were like a fast flu, she seems to have a cold with a runny nose, worst part was the chills, almost like a seizure, she was so sick she had to get back in bed yesterday was unknown; she started to feel nausea later Monday, she cut her lip in two places from her teeth chattering, feeling tired/she is tired was recovering; stiff neck on the right side of the back of her neck the day after the vaccine was recovered on 25Jan2021, and re-maining other events extreme chills and freezing, she had extreme chills and freezing for 3 hours start-ing when she went to bed, uncontrollable shaking recovered on 26Jan2021. She was asking about getting the second dose considering her chills, Mentioned she talked to a few people who had the chills and were tired after the second dose but they were not as bad and every-thing was over in a day or so. Caller declined to report on anyone she knows who had chills and was tired after the vaccine. Adds she is scheduled to receive the next dose of the vaccine 10Feb2021. Adds it scares her a little bit because of the extreme chills. Follow-up attempts are completed. No further information is expected.
84 2021-06-09 decreased appetite blood pressure was 116/69, which was pretty low for her; last night when she had checked her blood p... Read more
blood pressure was 116/69, which was pretty low for her; last night when she had checked her blood pressure it was 180/90; she feels like she was hit by a truck; all she wanted to do was lay down and go to bed; she didn't feel good yesterday; walking really funny; didn't want to eat; had no interest in anything, like watching TV; all she wanted to do was lay down and go to bed; Joint pain; Muscle pain; her left shoulder really started to hurt; This is a spontaneous report from a contactable nurse(patient). A 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration, administered in arm left on 08Mar2021 10:30 as 1st dose, single dose for COVID-19 immunization. No prior Vaccinations within 4 weeks. Medical history included diagnosed with Congestive heart failure a couple of years ago(ongoing) and she had been taking several blood pressure medicines for Congestive heart failure and had a shoulder replacement in the past. Back in Sep2020 patient blood pressure was down to 40/30 and she could hardly hold head up and she had to go to the hospital and be admitted. The patient's concomitant medications were not reported. On 08Mar2021, the patient left shoulder really started to hurt in the night. and on 09Mar2021, patient was not feeling good and her pain got really bad (joint and muscle pain), she told herself that she had to get to bed. She said she was really hurting, clarifying she had both joint and muscle pain. Every time patient moved she was crying and screaming from the pain. Her blood pressure had dropped. Patient said she knows her blood pressure gets very high with pain. Patient blood pressure medications can drop her blood pressure too fast, and too low. The patient underwent lab tests and procedures which included blood pressure measurement: her blood pressure was dropped to 116/69 mmhg, which was pretty low for her. She said last night when she had checked her blood pressure it was 180/90 mmhg. Patient was walking really funny, and hoped she did not fall. She was not interested in eating and She had no interest in anything, like watching TV all she wanted to do was lay down and go to sleep. On 10Mar2021, She feels like she was hit by a truck. It was reported on 09Mar2021(last night), things got worse; events left shoulder really started to hurt, did not feel good, joint pain and muscle pain was worsened. Patient reported she did not have a headache. She had been laying on her couch the whole time. Therapeutic measures were taken with 2 Tylenol PM 500mg (1000mg total) last night(09Mar2021) and again this morning(10Mar2021) but it did not work. Relatedness of drug to reactions/events was reported. No Investigation Assessment. The outcome of the events Joint pain, muscle pain, left shoulder really started to hurt and she didn't feel good yesterday was not recovered and other events was unknown.; Sender's Comments: Based on the temporal relationship and the information provided, A possible contributory role of the suspect product to the development of shoulder pain,malaise, gait disturbance, myalgia, decreased appetite, decreased interest and arthralgia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
84 2021-06-09 profuse gastrointestinal bleeding Pneumonia, unspecified organism Acute lower GI bleeding
84 2021-06-23 decreased appetite ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrat... Read more
ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: ischemic stroke; infection
84 2021-06-28 difficulty swallowing Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flo... Read more
Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss of smell/taste. o Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss Issues Addressed/ Plan Diagnosis Plan 1. Viral upper respiratory tract infection (s/p covid 19 vaccine) predniSONE 20 MG Oral tablet albuterol (PROVENTIL HFA) 90 mcg/actuation Inhl inhaler (afebrile) Counseled on supportive measures Has declined covid 19 test Informed: if conditions worsens: present to ED (immediatetly) 3/25 pt's son in the room, updated and answered all questions at this time. 4/2 Pt's husband also inpatient and covid+. Spoke with daughter today and updated r/t quarantine. 2. Nursing Education/Concerns: Care team met with family (husband, son and daughter) on 3/18/21 to discuss care goals/plan of care moving forward. Pt's code status officially updated to DNR only with trial intubation. 3/18/2021 spoke updated pts daughter on phone at 1031. Report given to SNF- they were made aware that she needs the second pfizer vaccine 3. Interdisciplinary involvement Social Work/Case Management: From home with spouse. STR- Referral out. STR reviewing. Will not take patient before her 10 day exposure quarantine is over. 4/9. STR- Bed offer for tomorrow pending insurance auth and negative COVID. sent for auth. Patient aware. Son updated. COVID exposure - exposure to covid positive visitor on 3/26 and 3/29 - discussed with infection control. Will test on 3/31 and if negative will test again on 4/7 (day 9 of quarantine) unless symptoms develop in interm. Acute hypoxic respiratory failure secondary to acute on chronic systolic LV failure requiring prolonged ventilation and SNF placement after discharge. Encephalopathy, dysphagia, anemia, tachy, AKI
84 2021-06-29 diarrhea Diarrhea; Patient received 1st dose on 02Feb2021, and received second dose on 12Feb2021; Patient rec... Read more
Diarrhea; Patient received 1st dose on 02Feb2021, and received second dose on 12Feb2021; Patient received 1st dose on 02Feb2021, and received second dose on 12Feb2021; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A 84-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 10:15 (at a age of 84-year-old) as dose 2 single for covid-19 immunisation. Patient received 1st dose BNT162B2 on 02Feb2021 at 12 in right arm with lot number EC-3249 for covid-19 immunization. Patient did not received other vaccines in four weeks. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. The patient medical history was not reported. Patient was not aware of allergies. Concomitant medications included Losartan, Pravastatin and Multivitamin. The patient experienced diarrhea on 13Feb2021 at 02:00 AM. Patient received treatment with dicyclomine. The outcome of event was not recovered. Outcoem of other events were unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.
84 2021-07-17 diarrhea Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued... Read more
Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued; Chills; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and had abatacept (ORENCIA) infusion monthly. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alendronate sodium (FOSAMAX) and levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 23Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The clinical outcomes of the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
85 2021-01-03 diarrhea Low grade fever, Diarrhea
85 2021-01-04 diarrhea DEVELOPED DIARRHEA THE DAY AFTER INJECTION.
85 2021-01-10 nausea soreness in chest fever chills slight nausea body aches
85 2021-01-10 vomiting s/p vaccine-15-20 mins patient was having shortness of breath- gargling- unresponsive for 1 min. no ... Read more
s/p vaccine-15-20 mins patient was having shortness of breath- gargling- unresponsive for 1 min. no cpr done. no epi given, regained response in 1 mins- had vomitting after wards. vitals normal and WNL
85 2021-01-11 abdominal pain upper Resident was monitored for 20 min period post vaccine and had no complaints until the 20 minute peri... Read more
Resident was monitored for 20 min period post vaccine and had no complaints until the 20 minute period had just finished and she had a sudden onset of abdominal pain/epigastric pain that last about 45-60 minutes. She was unable to eat anything and needed to be helped back into bed. Her vital signs were stable (blood pressure slightly elevated) and she has had no complaints or issues since. I do not believe the resident had a bowel movement to coincide with her pain.
85 2021-01-15 diarrhea Resident reported loose stool, not feeling well, resident complaint of lost taste. Hospitalization o... Read more
Resident reported loose stool, not feeling well, resident complaint of lost taste. Hospitalization on 01/14/2020.
85 2021-01-17 nausea AFTER TAKING VACCINE AND WHILE SITTING IN WAITING AREA PATIENT BEGAN TO FEEL QUEEZY AND HEAD HEAVY F... Read more
AFTER TAKING VACCINE AND WHILE SITTING IN WAITING AREA PATIENT BEGAN TO FEEL QUEEZY AND HEAD HEAVY FEELING. THE PATIENT WAS ACCOMPANIED BY OTHER FAMILY MEMBERS. VILAT SIGNS WERE TAKEN AT TWO DIFFERENT TIME OVER A PERIOD OF 30 MINUTES AND WERE NORMAL. PATIENT DID STATE THAT SHE TOOK BENADRYL BEFORE TAKING THE VACCINE. BECAUSE THE PATIENT WAS FEELING BETTER SHE DID NOT WANT TO BE TRANSPORTED TO THE HOSPITAL AND SIGNED AN RMA. WE ASKED FOR A PHONE CALL WHEN THEY ARRIVE HIME AND AT 12:04 AM WE RECEIVED A PHONE CALL THAT EVERYONE WAS HOME SAFELY AND SHE WAS FEEKING OK.
85 2021-01-21 abdominal pain Generalized joint pain, abdominal cramping without nausea or diarrhea. Lasted 12 hours. Took 2 doses... Read more
Generalized joint pain, abdominal cramping without nausea or diarrhea. Lasted 12 hours. Took 2 doses of Tylenol .
85 2021-01-25 decreased appetite Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking de... Read more
Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination.
85 2021-01-27 vomiting Vomiting
85 2021-01-31 abdominal pain, nausea, vomiting Pfizer-BioNTech COVID-19 Vaccine EUA? Presents to the emergency department with syncope. Patient re... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA? Presents to the emergency department with syncope. Patient received her 1st dose of the COVID-19 1/28/21. She states she felt in her normal state of health yesterday. However, she was unable to sleep at all overnight. She took a nap between 5 a.m. and 9 a.m., Upon waking this morning, patient states she felt generally fatigued, had nausea with associated diffuse abdominal pain. Patient had 1 episode of emesis. No hematemesis. Immediately following emesis, she describes 1 to 2 episodes of syncope that occurred while she was seated in a chair. Patient did not fall or strike her head. She denies preceding chest pain, shortness of breath, back pain, numbness, tingling, weakness. Per EMS, patient was awake, somnolent but oriented, with stable vital signs including heart rate of 68, respiratory rate of 18, pulse ox of 90% on room air and blood pressure of 126 systolic. On arrival to the ED, patient appears somnolent, hemodynamically stable with normal blood pressure, afebrile. Patient feels symptomatically improved after 1 L normal saline bolus and Zofran. She was discharged home in stable condition.
85 2021-02-05 retching, nausea Severe gut wrenching nausea and dry heaves, fever, chills;Fatigue Very severe for eight hours and co... Read more
Severe gut wrenching nausea and dry heaves, fever, chills;Fatigue Very severe for eight hours and continuing with fatigue for 24 hours. Also head headache
85 2021-02-06 abdominal pain upper Next day after getting the shot, I had sore muscles & became very sick at stomah for half day
85 2021-02-06 decreased appetite Patient with failure to thrive symptoms prior to 2nd dose, not eating, not taking medications.
85 2021-02-07 diarrhea I didn't sleep well night of Feb. 7, got up three times to pee. I got up finally Feb. 8 at 6:30 an... Read more
I didn't sleep well night of Feb. 7, got up three times to pee. I got up finally Feb. 8 at 6:30 and tried to stand but was too dizzy. Finally I was able to get to the bathroom, where I had diarrhea. I managed to make and eat breakfast, but was on and off dizzy, one more diarrhea episode. Took my blood pressure around 10:45, not too high, but heart rate low: 45bpm. I was ready to drive to the woods and take a walk, no further problem.
85 2021-02-08 decreased appetite I had all the symptoms I had when I was coming down with the disease. Cough, fatigue, headache, nec... Read more
I had all the symptoms I had when I was coming down with the disease. Cough, fatigue, headache, neck & shoulder aches, no appetite, blah feeling lasting 3 days
85 2021-02-09 nausea Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who... Read more
Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). .
85 2021-02-14 vomiting Appears to have had a vasovagal response, vomiting and syncope approx. 7pm same day of 2 vaccine.... Read more
Appears to have had a vasovagal response, vomiting and syncope approx. 7pm same day of 2 vaccine. Hit head causing head injury.
85 2021-02-15 vomiting, decreased appetite, nausea, diarrhea Nausea, Throwing up, Chills, fever, Happened on days 1-5 after vaccine. Diarehia, cramps..painful ... Read more
Nausea, Throwing up, Chills, fever, Happened on days 1-5 after vaccine. Diarehia, cramps..painful to rib cage & Pelvis, Bone pain, cannot walk, loss of appetite & loss of balance I feel now!
85 2021-02-16 nausea, vomiting, diarrhea severe nausea, chills diarehha, throwing up
85 2021-02-22 vomiting, nausea, abdominal pain upper 1st Dose vaccine 1/29/21; Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA, d/c'd home. ; 2nd dos... Read more
1st Dose vaccine 1/29/21; Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA, d/c'd home. ; 2nd dose vaccine 2/19/21; seen in ED 2/22/21 for SOA, congestion, N/V, and Left flank pain x 3 days; admitted to hospital from ED 2/22/21 Dx: 1. Epigastric pain R10.13 789.06 2. Elevated brain natriuretic peptide (BNP) level R79.89 790.99 3. Dyspnea, unspecified type R06.00 786.09 4. Abnormal CT of the abdomen R93.5 793.6 5. Hypomagnesemia E83.42 275.2 6. Hypokalemia E87.6 276.8 Currently still admitted to hospital at time of this report.
85 2021-02-23 nausea, vomiting I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was fre... Read more
I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was freezing. I had a chill. I checked my temperature and it was around 99-100. During the night I woke up with a bad chill, I was really cold and I was shaking really bad. I checked my temperature and it was 102. Tuesday I checked my temperature all day it never went over 102. I took Ibuprofen all the day, no more then 4 tablets. I took a nap in the afternoon for about 2 hours and I when I woke up I was really cold and I was freezing and shaking. I was so cold my teeth were chattering. My mouth was very dry, I tried to drank a sip of water, which made me nauseous and I throw up slightly. My husband was concerned because he couldn't get me warm and he called our son. Our son came over, and asked do I know who he is and I responded no. I have reconciliation of my son coming over or my husband calling our son over to come check on me. My son immediately to called 911, EMS arrived and they transported me to hospital. I do not remember any of this, I didn't become appear until I was stretcher , at that point I became aware and knew the answers to the questions being asked but I couldn't respond. I remember hearing the EMT say to turn the air on, I was burning up and had a temperature of 105. I was transported to Medical Center. They run a lot of tests and they were trying to get my fever down. Sometime late that night they were finally able to my temperature down. I was released about 10 AM on Wednesday morning. I have been fine since then. The doctors who all seen me in the ER all said they have not seen anything like this.
85 2021-02-24 nausea "Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe def... Read more
"Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.
85 2021-02-25 nausea, abdominal distension o Chief Complaint Pt is an 85 y/o female presenting to the ED by squad with c/o nausea, body aches, ... Read more
o Chief Complaint Pt is an 85 y/o female presenting to the ED by squad with c/o nausea, body aches, and feeling bloated s/p receiving her first COVID-19 vaccine shot yesterday. Pt states that she felt fine up until last night. Pt denies HA, dizziness, lightheadedness, CP, SOB, cough, V/D, abd pain, urinary complaints, fevers, chills, or rashes. PMHx includes COVID-19 pneumonia in December.
85 2021-02-25 nausea Developed 101.1 fever starting 12 hours after injection. Went from 99.9 at first onset. Next day gre... Read more
Developed 101.1 fever starting 12 hours after injection. Went from 99.9 at first onset. Next day grew to 101.1 degrees. Finally fever broke in early morning hours after 1-1/2 days of feeling ill. Stayed hydrated with 7-up and water every hour or so, no food. Slight bit of nausea. Normal temperature is 97.6. Some aches in neck area, slight hurt at injection site.
85 2021-02-28 nausea, diarrhea, vomiting 1351: Complaint of nausea, diarrhea and not feeling well. Patient vomited yellowish phlegm. Patient ... Read more
1351: Complaint of nausea, diarrhea and not feeling well. Patient vomited yellowish phlegm. Patient denied dizziness, shortness of breath, pain and difficulty breathing. Patient alert and oriented x 3. Vitals T 97.2, O2 96%, P 86, BP 160/78, R 22. 1420: Vitals T 98.6, O2 97%, P 80, BP 120/62, R 20. Patient discharged from clinic.
85 2021-03-03 abdominal discomfort dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a con... Read more
dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the right arm, on 01Feb2021 at a single dose for COVID-19 immunization. The first dose was received on 11Jan2021 (lot number: EL0142) Medical history included GERD. Concomitant medication included pantoprazole and other unspecified product. Patient got the first shot of the COVID vaccine three weeks ago, and she didn't know anything had happened to her. She got the second dose of the vaccine yesterday at noon, and she was fine, although she didn't sleep very well on 01Feb2021. But the morning of 02Feb2020, she went in the kitchen and dropped some blueberries because the plastic boxes don't close easily, and she bent over to pick the blueberries up and she got dizzy. She did not know why she should get suddenly dizzy, and her stomach seemed a little upset, but she has no fever on 02Feb2021. Patient was just wondering if the dizziness is a side effect of the vaccine. Patient had no other vaccines on the same day as the COVID vaccine and stated when she had the incident where she bent over and was dizzy, it felt just really terrible, but she was feeling fine now, but the incident did shake her up a bit. Outcome of the events was unknown.
85 2021-03-17 anal incontinence, vomiting, diarrhea 02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2... Read more
02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x; fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited
85 2021-03-17 difficulty swallowing hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; ... Read more
hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; This is a spontaneous report from a contactable consumer (patient's daughter) received via Medical Information Team. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 04Feb2021 (at the age of 85 years) at single dose for COVID-19 immunisation. The patient medical history included allergic to different medications. The patient's concomitant medications were not reported. It was reported that on 04Feb2021, the patient an hour after the vaccine developed a hoarse voice and two hours later felt like she had a big lump in her throat and had difficulty swallowing, their healthcare provider said he didn't believe it was an allergic reaction and was leaving it up to her if she wants to get it or not. The reporter stated her mother is allergic to different medications and those allergic reactions started the same way this did. The patient outcome of the events was unknown.
85 2021-03-18 nausea Mild mental queasiness with several hours of sustained blood pressure elevation during a severe chil... Read more
Mild mental queasiness with several hours of sustained blood pressure elevation during a severe chilling of extremeties requiring flannel pajamas & robe, wool socks, down comfort and topped by electric blanket for 2 hours. Transient, mild temperature elevation (2 degrees). This event occurred 3/18/21 (26 days after dose#2.).
85 2021-03-23 decreased appetite Extreme Exhaustion followng day - could not left head from pillow - did not eat for 3 days - appitie... Read more
Extreme Exhaustion followng day - could not left head from pillow - did not eat for 3 days - appitiete has returned - But am left with deep fatigue for over 2 weeks - Friday, March 26th will be 3 weeks - leg still week - fatigue - is this normal what can I do - Too weak to drive to see doctor - Last week he said - do what you can and take Tylenol - First dose same reaction for 2 weeks - but was fine for second dose - Now I am going into 3 weeks with fatigue. Is this normal - I did have the virus in April - had antibodies but did not have this reaction after. Please will this cease? Acknowledge ASAP
85 2021-03-23 nausea Pt reports that 48 hours after the inital vaccine she developed headache, chills, nausea, heart palp... Read more
Pt reports that 48 hours after the inital vaccine she developed headache, chills, nausea, heart palpitations. Had blood work completed by her primary provider and was dicovered to have a significantly high WBC. Was admitted to hospital with diagnosis of UTI and started on IV antibiotics. Provider directed client not to get booster.
85 2021-03-24 vomiting Patient's daughter reports that ever since patient received the vaccine she has been intermittently ... Read more
Patient's daughter reports that ever since patient received the vaccine she has been intermittently ill. She has experienced general malaise and vomiting for a few days, then recovers, then gets ill again. The cycle has repeated about 3 times since her vaccination. Advised patient to make an appointment with her doctor to rule out any other contributing causes.
85 2021-03-25 nausea Patient monitored for reaction as recommended per ACIP guidelines after vaccine administration. Pt r... Read more
Patient monitored for reaction as recommended per ACIP guidelines after vaccine administration. Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). Electronically Signed by RN on 02/10/21, 1707
85 2021-03-25 vomiting, diarrhea hospitalization day after vaccine. fever/vomiting/diarrhea/weakness/dizziness
85 2021-03-30 nausea Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spo... Read more
Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 29Jan2021 as single dose for prophylaxis, COVID-19 immunization. the patient does not received other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported but other relevant medical history including but not limited to these conditions: Diagnosed allergies, compromised immune status, Respiratory illness, Genetic Chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity from unknown. The concomitant medications were not reported. On 04Feb2021 08:00 patient experienced (at the age 0f 86-years-old time of onset reaction or event occurred) very tired (fatigue), nauseous (nausea), slight cramp in left thigh or leg (muscle spams) and tiredness and feeling unwell (malaise). Received call from consumer regarding the Pfizer COVID vaccine. She was called on behalf of someone else. They received their first vaccination on 29Jan2021, and on page 3, she was reading the side effects. Patient reports being very tired today. She also felt nauseous and had a cramp in her leg that disappeared almost as quick as it came. The outcome of the events was recovering. Information on the Lot/batch number has been requested.
85 2021-04-02 vomiting, nausea This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 85-... Read more
This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm on 28Jan2021 08:15 (at the age of 85-years-old) at a single dose for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications included mirtazapine (manufacturer unknown), montelukast (manufacturer unknown); and atorvastatin (manufacturer unknown) all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced nausea and vomiting on 28Jan2021 12:15 and the whole evening. Patient was okay in the morning. Events were assessed as non-serious. Treatment was not received for the events. The outcome of events reported was recovered on 29Jan2021. Information on the lot/batch number has been requested.
85 2021-04-05 vomiting, nausea About 8 hours after shot #2, started having headache and nausea. Was hard to think clearly. Was al... Read more
About 8 hours after shot #2, started having headache and nausea. Was hard to think clearly. Was already having back pain which contributed to poor feeling. On 3/23/21 began to have vomiting, and felt very poorly on 3/24/21, then was hospitalized with vomiting and hyponatremia on 3/25/21. (Note, had bounce-back admission on 3/31/21 for 2 more nights for fluid overload.)
85 2021-04-09 vomiting My sugar have been crazy/my blood sugar is continually 195 to 240, well the worst was 294; vomited t... Read more
My sugar have been crazy/my blood sugar is continually 195 to 240, well the worst was 294; vomited twice/threw-up; exhausted; shivering; malaise/I didn't feel well; I threw-up; I did not need eat the rest of the day; Hard of hearing; This is a spontaneous report received from a contactable nurse (patient herself). An 85-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL1283) via an unspecified route of administration in the right arm on 04Feb2021 at 18:30 (at the age of 85-year-old) as single dose for COVID-19 immunization and Insulin via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history included Diabetic, Cardiac, unstable gait, hypothyroid and Known allergies: PCN (penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and furosemide. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 14Jan2021 at 18:45 for COVID-19 immunization. On 05Feb2021 at 9:30, the patient experienced shivering, malaise, vomited twice and exhausted. On 06Feb2021 patient was reported that her sugar has been crazy, she has hardly even eating because she doesn't feel well; her blood sugar is continually 195 to 240, well the worst was 294, that's not me usually my high at night is 166 or 157, she threw-up; she did not need eat the rest of the day, she doesn't feel comfortable this way; yesterday she didn't feel well the day before she didn't feel well and hard of hearing. Patient stated that "on the 5th the next day she did not feel well, she ate almost a soft-boiled egg in the morning with a slice of toast and she threw that up and she did not need eat the rest of the day and her blood sugar went up to 294 which she never had that high." Patient reported as "that night (07Feb2021), when she went to the bed 3 or 4 hours after she ate it was 294. She took 15 units of insulin and in the morning, it was 137 which is unusually high for her. That night it was 230 before she went to bed the next morning after 15 units of insulin it was 195 in the morning 7:53 in the morning and then at 9:50 last night she went to bed early it was 240 this morning after 17 units of went insulin it was 198. She checked it contour and it was 211. The patient did not receive any treatment for the events. Action taken for the insulin with respect to the events was unknown. The clinical outcome of the events shivering, exhausted was recovering, malaise, vomited twice, blood sugar abnormal, did not need eat the rest of the day was not recovered and hard of hearing was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Blood glucose abnormal and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including fasting plasma glucose at baseline, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
85 2021-04-14 vomiting Patient presents with a potential reaction to the COVID19 vaccine. I was summoned to the patient's c... Read more
Patient presents with a potential reaction to the COVID19 vaccine. I was summoned to the patient's car by staff. The patient was a passenger in her car. She was found to be responsive but slumped, and lethargic. She is both demented and also non-English speaking. The daughter functioned as a historian and interpreter. She reported the patient was not feeling well on the way to the vaccine and that the drive from home was long. Just prior to the vaccine, the patient had emesis in the vehicle. The vaccine was given. The patient entered the monitoring area and started to report chest tightness. Unfortunately, she was not able to give much more of history at the time of the interview. EMS was summoned and the vehicle was moved to the monitoring area adjacent to the EMS post. The daughter reported that the patient has had a "small heart attack" within the past few months, for which she was hospitalized.
85 2021-04-17 nausea 1st shot, she experienced nausea and pain; 1st shot, she experienced nausea and pain; This is a spon... Read more
1st shot, she experienced nausea and pain; 1st shot, she experienced nausea and pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. An 85-year-old female patient received first dose of bnt162b2, Solution for injection (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced nausea and pain. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
85 2021-04-23 abdominal pain upper Chills; Not feeling good at all; Achiness; Back pain; Stomach cramps; Felt terrible; It was a slight... Read more
Chills; Not feeling good at all; Achiness; Back pain; Stomach cramps; Felt terrible; It was a slight fever 99; cannot sleep; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetic. Concomitant medications were reported but was unspecified (patient stated that she have too many of them). The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 for covid-19 immunisation (85 years old). The patient experienced chills on 10Feb2021 22:00, not feeling good at all, achiness, back pain, stomach cramps, felt terrible, it was a slight fever 99 and cannot sleep on 10Feb2021. The patient underwent lab tests and procedures which included blood work: have a lot of blood work. Every 6 months she had to have my blood taken. Because of the pandemic she have not been going to doctor and body temperature: it was a slight fever 99 on an unspecified date. Therapeutic measures were taken as a result of fever included Tylenol. Outcome of the events was recovering. Information on the lot/batch number has been requested.
85 2021-04-23 nausea chills; Fatigue; Some shortness of breath; Very slight headache; slight nausea; This is a spontaneou... Read more
chills; Fatigue; Some shortness of breath; Very slight headache; slight nausea; This is a spontaneous report received from a contactable consumer. This 85-year-old female consumer (patient) reported in response to Non-HCP letter sent in cross reference case. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EN6203, Expiration date not reported) via intramuscular route on upper Left arm on 24Feb2021 at 07:15 A.M single dose for COVID-19 immunisation. Patients medical history included Pain, swelling in left wrist from 15Nov2020 (ongoing, doctor suggested wrist brace and ibuprofen when needed) and on 15Feb2021, the patient had Pain still in wrist (ongoing, was given injection of 40mg, Kenalog eased pain immediate). Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EL9264) via intramuscular route on upper Left arm on 03Feb2021 at 09:40 A.M as single dose for Covid-19 immunization and experienced pain in wrist. The patient's concomitant medications were not reported. Patient experienced in reaction to vaccine was chills, fatigue, some shortness of breath, very slight headache, slight nausea on unspecified date. Outcome of event was reported was reported as unknown. Follow-up (15Mar2021): The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (15Mar2021), this case now contains all required information to be considered valid.
85 2021-04-24 nausea Fever; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient's ... Read more
Fever; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient's husband). An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 17Feb2021 (lot number: EM9810; expiry date: unknown), at a single dose, for COVID -19 immunisation. The patient has no relevant medical history and was not taking concomitant medications. The patient previously received first dose of BNT162B2 for COVID-19 immunisation. Patient's husband reported that his wife had a reaction to second COVID shot. On 18Feb2021, the patient experienced fever, nausea and was extremely tired. The patient did not receive treatment for the events. Outcome of the events was not recovered.
85 2021-04-27 nausea patient had some nausea, headache after receiving 2nd shot.
85 2021-04-29 decreased appetite After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoi... Read more
After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoing; Little appetite, lethargy, no energy, in bed sleeping 18 plus hours out of a 24 hour period, continued until the morning of March 13, unremarkable symptoms from March 14 thru March 22, March 23 in home nurse recommended she see a cardiologist, March 24th rushed to the hospital short of breath with irregular heartbeat; released from hospital 24 hours later -could not determine cause; 1.5 days later second visit to emergency room with the same symptoms; release from hospital 2 days laters; saw cardiologist, symptoms have persisted and progressed, currently only able to take 1/2 to 1/4 short breathes; about 15 minuets per 24 hour period will full breath capacity; 3+ pillow orthopnea: sitting up at 45 angle in order to sleep, any lower angle cannot breathe; symptoms ongoing and worsening, cause unknown
85 2021-04-30 decreased appetite, nausea like she has been wanting to throw up/nausea, whenever she felt like throwing up; may be a stomach f... Read more
like she has been wanting to throw up/nausea, whenever she felt like throwing up; may be a stomach flu; weakness; has been feeling unwell; loss of appetite; she has been feeling shaky/nervousness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8733; expiration date: 31Jul2021), via an unspecified route of administration, administered in left arm on 25Mar2021 04:00 as single dose for covid-19 immunisation. Medical history included high blood pressure, and allergies to dust, grass, and loud smells like perfume, a lot of smells. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 on 04Mar2021 for covid-19 immunisation. She had her second dose on 25Mar2021 and had no symptoms until 20Apr2021. On 20Apr2021, she first went to urgent care because of her no appetite and they didn't do anything so then she went to the emergency room on 21Apr2021 because she tried to throw up. They gave her fluids but did not know the name of it, just that it took about 1 to 1 and a half hours. They took her blood and took her urine and did a chest x-ray. She did not have blood taken at the hospital emergency room but did have her urine taken and a chest x-ray and they didn't find nothing wrong with her. They stated it may be a stomach flu and she went home. She reported she had side effects and didn't know if it was supposed to happen. On 20Apr2021, she also had nervousness, and had no appetite, and was feeling shaky, weakness and has been feeling unwell. She has never had nothing like this and overall she has been in good condition. She stated that the side effects do not happen everyday and she tried to drink a lot of fluids and electrolytes, water and Gatorade and lays down in bed. She tried a little oatmeal but didn't have a taste for it so she ate a little soup, a noodle soup. She reported that she did not have an appetite this morning (as reported) but she did eat some soup and a lot of crackers. She was feeling good until this sickness. Her daughter stated she shouldn't have gotten the shots. She stated that maybe something was wrong, and she never had this before. Her primary prescribed Famotidine, one tablet a day 20mg, by mouth. She stated she just started taking the other day. It's for 14 days. She has 10 left, so she's been taking for 4 days. She was also prescribed Ondansetron at the hospital for nausea, whenever she felt like throwing up. She stated she does not like it and stated you put it on top of your tongue and don't drink water or eat with it. It was 1 tablet every 8 hours as needed. She reported that she was about 4'10" in height and she had shrunk because she used to be 5' height. She followed up with her healthcare provider on 04Apr2021 (as reported), who prescribed her something for acid reflux and she stated acid reflux wasn't it. The events loss of appetite and throwing up required a visit to emergency room. The patient had no previous immunization with Pfizer vaccines and no additional vaccines administered on the same date of the vaccine. There were no prior vaccinations within 4 weeks. Outcome of event may be a stomach flu was unknown; outcome of the rest of events was unknown. No follow-up attempts are needed. No further information is expected.
85 2021-05-13 vomiting, nausea Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HP... Read more
Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HPI, given patient's AMS. Daughter reports that she went over to see her mom at approximately 930 this morning and found her alert and oriented x3 with complaints of nausea, congestion and cough s/p her second COVID-19 vaccination, which she received yesterday. Daughter reports that at approximately noon, her mom had an episode of emesis, with her arms clenching up and shaking for approximately a minute, for which she called EMS. Daughter reports that her mom has been lethargic with AMS s/p episode. Daughter reports her mother has never had seizure activity before, but she has had several previous TIAs. She denies any recent injury, fall or medication changes. Patient lethargic with AMS noted, unable to follow simple commands, does tell me her first name with several prompts. PATIENT REMAINS HOSPITALIZED AT THE TIME OF THIS REPORT.
85 2021-05-18 indigestion I am chair bound right now, I am recovering from Covid; I am chair bound right now, I am recovering ... Read more
I am chair bound right now, I am recovering from Covid; I am chair bound right now, I am recovering from Covid; heart burns; arm swelled around the injection site; Arm swelled around the injection site and it hurts and burns; her arm swelled around the injection site and it was all red; arm day swell up all around the injection site and it was still hard; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration administered in Arm on 19Feb2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number EL3248, expiration date unknown), via an unspecified route of administration as single dose for covid-19 immunization 29Jan2021 and stated that she did not have a reaction after the first dose of the vaccine and she only had a slight rise of temperature after the first dose. The caller stated that after receiving the second dose of vaccine on Friday and on the next day on 20Feb2021 her arm swelled around the injection site and stated that it hurts, it burns, and it was all red and mentioned that it was still hard and red and painful, and she been putting ice on it, but it still was red, hard and it did not seem to have helped. On an unspecified date, she was also experiencing heart burns and further stated that she was chair bound right now and was recovering from Covid (considered as covid-19 and drug ineffective). Patient stated that blood work has not yet been ordered and they are going to come to her house to do it in her house, but they have not come yet. The outcome of events drug ineffective and COVID-19 was recovering, and outcome of the other events were unknown. Information about batch/lot number has been requested.
85 2021-05-27 nausea, vomiting Hospitalization due to nausea and vomiting
85 2021-05-30 vomiting 5/24/21 - feeling tired, vomiting 5/25/21 - speech impaired
85 2021-06-06 diarrhea felt terrible, had covid, diarrhea, tired
85 2021-06-08 diarrhea Transient diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reportin... Read more
Transient diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 85-years-old female (not pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no and expiration date was not reported), via unspecified route of administration in left arm on 09Mar2021 at 12:30 as 1st dose, single for COVID-19 immunization (at the age of 85-years). Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced drug hypersensitivity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. On 10Mar2021 at 10:00, the patient experienced transient diarrhea. The patient did not receive any treatment for the events. The clinical outcome for the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
85 2021-07-08 loss of appetite Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, ... Read more
Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.
86 2021-01-10 nausea DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUS... Read more
DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUSEA, AND MALAISE. SYMPTOMS RESOLVED IN 1 HOUR.
86 2021-01-17 nausea Within minutes of injection Mom started getting nauseous. When she stood to leave she was very ligh... Read more
Within minutes of injection Mom started getting nauseous. When she stood to leave she was very light headed. The nausea lasted about 3 hours, the lightheadness lasted all day, diminishing as the day went on, but still a problem at bed time. She did sleep a lot that day. When she awoke the following day, symptoms had abated.
86 2021-01-18 nausea, abdominal pain upper She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine,... Read more
She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16, she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)
86 2021-01-21 vomiting, nausea, abdominal discomfort Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she cont... Read more
Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she continued with GI upset, fever, and body aches. Toward the afternoon with Tylenol she appeared to be feeling better. At around 6pm she had sudden onset shortness of breath and respiratory distress. Nebulizer was given without improvement, O2 sats were in the 70's and 80's. Tenant was transported to the hospital via ambulance
86 2021-01-23 decreased appetite FEVER -101.5 FALL MUSCLE WEAKNESS BODY ACHES RHINITIS POOR APPETITE
86 2021-01-24 vomiting throwing up; Sweating; Lightheaded; the patient can barely speak to her/she just whispered it; This ... Read more
throwing up; Sweating; Lightheaded; the patient can barely speak to her/she just whispered it; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC9231, expiry date Apr2021), intramuscular in the left arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 13Apr2020 and she got a plasma donation, in Apr2020 because she was not in good shape when she had COVID. There were no concomitant medications. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The reporter said that the patient's doctor told her to still get the COVID vaccine and on 10Jan2021, she had been throwing up, sweating, and lightheaded and these were the side effects with the second dose. The caller stated that no one else had side effects like these. It was reported that the patient had no other family and the reporter felt really bad for the patient and wanted to get her some sort of information. The patient said that she was feeling a little better than she did last night, but she was laying in bed. The patient's symptoms started yesterday 10Jan2021, the next day after receiving the vaccine. The reporter said that the patient can barely speak to her. She said that the patient said that she was feeling a little better, but she just whispered it. The reporter asked if it was because the patient had antibodies. Clinical outcome of the events was unknown.
86 2021-01-25 diarrhea Itchiness and redness to site. Seeing "spots in front of eyes". Diarrhea
86 2021-01-27 diarrhea, loss of appetite Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COV... Read more
Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COVID-19 by rapid testing on 1/21/21, with c/o hurting all over and loose stools. She became non-verbal on 1/23/21 with poor intake. On 1/24/21 at 0537 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.
86 2021-02-02 decreased appetite Congestive cough; Weakness; didn't have an appetite; legs felt stiff, or almost frozen; Severe muscl... Read more
Congestive cough; Weakness; didn't have an appetite; legs felt stiff, or almost frozen; Severe muscle weakness/extreme weakness was only in her mother's lower body; tremendous fatigue/Tiredness; Couldn't walk; This is a spontaneous report from contactable consumers. An 86-year-old female patient (mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) for years; COVID-19 Virus from 23Apr2020 to an unknown date, patient was not on a vent or in the ICU but did receive plasma as part of her COVID-19 Virus treatment; ongoing cough. Caller's grandmother had Multiple Sclerosis. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine dose, and had significant side effects. Patient weight was 175 lbs as provided by caller, who stated her mother recently moved into an independent living facility, and gained weight because the facility has a really good pastry chef. Patient height, reported her mother shrunk, and was 5'5-1/2". Reported her mother couldn't walk after receiving the first dose. She said her mother was not able to walk the next morning, 13Jan2021. The caller stated she had to spend 3 days with her mother, after her mother received her first COVID-19 Vaccine dose on 12Jan2021. Reported she thought initially what her mother was experiencing was either neurological or muscular. She said it was like her mother's brain wanted her to move, but her mother's legs wouldn't move. She said her mother needed to use a walker and have someone hold her from behind. She said now, at a week later, her mother still was not back to normal. She clarified her mother needed a walker to maneuver around, but didn't need someone holding her from behind. Reported she assumed her mother may have had tiredness, weakness, severe muscle weakness from receiving the first COVID-19 Vaccine dose. She clarified if her mother wasn't able to walk after receiving the first COVID-19 Vaccine dose, then what her mother had was the epitome of weakness, and the weakness was only in her mother's lower body. She said her mother had tremendous fatigue on days 2, 3, and 4 after receiving the first dose. She said her mother was able to function as of 19Jan2021, but her mother couldn't keep her eyes open during that time period. Reported her mother developed a congestive cough. She said her mother's cough was not continual, but persisting. She stated her mother said the cough was there before she had her first dose of the COVID-19 Vaccine. The caller stated she disagreed with her mother. She said her mother has COPD, but her mother was not a cougher. She said her mother's cough now, reminded her of the cough her mother had when her mother had the COVID-19 Virus in 2020. She clarified her mother was tested on 23Apr2020 for the COVID-19 Virus, and diagnosed positive for the virus on 24Apr2020. The caller said she was perplexed by her mother's cough, and her mother will be seeing her doctor this Thursday, 21Jan2021. She said she gave her mother some Robitussin for the cough. She said her mother's cough was not persistent, but the cough was still there. She said her mother's cough was not constant, but her mother's cough was congested. She said she didn't know when her mother's cough started. She said she thought giving her mother the Robitussin doses was kind of insignificant, because her mother did not have a constant cough, where she needed to take the Robitussin. She said her mother didn't even use half of a normal sized Robitussin bottle. Caller stated she did not have the Robitussin UPC, Lot, and Expiration Date. Reported her mother has an annual lung x-ray and MRI, clarifying she believed her mother had both within the past 3 months. Reported her mother was concerned about receiving the second COVID-19 Vaccine dose. She said she told her mother that it was better to get the second dose of the COVID-19 Vaccine than to get the COVID-19 Virus again. Reported her mother had asked her primary care doctor if she should get the COVID-19 Vaccine, and her doctor told her absolutely. She said her doctor told her she needed to take the COVID-19 Vaccine even if she had the plasma treatment with the COVID-19 Virus in Apr2020. Reported she planned to stay with her mother after her mother received the second COVID-19 Vaccine dose. She said she didn't anticipate her mother having a reaction after the first COVID-19 Vaccine dose because people said most reactions are happening after getting the second COVID-19 Vaccine dose. She said now people are reporting having reactions after the first COVID-19 Vaccine dose. Reported she thought her mother's side effect after having the COVID-19 Vaccine to be unusual, since most people say it feels like they have the flu, or they are tired, or they have a headache. Reported her mother not to be able to walk wasn't that her mother was not walking, but that her mother's foot wouldn't move. She said mother not walking was either neurologic or muscular, unless that is what extreme weakness is. She said she wondered if others have experienced what her mother has. She said if her mother was experiencing just extreme weakness, the extreme weakness was only in her mother's lower body, not in her upper body. She said her mother didn't have an appetite, but her mother was not too weak to put a spoon to her mouth. She said her mother couldn't move her legs, and her mother said her legs felt stiff, or almost frozen. She said if her mother had extreme weakness, and couldn't walk, what did that mean. She said if a person is really tired, the person can still move and get out of bed. She said her mother said she was really, really tired, and couldn't move. The caller said her mother said she couldn't move, and it took her mother 20 minutes to get her legs over the side of the bed. She said her mother not being able to move her legs could be extreme weakness, but observing her mother first hand, she said it looked like her mother not being able to move her legs was neurologic. She said her mother was strong in character and body, and her mother would do everything she could in her body to move, but it was like her mother's brain said "go", and her body said "not now". The outcome of the event Congestive cough was not recovered, of the other events was unknown. Information on the lot/batch number has been requested.
86 2021-02-03 nausea, abdominal pain upper Severe weakness, acute stomach pain, nausea, shortness of breath.
86 2021-02-04 vomiting she threw up; her legs hurt; so tired; This is a spontaneous report from a contactable consumer (pat... Read more
she threw up; her legs hurt; so tired; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She got the vaccine on 15Jan2021 and on an unspecified date in Jan2021 she threw up and her legs hurt, and it just keeps on going down the list. She also reports that she was feeling "so tired" on an unspecified date in Jan2021. She reported that it has almost been 7 days and she is still having side effects. Information on the Lot/Batch number has been requested
86 2021-02-06 nausea injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell
86 2021-02-06 nausea general body aches, chills first- went to bed- then body shaking-during night had nausea, more of bo... Read more
general body aches, chills first- went to bed- then body shaking-during night had nausea, more of body issues and felt hot- took Tylenol PM-apparently passed out coming from bathroom. took one Tylenol and one Ibuprofen. stayed in bed until late morning. tried to hydrate but probably not enough. stayed up most of day- late afternoon chills returned and temperature 100.1 - took 2 Tylenol. went to bed 8:00- woke during night sweating and nightclothes drenched. got up this morning - 02/07- feeling better- some body aches and fatigue which could be from inactivity.
86 2021-02-07 diarrhea, vomiting, nausea Headache and "Not feel well" 2/3/21 4:20AM Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and... Read more
Headache and "Not feel well" 2/3/21 4:20AM Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and "almost" diarrhea 2/3/21 2:04PM Loose BM and nausea 7:10PM 2/3/21 7:10PM
86 2021-02-07 vomiting 24 hours post event patient had vomiting and fevers. She was unable to walk to the ambulance and ha... Read more
24 hours post event patient had vomiting and fevers. She was unable to walk to the ambulance and had to carried. Patient was admitted to hopsital and diagnosed with pneumonia on CXR. COVID PCR negative. CT did not show pneumonia and only showed bibasilar atalectasis. Pt's WBC was 37,000 on Day 2 of admission. This resolved with antibiotics. No source was found.
86 2021-02-08 abdominal pain upper bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consum... Read more
bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks. The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation. An autopsy was not performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation
86 2021-02-09 diarrhea Patient had no discomfort following vaccination until 2 days later on 2/5. She began to have extreme... Read more
Patient had no discomfort following vaccination until 2 days later on 2/5. She began to have extreme pain, a hard knot, and redness at the injection site. On 2/6, she had diarrhea, altered vision in the right eye. and "face hung down" Symptoms lasted about 36 hours. By Monday 2/8/2021, symptoms were completely resolved with no residual effect.
86 2021-02-09 nausea Extreme vertigo starting about 6:30 am on 1/21/2021, unable to get out of bed until 12:30pm on 1/22/... Read more
Extreme vertigo starting about 6:30 am on 1/21/2021, unable to get out of bed until 12:30pm on 1/22/2021 due to dizziness and nausea, hallucinations during this time, some low fever. Continued spells of weakness, dizziness and nausea for two weeks.
86 2021-02-10 decreased appetite, hunger, abdominal discomfort Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she wa... Read more
Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she was really working hard to talk; Muscle tightness around her whole face; Legs weren't steady enough; Didn't feel well; She was very weak; Could only stay awake for very short amounts of time; She never had trouble with her stomach like this before; Lip has a slight droop on left side of her face; Felt like she was having a heart attack; Felt extreme exhaustion; Not able to eat; She thought she has low blood sugar; This is a spontaneous report from a contactable consumer (the patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (left arm) on 21Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history includes therapy on her back from the past, from an unknown date. Concomitant medication included melatonin to sleep and, paracetamol (TYLENOL) to sleep. The patient received the first dose of the vaccine on 21Jan2021 at around 2:50 PM, the next morning on 22Jan2021, she felt extreme exhaustion, she'd get up and have to get back to bed, not able to eat, and she thought she has low blood sugar. She got up and had a bowl of cereal. On an unspecified date, the patient also reported numbness in face, legs and slight headache, and need to eat all of a sudden or pass out, and these has gone on for five days now (at time of report). The patient also reported that her lip has a slight droop on left side of her face which was concerning her. The patient reported that after numbness and not eating, she had some ice cream and her whole chest froze up, and it felt like she was having a heart attack. Her chest felt like ice which never had happened before. It has been an effort to talk, she was really working hard to talk. The patient explained she got the vaccine 5 days ago (from the time of report) and reported she had muscle tightness around her whole face, she had a slight droop on the left lip, a slight headache right across the eye brows, her legs feel a little numb off and on, she got feeling of tiredness but that passes, she had the need to go eat suddenly or she will get very weak. The reason for the call was she was wondering if she should she go for the second vaccine when 5 days after having the vaccine she was experiencing numbness. Slight droop on the left lip started but never looked close until the time of report, not a lot but the lower lip on the left side it is slightly droopy, with slight headache right across the eye brows. Her legs felt a little numb off and on, and she stated that about 3 days after the vaccine, she was afraid to take a shower because her legs weren't steady enough. They are still that way at the time of report, but this did go away for a while on a day and she was able to take a shower. She also didn't feel well after the vaccine. On the day of the vaccine, she had a good dinner and felt good; but the next morning she was very weak and could only stay awake for very short amounts of time. She was in bed and couldn't stay up and this is not like her, she did not like to be in the bed. She got the feeling of tiredness but that passes and she can stay up for longer periods of time. She had to go eat or she gets very weak, she didn't feel like eating in the beginning. It was on the 4th day after the vaccine she would have to get a bowl of cereal all of a sudden or she would feel like she was going to pass out. She never had trouble with her stomach like this before where she felt the need to have to go and eat. She explained she never had trouble with stomach, she never had headaches, and never had a vaccine before. Muscle tightness around her whole face started 2 days after getting the vaccine and was getting worse. Her face felt really tight almost numb feeling. The outcome of the events was unknown.
86 2021-02-12 decreased appetite much more dizzy than first vaccine. Completely weak. 2/11 Next day: same symptoms plus chilled all d... Read more
much more dizzy than first vaccine. Completely weak. 2/11 Next day: same symptoms plus chilled all day. No appetite. 2/12 third day: weakness subsiding, slightly dizzy, very little appetite. 2/13 fourth day: Legs weak but much improvement
86 2021-02-20 abdominal pain lower, abdominal pain upper RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/07/2021. ON 02/20/21 WENT TO URGENT CARE WITH COM... Read more
RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/07/2021. ON 02/20/21 WENT TO URGENT CARE WITH COMPLAINTS OF LOWER BACK PAIN AND LOWER ABDOMINAL PAIN X4 DAYS. DIAGNOSED ACUTE RIGHT FLANK PAIN AND RUQ ABDOMAINL PAIN. SENT TO ER FOR IMMEDIATE EVALUATION. ON 02/20/21 WENT TO ER FOR RUQ ABDOMINLA PAIN THAT RADIATE STO RIGHT FLANK. DIAGNOSED WITH BILARY COLIC AND CALCULUS OF GALLBLADDER WITH OUT CHOLECYSTITIS WITHOUT OBSTRUCTION. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL.
86 2021-02-24 abdominal pain upper, vomiting, nausea, abdominal discomfort, diarrhea Pt seen on 2/24/2021 for vaccine reaction, initial encounter, acute gastroenteritis, chest pain, uns... Read more
Pt seen on 2/24/2021 for vaccine reaction, initial encounter, acute gastroenteritis, chest pain, unspecified type; GI s/s following COVID vaccination and 4 days of chest pain, cardiac workup negative, MD felt overall may be from recent GI Illness causing chest pain, IV's given and antiemetics, able to eat small amount of food here in ER, discharged home, close follow up with PCP and cardiology, concerned over possible COVID - tested and negative in ER, shortly after COVID vaccine began to have nausea, vomiting, diarrhea, inter. stomach cramping, sensitive stomach, past 4 days chest heaviness and pain around heart, cardiac history in past. To follow up with APNP ASAP.
86 2021-02-24 diarrhea Chills, Diarrhea, soreness at Injection site, red line streaking from injection site
86 2021-02-25 diarrhea, abdominal pain 1st vaccine 2/12/21; developed diarrhea and abdominal pain 2/19/21; seen in ED for ongoing symptoms ... Read more
1st vaccine 2/12/21; developed diarrhea and abdominal pain 2/19/21; seen in ED for ongoing symptoms 2/20/21 and d/c'd home; seen again in ED for same ongoing symptoms 2/25/21 and d/c'd home.
86 2021-02-26 vomiting 86-year-old female presenting with severe dizziness. She states she was in her usual state of healt... Read more
86-year-old female presenting with severe dizziness. She states she was in her usual state of health yesterday, went to bed at 9 PM last night, when she woke up this morning she was so severely dizzy she was not able to walk and was vomiting multiple times. She states that feels like she is spinning and unsteady. She denies any focal numbness or weakness. No speech changes. No headache. No prior history of vertigo however she did have some dizziness in the very distant past which was attributed to a mass in her brain which was surgically removed, she has not had any problems with dizziness since then. Almost 1 month ago she was diagnosed with nonobstructing bilateral renal calculi but completely denies any urinary symptoms, abdominal pain or flank pain today. Has any fever.
86 2021-02-28 decreased appetite Felt fine for 2 1/2 or 3 days. Then2-3 days...extreme fatigue...total loss of appetite......some f... Read more
Felt fine for 2 1/2 or 3 days. Then2-3 days...extreme fatigue...total loss of appetite......some fairly severe muscle aches.....no fever (possibly less than 1degree one night)....
86 2021-03-04 nausea Started to feel poorly about 20 hours after the vaccine. Low grade temp of about 99, chills, nausea,... Read more
Started to feel poorly about 20 hours after the vaccine. Low grade temp of about 99, chills, nausea, arm sore at the injection site, overall fatigue. Symptoms lasted for about 24 hours.
86 2021-03-04 retching, nausea Started feeling poorly about 9 hours after the vaccine. Chills, nausea, dry heaves, body aches, head... Read more
Started feeling poorly about 9 hours after the vaccine. Chills, nausea, dry heaves, body aches, head ache, low grade temp, sore arm at injection site. Felt really bad for about 72 hours
86 2021-03-07 nausea light-headed, dry mouth, nausea, dizziness, abnormal sensation in tongue, anxiety & hypertensive 197... Read more
light-headed, dry mouth, nausea, dizziness, abnormal sensation in tongue, anxiety & hypertensive 197/96 post vaccine administration. Transported to ED, observed and symptoms resolved discharged to home. - history of anaphylaxis to shellfish and PCN, IV contrast dye allergy history
86 2021-03-11 abdominal pain, diverticulitis On 3/7/21 the patient presented to the ED with abdominal pain. Reason for admission: diverticulitis.... Read more
On 3/7/21 the patient presented to the ED with abdominal pain. Reason for admission: diverticulitis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.
86 2021-03-11 abdominal pain The patient presented to the ED on 3/10/2021 after falling. She reported lower back pain and left-si... Read more
The patient presented to the ED on 3/10/2021 after falling. She reported lower back pain and left-sided abdominal pain. It was found that she has a closed wedge compression fracture of fourth thoracic vertebra.
86 2021-03-17 nausea Patient was awoken in her sleep by a significant amount of blood coming from her nose and mouth. She... Read more
Patient was awoken in her sleep by a significant amount of blood coming from her nose and mouth. She also reported nausea and high blood pressure as well.
86 2021-03-18 difficulty swallowing, decreased appetite In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to ... Read more
In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to eat it, it did not go down and it did not go down. She ate dinner and at 10:30 she had terrible burning that went through to her back, had shortness of breath like she could not catch her breath. Her daughter took her to the ER as the pain was so severe she thought she was having a heart attack. In the ER they ran a bunch of tests, did an EKG and took blood, she did not have a heart attack. She was admitted and monitored her. She did have a chest x-ray in the ER as well Nothing showed blood clots in her lungs, nothing in her lungs, but she still had the SOB and the pain went away. She thinks they may have given her some medicine and the pain was gone, but she still was shortness and still is today 3/19/21. She has an appointment next week to have an echocardiogram. She has had check ups with the cardiologist and her PCP since coming home from the hospital. Her PCP gave her an inhaler to use but she has not used it. She did not have any reaction to the injection site itself. Ever since this has happened has had no appetite, brain fog, shortness of breath, fatigue and nothing sounds good to eat She can taste okay, but nothing tastes good to her. She said she doesn't think she can handle this much longer, it's been over a month.
86 2021-03-21 abdominal pain, diarrhea, nausea, abdominal pain upper Abdominal pain, nausea, diarrhea, headache, muscle aches, and fatigue1-2 days after vaccination prom... Read more
Abdominal pain, nausea, diarrhea, headache, muscle aches, and fatigue1-2 days after vaccination prompting transport via EMS to ER from home. Had cardiac arrest while in the ER x2, subsequent anoxic brain injury and death following removal of ventilator support.
86 2021-03-30 diarrhea Became aware of this individual when noted that she met the definition of a Vaccine Breakthrough Cas... Read more
Became aware of this individual when noted that she met the definition of a Vaccine Breakthrough Case. Tested Covid + >14 days after receiving 2nd Covid vaccine. She is a resident of a Long Term Care Facility who reported that she tested Covid negative on 3/8/21 but was experiencing diarrhea so brought to Hospital on 3/9/21 where she was Covid tested again and was +. Was hospitalized at that time.
86 2021-03-30 nausea Patient experiencing nausea anxiety SOB. On-site emergency response performed assessment. Vital si... Read more
Patient experiencing nausea anxiety SOB. On-site emergency response performed assessment. Vital signs all within normal limits; patient and husband advised to continue monitoring for life-threatening signs and symptoms; further medical transportation and treatment not advised; patient advised to hydrate and wait additional time. no transportation utilized RN
86 2021-03-30 vomiting received vaccine on 01/20/21. 02/06/21vomiting, difficulty eating, hypotension, sent to hospital a... Read more
received vaccine on 01/20/21. 02/06/21vomiting, difficulty eating, hypotension, sent to hospital and admitted with hypotension and hypothermia, placed on Bi-pap, 02/15/21 resident returned to facility under hospice care, expired on 02/24/2021
86 2021-04-07 decreased appetite, nausea nausea; dizziness; no appetite; This is a spontaneous report from a contactable consumer (Patient). ... Read more
nausea; dizziness; no appetite; This is a spontaneous report from a contactable consumer (Patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 at 10:00 (at the age of 86 years-of-old) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included atenolol, pravastatin and Aspirin. On 07Feb2021 at 07:00, patient experienced nausea, dizziness and no appetite. The patient had no other vaccinations within 4 weeks prior COVID-19 vaccination and was not tested for COVID-19 since vaccination. The outcome of all the events was recovered on an unspecified date Feb2021.
86 2021-04-12 diarrhea, vomiting Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Em... Read more
Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Emboli in Brain; thrown more clots; Aphasia; Difficulty Walking; potassium dropped and she went into A-Fib and threw clots; potassium dropped and she went into A-Fib and threw clots; has problems with recent memories; confusion; food sensitivities; This is a spontaneous report from a contactable physician (patient's daughter). An 86-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 24Mar2021 at 14:00 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed in 1971 (reported as 50 years ago) and ongoing; type 2 diabetes in 2011 (reported as 10 years ago) which resolved in 2019 (about 2 years ago) after the patient lost some weight; she had an episode of A-Fib in 2019 when her potassium was low (lower than the current hospitalization), once the potassium was corrected, her A-Fib resolved. The physician stated that patient has shrunk and was now about 5 foot 2 inches. Clarified that this has not recently occurred since the vaccine; stated it was happening just with age. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not have any issues with the first dose of the vaccine. She received her second vaccine dose on 24Mar2021. The physician spoke with the patient on Friday, 26Mar2021, and the patient was fine. On Saturday, 27Mar2021, the patient had an episode of diarrhea, vomiting and was weak. The lady cleaning the patient's house found her slumped against the wall. The physician met them at the hospital and said the patient seemed okay. They thought it was just an issue from her potassium being low on Mar2021, so they gave her that. The hospital did a CT scan that showed nothing on Mar2021. The hospital did an MRI of the head that showed multiple small emboli in the brain on Mar2021. The physician believed that the patient must have thrown more clots because she became aphasic on Mar2021 and could not name things. The patient also had difficulty walking on Mar2021. The physician felt it was important to call and report this since she has heard of people throwing clots with vaccines. The physician did not know if the events were related to the vaccine. The patient was in the hospital for 7 days (as reported). She was now able to walk with some assistance. The patient's son thought that the patient was okay when he went to see her. Since the reporter was a physician, she knew which questions to ask the patient and saw that she still had some problems. The patient could remember some things but has problems with recent memories on an unspecified date in 2021. She also has some confusion on an unspecified date in 2021, such as she thought she was in a boat hospital. The physician was uncertain if the vomiting and diarrhea was somewhat better. They were wondering if the patient has some food sensitivities (2021). The patient also had carotid studies done in the hospital on Mar2021 and they were fine. They believed that patient's potassium dropped, and she went into A-Fib and threw clots on Mar2021. The clots must have come from the heart valves since the carotid studies were fine and if the clots had been in her legs, they would've gone to her lungs not to her brain. The patient underwent lab tests and procedures which included CT scan: negative, potassium: low, carotid studies: fine, MRI of the head: multiple small emboli in brain, all on Mar2021; and potassium: low, height: 5 foot 2 inches (shrunk), and weight: lost, all on an unspecified date. The events diarrhea, vomiting, weakness and fall required emergency room visit. The outcome of the event difficult walking was recovering and unknown for all other events. The events diarrhea, vomiting, weakness, fall, potassium low, cerebral embolism, thrombosis, and "potassium dropped and she went into A-Fib and threw clots" were assessed as serious due to hospitalization and being life threatening; and the events aphasia and gait disturbance were assessed as serious due to hospitalization. All other events were non-serious. The patient was hospitalized from 27Mar2021 until 02Apr2021. Information about the lot/batch number has been requested.
86 2021-04-20 nausea, vomiting, abdominal pain Severe abdominal cramps, HR down to 28, BP would not register for 3-5 minutes, then HR increased to... Read more
Severe abdominal cramps, HR down to 28, BP would not register for 3-5 minutes, then HR increased to 40and BP 100/41, nausea and vomiting, temp of 102, extreme weakness for 2-3 days. Cardiology f/u appt end of week was satisfactory.
86 2021-04-20 vomiting, abdominal pain, diarrhea with profuse bleeding, nausea headache, chills, weakness, nausea the day after - progressed to severe abdominal pain, vomiting bil... Read more
headache, chills, weakness, nausea the day after - progressed to severe abdominal pain, vomiting bile, bloody diarrhea on day 2.
86 2021-05-03 nausea Patient with no reported past medical history or past surgical history presented to ED and found to ... Read more
Patient with no reported past medical history or past surgical history presented to ED and found to have massive bilateral pulmonary embolism. Upon presentation, patient was confused and lethargic. The morning of the event, niece reports that patient was in her usual state of health this am and had gone downstairs to the kitchen this afternoon, when she was downstairs she began complaining of nausea and generalized back pain. Her niece went to grab her things to take patient to the hospital but when she returned she found the patient laying on the floor due to weakness and pain, no reported fall or trauma. Chest/Abd/Pelvis CT Angio was significant for large PE in R and L main pulmonary arteries. No family history of DVT/PE.
86 2021-05-05 nausea Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nau... Read more
Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea. By the 4th day, her legs would not hold her when she tried to stand getting out of bed. She was nauseous to the point of not being able to eat or drink. Infact, she did not have the strength or desire to eat or drink. By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink. She was able to get to the car with a walker, but that was the last time she walked. After time at hospital and then Skilled nursing, she passed away on 03/21/21. She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids. Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital
86 2021-05-11 nausea SOUR THROAT NASAL CONGESTION NAUSEA FEVER
86 2021-05-13 abdominal pain, hunger, diarrhea At 11: 53 AM Client sitting in observation area c/o "a little dizzy, i feel hungry." 11:55 am cookie... Read more
At 11: 53 AM Client sitting in observation area c/o "a little dizzy, i feel hungry." 11:55 am cookies and water given to client. Client ate a few bits. Vitals check: BP 180/90, 75 bpm, 97%, 16 RR. 11:58 Vitals check: 210/100, 78 bpm, 96%, 16 RR. 12:00 pm Client c/o sudden urge to have a BM and stated, "I need to move my bowels." Escorted by PHN and caregiver at 12:05 pm to nearest restroom. Client walked with steady gate using walker. 12:20 pm Client returned to observation area, reported a loose BM. Stated abdominal pain resolved after using the bathroom. Continues to C/o dizziness and now weakness. Client A x O x4 Vitals check 12:20 pm 230/100, 87 bpm (pulse regular per palpitation), 97%, 19 RR. Client continues to eat cookies given. Vitals check 12:20 pm: 190/90, 79 bpm, 97%, 18 RR. T.C. to 9-1-1 at 12:28 pm. At 12:30 pm client states not feeling dizzy anymore, just tired, wanted to lie down. At 12:31 pm PHN called lead RN, advised to give Benadryl per protocol. 12:34 pm Benadryl given PO. 12:45 pm Vitals check: 190/90, 75 bpm, 98%, 16 RR. EMS arrived and assumed care at 12:50pm. Client signed Against Medical Advice at 1:36 PM. PHN educate need to follow up in 24 hours with PMD clinic, educated risks of elevated BP and possible adverse reactions to vaccine. At 1:38pm Client walked off with stead gait with caregiver.
86 2021-05-20 anal incontinence The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week... Read more
The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week. After the second dose, days out she started feel very tired and bad pain in her feet that went to her hands and she couldn't get out of bed or urinate properly. Her facility doctor gave her Gabepentin for the pain but it did not help. She declined over a week or so and then She was admitted into the hospital for dehydration (March 19, 2021). The put a catheter in her to get urine out and bring her kidney function back to her normal (she does have kidney disease). Gave her more Gabepentin (which does not help pain in feet an hands) and released her to rehab. and she is now on oxygen. Rehab was bad so I got her out and released to her facility so she could receive rehab there. She declined again with the same reaction: extreme fatigue, can't walk and now urinates and defecates in an adult diaper and now breathing is very labored. She was admitted to the hospital and they can't find out why she is in this way. They did blood work, tests, scan and X-rays without any answers. They switched up meds on her and then released her to rehab since she hasn't walked in weeks/month at this point. She is regaining strength but now on oxygen even when sitting. She is 86 and walked with a walker all around her facility and when going to doctor appointments. Now she is in a wheelchair for doctor appointments since she has no strength and needs oxygen to walk. Her facility saw her decline after the second shot and my mom is very vocal and each day told them how she felt awful and it is because of the shot. She still has neuropathy in her feet and hands but it is not as painful as it originally was and it peaked and now just painful about a 5-6 on a scale of 0-10.
86 2021-05-25 diarrhea, abdominal discomfort COVID 19 test POSITIVE Patient's husband was notified of positive test results from test complete... Read more
COVID 19 test POSITIVE Patient's husband was notified of positive test results from test completed on 5/2/21. Stated patient was sleeping at this time, but she is already aware of the diagnosis. Signs and symptoms: 1. When did your symptoms start? 5/2/21 2. What symptoms have you experienced? Diarrhea, weakness, upset stomach. Close contact questions: 1. # in household: 2 2. Have you been in close contact with anyone two days before symptoms including going to work while you were sick? Yes
86 2021-06-03 nausea Arm sore; Joint pain all over my body; Bad headache; Nauseated; This is a spontaneous report from a ... Read more
Arm sore; Joint pain all over my body; Bad headache; Nauseated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant was not reported. On an unspecified date, the patient reported that she had Pfizer shot yesterday at 9:00 o'clock and she did not felt that day and later in the evening at 8:00 o'clock, her arm was really sore and she continued to have joint pain all over the body and had a bad headache and nauseated. She wanted to know that she can take Anacin or Tylenol or Dramamine because she got a bad headache and nauseated. When probed for vaccine details, consumer stated, "The one we got yesterday. I am 86 and I don't know why I am feeling like this (headache and nauseated). My husband was trying to help me here. We both got this one but he has a joint pain but now I have (incomplete sentence). They gave 2 little card and they said come back the 26th of this month. All I see on this just little card. (name) , I don't know what else is here, it says CBC in the corner. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
86 2021-06-15 vomiting, diarrhea Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, ... Read more
Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, I cant walk anymore; the pain is in my legs, in my feet, in my arms/fingers hurt; I had diarrhea and I had to throw up; I had diarrhea and I had to throw up; back hurts; all my bones are hurting; This is a spontaneous report from a contactable consumer (patient). This 86-year-old female patient received 1st dose of BNT162B2 (lot# ER8732) at the age of 86 years old, on 26Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Ulcer pain since got the shot. Cant walk anymore, the pain is in her legs, in her feet, in her arms (if take a pain killer it do not work). She cannot drive car nor go no places. Also Diarrhea, Had to throw up. Since I got this shot the first day I got, for 4 days I had diarrhea and I had to throw up, well I have never seen this in my life because when I throw it up it was (not clear), it was like two. Now I got this shot on 03/26 and now I am in ulcer pain, I cant walk, all my bones are hurting, I cant drive my car anymore, I cant go no place. I am 86 years old and all by myself. I dont know what to do I am in pain. My leg hurts I hardly can walk, my back hurts, my arms hurt, my fingers hurt. I dont know what I have to do. I am 86 years old and I live by myself and I dont know what to do. The first shot I got was on (03/36) and I had no problem with this one, but the second one I got is killing me (refer to AER#2021630678)." Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
86 2021-06-16 vomiting Patient experienced vomiting and ached all over x 24 hours.
86 2021-06-18 diarrhea, nausea, hunger, gastrointestinal disorder This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received first dose of BNT162B2 (lot number: EW0191) on 29May2021 (at age of 86-year-old) on left arm at single dose for COVID-19 immunization. Medical history included ongoing Asthma, ongoing degenerative osteoarthritis, ongoing Stent, COVID-19 from 15Jan2021, diarrhea. Concomitant medications included paracetamol (TYLENOL) 500 mg tablet for pain. The patient previously took Plavix from unspecified date and ongoing. Caller states she is calling about the immunization, says she got it last Saturday in the afternoon (39May2021). She felt alright on Saturday, but from Sunday (30May2021) on, she began to have problems. Caller states she has advanced, degenerative osteoarthritis, and says it has been storming in Indiana this week. Caller states she has been in terrible pain, says she usually doesn't complain, and has been living with pain for years. Caller says she has to be pretty bad to complain. Sunday was really miserable with the arthritis. Caller says she is telling Pfizer not because she expects Pfizer to do anything with it, but says maybe she can help someone else who calls in because obviously she survived and the pain has gotten better through the week. Caller says Monday was another bad day, and she finally just had to give up and leave everything where it was and just go in the bed because she was hurting so bad. She clarifies she had to give up, says she tried to stay up but had to go back to bed because of the pain. Caller states her symptoms were an elevated temperature, which was a low grade one and still has it today, and she had GI symptoms. Caller states she and her grandson were running parallel, says they were both exposed at the same time, and both came down at the same day, and their symptoms were the same except her grandson does not have arthritis. Caller states they had a low grade temp, GI problems where they were not exactly nauseated, but it was kind of like a hunt. Some things went in their stomach and her stomach felt a little better with food in it, and then the problem was the diarrhea. Her and her grandson both had diarrhea and both slept quite a lot. Caller states she slept the clock around a couple of days. Caller stated both her and her grandson were hazy, mentally. The caller states she was surprised because her grandson is a very sharp young man, and he was sort of numb. When attempting to verify the details above and if her grandson also received the vaccine at the same time she did, the caller clarifies she is confusing things. She was talking about when they both had the COVID virus about the 15Jan. Caller says they were both exposed and came down with it the same day, says they ran parallel for 3-4 weeks. Caller confirms she is the only calling about herself today having received the vaccine. Caller states she is about 140 lbs, says she hasn't been very active lately. Caller states she received her vaccine at noon, says she was supposed to be there at 11, got lost getting there, waited in line, and then was ready at noon. Caller states they made her wait awhile longer because of her reactions to medications, says she waited a half of an hour. Caller states because felt it was wise for her to take the COVID-19 vaccine in lieu of her medical history with asthma, a stent, things like that. Caller says the doctors said it was wise for her to take it even though she had had the virus. She trusts , and has been with the doctor for 30 years, says she started with him when he first started his practice, says she trusts him, he's excellent, so when he said she should take it, she said ok. Caller states she didn't want to. Causality: Caller states she is inclined to think pain is related to the vaccine, but she is not going to say positively it was related, but it certainly is a coincidence. Caller states what she felt was that whatever was in the vaccine sort of irritated the irritation in her back and hips and leg and everything. Caller says they had some stormy weather this week and that always makes arthritis worse, but something caused the low grade fever. Caller states she is kind of assuming it's the COVID-19 vaccine. To be honest, she is kind of scared of the second dose so that's why she changed her appointment until the day after Father's day. Father's day will be the first time to see her entire family since the virus. Caller says her second dose was scheduled for the day before Father's day, but after the week she has had, she's going to get the immunization afterwards so she gets to see everybody. Caller then states she does feel the low-grade fever, and pain she was feeling, and the GI upset, were related to the vaccine. The GI upset was kind of a milder version of what she had when she had the virus. Caller states both she and her grandson had the GI upset when they had the virus. Caller says he wouldn't eat for awhile, but she got him to eat what she was eating because she figured out what her stomach would tolerate. Her and her grandson both had diarrhea and that was the bothersome part of it. After the vaccine, the caller did a lot of sleeping, says sleeping didn't last as long with the vaccine as it did with the virus. Caller says it was just a feeling of tiredness and she felt kind of blah. She really felt kind of stupid, it was hard to think- she doesn't know whether it was because she slept so much or what. Caller states she does not take strong pain medications for her arthritis because she has a stent and is on Plavix 24/7. She was told two years ago there is an incidence of internal bleeding for people who take arthritis medication and those who have a stent and are on a blood thinner 24/7. Caller states she was given the option of either taking a chance or not to take the pain medication. Caller says she didn't take the chance and opted not to take the pain medication. Caller says she only takes Tylenol extra strength, she does not use anything else. Caller says it can't be a pain medication that made her sleepy and stuff. Terrible pain: Caller states that one day, she just gave up and went to bed because she hurt so bad. She is not sure she would say the pain is disabling. The pain began on Sunday. She was a mess when she woke up. She clarifies she might have been up through the night to go to the bathroom and was miserable. Sunday was miserable, and Monday was a miserable day. Elevated temperature: Caller states fever began in the night, says she can't remember whether it was Sunday night or during the day on Sunday, says she's not exactly sure when. When probed for the seriousness, she said the significance might be due to the immunization. She confirms the fever is getting better, she felt better yesterday. Caller says today her eyes are burning. She took her temperature earlier and it was up, and her temperature is still up. Caller states because she takes Tylenol morning and evening, before she goes to bed, says it helps the pain somewhat. Caller says the first part of the week, Monday and Tuesday, the Tylenol might have taken the edge off. Extra Strength Tylenol: 500 tablets per bottle, 500 mg per tablet. Caller states the NDC:3014256190. Caller says she doesn't see a lot number, but there is a number underneath the expiration date: 9EE2582B.Exp: Feb 2021. Caller states the pain today is about the same that it always is, says she's pretty much in pain all the time, says it's something she has to live with. Caller states about the only time she is pain free is when she's in bed and has relaxed and taken a dose of Tylenol and it has taken effect. Caller states after she gets up in the morning and starts moving around, she starts having pain. Sometimes she has pain early in the morning, depends on what she does, like run the sweeper or when she's getting groceries. Caller states getting her groceries are one of the worst things, and she will have more pain the next morning. GI upset symptoms: Caller says she's pretty sure it started Sunday or just right away after that. Caller says it's a strange feeling, it's kind of a queasy, hungry feeling, it's a weird feeling. Caller says she puts a little food down there and it helps. Caller says she's been eating a lot of crackers, wheat thins, and ginger snaps. Caller says she has eaten and is pretty comfortable, says she would say it's getting better. Caller states she thinks in general, she is getting better- it's not perfect, but she is getting better. Caller states the reason she called is, for instance, her daughter in law, the mother of her grandson, was tending to think his symptoms from the virus were psychological and so forth. Her daughter in law is sort of that way, and she thinks everybody's else pain is psychological but hers. Caller states she came to her grandson's defense and fixed him up three care packages over a month with food that her stomach would tolerate- like crackers, ginger snaps, powdered chicken noodle soup, not canned, and oddly enough canned green beans, just plain old green beans, nothing on them- she didn't even have to warm them. Caller says her stomach tolerated them. Also, baked beans helped, she needed protein in there, says she tolerated baked beans and so did her grandson. Caller can't say everything she put in the care package, but tea was one thing, and another thing was cocoa. Caller says she got a generic mix. She mentions she tried some others, but they were not that good which was also because her taste doesn't enjoy food. Caller states this cocoa was good and was the generic brand. She gave her grandson a couple of cans of that because she drank that every evening when she took her medicine and ate crackers with her medicine before bed, and it was kind of soothing to her stomach. She knows it sounds weird, but it worked. Her GI upset she would consider medically significant because there was definitely a tie up. She explains it wasn't disabling and she doesn't consider it serious. She explains it was annoying, especially when she had the diarrhea. Unable to determine if caller was referring to vaccine symptoms or virus symptoms. Tiredness: She states she would consider the tiredness medically significant because she would sit down and she would get sleepy and then she did all this sleeping. Caller states it wasn't serious. She states the whole thing about this virus is kind of annoying because it was just bad enough it kept her from functioning normally and kept her feeling kind of lousy. Caller states she is feeling better, says it's improving. Hard to think: Caller states she would also consider this medically significant. She wouldn't have driven, says she wasn't sharp enough to drive or do anything important. Caller states today she is a little tired, but her temperature is up- it all goes in together. Attempted to clarify symptoms of the vaccine with caller. Caller states one thing she wants to tell Pfizer about her grandson is about the mental fog. The caller and her son were very afraid her grandson had that because her grandson was just a blob sitting there. He has been depressed because his parents are in a custody battle, so she doesn't know what part that played in it. Caller says she was concerned about him. He is 15 and he is very intelligent, but his grades went to Ds and Fs. Caller says her son got ahold of the high school counselor and the mother wouldn't do anything about it. The high school counselor got in on it, her son got on it, then they got someone got on it. Caller says they got her grandson through the work he was behind on, says he was behind for the whole thing. His mother didn't encourage him to do any school work. Maybe it wouldn't have done any good, maybe he was too far gone to do any work. Caller says they were concerned about the mental fog. She says her grandson is coming out of that and becoming his old self again. Caller says he is very intelligent and inquisitive, and he was just a blob for a long time. Medications: Caller stated she has been taking Plavix since 2008. She clarifies she started taking the Plavix because of her stent. She was on brand Plavix for a while and at one point she was switched to generic and she is on the generic 24/7. Tried to confirm with caller the generic name, but the call disconnected. Outbound call,was placed on 04Jun2021 at 3:24pm and was unsuccessful. Placed second outbound call, on 04Jun2021 at 3:25pm and was unsuccessful. The outcome of the events was unknown. The causality was reported as related. The seriousness was reported as medically significant.
86 2021-06-30 vomiting patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell a... Read more
patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell asleep; unconscious; vomited all over herself; urinary tract infection; 'weakened state'; muscle aches; This is a spontaneous report from a contactable other hcp. A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 (at the age of 86-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to Feb2021, callers mother had covid back in Feb2021. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jun2021 11:00 wednesday, the patient was found unconscious in the living room floor by a neighbor, had vomited all over herself, her arm hurting, muscle aches, body pain, very weak, was diagnosed with a UTI and patient was confused on an unspecified date. She has since been discharged home, is in a weakened state and was advised not to get the 2nd shot. Caller concerned that 2 individuals came over to her mothers house to administer the vaccine. Patient was advised no to receive the second dose Pfizer Covid 19 Vaccine by the doctor. Yesterday (16Jun2021), the caller's mother ended up in the emergency room with an adverse reaction: clarified her mother was discharged from the emergency room. The patient arm was still hurting. When asked if the arm hurting is improved, worsened or persisting, the caller replies it is probably about the same. Stated she was informed on Tuesday evening 15Jun2021 that an individual came to her mother's home and administered the first dose Pfizer Covid 19 Vaccine to the patient. The caller said she spoke to her mother at 11:00 on Wednesday 16Jun2021, had an uncomfortable feeling that someone came to her mother's home and administered her mother the first dose Pfizer Covid 19 Vaccine. At this time on 11:00 on Wednesday, 16Jun2021 was when the caller mother told the caller about her symptoms. The caller clarified the mother's symptoms all began less than 24 hours after the mother received the first dose Pfizer Covid 19 Vaccine. Patient has fatigue, body pain is persisting and being very weak is persisting. The caller has reached out to the doctor and had tried to get home healthcare in to help her mother get her strength back up. The caller said when her mother had come to with the neighbor, her mother said she was in the kitchen and fell and crawled into the living room and that was when the patient got sick all over herself. The caller mother just fell asleep and the caller believed her mother was unconscious at that point. Time the Vaccination was given in mid-afternoon. Patient was on the fence about receiving the Pfizer Covid Vaccine. Patient antibodies were probably just as good as the Pfizer Covid 19 Vaccine. Due to the patients age, she was capable of handling any possible side effects from the Pfizer Covid 19 Vaccine. The patient went ahead and set up to receive the Pfizer Covid Vaccine.The patient underwent lab tests and procedures which included blood test: normal, chest x-ray: normal on 16Jun2021. Events resulted in emergency room visit. The seriousness of unconscious was medically significant. The outcome of all events were unknown. Information on Lot/Batch number has been requested.
86 2021-07-06 decreased appetite, nausea Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk... Read more
Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk with her walker; severe nausea; shaking from head to toe/having tremble; felt like burning up inside; Weakness; Has zero appetite; Anxiety.; This is a spontaneous report from a contactable consumer (daughter). This consumer reported for an 86-year-old female patient that: An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 11:00 (at the age of 86 year) as single dose for covid-19 immunisation. Medical history included Chronic hives from an unknown date and unknown if ongoing, ongoing Unspecified reactions, ongoing Unspecified medication allergies and patient had a prior fall where she suffered a broken ankle. Concomitant medication(s) included dupilumab (DUPIXENT) taken for eczema from Sep2020 and ongoing and latanoprost (LATANOPROST) taken for glaucoma from an unspecified start date and ongoing. Patient historical vaccine includes shingles vaccine for immunization and within 48 hours, the patient broke out in severe eczema from head to toe and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via unspecified route of administration on Right arm for Covid-19 immunization and experienced no adverse event. She had Called on behalf of her mother who was 86 years old. Mother received the second dose of the Pfizer BioNTech Covid-19 vaccine last 27Apr2021, within 24 hours, mother experienced severe nausea with shaking from head to toe and felt like burning up inside. The weekend after the second dose, the mother experienced heaviness in the chest and jaw pain and was brought to the ER. Full cardiac work up was done, and results were fine. Doctors said this may be due to anxiety. Mother had CT abdomen, an endo scan, and blood works but they were all fine. Mother continues to weaken, having tremble and is nauseous. These symptoms would come and go. Mother was in the ER twice this past week and they could not find anything. Nausea got worse. It would come back strong around 3:30 in the morning. Caller wanted to know if these were reported with the Pfizer Covid-19 vaccine and if there was anything they could do further. Mother was taken to different doctors and tests were done but no findings. caller mentioned that the symptoms happened right after the shot. She reported that the patient has been seeing an infectious diseases doctor as during her lifetime, the patient has always had chronic hives. Caller reported that the patient has reactions to many things and is allergic to many medications. She reported that that weekend it got so severe, the patient was experiencing a heaviness in her chest and jaw pain. She reported that they thought the heaviness in the patient's chest and jaw pain might be cardiac, so the patient was taken to the emergency room. She reported that the patient stayed 2 nights in the hospital. Caller reported that the patient's heart was ruled out and her bloodwork came back ok. Caller reported that the hospital physicians thought that the heaviness and jaw pain could be anxiety and prescribed anxiety medication for the patient. She reported that the patient went to her primary care physician after leaving the hospital. Caller reported that the patient got worse and was experiencing nausea more and more. She reported that the patient's physician ordered an endoscopy and brain scan to rule out everything medically. Caller reported that the patient's physician informed her that her blood pressure was fine, her bloodwork was fine, and that all of her test results were normal. She reported that the patient just continues to weaken and trembles and burns up. Caller reported that the patient was so severely nauseous but never throws up. She reported that they are just at their wits end and do not know where to turn. Caller inquired if anyone else was calling with these side effects and if there was anything they can do. She reported that the patient went from being just fine, on no medications, to this. Caller reported that everyone keeps saying they do not know what was wrong with the patient. Caller reported that the patient's physician keeps saying that maybe it is anxiety, but the patient has been on the anxiety medications for 6 weeks and there are no signs of improvement. She reported that she does not want the patient to take the anxiety medications if they are not helping. The patient has been taking the generics for Lexapro and Xanax, escitalopram and alprazolam, for 6 weeks and has shown no improvement. Product strength and count size dispensed: Escitalopram 5 mg; dispensed in pharmacy bottle Alprazolam 0.25 mg; dispensed in pharmacy bottle Additional lot numbers: Caller unable to provide product lot numbers as they were dispensed in a pharmacy bottle. Caller reported that the Escitalopram was manufactured by Accord and the Alprazolam was manufactured by Sandoz. She reported that the patient was started on 5 mg of Lexapro, but the dose has been increased to 10 mg. Caller reported that the patient was taking two 5 mg tablets. Severe nausea: Caller reported that the patient's nausea has worsened. Caller reported that the patient initially would experience nausea for a couple of hours then it would ease. Caller reported that the last 10 days, the patient's nausea is almost all the time. Caller reported that the patient gets a couple good hours maybe before going to bed and that is it. Caller reported that the patient wakes up with severe nausea around 3:30 in the morning like clockwork. Shaking from head to toe: Caller reported that the patients shaking comes and goes. Caller reported that the patients shaking was definitely worse in the morning when she was the weakest or if she was getting a bad bout of it, like the nausea comes on stronger. Burning up inside: Caller reported that the patient feels like she is freezing outside when she was burning up inside. Heaviness in chest: Caller reported that the patient experiences heaviness in her chest when she gets episodes where the nausea and burning up inside, freezing outside come on. Caller reported that the patient does not always have the heaviness in her chest. Weakness: Caller reported that they took the patient to the emergency room a second time because she could barely walk with her walker. Jaw pain: Caller reported that the patients jaw pain comes and goes. Has zero appetite: Caller reported that they have to force the patient to eat. The patient underwent lab tests and procedures which included abdominal x-ray: normal on Apr2021, blood pressure measurement: fine on Apr2021, blood test: normal on 30Apr2021, cardiac function test: normal on 30Apr2021 results were fine computerised tomogram abdomen: all fine on Apr2021, endometriosis: all fine on Apr2021, endoscopy: normal on May2021 and scan brain: normal on May2021. Patient was visited to emergency room and physician's office for the events Jaw pain, heaviness in chest, nausea and weakness. Patient was hospitalized for the events experiencing a heaviness in her chest and jaw pain from 30Apr2021 to 02May2021. Therapeutic measures were taken as a result of the events with Escitalopram and Alprazolam. The outcome of the event's severe nausea, shaking from head to toe, felt like burning up inside, jaw pain, Weakness, has zero appetite, anxiety was not recovered and experiencing a heaviness in her chest, she could barely walk with her walker, like she is freezing outside and she could barely walk with her walker was unknown. Information on Lot/Batch number has been requested.
86 2021-07-25 profuse gastrointestinal bleeding death - Gastrointestinal hemorrhage, unspecified - Acute kidney failure, unspecified
87 2021-01-20 diarrhea, nausea Cough, loss of taste; then chills, diarrhea, mild nausea
87 2021-01-20 profuse gastrointestinal bleeding Admitted 1/10 for GI bleed; treated and discharged 1/12/21. Returned to ED 1/17/21 for spell of alte... Read more
Admitted 1/10 for GI bleed; treated and discharged 1/12/21. Returned to ED 1/17/21 for spell of altered consciousness and tested positive for COVID. Vital signs stable, afebrile. No STEMI. Daughter and patient wishing to go home as she was just in the hospital; not admitted.
87 2021-01-20 nausea Joint and muscle pain, feeling unwell, nausea, weakness, dizziness, shaky, fast heartbeat, tiredness... Read more
Joint and muscle pain, feeling unwell, nausea, weakness, dizziness, shaky, fast heartbeat, tiredness, headache. chills, injection site pain and swelling
87 2021-01-20 vomiting Elevated temperature 102.1 and chills. on 1/15/21 vomited.
87 2021-01-26 diarrhea, vomiting Loose stools, vomiting, change in mental status
87 2021-01-28 difficulty swallowing pt c/o difficulty swallowing and a scratchy throat within 20 min of receiving vaccine. Patient give... Read more
pt c/o difficulty swallowing and a scratchy throat within 20 min of receiving vaccine. Patient given 25mg Benadryl and monitored for 30 min. vital signs stable. 25 min later, no further symptoms and patient was released to home
87 2021-01-31 nausea profound dizziness and nausea leading to hospital admission
87 2021-02-01 vomiting Found confused, vomited, admitted and dx with ICH.
87 2021-02-02 diarrhea Cold symptoms on Sunday 1/31/21 (runny nose, headache), on 2/1 & 2/2/21 1 episode of "diarrhea" each... Read more
Cold symptoms on Sunday 1/31/21 (runny nose, headache), on 2/1 & 2/2/21 1 episode of "diarrhea" each day. On 2/3/21 sore throat and chills, seen by PCP and diagnosed as "Pharyngitis" and treated with Ampicillin for 7 days.
87 2021-02-04 abdominal pain upper like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to f... Read more
like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to feeling herself; getting dizzy/ lightheadedness / felt dizzy/ dizziness; She didn't feel good/sick; She wakes up in the night crying; feel like she was little warm; she felt like she was going to die; pain in her stomach was like she had an ulcer; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included leg problem, it's severe pain in the right leg in the back; very bad nerves. Concomitant medication included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for pain in her right leg. The patient had severe pain in her right leg and she was going to pain clinic for that, he was giving 'Propacet' for that. Caller stated that she had the injection on Monday (18Jan2021) at fair grounds, its the Covid Vaccine. She didn't feel good the day she got it on Monday. Then Tuesday she felt good. Wednesday (20Jan2021) she was sick again, and having pains in the stomach, well she can't say stomach, but also towards the afternoon around 2'o clock, she got light headed and dizzy, she felt like she was about to pass out (21Jan2021), and she thought to herself she had to hurry and get something to eat and that feeling last 4-5 hours. She took a pain pill when she got something to eat, and thought to sit down watch a program to take her mind off of it because she felt like she was going to die (Jan2021). After the pain pill and the food it seemed to get better. She wakes up in the night crying (Jan2021), because she was scared if she didn't get better the shot would kill her. Maybe it's her nerves getting the best of her. Her son had the vaccine and had no side effects. She wanted to know if she is the only one having the side effects. While on the phone with this call handler, caller states that she was starting to get dizzy again but she just had breakfast. Her First Dose was on 18Jan2021 Mon, and on the way home she said to her son she was getting dizzy/ lightheadedness. Her son said to her its not from the shot, but she was getting dizzy. On 19Jan2021 Tuesday, she felt good that day. On 20Jan2021 Wednesday, she was Sick again, with weakness, dizziness, she can't get to feeling herself and she had Pain in the stomach. On 21Jan2021 Thursday she felt dizzy, like she was going to pass out. On 22Jan2021 Friday she was feeling dizzy again, and her stomach was acting up and she was weak again. Caller was dizzy and weak. The dizziness was a different each time, sometimes she has got it, sometimes she didn't, its intermittent, she would be doing something and then she needed to grab a hold of something when the dizziness come on. Her Weakness was about the same. She was not feeling the stomach pain right at this minute, when she woke up during the night with it and last felt it 5 or 6AM this morning, she had chores and tasks to do this morning, but her heads going at that time also around 5 or 6 o clock, it was about the same as Wednesday, she just felt like she needed to get something to settle her stomach down, like she needed something for the energy. When attempting to get the product details, caller states that she was getting old, she provided EL3248, she needed light to read it. The card did have an Expiry date but she can't read it, it's 20 something, she just can't read. She was on nothing new. She took a pain pill when she got home but it didn't help, she was still dizzy. The pain pill was Percocet, it was dispensed in a brown pharmacy vial. Medical Conditions: She has a leg problem, it's severe pain in the right leg in the back, she wears a back brace, she needed an MRI Monday. Caller stated the date 12Feb2021, but did not confirm what this date was for. She didn't know how she would get the MRI if she didn't feel better. They were trying to pinpoint the pain in the leg. They tell her that she was in good health for 87 years of age, when they put her in back brace she felt good. On Monday when she got up there she was a little weak and they put her in a wheelchair that day, this past Monday. She had No results to share but she had a X ray a couple weeks ago (Jan2021), and that would lead up to MRI she was going to have. Caller stated that she had very bad nerves, her husband passed away 2 years ago and she hasn't overcome that, she lived by her-self, and was wondering if some of this stress, would lead to the symptoms she was having right now. She wanted to know if these are normal side effects and if it safe to have the second dose. Caller stated that she was slow and old. Consumer further stated, she didn't know if she got the right party or not. She just want to know if she was having a reaction to the COVID-19 injection (COVID-19 Vaccine) that she had on Monday, she didn't have a (distorted voice) that serious, like the whole Monday she was sick, Tuesday she felt fine, yesterday she was so stressed she can't hold her head up today she felt good but about 2 o'clock, she had pain in her stomach and she had it all the time, the pain in her stomach was like she had an ulcer and all of sudden she feel like she was little warm (Jan2021) and had to pass out and then get something to eat and sit down and take something for pain and it last about two hours and then go away and about 4 hours later she got it right back. She just wanted to know if that has anything to do with (incomplete sentence). She was not sure if she should (incomplete sentence), she was scared to have a second injection. Second due date of vaccine was 08Feb2021. The outcome of the events getting dizzy/ lightheadedness / felt dizzy/ dizziness, Weakness, pains in the stomach/stomach was acting up was not recovered, of the other events was unknown.
87 2021-02-07 vomiting ABOUT 9:30 P.M. ON THE 7TH OF FEB. STARTED FEELING EXTREMELY DIZZY TO THE POINT OF ALMOST FAITING, ... Read more
ABOUT 9:30 P.M. ON THE 7TH OF FEB. STARTED FEELING EXTREMELY DIZZY TO THE POINT OF ALMOST FAITING, ALSO STARTED TO VOMIT. LASTER ABOUT 2 HOURS.
87 2021-02-08 diarrhea Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wi... Read more
Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wife/caregiver, patient appeared anxious, skin color appeared abnormal, and pulse was weak and bradycardic (not unusual for patient). Albuterol nebulizer treatment attempted but patient was too anxious to complete. Gave 2 puffs albuterol oral inhaler, and repeated treatment 15 min later followed by a small glass of cola. About 30min later patient calmed, no longer short of breath and pulse strong but face remained flushed. Vitals at 9:20pm included BP 116/47, pulse 67. Following day patient had multiple involuntary diarrheal stools. Symptoms reported to provider 2/8 and noted to be resolved.
87 2021-02-15 diarrhea, nausea, vomiting Patient presents to our emergency department on 2/13/2021 with complaints of nausea, vomiting & diar... Read more
Patient presents to our emergency department on 2/13/2021 with complaints of nausea, vomiting & diarrhea, dehydration and headache. Iv fluids administered, patient kept observation for 24+ hours.
87 2021-02-15 vomiting 2/6 vomiting; 2/7 temperature
87 2021-02-20 diarrhea, abdominal pain upper ON 01/26/21 THE DAY FOLLOWING MY FIRST DOSE OF COVID-19 I BEGAN FEELING SOME LIGHTHEADNESS & WEAKNES... Read more
ON 01/26/21 THE DAY FOLLOWING MY FIRST DOSE OF COVID-19 I BEGAN FEELING SOME LIGHTHEADNESS & WEAKNESS. I ALSO EXPERIENCED SEVERE STOMACH CRAMPS & SEVERE DIARRHEA. THE SECOND DAY (01/27/21) AFTER MY VACCINE, I BEGAN FEELING WEAKER, LIGHTHEADED, AND THEN LATER THAT EVENING I EXPERIENCED A PEIRCING HEADACHE WITH INTENSE PAIN ON FRONT LEFT SIDE OF MY HEAD. THE LIGHTHEADNESS CONTINUED FOR 3-4 DAYS. IT WAS WITHIN THAT FIRST WEEK I REALIZED MY PULSE OX WAS READING 88-90 bpm . PRIOR TO THIS MY PULSE RATE ROUTINELY WAS BETWEEN 60-64 bpm. I SAW CARDIOLOGIST ON 2/5/21, AFTER ECG AND EXAM DOCTOR STATED MY HEART RATE WAS IRREGULAR, POSSIBLY A FLUTTER, AND ORDERED A HEART MONITOR TO WEAR AT HOME FOR 2 WEEKS.
87 2021-02-24 gastrointestinal disorder Patient received vaccine in public vaccine clinic, was recovered for 15 minutes and drove self home.... Read more
Patient received vaccine in public vaccine clinic, was recovered for 15 minutes and drove self home. Upon walking into her apartment, began feeling extremely tired, dizzy and weak, then developed GI symptoms. Was seen by her pcp on 02/19. It was noted that she was newly bradycardic, 40 bpm.
87 2021-02-25 abdominal pain upper Sharp pains in stomach, hip, and back muscles aprroximately 32 hours after vaccine. Spasms in stoma... Read more
Sharp pains in stomach, hip, and back muscles aprroximately 32 hours after vaccine. Spasms in stomach continue to date, as do weakness in legs to the point of using a walker to get arounds, and an overall feeling of unwellness. Have had no fever. Contacted personal physician 8 days after vaccine and was advised to take Tylenol, which I have been doing for a few days, but am now taking consistently every 8 hours as directed.
87 2021-02-27 retching Severe Dizziness, dry heaves, chills, weakness, lasting 2 1/2 days, 4 days after shot #2
87 2021-03-03 abdominal pain upper, abdominal distension, nausea Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a ... Read more
Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a non-contactable consumer reported for herself. An 87-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 05Feb2021 10:30AM on right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe gas bloating, stomach cramps, nausea, feeling very weak on 07Feb2021 with outcome of not recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was unknown. The case was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
87 2021-03-04 decreased appetite Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antib... Read more
Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.
87 2021-03-08 diarrhea diarrhea
87 2021-03-11 diarrhea a few hours Pt states after getting shot had very bad diarrhea dehydration & colon infection & UTI ... Read more
a few hours Pt states after getting shot had very bad diarrhea dehydration & colon infection & UTI went to ER on 2/21/21-
87 2021-03-12 diarrhea Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pai... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pain on right side of hand and leg, diarrhea, chills, difficulty urinating, and fever one day after vaccination. By the time of clinic visit symptoms resolved except for diarrhea. No rash or respiratory symptoms reported. Patient able to manage symptoms at home.
87 2021-03-14 nausea Presyncopal episode with nausea, flushing, lightheadedness, need to defecate
87 2021-03-18 nausea Injection site pain; severe tiredness; chills; fever 99.8 for 3 days; nausea; Feeling unwell; This i... Read more
Injection site pain; severe tiredness; chills; fever 99.8 for 3 days; nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient (pregnant: No) received first dose of bnt162b2 (Batch/Lot Number: EN5318, Pfizer), via an unspecified route of administration in arm left on 06Feb2021 11:00 AM as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium; alendronate sodium (ALENDRONATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced injection site pain, severe tiredness, chills, fever 99.8 for 3 days, nausea, feeling unwell all on 07Feb2021. The case was reported as non-serious. The outcome of events was resolving. No other vaccine in four weeks. Other medications in two weeks included: Levothoryoxine and alendronate sodium (ALENDRONATE). The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. Not known allergies.
87 2021-03-18 vomiting Pt developed dizziness about 3-4 minutes after vaccination. Proceeded to start vomiting. Vitals in... Read more
Pt developed dizziness about 3-4 minutes after vaccination. Proceeded to start vomiting. Vitals initially stable, however, pt became less alert, with rapid deterioration of status (BP 70/40, pulse 40's, sat 84% on RA). EMS arrived and transported to hospital within 20 minutes of onset of symptoms. Transported to Medical Center.
87 2021-03-19 difficulty swallowing 2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficu... Read more
2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficulty swallowing when eating, throat congestion throughout the day for 4 weeks 2/24/2021 benadryl 25 mg up to 4 times/day; prednisone 10 mg increased to 30 mg 2/26/2021; famotidine 20 mg once/day; zyrtec 5mg discontinued after 2 days due to reactions - replaced with claritan 10 mg daily 3/1/2021 emergency room admission for observation continuing above medications
87 2021-03-21 retching, nausea Patient was AAOx3, ambulating independently prior to obtaining vaccine. Medical Assistant gave patie... Read more
Patient was AAOx3, ambulating independently prior to obtaining vaccine. Medical Assistant gave patient vaccine in Left Deltoid. Patient ambulated to observation area and sat in a chair. Five minutes into her observation, patient reported not feeling well. Medical Assistant notified Nurse Practitioner. Upon exam, patient was pallor, eyes intermittently rolling back, lethargic and unable to keep her head upright, nauseous and dry heaving, developed rigors, unable to verbally communicate but did nod her head yes to having difficulty breathing. No hives or rash noted. Epinephrine 0.3mg Pen (Lot # 0FM406, Exp Feb 2022) was administered in Right Deltoid. 911 was called by the Vaccine Clinic Supervisor. Vitals: Temp 97.7, HR 77, BP 134/76 (sitting), Pox 96% Room Air. After Epi administration, patient continued to be lethargic and the only thing she stated was "I do not feel well" but was able to communicate with head nods. EMS arrived and patient was taken to a Hospital.
87 2021-03-24 abdominal discomfort She got the vaccine, went home and went to bed. She woke up around 5:00 AM and was a little light h... Read more
She got the vaccine, went home and went to bed. She woke up around 5:00 AM and was a little light headed, but as the day went on she found herself holding onto the wall and then had to get her cane. She does have Meniere's disease. She had a sick stomach, not nausea. Some days were a little better than others. She got up slower, and that didn't help that situation. She called her doctor and told them how she was feeling, and she was asked if she wanted to come into the office, and she declined. Then a few days went by and she did not feel any better. She reached out to her family and they told her to call somebody and that's when she read her paperwork and called us.
87 2021-03-27 nausea MEGA LACK OF FATIGUE, DIZZINESS, NAUSEA,REGRESSION RELATED TO IMPAIRED MOBILITY
87 2021-03-30 vomiting Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs... Read more
Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak. The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021 and worsened urinary tract infection on 16Feb2021. Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown. Information on the lot/batch number has been requested.
87 2021-04-01 nausea, vomiting Nausea, vomitting - Blood clot on kidney. No hx of clotting issues prior.
87 2021-04-04 abdominal discomfort I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and ... Read more
I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and awoke at 9:00AM...got up and proceeded to do daily chores....and sudenly i did not feel very good, had a head ache, chills, body aches, trouble catching my breath, stomach discomfort, (not an feeling like i was going to be sick to my stomach, but just did not feel like eating anything), was dizzy, and very tired....the worst was the disorintation....was afraid i was going to pass out....laid down and fell asleep...when i awoke an hour later i felt worse....fell back asleep for another couple of hours....drank a lot of water, ate some cheese and crackers late in the day....slept thru the night and woke up on Sunday morning feeling fine....again arm never was sore....I have described all the symptoms i had on Saturday April 3rd.....i do not know what else you want
87 2021-04-12 abdominal pain upper, blood in stool, faeces discoloured, diarrhea Started to have stomach cramps. Had black diarrhea due to blood in stool.
87 2021-04-13 profuse gastrointestinal bleeding Death Anemia GI bleed Lactate blood increased CKD (chronic kidney disease) Jefferson fracture
87 2021-04-17 abdominal discomfort, vomiting she had a cold chills through the day; she was in bed most of the day almost all those day; upset st... Read more
she had a cold chills through the day; she was in bed most of the day almost all those day; upset stomach; She is not been eating; She is not dehydrated; Dizziness; Headache; she already getting the flu; she ended up with such bad shake; she is allergic to lot of prescription medication; Vomited; This is a spontaneous report received from a contactable consumer. A 87-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history included asthma, fibromyalgia, arthritis (patient had arthritis from long time) and high blood pressure. Concomitant medications included lisinopril 20 mg, 1x/day. It was reported that patient started to vomit few hours later and then she had a cold chill through the day. She had like on Thursday with a vaccine and here it is Monday this is Tuesday now really and she was getting better, but she was in bed most of the day almost all those days and she was upset stomach. It was reported that patient was on real like she gonna jump right out of the bed and she finally settle down. On 30Mar2021, patient had a very bad reaction, she had a shake. It was reported that patient was not been eating. She was not dehydrated she is not been drinking lot of water. The patient had took the dramamine for her upset stomach and motion sickness. The takes only when she needs it about twice a day mostly so far. It was reported that at first because of motion sickness in the car but it quite away we had to go and after that it was terrible, it just continued every day after that. She vomited first day very bad and rest of the day upset stomach then when she started taking dramamine. The patient also had like dizziness, headache and shake. The patient acted like she already getting the flu of some sort. It was reported that patient was allergic to prescription medication. She took Dramamine for upset stomach and then took Tylenol (Acetaminophen), 500mg each, every 4 hour 2 tablets for headache." It was reported that patient will not get second vaccine then because she does not want to experience this all over again. Outcome was reported as not recovered for chills, dizziness, headache, influenza and unknown for bedridden, upset stomach, vomiting, ended up with such bad shake, She is not been eating; She is not dehydrated and is allergic to lot of prescription medication No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
87 2021-04-23 diarrhea, decreased appetite no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous ... Read more
no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous report from a contactable Nurse (patient herself). A 87-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249; Expiration Date: May2021) intramuscularly administered in right deltoid on 02Feb2021 at 0.3 ml single, for COVID-19 immunization. Medical history included hypertension (she had hypertension, or high blood pressure, which she was treated for). There were no concomitant medications. Caller says she has not had any other recent vaccinations or started any new medications. On 02Feb2021, the patient experienced cough, nasal congestion, fatigue and pain in arm, on an unspecified date, patient experienced chills, diarrhoea and no appetite. Retired RN (registered nurse) called as patient about the Pfizer COVID-19 vaccine, who says she was wondering about the shot that she got the first dose of last Tuesday. She says she has been looking at the sheet of side effects etc, and she had cough, which was not listed, and nasal congestion, no appetite, chills, and diarrhoea started on the second or third day after getting the vaccine. Caller says her cough started when she came home, and she was really exhausted after that, the cough was not bad. She asks if the vaccine is made in Germany. She says that the fatigue and pain in her arm lasted three days. Caller says that she feels it is medically significant, and she is not going back for the second shot. She took Mucinex for the nasal congestion, and for her diet she ate soup. Caller says this medication was over the counter and not prescription. Caller says that she feels it is medically significant, and she is not going back for the second shot. The outcome of the events was unknown.
87 2021-04-26 nausea, retching, abdominal pain upper After 1st dose of Pfizer: Nausea, and trouble breathing (Oxygen went up and down from 90 to 95) - T... Read more
After 1st dose of Pfizer: Nausea, and trouble breathing (Oxygen went up and down from 90 to 95) - Took to Dr and advise to watch oxygen levels After 2nd dose of Pfizer: Nausea, Dry heaves, Stomach Pain, Head Aches, Back Pain, Loosing Control of Bladder (Kidney Failure), Trouble Breathing (Oxygen went under 90) - Took to her Dr and she said to take her to the Emergency Room due to her Oxygen going below 90. I took her to Hospital.
87 2021-05-03 vomiting, nausea, abdominal pain upper Severe Nausea, Vomiting and Stomach Pains
87 2021-05-12 nausea History Chief Complaint Patient presents with ? Covid-19 Screening ? Nasal Congestion ? Chills ... Read more
History Chief Complaint Patient presents with ? Covid-19 Screening ? Nasal Congestion ? Chills sweats ? Nausea ? Headache
87 2021-06-11 nausea Headache; Queasy; chills; This is a spontaneous report received from a non-contactable consumer (pat... Read more
Headache; Queasy; chills; This is a spontaneous report received from a non-contactable consumer (patient). A 87-year-old non-pregnant-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration in her left arm on 16Mar2021 at 2:45 PM as single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no allergies to medications, food or other products. The patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. On 17Mar2021 at 6:00 AM the patient experienced headache, queasy and chills. The patient did not receive any treatment in response to the events. At the time reporting, the patient was recovering from the events headache, queasy and chills. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient details (Patient's first/middle/last names initial captured in corresponding field, Patient's country captured as US), Historical vaccine added, Concomitant Therapy captured as Yes, Events details (treatment received) and Narrative lead sentence updated.
87 2021-06-24 decreased appetite Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous... Read more
Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous report from a contactable consumer (patient). A 87-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) 0.3ml, via an unspecified route of administration, administered in Arm Right on 20Jan2021 (at the age of 87-year-old) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included apixaban (ELIQUIS) taken for anticoagulant therapy from an unspecified start date and ongoing; metoprolol succinate (TOPROL XL) taken for hypertension from an unspecified start date and ongoing; amlodipine besylate taken for hypertension from an unspecified start date and ongoing; olmesartan medoxomil taken for hypertension from an unspecified start date and ongoing. Patient had no problems before with her medications. On an unknown date in 2021, the patient experienced feeling so weak, does not have much of an appetite to eat anything. She noticed on Monday it was getting worse, then she had another attack of it today. It suddenly comes on and all of a sudden she is so weak. Its like she can not balance herself out. On 01Feb2021, patient experienced tiredness. The patient underwent lab tests and procedures which included magnetic resonance imaging: cyst on her right kidney on Mar2020. MRI was done prior to the vaccine, she had been having issues with pain on her right side so they did an MRI. They told her she has a cyst on her right kidney. She has not taken any kind of medications for that. They want to do another MRI before doing anything. She asks, what should she do about the second dose. Patient was supposed to get the next dose on 09Feb2021. She does not really want to take it if it will do her like this. The outcome of the events so weak, does not have much of an appetite to eat anything were not recovered and the outcome of the event tiredness was unknown. Follow-up attempts are completed. No further information is expected.
87 2021-06-24 diarrhea Diarrhea; Is not feeling well; This is a spontaneous report from a contactable consumer. A 87-years-... Read more
Diarrhea; Is not feeling well; This is a spontaneous report from a contactable consumer. A 87-years-old female patient (age at vaccination: 87years) received first dose BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in right arm on 04Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation (at clinic) patient stated the appointment time of vaccination was 10:30. Medical history of the patient was allergic to molds and mucus and concomitant medications unspecified allergy spray indicated for stuffy mucus, allergy shots indicated for allergy to molds from unknown to ongoing. No relevant tests were performed to patient prior to vaccination. Patient didn't receive any other vaccinations with in 4weeks time of vaccination. The patient stated that she got the vaccine she did not report that she takes a shot for allergies. Since getting the vaccine she has not been feeling up to par. On 04Feb2021 She has also been having diarrhea. she stated that the diarrhoea was not watery. It was soft and not much is coming out, Patient is not feeling well. Events did not require a visit to emergency room or physician office. The outcome of the events Malaise was unknown and the outcome of diarrhoea was recovering. Follow-up attempts are completed. No further information is expected.
87 2021-06-29 vomiting urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg... Read more
urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg pain; fatigue; Severe headache; This is a spontaneous report from a contactable consumer. A 87-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 10:00 as a single dose for COVID-19 immunization and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 16:00 as a single dose for COVID-19 immunization. Medical history included allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergies to medications that contain dynacin; Allergic to Gabapentin; and has allergies to all antibiotics that end with 'cycline'. Pertinent Details Include surgical procedures and dates: She was given doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The pharmacy gave her about 5 other medications that end with 'cycline' and she was highly allergic to all of that so when she goes to the doctor she cannot take anything that has that in it. There were no concomitant medications. About a week after her second dose, she started having severe headache, pain in her legs, weakness, and fatigue. At one point, she collapsed because of weakness in her legs. Caller said they have gone to their HCP 6 times: 3 times with their urgent care doctor, 2 times with doctor, and 1 time in the emergency room. She wanted to know what to do with the adverse events. On 04Feb2021 she was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 14Feb2021 she saw her primary care doctor for severe headache. She was sent to the emergency room for the severe headache where she had a CAT scan in case she was having a brain bleed or stroke, but everything checked out just fine, they thought they were safe. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. On 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed Cyclobenzaprine as a muscle relaxer and Tramadol as pain medication. Before she took any of the Cyclobenzaprine or Tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again and he said to stop the Cyclobenzaprine and changed Tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the Tramadol and start taking Tylenol. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being real shaky and real weak. Each time they were seen by the doctor or at urgent care they drew blood and said everything was ok. On 02Mar2021 they started thinking maybe it's the Pfizer COVID-19 Vaccine. She called to ask if these events are side effects of the Pfizer COVID-19 Vaccine. Her bloodwork was fine, her urine tests since after 16Feb2021 are fine, the CAT scan showed her head is fine; but she still has severe weakness; she was walking with a cane now and before she was very active. The patient was treated with cyclobenzaprine: 5mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022; Tramadol: 50mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022. There are only 2 tablets missing from the bottle so caller believes patient took 1 whole tablet once, and then 1/2 tablet 2 different times and started vomiting so Tramadol was stopped; Tylenol 8 Hour Arthritis: 650mg strength. Lot: SBA002, Expiry: Dec2022; UPC: Unknown, there is no UPC or barcode on the bottle she has with her, but there is a little kind of icon with a stamp with some numbers above it; Phenazopyridine: 100mg strength tablets, Ciprofloxacin: 500mg strength, Cephalexin: 500mg strength. Outcome of the events was unknown. Medications that contain dynacin: Lots/NDCs/Expiries: Unknown, they do not have products, this occurred in before patient moved about 1 year ago. Gabapentin: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Doxycycline: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Antibiotics that end with 'cycline': Lots/NDCs/Expiries: Unknown, they do not have products, this occurred before patient moved to about 1 year ago. Reported patient was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. Urine tests since after 16Feb2021 are fine. Phenazopyridine: 100mg strength tablets. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC# Ciprofloxacin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #.Cephalexin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #. No follow-up attempts are possible. No further information is expected.
87 2021-07-01 nausea Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mout... Read more
Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mouth, fatigue, severe headaches, and confusion. On and off symptoms daily until 05/10/2021 severe weakness ER (by ambulance) confirmed Stroke. Bed-riddened currently and still severe confusion.
87 2021-07-01 nausea tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; This is a spontaneous report f... Read more
tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 87-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right at the age of 87-year-old on 03Feb2021 at 13:45 as single dose for covid-19 immunization. Medical history included 10-year cancer survivor, 2016 mild heart attack, thyroid imbalance, dust mites, mold, mildew. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Feb2021 02:15 the patient experienced tiredness, headache, muscle pain, joint pain, nausea, feeling unwell. The patient did not receive treatment for the events. The outcome of events was recovered on an unspecified in Feb2021. Follow-up attempts are completed. No further information is expected.
87 2021-07-10 nausea Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. An 87-year... Read more
Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. An 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 10Feb2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of cancer survivor. The patient had no known allergies to medications, food, or other products. The patient did not take any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 22Jan2021 at 16:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 12:00, the patient experienced dizziness and nausea. The adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient had received any treatment for reported events. The clinical outcome of the events of dizziness and nausea was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
87 2021-07-10 nausea she started really itching; red spots one on each finger and each arm; nausea; she can't really slee... Read more
she started really itching; red spots one on each finger and each arm; nausea; she can't really sleep; This is a spontaneous report from a contactable consumer (patient). via information team. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: Unknown), via an unspecified route of administration in the right arm on 28Jan2021 about 15:00 ( at the age of 87-years) as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to penicillin. Patient had no concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect nor any prior vaccinations within 4 weeks or additional vaccines administered on same date of the pfizer suspect vaccines. After vaccination, the patient was doing fine until around 13Feb2021 when she started really itching, red spots one on each finger and each arm, nausea, and can't really sleep. The events did not require any emergency room or physician office visit or hospitalization. No relevant tests were done. She was due to receive her second dose of vaccine on 19Feb2021. She asked if this was normal side effect and whether she should receive her 2nd dose of the Pfizer Covid vaccine if she suspects a non-immediate allergic reaction about a week later. Outcome of the events was not recovered. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
88 2021-01-13 nausea, vomiting On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired.
88 2021-01-13 vomiting EVENING OF 1/13/21, DEVELOPED FEVER OF 100.2, THREW UP, AND WAS THIRSTY.
88 2021-01-13 vomiting Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and ... Read more
Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.
88 2021-01-18 abdominal pain lower 1. Lower abdomen pain 2. Confused Attending physician requested resident be sent to ER for further e... Read more
1. Lower abdomen pain 2. Confused Attending physician requested resident be sent to ER for further evaluation
88 2021-01-20 nausea, abdominal discomfort sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); ... Read more
sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); Dry mouth; nausea; This is a spontaneous report from a contactable consumer (patient). This 88-year old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient experienced sore arm. Since an unspecified date in Jan2021 she was lightheaded and kind of dizzy, her stomach did not feel great, she had dry mouth and nausea. She was feeling as if she could get sick (further specified as nausea). She had not got sick but her stomach wasn't the best. Events outcome was unknown. Information on the lot/batch number has been requested.
88 2021-01-21 nausea very nauseated after injection. Close to vomiting. BP 149/74, HR 95. Given water to sip on and mon... Read more
very nauseated after injection. Close to vomiting. BP 149/74, HR 95. Given water to sip on and monitoring. Repeat BP 151/72, HR93. Nausea resolved after 20 minutes
88 2021-01-24 nausea Extreme nausea, hot flashes, dizziness, strange head, fatigue, nasal congestion, sore throat, runny ... Read more
Extreme nausea, hot flashes, dizziness, strange head, fatigue, nasal congestion, sore throat, runny nose, sneezing, sore arm,
88 2021-01-25 diarrhea, vomiting Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of th... Read more
Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of the night; delusional; confused; This is a spontaneous report from a contactable consumer. A 88-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 13:30 at a SINGLE DOSE for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and COVID-19 prior vaccination. Concomitant medication included gabapentin (GABAPENTIN), hydrocodone (HYDROCODONE), haloperidol (HALDOL), levothyroxine (LEVOTHYROXINE), insulin aspart (NOVOLOG) , lisinopril (LISINOPRIL), lorazepam (LORAZEPAM), sennoside a+b (SENNA [SENNOSIDE A+B]), trazodone (TRAZODONE). The night after the vaccine was administered (10Jan2021), the patient experienced a bad case of vomiting and diarrhea. The patient has become aggressive, combative and short tempered. She was up and down most of the night, delusional and confused. Therapeutic measures (Lorazepam) were taken as a result of the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
88 2021-01-29 nausea, diarrhea, vomiting Mild headache, diarrhea, nausea, vomiting, sore arm
88 2021-02-03 faeces discoloured BLACK STOOLS 2 days ago (Tuesday) she started with watery, black stools It was very frequent. Wed... Read more
BLACK STOOLS 2 days ago (Tuesday) she started with watery, black stools It was very frequent. Wednesday - it was still black but not as often Thursday - This morning it has been brown. No pain or cramping. No dizziness.
88 2021-02-04 difficulty swallowing 1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with func... Read more
1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with functional decline and overall decline in mentation. Has impacted functional level (requiring increased assistance with feeding, bathing, dressing, toileting) and speech/swallow ability. Decreased ability to respond/converse with staff
88 2021-02-05 nausea, diarrhea joint pain & cold symptoms, diarrhea & nauseam , high pressure , lethatgy, called dr. and was ... Read more
joint pain & cold symptoms, diarrhea & nauseam , high pressure , lethatgy, called dr. and was treaTED OVER PHONE
88 2021-02-07 nausea Very dizzy when I got up at night. In morning somewhat nauseous, could not get out of bed. chills ... Read more
Very dizzy when I got up at night. In morning somewhat nauseous, could not get out of bed. chills and light headed. general feeling terrible. felt somewhat better by around 4PM. but still a little headed the next morning. Took Aleve and 2 Magnesium pills
88 2021-02-08 abdominal discomfort, stomatitis Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightn... Read more
Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face
88 2021-02-08 diarrhea, vomiting I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset... Read more
I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.
88 2021-02-09 nausea, abdominal pain upper high blood pressure/blood pressure was sky high; she didn't feel well/not being well; dizzy; nausea;... Read more
high blood pressure/blood pressure was sky high; she didn't feel well/not being well; dizzy; nausea; sharp pain in stomach; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 into left arm at single dose so she wouldn't die from COVID-19, she is 88. Medical history included cancer survivor, patient had one kidney, that kidney was stage 4 kidney disease and was not on dialysis, the one kidney was kidney cancer in 2010; high blood pressure; had blood clots from 2017; heart disorder; iron was low; having problems with memory. Concomitant medications included amlodipine started taking it years ago and hydralazine both for high blood pressure, bupropion, iron started a year and a half before (in 2019) for iron was low, all ongoing; donepezil started taking it in 2011 or 2012 as memory medication, apixaban (ELIQUIS) started taking two years before (in 2019) for blood clots, isosorbide started it so many years for heart, quetiapine from 2011 for having problems with memory. The patient previously took another medicine for blood clots. The patient went to hospital for the following side effects: dizzy and nausea on 23Jan2021, sharp pain in stomach in Jan2021, high blood pressure on 24Jan2021. Reporter would like to know if this side effects were reported or what should she do for her mom. Patient had just not being well in Jan2021 after received bnt162b2. Reporter had to take her mother to the ER 24Jan2021, and right now patient was dizzy, had nausea, and reporter took her to the ER yesterday and they couldn't find anything, and reporter was trying to find: was this due to the vaccine. Patient said she didn't feel well, since Saturday (23Jan2021). Patient now had a lot of stomach pain, so reporter took patient to the ER on 24Jan2021, and did a lot of tests, and her blood pressure was sky high, reporter wondering did the vaccine affect blood pressure. Patient was just not herself, and reporter knew the patient, patient had been doing pretty good, but was not herself. Reporter stated they let patient came home from the hospital on 24Jan2021, clarified she was in the ER on 24Jan2021, was not admitted to hospital. The outcome of event nausea was not recovered, outcome of the other events was unknown.
88 2021-02-09 vomiting throwing up/vomiting; got very sick; This is a spontaneous report from a contactable consumer. An 88... Read more
throwing up/vomiting; got very sick; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 to 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient reported that she was taking unspecified concomitant medications. On 21Jan2021 at 11:30, the patient got very sick, throwing up/vomiting and it lasted about 3 and a half hours until 3 or 3:30 or 4. The patient took Zofran to s top throwing up. The outcome oft he events was recovered on21Jan2021. The next dose is scheduled on 11Feb2021. Information about lot and batch number was requested.
88 2021-02-09 vomiting Vomiting episodes 2/6/21
88 2021-02-10 diarrhea, decreased appetite 7 days after receiving the vaccine, patient suffered excessive diarrhea and slight coughing. 9 days... Read more
7 days after receiving the vaccine, patient suffered excessive diarrhea and slight coughing. 9 days after vaccine, patient was tested for Covid 19, and received positive results. Patient was transported to hospital via ambulance but hospital returned her to the nursing home since chest was clear, no respiratory issues, and no fever. 10 days after receiving the vaccine, patient was turned over to hospice care but still in the nursing home. Hospice was called in to provide better physician advice and access 24/7. 14 days after receiving vaccine, patient began experiencing excruciating body aches, coughing, low oxygen levels, and no appetite. 18 days after vaccine, patient died.
88 2021-02-12 diarrhea, painful swallowing Very loose bowels, causing incontinence twice, intermittently from Feb. 8 through today (13th). Al... Read more
Very loose bowels, causing incontinence twice, intermittently from Feb. 8 through today (13th). Also, since Feb. 10, a mild sore throat, hurting only when I swallow. Both of these symptoms are unusual for me. Generally, I feel normal, able to eat, sleep, take walks, etc.
88 2021-02-16 nausea SOB, DOE, oxygen desaturation, nausea. Ems transport to ER for eval
88 2021-02-18 nausea Patient experienced nausea. consulted with NPdid vitals o2 98% hr 94 hx of afib bp 146/91; patient ... Read more
Patient experienced nausea. consulted with NPdid vitals o2 98% hr 94 hx of afib bp 146/91; patient was feeling fine stayed 30 minutes had caregiver with her to drive home
88 2021-02-25 diarrhea Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 202... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 2021. On February 25th at 10:36 AM,Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a "hacking cough,feels terrible, and now has had diarrhea x2". Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired.
88 2021-02-28 nausea hardly got sore; Chills; Nausea/Nauseated; This is a spontaneous report from a contactable consumer,... Read more
hardly got sore; Chills; Nausea/Nauseated; This is a spontaneous report from a contactable consumer, the patient. A 88-years-old female received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration in left arm on 11Jan2021 at 14:00 (at the age of 88-years-old) as a single dose for Covid-19 immunisation. Medical history included Covid-19 from Dec2020 to an unknown date ('quarantine was over a few days before Christmas'.), Heart attack, Had four stents placed, ongoing Blood pressure high , ongoing blood cholesterol , drug hypersensitivity ('allergic to lots of medications'). Concomitant Medication include 'blood thinners, blood pressure, cholesterol, that sort of thing'. No additional details provided. No other vaccines were given within 4 weeks. On 12Jan2021, The patient experienced chills all day long. She never ran a temperature. She got nauseated around 9:00 PM-9:30 PM and on an unspecified date reported she hardly got sore, no additional details provided. She drank ginger ale, went to bed. She got up the following morning and was fine. By 13Jan2021 she felt fine and no longer had chills or nauseated. The adverse events did not require a visit to the emergency room or physicians office. Consumer inquired if she can use antipyretics before or after vaccination of the covid-19 vaccine. The patient is scheduled to get the second dose on 01Feb2021. The clinical outcome of the event is chills and nausea were recovered on 13Jan20201 while hardly got sore was unknown.
88 2021-03-01 abdominal discomfort, diarrhea, abdominal pain upper Starting the morning after the injection experienced gastric upset and loose bowels and general mala... Read more
Starting the morning after the injection experienced gastric upset and loose bowels and general malaise. Loose stools have subsided but still feeling very tired and having gastric cramping.
88 2021-03-02 nausea Pt c/o "feeling different". Paramedic assessed pt- HR- 49; B/P- 190/91; R-12; SpO2- 99%. Pt states... Read more
Pt c/o "feeling different". Paramedic assessed pt- HR- 49; B/P- 190/91; R-12; SpO2- 99%. Pt states she was nauseated. Per caregiver, pt tends to be hypotensive. Rechecked B/P- 180/80; P-42. Continued to talk with pt and caregiver. Pt requested PHN call her PMD. Attempted to call PMD- he was not in the office and staff didn't know what time he would be back. Decision made to send pt to ER for evaluation as B/P continued to be elevated and HR was low. Final vitals as leaving- B/P 191/91; HR-40. Pt given Zofran in ambulance for nausea.
88 2021-03-08 loss of appetite, decreased appetite 1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimpose... Read more
1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA
88 2021-03-11 nausea Patient felt weak and nauseated, was hypotensive and heart rate was 41. Patient was pale but respons... Read more
Patient felt weak and nauseated, was hypotensive and heart rate was 41. Patient was pale but responsive. Ambulance was called, patient taken to Hospital Medical Center via ambulance.
88 2021-03-18 diarrhea She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and... Read more
She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing. She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish. Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM. She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles. She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom. She then took her temperature and it was 100.7, which her normal is 97. 3. She slept from 11:00 PM Wednesday until 11:00 AM Thursday. She could not stay awake for long before falling back to sleep. Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday. Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period. She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s. She's achy, and has rubbed on Aspercreme and has taken Tylenol a couple of times. She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up. She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
88 2021-04-01 vomiting She needs to get her magnifying glass, she states she's going blind/macular degeneration; She needs ... Read more
She needs to get her magnifying glass, she states she's going blind/macular degeneration; She needs to get her magnifying glass, she states she's going blind/macular degeneration; temperature 99.2; vomiting; very tired; arm was sore, couldn't lay on it; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809) intramuscularly, administered in left arm on 23Feb2021 at 10:30 (at age of 88 years old) at a single dose for COVID-19 immunization; gabapentin, via an unspecified route of administration from 08Feb2021 to 15Feb2021 at 100 mg, daily, then via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported; Expiration Date: 08Feb2022) to an unspecified date, at 200 mg, daily for feet burn. Medical history included hiatus hernia surgery from Nov2019, surgery from an unknown date, vomited after surgery for three nights/days, gastrooesophageal reflux disease (GERD), cancer, feet burning, feet red, asthma and thyroid. Concomitant medication included paracetamol (TYLENOL EXTRA STRENGTH), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, montelukast sodium (SINGULAIR), fluid pill, vitamin D, vitamin C, potassium, acid reflux pill before nighttime before supper, thyroid pill, singulair pill. The patient previously took Codeine and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. Two years before in Nov2019 she had hiatus hernia surgery. Her stomach went into her chest. She was in rehab. She had to have the surgery done twice. She went from one hospital and then she went to another and it was taken care of there. When she went to rehab after her surgery, all she did was vomit day in and day out. Her current vomiting reminds her of this experience. They finally did take care of it. She came out of the hospital and was vomiting. She clarifies she had problems with vomiting for the last 6 months before this current experience. She doesn't know what she's eating. They say it's acid and she has Gerd. She does try to get her exercises in. When she was in the hospital, they found she had cancer, which they are just watching for now. When querying what kind of cancer she has, the caller explains she didn't have them do a biopsy. She didn't want to go that far into it. She didn't want any extensive treatment. At first, they were keeping check of the cancer every 3 months. Now, she is going ever year. She last went in November. The patient experienced macular degeneration on an unspecified date, vomiting on 23Feb2021 at 17:30, temperature 99.2 on 25Feb2021 at 10:00, very tired on 23Feb2021, arm was sore couldn't lay on it on 23Feb2021. Patient had the first Covid vaccine Tuesday morning, clarified to 23Feb2021 at 10:30AM and around 5:30PM that night she started vomiting. She vomited all night long and all day Wednesday and Wednesday night, and this morning. So far, it had stopped. She was trying to hold water down, but she couldn't keep water down, the water would come up. She clarifies further she tried to take a sip but it kept coming up. She called her doctor who was a practitioner and she told her to drink ginger ale and maybe crackers. She told the doctor that her daughter sent her electrolytes and she was told that was fine to take. She tried toast this morning and she couldn't hold it down. She's been eating very slow, taking little bites at time and she had been holding it down. She did have temperature of 99.2 on 25Feb2021, but half hour or so before it was down to 96 now. She couldn't take medicine that she normally takes because she'll throw it up anyway. She tried to take a few of her pills but it didn't stay down, she threw them up. Around 9am, she took her thyroid and that stayed down. So far, that's doing good. She takes Advair for asthma and she took that, that's okay. She took her singulair pill. So far, the three of these medications have stayed down, and she took 2 Tylenol. Patient took Tylenol twice. She knows it was Extra strength, took 2 pills Tuesday night but it didn't stay down. She Took 4 Tylenol today, 2 pills this morning and 2 right before her CNA left at around 3pm. Caller mentions she can't see the dosage on her Tylenol bottle. She doesn't see the dose. She mentions she will get her magnifying glass to check it out. She's afraid because she had surgery a couple years before and she vomited after surgery for three nights/days, or whatever. Today (25Feb2021), when she spoke to her doctor she was advised to call Pfizer to let them know how the vaccine is affecting her. Right now, she feels pretty good, but she was very, very tired. She's going to lay down when she gets off the phone. She had a CNA with her today and she also spoke to the nurse practitioner. The last time she vomited was around 10am. When the CNA came in, she told the caller to call the doctor but she told the CNA she'd be fine. However, the CNA urged the caller to call her doctor and let them know what was going on. Her second dose was scheduled for 16Mar2021. Her doctor told her don't drink the water, drink the ginger ale and don't drink it too fast, and try crackers and toast. The patient took her temperature last night (24Feb2021) but couldn't read it that great, she thought it was 98. When the CNA came this morning (25Feb2021), she took it around 10:00AM and it was 99.2. She told the CNA to take another temperature because she didn't think she had a fever. When the CNA left, she had to leave at 3:00PM, her temperature was normal, it was 96. She thinks maybe her temperature went to 99.2 because she was drinking her tea. However, she wasn't drinking it right away, because she threw up on it. She stopped drinking an hour before her temperature was taken. She clarifies wasn't drinking the tea when the CNA came. She also mentions she broke up her the toast into little tiny pieces and felt like she was eating like a bird, but it didn't stay down so she stopped. The CNA came around 9am, maybe 8am, and clarifies it was maybe around 1030AM when she took the temperature. When the CNA left her temperature was at 96. The patient was very tired the same day she received the vaccine. She remembers went to bed with clothes on. Last night, she wanted to go to bed again with her clothes on but she couldn't stand it and she changed into her pajamas. Then, she went to the bathroom and vomited, she has a bucket by the side of her bed. It wasn't the dry heaves, stuff was coming up. She was still very tired currently. She makes the comment "I forget things and then I remember afterwards". She had to get under the light to see the Covid card, it's small, it is handwritten. Caller mentions she sees the month on it. Caller reports her arm bothered her for quite a while. Last night, she went to sleep on her left side and her arm was feeling better which gave her some hope. Her arm started hurting her the day she got the vaccine, but her arm wasn't red or anything. Her arm was feeling better this morning. She thinks if she can sleep on it and didn't hurt, it's getting better. The last pills she took were Gabapentin she has been on for about 2 weeks. She explains her feet burn during the night and the doctor recommended the Gabapentin for now. However, she has had too much time trying to stop the vomiting that that took over her feet burning, so her feet didn't bother her as much. She was initially prescribed 1 pill at night before going to bed at 10pm, then when the 1 pill didn't work for a week, the doctor increased it to 2 pills at bed time at 10pm because it takes an hour to work. She stated that she was going to take the Gabapentin on Tuesday night, which was a mistake because she threw it right up and it tasted awful. Caller makes the comment she has not given the doctor the report of how that reacted yet. When probed for an NDC, Lot number or expiry date for the Gabapentin, the caller explains she can't see writing, it's in small print. She does see the Discard After: 08Feb2022. She needs to get her magnifying glass, she states she's going blind. She's been told she had macular degeneration. She doesn't think the Gabapentin is agreeing with her. She reads that it "May cause drowsiness, operating vehicle which she doesn't drive, may cause dizziness, may cause vision. Call if you experience mood changes, sadness, depression.." She started out taking one pill of the Gabapentin every night from Monday to Monday. The second Monday, 15 Feb2021, she started taking 2 pills at night for a total of 200mg. She took it this past Monday night until she had the vaccine and then she took it again, and now she was not taking it anymore. Her burning feet wake her up during the night, it starts at her ankles and goes halfway up her leg. She had to put her feet on a cold floor. Normally, she feels good and she usually doesn't get pain so whatever little bit of pain she has, that's the pain she gets. Her feet were burning like that for month before she called the doctor. she didn't know. Her feet were red before they started to burn, this is the latest thing. During the day, she is fine, only a nighttime her feet burn. The patient underwent lab tests and procedures which included body temperature: 98 on 24Feb2021; 99.2 on 25Feb2021; 96 on 25Feb2021. Therapeutic measures were taken as a result of vomiting. She was going in for a test, clarified as an MRI on the 3rd of March for her eyesight. The action taken in response to the event for gabapentin was permanently withdrawn on an unspecified date. The outcome of the event "Pain in arm" was recovering, the outcome of the event fatigue was not recovered, the outcome of the events "temperature 99.2" and "Vomiting" was recovered, and outcome of other events was unknown.
88 2021-04-07 vomiting, decreased appetite I threw up my dinner that night, had 4 terrible shaking Chills over that weekend and continued chil... Read more
I threw up my dinner that night, had 4 terrible shaking Chills over that weekend and continued chill for about a week, weakness in legs, fatigue, sleeping for hours, no energy, itchy skin, no appetite (lost 8 pounds), continued mental disorientation and unusual forgetfulness, also inablity to type correctly or to tell stories that I had just rehearsed, I also lost 20% of hearing in left ear, After 5 weeks I am about 95% OK physically, but still very slow with brain power and typing.
88 2021-04-09 decreased appetite, abdominal pain hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pai... Read more
hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician. A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative. No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
88 2021-04-11 nausea On day 4 after second shot, I had headaches and nusea which lastes for several days.
88 2021-04-14 profuse gastrointestinal bleeding GI Bleed Anticoagulant adverse reaction, initial encounter ALTERED MENTAL STATUS EXTREMITY WEAKNESS ... Read more
GI Bleed Anticoagulant adverse reaction, initial encounter ALTERED MENTAL STATUS EXTREMITY WEAKNESS Angiodysplasia of colon with hemorrhage
88 2021-04-30 vomiting, decreased appetite chills; legs were weak and wobbly; legs were weak and wobbly; so tired; sleep for hours; no appetite... Read more
chills; legs were weak and wobbly; legs were weak and wobbly; so tired; sleep for hours; no appetite; lost 20% of hearing in left ear; diminished mentally, unable to think or talk straight or type properly; I threw up; cold; lost 8 pounds; This is a spontaneous report from a contactable consumer (patient). An 88-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 19Feb2021 11:45 as single dose for covid-19 immunization in a nursing home. The patient's medical history was not reported. No known allergies. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient has not had COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient previously received the first dose of bnt162b2 (lot number: not reported) on 29Jan2021 on the Left Arm for COVID-19 immunization. On 19Feb2021 20:00 (8:00 pm), the patient experienced chills, legs were weak and wobbly, so tired, sleep for hours, no appetite, lost 20% of hearing in left ear, diminished mentally, unable to think or talk straight or type properly, threw up, cold for 2 weeks, and lost 8 pounds. The patient underwent lab tests and procedures which included weight: lost 8 pounds on 19Feb2021. No treatment was received. The reporter considered the events to have caused disability. The outcome of the event chills was recovered with sequela on 22Feb2021 while for the rest of the events was recovered with sequela on unspecified dates. Information on the lot/batch number has been requested.
88 2021-05-04 vomiting I thought I had the COVID; I thought I had the COVID; Flu like symptoms; Throwing up/I threw up; sic... Read more
I thought I had the COVID; I thought I had the COVID; Flu like symptoms; Throwing up/I threw up; sick/deathly sick/ ill; chills; hot flashes/hot spells; night sweats/I perspire the whole night; Sweating; I had stomach problems; I hurt all over; I fell and tore two ligaments in my hand; I fell and tore two ligaments in my hand; This is a spontaneous report from a Pfizer sponsored program and medical information team. Two contactable consumer (one of them was patient herself) reported that an 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration in right shoulder on 11Mar2021 (at the age of 88-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, thyroid, cholesterol, sleep. Concomitant medications included apixaban (ELIQUIS) orally at 5 mg, twice a day, mirtazapine orally at 15 mg, once a day (one at night) for sleep, levothyroxine orally at 150 ug, once a day for thyroid, metoprolol orally at 25 mg, twice a day, fenofibrate orally at 150 mg, once a day, benazepril orally at 10 mg, once a day for blood pressure. Consumer stated, "patient was taking these from years and she would take them for rest of her life." The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 16Feb2021 (at the age of 88-year-old) as a single dose in right shoulder for COVID-19 immunization. It was reported that, caller states that she was transferred from reporting her side effects after receiving the second dose of the Pfizer COVID-19 vaccine. She was not sure if it was someone in DSU, however, she states, "they took all of her information." The caller was an 88-year-old female who received the second dose of the Pfizer COVID-19 vaccine on Thursday 11Mar2021 and then the next day (12Mar2021) she states, "patient thought she had the COVID, she had flu like symptoms, and throwing up, she was so sick but now (on an unspecified date in 2021) she was just stuck with chills, hot flashes and night sweats. Today patient have not had any chills but mostly just the hot flashes. Patient don't think she have a fever. Patient went to the Ear Nose and Throat doctor yesterday for her ears and she did not have a fever there and the doctor told her he does not know anything about chills. Caller wants to know what she take to help these symptoms. Consumer stated, "patient tried calling last night but she waited for 2 hours and she felt asleep. Patient had her COVID second shot last Friday she have been sick since. Patient have the chills off and on in the day and at night she perspire the whole night. Patient have never felt this before it was crazy. Enquired was that from the COVID vaccine or not. Could she ask you a question. Do other people have chills and sweating or not. Was that one of the problem or side effect of vaccine." Consumer was informed about Pfizer Medical information department. When probed if still experiencing the events, Consumer stated, "no she was only experiencing chills and sweating on an unspecified date in 2021, and she never sweat it was something new for her. It was persisting at least 3 times a day she have chills and at night it hits her. Enquired was there something she could take or not. Patient tried Tylenol, she tried Norco it doesn't work." Consumer stated, "when she got her last shot which was on the 12th and she got sick, and it was horrible. Patient threw up, she had stomach problems on an unspecified date in 2021. Patient was chilling, she was sick. Patient thought she had the COVID, she hurt all over on an unspecified date in 2021. Chills and sweating. Patient thought she have got the COVID." Consumer stated, "no she was only experiencing chills, sweating and she never sweat it was something new for her. Its persisting at least 3 times a day she have chills and at night it hits her. Enquired was there something she could take. Patient tried Tylenol, she tried generic Norco it doesn't work." Received call from consumer regarding the Pfizer COVID vaccine. She was very ill. She thought she had the COVID. There was no prescriber. She spoke with someone else and was completing report and got disconnected. She does not have a report reference number. He got the medications and was going to speak with someone about a nurse where she could get questions answered. She was having hot flashes really bad and wants to ask someone what she can do to help with that. At the end he told her he would give her a number to call to talk to a nurse about symptoms and what she could do about it. She was having hot flashes really bad and wants to ask someone what she could do to help with that. Caller received second dose of vaccine and felt "deathly sick" afterwards. Has been experiencing "hot spells and chills". Consumer stated, "patient got an X-ray on Wednesday (on an unspecified date in 2021) as she fell and tore two ligaments in her hand." Consumer stated, "she took Tylenol and generic Norco. Patient took generic Norco 10/325 this morning. Patient don't take Tylenol and generic Norco together." The patient underwent lab tests and procedures which included weight: 88.9 kg on an unspecified date, X-ray: Unknown results on an unspecified date in 2021. The outcome of the events chills, sweating was not recovered and unknown for the other events. Description of Product Complaint: Consumer stated, "patient tried calling last night but she waited for 2 hours and she felt asleep. Patient had her COVID Second shot last Friday she have been sick since. Patient have the chills off and on in the day and at night she perspire the whole night. Patient have never felt this before it was crazy. Enquired was that from the COVID vaccine or not. Could she ask you a question or not. Do other people have chills and sweating. Enquired was that one of the problem or side effect of vaccine."
88 2021-05-05 decreased appetite weakness loss of appetite continue fluids, continue soft diet, chicken soup Tylenol extra strength ... Read more
weakness loss of appetite continue fluids, continue soft diet, chicken soup Tylenol extra strength for aches and pains and fever
88 2021-05-11 nausea, diarrhea Dx Diarrhea ? Cough ? Nasal Congestion ? Nausea
88 2021-05-18 decreased appetite ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team W... Read more
ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 3/30/2021 Admission Date: 3/28/2021 Length of Stay: 2 Days Discharge Date: 3/30/2021 Admission Diagnosis Hospital Problems POA * (Principal) Weakness Yes Hypothyroidism Yes Pure hypercholesterolemia Yes Benign essential hypertension Yes Atrial fibrillation Yes Acute cystitis without hematuria Yes Generalized weakness Yes COVID-19 virus infection Yes Chronic respiratory failure with hypoxia Yes Home Under Care of a company unnamed CODE STATUS: Full Code Active Issues Requiring Follow-up Finish course of antibiotics. Participating remote monitoring. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture Preliminary result Blood culture Preliminary result Hospital Course HPI: Patient is a 89 y.o. female with PMH listed who presents from home with her daughter complaining of about a week of increased weakness/fatigue and cough. The fatigue is their primary concern, as this is so profound she will fall asleep on the toilet or even in the middle of getting dressed. Appetite is decreased, but she denies N/V/D. She feels "chilled", but no known fevers, no rigors/sweats. Cough is occasionally productive of sputum, mostly clear but sometimes with small "chunks"; no hemoptysis. No LE edema. No HA or changes in taste/smell. No known sick contacts, but patient has exposure to multiple daughters who help care for her, and she has been attending church recently. Urine is dark/strong, but she denies dysuria. Pt has received both doses of COVID-19 vaccine, second dose on 3/17/21. Hospital Course: Patient was admitted to medical floor for COVID-19 infection and urinary tract infection. Patient had a very mild course of illness. Decadron was started but patient did not require any remdesivir. Patient has remained at her seen home oxygen requirement. Patient was seen by PT and OT services for generalized weakness. Blood cultures have been negative. Patient is medically stable for discharge home today. She will need another 2 days of antibiotics treatment for urinary tract infection. Since her respiratory status has been very stable, we have chosen to discontinue the use of Decadron upon discharge to avoid any changes in mental status induced by steroids in an elderly patient. Home health services and remote monitoring kit have been ordered at the time of discharge. I have called patient's daughter to provide update that patient is coming home today and answered her questions
88 2021-05-30 loss of appetite poor oral intake and fatigue, found to have acute kidney injury, hematuria and proteinuria. Renal f... Read more
poor oral intake and fatigue, found to have acute kidney injury, hematuria and proteinuria. Renal function progressively worsening. kidney biopsy performed on 3/30/21 showed granulomatous ANCA glomerulonephritis+ anti-GBM nephritis
88 2021-06-01 decreased appetite She got her vaccine, she had very little soreness, a little fever. Then two weeks later to the day ... Read more
She got her vaccine, she had very little soreness, a little fever. Then two weeks later to the day she was lethargic and she wouldn't stand up and said that she was not able to stand up. She seemed tired or having clarity and they did not know what was going on with her. She has never been one to express how she feels. She had ambulation difficulties and needed help getting out of bed or walking. She would hardly eat or drink water. This got progressively worse. They had to fine methods and ways to help her stand up and get her moving to go the restroom. She has improved. She was taken to an orthopedist and she has problems with her legs and knees arthritis. She did get a cortisone shot on 4/13/21 in both knees. They did not find anything wrong with her hips. Eventually the symptoms did go away and is almost back to normal. They had to get a lift chair to stand her up so she would not have to use her strength in her legs to stand up. She is now back to eating and drinking like she was. It took 2 1/2 weeks for her to recover from this.
88 2021-06-09 blood in stool, decreased appetite she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of ... Read more
she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of blood; Is having difficulty breathing; Slight temperature; Wakes up in morning with sweat; Food just doesn't taste right; Has been drinking a lot of water because she wants water; Mouth is so dry; Walking is much worse, has to hold onto everything; Weak; Not eating like she used to, eating the minimum to survive; Coughing and bringing up phlegm; Gets chills once in a while; Sleeping an awful lot; Coughing and bringing up phlegm; she had pressure in her heart; pain as aches and pain; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021),via an unspecified route of administration, administered in Left Arm on 19Feb2021 in between 2:15-2:30 as 1st Dose,0.3mL, Single Dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, blood pressure abnormal(High blood pressure), hospitalized prior to the COVID Vaccine. It was two years ago and she was hospitalized for COPD. Three years ago she went to visit her sister in and wound up with the Flu and Pneumonia where she almost died. She was still here. Cardiac disorder, atrioventricular block, heart problems for several years, Had a blockage, blood glucose abnormal, Had the Flu and that was how she felt. When she had a hard time breathing she did not know if it was the flu or pneumonia. So much stuff was put in her. Needles were being plunged in her. She did not know what she was given. It was a really rough time. Patient also broke her finger in Dec2020. Infection set in after her finger was set with a metal plate. The metal plate dug into her finger and created an infection. She was in excruciating pain. The metal plate was taken off and has been told she will have a mullet finger. Stated kids get it from sports and is where the finger just hands. The finger doctor told her there was nothing that can be done because the bone has disintegrated into her body. Concomitant medications included insulin glargine (LANTUS)Product strength and count size dispensed: 100 units ml 3mg prefilled pen, was originally taking Lantus, 20 at night, but it wasn't doing the job. Dose was split to 15 in the morning and 15 at night, NDC: 0088-2219-01,Lot: OF7051A,Exp: 2023 ; Insulin (HUMALOG) NDC: 0002-8799-01 ,Lot: Unknown, Expiry:Jun2022,Had to get into light to read Humalog. Didn't see lot number, taken for blood glucose abnormal. Doesn't take that often. Only takes if blood sugar is over 150. No History of all previous immunizations with Pfizer vaccine considered suspect were provided. With regards to prior vaccination within 4 weeks, stated she fell and hit her head and had to get four staples in Dec2020. She was given a vaccine for tetanus and diphtheria and stated maybe a slight rash or achy, a little red, but never any other reaction. No Additional vaccines administered on same date of Pfizer suspect. Did not require a visit for AES. The patient received the 1st dose of the Pfizer covid vaccine on 19Feb2021, scheduled for her 2nd dose on 12Mar2021. She says this was the 5th day of her having flu-like symptoms, which she previously reported. This morning she had pressure in her heart for which she took Nitro. As she was trying to get to the bathroom, she almost passed out however she was able to grab unto the bed and did not fall. She then went to the bathroom and had a bowel movement with quite a bit of blood. She does report a history of heart problems for several years. Had a blockage. Had one COVID Vaccine and now has all kind of Flu like symptoms. Had a slight temperature. Wakes up in the morning with sweat, pain, and food just didn't taste right. Had Flu before and was having a lot of Flu like symptoms. Was having difficulty breathing and coughing. Also had COPD. Wanted water and had been drinking a lot of water. Her mouth wa so dry. Stated she was sort of used to the difficulty of breathing. Had been in the hospital for COPD. Stated her walking wasn't that great to begin with, but now was much worse. She had to hold onto everything. was not eating like she used to, only the minimum to survive. She was weak. Had been having difficulty breathing a lot before the COVID Vaccine. Didn't know if she COVID Vaccine just got it started a little more. Was constantly blowing her nose and bringing up a lot of phlegm, but she knew that was from her COPD. Got the chills once in a while. Was freezing and then warm. Has been sleeping an awful lot. The patient underwent lab tests and procedures which included body temperature: 99.4 slight, glycosylated haemoglobin:10.Wanted to finally go out a little bit and walk around. Had been in the apartment for so long. Went back for second COVID Vaccine on 12Mar2021. Wanted to get back into the swing of things. Therapeutic measures were taken as a result of, she had pressure in her heart (cardiac discomfort). The outcome for the events was Unknown.
88 2021-06-15 nausea Previously reported with Moderna as vaccination which is in-correct. Pt received Pfizer so am re-su... Read more
Previously reported with Moderna as vaccination which is in-correct. Pt received Pfizer so am re-submitting. reports severe headache, nausea and weakness, no fever. Saw MD on 6-14 or 6-11; says MD told her it was a reaction to vaccination.
88 2021-06-16 diarrhea cough and had clear and sticky stuff that looked like jelly fish coming out; diarrhea; fever 100F; T... Read more
cough and had clear and sticky stuff that looked like jelly fish coming out; diarrhea; fever 100F; Tired; Chills/ has the shivers; feels really "limpy", "blah"; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female consumer intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 15Mar2021 at 11:00 at single dose in left arm for COVID-19 immunisation at the age of 88-year-old. Lot number EN6207, expiration date was 31Jul2021. Medical history included blood pressure high, arthritis. Historical vaccine included first dose of bnt162b2 on 22Feb2021 for covid-19 immunisation at the age of 88-year-old (1st dose, Lot: EM9809, Expiry date: 30Jun2021, Route: Intramuscular, Anatomical Location: Right arm). On 17Mar2021 at 03:45, the patient experienced cough and had clear and sticky stuff that looked like jelly fish coming out, diarrhea, fever 100F, Tired, Chills/ has the shivers, feels really limpy, blah (as reported). On 16Mar2021, body temperature was 100 and 99 Fahrenheit, Oxygen saturation 95-98%. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
88 2021-06-20 difficulty swallowing 2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and ... Read more
2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and difficulty in swallowing ease was noted. Repeat blood work confirmed kidney numbers still high after hydration, IV fluids given at home. Fatigue increased and I took my mother to the ER. She was admitted and she spent 3 weeks in the hospital, 1 week in ICU. She was eventually diagnosed with the autoimmune disease ANCA Vasculitis. Biopsy confirmed. No previous kidney disease or abnormal blood work. She was treated with high dose steroids and chemotherapy. There was no positive response to treatment. Condition worsened and she was moved to Hospice care. My mother died on 05/16/2021
88 2021-07-08 diarrhea, abdominal discomfort, abdominal pain upper, decreased appetite Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at In... Read more
Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at Injection Site/hives all over; Skin and Eyes Burning and Itching/her whole body is hot and itching; Couldn't Sleep; sweating and felt hot; Skin and Eyes Burning and Itching; sweating and felt hot; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; Diarrhea and Upset Stomach; Stomach Hurting; No Appetite; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; sickness; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 88-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation (reason: giving them and because she had bone marrow disease and doctor thought she should get it) at doctor office. Medical history included 2 aortic valve replacements (last one was replaced 3 years ago in May and the first one was replaced 5 years ago), ongoing autoimmune disease and ongoing acid reflux, bone marrow disease and Covid. Concomitant medication(s) included prednisone (5mg once a day by mouth; she had been taking it for a number of years for a condition auto immune disease and she has to take it for the rest of her life) taken for autoimmune disorder, and pantoprazole (40mg once a day by mouth; started probably 5years ago) taken for acid reflux, start and stop date were not reported. The patient previously took BNT162B2 (Lot: EM9809) as dose 1, single on 12Feb2021 for covid-19 immunisation; flu vaccine for asthma (when she got a flu shot years ago, she had to go to ER for an asthma attack from that; it was way back in the 1990s; NDC, Lot, Expiration: Unknown). No investigation assessment was done. No vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations (within 4 weeks). Family medical history relevant to adverse event was none. The patient experienced sickness on 05Mar2021; fever chills on an unspecified date, sinuses and nose plugged up; diarrhea and upset stomach; stomach hurting; no appetite on 08Mar2021; sweating and felt hot; and skin and eyes burning and itching/her whole body is hot and itching; and couldn't sleep on 12Mar2021; hives at injection site/hives all over on 14Mar2021, hurts to breathe on 15Mar2021; cough on 17Mar2021; tiredness; joint pain on 21Mar2021; muscle soreness on 22Mar2021, weakness on 23Mar2021. Therapeutic measures were taken as a result of this with BENADRYL, Z PACK, MYLANTA AND TYLENOL. Clinical course was as follow: The patient stated that she wondered if should've even had the vaccine. The patient had Covid in Mar2020 (a year ago in March) and she had long haulers until Jan2021. In March, her hematologist called and said she could get vaccine and stated that she shouldn't have. She stated that the second one made her really sick. This sickness was getting too long. Her second dose of the vaccine was on 05Mar2021. She was so tired; stated she doesn't feel good. She stated that she felt like she has long haulers all over again, it was horrible. Stated she felt like she shouldn't have gotten the second one. States she was doing okay with first one. Caller states that she already gave up a whole year of her life because of this. She tried to call before, but she didn't wait to talk to someone, she had to go somewhere. The patient stated that she had hives, tiredness, problems with her intestines, got really sick, her skin and eyes started to burn, she felt like she had hives all over, her skin was burning, she was sweating and felt hot, stated on the 14th it really got bad, her whole body was hot and itching. States that she took a BENADRYL and felt better the next 2 days and then started getting sinuses and nose plugged up and it hurt when she was breathing, had a slight fever, and her skin was itchy. She states that she went to doctor on 15Mar2021 (physician office visit), and he didn't think too much of it because her oxygen was okay. States that she felt worse, she was coughing bad, felt terrible, her muscles ache, and when she was hot, she couldn't sleep, now all she wanted to do was sleep and she had fever and chills. She was supposed to do exercises, but she couldn't, and it started two days ago. States she was not coughing as much but it was still hard and hurting. It was some of her joints, not all of her joints were hurting like when she had long haulers. Fever and chills started when her sinuses started acting up. The fever and chills kept getting occasional slips in and out. Her fever was not high but enough to get the chills. Sinuses and nose plugged up: it came and went with MUCINEX and it helped a little. Her intestinal problems were diarrhea that started on 08Mar2021 and upset stomach. She had a problem and it hurt terrible for days after. No appetite lasted for one week, so probably ended 15Mar2021. Caller states that she felt a little better but can't get rid of her cough. Couldn't Sleep: started when she had the burning and lasted a little after because she had to get herself together again. She could only sleep three hours at time. Skin and Eyes Burning and Itching: The burning and itching went away for a while, but it was back again because she had been lying in bed and tired, stated that it was not so bad. The burning stopped 15Mar2021 when the hives were gone, but she stated that right now it was back, her skin gets hot and then starts burning and itching. Patient stated that she did not have too much problems with first but this second, oh my god. She thought she got it too soon after having long haulers. She got rid of that in Jan2021 and was feeling good but now she felt terrible again. States there were no tests, she didn't have any. She was so weak, and she was having a hard time now, and she was doing so good. She was worried about her heart and valves. She guessed that call handler couldn't help her either, she stated that she didn't know what to do to feel better. She thought she had better call and report it. She has already gone to doctor and had only gone to him for 2 years, but hopefully he knew enough about her. She states that she probably should call him because she wasn't getting any better. The outcome for hives at injection site/hives all over was recovered on 15Mar2021, skin and eyes burning and itching/her whole body is hot and itching was not recovered, muscle soreness was not recovered, weakness was not recovered, cough was not recovered, tiredness was not recovered, joint pain was not recovered, fever chills was not recovered, sinuses and nose plugged up was unknown, diarrhea and upset stomach; stomach hurting was recovered on 11Mar2021, hurts to breathe was recovering , couldn't sleep was unknown, no appetite was recovered on 15Mar2021, sickness was unknown, sweating and felt hot was not recovered , sinuses and nose plugged up was unknown, skin and eyes burning and itching was not recovered, sweating and felt hot was not recovered. No follow-up attempts are possible. No further information is expected.
89 2021-01-12 decreased appetite, nausea, vomiting Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 ... Read more
Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.
89 2021-01-12 diarrhea, vomiting The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bl... Read more
The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bloody, non-bilious vomiting. At 12:00 pm she had an episode of loose stool. At 12:15 pm she was noted with generalized tonic-clonic seizure-like activity. Oxygen was applied via non-rebreather mask and resident was transferred to the Hospital Emergency Department for further evaluation. At the time of this report, she is stable in the ED and awaiting imaging studies. (head CT)
89 2021-01-17 decreased appetite Lack of Energy and Poor appetite
89 2021-01-18 vomiting, diarrhea Emesis, LBM, Grand Mal seizure activity
89 2021-01-21 diarrhea, nausea, vomiting Nausea and vomiting, diahrrea. Treated with Zofran and OTC Immodium. Symptoms decreasing but not gon... Read more
Nausea and vomiting, diahrrea. Treated with Zofran and OTC Immodium. Symptoms decreasing but not gone.
89 2021-01-21 nausea DEVELOPED NAUSEA WITHOUT VOMITING AROUND 0300 ON 1/19/21. WEAKNESS, LETHARGY, FATIGUE, AND REPORTS G... Read more
DEVELOPED NAUSEA WITHOUT VOMITING AROUND 0300 ON 1/19/21. WEAKNESS, LETHARGY, FATIGUE, AND REPORTS GENERALIZED BODY ACHES. HYPERTENSIVE AND TACHYCARDIC. WAS SENT TO PCP FOR EVALUATION. SYMPTOMS RESOLVED.
89 2021-01-21 vomiting, diarrhea, nausea Pfizer-BioNTech COVID-19 Vaccine EUA: Nausea & vomiting, diahrrea. Treated with Zofran (generic) and... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Nausea & vomiting, diahrrea. Treated with Zofran (generic) and OTC Immodium
89 2021-01-24 painful swallowing Patient developed rash 24-36 hours after vaccination received to L deltoid, started on arms and has ... Read more
Patient developed rash 24-36 hours after vaccination received to L deltoid, started on arms and has spread over body. 48 hours after vaccination patient reported painful swallowing due to swollen lymph nodes. Patient has been monitored at home by daughter, given tylenol as needed for discomfort, denies worsening symptoms at time of reporting to this clinic 1/25/21 10:00 am. Daughter denies need for evaluation at ED or office visit at this time, continuing to monitor. Discussed reporting any new or worsening s/s and seeking emergency medical treatment.
89 2021-01-27 loss of appetite, decreased appetite Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive fo... Read more
Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.
89 2021-01-28 nausea family states seemed short of breath since after the covid vaccine. Staff said beginning on 1/22/21... Read more
family states seemed short of breath since after the covid vaccine. Staff said beginning on 1/22/21 the patient seemed sluggish, more tired, and nausea noted. She stayed in her room more after the vaccine because worried about giving/getting COVID to others. was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room. at 12:15 AM on 1/27/21 staff noted not breathing, started CPR and called EMS. When EMS arrived they stopped the code because she was too long deceased.
89 2021-01-30 diarrhea Chills, Fever, Diarrhea
89 2021-02-02 vomiting, diarrhea on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30... Read more
on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30 Min Later. complaint of & Noted Diarrhea, Shivering, and vomiting SenT To ER 2/1 And Admitted Diagnosis: Sepsis
89 2021-02-02 vomiting Felt fine after shot. Around 3:45pm she was sitting on the sofa, saw a flash of light (which quickly... Read more
Felt fine after shot. Around 3:45pm she was sitting on the sofa, saw a flash of light (which quickly disappeared) and she started vomiting. No fever or muscle aches. She felt better after getting sick and has been drinking/eating light meals.
89 2021-02-17 diarrhea Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Syst... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: SLURRED SPEECH, INABILITY TO HOLD SELF UP IN CHAIR, INCONTINENCE-Medium, Additional Details: RN ADVISED PT HAD FEVER OF 101, DIARRHEA, WHOLE-BODY MUSCLE SORENESS, STROKE LIKE SYMPTOMS INCLUDING SLURRED SPEECH, INABILITY TO HOLD SELF UP WHILE SITTING IN A CHAIR, INCONTINENCE, AND CONFUSION ABOUT HER SURROUNDINGS, DATE, TIME, AND SITUATION. ALSO ADVISED THAT PT IS A GREAT HISTORIAN & NORMALLY KNOWS CURRENT DATE, TIME, AND SITUATION. SYMPTOMS LASTED ROUGHLY 72 HOURS, AND PATIENT DID COMPLETELY RETURN TO BASELINE AFTER 72 HOURS HAD PASSED
89 2021-02-20 vomiting, diarrhea Extreme vomiting, diarrhea, patient unable to get up without assistance
89 2021-02-21 nausea Patient was found with no pulse no heart rate by a staff member around 11 pm. Earlier that day seen... Read more
Patient was found with no pulse no heart rate by a staff member around 11 pm. Earlier that day seen by myself for fatigue, sorethroat, nausea.
89 2021-02-27 vomiting severe vomiting for 36 hours that led to dehydration; loss of sodium and potassium; lack of mobility... Read more
severe vomiting for 36 hours that led to dehydration; loss of sodium and potassium; lack of mobility and hospitalization
89 2021-03-01 diarrhea symptoms on second day was tiredness, feeling unwell, chills, fever, muscle pain and diarea.
89 2021-03-03 nausea Patient receive her 1dose of covid vaccine at 0900. At around 0915 pt stated she feels nauseated and... Read more
Patient receive her 1dose of covid vaccine at 0900. At around 0915 pt stated she feels nauseated and was having a hard time breathing with her mask on in a confined space. RN took her out to the hallway with door opened for ventilation. Patient felt better right away. Patient stated she felt better and want to go home. RN stayed with patient till 1000 and walk patient to her car.
89 2021-03-03 nausea Patient presented to the ED with complaints of nausea and feeling unwell. She was found to be hypert... Read more
Patient presented to the ED with complaints of nausea and feeling unwell. She was found to be hypertensive with BP in the 220s/120s. Patient was started on a nicardipine drip and transferred to ICU for management. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
89 2021-03-11 abdominal pain ABDOMINAL PAIN death
89 2021-03-14 nausea Patient was transported to hospital. She was diaphoretic, nauseas and almost passed out. She just ha... Read more
Patient was transported to hospital. She was diaphoretic, nauseas and almost passed out. She just had a pacemaker put in 3 months ago. EKG was done by paramedics and they immediately recommended transport to the hospital.
89 2021-03-16 vomiting, diarrhea PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DI... Read more
PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DIARRHEA, VOMITING AND AMS. ADMITTED AND REMAINS HOSPITALIZED ON 3/17. PATIENT TESTED POSITIVE FOR COVID-19 ON 3/15 AND HAS RECEIVED BOTH DOSES OF VACCINE MORE THAN 2 WEEKS AGO. HOSPITALIZATION REPORTED TO BE RELATED TO PATIENT SEPTIC WITH GI INFECTION. POSITIVE COVID INFECTION IS INCIDENTAL. PATIENT ON ROOM AIR. NO FINDINGS ON CHEST X-RAY.
89 2021-03-24 profuse anal bleeding, abdominal pain ABDOMINAL PAIN RECTAL BLEEDING
89 2021-03-29 difficulty swallowing soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling ha... Read more
soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling hands and feet; legs are jerking; This is a spontaneous report from a contactable consumer An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) via an unspecified route of administration, in Arm Right on 20Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included parkinson's disease, cardiac pacemaker insertion and seafood allergy. Concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number EL1283) on 30Jan2021 at 10:30 on right arm. On 20Feb2021 the patient experienced soreness muscle and joint, stiffness, difficulty swallowing, trouble controlling hands and feet, legs are jerking. All the events were reported as non serious. No treatment was administered for the events. At the time of the reporting the patient had not yet recovered from the events.
89 2021-04-03 nausea nose ran all day and night too of a clear liquid; sore throat; had a temperature at "98.3, which is ... Read more
nose ran all day and night too of a clear liquid; sore throat; had a temperature at "98.3, which is a fever for [her]"because 'at 97 that's [her] normal; dry cough; feels a little tired; had some congestions; trouble sometimes with nausea; scratchy throat and the sinuses came; scratchy throat and the sinuses came; she thinks her allergies are acting up again; a little headache; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. Medical history included A Fib, the patient had a light stroke in Apr a year ago, and she was put on another medication that did not agree with her. But caller has been on Eliquis for over a year now. Her eyes are so bad that she does not read a lot. She has allergies, and the 1 degree fever is normal with her allergies. Concomitant medication(s) included apixaban (ELIQUIS) taken for blood disorder from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for atrial fibrillation from an unspecified start date and ongoing; losartan potassium (LOSARTAN POTASSIUM) taken for blood pressure abnormal from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient had been on this product for years, more than two years for her heart, for the A Fib. She has been on Losartan potassium for years. The patient stated she is 89 years old, received the first dose of the COVID-19 vaccine on 28Jan2021. She said she didn't read the Fact Sheet until last night and went through the list of side effects of the vaccine. She explained that on Friday and Saturday, her 'nose ran all day and night too' of a 'clear liquid'. She added she had a sore throat. She said she had no fever or chills but had a temperature at '98.3', which is a fever for [her]' because 'at 97 that's [her] normal'. She added she 'developed a dry cough, not an allergy cough like having mucus in [her] throat'. She pursued saying she 'doesn't know about the shortness of breath' and sometimes she 'feels a little tired' but isn't sure if it's related to the vaccine, due to her age. She said regarding headaches, she thinks it was 'not a bad headache' because '[she] remembers putting something on her head'. She added she 'had some congestions so [she] took an allergy pill'. She lastly described she had 'trouble sometimes with nausea' but did 'not vomit' and had no 'diarrhea'. She then said she is concerned with her 'clear runny nose' and her 'dry cough', which she also qualified as 'out of the ordinary'. She then mentioned that last night, her room was 'too cold' and therefore she had a 'scratchy throat and the sinuses came'; she said she took a sinus pill. She asked if it is normal to experience a 'clear runny nose' and 'dry cough' after the receipt of the COVID-19 vaccine. Caller asked if she should receive the second dose of the COVID-19 vaccine after her reaction to the first dose. Caller explained that while having her symptoms she was exposed to her son who will get married "on the 28th". She expressed her concern on potentially being infected with COVID and its impact on her son. She asked if you can get COVID from the COVID-19 vaccine. She also asked if she should get tested for COVID given her experience. Caller had her first dose of the COVID vaccine on 28Jan2021. By Friday night, caller had a dry cough, was tired, had a little headache, and a runny nose. Caller is wondering if she had a light case of COVID but caller is hesitant to leave her home to go to the doctor's office for a test because of the cold weather. Caller had her first COVID vaccine on 28Jan2021 at pharmacy and caller stated that the Pharmacist said that she might gets chills and kind of like a fever, but caller did not get that. But, caller states that a couple of days after receiving the vaccine, caller looked at the facts sheet that had been given to her. Caller states that she didn't previously read the facts sheet, until last night, as her eyes are so bad that she does not read a lot. Caller states that she has had a 1 degree fever, but she has allergies, and the 1 degree fever is normal with her allergies. Caller states that her fever is 98.3, so it is not considered a fever really, but she normally runs 97 degrees. Then caller states that few nights ago, Friday night maybe, she got a dry cough, no mucus, just a dry cough, and she coughed for a couple hours but she was in bed, as it was nighttime. Caller states that she was also tired for a few days, as she is 89 years old. But caller states that she is in reasonably good health, and she lives alone and takes care of herself. So caller just had the tiredness and had a little headache, but she did not lose her taste or smell. Caller states that she had a sore throat, and some congestion, and her nose ran for two days. Caller states that her nose was running like clear water for two days, and then it just stopped. Caller states that it is cold and the weather is bad where she is, so she thinks her allergies are acting up again. Caller states that she is wondering if she had a light case of the virus and overcame it, or she is seeking advice about if it would be necessary for her to go out and get tested. Caller states that she can't tell if she got the virus or not, and she does not want to drive and go out in the cold to see her doctor. Caller states that a telehealth appointment is not possible because she got a new laptop but she does not like it, so the laptop is all wrapped up and set aside ready to be returned to (courier name). Caller states that she has two sons who could come over to help her with a telehealth appointment but she does not want them to get COVID, if that is what she has. Caller states that she is also concerned because her granddaughter is getting married on the 26th, and she does not want to give anyone COVID. Caller states that the symptom that really got her was that she had clear water running from her nose for two day and then just stopped, as the caller does not get this symptom with her allergies. Caller also has the sore throat. Caller is wondering if these could have been a side effect from the vaccine. But to be honest, caller thinks that what she has now, she is pretty sure is just her usual allergies. Caller states that she has just been staying home so that she would not get the virus, and so far so good. Caller just keeps herself busy around the house. Caller had no other vaccines on the same day as the COVID vaccine. Caller states that she has A Fib, but she has not been to her doctor in over a year because of the Virus she has not gone out. But caller states that she has not felt bad or anything, she just has not kept up with her yearly visit. No Investigation Assessment. Outcome of the event nose ran all day and night too of a clear liquid was recovered and outcome of all other events was unknown.
89 2021-04-15 decreased appetite, nausea, abdominal discomfort Nausea, upset stomach, no appetite, fever of 101.7 degrees F for 3 days (relieved by Tylenol), extre... Read more
Nausea, upset stomach, no appetite, fever of 101.7 degrees F for 3 days (relieved by Tylenol), extreme fatigue for 4 days, depressed mood for several days.
89 2021-04-22 diarrhea Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking... Read more
Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking short distances, diarrhea/loss of bowel control, extremely pail skin, cold extremities, low blood pressure. Started approximately 27 hours after vaccine and continued to get worse. Dr. was consulted and diagnosed Shy-Dragers Syndrome related to Dementia as a possibility. We were to increase salt intake and observe for worsening. Patient began showing improvement after about 5 days. Was taken to hospital ER for UTI evaluation per Dr.; no UTI present but bloodwork showed the need for a two-unit blood transfusion.
89 2021-05-04 nausea been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days... Read more
been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; This is a spontaneous report from a contactable consumer (patient). A 89-year-old female patient received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unknown date (at the age of 89-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the vaccine last Friday and it had been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed. The outcome of the events were not recovered. Information on Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.
89 2021-05-11 nausea The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother pass... Read more
The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother passed away on 04/18 after 3 days of post vaccination. A home hospice patient with Stage 5 Chronic kidney disease and Stage 4 COPD (Oxygen dependent) came in on 04/15 around 4:30 pm to receive a first dose of Pfizer. After 15 mandatory waiting in the pharmacy, she went home. Around 5:00 pm, patient told her son that she is feeling nauseated. Hospice nurse was contacted. On 4/16, patient experienced hallucination. She told her son that her fingers were disappeared. Hospice nurse was contacted. Please note that vaccine adverse event is not clearly related to vaccine, since patient was on hospice, stage 5 CKD and stage 4 COPD.
89 2021-06-03 diarrhea, vomiting, decreased appetite Extreme Fatigue; Vomiting; Diarrhea; Headache; Loss of Appetite; Low Grade Fever lasting over 3 week... Read more
Extreme Fatigue; Vomiting; Diarrhea; Headache; Loss of Appetite; Low Grade Fever lasting over 3 weeks; This is a spontaneous report from a contactable consumer (patient). An 89-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: Unknown, Expiration date: Unknown), via an unspecified route in the left arm on 09Feb2021 at 14:30 as a single dose for covid-19 immunization. Medical history included known allergies with heparin, penicillin, isosorbide, blood pressure, stroke, heart & ureter stents, pacemaker, minor heart attack, hysterectomy, and temporary nephrostomy. Concomitant medications included statins and mirtazapine. Prior to vaccination, patient did not have covid. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Feb2021, patient experienced extreme fatigue, vomiting, diarrhea, headache, loss of appetite and low-grade fever lasting over 3 weeks. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included OTC Tylenol and anti-diarrhea medications. The outcome of the events was recovered on an unknown date. Information on the lot/batch number has been requested.
89 2021-06-03 nausea, decreased appetite Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received... Read more
Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 89-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart & ureter Stents, mild heart attack, stroke, pacemaker, hysterectomy, temporary nephrostomy, blood pressure, pain, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medication(s) included mirtazapine (MIRTAZAPINE); blood pressure medication (unspecified), statins medication (unspecified) and pain medication (unspecified) all taken for an unspecified indication, start and stop date were not reported. The patient previously took isosorbide, heparin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on Feb2021 at 02:15 PM (Batch/Lot number:Unknown) as SINGLE DOSE for covid-19 immunisation and expereinced fatigue, vomiting, diarrhea, headache, loss of appetite and low grade fever lasting over 3 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021. On 09Feb2021, the patient experienced extreme fatigue, headache, loss of appetite, weakness, low grade fever and nausea. Therapeutic measures were taken as a result of extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea with otc tylenol, zofran. The outcome of the events extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea were recovering and unknown for other events. Information about lot/batch number has been requested.
89 2021-06-03 vomiting, nausea Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days aft... Read more
Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; This is a spontaneous report from a contactable consumer. An 89-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 15:00 at single dose in left arm for COVID-19 immunisation at the age of 89-year-old. Medical history included dementia, breast cancer, high blood pressure, high cholesterol, depression, thyroid disease, Allergy. Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she was coughing. The patient did not receive any treatment for the events. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
89 2021-06-20 abdominal discomfort shaking, loss of balance, stomach issues, cant walk without a walker, weakness,
89 2021-06-30 abdominal pain VAGINAL BLEEDING ABDOMINAL PAIN N17.9 - AKI (acute kidney injury) (CMS/HCC)
89 2021-07-21 diarrhea, faeces discoloured Diarrhea. black stools for 7 days after vaccine... still black today...
89 2021-07-27 abdominal distension I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood... Read more
I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date. Follow-up attempts are completed. No further information is expected.
89 2021-07-28 decreased appetite, nausea Pt brought to ED after presenting with 1 week hx of cough, SOB and 2-3 day hx of nausea, decreased a... Read more
Pt brought to ED after presenting with 1 week hx of cough, SOB and 2-3 day hx of nausea, decreased appetite, somnolence. Was found to be COVID positive (7/24) despite receiving Pfizer vaccines on 1/20 & 2/10. Was admitted for management of acute hypoxic respiratory failure secondary to COVID-19 PNA in which she received respiratory support via O2 and dexamethasone. Was ultimately discharged w/home O2 therapy and follow-up on 7/28.