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