Pfizer

Flu-like symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-09 fatigue, headache Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing m... Read more
Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM. Headache eased up in evening of 1/7.
76 2021-01-12 throat irritation Systemic: Scratchy Throat 10 minutes Post Injection-Mild
76 2021-01-14 headache Dizziness, headache
76 2021-01-17 fever, cough, fatigue, headache Very tired, cough, fever 99 to 102, mild headache
76 2021-01-17 fever, fatigue, chills Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion ... Read more
Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.
76 2021-01-17 sluggishness, headache, chills 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 headache dizziness, headache, nausea
76 2021-01-21 fatigue, fever high fever 102, fatigue, no energy, aches in muscles in joints, nauseous
76 2021-01-21 headache, productive cough DEVELOPED HEADACHE, MOIST, PRODUCTIVE COUGH, ELEVATED IRREGULAR HEARTRATE. FOLLOWING UP WITH PCP
76 2021-01-22 chills, malaise, fever 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 2021-01-22 chills Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Sever... Read more
Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.
76 2021-01-23 fatigue, headache 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 2021-01-24 cough Dep Cough, Chills
76 2021-01-24 fever, malaise, fatigue Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing... Read more
Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball. Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal. Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this, severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days. Took Tylenol. Today, 01/25/21 at 11:27AM, temperature is 98.3.
76 2021-01-25 body temperature increased I felt worse than when I began covid in Dec. Temp up to 102, achy body, just felt terrible
76 2021-01-25 cough Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (... Read more
Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient was getting a cough and has a metallic taste in her mouth in Jan2021. Wanted to know if it was from the vaccine or Covid. The outcome of events was unknown. Information on the lot/batch number has been requested.
76 2021-01-25 fatigue, fever, headache 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 throat irritation 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 2021-01-26 cough, headache, runny nose, nasal congestion, throat pain 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 head discomfort 1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a ... Read more
1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.
76 2021-01-26 headache 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 2021-01-26 nasopharyngitis, sleepiness, malaise, sweating, headache, fatigue, body temperature increased 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 2021-01-28 fatigue 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 headache, fever 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 2021-01-28 sneezing, runny nose, cough Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I tol... Read more
Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.
76 2021-01-29 fatigue, sweating, chills 16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tyleno... Read more
16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tylenol and motrin, followed by feeling hot and sweaty, the next day I was wiped out and rested ... the shortness of breath began somewhat later on weds pm and worsened on Thursday ... I had several breathing treatments thurs and friday which seemed to help somewhat.. On Saturday I am feeling better overall with less dyspnea . still feeling wiped out after several hrs of mild activity.
76 2021-01-29 throat irritation Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reporte... Read more
Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reported that drinking water made her throat feel better. No chest pain or shortness of breath. She reported some anxiety. VS: BP 133/81, HR 83, O2 sat 96-97% on RA Patient felt stable and went home after over 30 minutes of observation.
76 2021-01-30 chills 36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about an... Read more
36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about and remembering past experiences. At 11;00 PM I started feeling cold with muscles twitching in legs. Got out of bed with difficulty walking and shaking and teeth chattering. Shaking became more intense. Put on more clothes and sat by fireplace. Took 2 Tyneol and ate banana. Continued to shake all over for 10 mins. Shaking so much could not hold phone. Subsided. Startrd again lasting for 10 mins. Subsided and finished at 11:30 PM. Stayed up until 1;00 PM. To bed and had difficulty sleeping. Feel alright today.
76 2021-01-30 headache Nausea and diarrhea plus headache
76 2021-01-30 fever, chills, fatigue Following day feeling tired, no fever, no chills, etc. Second day feeling well.
76 2021-01-31 body temperature increased, headache red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection s... Read more
red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.
76 2021-01-31 headache 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 malaise, lethargy, sweating, sleepiness 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 2021-01-31 throat irritation Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is... Read more
Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.
76 2021-02-01 chills, fatigue dizzines lasting for 24 hr. 3 days after injectiion--then again 3 days later. tiredness ,chills.
76 2021-02-01 chills 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 2021-02-01 fatigue tested positive; tested positive; being a little tired/she was tired after it; This is a spontaneous... Read more
tested positive; tested positive; being a little tired/she was tired after it; 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, lot number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown. No follow-up activities are needed. No further information is expected.
76 2021-02-01 headache, fatigue Fatigue injection site warm, itch Headache
76 2021-02-01 sweating 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 2021-02-02 headache Headaches, becoming more intense. I wake up every morning with a headache.
76 2021-02-02 throat pain Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat... Read more
Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,
76 2021-02-02 fever, chills A fever of 102.5, chills, body aches, swelling, tenderness & redness on left arm- lymphedema
76 2021-02-03 headache, chills 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 2021-02-04 fatigue, malaise, fever, headache After second, very ill with fever, body aches, headache, debilitating lassitude headache. Lasted 36... Read more
After second, very ill with fever, body aches, headache, debilitating lassitude headache. Lasted 36 hours.
76 2021-02-04 fatigue Felt nauseous Tired
76 2021-02-04 headache headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spon... Read more
headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer-sponsored program Pfizer First Connect. This pharmacist reported similar events for two patients. This is the first of two reports. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 10:30 AM at single dose on left arm for COVID-19 immunization. Medical history included temporomandibular joint (TMJ) pain in jaw and headache. Concomitant medication included Tylenol for temporomandibular joint (TMJ) pain in her jaw. The patient (retired pharmacist) stated that she and her husband got the COVID shot on Tuesday (19Jan2021) and prior to getting the vaccine, she was suffering temporomandibular joint (TMJ) pain in her jaw and took Tylenol that morning. Patient just came back from urgent care and was prescribed a dose pack of prednisone to take for 5 days for the TMJ and she is concerned about taking it because she knows it can suppress the immune system and she does not want to make the vaccine less effective. She was trying to figure out if she should just tough it out and not take the steroid. She and her husband, who was on warfarin, had a mild headache after the first shot but he has sinus issues and she had the TMJ, they were not sure if the headaches were from those things or the vaccine. Patient asked if she can take Tylenol since she found out that that may not have been a good idea. She was advised to take Prednisone and she was asking if she can take it or will it affect the efficacy of the vaccine. She stated not knowing that taking Tylenol can effect the efficacy of the COVID-19 Vaccine, she had taken Tylenol before she received her COVID-19 Vaccine on 19Jan2021 (Tuesday). Patient said her TMJ jaw pain was still a problem after she received her COVID-19 Vaccine, so she had gone to her doctor, and her doctor prescribed Prednisone, a corticosteroid. She said she was not going to take the Prednisone because she does not want the Prednisone to cause an issue with the efficacy of the COVID-19 Vaccine. Patient said she then read that studies performed on children said that children that took Tylenol did not get as good of an immune response from the COVID-19 Vaccine. Patient said since she already took a dose of Tylenol for her TMJ jaw pain before receiving her first COVID-19 Vaccine dose, she was afraid to take any further Tylenol. Patient clarified that the Tylenol she took was the generic Equate brand, 500mg. She said she took 2 Equate brand generic Tylenol 500mg for jaw pain on Tuesday morning (19Jan2021) prior to getting her first COVID-19 Vaccine. She said she had disposed of Equate brand generic Tylenol bottle and cannot provide the UPC, Lot and Expiration Date. Reported that both her and her husband did have a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. She said she was not sure if her headache was from the COVID-19 Vaccine or from her TMJ jaw pain. She said when she has TMJ jaw pain, she usually has a headache accompanying the TMJ jaw pain. Also reported that she always gets her vaccines in her left arm. Patient was surprised she and her husband did not have anything more than a headache after receiving the COVID-19 Vaccine. She said when she had the Shingles Vaccine, she could not lay on her left side for a week because her arm was so sore for 2 days, and when she had the flu shot she could not get out of bed for a day. Patient clarified she got her first dose of the Shingrix Shingles Vaccine in Nov2020, and does not plan to go and get her second Shingrix dose until the summer of 2021. Patient stated that she does not want the second dose of the Shingrix Vaccine interfering with the COVID-19 Vaccine. The patient had headache on 19Jan2021, reported as mild. Patient also had a mild soreness in her left arm after getting the COVID-19 Vaccine on 19Jan2021, and the left arm soreness was gone in less than 24 hours. Patient further clarified that she had a headache before getting the COVID-19 Vaccine. She said her TMJ jaw pain acts up if she eats. She said when she has TMJ jaw pain, she gets an excruciating headache. She said she has no headache pain at all right no. Patient expected to have kind of a worse reaction to the COVID-19 Vaccine based on what other people have been saying. The events were assessed as non-serious. Outcome of the event headache and mild soreness in her left arm was recovered in Jan2021. Patient does not think her headache pain was related to the COVID-19 Vaccine.; Sender's Comments: Based on the time association and drug's safety profile, the possible contribution of suspect vaccine BNT162B2 to the event headache cannot be totally excluded. The underlying temporomandibular joint and headache may be cofounders.,Linked Report(s) : US-PFIZER INC-2021082288 same drug/reporter, similar events, different patient
76 2021-02-04 sweating 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 malaise, headache 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 2021-02-06 headache, chills, fatigue , fatigue, headache, achy, chills
76 2021-02-07 fatigue, headache, chills, fever 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 headache, fever Minor headache, low grade fever,
76 2021-02-07 headache 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 chills, fatigue, fever 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 2021-02-08 fatigue, influenza like illness, chills, headache flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with... Read more
flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with itching Treated with benadryl with little effect. Received Rx for dosepack Prednisone. Also applied cortizone OTC to rash area. Flu like symptoms abated wtihin 36 hours; rash improving more slowly.
76 2021-02-08 fatigue, fever fever, fatigue, nausea, muscle aches
76 2021-02-08 headache, fatigue Headache, exhaustion
76 2021-02-09 sleepiness 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 headache 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 chills 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 2021-02-12 headache, fatigue Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the mornin... Read more
Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the morning of the next day. Complete loss of energy...and I am a VERY energetic person. Tiredness and light headedness has continued from 2/4 thru 2/13 with no let up. 11 hrs of sleeping at night after being on couch all day. NO loss of appetite, taste, smell, fever, or aches. Headache lasted only a few days.
76 2021-02-12 headache 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 body temperature increased, chills, headache 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 chills, fatigue, fever Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to ... Read more
Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to bed
76 2021-02-14 chills, fever, sinusitis Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, an... Read more
Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, and every part of body hurt. Went back to bed. 6 am still hurt everywhere, short of breath (oxygen concentration at 90 and sometimes below--thankfully I had oxygen as I sleep with it). Running a temperature of 100., disoriented, heart rate at 115+ and I hurt everywhere. 8 am called Dr. & left call-back. 1 pm tried Dr. again. Told person on telephone and he told Nurse Practitioner. They ordered nose spray because I mentioned I may have a sinus infection as my head hurt, my ears hurt. I continued Tylenol every 6 hours on Friday and Saturday (all day). I was able to get up and do a few things on Saturday. Felt better on Sunday but still weak feeling. Oxygen saturation back to 95-96 and heart rate under 100.
76 2021-02-14 fever, chills, fatigue, body temperature increased I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had... Read more
I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had terrible chills, My hands were so cold that they were hurting me. I took some advil and that helped. By Sunday I was starting to feel to better, Monday I was still tired and a low grade fever.
76 2021-02-14 fever, malaise Have not felt well fir a few days and night before last night had a fever.
76 2021-02-15 chills, fever 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 lethargy Lethargy, confusion, unsteady gait. Decreased O2 saturation, difficulty swallowing.
76 2021-02-15 fever, fatigue Woke up at approx 1:30 am on the morning after the 2nd Covid vaccination with a fever of 101 degrees... Read more
Woke up at approx 1:30 am on the morning after the 2nd Covid vaccination with a fever of 101 degrees. Took one Ibuprophen tablet. Fever subsided by 7:30 am. Felt exhausted and slept off and on for the next 24 hours. All symptoms gone as of today 2/16/2021.
76 2021-02-17 body temperature increased, influenza like illness, fatigue 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 chills 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 fatigue, fever Felt tiredfrom after vaccine, may have had a fever. Had a syncopal event 34 hours after vaccination
76 2021-02-17 fatigue All over body aches and fatigue, once ibuprofen, throat slightly irritated
76 2021-02-17 throat pain, headache 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 2021-02-18 headache Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had l... Read more
Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had little strength in left hand and was dropping things. patient was scheduled for ct scan for headaches later that week. Called and got ct scan to be done state. Patient had a CT scan on 02/09/21 which was negative and saw the doctor on 02/12/21 and he ordered an MRI which showed patient had a CVA, cerebrovascular accident-stroke, MRI results revealed the CVA.
76 2021-02-18 productive cough My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. ... Read more
My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD
76 2021-02-18 runny nose Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second do... Read more
Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second dose of Pfizer. She \ requested to lie down and was escorted to a stretcher. She was provided oral loratidine with slight improvement of symptoms. Approximately 30 minutes after her inoculation her status had not worsened but she requested to be taken to the emergency department. Rapid Response team was notified and assisted her to the ED.
76 2021-02-18 sinus pain swollen face, sinus pain, sore arm
76 2021-02-19 fatigue, body temperature increased 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 2021-02-19 influenza like illness Mild flu-like
76 2021-02-22 chills, fever Fever 100 Achy joints Chills
76 2021-02-22 malaise, headache, chills Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache on... Read more
Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.
76 2021-02-23 fatigue Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was... Read more
Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200
76 2021-02-23 headache Patient experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 15... Read more
Patient experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 158/94 99% O2 room air HR 64. Patient Refused Evaluation/Care released against medical adive.
76 2021-02-24 malaise Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated ... Read more
Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.
76 2021-02-24 fever Same day pt developed burning pain with urination and fever of 101F the same day. Pt came to the ho... Read more
Same day pt developed burning pain with urination and fever of 101F the same day. Pt came to the hospital, was not determined to have a urinary tract infections. No fevers during time in the hospital.
76 2021-02-24 runny nose, chills 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 2021-02-25 body temperature increased, chills, fever, malaise 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 cough Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny ... Read more
Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again. She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.
76 2021-02-25 cough Shortness of breath, difficulty swallowing, coughing. BP 230/98
76 2021-02-25 headache migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient.... Read more
migraines; anxious; headache; 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 MRNA VACCINE, Lot number EL1283), intramuscularly, on 23Jan2021 at 11:30 (at the age of 76-years-old) as a single dose in the left arm for COVID 19 vaccination. Medical history included stress related to work and a preservatives allergy which give her headaches. Historical vaccinations included pneumonia vaccine (UNKNOWN MANUFACTURER but reported as "Pneumonia 13") on an unspecified date "four years ago" after which she developed a headache which she attributes to an allergy to unknown preservatives. She never received the second "Pneumonia 13" because of the reaction with the first one. She also reported that she has had this same reaction of headache attributed to allergy to unknown preservatives when eating fast foods and foods with sauces. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered at a County Convention Center. On 23Jan2021 at 11:45, fifteen minutes after she received the vaccination, the patient developed a headache which she has had ever since she got in on Saturday. She also stated that it feels like "a migraine on steroids." She did tell the person at the clinic where she received it. She stated that she is "hypoallergenic" and she had to sit for thirty minutes after receiving it. She was already anxious and about fifteen minutes in, she developed the headache and nothing has helped so far. She added that she has not had a headache in a long time and that is why she feels it is the shot. She reported that what she took for treatment did not work. These treatments included: Acetaminophen Extra Strength 500mg NDC 21130-111-90. Lot 9ME2806A, expiration 20Jul2021. Count size is 500 caplets, Motrin Ibuprofen tablets 200mg. Lot 6ME1058A, Expiration Sep2018. Count size 100 caplets which when taken was an expired product, SalonPas Roll On Lot 192498, Expiration Jan2022. Count size is 1 container with 3 fluid ounces or 88ml and Neck Wrap and Wrist Heat Wraps which is reported as "a generic equivalent of Thermacare" with Lot number 91211OC16, Expiration 10Dec2022. She did not take the heavy duty Motrin because it was out of date. She commented that all of these things had helped in the past. The clinical outcomes of the event headache, migraine and anxiety were reported as unknown.
76 2021-02-25 fever, influenza like illness, fatigue, headache 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 sinusitis, throat pain Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still h... Read more
Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain
76 2021-02-25 throat irritation scratchy and tingling in throat.
76 2021-02-26 chills, fatigue, body temperature fluctuation, throat pain, fever, headache 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 2021-02-26 headache, fatigue, chills, fever After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve a... Read more
After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve and was able to sleep off and on during the night. The following morning still had headache and fever. I could not eat breakfast. I took a two-hour nap during the afternoon. Symptoms dissipated slowly by evening.
76 2021-02-26 fever Fever, body aches.
76 2021-02-27 fatigue Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, di... Read more
Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.
76 2021-02-27 malaise 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 headache, fatigue 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 2021-02-28 throat pain sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (... Read more
sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it. The outcome of the event sore throat was not recovered, while for the other event, it was recovering.
76 2021-03-01 fever, malaise, headache, fatigue Injection site pain, tiredness, headache slight, joint pain, fever up to 101.6, feeling unwell
76 2021-03-02 fatigue, chills, malaise, headache headache; chills; muscle pain; tiredness; feeling unwell; This is a spontaneous report from a contac... Read more
headache; chills; muscle pain; tiredness; feeling unwell; 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, lot: EL3302), via an unspecified route of administration at the left arm from 30Jan2021 3:00 PM at SINGLE DOSE for covid-19 immunization. The patient is not pregnant at the time. The patient was vaccinated at a Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included cancer cured. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that there are other medications the patient received within 2 weeks of vaccination, however it was unspecified. The patient previously took demerol and experienced allergy. It was reported that the patient experienced headache, chills, muscle pain, tiredness, feeling unwell on 30Jan2021 09:00 PM. The outcome of the events was recovered. No treatment was received for the adverse events. The case/ events were reported to be non-serious.
76 2021-03-02 sweating, chills, dehydration, headache 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 2021-03-02 influenza like illness Pfizer-BioNTech Covid 19 Vaccine EUA Started getting light headed and dizzy on early morning Sat. H... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA Started getting light headed and dizzy on early morning Sat. Have been having off and on since then. Have not been able to shower, drive for fear of having it happen again. I did have a B12 injection on 2/15/2021 after checking with my physician to see if would be a problem with getting vaccine.
76 2021-03-02 sleepiness, fatigue more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This i... Read more
more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; 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: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.
76 2021-03-03 fatigue, headache 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 headache Every joint in my body hurts. No apparent rash. Headache but no fever
76 2021-03-03 malaise Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o thro... Read more
Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o throat tightness w/ small amount of dyspnea. states throat feeling better now, still having some tightness in chest. Patient received IV benadryl and IV famotidine and felt fine. No need for treatment with epinephrine IM. Was discharged home.
76 2021-03-03 fever, malaise, chills, headache 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 body temperature increased, chills 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 2021-03-04 fever, headache MS symptoms escalated, everything hurt, major trouble walking, fever for about 24 hours, headache, a... Read more
MS symptoms escalated, everything hurt, major trouble walking, fever for about 24 hours, headache, ache all over.
76 2021-03-06 chills 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 fatigue, throat pain, headache 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 2021-03-07 fatigue only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a co... Read more
only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown. Information on the lot/batch number has been requested.
76 2021-03-08 fatigue, headache Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 da... Read more
Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 days. Increasing muscle pains for 3 weeks.
76 2021-03-08 headache feeling dizziness contacted the patient , patient states that she is not having any more dizziness ... Read more
feeling dizziness contacted the patient , patient states that she is not having any more dizziness , but some HA , took some tylenol .
76 2021-03-08 headache 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 chills Had chills for 3 hours in middle of night..
76 2021-03-09 headache, fatigue, fever 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 headache, fatigue, fever Fever, fatigue, headache, eye infection, cold sore on left lower lip
76 2021-03-09 fever, headache, fatigue headache, body aches, fever, fatigue, nausea, trouble sleeping, still happening 3/10
76 2021-03-10 fatigue 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 malaise 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 2021-03-13 fatigue ACHY MUSCLES, BONES HURT/ACHED, FATIGUE FOR ABOUT 24 HOURS.
76 2021-03-14 chills 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 2021-03-14 fatigue Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a... Read more
Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a period of 2 days
76 2021-03-14 headache, fatigue 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 sweating, chills, headache 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 malaise, chills, fatigue, headache tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontan... Read more
tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested.
76 2021-03-14 malaise, fatigue, headache 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 malaise was ill as soon as she got home; Hasn't been able to get out of bed. The patient states she has been... Read more
was ill as soon as she got home; Hasn't been able to get out of bed. The patient states she has been taking ibuprofen but it doesn't help much; Says she's never had to stay in bed this long; We recommended being evaluated by a doctor at an Urgent care center because of continued a/e that are reportedly worsening.
76 2021-03-14 fever, chills, lethargy, dehydration Chills Fever Severe diarrhea for 6 weeks Dehydration Pleurisy Esophagus inflammation Lethargy
76 2021-03-14 fever Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her l... Read more
Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her legs, thighs, neck, back, and head; This is a spontaneous report from a contactable nurse (patient husband). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3247, Expiration date: 31May2021) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history included allergy. The concomitant medication was not reported. The patient previously took septra and experienced allergic to septra (she had taken many years ago. She took something and developed an allergy, but she hasn't used it in maybe 20 years). It was reported that patient received first dose of the Pfizer COVID-19 vaccine on Monday (01Feb2021) and she felt good, then late Tuesday she got a rash at 09:30 (about 30 hours after her injection) and a fever on (02Feb2021), which was listed on the brochure and was kind of expected, but he wanted to be reassured this was ok and not something like a severe allergic reaction. It was reported that patient second dose was scheduled for 22Feb2021. It was reported that patient has been taking Benadryl 25mg, 50mg total a day, 25mg one in the morning and then one in the evening by mouth. The reporter informed that the benadryl (Lot number: P119020, EXP: Feb2022) seems to calm the rash down, though it was more like hives than a rash. It was reported that patient had rash or hives are on her legs, thighs, neck, back, and head on an unknown date in Feb2021. The reporter told that the rash was not getting worse, and Benadryl seems to help it. The reporter told that the vaccine instructions they got said it was possible to get a rash or have a side effect, he just wanted to be reassured. Therapeutic measures were taken as a result of rash, rash or hives are on her legs, thighs, neck, back, and head. The outcome of the event fever was unknown while for other events was recovering.
76 2021-03-15 fatigue, chills, fever Fever of 101.4; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer. A... Read more
Fever of 101.4; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for an unspecified indication. Medical history included ongoing acute myeloid leukaemia, ongoing hypertension. Concomitant medications included gilteritinib fumarate (XOSPATA) taken for an unspecified indication, start and stop date were not reported; timolol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; latanoprost (LATANOPROST) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever of 101.4 (pyrexia) (non-serious) on 30Jan2021 10:00, chills (chills) (non-serious) on 30Jan2021 10:00, aches (pain) (non-serious) on 30Jan2021 10:00, fatigue on 30Jan2021 10:00. The patient underwent lab tests and procedures which included body temperature: 101.4 on 30Jan2021. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as recovered.
76 2021-03-15 headache, fever Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the si... Read more
Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
76 2021-03-15 headache 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 fever, chills, headache High fever 99.8 F, Chill, headache
76 2021-03-16 chills, fever generalized weakness, subjective chills, fever, diarrhea
76 2021-03-17 chills tremor and chills onset last night, body rigid, could not sleep
76 2021-03-17 nasal congestion, cough, nasopharyngitis, influenza like illness, fever A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy... Read more
A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy head cold. I slept the whole day. The fever was gone by morning of the 5th day, but I felt like a piece of "rubber" the following 2 days. The cough has lingered until today (2 weeks after the first vaccine).
76 2021-03-18 chills, fatigue 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 2021-03-18 headache onset itching and rash on face and upper chest with headache for 3 days. Rash on face and neck
76 2021-03-19 throat pain half hour after receiving shot tongue and throat swelled up and short of breathe. Throat was sore ... Read more
half hour after receiving shot tongue and throat swelled up and short of breathe. Throat was sore for few days and short of breathe remained for almost a week It is 12 days and feel better but do not know if I should get second shot
76 2021-03-20 headache, chills Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, k... Read more
Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.
76 2021-03-20 headache, nasopharyngitis Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on an... Read more
Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.
76 2021-03-20 headache, fever Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong ... Read more
Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
76 2021-03-20 malaise, throat pain right side sore throat on 02Feb2021 for 2 days and still slightly painful; Feeling unwell; I had the... Read more
right side sore throat on 02Feb2021 for 2 days and still slightly painful; Feeling unwell; I had the flu for 2 days on 28Jan2021; 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: EL1283) via an unspecified route of administration in the let arm on 25Jan2021 13:00 (at the age of 76-year-old) , single for COVID-19 immunisation. The patient relevant medical history included mitral valve prolapse, Allergies to medications, food, or other products: Codeine, Dexamethasone, Keflet, Paxil, Sulfa Class, Tetracycline. Concomitant medications included propranolol hydrochloride (INDERAL); estrogens conjugated (PREMARIN); lisinopril (LISINOPRIL); digoxin (DIGOXIN) all were taken for an unspecified indication, start and stop date were not reported. Feeling unwell like I had the flu for 2 days on 28Jan2021 12:00 AM and right side sore throat on 02Feb2021 for 2 days and still slightly painful. 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 and Since the vaccination, patient not been tested for COVID-19. Outcome of the event right side sore throat on 02Feb2021 for 2 days and still slightly painful was recovering and Outcome of the other events was recovered on unspecified date in 2021.
76 2021-03-21 chills, fever, malaise, headache, fatigue 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 2021-03-21 fatigue 2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; ex... Read more
2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date
76 2021-03-21 runny nose, fatigue, nasal congestion 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 2021-03-23 headache, fatigue, chills 12 hours post vaccination I developed chills, headache, unable to relax (shaking). 24 hour post vacc... Read more
12 hours post vaccination I developed chills, headache, unable to relax (shaking). 24 hour post vaccination I was exhausted and slept for 24 hours. Now, at day 3 post vaccination, I am still tired, unable to do anything that requires exertion.
76 2021-03-23 headache, sinus disorder, chills Nauseous, diarrhea, chills, aches, headaches, sinus, could not turn off my brain. Awake till 3 am.
76 2021-03-23 pneumonia 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 chills, fatigue, nasal congestion 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 2021-03-24 fatigue, fever, headache, chills I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 ... Read more
I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 I started having headaches that travel around my head: some are behind my eyes and my teeth ache; some more like migraines that go up the back of my head; some more on the top of my head or on the side. My sense of taste changed. My second shot was 2/27. The day after I slept all day. The headaches continued (I have had a headache of one kind or another since 2/7). I had a tooth that broke off last June and was removed on March 8. I thought the tooth was infected and part of the headache problems, but since then I have been having really bad fibro pain and for the week of 3/8- 12 I ran a fever, had chills and more headaches. I was on amoxicillin from 3/8 to 3/14, but the tooth was not that badly infected and is healing well. The headaches do not seem to relate to the tooth. I have had a headache every day since 2/7 of various intensity and in different areas of my head. I am extremely fatigued and need to nap some days. My fibromyalgia symptoms are worse than they ever have been and some nights keep me awake. I also muscle stiffness and spasms in my neck occasionally. This is not normal for me. I saw a ARNP on 3/16 and she tested me for neurologic symptoms. Here are her notes: NEUROLOGIC: negative findings: speech normal, mental status intact, cranial nerves 2-12 intact, gait, including heel, toe, and tandem walking normal, Romberg negative, muscle tone normal, muscle strength normal, rapid alternating movements normal, finger to nose normal, reflexes normal and symmetric I have a video appointment with my primary care provider 3/26 to discuss this further
76 2021-03-24 headache, fatigue 3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a ... Read more
3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.
76 2021-03-24 pneumonia chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers wer... Read more
chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
76 2021-03-24 fever fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/... Read more
fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/1, and 3/15-current
76 2021-03-24 throat irritation SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, W... Read more
SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, WORSE IN EVENING; HURTS TO TALK. HAS HAD SIMILAR SYMPTOMS IN PAST BUT BROUGHT ON BY STRONG SCENTS/SMELLS (HAS HYPERSENSITIVITY TO SMELLS) AND RESOLVES WHEN SHE IS ABLE TO GET FRESH AIR. THESE SYMPTOMS STARTED ABOUT 24 HOURS AFTER VACCINE AND HAVE STILL NOT RESOLVED AS OF TODAY PER PATIENT. HAS CALLED DR. 2 TIMES AND WAS SEEN ONCE IN HIS OFFICE. HAS TAKEN A ZPAK.
76 2021-03-26 headache, fatigue 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 2021-03-27 sweating, malaise Patient daughter told clinic team her mother was not feeling well after receiving vaccine. Daughter... Read more
Patient daughter told clinic team her mother was not feeling well after receiving vaccine. Daughter also states patient was lightheaded and unbalanced prior to receiving vaccine. After receiving vaccine, patient became diaphoretic, light headed, BP 110/82. States her blood sugar was normal at breakfast, but could not remember #. Daughter states patient showing signs of confusion. Gave patient soda in case BS related. Decision was made to take patient to ED for further evaluation of DM vs. reaction to CoVID vaccine.
76 2021-03-27 pneumonia pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer... Read more
pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 76-year-old female 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, at the age of 76-year-old, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was due to get the second dose on 18Feb2021 but was in the hospital with pneumonia and was unable to get the second dose. She is coming up on 60 days now. Outcome was unknown. Information about lot/ batch number has been requested
76 2021-03-28 cough 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 2021-03-28 fatigue 1st dose, none Second dose administered 02/18/2021, 11:00 AM 1st 10 days: lymph node swelling of le... Read more
1st dose, none Second dose administered 02/18/2021, 11:00 AM 1st 10 days: lymph node swelling of left breast and later, right breast, First evening required a hot pack to reduce pain. Left shoulder was rehabbed from torn rotator cuff over a year ago, now joint pain for 3 weeks, varying in severity Brain fog, fatigue, irritability 3 1/2 weeks Changes in taste but not smell, last 7 days, continuing today 03/29/2021
76 2021-03-28 upper-airway cough syndrome 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 2021-03-29 fatigue 3/5/2021 - 3:00 p.m. - forward - Fatigue 3/8/2021 - Fatigue - All day
76 2021-03-30 headache, fatigue, malaise, sinusitis, chills 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 2021-03-30 malaise, fever, headache, fatigue, chills On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her... Read more
On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
76 2021-03-30 fever 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 2021-04-02 throat pain 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 2021-04-03 headache headache; This is a spontaneous report from a contactable consumer (patient). This 76-year-old femal... Read more
headache; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female consumer (patient herself) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246) via an unspecified route in Left arm on 16Jan2021 being 02:34 PM (at the age of 76-years-old) as single dose for COVID-19 immunisation. Relevant medical history and concurrent conditions included Blood pressure high started on 2009, Glaucoma, she had a car accident in 2009 where she got hit from behind that caused issues with her neck and she has this in her right eye, and her doctor put her on a new eyedrop in November, but other than that her meds stayed the same. Concomitant medications were not reported. Patient stated that her husband and her took the first dose of the vaccine on Saturday 16Jan2021. She says she was fine Saturday, then she woke up on Sunday morning with a headache behind her eyes that was not bad but she noticed it most of the day and then at night it was behind her eyes, the top of her head, and behind her head on 17Mar2021 at 07:00. She says she has had headaches all last week, and she took Advil and Tylenol which sometimes helped. She says she finally saw her doctor last Friday on the 22nd because she felt that was a long time for her to have headaches as a result of a vaccine and her doctor had her do a CAT scan to be sure, since she is 76, to check if she might be having a stroke or something. She says she has continued to have headaches, though not as bad as last week, and she was reading the material they got at the hospital because they are supposed to have the second shot 06Feb2021. She says she would like to know, have they had people report having headaches that long. She says she took both Tylenol, clarified to being Equate brand Acetaminophen, and Advil. Equate brand Ibuprofen 200mg: She says she normally doesn't take Advil. Equate brand Acetaminophen: She says she has two bottles one of which she keeps in the bedroom, so she doesn't know which bottle her doses came from. She says both of the Equate brand Acetaminophen bottles are extra strength, 500mg. She says when she took these two medications she was careful not to overtake or take too much, but she can't really tell how much she took. She says she thinks she first took one Tylenol and one Advil, then later that night when it really bothered her, she thinks she took maybe two Advil's and one Tylenol, but she didn't write it down. She says now her headache is not nearly like it was last week. She says that she spoke to her doctor on Friday because she was starting to get concerned about it, but it was not unbearable all day long, she would wake up with it then take something, and during the day it was better, then at night it would be worse. She says this week it mainly bothered her that it was at the back of her head and neck area, since she does have problems sometimes with headaches at the back of her head after she had a car accident in 2009 where she got hit from behind that caused issues with her neck. She says she doesn't have sinus issues, so the headache behind her eyes was odd, and since the information said side effect, it is too big of a coincidence that she got the shot Saturday and she had a headache on Sunday. probably in 2009, and she started taking Amlodipine 5mg then, and then after she retired from teaching her doctor decided she didn't need it and she stopped taking it. She says she has been taking again since about a year and a half ago, in 2018 at the end of the year. Amlodipine NDC/LOT/EXP: Unknown, it was dispensed in a pharmacy bottle, it says use before 14Nov2021. Laboratory tests included CT scan resulted negative on 22Jan2021. The outcome of the event was recovering.
76 2021-04-04 chills 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 2021-04-04 fever, chills, headache Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4... Read more
Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4° fever Legs felt 'heavy'
76 2021-04-06 fever 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 fatigue, headache, chills 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 2021-04-07 headache, chills, fatigue She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st ... Read more
She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.
76 2021-04-07 headache, fever 10 days and about 10 hours following my second vaccine, I experienced significant headache, body ac... Read more
10 days and about 10 hours following my second vaccine, I experienced significant headache, body aches and fever (that was initially, 100.8 and peaked the following night at 101.6 F.). This morning (about 30 hours from the first appearance of symptoms, all symptoms had abated).
76 2021-04-08 chills, throat pain, cough, fatigue, headache 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 2021-04-09 fatigue impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; s... Read more
impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; she had arrhythmia episode; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 76-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 09Mar2021 at 01:30 PM, as a single dose for COVID-19 immunization, at hospital and administered by a Nurse. Patient's medical history was not reported. Concomitant medications included rosuvastatin calcium, at 10 mg, 3x/day, (three days a week) and then at 5 mg, 4x/day, (5 mg four days a week); levothyroxine (50 ug) for Thyroid disorder and amlodipine besylate (2.5 mg) and had been taking fiber and probiotics. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number; EN5318, expiry date; 31May2021, Received in right arm) for COVID-19 immunization; Had no problem with first COVID-19 Vaccine. No pain at site, nothing. Patient stated that she had arrhythmia episode and that was unusual for me; Since then I have had four more episodes in Mar2021. Patient stated that her second dose of the vaccine at 1:30 pm. The same day at 10 pm, she experienced an impacted stool. She stated that she was on the toilet from 10 pm-12:15. She wanted to know if this is a reported side effect of the vaccine. After receiving second dose, patient stayed 30 minutes and felt fine. At 10 PM felt that need to go to the bathroom, which she thought was odd. More than two hours she tried to pass a BM. It was so impacted she could feel it all around her anus. Was ready to go to the hospital. Didn't know what to do. Waited and waited sitting on the toilet. Was trying to see if she could dig anything out and it was non-productive. At 12:15 AM bowel movement finally left. It was 13 inches long and 3 inches around. She actually tore and was bleeding really bad. She usually drinks a lot of water, but was not able to the day of the second COVID-19 Vaccine. It was stated that total time of bowel movement impaction was two hours and 15minutes (Began 10PM on 09Mar2021 and passed at 12:15AM on 10Mar2021). She was not supposed to push with bowel movement impactions. Patient was told by Doctor, patient could get a heart attack or stroke from pushing impacted bowel movements. Patient was so exhausted and a very bad experience. No further details provided. Had a lot of vaccinations over the time due to living in Honduras for 2 years and traveling in Brazil. No further details provided. Scheduled mammogram fourth months from second dose. Patient did not receive other vaccines within 4 weeks or prior vaccination. She had a colonoscopy 6-8 months before the vaccine and had been taking fiber and probiotics. Outcome of the events impacted stool and Impacted bowel movement was recovered on 10Mar2021; for all other events it was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
76 2021-04-10 fatigue For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the a... Read more
For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the afternoon of shot heart rate started to fluxuate. had appt with heart Dr. took EKG was ok but stated that there were several patients with same systems. by Thursday April 1st, heart rate was up to 143, called 911, by the time I got to ER it was going down. Had another EKG with in range and all other blood work was OK. Right ankle that swells because of arthritis swelling is now worse.
76 2021-04-10 fever, headache Fever, headache muscle ache for two days. Yook Tylenol
76 2021-04-11 chills Presented to emergency department with chest pain, report symptoms a few days prior to presentation.... Read more
Presented to emergency department with chest pain, report symptoms a few days prior to presentation. Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.
76 2021-04-12 headache is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no sid... Read more
is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.
76 2021-04-14 malaise, chills, headache, fever FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am goin... Read more
FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.
76 2021-04-15 headache 03/29/21 - severe headaches started and continued 04/03/21 - balanced/dizziness/vertigo feeling star... Read more
03/29/21 - severe headaches started and continued 04/03/21 - balanced/dizziness/vertigo feeling started and continued 04/04/21 - admitted to ICU and diagnosed with Hemorrhagic Stroke
76 2021-04-16 chills, headache chills; Bad Headache; This is a spontaneous report from a contactable consumer(patient). A 76-year-o... Read more
chills; Bad Headache; This is a spontaneous report from a contactable consumer(patient). A 76-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809 and Expiration Date: UNKNOWN), via unspecified route of administration in left arm on an 13Feb2021 09:45(at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Patient relevant medical history included, Sulfa Allergy, drug allergy (Amoxicillin). Other medical history reported as very good health. The patient was not diagnosed with COVID-19 prior to vaccination. Patient concomitant medications included in two weeks alendronate sodium (FOSAMAX) (MANUFACTURER UNKNOWN) on 15Feb, simvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN). Headache and chills since 16Feb Take Advil every 6 hours to mitigate reaction. Was fine day after shot, Took Fosamax on 15Feb and chills and fatigue set in that PM. On 15Feb2021 at 19:00 the patient experienced bad Headache and chills. Headaches started on 16Feb and continue. Since 16Feb2021 patient took Advil every 6 hours to mitigate reaction. On 20Feb2021, Nasal Swab COVID test was performed post vaccination included, negative result. The outcome of the event was reported as not recovered.
76 2021-04-16 headache 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 fatigue, fever 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 2021-04-17 fatigue Pt reports feeling a little tired; This is a spontaneous report received from a spontaneous Program.... Read more
Pt reports feeling a little tired; This is a spontaneous report received from a spontaneous Program. A contactable other healthcare professional and a consumer (patient) reported that a 76-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on 17Mar2021 (Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ), via an unspecified route of administration from 10Jan2021, at 5 mg tablet, cyclic for an unspecified indication. The patient previously received the first dose of COVID-19 vaccine on an unspecified date for covid-19 immunization. Patient reported a 1 week pause in tofacitinib citrate treatment as advised after her 2nd COVID vaccine on 17Mar2021. Patient reported feeling "a little tired", but could not be sure if from tofacitinib citrate or recent move back form winter home. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-04-19 cough, fatigue On 2/16, a few hours after the second shot, I started to feel exhausted. For 2 days I slept about 17... Read more
On 2/16, a few hours after the second shot, I started to feel exhausted. For 2 days I slept about 17 hours total. When I got up, I coughed nonstop and wheezed. Codeine cough syrup did nothing. On Mar 5, I was no better, so I went to Urgent Care. They said I had an exacerbation of COPD, but I have never had COPD. They prescribed erythromycin, prednisone, and a Wixela inhaler. On Mar 15, my PCP, Dr. put me back on prednisone for 10 days and added 2 OTC asthma meds. Within 10 days I was much better. On Apr 5, I had some breathing tests that were normal. I saw pulmonologist Dr. on 4/16. He said it might have been a vaccine reaction. I have never experienced anything like this before.
76 2021-04-19 headache, fatigue, cough Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, sl... Read more
Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, slept 10 hours and was fine
76 2021-04-20 headache Mild headaches that started the afternoon of the second vaccine. I took tylenol the first few aftern... Read more
Mild headaches that started the afternoon of the second vaccine. I took tylenol the first few afternoons, but discontinued daytime use and took the tylenol every night at bedtime. Headache is not continuous, but does occur for several hours at sometime during the day.
76 2021-04-23 fatigue, productive cough, cough, bronchitis coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm... Read more
coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened. Information about Batch/Lot number has been requested.
76 2021-04-24 headache Headaches, getting worse.; getting worse; This is a spontaneous report from a contactable consumer. ... Read more
Headaches, getting worse.; getting worse; This is a spontaneous report from a contactable consumer. A 76-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 14:00 (Batch/Lot Number: EL5318) at single dose for covid-19 immunisation. Medical history included bradycardia and overweight. Concomitant medication(s) included amlodipine; hydrochlorothiazide; rosuvastatin and potassium chloride. The patient experienced headaches, getting worse on 15Feb2021. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; 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. No follow-up attempts are possible; No further information is expected.
76 2021-04-24 headache This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration on 24Mar2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing pollen allergy from an unspecified date and ongoing ribs sore from an unspecified date. The patient stated that the pollen was bothering her and that she had been taking Zyrtec in the morning and at night. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the event was reported as "her son also had a seizure after the polio vaccine when he was 7 years old". Concomitant medications were not reported. It was reported that the patient denied any medications or medical conditions relevant to symptoms. There were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations received within 4 weeks of the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN202) via an unspecified route of administration on 24Feb2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient previously received the polio vaccine on an unspecified date for immunization and experienced seizure and the patient previously received the flu shot on an unspecified date (6 years ago) for immunization and 8 hours after the vaccine was achy, sick, in bed for 9 days. Developed bronchitis and coughed so hard she cracked her ribs. Stated her ribs were still sore at times to this day. The patient stated that she would never get another flu shot and that her doctor agreed with her on that decision. On 25Mar2021 the patient experienced headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing. The patient stated that she got her second dose of the vaccine on 24Mar2021. She reported that after her first shot she was fine. She stated that she started having headaches and dizziness the day after her second vaccine and this had lasted for 14 days. It has gone on now for several weeks and was not getting any better. She felt her symptoms went in different degrees at different times of the day. She might go one day without a headache. Today her headache was more like a numbness all around her head. She stated that her headaches come and go, sometimes start when her eyes pop open in the morning or at 10 AM. If she was going to have a headache that day, it usually started by 10 AM and was a full-blown headache. Stated her head always fely fuzzy and woozy and sometimes she felt like her eyes were crossing. She stated that she never got headaches; not since her early 20s. Dizziness continued to come and go, but it affected her vision and she was scared to drive and have a wreck. She reported that the symptoms were driving her bonkers. She also reported that she had to hold onto walls when she walked. The dizziness did not go away even when she laid down. She was dizzy when sitting on the sofa. Her head also felt fuzzy and numb, the fuzziness was constant. She reported that she felt disabled and felt like she was turning 100 instead of 77. She cannot lay in bed all the time and wanted to know how long these symptoms would last. The patient denied any labs, testing or treatment relevant to symptoms. She had not been to the doctor or to the emergency room in relation to these symptoms. She stated that she thought about it at times. She stated that she would have to call an ambulance to take her since she was scared to drive. Yesterday she thought she was not doing so bad and drove to the store. She stated that while in the store, her dizziness had her to where she could hardly pay for her items. Stated that it kind of felt like she was drunk, but she was not drunk. The patient stated that her experience with the polio vaccine made her almost not get the COVID-19 vaccine for fear it would bring on a similar situation. The clinical outcomes of the events headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing were all not recovered/not resolved. No follow-up attempts are needed. No further information is expected.
76 2021-04-24 malaise, chills, fatigue, headache, fever 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 fever, chills 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 dehydration 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 2021-04-25 headache, sweating, nasopharyngitis, fatigue, chills, fever 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 2021-04-27 chills sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore musc... Read more
sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
76 2021-04-27 cough No adverse event, but patient and her husband (both fully immunized) tested positive for COVID19 on ... Read more
No adverse event, but patient and her husband (both fully immunized) tested positive for COVID19 on 4/24/2021. Patient's symptoms started April 14 (cough only)
76 2021-04-27 headache, malaise Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; Thi... Read more
Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; 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 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown. Information about lot/batch number has been requested.
76 2021-04-27 malaise, fatigue Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depressio... Read more
Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.
76 2021-04-28 cough 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 chills, headache, fever, runny nose, fatigue 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 2021-04-30 chills, fatigue Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a li... Read more
Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a little; This is the spontaneous report received from a contactable consumer(patient). A 76-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history included usually constipated, her doctor put her on magnesium and docusate sodium (COLACE). Concomitant drugs included magnesium and docusate sodium, both for constipated. She experienced tiredness, arm hurts a little bit, chills, back hurts a little. The clinical course was reported as follows: the tiredness did not start until a couple days later and eventually went away. The arm hurting did not happen the first few days, it was not as bad the second day. She added that she could not complain about it. She did not have a fever, her temperature was 97.5. Her back hurts a little, but it hurts a lot anyways. She did not like to sit a lot. She liked to be active because it helps, but it was too gloomy to do anything on 12Apr2021. The seriousness of the events was unspecified. Outcome of tiredness was resolved. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-05-02 headache, malaise, influenza like illness 03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has... Read more
03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.
76 2021-05-03 fatigue shortness of breath, fatigue
76 2021-05-04 fatigue she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin under... Read more
she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.
76 2021-05-04 sleepiness Dizziness and sleepy. At 1314: BP 174/88, HR 50, O2 95%. Observed 15 minutes and pt drank water. At... Read more
Dizziness and sleepy. At 1314: BP 174/88, HR 50, O2 95%. Observed 15 minutes and pt drank water. At 1338: BP 155/77, HR 54, O2 96%. Pt stated feeling better and had steady stable gait. Advised to seek ED if sx worsen. Stable and released.
76 2021-05-05 chills, headache, fever 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 2021-05-07 cough, fatigue 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 2021-05-07 fever, chills, headache, fatigue tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report fr... Read more
tinnitus; joint pain; headache; extreme fatigue; chills; then fever; 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 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
76 2021-05-10 chills Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer... Read more
Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EL9266, Batch number- DDM#32), intramuscular, in left arm on 23Feb2021 (at the age of 76-years-old) at a single dose for COVID-19 immunization. Medical history included covid-19 in Nov2020 (reported as also had the virus) with no taste or smell for 4 months and was very tired for 2 weeks and Stage 3 kidney disease from Feb2019 and ongoing. There were no concomitant medications. The patient was vaccinated at Pharmacy/drug store. No other vaccine was given in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318, Batch number- DDM#32), intramuscular, in left shoulder on 02Feb2021 at 5:00 PM at a single dose for COVID-19 immunization after which the patent experienced mild sore arm and chills. The patient experienced mild sore arm and chills on an unspecified date. The events lasted for about 4 hours. The outcome of the events was recovered. Information about lot/ batch number has been requested. Follow-up (23Apr2021): New information received from the same contactable consumer (patient) included: Patient medical history and details, Product batch number and lot number, Outcome and duration of the events. Follow-up attempts are completed. No further information is expected.
76 2021-05-11 chills 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 2021-05-11 cough, respiratory tract congestion Cough pt states that she has had a cough x 3 days with congestion. pt states that she got her 1st CO... Read more
Cough pt states that she has had a cough x 3 days with congestion. pt states that she got her 1st COVID shot 2/6/2021
76 2021-05-13 throat pain 1/2 hr after receiving dose my throat and tongue swelled up; 1/2 hr after receiving dose my throat a... Read more
1/2 hr after receiving dose my throat and tongue swelled up; 1/2 hr after receiving dose my throat and tongue swelled up; My chest started bothering me and I was short of brreathe.; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in right arm on 08Mar2021 10:30 as first dose single for covid-19 immunisation. Medical history included known allergies to various chemicals, foods, red dyes, high blood pressure and AFIB. Concomitant medications included hydrochlorothiazide, lisinopril, apixaban (ELIQUIS), montelukast, duloxetine and metoprolol tartrate all are taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reports a half hour after she left the facility, she started getting a sore throat, then her throat and tongue swelled up. A little later my chest started bothering me and patient was short of breath on 08Mar2021 11:00 AM. Patient states she is getting better very slowly. This lasted all night and started to ease up the next day. patient took some Benadryl and that helped. As per the reporter seriousness criteria reported as medically significant. Patient received treatment that patient took of Benadryl and she has an inhaler. The outcome of the events was recovering. Follow up needed and additional information has been requested.
76 2021-05-14 runny nose, sneezing, cough Runny nose, cough, post-nasal drainage, sneezing, itchy/watery eyes Alka-seltzer plus hot caramel ... Read more
Runny nose, cough, post-nasal drainage, sneezing, itchy/watery eyes Alka-seltzer plus hot caramel tea with honey
76 2021-05-16 fatigue, sweating, headache Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of th... Read more
Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of the day. That kept the systolic pressure slightly under 160. Diastolic pressure was never over 75. Symptoms were sweating, heart pounding, headache, and fatigue.. Resolved itself on May 16, 2021 at approximately 6 p.m. when blood pressure again registered 125/74.
76 2021-05-17 fever Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) ras... Read more
Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.
76 2021-05-18 cough Exposure to COVID-19 virus COUGH
76 2021-05-18 headache, nasal congestion, cough, fever Cough Fever, unspecified fever cause Loss of taste Loss of smell Nasal congestion Acute nonintr... Read more
Cough Fever, unspecified fever cause Loss of taste Loss of smell Nasal congestion Acute nonintractable headache, unspecified headache type
76 2021-05-19 headache, malaise, fever, chills, fatigue she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low ... Read more
she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low grade fever; didn't feel well; She had chills; didn't sleep well; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Deltoid Right on 26Jan2021 15:00 (at the age of 76-years-old) (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient was not Vaccine Administered at Facility. The patient had no medical history (including any illness at time of vaccination). The patient had no family medical history relevant to AE(s). There were no concomitant medications. Historical vaccination included flu vaccine for the indication of flu vaccination which gave a reaction of sore arm. On 26JAN2021 patient experienced fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, arm hurt and she felt lousy. The patient underwent lab tests and procedures which included body temperature: 99.5 on 26Jan2021 low grade fever; Her normal temperature is 96-97.0. On 27Jan2021, the patient had slight headache. On 28Jan2021, body temperature was 98.1 and she is a little tired, but her fever was 98.1. Therapeutic measures were taken as a result of fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, slight headache, she is a little tired, arm hurt, she felt lousy. The patient got the first dose yesterday and had some reaction. She got a fever, her arm hurt and she felt lousy. She also mentioned that she took Tylenol yesterday. She and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could effect the efficacy of the vaccine. She wants to know does it effect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not gotten through the day without the Tylenol. Today, she is a little tired but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really lucky. The patient had no prior vaccinations (within 4 weeks). No AE(s) require a visit to Emergency Room. The patient had no relevant tests. The patient is healthy. The seriousness of the events was reported as non-serious. Outcome of the events fever/she was running at 99.5 low grade fever, She had chills, didn't sleep well, slight headache was reported as recovered on 28Jan2021, didn't feel well, she felt lousy and arm hurt was reported as unknown, she is a little tired was reported as not recovered. No investigation assessment needed. Follow-up attempts are completed. No further information is expected.
76 2021-05-21 headache 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 2021-05-25 chills chills; body aches; This is a spontaneous report from a contactable other HCP. This Other HCP report... Read more
chills; body aches; This is a spontaneous report from a contactable other HCP. This Other HCP reported that a 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration date not reported), via an unspecified route of administration on 11May2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included pre-existing condition of mouth ulceration from an unknown date. The patient's concomitant medication included palbociclib (IBRANCE, 125mg,) taken orally from 31Mar2021 as daily dose (day 1-21 of 28 day cycle) for breast cancer and is ongoing. The patient experienced chills and body aches on an unspecified date. The outcome of both the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-05-25 fatigue Hint aches throughout body; very fatigued; This is a spontaneous report from a contactable consumer ... Read more
Hint aches throughout body; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:30 (at 76 years old) (Batch/Lot Number: EN6201) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Feb2021, patient experienced Hint aches throughout body and very fatigued. No treatment for the events. The outcome of the events was not recovered. No other vaccine_in_four weeks. No covid_prior_vaccination. Not covid tested post vaccination.
76 2021-05-26 fatigue Unrelenting exhaustion. More exhaustion than usual fibromyalgia symptoms.
76 2021-05-26 headache, chills, fatigue, nasopharyngitis, malaise 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 2021-05-26 headache, chills, fever This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant fema... Read more
This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
76 2021-05-27 fever 1 week later: Fever 102 several days diahhrea
76 2021-05-28 chills, fatigue, headache 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 2021-05-28 fatigue 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 headache, chills This is a spontaneous report from a contactable consumer or other non-HCP. A seventy-six-years-old n... Read more
This is a spontaneous report from a contactable consumer or other non-HCP. A seventy-six-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) (At the age of seventy-six-years-old) via an unspecified route of administration, administered in left arm on 13Feb2021 at 09:45 as 1ST DOSE, SINGLE for COVID-19 Immunization. Patient did not receive any other vaccine in four weeks. Patient did not experience COVID-19 Infection prior vaccination. The patient medical history Includes known allergies: Sulfa drugs, Amoxicillin. Concomitant medications included Simvastatin, Levothyroxine Sodium and Alendronate Sodium taken for an unspecified indication, start and stop date were not reported. On 16, Feb2021 at 05:00 PM, the patient experienced headache and chills developed 3rd day. severe headache for seven days, mild headache for four days She was worried about 2nd dose. The patient underwent lab tests and procedures which included Nasal swab and CVS swab post vaccination and showed negative Sars-Cov-2 test on 18, Feb2021. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.
76 2021-05-28 headache, fatigue At the time of vaccination, I had a headache and sore arm and felt tired for 24 hrs or so. My l... Read more
At the time of vaccination, I had a headache and sore arm and felt tired for 24 hrs or so. My last check in report I would like to change my health status to serious vertigo experience beginning on May 1, 2021. In the middle of the night while in bed I felt like I was falling. The next day I had the need to fall to the left side all the way to the floor 2 times safety and felt very dizzy for the 2 days. I began my balance exercises. I continue to have frequent serious dizziness episodes since May 1. Can this recent on set of strong vertigo be a result of the vaccine? Until now all vertigo expressions were mild.
76 2021-05-28 malaise 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 2021-05-29 headache, chills, fatigue 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 2021-05-31 chills Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after ... Read more
Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-01 chills, fatigue, headache, malaise, fever This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female pa... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
76 2021-06-02 headache, chills and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right... Read more
and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-03 chills urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; fe... Read more
urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date. she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-06-03 fatigue, headache pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She alread... Read more
pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.
76 2021-06-03 malaise 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 2021-06-03 sneezing, cough, fatigue, headache 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 2021-06-04 fatigue, influenza like illness Major Fatigue & flu-like symptoms since 4 days following injection; Major Fatigue & flu-like symptom... Read more
Major Fatigue & flu-like symptoms since 4 days following injection; Major Fatigue & flu-like symptoms since 4 days following injection; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:45 (at the age of 76-year-old) as single dose for covid-19 immunisation. Medical history included fatigue from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced major fatigue and flu-like symptoms on 23Feb2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained
76 2021-06-04 fatigue Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable con... Read more
Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021. No follow-up attempts are possible. No further information is expected.
76 2021-06-08 chills, fatigue Patient developed chills, fatigue, nausea, and a generalized rash (inflammed and red).
76 2021-06-09 malaise, headache, fever 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 2021-06-10 headache Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Nod... Read more
Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.
76 2021-06-13 sleepiness Arthritis, body aches, swelling in joints, felt groggy or in a fog.
76 2021-06-14 fever, chills, fatigue I was very tired and I experienced Chills like I've never felt before and I had a high fever. After ... Read more
I was very tired and I experienced Chills like I've never felt before and I had a high fever. After I was admitted in the hospital I was diagnosed with cellulitis.
76 2021-06-15 headache significant level of pain in the left hemisphere of the head/pain had gotten progressively worse; Th... Read more
significant level of pain in the left hemisphere of the head/pain had gotten progressively worse; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9264), via an unspecified route of administration, administered in the left arm on 09Feb2021, 09:00 (at the age of 76 years old) as second dose, single dose for COVID-19 immunisation. Medical history included atrial fibrillation (reported as Afib) controlled by medication. The patient had no known allergies and was not pregnant by the time of the report. Concomitant medications included sotalol, rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), loratadine (CLARITIN), and Aci (as reported). The patient previously received the first dose of BNT162B2 (Lot number: EL3302), administered in the left arm on 19Jan2021, 09:00 (at the age of 76 years old) for COVID-19 immunisation. Approximately five days after second shot (13Feb2021), the patient experienced significant level of pain in the left hemisphere the of head and reported that the pain had gotten progressively worse. The event resulted doctor or other healthcare professional office/clinic visit; she had seen a dentist, an ENT, and a primary physician. No signs of dental, sinus, or other problem, and the patient was being treated for neurological reaction. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of the event and included treatment with prednazone (as reported), then gabapentin, and currently carbamazepine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
76 2021-06-16 fever, fatigue, chills 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 2021-06-17 headache 12 hrs after shot, sharp pain in r side of head, Same in heart. Could not sit up for 12 hrs, drank ... Read more
12 hrs after shot, sharp pain in r side of head, Same in heart. Could not sit up for 12 hrs, drank only cold water from caregiver.
76 2021-06-17 nasal congestion, runny nose, nasopharyngitis, cough Vaccinated with Pfizer 2/1/21 and 2/22/221. Symptom onset 6/8/21 - cough, runny nose and nasal cong... Read more
Vaccinated with Pfizer 2/1/21 and 2/22/221. Symptom onset 6/8/21 - cough, runny nose and nasal congestion. - mild cold symptoms. Sample sent for genomic sequencing
76 2021-06-17 runny nose, cough, nasopharyngitis, nasal congestion Vaccinated with Pfizer 2/1/21 and 2/22/21. Symptom onset 6/8/21 with cough, runny nose and nasal co... Read more
Vaccinated with Pfizer 2/1/21 and 2/22/21. Symptom onset 6/8/21 with cough, runny nose and nasal congestion - mild cold symptoms. Sample sent for genomic sequencing.
76 2021-06-18 headache Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or othe... Read more
Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, Expiration Date: unknown), via an unspecified route of administered in Arm Left on 03Jun2021 08:00 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus Verbatim: Diabetic (She takes medication.Caller stated she probably was diagnosed 25 years ago. It's been a while), allergy (she took the shot because of her allergies), peripheral swelling (Her arm swelled up 3 times), compromised immune status, respiratory illness, genetic, chromosomal abnormalities, Endocrine abnormalities (endocrine abnormalities, including diabetes and obesity) from an unknown date and unknown if ongoing verbatim. The patient concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. smallpox vaccine, vaccination Date: 1969. Her daughter was getting her smallpox vaccination at the same time. The caller had never had a smallpox vaccination. They decided to give it to her and her daughter at the same time. Her arm swelled all up again to the point her daughter took her to the emergency room. patient took Tetanus vaccine in 1996 and experienced allergy to vaccine, they told the caller she was allergic to the tetanus. She now wears a bracelet. Hopefully no one will give her a tetanus shot. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Caller stated she probably was diagnosed 25 years ago. Caller stated she does take diabetic medication. Vaccination Facility Type caller stated the clinic is connected to the hospital. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated, She had her first shot. She was advised to be near a hospital when she took the shot because of her allergic to the Epinephrine. she took the shot there. On 03Jun2021, patient experienced headache. she didn't had a headache before the shot. By noon, she was felt this headache. Caller stated she still has a little bit of it right above her left eye. the headache didn't go away with the Tylenol. The Tylenol doesn't seem to help much. She had to go buy some Tylenol. She had a major nosebleed on 05Jun2021 14:35 Saturday. Her headache kept getting worse. Reporter stated she did go to the physician office to get the packing removed from her nose. She went to the Emergency Room on Saturday. They had to cauterize her nose and packed it. She had no idea if it was from the shot or if the shot contributed to it. She hasn't had a nosebleed like that in years. It has been a long time since she had a bad nosebleed. She just wanted to let Pfizer know what's going on with her because it may help someone else. Her daughter was in healthcare and said caller should call and let Pfizer know. What good was it going to do to continue with the report. Reporter stated she still has a little bit headache on right above her left eye. It's not quite as bad as it was. It's there. She can tell it's there. Reporter stated she has no idea about dose. Caller stated she was not hospitalized. The outcome of the event major nosebleed was reported as recovered on 08Jun2021 and the headache was recovering. Description of complaint: Caller was reporting an AE to the Pfizer Covid Shot. Caller reports taking Tylenol for a headache and the headache did not go away. Caller reports the Tylenol doesn't seem to help much. Product strength and count size dispensed: Caller confirmed that it is 500 mg of Acetaminophen. She only took 2 like the instructions tell you. Count size is 60 tablets in the bottle. Packaging sealed and intact: absolutely. Information on the lot/batch number has been requested.
76 2021-06-22 headache, fatigue Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those sympt... Read more
Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those symptoms lasted 1 week to 10 days. I took Tylenol. This is long term issue (happening before the vaccine): Thyroid- I was going through a series of tests that the doctor was doing. My diet was changed and the medications were changing. I called the doctor most recently about Pinworm- went to see grandchildren and got that from them. They prescribed me Pinworm Medicine - the active ingredient is - Pyrantel Pamoate. I started taking that on June 10th. That's helping with my symptoms. I have to wash everything all the time. I have to repeat the Pinworm medication on the 24th of June.
76 2021-06-23 cough, headache Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has ... Read more
Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
76 2021-06-24 chills, malaise chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet a... Read more
chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-24 fatigue, headache, malaise 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 2021-06-24 fatigue, sleepiness I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the ... Read more
I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the headache started getting better but I still feel exhausted and tired all the time. I have no energy and I sit down and fall asleep and someone has to wake me and that's not normal. I go to see a cardiologists on 7/06/2021.
76 2021-06-24 malaise, headache consumer reported that after first dose, she felt unwell; had headache; body pain during 3 days; Thi... Read more
consumer reported that after first dose, she felt unwell; had headache; body pain during 3 days; This is a spontaneous report from a contactable consumer or other non hcp. The consumer reported about the first dose administered. A 76-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 on an unspecified date (Age at vaccination 76-year-old) as dose 1,single for covid-19 immunisation. Medical history included hypersensitivity. The patient's concomitant medication included unspecified profilactic medication. Reporter states during the call patient mentioned she had chronic allergy and prior to first dose administration she took profilactic medication as her physician recommended. On an unspecified date, during the call consumer reported that after first dose, she felt unwell, had headache and body pain during 3 days. She mentioned taking Tylenol for management symptoms subsequently to vaccination. Reporter wanted to know about whether she could change appointment hour for second dose administration. The outcome was resolved on an unspecified date. Information about lot/batch number has been requested.
76 2021-06-29 chills couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; This is a spontaneous ... Read more
couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; 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, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office. The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown. No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.
76 2021-06-29 fatigue, chills 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 2021-06-29 malaise 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 2021-06-30 fatigue Fatigue; This is a spontaneous report from a Pfizer sponsored program regulatory authority support v... Read more
Fatigue; This is a spontaneous report from a Pfizer sponsored program regulatory authority support via contactable consumer (patient) and contactable physician A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Apr2021 as a single dose (at the age of 76-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Apr2021 as a single dose at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing breast cancer. Concomitant medication included tamoxifen taken for breast cancer from an unspecified start date and ongoing. The patient states that both of her vaccines went very smoothly, and she only had some minor side effects, which includes fatigue. The patients antibodies test is negative and wanted to know if she can do another test to check the antibodies. Also wanted to know what she can or cant do there after the vaccination. The outcome of the event was unknown. Information about batch/Lot number has been requested.
76 2021-07-06 lethargy, malaise Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a bi... Read more
Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; 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 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.
76 2021-07-07 malaise, fatigue 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 2021-07-08 fatigue I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt t... Read more
I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt tired; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 16:00 as (At the age of 76-years) DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal, patient Was on blood pressure medication for many years. After losing 20 pounds did not need it anymore, blood cholesterol abnormal from an unknown date and unknown if ongoing Take Crestor 10 mg for cholesterol (total around160). Patient had no Known allergies except latex band aids. Concomitant medication included vitamin d3 and rosuvastatin calcium (CRESTOR). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and post vaccination. It was reported that After the first shot patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired. As treatment patient received Benicar 40 mg and Lorazapam.5 mg, Zicam. The patient underwent lab tests and procedures which included blood pressure measurement: rise on Feb2021 slight rise in blood pressure and pulse, heart rate: rise on Feb2021 slight rise in blood pressure and pulse. On an unspecified date in 2021, the events was resolved with sequelae. No follow-up attempts are possible. No further information is expected.
76 2021-07-11 fatigue Room began to spin around while I was sitting in, I was so dizzy that I couldn't open my eyes; could... Read more
Room began to spin around while I was sitting in, I was so dizzy that I couldn't open my eyes; couldn't lift my head off the pillow/Extreme dizziness for 7 hours. Unable to function or open eyes.; My lips started tingling slightly and my tongue started tingling slightly; tired a little; This is a spontaneous report from a contactable consumer (patient). This is the clone master case and was report 1 of 2. A 76-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021, UPC, NDC number of Covid 19 vaccine: Unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:45 (vaccination at the age of 76 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia, slight hypertension and high blood pressure. Concomitant medications included atenolol and menthanenine; the patient received both medications within 2 weeks of vaccination and taken for an unspecified indication, start and stop date were not reported. The patient was allergies to medications, food, or other products includes clindamycin, ampicillin, erythromycin and novocain. Vaccination facility type was reported as hospital. The patient stated, patient received my first shot 06mar2021, Saturday and about 15 minutes after the shot, my lips started tingling slightly and my tongue started tingling slightly so they had me sit there extra 15 minutes that was okay, basically no big deal. The problem came in was, now I got the shot at 10 o'clock in the morning, at 7 o'clock in the evening, the room began to spin around while I was sitting in, at 7:45 PM, was so dizzy that I couldn't open my eyes because every time I open my eyes I felt like I was on a carousel it was just going round and round so my husband helped me to bed, helped during the night, this lasted till 4 o' clock in the morning. My concern is what will happen with the next shot. states she tried to open her eyes and could not open her eyes and it was like she was on a carosel and the room was spinning which lasted until 4:00am the following morning and is now completely resolved. The patient stated she was not too much concerned and heard from people that might have happened with them. The sensation on her tongue and lips after the 1st dose of the Pfizer COVID19 vaccine was very slight in sensation and it was completely resolved and did not last long at all and was resolved within a minute. Caller states she was tired a little bit but at her age that happens and she had a full day yesterday and is going to say that her arm did not bother her after the Pfizer COVID19 Vaccine and other people said that their arms bothered them but she did not have that; She has no other patient information to provide. Event dizziness resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient not had covid prior vaccination and the patient was covid tested post vaccination. Prior and since the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included blood test and covid-19; both were negative on 22Mar2021, and reported as In the last 2 weeks, the patient did go for a Covid test because patient supposed to go for surgery on Wednesday to have, had a problem with bladder, it's kind of dropped down on one side. Outcome of the event My lips started tingling slightly and my tongue started tingling slightly was recovered on 06Mar2021 and other was recovered on 07Mar2021 and event tired a little was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-07-17 chills, fatigue 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 fever, lethargy, influenza like illness, chills, fatigue 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 fever, fatigue, chills, headache 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 2021-07-20 fever, chills, runny nose, fatigue, respiratory tract congestion, headache Fever or Chills Fatigue Muscle or body aches Headache Congestion or running nose
76 2021-07-21 cough, lethargy, respiratory tract congestion PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19... Read more
PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19PM: TESTED POSTIVE FOR COVID-19. COUGH WITH CONGESTION NOTED. 02 SAT 97%. 7/20/21 10:57AM: O2 SAT 98%, AFEBRILE. NO COMPLAINTS. 7/20/21 8:30PM: PATIENT 02 sat 77% RA, SOB, non-prod cough, wheezes/crackles TO LUNG FIELDS. PLACED ON O2 @4L, O2 CAME UP TO 82%. PATIENT VERY LETHARGIC. AFEBRILE AT 98.4. NURSING FACILITY SENT TO ER.
76 2021-07-21 cough Patient experienced 1 week of cough starting on 7/2 , tested positive for COVID-19 on 7/9 and was ad... Read more
Patient experienced 1 week of cough starting on 7/2 , tested positive for COVID-19 on 7/9 and was admitted to the hospital from Nursing Home - brought in by EMS. Per EMS - patient was on antibiotics at the nursing home. Only received one dose of Pfizer vaccine.
76 2021-07-27 chills she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a ... Read more
she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
77 2021-01-04 body temperature increased Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38,... Read more
Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,
77 2021-01-04 fatigue Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-o... Read more
Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.
77 2021-01-10 headache After receiving the vaccine, she verbalize feeling different in her head and headache. She was eval... Read more
After receiving the vaccine, she verbalize feeling different in her head and headache. She was evaluated onsite by Fire Rescue and Dr. onsite and released home at 10:50 am feeling better.
77 2021-01-19 fatigue, sleepiness, malaise Excessive Fatigue, sleeping all day, complaints of just not feeling well.
77 2021-01-19 malaise Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiat... Read more
Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.
77 2021-01-20 fatigue, chills, fever 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 2021-01-20 head discomfort, headache Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme sor... Read more
Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme soreness to touch and like nerves were tingling. Did not have any of this before injection. This went on for rest of evening , all next day. Next morning was back to normal. Never any severe pain just pressure and soreness. Got inj. At 3:35 on Tuesday 1-19 2021 started feeling apps 4:30 same day into night. All next day Wednesday 1-20-2021 into night. Next morning Thursday 01-21 it was gone. Could not stand to touch that area on top of head.
77 2021-01-21 throat pain, headache Sore throat, headache
77 2021-01-22 fatigue 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 2021-01-23 fever About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left a... Read more
About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left arm felt very heavy.
77 2021-01-24 chills 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 chills, headache, fever Fever; Headache; Chills; This a spontaneous report from a Pfizer-sponsored program by a contactable ... Read more
Fever; Headache; Chills; This a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (Covid-19 vaccine, Batch/lot number: EL3246), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE on left arm for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included amlodipine (AMLODIPINE), bisoprolol fumarate/hydrochlorothiazide (BISOPROLOL/HYDROCHLOROTHIAZID), both since 2015 and ongoing for blood pressure. The patient experienced fever, headache, chills on 08Jan2021. Everything happened at night time. Her temperatures have been 100.4 and 100.5 degrees. The headache only lasted for a couple of days. It was also only at night. The patient underwent lab tests and procedures which included blood pressure measurement: fine on 12Jan2021, body temperature: 100.4 and 100.5 degrees on an unknown date. The event outcome of fever, headache was not recovered; outcome of chills was recovering.
77 2021-01-25 headache, headache Headache / Pruritus / erythema/flushed / elevated B/P
77 2021-01-25 headache Headache / rash / pruritus / erythema / elevated B/P
77 2021-01-25 lethargy, headache Approximately 25 minutes after receiving the vaccine, pt. started c/o headache. Upon assessment, pt... Read more
Approximately 25 minutes after receiving the vaccine, pt. started c/o headache. Upon assessment, pt. appeared to be weak and lethargic. BP: 130/74, HR: 42, RR: 16, O2 sats: 93-98%. No other symptoms noted at this time. Local EMS was called for assessment. Pt. and daughter decline taking patient to emergency room, but is going to make an appt. with PCP at this time.
77 2021-01-25 runny nose, headache Light head ache, Light runny nose.
77 2021-01-26 fatigue, throat pain 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 2021-01-26 headache, chills, fatigue After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were... Read more
After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.
77 2021-01-26 influenza like illness flu-like symptoms, swollen tongue
77 2021-01-26 sleepiness, chills, fatigue, headache, malaise Tiredness, sleeping more, headache, muscle pain, mild chills, feeling unwell
77 2021-01-27 malaise Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started ... Read more
Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started feeling ill and lightheaded so reportedto site nurse/ems. Bp 190/100 which I have never experienced before. Bp on diovan 80 mg typically 110/60; without diovan is 140/80 -90. Given 2 benadryl and monitored and given 2 more. About 60-90 min bp 155/90 and I went home. Took more benadryl and bp 134/80 this morning and have not taken ot for 10 hrs but feel ok. No local rx.
77 2021-01-27 runny nose Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Si... Read more
Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.
77 2021-01-28 nasal congestion, fever fevers; congestion/stuffiness; This is a spontaneous report from contactable consumer (patient). Thi... Read more
fevers; congestion/stuffiness; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for two patients. This report is for the first of two patients. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included metoprolol for high blood pressure. The patient experienced fevers and congestion/stuffiness on 15Jan2021. Patient stated that she and her husband got the first shot of the COVID 19 vaccine on 09Jan2021. She began to run a fever today and has stuffiness. Patient wanted to know are these side effects of the vaccine and would these side effects start so many days after the vaccine. She was told that she can not get tested for COVID because she has had the vaccine. Patient is supposed to go back on the 30th for second shot. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046472 same reporter, drug, event, different patient
77 2021-01-29 chills, fatigue Dizziness, Chills, Diarrhea Nausea Weakness, Tiredness
77 2021-01-30 chills Chills; Sore Arm; Shakes; Anxiety; Dizzy
77 2021-01-31 malaise, fatigue Felt ill, tired, achy. No fever detected. Sore arm, nothing too serious. Symptoms lasted one day.
77 2021-02-01 fever Chest pain; Fever; Hypokalemia; Pyelonephritis
77 2021-02-02 chills, fatigue Chills and tiredness, for 4 days so far
77 2021-02-03 cough, chills, throat irritation Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with... Read more
Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with raspy voice and urge to cough. Took at approx. 10am. By 1030 itchy throat mildly decreased but with dizziness and chills. O2 sat was 98%. By 1200 most symptoms resolved. At 1400 again with increased itchy throat so took 25mg of Benadryl. No other symptoms, O2 sat 96% and heart rate in the 80's.
77 2021-02-03 headache 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 headache Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two t... Read more
Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; 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 EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.
77 2021-02-03 headache I developed a headache; This is a spontaneous report from a contactable consumer (patient). A 77-yea... Read more
I developed a headache; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 10Jan2021 17:00 at single dose for covid-19 immunisation. The patient's medical history included Anemia, Chronic Rhinitis, Rheumatoid Arthritis, Osteoarthritis, Kidney Disease Stage 3, and Gerd. The patient's concomitant medication included fexofenadine hydrochloride (ALLEGRA), rosuvastatin calcium (CRESTOR), prednisone, darbepoetin alfa (ARANESP), and clopidogrel. The patient previously took Phenergan and ACE inhibitors; both experienced allergies. On 16Jan2021 18:30, the patient developed a headache. The patient did not received treatment for the event. The outcome of the event was unknown.
77 2021-02-03 fever, fatigue, chills Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contacta... Read more
Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contactable Physician. A 77-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose (2nd dose) for covid-19 immunization. Medical history included high cholesterol and has no known allergies. The patient's concomitant medications were not reported. The patient had her first dose on left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685) at 12:00 on 22Dec2020 but had slight discomfort site injection and occasional soreness site injection over the subsequent 3 weeks. For vaccine dose 2, it was reported that after 30-36 hr, patient developed chills, low grade fever 99.4 orally, fatigue, weakness and took ibuprofen. She slept normal by 42 hrs and no further complications. The outcome of events recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in a school clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.
77 2021-02-04 influenza like illness, cough Flu like symptoms, chest heaviness, anorexia, cough...symptoms have resolved as of 1/29/21
77 2021-02-05 headache Headache
77 2021-02-05 sweating Patient complained of dizziness and said she was going to pass out. Observation nurse called site cl... Read more
Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.
77 2021-02-06 fatigue Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint p... Read more
Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue
77 2021-02-06 fatigue Sore arm started in the middle of the night--still sore two days later. General achiness all over. ... Read more
Sore arm started in the middle of the night--still sore two days later. General achiness all over. General tiredness.
77 2021-02-06 headache, fever About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme m... Read more
About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme muscle aches and headache. My fever lasted about 12 hours running between 100 and 102 (on tylenol) Headache continues. Muscle aches and fever subsided about 24 hours after onset.
77 2021-02-07 chills, fatigue 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 2021-02-07 fatigue, fever, headache 24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feel... Read more
24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feeling like i had inflammation in my butt, external in vaginal area and was hard to use the restroom and back of thighs area. felt like a had a rash but there was nothing there. like it was burning. it just felt inflamed. It felt good to apply cold to it. it lasted until the next day.
77 2021-02-07 headache Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at... Read more
Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at 1pm that lasted for only a few seconds. Pt also experienced a mild SOB while walking in the hallway. Mild SOB was only lasted for a few secs (prior to chest pain). Pt stopped and rested and Pt felt fine afterwards. Chest pain Hx: Upon assessment, Pt also reported that pt experienced chest pain x1 (6 months ago) which also lasted for a few seconds. But, pt never reported this to pt's physician. Other Sxs: Symptoms: Headache. Onset: 2/8 AM. Pt took Tylenol 1000mg this 9am. Pt states she usually takes QAM for her arthritis. Effect: "It did not help." Pt denies any change in vision, blurry vision, double vision. Denies NV. Pt denies any chest pain or SOB today. Pt was able to speak clearly in full sentences. Pt was able to do ADLs without this morning. Pt stated, " I am able to carry on all my chores without difficulties. Other than headache I feel completely fine." No distress noted that needed an emergent care. Recommendation -Pt denies any significant related symptoms such as ?worst headache of life? or changes in vision, speech, or coordination, or nausea/vomiting. -Instructed to take analgesics such as Acetaminophen after 4-6 hrs (Adult dose: DO NOT EXCEED 4,000mg per day unless directed by the doctor) according to package instructions provided there are no contraindications. -Advised to rest and increase water intake. Education: -If pt experiences any chest pain, SOB, visual changes, change in mental status, N/V or ?worst headache of life?, pt was advised to go the nearest ED. -If headache is severe, focal, progressive or persists > 1 day: Pt was advised to reach out to PCP same day.???If PCP is not available should seek care at Urgent Care. Pt verbalized understanding and agreed with the plan.
77 2021-02-07 throat pain, headache Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yeste... Read more
Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation." Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.
77 2021-02-07 fever, chills Injection site- swelling, redness, pain, tenderness, itching - chills, fever, body aches
77 2021-02-08 fatigue, chills, cough Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began ar... Read more
Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began around 7 or 8 am February 5 and continued all day and evening. I slept most of the day. Around 11:30 that night I woke up feeling quite a bit better. I slept all night. The next morning, Saturday, the aches had gone away and I was alot better. The cough, however, continued. The cough continued through Sunday. Monday the cough happened only a few times and I felt energetic and completely back to normal.
77 2021-02-08 fatigue diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a c... Read more
diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
77 2021-02-08 headache Shingles break out 10 days after first injection, pain and pox on neck and head
77 2021-02-09 fatigue, malaise, headache 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 2021-02-09 headache, chills trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurti... Read more
trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.
77 2021-02-09 throat irritation Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injectio... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injection site and in throat. Initial vital signs within normal ranges except pulse 100-110 beats per minute and blood pressure 180/90 mmHg. Patient administered diphenhydramine 25 mg orally and transported to the emergency department. On arrival and during physical exam patient noted to have red "splochyness" on chest wall but no hives. Patient awake, alert, oriented: no shortness of breath, stridor, or oral or pharyngeal swelling. Patient observed, symptoms improved, vital signs stable, and discharged to home.
77 2021-02-10 chills, fatigue, fever, headache, malaise 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 chills, fatigue chills; general body aches; fatigue; This is a spontaneous report from a contactable consumer (patie... Read more
chills; general body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: el9262, exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 22Jan2021 15:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other (not specified). Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient had no allergies to medications, food, or other products. There were other medications patient received within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced severe chills lasting for another 24 hrs; then general body aches and fatigue lasting for 3 days. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
77 2021-02-10 sweating, chills, throat pain Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain... Read more
Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain, swelling, lymphadenopathy persist now Taking acetaminophen. At home for now. Also adv warm compresses/drinks for comfort. Adv to FU with HCF trouble breathing or if symptoms persist/worsen.
77 2021-02-10 sweating, fatigue, malaise, chills 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 2021-02-11 fatigue, respiratory tract congestion, headache RECEIVED COVID VACCINE 1ST DOSE ON 02/03/21. REPORTED TO ICC ON 2/12/21 FOR HEADACHE, NO TASTE, FAT... Read more
RECEIVED COVID VACCINE 1ST DOSE ON 02/03/21. REPORTED TO ICC ON 2/12/21 FOR HEADACHE, NO TASTE, FATIGUE, AND CONGESTION. REPORTED COVID EXPOSURE 1 WEEK PRIOR. HAD POSITIVE COVID PCR 02/12/21. RECIEVED BAM INFUSION ON 02/12/21.
77 2021-02-11 head discomfort Had shot on 2/3/21 and on Thursday around 2.00am started to feel pressure in temple area. It lasted... Read more
Had shot on 2/3/21 and on Thursday around 2.00am started to feel pressure in temple area. It lasted until Wed ..one week like a vice on my temples. Called Primary Dr. office and spoke to PA. She prescribed IMITREX for migraine but I took Excedrin with Caffeine and it did not help. I have not taken the IMITREX because we've had an ice storm and couldn't get it. Wed my head felt much better...I was so happy..then last nite around 2.00am again it returned! Not as bad as before but it still returned.
77 2021-02-11 headache DIZZINESS,,,,, HEADACHE UNRELIEVED WITH TYLENOL, GENERALIZED ACHINESS, WEAKNESS,SPO2 L0W 90%
77 2021-02-12 fatigue 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 chills, fatigue, throat pain On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle... Read more
On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle pains. Third day, some muscle pain.
77 2021-02-13 headache, fatigue, influenza like illness, chills 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 sweating, fever, headache, chills 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 2021-02-13 respiratory tract congestion, fever, runny nose 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 2021-02-14 headache She had Pain: Headache or Migraine after the vaccine. Onsite EMS was requested.BP 142/86 HR 86 99% ... Read more
She had Pain: Headache or Migraine after the vaccine. Onsite EMS was requested.BP 142/86 HR 86 99% O2 on room air. They were able to find a specific cause and she refused additional workup
77 2021-02-15 fever, fatigue Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was ... Read more
Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was not tolerated as well. Patient experienced 4 days of a low-grade fever, fatigue, facial flushing, injection site pain, and itching of the upper arm with little relief from OTC ibuprofen. Recommended OTC acetaminophen and a follow-up appointment with her PCP.
77 2021-02-16 body temperature increased Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Se... Read more
Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16.
77 2021-02-16 fatigue Diarrhea , fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14
77 2021-02-16 head discomfort, chills Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left s... Read more
Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left side) and painful throbbing on right side of neck.
77 2021-02-17 fatigue, head discomfort fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable co... Read more
fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.
77 2021-02-17 fatigue Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 0... Read more
Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 02/18/2021
77 2021-02-17 headache, fatigue, sinus congestion 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 headache pt stated that she developed hives on her torso and both legs down to the knees and slight headache ... Read more
pt stated that she developed hives on her torso and both legs down to the knees and slight headache after taking the covid. Pt states her symptoms are improving.
77 2021-02-17 influenza like illness, fatigue, headache 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 fever, headache Fever, splitting headache, nausea, vomiting
77 2021-02-17 throat irritation Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site.... Read more
Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.
77 2021-02-18 chills As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/... Read more
As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD.
77 2021-02-19 fever Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever... Read more
Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.
77 2021-02-21 chills This was my second vaccination at the same site. I was fine with the first shot, and seemed fine wi... Read more
This was my second vaccination at the same site. I was fine with the first shot, and seemed fine with the second one until the next afternoon around 3:00 p.m. All of a sudden I could feel some aching in the back of my neck and just a feeling of aching down my back. Then I started to get the chills, chills that were so bad my body was almost convulsing with chills. I ended up going to bed and I turned my electric mattress pad on to warm up. I then slept very well and I don't think I moved all night. I woke up sort of achy, but not much to be concerned with.
77 2021-02-21 fatigue, headache, chills chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous rep... Read more
chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.
77 2021-02-21 influenza like illness, headache on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke... Read more
on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms
77 2021-02-21 nasal congestion, headache severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer ... Read more
severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.
77 2021-02-22 body temperature increased Mild temperature as high as 101 for 3 days
77 2021-02-22 paranasal sinus discomfort, chills, fatigue, headache, nasal congestion 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 chills 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 headache 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 headache 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 2021-02-23 sweating PATIENT BEGAN TO FEEL HOT AND SWEATY POST VACCINE
77 2021-02-24 body temperature increased, fatigue The day after 2nd vaccine, temp went to 100, body aches, severe fatigue. My temp went back to normal... Read more
The day after 2nd vaccine, temp went to 100, body aches, severe fatigue. My temp went back to normal on 3rd day, however had fatigue and body aches for 4th and 5th day.
77 2021-02-24 malaise, fever 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 2021-02-24 fever Fever, syncope. Pt has small rash to administration site.
77 2021-02-26 headache, chills, fever 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 malaise, chills 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 fatigue, sleepiness, chills, nasopharyngitis Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covere... Read more
Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covered up with more blankets. Upon wakening, felt felt totally exhausted and weak. I slept and took naps throughout the day. Some aches in the body and sore arm where injection was given. Continued to feel extremely weak and cold the next 24 hours. Felt better day after but still tired and weak. injectgion site reddened and sore. Injetion site still sensitive, rpink discoloration and lump under the skin
77 2021-02-28 fatigue Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, re... Read more
Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, reaction of SOB began two hours later. SOB progressed to chest pain and fatigue. She sat at kitchen table to relax and rest, fell asleep for 2 hours. When she woke up she continued to have trouble breathing, drank some warm tea, went to bed and slept for 12 hours. This is not usual for her sleep schedule. The next day she felt better for a couple of hours then had some difficulty breathing again. She went to Urgent Care. EKG and chest X-ray preformed came back normal. Blood pressure was elevated. Client given 4 puffs of an inhaler. Discharged to home.
77 2021-02-28 fatigue patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 3... Read more
patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 30 min and improved after 30 minutes
77 2021-02-28 headache, chills, fatigue Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of... Read more
Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of control/ She got the shakes so bad she shook for like 5 hours; Neck froze completely; She can't move her head up and down normal/ couldn't move her head; Pain in her neck; pulled muscles; Muscles were so sore; Fatigue/Extreme tiredness; Weakness; Muscle pain; Joint pain; 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: EL0140), via an unspecified route of administration at the right arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient had anaphylactic shock in the past to a sulfur antibiotic. There were no concomitant medications. She stated she did not have an extreme reaction for the first 3-4 days, it was fine and went away. She had fatigue, joint pain, all the regular things and they were easing up. She had an appointment on the 20Jan2021 and thought things were going okay. On day 7, 20Jan2021, that night, she had an extreme reaction of blinding headache, the shakes, her whole body was shaking out of control for hours, her neck froze completely, and she can't move her head up and down normal (this is still occurring). The patient has had joint paint on 14Jan2021; extreme tiredness, weakness and muscle pain on 15Jan2021; chills, pain in her neck and muscles were so sore from 20Jan2021. She figured that was side effects, and she was handling, and then exactly a week after, she got the shakes so bad she shook for like 5 hours, she had to put nightguard in her mouth to stop from cracking, and severe headaches and her neck completely locked up, she couldn't move her head, and she still can't. She had extreme headache, and she went to the ER on 26Jan2021, since she was in really bad shape, they wouldn't believe her that it was a COVID reaction, she was there for 12 hours, they did every test, she had spinal taps, she had a head X-ray, everything, as they said she had meningitis, but then ruled that out, they wouldn't believe she was having a reaction to the COVID shot, she can't move her head, her joints and that are ok otherwise, but she can't move her head, she has pain in her neck, and she is taking Excedrin for that. She stated her doctor told her to go ahead and take the second dose of the vaccine and just take Tylenol after. She stated Tylenol has no effect whatsoever. If she takes Excedrin the headache will go away and Tylenol won't budge it. She stated she is taking Excedrin regardless of what the doctor says. When asked for age of onset, states she was on Valium and she was not thinking straight, and asked her husband her age. She was not sure why it was given, now provides name as Diazepam 5mg. Muscle pain is fine now, it went away. She went to the doctor on 20Jan2021, as she had a regular appointment for bloodwork to be done, and said she felt pretty good, she had some reaction but was fine, and that night is when she got shakes and shivers so bad, she had 3 quilts on and couldn't warm up, her body was out of control, she couldn't stop, now states for 3-4 hours. Severe headaches started the night of the 20Jan2021. Her neck pain started right after the shakes, so maybe she pulled muscles when she had the shakes, the muscles were so sore, and she couldn't move her head, like down or to the side, she couldn't move it, which is why she went to the hospital, to the ER. She was there for 12 hours. She started taking Excedrin, states she ignored what the doctor told her. She knows her body and she can take Tylenol and Ibuprofen like it is candy, and it does nothing, one Excedrin puts everything away, she swears by Excedrin. The outcome of the event shaking recovered on an unspecified date; Joint pain and Muscle pain recovered on 19Jan2021; Blinding headache/ severe headache, Fatigue/Extreme tiredness was recovering, chills/ shivers, couldn't warm up, Neck froze completely, pulled muscles, fatigue was unknown; she can't move her head up and down normal/ couldn't move her head, Pain in her neck, Muscles were so sore, Weakness was not recovered.
77 2021-02-28 fever, chills 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 chills, sweating 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 chills severe chills, usually after getting up in mornings weakness muscle and joint soreness pain
77 2021-03-02 fatigue, headache Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itch... Read more
Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.
77 2021-03-02 fatigue, throat pain 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 2021-03-02 fatigue Two hours after injection severe pain in my right knee began and continues moderately today 3/3/202... Read more
Two hours after injection severe pain in my right knee began and continues moderately today 3/3/2021. (injection given at 1452) The doctor suggested heat/cold, anti-inflammatory, brace and finally an x-ray which indicated nothing. Four days after the second injection I've experienced mild pain in my opposite thigh and fatigue. The second injection was given in the opposite arm (left). While chatting with others in recovery after second injection about knee pain, another woman said she was experiencing the same and thought it was her arthritis but it felt different.
77 2021-03-02 fatigue Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This mo... Read more
Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This morning she had swelling in her arms, real bumpy about 2 1/2" in diameter, looks like rocks, red/pink area 1 1/2". It is very painful throbbing area on her arms, getting worse. She has been taking Tylenol. She felt a little relief of the pain with the Tylenol. She rested all day yesterday. She left at 10:00 for her bridge club and that's where she noticed the reaction and has gotten home around 3:00 and not feeling well. They told her to call us as they did not have any side effects from the vaccine. She does have an appointment on 3/11/21 with her PCP.
77 2021-03-02 headache, chills, fatigue, sweating DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, f... Read more
DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, fatigue, and sore arm (like tetanus). DAY 2-Migraine all day, chills, sweat, dizziness, fatigue, and sore arm. DAY 3- Migraine downgraded to functional migraine (I could open my eyes), sweat, dizziness, sore arm, fatigue, chills gone. DAY 4-headache, painful to move arm. DAY 5-Arm still painful to use.
77 2021-03-02 headache 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 sweating 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 sweating she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vac... Read more
she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect 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/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.
77 2021-03-02 malaise, fatigue, chills 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 fever, headache Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Heada... Read more
Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Headache; Nervousness; like a chronic ear ache; infection somewhere/earaches which turned out to be infected; 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: EL1284; expiry date: unknown) , via an unspecified route of administration in the left arm, on 18Jan2021, at a single dose for COVID-19 immunisation. Medical history included ear problems in the past and sick. There were no concomitant medications. The patient had her first COVID shot on 18Jan2021. By Wednesday, two days later (20Jan2021), both ears were messed up, she was running a temperature (also reported as low-grade fever), had a headache, and was very nervous. She went to the doctor and her doctor gave her an antibiotic shot, two steroid shots, and some antibiotic ear drops, which did not work. She then did a home call with the doctor and she provided more steroids, an oral pack, and an oral antibiotic for 5 days. She was still having problems with her ears. Mainly her left ear. It goes from ear to ear. She went to the ENT about the earaches which turned out to be infected, and has subsequently been on two rounds of antibiotics, with persistent symptoms that have gotten better over time. Patient wanted to know if this could relate to the COVID Vaccine. She has never had this happen before, and she has been really sick but not this bad. She has had ear problems in the past, but normally the antibiotic liquid drops clear it up. It was like a chronic ear ache. Her earaches were hurting bad. What she is wondering is if it could be a side effect from the first COVID shot. She clarifies that her ears are swollen on the inside. It was an infection somewhere. The antibiotics and steroids have not healed it up. All of these events were still occurring but come and go. For instance, yesterday she had a low temperature but has not yet had one today. The antibiotic ear drops prescribed were Neopoly HC OTSC 1% OTIC SU. NDC: 24208-635-62. Expiry date: Jun2022. She was unsure what the lot was but also sees: 349111. The oral antibiotics she has is Amoxicillin 875mg/125mcg. These are in a pharmacy vial. Use before: 26Jan2022. She was given two steroid shots. One shorter acting and one longer acting. She was unsure of the names. Oral steroid pack: Manufactured by Pharmaceutical name. Prednisone USP 5mg. REV 1016. 314518. lot: 1150419. Expiry date: Feb2022. She also pre-treated with allergic reaction medications. She goes back to the ENT on Thursday. Patient wanted to know if these had happened to anyone before. Outcome of the event pyrexia was unknown, for events ear swelling, ear pain and ear infection was recovering, while for the other events was not recovered.
77 2021-03-02 sleepiness, nasopharyngitis, fatigue, chills 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 2021-03-03 fatigue Aches all over my body, tiredness; lasted only one day. Got some sleep no symptons the following da... Read more
Aches all over my body, tiredness; lasted only one day. Got some sleep no symptons the following day
77 2021-03-03 headache 1o minutes after receiving the vaccine client started c/o feeling her heartbeat in her head. This la... Read more
1o minutes after receiving the vaccine client started c/o feeling her heartbeat in her head. This lasted for a few minutes. Information was obtained by a neighbor that lives 4 doors down from her. She has had no other problems.
77 2021-03-03 malaise, dehydration 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 headache, fatigue fatigue, headache, hip pain, site redness - all 8 hours - no treatment
77 2021-03-04 malaise It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It... Read more
It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.
77 2021-03-04 throat pain, headache, fever fever with strong chilling, body aches, head ache, slight sore throat
77 2021-03-04 throat irritation, fatigue, cough Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & lig... Read more
Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.
77 2021-03-05 fatigue, chills Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (at injection site) starting one day after receiving vaccination. Patient previously had COVID-19. During clinic visit three days after vaccination symptoms have resolved without intervention.
77 2021-03-06 chills, fatigue, fever chills, fever, neausa, fatigue, 48 hours, I thought I was going to die
77 2021-03-06 fatigue, headache, fever Sore arm, headache, fatigue, fever (100.7 deg F), took Tylenol
77 2021-03-06 influenza like illness, body temperature increased Started having flu symptoms 3 hours after shot. By following morning had a temp of 105 and was not ... Read more
Started having flu symptoms 3 hours after shot. By following morning had a temp of 105 and was not responsive. Rushed to Hospital by ambulance. Not responsive for 2 days. In hospital for 4 days. Hospital concluded she had a temp induced seizure. Worst response they had seen. Still rests and sleeps more than normal.
77 2021-03-07 chills, headache, fatigue 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 2021-03-07 nasal congestion, respiratory tract congestion She can breathe better moving around but when she sits down, her breathing seems to be congested; No... Read more
She can breathe better moving around but when she sits down, her breathing seems to be congested; Nose started stuffing up again; Her nose just swells; congestion in her chest; her arm was sore/ Little pain in her right leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) solution for injection, intramuscular on right arm on 01Feb2021 at 09:10 AM at single dose for COVID-19 immunization. Medical history included breathing problems and COVID-19 on 31Oct2020 in which she waited exactly 90 days to get the vaccine. The patient had a small touch of pneumonia on her lower lobe of her right lung, she was on a lot of antibiotics and a strong herbal solution. She was on one antibiotic for 5 days and another for 7 days. She was on the herbal stuff for 7 days. She took all that stuff and was drinking lemon juice and hot water and breathing in lemon scent and Vicks Salve all in her nose. She also was prescribed an asthma pump. She had all that stuff going into her system. She also was tested, and she has H. Pylori bacteria. She explained her whole family must have that, it's hereditary. That wasn't her issue. However, all that she put in her stomach and in her system caused her to have stomach issues. She told the doctor that antibiotics made her sick. She told the person administering the vaccine that antibiotics made her sick and she was told it didn't matter and that this wouldn't interfere with the COVID-19 vaccine. Her stomach was all messed from all that stuff. The patient also has anxiety. She has never been treated with anxiety. She has had anxiety since she was a very young women and she has never been treated for it. When probed for any product information she had available for the medications that messed her stomach up and made her sick she provided the following information: The first medication she took was azithromycin (Z-PAK, lot number: KG0706, expiration date: Nov2021, NDC number: 0781-8089-26) that was dispensed in a little box. Dose was 250 mg which she took daily doses for 5 days. One of the doctors gave her a levofloxacin 50 mg for 7 days. She was given the pump, salbutamol (ALBUTEROL SULFATE HFA INHALATION AEROSOL, lot number: 102B4, expiration data: 20Jan2022) 90mcg per actuation. She explained she only took this once. She was so scared from this stuff. It squirted down her mouth. Another doctor prescribed her omeprazole 40 mg capsule every day because she told him her stomach was messed up. The patient was prescribed amoxicillin 500 mg tablet, take one tablet, by mouth three times daily for 14 days and clarithromycin 500 mg tablet, take one tablet by mouth twice daily for 14 days. The new doctor also had her taking omeprazole (the doctor wrote another prescription for this). However, this time the dose was 20 mg and she was prescribed to take that twice daily for 14 days. She didn't finish this medication. She told the doctor that antibiotics made her sick and the doctor explained because of her bacteria, she ordered the antibiotics to make her feel better. The patient told the doctor if she could live like this, let her not take these medications until she gets her stomach better and she would eat healthy food and find natural antibiotics at the health food store. She mentioned using oregano. She took that once a day. When she knew she was getting ready to take the COVID-19 vaccine, she stopped taking that 2 weeks before taking the vaccine. She stopped taking cholesterol medicine at night 2 weeks ago, it was making her sick to her stomach. She stopped her potassium medicine. She didn't want any of the medicines interfering with the vaccine. The patient also took an herbal medicine that was called a Spiritual, Mental, Emotional, Elevation Science of Eternal Life. It's a detox mixture that was very strong. She took this for 7 days. She had lost weight because she was not eating. The patient has always been a junk food eater. She quit eating junk food and that probably also had something to do with her being sick. She cooks all her food. There was no additional vaccine administered on the same date with COVID-vaccine. The patient has no prior vaccinations within 4 weeks. She has never had a flu vaccine, pneumonia vaccine or shingles vaccine. This was her very first vaccine. Concomitant medication was reported as none. The patient didn't know if it was anything serious, but she tried to read all the information that was given to her. She was looking at the information and she saw "if you have any difficulty breathing". That was the only one that she was having. She could breathe better moving around but when she sits down, her breathing seems to be congested. She was calling to see if this was anything serious and if she needed to go the emergency room. Since her breathing has been acting funny, she has been trying to keep moving around. She was cleaning her bathroom and the Bleach Cleaner and other cleaner opened her nose. She was listening to a town hall meeting and when she sat down to listen to it, her nose started stuffing up again. She has just been trying to get up and move around. Since she has been talking on the phone, her breathing was a little better. Her nose just swells. She got up and was beginning to eat breakfast when all of a sudden, the difficulty breathing started happening. It was around 8:45 am this morning (02Feb2021). It has improved, but when she would sit down, it would tighten up and she would have congestion in her chest. Since she has been moving around talking, it has gotten better. Sitting down has something to do with the difficulty breathing. She has had breathing problems before. The patient received the COVID-19 vaccine yesterday, 01Feb2021. She sat for half an hour afterwards and then came home. She then slept all night and stated her arm was sore on Feb2021, but it was feeling better. She also had a little pain in her right leg on the side she received her vaccine on Feb2021, which was currently gone. She wasn't sure if the breathing problems were from the vaccine or something else. The patient did not go to the emergency room or visited his physician in response to the events. She mentioned that if this continues, she probably will go to urgent care. The outcome of the event dyspnea at rest and respiratory tract congestion was recovering, recovered on Feb2021 for pain in extremity, and unknown for all other events.
77 2021-03-08 chills, fever, fatigue Fatigue began first lasting for 24 hrs. Fever noticed after first 12 hours along with chills. Took... Read more
Fatigue began first lasting for 24 hrs. Fever noticed after first 12 hours along with chills. Took one Tylenol 15 hrs after first symptom which did not provide any relief. At hour 20 the fever returned to normal and fatigue and chills subsided.
77 2021-03-08 fatigue Fever of 101 for one day, extreme ongoing, almost incapacitating fatigue is still continuing almost... Read more
Fever of 101 for one day, extreme ongoing, almost incapacitating fatigue is still continuing almost three weeks and counting
77 2021-03-08 headache, fatigue has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not cle... Read more
has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; 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, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.
77 2021-03-08 headache Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followe... Read more
Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followed by sinking feeling in head, followed by spasms in center of head felt like seizures. 2-19 hospitalized for CT Scan of Head 2-23 EEG in Doctor Office
77 2021-03-08 lethargy Only a lack of energy, lethargic, about 24 hours
77 2021-03-08 malaise, chills, fever, fatigue Pain in left arm; slight fever; lots of chills for 1 1/2 days; fatigue; generally feeling lousy
77 2021-03-08 fever 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 2021-03-09 chills body aches, chills
77 2021-03-10 chills, fever, headache Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Sh... Read more
Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Shortness of breath Chills lasting 6hours Fever 12 hours Fatigue 2 days Weakness on going.
77 2021-03-10 fatigue, headache 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 headache, chills, fatigue 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 fever Fever and diarrhea since 3/4. Tested positive for COVID on 3/7 and was admitted as an inpatient.
77 2021-03-11 throat pain, productive cough, nasopharyngitis, nasal congestion Second Pfizer on 3/1, head cold and congestion on 3/7-9, with productive cough, stuffy nose, sore th... Read more
Second Pfizer on 3/1, head cold and congestion on 3/7-9, with productive cough, stuffy nose, sore throat,
77 2021-03-11 throat pain Constant pain in right leg when walking. Soreness on tongue and throat.
77 2021-03-11 fever severe body aches, fever, swelling at injection site, that lasted 5 days
77 2021-03-13 malaise Bacterial pneumonia diagnosis, felt sick one week after vaccine
77 2021-03-13 fever, chills, sleepiness, fatigue, lethargy, headache High temp, dizzy, headache, sleepy, exhausted, lethargic, chills
77 2021-03-14 chills, influenza like illness, headache, fever, fatigue Week 1 flu symptoms chills, fever ,fatigue, headache Week 2 chills, fever, fatigue Week 3 intermitt... Read more
Week 1 flu symptoms chills, fever ,fatigue, headache Week 2 chills, fever, fatigue Week 3 intermittent chills, fever, fatigue, night sweats week 3 continuing, some days no issue, next day all symptions
77 2021-03-14 chills Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report fr... Read more
Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination. The information on the lot/batch number has been requested.
77 2021-03-14 fatigue, chills, headache, fever pain, arm swelling, fever, chills, fatigue, muscle aches, and headache for 36 hours.
77 2021-03-14 fatigue 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 2021-03-14 headache she felt a little dizzy/a little dizziness; headache; This is a spontaneous report from a contactabl... Read more
she felt a little dizzy/a little dizziness; headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 04Feb2021 (at the age of 77-year-old) at a single dose for COVID-19 immunisation. Medical history included cancer, heart problems and ongoing COVID. The patient's concomitant medications were not reported. The patient reported that she has had a light case of COVID and took the COVID vaccine this morning. She said that after receiving the vaccine, she is experiencing, not major, a little dizziness/dizzy and headache on an unknown date in Feb2021. She is not really worried about it. She did not want to take anything before she called and verified if it was ok; but she called to ask if she can take TYLENOL after having gotten the vaccine. The outcome of the events was unknown. Information on the lot/ batch number has been requested.
77 2021-03-15 head discomfort 1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Sc... Read more
1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.
77 2021-03-15 headache, chills, fatigue 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 2021-03-15 pneumonia 3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the las... Read more
3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the last 2 days. Diagnosed with pneumonia and hypoxia, confirmed by imaging. Covid test negative on admission.
77 2021-03-16 fatigue, head discomfort, headache, chills, fever Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in m... Read more
Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in my head. Came home and covered up as chills started. After 12 hours the fever gradually subsided as did the pain in my neck and shoulder. Was left with headache that remained overnight but the pressure was not like the day before. Saturday I was just tired, I think from the fever, but by the evening I was back to normal.
77 2021-03-16 fatigue felt OK til 3 days later...very very tired.....and dizzy
77 2021-03-16 fever Weakness, fiver. 98.3 Usually runs 97.3
77 2021-03-17 body temperature increased flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx... Read more
flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx-HTZ, increased cholesterol, hypothyroid.
77 2021-03-17 cough, dehydration, lethargy, pneumonia, productive cough 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 fatigue, fever, cough 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 fatigue Rapid onset of fatigue following 15 minutes post observation time, guest sat in chair and notified s... Read more
Rapid onset of fatigue following 15 minutes post observation time, guest sat in chair and notified staff (11:42). Took her own prescribed carbidopa prescription as she stated she was due for a dose and that fatigue is common feature of her Parkinson's and that she usually feels better 20 minutes after medication. She then reported shortness of breath that felt "different" than her usual shortness of breath so internal aid was called for. EMT staff assessed guest to find vital signs stable and able to speak full sentences. Guest reported feeling better at 12:15 and was moved by wheelchair to her ride to go home.
77 2021-03-17 malaise, fever, chills Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activ... Read more
Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; 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), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose. Information about Batch/Lot number has been requested.
77 2021-03-18 headache Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from ... Read more
Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.
77 2021-03-18 throat irritation Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation... Read more
Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing. She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96% pulse 115 BPM. A dose of 50 mg of benadryl was given to the patient orally. Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent. BP remained elevated 200/100 , transported to hospital for further Tx & observation.
77 2021-03-19 runny nose, fatigue, sneezing, cough 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 chills, fever aches; Chills; Fever; This is a spontaneous report from a contactable consumer. A 77-years-old femal... Read more
aches; Chills; Fever; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. The patient experienced aches (pain) (non-serious) on 10Feb2021, chills (chills) (non-serious) on 10Feb2021, fever (pyrexia) (non-serious) on 10Feb2021. The outcome of the events aches and chills were reported as recovering. The outcome of the event fever was reported as not recovered.
77 2021-03-20 cough Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had com... Read more
Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.
77 2021-03-20 headache, fatigue 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 headache, chills, fatigue 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 2021-03-21 headache Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Dem... Read more
Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.
77 2021-03-21 fever Fever, body aches, and weakness requiring IV fluids in the ER
77 2021-03-22 sleepiness, fatigue Extreme Fatigue -falling asleep whenever I sit down up to 20 hours in one day. Memory loss includin... Read more
Extreme Fatigue -falling asleep whenever I sit down up to 20 hours in one day. Memory loss including names of medications and exercises which I have been doing 2 times daily for back problems for the last 5 months. Gout type pain for a couple hours, which started and stopped suddenly!
77 2021-03-24 fatigue, chills, cough, fever, throat pain, headache 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 2021-03-24 headache She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the... Read more
She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.
77 2021-03-24 malaise She had been in her usual state of health until tonight. Assisted living facility staff called. He m... Read more
She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.
77 2021-03-24 fever, chills, headache, fatigue Severely sore left arm; chills, headache; fever; severe back and knee pain; fatique
77 2021-03-25 fatigue 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 2021-03-25 headache, fatigue, chills chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of bre... Read more
chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing
77 2021-03-27 headache, fever, sweating, chills Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and ... Read more
Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and a half the took it easy for the next two days. Back to normal the following day (Saturday).
77 2021-03-29 fatigue, malaise Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week.... Read more
Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week. This past week the decedent stated she had been more tired and was experiencing shortness of breath.
77 2021-03-29 fever Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by re... Read more
Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)
77 2021-03-29 sleepiness, fatigue 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 2021-03-31 chills 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 2021-03-31 sinus disorder vomiting, diarrhea, sinus
77 2021-04-01 chills, fever The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able ... Read more
The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able to control with Tylenol for the most part. However, over the next 4 weeks, my mom gradually lost the ability to control her bladder function, and her ability to transition between sitting, standing and lying down w/o help. She also exhibited even more difficulty with walking than she did before (shuffling). My mother experienced pain all throughout her body, and the pain became as bad as an 8-9 in a range of 1-10. She struggled to raise her arms, reach her arms out, or grasp objects. She lacked energy, she would sleep for 10 hours every night, and she had difficulty concentrating and remembering what she was reading,
77 2021-04-01 headache Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with ... Read more
Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home
77 2021-04-03 fatigue Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This p... Read more
Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This patient reported different events with two vaccine doses: This is the second of two doses. This 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810), via an unspecified route of administration in the left deltoid arm on 19Feb2021 from 08:15 to 08:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 08:15 (at the age of 77-year-old) as a single dose for COVID-19 immunization, then on 31Jan2021 she became totally nauseous, light headed, very chilled, extremely tired, very cold and felt asleep under warm down quilt until 14:00 (total 13 hours) with recovery without any hospital admission and treatment received. On 25Feb2021, the patient experienced some fatigue for one day. The clinical outcome of some fatigue was resolved in Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093680 Same patient, different drug (first vaccine dose) and events.
77 2021-04-04 fatigue Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sun... Read more
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports soreness at injection site and fatigue.
77 2021-04-06 cough Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine... Read more
Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine. Feeling like i might be getting a cough now.
77 2021-04-06 headache 04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medicati... Read more
04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medication. I usually take 2 puffs of Advair and 2 puffs Xopenex an hour or two after waking (daily treatment. I don't wake up with a tight chest. 6:30 a.m. breathing has normalized. Have headache, earache and some nasal drainage.
77 2021-04-06 malaise Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a s... Read more
Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-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 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.
77 2021-04-07 headache, fever, fatigue fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue;... Read more
fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1). On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.
77 2021-04-07 headache SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened ... Read more
SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened as a result of the adverse event? SAW DOCTOR
77 2021-04-08 chills, fever, headache, fatigue headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; ch... Read more
headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering. Additional information has been requested.
77 2021-04-08 fatigue She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7... Read more
She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7:00 PM her arm started to get a little sore but kept moving it and massaging it. She then could not move anything by 10:00 PM, and had gone straight to bed as she felt so bad. She was dizzy, light headed, and these symptoms continued all night and all day Thursday. She dozed to sleep off and on all day Thursday and was in so much pain, didn't have to move to have pain. She is still having some pain today, but feeling much better. She still is a little bit dizzy. Feels as if she laid down she could sleep for a long time. She has pain in her back area, her arms, her hips. She did not take anything for her reaction as was told not to take aspirin and does not use other medications. She feels exhausted and if she moves her arm too much and also her legs then they start to hurt. Getting in and out of bed is easier today, but she could not get them over the bed to get in or out on Wednesday. Her neck also hurt to turn. She had similar symptoms to when she had the COVID virus in November/December. She had been hospitalized for it twice, was informed that she had a stroke after she had passed out.
77 2021-04-08 influenza like illness Stated that she felt like she had flu; severe allergic reaction; This is a spontaneous report from a... Read more
Stated that she felt like she had flu; severe allergic reaction; 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: EM9810), dose 1 via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included blocked subclavian artery and arteriosclerosis, both were diagnosed seven years ago and are ongoing. The concomitants medication was not provided. About 36 hours after vaccination, the patient experienced all side effects except fever and nausea, felt like she had flu and severe allergic reaction. The patient ended up going to bed and taking fluids for two days. The patient had flu for a few days and slept for a few days. She was back to normal. She is scheduled for a second shot in couple of weeks. She wanted to know the likelihood is great for this to happen again so that she can mentally prepare. The patient stated that the majority of the side effects in her age group did increase after the second dose. She stated one should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine. The reporter assessed the event as non-serious. The outcome of the events was unknown.
77 2021-04-09 fatigue, fever, chills, headache, influenza like illness 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 2021-04-09 headache, fever, malaise a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling ... Read more
a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took Historical Vaccine BNT162B2 (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101. The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown. Information on the lot/batch number has been requested.
77 2021-04-09 throat pain Received vaccine 3/4/21 second dose. On 4/2/21 got soar throat and both glands swollen. Called docto... Read more
Received vaccine 3/4/21 second dose. On 4/2/21 got soar throat and both glands swollen. Called doctor right away and was given prescription for Z Pack. Felt better in 2 days.
77 2021-04-12 headache, chills, fatigue, runny nose Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills to... Read more
Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired
77 2021-04-12 sweating 1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle... Read more
1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle of water when given. Pt unable to open water bottle and increase hand trembling noted. Pt began leaning forward. Pt did not respond when asked name or if she needed help opening water bottle. Pt became unresponsive and slouched forward with left UE contracted and gerbilled words unable to identify. EMS activated. Pt eased to floor without complications with EMS asst. Pt aroused after appx 10-15 sec with verbal cuing. Pt alert and oriented, unable to remember all details, diaphoretic. Pt asst to med eval room via WC. Within 2 minutes of obtaining pt demo and info, pt displayed another episode as previous: unresponsive, left UE contractured and diaphoretic. EMS assessed eyes/pupils-fixed and non-reactive. Pt arouse again with vague and confusion. Pt denies hx of SZ or TIA. No loss of bowel or bladder. Reports dizzy and confused. IV started to left posterior wrist by EMS and EKG complete-SR. TC to pt daughter information given. Pt to be transferred to medical center. Pt A&O. Pt transferred to stretcher with asst. and HOB elevated. Pt with personal belongings and reassured to return in 3 weeks for 2nd dose of vaccine.
77 2021-04-13 fatigue right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
77 2021-04-15 sweating, fever, chills, headache 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 chills, headache, fatigue 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 fatigue fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female pa... Read more
fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included diabetes mellitus and hypertension. The patient took the first dose of BNT162B2 (Batch/Lot Number: ER8733) on 08Mar2021 for COVID-19 immunization and experienced achy in arm. Concomitant medications included ongoing metformin (strength: 1000 mg) taken for diabetes mellitus; ongoing sitagliptin phosphate (JANUVIA, strength: 100 mg) taken for diabetes mellitus; indapamide (strength: 1.25 mg) taken for hypertension; lisinopril (strength: 40 mg) taken for hypertension. The patient experienced fatigue on 30Mar2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
77 2021-04-18 fatigue Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43... Read more
Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43% blasts on peripheral CBC indicating a transformation from CMML to AML.
77 2021-04-18 malaise Initially pt had general myalgias- now only have numbness and tingling in left hand
77 2021-04-19 chills Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Pa... Read more
Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.
77 2021-04-21 cough, fatigue Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Pat... Read more
Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Patient had cough, myalgia, anosmia, dysgeusia, fatigue. Hospitalized 4/14-4/19/21. Received Remdesivir and monoclonal antibody treatment.
77 2021-04-22 influenza like illness, chills chills flu like symptoms weakness sore gums sore lips with sores painful bumps at injection site
77 2021-04-23 body temperature increased, malaise allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2n... Read more
allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC
77 2021-04-23 fatigue, lethargy, malaise bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours... Read more
bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.
77 2021-04-23 fatigue I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a sponta... Read more
I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a spontaneous report received from a contactable consumer (reporting on herself). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EK9231and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on 12Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included, asthma, urticaria from an unknown date and unknown if ongoing , crohns disease all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunisation and experienced drug ineffective, covid-19 pneumonia, rash. The patient previously took cephalexine and experienced drug hypersensitivity. It was reported that when patient received her second injection, 2 was out of Quarantine for Covid. Also she asked her doctor If she Should even both to have this injection because apparently she had had Covid pneumonia, through by 02Jan2021. She was feeling a lot better , she was advised by her doc to go ahead & have it., which she did. No problem from Noon when she got shot to Noon Next day, but after lunch ,felt very tired, exhausted & low energy, was very wcepcited, lay on the cover, went to bed early & woke up next day feeling fine. Test: Blood test for HLA-B27 had lite @ 3x the testing Date: 15 years ago Also 25 yrs ago Result: Yes always 3x Comment: This is for Ankylosing spondylitis, Crohn's disease, Citifies, All of which she have had, the as ongoing.The outcome of the events was unknown.
77 2021-04-23 headache Throbbing headache; This is a spontaneous report from a contactable consumer or other non hcp (Patie... Read more
Throbbing headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EM9810) via an unspecified route of administration at arm right on 04Feb2021 evening as single dose for COVID-19 immunization. Medical history included hypothyroidism, High Cholesterol and allergic to Penicillin. Patient could had not taken Sulfa or steroids and she non-drinker. It was reported that patient had swelling of hands with penicillin when she was a child. She developed oral ocular dermatitis caused by the steroid in Flonase. That was diagnosed by dermatologist. It had been about 3 years now. Concomitant medications included levothyroxine (LEVOTHYROXINE), 75mcg once daily for thyroid disorder, monascus purpureus (RED YEAST RICE) and cinnamomum verum (CINNAMON) for blood cholesterol. It was reported that patient took lots of vitamins and she did not like taking medications because she was allergic to all sorts of stuff, including statins, but had no trouble with any vaccine or flu shots which she was took in October. On 05Feb2021, the patient awoke because experienced throbbing headache in the middle of the night. Patient took a Tylenol 500mg (acetaminophen, lot no. 8JE2158A, Exp. Date Jul2020) once at 6am, after about 12 hours after the shot. The event subsided a little, but it was still there. She said it was rampant. Life had been on hold and she wanted to go back to normal life. The outcome of the event was not recovered.
77 2021-04-24 chills, fatigue, headache 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 2021-04-24 fatigue Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a ... Read more
Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.
77 2021-04-24 headache, pneumonia, respiratory tract congestion 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 2021-04-29 fever, sweating 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 2021-04-30 head discomfort, fatigue stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is... Read more
stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.
77 2021-04-30 throat pain, malaise sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling u... Read more
sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.
77 2021-05-01 headache 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 fatigue SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 mon... Read more
SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.
77 2021-05-04 fever, headache, cough, fatigue, throat pain, bronchitis 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 2021-05-06 headache sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from... Read more
sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from where she was vaccinated (left arm). headache resolved with apap dosing. but rt shoulder pain/tightness has persisted on and off for the last 9days. pt said she is not using apap on regular basis. and also admitted to doing light gardening during this time.
77 2021-05-09 pneumonia This 77 year old female received the Covid shot on 4/1/21 and went to the ED on 4/11/21 and admi... Read more
This 77 year old female received the Covid shot on 4/1/21 and went to the ED on 4/11/21 and admitted on 4/12/21 and again to the ED on 4/24/21 with the below listed diagnoses and died on 5/9/21. J18.9 - Pneumonia, unspecified organism
77 2021-05-10 chills, fatigue sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a c... Read more
sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 04Feb2021 at 22:00, the patient experienced sore arm, chills, and exhaustion so bad it almost bordered nausea. The patient did not receive any treatment for the adverse events. The outcome of events was recovered.
77 2021-05-10 chills, lethargy, nasopharyngitis afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain... Read more
afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation. The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported. on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The outcome of events was unknown. The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart. She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.
77 2021-05-10 headache, chills, fever, sweating, fatigue headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This ... Read more
headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021. No follow up attempts are needed. No further information is expected.
77 2021-05-10 fever 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 2021-05-11 fatigue Patient was feeling a little tired; This is a spontaneous report from a contactable consumer (patien... Read more
Patient was feeling a little tired; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 10Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient was feeling a little tired. Clinical outcome of the adverse event was unknown at time of this report. The case was assessed as non-serious. The lot number is not available despite follow-up attempts made. Follow-up attempt have been completed and no further information is expected.
77 2021-05-12 fatigue Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very wea... Read more
Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.
77 2021-05-12 fever, lethargy, headache 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 chills, fatigue, headache 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 2021-05-13 headache, chills, fever headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patie... Read more
headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patient).A 77-years-old (non-pregnant) female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: BN5318 and expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 12Feb2021 12:00 (at 77-years age) as a 2nd single dose for COVID-19 immunisation and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982 and expiry date was not reported) dose 1 via an unspecified route of administration in left arm on 22Jan2021 12:00 as a 1st single dose for COVID-19 immunisation. The patient medical history included AFib and latex allergy. Concomitant medication(s) included rivaroxaban (XARELTO); flecainide (FLECAINIDE); amlodipine (AMLODIPINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 AM the patient experienced with headache, chills, fever and sore muscles. The patient had no covid tested post vaccination. The patient did not receive any treatment medication for the events. The outcome of the events was recovered.
77 2021-05-13 pneumonia Pneumonia s/p Covid-19 resulting in hospitalization
77 2021-05-13 pneumonia J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified
77 2021-05-14 headache, sleepiness 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 2021-05-15 fever, fatigue, chills Fever, chills, achy, exhausted.
77 2021-05-17 headache, nasopharyngitis April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful;... Read more
April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.
77 2021-05-17 headache 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 cough, fatigue 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 fatigue 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 2021-05-19 headache 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 2021-05-23 fatigue, headache, malaise 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 2021-05-24 fatigue, sinus disorder brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing ... Read more
brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing eyes when reading, eye events such as "flaters" flashing at outer sdges of eyes, exhaustion and needing more sleep than usual
77 2021-05-25 fever, runny nose 5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, ... Read more
5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, back pain and leg pain for the past week. Does not seem to be getting any better but also not getting any worse. She has a procedure that is supposed to be done on 4/30. Patient states that she did have her 2 Covid vaccinations and the last vaccination was 5 weeks ago. She plans on canceling the procedure. Care Coordination Progress Note RN (Registered Nurse) COVID 19 Infusion Navigator Post Infusion Outreach #1 Infusion Date: 4/30/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab
77 2021-05-26 chills, fever, throat pain 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 malaise, chills, headache 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 2021-05-26 sneezing, nasal congestion, runny nose, sleepiness Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleep... Read more
Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.
77 2021-05-28 fatigue 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 2021-05-28 headache headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient)... Read more
headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 11:00 am (age at vaccination was 77 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included atrial fibrillation and high blood pressure. The patient did not have any allergies. Concomitant medication patient received within 2 weeks of vaccination included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), atorvastatin and amlodipine besilate, olmesartan medoxomil (OLMESARTAN E AMLODIPINA EG). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EI9265, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 am (age at vaccination was 77 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 27Feb2021 at 19:00 pm, the patient experienced headache, low energy and body aches. Today on 01Mar2021, 3 days after second dose patient was still experiencing headache, low energy, and body aches. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date. The patient received treatment with Tylenol Extra Strength. The outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.
77 2021-05-31 headache 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 2021-05-31 headache 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 sleepiness sleep for two days; This is a spontaneous report from a contactable consumer or other non hcp (patie... Read more
sleep for two days; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 77-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm right on 03Feb2021 13:45 as unknown, single dose for COVID-19 immunization. Medical history included subclavian artery stenosis from an unknown date and unknown if ongoing, arteriosclerosis from an unknown date and unknown if ongoing and allergy to penicillin. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for covid post vaccination. The patient concomitant medications were not reported. On 05Feb2021, 36 hours after the injection and the patient experienced all the side effects except fever and nausea and needed bed rest and sleep for two days and was worried about what will happen with the second dose of the vaccine. Will she get all the unpleasant effects again and could it be worse enquired. The treatment was not received. The outcome of the event was recovered. Information about lot/batch number has been requested.
77 2021-06-01 cough, headache, runny nose, chills, sneezing 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 2021-06-01 fatigue, sleepiness, headache headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal... Read more
headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.
77 2021-06-01 head discomfort, runny nose, headache Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she wa... Read more
Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Headaches; Her nose was running continuously; When she got the headaches, she felt like her head was pounding or coming through her ears in her head; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Feb2021 probably around 1 or 1:30 (Batch/Lot Number: EN5318) as single dose, dose 1 via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 (Batch/Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included atrial fibrillation (A-fib) has been diagnosed for approximately 2 years. Concomitant medications included metoprolol taken for atrial fibrillation for a couple of years; apixaban (ELIQUIS) taken for blood thinner for a couple of years; lovastatin; vitamins. Vaccine was injected by a nurse. No AEs following prior vaccinations. The patient has had both doses of the vaccine. Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed positive with COVID-19 by a COVID-19 rapid test. No other tests reported. Patient stated the case she has was not too severe. She got a knee injection on the same day of the vaccine. She was not sure what medication it was but she thought it was cortisone. She stated it appeared her immune system didn't react properly so it made her feel she was not properly protected by the vaccine. Patient added that she had a couple of injections into her knee and she did not know if that can have any effect on the vaccine and break down immunity. Patient asked if she can get an additional shot since this one obviously did not work. Patient added that she did not want to get COVID19. She wanted to find out why did it breakdown, why did her immunity breakdown. Secondly, once this is all over, can she get another shot? She is not going to get comfortable based on what is going to happen. Diagnosed with COVID19 after receiving vaccines, patient stated that she had a few symptoms and was shocked it came back positive. She had no fever, she had no nausea. She had headaches, chills, and a really bad cough in 2021. Her nose was running continuously in 2021. When she got the headaches, she felt like her head was pounding or coming through her ears in her head. It was like something she never experienced before and it was out of the ordinary. She thought it was something more than an ordinary cold so she went and got tested. Patient was taking paracetamol (TYLENOL) and she took some Coricidin for treatment, and stated this was an over the counter decongestant. AEs did not require a visit to Emergency Room and Physician Office. Patient just went to the medical building. Information on Lot/Batch number was available. Additional information has been requested.
77 2021-06-02 fatigue, fever 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 2021-06-03 fever Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spont... Read more
Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 77-years-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient previously took tylenol as per her common sense and epipens (double dose) for swollen mouth and lips (due to a cleaner) two months ago. Concomitant medications were not reported. As per the description, it was reported that the patient was scared because she didn't had anyone. She was hesitated to get a vaccine. She experienced some reactions after her 2nd dose of the Pfizer vaccine. Her joint hurt and she was in a bad situation. She had a very low temperature than the normal temperature, blood pressure was high when she got upset. She was very angry that she had fever and had nobody to ask a question. She reported that no one told her about a high fever (100.4) or to go to the hospital. She said it was not worth it for her to get a fever. She reported the information on the paper was very vague and not clear, she felt horrible as she suffered and wanted to let know. She wanted to complain that the temperature of fever was not written and none of those were approved. She was asked to contact her local doctor. That was the most horrible experience for her. The patient underwent lab tests and procedures which included blood pressure measurement as high, body temperature as and 100.4. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
77 2021-06-04 fatigue Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness... Read more
Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness for a few days after second shot; she was frozen; Blood oxygen level was at 163; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were unknown) via an unspecified route of administration, administered in left arm on an unknown date at 10:45 AM (3 weeks after 1st dose) as 2nd single dose for COVID-19 immunisation. The patient received glycopyrrolate (batch/Lot Number and expiry date were unknown) via unspecified route of administration on an unknown date at a dose of 2 mg tablets daily (once daily in the morning) orally for peptic ulcer. The patient stated that she guesses glycopyrrolate would be expired when the 30 days are up. The patient did not have glycopyrrolate during reporting. The patient had just called the office and ordered a new refill when the freezing thing started. The patient was blind, so she could not read the label and batch number. The patient medical history included blindness called retinitis pigmentosa, diagnosed at 43 years old, she did not take anything for retinitis pigmentosa and it was genetic, ongoing and low thyroid (for several years). Family Medical History was mentioned as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration in left arm in Jan/Feb2021 at 10:45 AM. The patient's concomitant medications included unspecified thyroid medications (for several years) and unspecified sleeping pill daily. On 25May2021 at 08:45, the patient went for her physical exam, the patient's blood oxygen was up to 163. The patient added high blood oxygen levels could affect the heart. The patient never had blood oxygen over 98. The consumer clarified she meant low oxygen and not low blood pressure. The patient had the writing on the tape recorder. Recorder spelled the term as Hyperoxia. The patient stated that a week and a half ago, she was sitting in a chair after both of her vaccines but that she started those pills again and felt tired. Tiredness was first noticed after second shot that evening and it lasted for some days. She was taking a nap while watching tv and that lasted couple of days. She would be tired and then have to take a nap, but did not feel bad. The patient sat in the recliner and went to sleep and when she woke up, she was frozen and could not move her body or a finger or anything. She went in around 1400 and had no idea how long she was asleep but her mind was working. The patient stated she told herself to concentrate and to move but could not. She had no idea how long she was in that state but kept concentrating on trying to move a finger and was able to get a finger to move. Her arm was starting tingling like when it falls asleep and she was just cautious when she finally got up to walk. The patient did not visit emergency room/physician office. The patient told that she did not feel this bad before the vaccines and that was why she thought it was the medication (glycopyrrolate) that caused it. The patient started back taking the medication a few weeks after and did not know what it was for and that was why she thought it was this medication. The patient underwent lab t