chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Scan, Taste disorder, X-ray normal
Clinical narrative: chest pain; pain under arm pits; pain under arm pits, up neck, and down her arms; dizziness; pain is now in hands, elbows; pain is now in face; Pain in neck and throat; pain is now in upper pallet; different taste in her mouth; lips, tongue, and mouth numbness; tingling; shortness of breath; pain in her joints/elbows; This is a spontaneous report received from a contactable other HCP (Nurse, patient). This female patient of unspecified age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 vaccination. The Patient was completely healthy before this with no history. The concomitant medications included zoloft, steroids, tylenol and protonix. On 9Feb2021 she began having the following symptoms: chest pain, pain under arm pits, up neck, and down her arms. She had visited the physician several times and everything was normal. symptoms got worse with dizziness, pain is now in hands, elbows, face, upper pallet, neck and throat. It did not go away. She has a different taste in her mouth. She has lips, tongue, and mouth numbness and tingling that comes and goes. She has shortness of breath and pain in her joints. At one point she was admitted to the hospital for 6 days- all labs, scans, xrays, MRI's were normal. She would see a rheumatologist and getting out lab tests done. She said her Rheumatologist was treating another nurse that now has paralysis due to the vaccine. The patient receive treatment for the events. The outcomes of events are unknown.  Information on Batch number/Lot number can not be obtained.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded.  This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Investigation, Pain
Clinical narrative: chest pain; pain under arm pits; pain under arm pits, up neck, and down her arms; dizziness; pain is now in hands, elbows; pain is now in face; Pain in neck and throat; pain is now in upper pallet; different taste in her mouth; lips, tongue, and mouth numbness; tingling; shortness of breath; pain in her joints/elbows; This is a spontaneous report received from a contactable other HCP (Nurse, patient). This female patient of unspecified age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 vaccination. The Patient was completely healthy before this with no history. The concomitant medications included zoloft, steroids, tylenol and protonix. On 9Feb2021 she began having the following symptoms: chest pain, pain under arm pits, up neck, and down her arms. She had visited the physician several times and everything was normal. symptoms got worse with dizziness, pain is now in hands, elbows, face, upper pallet, neck and throat. It did not go away. She has a different taste in her mouth. She has lips, tongue, and mouth numbness and tingling that comes and goes. She has shortness of breath and pain in her joints. At one point she was admitted to the hospital for 6 days- all labs, scans, xrays, MRI's were normal. She would see a rheumatologist and getting out lab tests done. She said her Rheumatologist was treating another nurse that now has paralysis due to the vaccine. The patient receive treatment for the events. The outcomes of events are unknown.  Information on Batch number/Lot number can not be obtained.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded.  This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Cough, Diverticulitis, Headache
Clinical narrative: Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Parkinsonism
Clinical narrative: Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She took the Covid test last 22Mar, and got the positive result today which is 24Mar; She took the Covid test last 22Mar, and got the positive result today which is 24Mar; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient got the first shot of the vaccine last 08Mar2021. She took the Covid test last 22Mar2021, and got the positive result today which was 24Mar2021. Her 2nd dose schedule would be on 29Mar2021, and the facility advised her for rescheduling. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Intraocular pressure increased
Clinical narrative: Conjunctive hemorrhage followed by eye pressure and extensive puss; Conjunctive hemorrhage followed by eye pressure and extensive puss; This is a spontaneous report from a contactable consumer (reporting for herself). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Mar2021 at 17:15 (Batch/Lot Number: EN6198) as single dose for COVID-19 immunization. Medical history included bee stings. The patient's concomitant medications were not reported. On 11Mar2021 at 15:00, the patient experienced conjunctive hemorrhage followed by eye pressure and extensive puss treated with antibiotic and anti-inflammatory. The outcome of the events was recovered on an unspecified date. The patient did not had COVID prior to vaccination and did not tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: got covid; got covid; really sick; This is a spontaneous report from a Pfizer-sponsored program,  from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.   An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter (patient's daughter) stated that the patient received her first dose on 07Mar2021 and got COVID on an unspecified date. She wanted to know when the patient can get the second dose. She said the patient have COVID-19 on an unspecified date and was really sick and have been under quarantine for the last 11 days now. She wanted to know how long after the patient was well can she get the second dose and also, if she can still get it. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335963 same reporter, drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had the Covid; I had the Covid; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266, expiration date: unknown) dose 1 via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.On 09Mar2021, the patient reported that he got his Covid shot and got a call the same day, a message from the place where the patient got it, that they have cancelled his second shot and was supposed to go back for his second shot on the 07Apr2021 but now they changed it to 14 Apr2021 (which is five weeks from the first dose). The patient was concerned that it should be four weeks. On an unspecified, date the patient reported that the patient had the Covid. The patient had it (further clarification unknown) so wanted to make it sure that  he get the shot.The outcome of the events was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Deafness, Head discomfort, Influenza like illness
Clinical narrative: can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported.   The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him.  He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the  left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported.   The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him.  He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the  left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Blood test normal, Computerised tomogram normal, Disturbance in attention, Dizziness postural, Feeling abnormal
Clinical narrative: I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Malaise, Mobility decreased, Nephrolithiasis, Pain, Presyncope
Clinical narrative: I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Urine analysis normal
Clinical narrative: I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: lost consciousness; vomiting; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included scarring on heart and frontal lobe neural observation (like epilepsy or seizure). There were no concomitant medications. 6-12 hours after shot, patient became ill; described as vomiting and lost consciousness. Patient was admitted to ICU and remained there for 4 days. Patient has recovered from the events on an unspecified date. The second shot is scheduled for the upcoming week.   Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Had a COVID-19 test this morning and tested positive for COVID after receiving first Pfizer COVID vaccine; Had a COVID-19 test this morning and tested positive for COVID after receiving first Pfizer COVID vaccine; his 10 year old grandson testing positive 10 days ago; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 70-years-old male patient received first dose bnt162b2 (Pfizer COVID-19 Vaccine, batch/lot Number: EN6205, via an unspecified route of administration, in left arm on 05Mar2021 10:10 am as single dose for covid-19 immunisation. The patient medical history was not reported. In concomitant medication patient states that he takes heart medications but doesn't think he needs to list them. Patient on 25Mar2021 had a COVID-19 test this morning and tested positive for COVID. Caller explains that he has no symptoms, the reason he got tested is due to his 10-year-old grandson testing positive 10 days ago. He adds that his grandson is getting ready to go back to school. Caller states the only symptoms his grandson had were no taste and no smell, which have resolved today. Caller goes on to explain that he is scheduled for his second Pfizer COVID 19 vaccine tomorrow, 26Mar2021 and wants to know what he should do. Patient said he received his 1st dose last 05Mar2021 and now he tested Positive with Covid Virus, he wanted to know if he can still get his second dose tomorrow 26Mar2021. Escalating because the caller tested positive after getting the 1st dose. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: right facial bells paulsey; This is a spontaneous report from a contactable consumer. An adult female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jan2021 for covid-19 immunisation. The patient experienced right facial bells paulsey on Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  Information of Lot /batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralysis; This is a spontaneous report from a contactable nurse via medical information team. A female patient (nurse) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 11Jan2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her rheumatologist was treating another nurse that now has paralysis due to the vaccine. On 09Feb2021, the patient experienced paralysis. The clinical outcome of the paralysis was unknown.  Information related to batch/lot number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event paralysis cannot be completely excluded based on temporal association and known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Computerised tomogram head, Fatigue, Headache
Clinical narrative: she got really tired; She started having problems on 12Mar2021 & went to the Emergency Room on 24Mar2021 & was diagnosed with Bells Palsy; he had a severe headache, as well. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number - EN6206, expiry date- not reported) via an unspecified route of administration in right arm on 10Mar2021 at 12:00 PM as single dose for COVID-19 immunization. Medical history included ongoing type 1 diabetes mellitus Stated she has had Type 1 Diabetes Mellitus for about 50 years, sleep apnoea syndrome for years, thyroid disorder and influenza immunisation. Concomitant medication(s) included trazodone. On 12mar2021, the patient started having problems on 12mar2021 & went to the emergency room on 24mar2021 & was diagnosed with bells palsy and he had a severe headache. She said the headache felt like major pressure and pain on the right side of her head, specifically behind her right ear and she got really tired. The outcome of bells palsy is recovering whereas the outcome of headache and tired is recovered and unknown respectively. The patient underwent lab tests and procedures which included computerised tomogram: normal on 24Mar2021 and computerised tomogram head: normal on 24Mar2021. Therapeutic measures were taken with events. The patient took Prednisone and Venlafaxine for Bell's palsy and myalgia pain and trazodone taken for sleep apnoea syndrome. The other medication used for events were Valtrex, Tylenol and Acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: experienced a mild allergic reaction, her throat was kinda closing but she can still breathe.; experienced a mild allergic reaction, her throat was kinda closing but she can still breathe.; This is a spontaneous report from Pfizer sponsored program . A contactable consumer (on behalf of patient) reported a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 16Mar2021, at a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date in 2021, patient experienced a mild allergic reaction, her throat was kinda closing but she can still breathe (as reported) and wanted to know if someone who had a mild allergic reaction after receiving the 1st dose can that someone still get the second dose. The reporter escalated because patient experienced a mild allergic reaction after receiving the first dose. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: ended up positive in covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient ended up positive in COVID-19 on Mar2021 and she got really sick. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report. A contactable male consumer, the patient of unspecified age received second dose of COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Mar2021 after receiving the second dose of vaccine, the patient experienced muscle pain and asking the recommended pain reliever. There was no unaddressed medical questions referred or forwarded to Medical Information. The outcome of the event myalgia (muscle pain) was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: Two weeks later he was diagnosed with Covid.; he was diagnosed with Covid. he was asymptomatic, but not feeling 100%; This is a spontaneous report received from a contactable pharmacist. A 50-year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first dose of BNT162B2 vaccine. Two weeks later he was diagnosed with COVID. He was asymptomatic, but not feeling 100%. The pharmacist asked if patient should receive the second dose of vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: 3 days after she tested positive with Covid-19; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose BNT162B2 (PFIZER COVID-19 VACCINE, lot no. and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included bamlanivimab. The patient received the first dose and 3 days after she tested positive with Covid-19. She is also due or the second dose on 25Mar2021, and she is asking if she should get it. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Reaction to preservatives
Clinical narrative: Chemical in covid vaccine caused reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after administration of vaccine Chemical in covid vaccine caused reaction. The outcome of the event was unknown.   Information about batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was very sick; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Oct2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that she could taste it right away and within a few hours, she was very sick in Oct2020. She was told that she cannot take the second dose. She was wondering if she was protected at all with just having first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Immediately after vaccination an overpowering metallic taste was present in my mouth; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at the age of 39 years, administered in Arm Left on 27Mar2021 12:45 (Lot Number: EP6955) at single dose for covid-19 immunisation.  Medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. Reported that Immediately after vaccination an overpowering metallic taste was present in my mouth. Even after eating, drinking and brushing teeth the taste remained. Food and drink still tasted the same but immediately after swallowing my mouth tasted like I was sucking on a roll of pennies. By the following morning it was gone on 28Mar2021. Adverse event started on 27Mar2021 12:45. No treatment received for the adverse event. Outcome of events was recovered on 28Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: he has sinus headache; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient got 1st dose of the vaccine he was cautioned to not take any kind of pain medication day before or after, which he did not need/want to do. But now wants to know if ok to take something for his allergies, like a Sudafed because he has sinus headache. The outcome of event was unknown.   Information about lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Migraine, Pain
Clinical narrative: Headache; migraine; Sore arm; Body aches; Hot flashes; chills; This is a spontaneous report from a contactable consumer (patient himself). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 31 years, at single dose in left arm on 24Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. Medical history was not provided. Concomitant medications included fluoxetine and oxymetazoline hydrochloride (CLARITIN ALLERGIC) both taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose in left arm on 02Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. The patient experienced headache/migraine, sore arm, body aches, hot flashes and chills on 25Mar2021 at 04:00. The patient had no Covid prior to vaccination and no Covid tested post vaccination. There was no treatment received. Events outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; migraine; Sore arm; Body aches; Hot flashes; chills; This is a spontaneous report from a contactable consumer (patient himself). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 31 years, at single dose in left arm on 24Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. Medical history was not provided. Concomitant medications included fluoxetine and oxymetazoline hydrochloride (CLARITIN ALLERGIC) both taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose in left arm on 02Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. The patient experienced headache/migraine, sore arm, body aches, hot flashes and chills on 25Mar2021 at 04:00. The patient had no Covid prior to vaccination and no Covid tested post vaccination. There was no treatment received. Events outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she had rashes on the side of her body and under her arm on the side; This is a spontaneous report from a contactable consumer (self reported) and received from a sponsored study. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection) via an unspecified route of administration on 08Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on unspecified date in Mar2021, she had rashes on the side of her body and under her arm on the side where she received the injection for the 1st dose. Patient was due for her 2nd dose of our COVID-19 vaccine on 29Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I tested positive for COVID; I became ill the following day Friday through Sunday; This is a spontaneous report received from a contactable consumer(patient) via medical information team. A female patient of unspecified age received first dose of (BNT162B2) (solution for injection/Lot/Batch number unknown), via unspecified route of administration on 25Feb2021 at a single dose for COVID-19 immunization. The patient's Medical history and concomitant medications were not reported. On an unspecified date the patient became ill, tested COVID positive and was admitted to the hospital on 06Mar2021. She was released and came home. While in the ER, they gave plasma and told that she won't be able to get the Pfizer vaccine in 90 days. There's nothing on the CDC that addresses this patient has stated that Efficacy in Participants 16 Years of Age and Older" regarding exclusion of participants with a previous clinical or microbiological diagnosis of COVID-19 and that Pfizer is unable to make recommendations surrounding delaying of the second dose. patient asking if she can't take the 2nd dose until 3 months later from the first dose, is the vaccine still going to be viable, Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive to COVID-19 yesterday; I tested positive to COVID-19 yesterday/didn't have any symptoms other than slight congestion; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient took the first dose on 12Mar2021. He scheduled for the second shot this Friday 02Apr2021. The patient tested positive to COVID-19 yesterday (29Mar2021). He didn't have any symptoms other than slight congestion. Events outcome were unknown.   Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 09Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had the shot on the 09Mar2021 back of arm has a bit and has gotten bigger and it was not the injection site where the mark is getting bigger. The outcome of the event was unknown.  Information on batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: diarrhea; headache; nausea; sick body; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 17Mar2021 12:30 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included fibromyalgia. Patient has no allergies to medications, food, or other products. The patient received medication(s) within 2 weeks of vaccination included letrozole (FEMARA). The patient was no pregnant at the time of vaccination. 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 was not tested for COVID-19. The patient experienced diarrhea, headache, nausea, sick body, all on 22Mar2021 12:00. Patient did not receive treatment for adverse events. The event outcome for all events was not recovered.  No follow-up attempts are possible.  No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: had a heart surgery; This is a spontaneous report received from contactable consumer from a Pfizer-sponsored program.  A 88-year-old male patient received first dose of BNT162B2 (Formulation: Solution for injection, lot number; unknown) via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported.On 24Mar2021, patient had a heart surgery.  The reporter asked for the confirmation of their second dose schedule for the covid-19 vaccine which is scheduled on March 26, 2021 and if the patient would be allowed to get the second dose of the vaccine when he just had a heart surgery yesterday March 24, 2021. The outcome of the event had a heart surgery was unknown.  No follow-up attempts are needed. No further information is expected.