chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Deep Vein Thrombosis/he have numbness , tingling on his left foot. It was also swollen; CT scan shows he have PE; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Feb2021 10:15 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included back pains, acid reflux and chest pain; all from an unknown date. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported. The patient reported that after several days of getting his first shot, he have numbness , tingling on his left foot. It was also swollen, he went to the Emergency and they found out he have deep vein thrombosis and CT scan shows he have PE on 27Feb2021. The reported events resulted in emergency room/department or urgent care. The patient received treatment for the events which was a blood thinner, Eliquis. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer covid vaccine on 12Mar2021 and tested positive for covid on 15Mar2021/not really feel anything, no signs; This is a spontaneous report from a contactable consumer (patient) via the sponsored program. A 54-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in left arm on 12Mar2021 16:00 (Lot Number: EN6208) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient received the first dose of the pfizer covid vaccine on 12Mar2021 and tested positive for covid on 15Mar2021. The patient asked if she may get the second dose of the vaccine as scheduled on 02Apr2021. On 15Mar2021 she was diagnosed with COVID by COVID mouth swab test with positive for COVID result. She did not really feel anything, no signs. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Electric shock sensation, Fatigue, Feeding disorder, Haematochezia
Clinical narrative: I can't eat anything; I feel like I'm going to throw-up; tired all day; pain in my arm; bloody stool/ blood in my stool; felt the left side back bone like an electric shock around my kidney; I didn't feel good; felt uncomfortable; could not sleep; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13Mar2021 at 18:45 (batch/lot number: ep7534) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated he took the vaccine on Saturday first dose, 13Mar2021 at 6:45 pm. At 8:30 pm when he was home, he felt the left side back bone like an electric shock around his kidney. At night time, he didn't feel good, felt uncomfortable and could not sleep. On Sunday (14Mar2021), he was tired all day and had pain in his arm. Also had bloody stool and then last night again around 12:30 am, he had blood in his stool. He can't eat anything, he felt like he was going to throw-up. He was scared, he doesn't have a family doctor. He asked if Pfizer provides help with primary care for health situations. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Nausea, Pain in extremity
Clinical narrative: I can't eat anything; I feel like I'm going to throw-up; tired all day; pain in my arm; bloody stool/ blood in my stool; felt the left side back bone like an electric shock around my kidney; I didn't feel good; felt uncomfortable; could not sleep; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 13Mar2021 at 18:45 (batch/lot number: ep7534) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated he took the vaccine on Saturday first dose, 13Mar2021 at 6:45 pm. At 8:30 pm when he was home, he felt the left side back bone like an electric shock around his kidney. At night time, he didn't feel good, felt uncomfortable and could not sleep. On Sunday (14Mar2021), he was tired all day and had pain in his arm. Also had bloody stool and then last night again around 12:30 am, he had blood in his stool. He can't eat anything, he felt like he was going to throw-up. He was scared, he doesn't have a family doctor. He asked if Pfizer provides help with primary care for health situations. The outcome of the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Polymyalgia rheumatica, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: polymyalgia rheumatica; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; This is a spontaneous report from a contactable physician. An 83-year-old female no pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included Hypothyroidism, known allergies: Morphine. No covid prior vaccination. Concomitant medications included Levothyroxine. No other vaccine in four weeks. In Feb2021, since receiving vaccination, patient developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP. Responded to prednisone. Patient insists no symptoms until she received first dose. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab in Mar2021: Negative. Medrol/prednisone were received. Outcome of the event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seronegative arthritis
Clinical narrative: polymyalgia rheumatica; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; This is a spontaneous report from a contactable physician. An 83-year-old female no pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included Hypothyroidism, known allergies: Morphine. No covid prior vaccination. Concomitant medications included Levothyroxine. No other vaccine in four weeks. In Feb2021, since receiving vaccination, patient developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP. Responded to prednisone. Patient insists no symptoms until she received first dose. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab in Mar2021: Negative. Medrol/prednisone were received. Outcome of the event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Syncope
Clinical narrative: fainted; This is a spontaneous report from a contactable consumer (patient) reported that a 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 11:30 as a single dose (at the age of 60-years-old) for covid-19 immunisation. The patient medical history was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medications included glipizide and lisinopril both were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 14:30, the patient fainted and was rushed to the hospital and admitted with outcome of recovered on Mar2021. The reported event resulted in emergency room/department or urgent care, and hospitalization for 1 day on an unspecified date. The patient received treatment for the reported event as Catscan (as reported). The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 13Mar2021.   Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: confirmed COVID positive on 17Mar2021, three weeks after her second COVID vaccine.; confirmed COVID positive on 17Mar2021, three weeks after her second COVID vaccine.; This is a spontaneous report from a non-contactable consumer (the patient). An elderly non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on 19Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 for COVID-19 immunisation. No COVID prior vaccination. The patient was confirmed COVID positive on 17Mar2021, three weeks after her second COVID vaccine. The event onset date reported as "15Mar2021". The patient not received treatment for the event. COVID test post vaccination included Nasal Swab with positive result on 15Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Blood pressure droppped; dizzy; Taking blood pressure when she feels funny or weird; Itches all over but has no hives or red spots, sometimes it is in the back of her neck or arms; Itches all over but has no hives or red spots, sometimes it is in the back of her neck or arms; Nauseous; Lightheaded; This is a spontaneous report from a female contactable consumer. This consumer (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She stated she received the first dose of the vaccine on Saturday. Her blood pressure drops and she gets very dizzy. She has been taking her blood pressure when she feels funny or weird and then eats something with salt in it to bring it back up. She said it has been 100/66, which she thinks was low. She stated when she got her vaccine she had to walk a mile and then stand in line for an hour and 15 minutes and then wait another hour before getting through and she stated the way she feels she would not be able to do that because she was so light headed and dizzy. She stated she knows it was a side effect and just needs to sit down. Additionally she itches all over but has no hives or red spots, sometimes it was in the back of her neck or arms. She has not changed detergents or soaps. She doesn't know if she should take the second dose. She asked how long the symptoms last. Upon follow up it was reported that since getting the vaccine her blood pressure has dropped. She took the shot on Saturday and the next day she was nauseous. She was nauseous on Sunday and Monday. On Tuesday, she started to feel dizzy and lightheaded. She took her blood pressure and it was 100/66. She has been able to get it up to 109 now by eating salt. She was wondering if the drop in blood pressure has anything to do with the COVID shot. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Blood pressure droppped; dizzy; Taking blood pressure when she feels funny or weird; Itches all over but has no hives or red spots, sometimes it is in the back of her neck or arms; Itches all over but has no hives or red spots, sometimes it is in the back of her neck or arms; Nauseous; Lightheaded; This is a spontaneous report from a female contactable consumer. This consumer (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She stated she received the first dose of the vaccine on Saturday. Her blood pressure drops and she gets very dizzy. She has been taking her blood pressure when she feels funny or weird and then eats something with salt in it to bring it back up. She said it has been 100/66, which she thinks was low. She stated when she got her vaccine she had to walk a mile and then stand in line for an hour and 15 minutes and then wait another hour before getting through and she stated the way she feels she would not be able to do that because she was so light headed and dizzy. She stated she knows it was a side effect and just needs to sit down. Additionally she itches all over but has no hives or red spots, sometimes it was in the back of her neck or arms. She has not changed detergents or soaps. She doesn't know if she should take the second dose. She asked how long the symptoms last. Upon follow up it was reported that since getting the vaccine her blood pressure has dropped. She took the shot on Saturday and the next day she was nauseous. She was nauseous on Sunday and Monday. On Tuesday, she started to feel dizzy and lightheaded. She took her blood pressure and it was 100/66. She has been able to get it up to 109 now by eating salt. She was wondering if the drop in blood pressure has anything to do with the COVID shot. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diplopia, Dizziness
Clinical narrative: stroke of the 4th cranial nerve; Dizziness; double vision; This is a spontaneous report from a contactable nurse. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), intramuscular, in the left arm on 16Mar2021 at a single dose (at the age of 60-years-old) for Covid-19 Immunization; vaccinated in the hospital. Medical history included hypertension and allergies to sulfa. Concomitant medications were not reported. No other vaccine in four weeks. The patient had no COVID prior to the vaccination. On 16Mar2021, the patent experienced dizziness and double vision. He saw the eye doctor who stated that he had a stroke of the 4th cranial nerve. No treatment was given. The patient was not COVID tested post vaccination. The nurse assessed the events as non-serious. The patient was recovering from the events.; Sender's Comments: A contributory role of BNT162B2 to event a stroke of the 4th cranial nerve cannot be excluded based on limit information. Case will be reassessed when further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Hyperhidrosis, Insomnia
Clinical narrative: she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021.   Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: she slept unbelievably good the night of 04Mar2021/she wanted to sleep a lot; she had no energy at all; she had achiness; she knewshe had a high fever; Sweating; unbelievable fatigue/she was really tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in the right arm, on 04Mar2021 16:30 (at the age of 66 years old) at a single dose for covid-19 immunisation. This was administered as a pharmacy/drug store. Medical history included asthma for a very long time and overweight. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular route in the right arm on 30Jan2021 (at the age of 66 years old) at a single dose for covid-19 immunization. She did not have any problems with the first dose. The patient had no additional vaccines administered on same date of the Pfizer vaccine. There were no prior vaccinations within four weeks. The patient reported she was really tired after receiving her second COVID-19 Vaccine on 04Mar2021, saying she slept unbelievably good the night of 04Mar2021. On 05Mar2021, the patient experienced she had instantly come down with unbelievable fatigue, she wanted to sleep a lot, she had no energy at all (if she tried to do something, she would have to lay down afterwards), she had achiness, she knew she had a high fever, even though she did not check her temperature, she knew her fever was high because she was sweating but it was nothing she was worried about. She stated she was concerned about the unbelievable fatigue she was experiencing. Her tiredness had improved some, and her achiness resolved about the second day (unspecified date in Mar2021). She stated her fever went away in two days (unspecified date in Mar2021). Reported the pharmacist told her to take TYLENOL after the second COVID-19 Vaccine. She bought a bottle of TYLENOL while she was at the drug store, but she decided not to use the TYLENOL for the symptoms. Reported she didn't take her PROLIA injection in Jan2021 because she didn't want it to interfere with her upcoming COVID-19 Vaccine. She said she self-administered her PROLIA injections, and hadn't restarted it at this time. All the events did not require a visit to emergency room or physician office. Outcome of the events fatigue, she wanted to sleep a lot, she had no energy at all was recovering. Outcome of the events achiness, fever and sweating was recovered on unspecified date in Mar2021.   Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296202 same reporter, drug and events, different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Negative antibody test after receiving both doses of Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is third of three reports. A 70-year-old male patient received the first and second doses of BNT162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot Numbers: UNKNOWN); both doses via unspecified route of administration on unspecified dates as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested negative for antibodies after receiving both doses of the Covid-19 vaccine. The outcome of negative antibody test after receiving both doses of Covid-19 vaccine was unknown.   The lot number for the doses of vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s): same reporter/drug/AE, different patient.; same reporter/drug/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer (Patient) via Medical information team. A female patient of an unspecified age received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced flu like symptoms. It was reported that 12 hours after receiving her first dosage of the Covid vaccine, she experienced flu like symptoms. The outcome of event was unknown.  Information on lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: tooth infection; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient had no other products taken together with those indicated above. The patient medical history was not reported. On an unspecified date, the patient had tooth infection and was on an antibiotic and was wondering if the antibiotic will affect the vaccine. It was unknown, whether patient was admitted to the hospital due to event. The clinical outcome for the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Burning sensation, Drug hypersensitivity, Malaise
Clinical narrative: she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported.  On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were.  The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling, Rash macular, Swelling face
Clinical narrative: she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported.  On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were.  The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Caller couldn't hear me; This is a spontaneous report from a non-contactable consumer received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 13Mar2021 as a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. On an unknown date, the patient called and stated she feels fine, but she took an 81mg aspirin because it's her daily medicine. It was mentioned that "patient couldn't hear me" and call was dropped. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had the covid virus in me and didn't know it didn't have any symptoms or anything; I had the covid virus in me and didn't know it didn't have any symptoms or anything; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (BioNTech COVID-19 Vaccine), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient called with question regarding the BioNTech COVID-19 Vaccine. The patient had the Pfizer vaccine, covid-19 vaccine on 11Jan, Unfortunately, on an unspecified date, the patient had the covid virus in him/her and didn't know it, didn't have any symptoms or anything, ended up hospitalized. The patient was in the hospital for 8 days, put on remdesivir, got out 8 days later. The patient was getting conflicting stories as to what he/she needs to do for the second shot which was past due now. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caught Covid_19 after receiving all the shots required.; Caught Covid_19 after receiving all the shots required.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (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 experienced caught covid_19 after receiving all the shots required on an unspecified date with outcome of unknown. Took all vaccines and still caught Covid_19.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb injury, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: arm hurt "a little bit" after the shot; night the arm that she received her shot in became sore; muscles in her arm were sore/muscles in her other arm became sore/muscle aches; she "rolled around a little bit"; sore spot where I got the shot; This is a spontaneous report from a contactable consumer (patient herself). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose in arm for COVID-19 immunisation. Medical history and Concomitant medication were not reported. It was reported that patient received her first dose of the Pfizer BioNTech COVID-19 vaccine and reported that her arm hurt "a little bit" after the shot. She reports that night the arm that she received her shot in became sore, stating it felt like the muscles in her arm were sore. She then states that a little later the muscles in her other arm became sore. She reports this was around midnight or 1:00AM and reports that she "rolled around a little bit" bit states that it was not excruciating pain, just "sore and ached." She reports that the next morning, the muscle aches were gone and didn't notice anything different, except "just a little sore spot where I got the shot." patient was wondering if because of these muscle aches, should she be concerned about receiving her second dose of the vaccine next week. The outcome of event muscle pain was recovered on unknown date, while for others was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Vomiting
Clinical narrative: experiencing some muscle spasms; vomiting; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. It was reported that with the second dose being given 60hours ago. She was now reporting that she's still experiencing some muscle spasms. She also mentioned in passing that she experienced vomiting and chills but those symptoms have resolved on an unknown date. She has already contacted her HCP who told her to follow-up if she was still experiencing the muscle spasms on 22Mar2021 (Monday as reported). She had some really bad reactions to the vaccine, right now she was still experiencing some muscle spasms. Vomiting, chills and everything were gone . Only been 60 hours since she took it. Patient already had plans to follow-up with her HCP. The outcome of events vomiting and chills was recovered on an unknown date and the event muscle spasms was not recovered.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: bronchitis; This is a spontaneous report from a contactable consumer (patient). The patient reported for herself that  A 78-years-old non female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN),1 via an unspecified route of administration on an unspecified date and The patient medical history was not reported.The patient's concomitant medications were not reported.The patient experienced bronchitis on an unspecified date and I've contracted bronchitis. What's the recommendation for getting my 2nd dose of the Pfizer COVID 19 vaccine next week and reporter replied Caller states that she has received her first dose of the Pfizer COVID 19 vaccine and has been diagnosed with bronchitis. She's 78 years old. and outcome of event was unknown   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: she developed itching and hives; SHe developed itching and hives on her neck, armpit, above the belly button, between her breasts, 21 bumps all over and very, very itchy.  She had one armpit with one bump and the other had 5 or 6 bumps; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 02:00 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication include fexofenadine hydrochloride (ALLEGRA, Strength: 180 mg). The patient reported, first dose on 4Mar2021 around 2 o'clock, right before the 24 hour mark she developed itching and hives. She developed itching and hives on her neck, armpit, above the belly button, between her breasts, 21 bumps all over and very, very itchy. She had one armpit with one bump and the other had 5 or 6 bumps. She put cream on them. She asked her doctor and suggested benadryl but she can't take benadryl. She started taking Allegra 180mg. She had bad hives for 4 days. The patient received treatment for the event. The seriousness was reported as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer (the patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 18Mar2021 (reported as "yesterday") at age of 65-year-old at single dose for COVID-19 immunisation. The patient reported he received the vaccine "yesterday", and he had chills overnight since 18Mar2021 and on 19Mar2021 (reported as "today" ) he had a fever between 100-101.The caller would like to know whether he should get a COVID test due to his side effects from a COVID vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Illness, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: muscle spasm; local soreness but I could move, it is like a muscle strain; could not swim, could not play tennis, do usual activities could not open the refrigerator door; sick; Received first dose 2 weeks before instead of the recommended 3 weeks period; Tension and soreness in the back of the shoulder; This is a spontaneous report received from a contactable female consumer reported for herself via Medical Information Team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on 12Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose 2 weeks before that, on 29Jan2021. Instead of the recommended 3-week period. The soreness in the back of the shoulder next day felt pretty sick, on Saturday. By Sunday felt better. A couple weeks went by and she had inflammation on the top of her left shoulder felt like it moved to her neck, ended up having shooting pains at night, it kind of went away she said she got this soreness went down to her side; had muscles spams, could not swim, could not play tennis, do usual activities could not open the refrigerator door. The patient stated that she experienced after second dose of the vaccine tension and soreness in the back of my shoulder one and a half days felt really sick, was fine for a couple weeks and then all of a sudden, it started; first the left side then right side and the neck, kind of a muscle spasm in the back-behind of the right armpit, down there is local soreness but I could move, it is like a muscle strain. The outcome of event pretty sick was recovered, for other events the outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: muscle spasm; local soreness but I could move, it is like a muscle strain; could not swim, could not play tennis, do usual activities could not open the refrigerator door; sick; Received first dose 2 weeks before instead of the recommended 3 weeks period; Tension and soreness in the back of the shoulder; This is a spontaneous report received from a contactable female consumer reported for herself via Medical Information Team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on 12Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose 2 weeks before that, on 29Jan2021. Instead of the recommended 3-week period. The soreness in the back of the shoulder next day felt pretty sick, on Saturday. By Sunday felt better. A couple weeks went by and she had inflammation on the top of her left shoulder felt like it moved to her neck, ended up having shooting pains at night, it kind of went away she said she got this soreness went down to her side; had muscles spams, could not swim, could not play tennis, do usual activities could not open the refrigerator door. The patient stated that she experienced after second dose of the vaccine tension and soreness in the back of my shoulder one and a half days felt really sick, was fine for a couple weeks and then all of a sudden, it started; first the left side then right side and the neck, kind of a muscle spasm in the back-behind of the right armpit, down there is local soreness but I could move, it is like a muscle strain. The outcome of event pretty sick was recovered, for other events the outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: had hives within an hour of the injection; itchiness all over the body; tingling on the right side which is the same side of my injection.; This is a spontaneous report received from a contactable consumer (reporting for herself) via medical information team. A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number and expiry date: Not provided) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported. On an unknown date in Mar2021 It was reported that patient had hives within an hour of the injection and itchiness all over the body and tingling on the right side which is the same side of my injection. I had to take an adequate amount of Benadryl. The outcome of the events was unknown.  Information on Lot and Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: she got a little dizzy; This morning around 4:00 she was getting up to go to the bathroom and she was feeling a swimming feeling in her head when she was about to stand up; This is a spontaneous report from a contactable consumer (patient) via medical information team. 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 on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the first dose of the vaccine on Wednesday, 17Mar2021 and didnot have any problems then but yesterday (20Mar2021 04:00) she got a little dizzy. This morning around 4:00 she was getting up to go to the bathroom and she was feeling a swimming feeling in her head when she was about to stand up. She stated it was kind of scary. She asked if this is a normal side effect and what she should do about it. She said she saw dizziness on her paper as a potential side effect. The outcome of the events was unknown.  Details: Originating AE Request: REQ-201563; Request Name: REQ-201563  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer-sponsored program,from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 16Mar2021 (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 experienced sore arm in Mar2021 with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous case received from a non-contactable consumer (patient himself). A 61-year-old male patient the patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was unknown whether the patient received any other product together with the vaccine. The patient complained of back pain when bending down. The patient was able to walk but when he bends down and get back up his back hurts. On an unknown date, the patient experienced back pain. It was unknown whether the patient was admitted to the hospital or received any treatment due to event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Ocular hyperaemia
Clinical narrative: redness and swelling of eyes; redness and swelling of eyes; Bottom lip is swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at single dose for Covid-19 immunization. The patient Medical history was not reported. Concomitant medications included Botox, 2 days prior to the vaccination. The patient experienced redness and swelling of eyes, Bottom lip is swollen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.