chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Jan2021 (Lot number was not reported) as single dose, then dose 2 via an unspecified route of administration on 20Jan2021 (Lot number was not reported) as a single dose; both for covid-19 immunisation. Medical history included hypertension. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported. Patient had the Pfizer first shot (Covid19 vaccine Pfizer) and her arm was a little sore on an unspecified date and within the second time she got the shot, she rubbed it really hard. It was also mildly sore but neither shot, patient had any feelings of any sort. No side effects whatsoever other than arm. No treatment was given. Outcome of the event was unknown.  Information of lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Joint pain; muscle pain; fatigue; nausea; fever; chills; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 12Feb2021 (Batch/Lot Number: EL 3247) at 33-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included hypothyroidism, and seasonal allergies; both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); buspirone hydrochloride (BUSPAR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC), and an unspecified birth control medication; all taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EL 3247, administration time: 14:00, location: left arm, dose number:1) for COVID-19 immunization on 22Jan2021. On 12Feb2021 at 23:00, the patient experienced joint pain (non-serious), muscle pain (non-serious), fatigue (non-serious), nausea (non-serious), fever (non-serious), chills (non-serious).  The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint pain; muscle pain; fatigue; nausea; fever; chills; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 12Feb2021 (Batch/Lot Number: EL 3247) at 33-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine.  Medical history included hypothyroidism, and seasonal allergies; both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); buspirone hydrochloride (BUSPAR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC), and an unspecified birth control medication; all taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EL 3247, administration time: 14:00, location: left arm, dose number:1) for COVID-19 immunization on 22Jan2021. On 12Feb2021 at 23:00, the patient experienced joint pain (non-serious), muscle pain (non-serious), fatigue (non-serious), nausea (non-serious), fever (non-serious), chills (non-serious).  The clinical outcome of the events was recovering. The patient was not tested for COVID post vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer.  A 74-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the right arm, on 23Jan2021 (Batch/Lot Number: EN9581; Expiration Date: 31May2021) as SINGLE DOSE for covid-19 immunization.  Medical history included rosacea, rash and CLL (chronic lymphocytic leukaemia); patient has history of CLL (leukemia) in remission for 6 years. Concomitant medications included hydroxychloroquine taken for rash, start and stop date were not reported; and doxycycline taken for rosacea, start and stop date were not reported.  The patient experienced shingles (herpes zoster) (non-serious) on 13Feb2021. The patient underwent unspecified lab tests and procedures which patient did earlier in Jan and stated that "all of it was fine".  The outcome of event was unknown. Therapeutic measures were taken as a result of shingles included Valtrex.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen face; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a swollen face after getting the vaccine. The patient was treated with a shot of diphenhydramine (BENDARYL). The clinical outcome of swollen face was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of  subject product, BNT162B2 vaccine,  cannot be excluded for the reported event of swollen face, based on temporal relationship and the known product safety profile. There is very limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Fatigue
Clinical narrative: blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient felt tired after the dose; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Feb2021 at 13:00, at a single dose, for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 12Feb2021, the patient felt tired after the dose and laid down to take a nap.  Patients husband later checked on patient and tested her blood sugar.  Husband reported that the patient's blood sugar was 25. The patient then asked for information about potential hypoglycemia post vaccination and whether she is safe to get 2nd dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of blood sugar decrease, cannot be completely excluded. The case will be reassessed should additional information become 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; headache; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 16Feb2021 at 08:30 (Batch/Lot Number: EL3247) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 27Jan2021 (Lot number: EL3247, Administration time: 08:30, Vaccine location: Left arm, Dose number: 1). On 16Feb2021 at 20:00, the patient experienced chills (non-serious) for 24 hours, and headache for 72 hours; with no treatment received.  The clinical outcome of the events was recovered on unspecified dates. The patient was not tested for COVID post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Hypoaesthesia, Imaging procedure, Laboratory test
Clinical narrative: on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Paraesthesia, Rash
Clinical narrative: on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain; Arm Soreness; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Vaccination; adalimumab (HUMIRA) via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg, single for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced vaccination site pain. On an unknown date, the patient experienced arm soreness after PFIZER Vaccine. On an unknown date, arm soreness after PFIZER Vaccine and resolved. The outcome of events was recovered. The reporter's causality for the events of vaccination site pain and arm soreness with Humira (Adalimumab) was no reasonable possibility, with COVID-19 VACCINE was not reported.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported same event for three patients. This is the second of three reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID after receiving the COVID vaccine. The patient had the COVID vaccine this morning (16Feb2021) and tested positive for COVID on 16Feb2021. The reporter made a comment about the patient being "cuckoo in the head". The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Weight
Clinical narrative: received her COVID vaccine yesterday, and today she tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). This consumer reported same event for three patients. This is the first of three reports.  A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration, in the left arm on 15Feb2021 13:00, at a single dose for covid-19 immunisation at a hospital. Medical history included Alzheimer's (mentioned that she is messed up, she has Alzheimer's) and she also gets needles put in her back because she can't walk too good. She gets them every 3 months (confirmed that this occurred prior to her receiving the COVID vaccine). The patient also mentioned that the last time she weighed, she was 175 pounds, but now she can't pull her underwear up. So, now she may be 300 pounds. All she does is eat junk and she gained a lot of weight. The patient has no concomitant medications. The patient got the shot yesterday, 15Feb2021. The lady made her wait 15 minutes. Then she went to the South End and the patient, her daughter, and her daughter's boyfriend all tested positive for COVID. The patient clarified that after she received the COVID vaccine she was made to wait 15 minutes. She received her COVID vaccine yesterday, 15Feb2021, and today (16Feb2021), she tested positive for COVID. When she was given her vaccine, she said that she didn't have COVID and then they had the needle and they did it and told her to wait for 15 minutes. She called the doctor and called the people that gave her the COVID vaccine. The next time she is due for her second COVID vaccine is on 08Mar2021, but they told her not to get it then. They said to get the COVID vaccine after that but gave her no actual date. They said don't come then, give it a couple weeks, like 2 to 3 weeks. Her second COVID vaccine is supposed to be on 08Mar2021 at 1, but now she has to wait a couple weeks because she tested positive. She didn't really want to have the COVID vaccine because she was scared, but her daughter suggested that she receive it because she is old. She has only had one vaccine and her next dose is on 08Mar2021, but she had to push the date because she doesn't know what will happen. They moved her second dose date to the end of the month (Mar2021). She had to go to the doctor's office to be tested. The patient stated that herself, her daughter, and her daughter's boyfriend all got their vaccines "today" (16Feb2021; pending clarification). The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201990 same reporter/drug/event, different patients;US-PFIZER INC-2021200814 same reporter/drug/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Diarrhoea
Clinical narrative: his blood sugar went up to 340; diarrhea; This is a spontaneous report based on the information received by Pfizer (Manufacturer Control No.: 01865903). A non-contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 05Feb2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient applied for patient assistance for JANUVIA and found out from the agent that he did not qualify for assistance. In this call, the patient reported that he received the COVID-19 vaccine on Friday 05Feb2021. On 06Feb2021, Saturday, his blood sugar went up to 340 when it was usually in the 100's. To treat his elevated blood sugars, his doctor "doubled" his dose of metformin. Doubling his dose of metformin caused him to have diarrhea on an unspecified date in 2021. No additional adverse event or product quality complaint reported. Outcome of the events was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: tested positive for COVID with symptoms; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient's husband). The consumer reporter similar events for two patients. This is the second of two reports.   A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in left arm on 30Jan2021 15:00 as single dose for COVID-19 immunisation. The patient has no medical history and concomitant medications. The patient received her first dose of COVID-19 Vaccine on 30Jan2021. On 12Feb2021, the patient experienced symptoms of being tired and started with sore throat. The patient went to the doctor to get checked and she was tested for COVID-19 on the same day. The patient tested positive for COVID-19 on both the rapid test and PCR test on 12Feb2021. The patient developed other symptoms of cough with some mucus with it but not much. She has no fever and no body aches. She does not have a sense of smell or taste. The patient thinks she has pink eye in both eyes. When she wakes in the mornings she feels stronger but as the day goes on she gets a little bit more symptoms, a little bit of a headache. Nothing major. Has been taking oxygen levels which have all been in the high 90s. Body temperatures taken have all been within normal range. They cancelled her second dose which was scheduled for 20Feb2021. The patient was vaccinated on a racetrack. The events required a visit to the physician's office but was not hospitalized. The outcome of the events was reported as not recovered.; Sender's Comments: Linked Report(s) PFIZER INC-2021196167 same reporter and vaccine, similar events, different patient
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the third of three reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID after receiving the COVID vaccine. The patient had the COVID vaccine this morning (16Feb2021) and tested positive for COVID on 16Feb2021. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021200814 same reporter/drug/event, different patients; PFIZER INC-2021200823 same reporter/drug/event, different patients
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at the age of 61 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported stopping medication on 10Feb2021 due to receiving COVID-19 vaccination on 12Feb2021 and then resuming therapy on 15Feb2021. Patient reported fever for 2 days after vaccination on 14Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This is a spontaneous report from a non-contactable consumer (patient). This 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration in left arm on 16Feb2021 at single dose for COVID-19 immunisation.  Medical history was none. No known allergies. Patient was not pregnant.  The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot Number: EN5318) on 26Jan2021 for COVID-19 immunisation. The patient experienced sore at injection site on 17Feb2021 with outcome of not recovered.  No treatment received. Patient did not have COVID prior vaccination, did not test COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported for a male patient (husband) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced muscle soreness on unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever and chills; fever and chills; This is a spontaneous report from a non-contactable consumer (patient). This 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient was not pregnant.  The patient experienced fever and chills on an unspecified date with outcome of unknown.  Patient did not have COVID prior vaccination, and did not test COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Complication associated with device
Clinical narrative: there was a problem with a stent that was put in before his 1st dose of the vaccine; This is a spontaneous report from Pfizer. A non-contactable consumer reported for friend that the male patient of an unspecified age received BNT162B2 (reported as COVID-19 Vaccine), 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 stent was put in before his 1st dose of the vaccine. The patient's concomitant medications were not reported.  The patient received 1st dose of COVID vaccine and then ended up in the hospital because there was a problem with a stent that was put in before his 1st dose of the vaccine. He was scheduled to get 2nd dose tomorrow (17Feb2021) but she was trying to reschedule his appointment. The event outcome was unknown.  No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue
Clinical narrative: Felt tired and some discomfort; Felt tired and some discomfort; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection)  via an unspecified route of administration on an unspecified date was as unknown  single, SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported.  The patient experienced felt tired and some discomfort (fatigue)  felt tired and some discomfort on an unspecified date and  The events were considered as non-serious by the  consumer  The outcome of the events was not recovered  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; This is a spontaneous report from a non-contactable nurse. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 01Mar2021 (at the age of 36-years-old; Batch/Lot number and expiry date were not reported) as single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient fainted on 02Mar2021 and recovered from the event on an unspecified date. No treatment was received for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Maternal exposure during pregnancy, SARS-CoV-2 test, Uterine contractions during pregnancy
Clinical narrative: Contractions and abdominal pain starting three days after receiving second dose of vaccine. Admitted to the hospital with contractions. Healthy pregnancy with no issues prior to vaccine.; Contractions and abdominal pain starting three days after receiving second dose of vaccine. Admitted to the hospital with contractions. Healthy pregnancy with no issues prior to vaccine.; Contractions and abdominal pain starting three days after receiving second dose of vaccine; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 39-year-old, via an unspecified route of administration, administered in arm right on 24Feb2021 (lot number: EN0200, expiry date not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's last menstrual period was on 05Sep2020. The patient was 25 weeks pregnant and is due on 12Jun2021. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) at the age of 39-year-old, intramuscular on the left arm on 03Feb2021 08:30 for covid-19 immunisation. The patient experienced contractions and abdominal pain starting three days after receiving second dose of vaccine on 27Feb2021. The patient was admitted to the hospital with contractions. Healthy pregnancy with no issues prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Jan2020. Therapeutic measures were taken as a result of the events which included treatment with Procardia 10 mg, every 6 hrs, by mouth; Betamethasone steroid injections. The patient was recovering from the events.; Sender's Comments: The maternal exposure during pregnancy and associated events of contractions and abdominal pain were possibly related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  However, contractions and abdominal pain were very common events. The patient experienced contractions and abdominal pain starting three days after receiving second dose of vaccine, therefore, there maybe other factors which may have impacted the occurrence of the events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She contracted Sars-Cov-2 infection 05Feb2021, then she was hospitalized 13Feb2021 to treat the infection; This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer (the patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Jan2021 (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 contracted Sars-Cov-2 infection 05Feb2021, then she was hospitalized 13Feb2021 to treat the infection. The patient underwent lab tests and procedures which included Sars-Cov-2 infection positive on 05Feb2021. The patient was supposed to have her second dose 14Feb2021 but it was not administered.  The patient was wondering if she needs to take the 1st dose again or if she can still take the 2nd dose of the vaccine. The outcome of the event Sars-Cov-2 infection was unknown. Information on the lot/batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder, Chest pain, Confusional state, Hypoaesthesia
Clinical narrative: Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Peripheral coldness, Pruritus
Clinical narrative: Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Dizziness, Nausea
Clinical narrative: A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Dizziness
Clinical narrative: A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arrhythmia, Bronchospasm, Cough, Dysphonia
Clinical narrative: tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient).  A 28-years-old female patient receive dose 2 of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation.   Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil)  to an unknown date.  Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID),  on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis.   The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season.  Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years.  The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia  on 08Jan2021 with outcome of unknown and "Vacematter 08:45".  Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28.  Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia.  The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Oxygen saturation, Respiratory disorder, Respiratory rate increased
Clinical narrative: tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient).  A 28-years-old female patient receive dose 2 of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation.   Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil)  to an unknown date.  Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID),  on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis.   The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season.  Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years.  The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia  on 08Jan2021 with outcome of unknown and "Vacematter 08:45".  Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28.  Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia.  The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.