chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 75-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at the age of 75-years, via intramuscular in left arm on 09Feb2021 13:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient experienced fatigue on 10Feb2021. Outcome of the event was unknown. Patient received second single dose of BNT162B2 (lot number: EN6208) via intramuscular in left arm on 11Mar2021 for COVID-19 immunization.   No follow-up attempts are needed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Encephalitis, Fatigue, Headache, Hypertension
Clinical narrative: Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received.  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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Memory impairment, Personality change
Clinical narrative: Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received.  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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Road traffic accident, Seizure
Clinical narrative: Seizure; crashed my car.; don't remember 45 minutes of my life; This is a spontaneous report from a Contactable Consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 13:15 (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation at a vaccine facility, at 26 years old. Medical history included known allergies: Penicillin from an unknown date. No other vaccine in four weeks. Patient did not COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included bupropion; and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. Patient waited 15 minutes and felt normal. Patient stopped for gas and soda and then patient stated to be honest he woke up surprised with EMT, police and fire just telling him he started having a seizure and crashed his car on 17Apr2021 13:30. Patient stated "that's craziest laser I don't remember 45 minutes of my life (onset 17Apr2021). Thought I would be like 140. It was 3 pm which leave a large gap. This is really scary for me and my family". The events resulted in emergency room visit for seizure and crashed his car. The patient was hospitalized for seizure and for crashed his car for 1 day. Therapeutic measures were taken as a result of seizure and crashed my car (Some things to regulate my heart rhythm). Outcome of the events seizure and crashed his car was not recovered while unknown for don't remember 45 minutes of his life.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she had COVID-19 but did received both vaccine shots.; she had COVID-19 but did received both vaccine shots.; This is a spontaneous report from a contactable consumer (patient) enrolled in a Pfizer-sponsored program this report regards an event part of the medical history of the patient. A 73-year-old female consumer reported that she received two single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dates, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had COVID-19 on an unspecified date but received both vaccine shots. Event outcome was unknown. Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sudden hearing loss, Tinnitus
Clinical narrative: idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after the 2nd Vaccine; tinnitus on my left ear on and off; felt extreme fatigue and tired; This is a spontaneous report from a contactable other healthcare professional (reporting for herself).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2, via an unspecified route of administration, administered in left arm on 02Feb2021 10:00 A.M. at the age of 49 years old, as a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient had no known allergies and no prior COVID vaccination. The patient was not also tested with COVID post vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 vaccine for COVID-19 immunization and experienced minor headache. On 08Feb2021, the patient reported that she experienced severe headache on her left head for full 3 days after the 2nd Vaccine. The patient had a minor headache when she had the first vaccine, but it lasted only a day and it was mild one. About 1 week after the 2nd vaccine, the patient had a tinnitus on her left ear on and off. She thought it was because she was tired. For some reason after the 2nd shot, the patient felt extreme fatigue and tired. The left ear ringing was happening more frequently and getting loud. The patient went to urgent care and also went to ENT, and there it was found out that she was having an idiopathic sudden hearing loss on left ear. The patient was treated with oral steroid and injection but the hearing sensory was not coming back yet. The outcome of the events was not recovered.   Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on idiopathic sudden hearing loss 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: Chest pain, Dyspnoea, SARS-CoV-2 test
Clinical narrative: my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 16:00 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included mild asthma. The patient is not pregnant. Concomitant medications included lisinopril; fexofenadine hydrochloride (ALLEGRA); and estradiol. The patient previously took morphine, tramadol, and nickel and all had known allergies. The patient experienced her chest started hurting and she couldn't breathe the next day (29Dec2020). She slept for 2 days. Symptoms progressed and got worse and she had been to the emergency room (ER) five times. She also had many Doctor (Dr) appointments and symptoms had not improved. The events assessed as serious with disability and hospitalization of one day. Treatment received for these events included dexamethasone, duo neb, lorazepam, and hydromorphone. No COVID prior to vaccination and COVID tested post vaccine (unspecified date): unknown results. No other vaccines received in four weeks. The outcome of the events was not recovered.  Information on about lot /batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product.    The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired for 1 day; This is a spontaneous report from a Pfizer- sponsored program via a non-contactable consumer (patient). The patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tired for 1 day on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia oral
Clinical narrative: Tired for 5 days; Lip tingling for 4 days; This is a spontaneous report from a Pfizer- sponsored program. Immediate Family and Household Vaccination Program from a non-contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient experienced tired for 5 days, lip tingling for 4 days. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Tired; slept for 2 days; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced tired and slept for 2 days. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizzy Spell after 1st vaccine on scene; Fatigue for 2 days; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 dizzy Spell after 1st vaccine on scene and fatigue for 2 days. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The patient experienced lethargic for 1 day. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Lymphadenopathy
Clinical narrative: uncomfortable; armpit completely swollen, sore and tender; armpit completely swollen, sore and tender; This is a spontaneous report received from a contactable consumer. This consumer(patient) reported for herself that the 39-year-old female patient received second dose of bnt162b2 (BNT162B2), via an Intramuscular, administered in Arm Left on 12Apr2021 10:30 (Lot Number: EL3247) at single dose for covid-19 immunization (because she thought that it would be safer she has an 82 year old mother that lives with her). Medical history included allergies: any type of penicillin all the "cillins"; Novocain; sulfa drug any type; aspirin gives an upset stomach, contraception from an unknown date and unknown if ongoing. Family Medical History included dad has agent orange; asthmatic and diabetic. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for contraception, start and stop date were not reported and Women's vitamin. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced armpit completely swollen, sore and tender on 13Apr2021 with outcome of recovering , armpit completely swollen, sore and tender on 13Apr2021 with outcome of recovering, uncomfortable on an unspecified date with outcome of unknown. Vaccination Facility Type was Other: Pfizer manufacturing facility. No Vaccine Administered at Military Facility. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Relevant Tests was none. The clinical course was reported as follows: Consumer states that she got her second vaccine Monday morning, 12Apr2021 and when she woke up Tuesday 13Apr2021 her armpit is completely swollen, sore and tender and it still is. Caller states it was very painful when she woke up yesterday morning, could barely touch it to put deodorant on. Caller states today, the pain is gone now, but it is extremely uncomfortable on a scale of 1-10 of uncomfortablity it is about 12.5. Caller states even her clothes touching it is just 'ugh'. Caller stated that the area is still big, but it is not painful.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: A little over a week after the First vaccination, I developed two blood clots in my leg; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in the left arm on 18Mar2021 as SINGLE DOSE, for covid-19 immunization  (at the age of 67 years-old). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration, administered in the left arm  on 14Apr2021 as SINGLE DOSE. The patient was not pregnant at the time of vaccination.   The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Medical history included peripheral arterial occlusive disease from an unknown date and unknown if ongoing and bad circulation. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient developed two blood clots in her leg on 28Mar2021 a little over a week after the first vaccination. There was no treatment provided for the blood clots. The outcome of the blood clots was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache; Light headedness; This is a spontaneous report from a Pfizer- sponsored program from a non-contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced headache, light headedness on an unspecified date. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache; Nausea; Dizziness; This is a spontaneous report from Pfizer Sponsored Program from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), 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 headache, nausea, dizziness. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report received from a Pfizer sponsored Colleagues Immediate Family and Household Vaccination Program. A contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE), 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 suffered from Metallic taste on an unspecified date. Outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for the day of the vaccine; This is a spontaneous report from a Pfizer sponsored Immediate via a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 headache for the day of the vaccine with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Headache and radiating neck pain for 1 day; Headache and radiating neck pain for 1 day; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced headache and radiating neck pain for 1 day. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired for 1 day; This is a spontaneous report from a Pfizer- sponsored program Pfizer Colleagues Immediate Family and Household Vaccination Program via a non-contactable consumer . A patient of unspecified age and gender received bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced tired for 1 day on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I was really really tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored programs. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization. The patient's medical history included chronic illness, auto-immune disease, surgical procedure from 12Apr2021, and chronic pain. The patient previously received the first dose of BNT162B2 (Batch/Lot number was not reported) on 12Mar2021 for COVID-19 immunization. The patient's concomitant medications included morphine taken for chronic pain, anti-depressant (unspecified), and acid reflux medication (unspecified); start and stop dates were not reported. The patient reported that she received both of the vaccines and she underwent a surgical procedure on 12Apr2021 due to chronic illness that might interfere with the effectiveness of the vaccine as per her daughter. She said that she didn't know about it and said if she knew, she would reschedule the surgical procedure. She received the 1st dose on 12Mar2021 and received the 2nd dose on 09Apr2021 (more than 21 days). She also took medication like morphine for chronic pain, anti-depressant, acid reflux medication and she also received sedative drugs through spine during the surgery. The patient said that she has auto-immune disease and she wanted to get a second opinion from Pfizer's professionals. The patient took the second shot on 09Apr2021 and had a procedure two days later. The patient also stated the she was really really tired, but didn't have any fever on Apr2021. The outcome of the event tired was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: injection site soreness; strong headache; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. Later on 13Apr2021, the patient experienced injection site soreness and had a strong headache. The patient did not experience any other adverse effects. Both issues resolved the following day (today). Outcome of the events was recovered on 14Apr2021.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: three blood clots in right leg; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613, Expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Mar2021 15:00 (age at vaccination was 45 years) as single dose for COVID-19 immunization. Medical history included drug hypersensitivity (sulfonamide allergy) from an unknown date and unknown if ongoing, and seasonal allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included fluticasone propionate taken for an unspecified indication, start and stop date were not reported; olopatadine hydrochloride (PATADAY) taken for seasonal allergy, start and stop date were not reported. The patient experienced three blood clots in right leg on 09Apr2021 20:00 with outcome of recovering. Therapeutic measures were taken as a result of three blood clots in right leg (thrombosis) that included blood thinners (Eliquis). The event was reported as serious, medically significant.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait inability, Headache, Vaccination site pain
Clinical narrative: soreness at his injection site; his hip, he could barely walk, his right hip / its still hurting; his hip, he could barely walk, his right hip / its still hurting; headaches; This is a spontaneous report from a contactable consumer (patient). This 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 12Apr2021 Between 13:30 and 14:00 (NDC: Unknown, Expiry Date: Unknown) as single dose on Left arm for COVID-19 immunization. Medical History was None. Family Medical History RELEVANT to AE was No. Concomitant medications included the only medication he takes is the one he takes on a regular basis. No Additional Vaccines administered on SAME DATE of the Pfizer suspect. No History of all previous immunizations with the Pfizer vaccine considered as suspect. Prior Vaccinations within 4 weeks, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he didn't have any numbers on his vaccination card. He unsure of expiry date, NDC, or LOT.  He got Pfizer Covid Vaccine cause everybody else is getting it because of the virus. He stated that was okay he didn't need to be transferred if they can't give him recommendations, he would just call his doctor. He stated he had the shot on 12Apr2021 and he had some soreness in his injection site from 13Apr2021 and ongoing, he stated it was a little sore, but not like it was. But 13Apr2021 he had started experiencing his hip, he could barely walk, his right hip. He states it was still hurting, he could barely walk 14Apr2021 morning, just unbearable and persisting, it hasn't improved at all. He was also experiencing headaches from 13Apr2021 and ongoing. He tried to call Pfizer last night it lasted about 2 hours, and he just hung up and went on to bed. He stated he was just hurting, he didn't have any medical conditions. No AE require a visit to Emergency Room/Physician Office. Patient stated he hadn't gone yet, he probably was going to have to go if this pain keeps persisting. No Relevant Tests, he stated about two weeks ago he had some blood dram and they said it came back negative and he assumes everything was okay. Investigation Assessment was No. The outcome of the event (soreness at his injection site) was Recovering, of others was Not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a spontaneous report received from a contactable consumer (patient). This 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) on 11Apr2021 14:15 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization and after the first dose, experienced strong soreness at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second dose, starting 12 hours after injection, on 12Apr2021 15:00, patient experienced pain at injection site, fever, body aches, headache, weakness/lethargy. Symptoms fully resolved 48 hours after injection. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 13Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a spontaneous report received from a contactable consumer (patient). This 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) on 11Apr2021 14:15 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization and after the first dose, experienced strong soreness at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second dose, starting 12 hours after injection, on 12Apr2021 15:00, patient experienced pain at injection site, fever, body aches, headache, weakness/lethargy. Symptoms fully resolved 48 hours after injection. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 13Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Rhinorrhoea
Clinical narrative: ache inside of her left eye; she has a continuous runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient (wife) that received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced ache inside of her left eye on an unspecified date with outcome of unknown , she has a continuous runny nose on an unspecified date with outcome of unknown.    The clinical course was reported as follows: The patient has an ache inside of her left eye and she has a continuous runny nose but no fever.They are both scheduled for their 2nd dose tomorrow 15Apr2021 and the caller wanted to know if her wife can go to receive her second dose. Both of them received the 1st dose on 25Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Her period started 14 days early; Heavy bleeding (period); This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date, at the age of 44 years old, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient did not have COVID-10 prior to BNT162b2. There were no known allergies. The patient stated having received BNT162b2 two weeks prior to the initial reporting. She had been off of her period for about 7 days and she had 14 days before her period started again; her period started 14 days early, on 15Apr2021 at 16:30, which seemed weird to her. The patient felt like this was a side effect from the vaccine. The bleeding was described as heavy. The patient still had menstruation at the time of the reporting. The patient had not tested positive to COVID-19 after the vaccination. The outcome of the event irregular menstrual period was unknown, while the patient had not recovered from the heavy bleeding.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Respiratory distress
Clinical narrative: respiratory distress issues; severe bloating; gas; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 at 17:45 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old), and dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 72 years-old) for COVID-19 immunisation.  Medical history included severe petro-chemical allergies: petroleum based products, etc. (i.e. gas - diesel fumes, sharpie pens,magic markers, paint, developers, paving materials).  The patient had no other relevant medical history. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine and no other medications within two weeks prior to the vaccine. On 03Mar2021 at 14:00 the patient experienced respiratory distress issues, severe bloating, gas, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient reported the severe bloating, gas, diarrhea are now chronic issues, they are constant. The patient did not receive treatment for the respiratory distress issues. The patient received unspecified treatments from the physician for severe bloating, gas, diarrhea but the treatments have been unsuccessful. The events have been now ongoing for 6+ weeks and the patient stated they have ruled out glutten, dairy, etc as exasperators.  The outcome of the events respiratory distress issues, severe bloating, gas, and diarrhea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loses his sense of smell and taste; loses his sense of smell and taste; This is a spontaneous report from a Pfizer sponsored program  from a contactable consumer (Patient's wife).   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient previously received first dose of BNT162B2 on 24Mar2021 as SINGLE DOSE for covid-19 immunisation. After second dose, loses his sense of smell and taste. The outcome was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear, nose and throat examination, Epistaxis, Nodule, Rash macular, Thrombosis
Clinical narrative: big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blood clots coming out of nose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 (Batch/Lot Number: EW0151) as single dose, for covid-19 immunization. Medical history included ongoing sjogren's syndrome and ongoing lupus. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  07Apr2021, she started having a nose bleed. She explains she wasn't doing anything in particular, just talking on the phone, and blood just started pouring out of her nose. Blood clots started coming out as well. She ended up calling 911 and they sent an ambulance. The EMS helped her stop the bleeding. She didn't go to the ER or anything. However, she is getting implants done for her upper teeth so she wanted to double check and make sure nothing was pressing against her nasal cavity because the nose bleeds were so off/random. The doctor said there was no pushing. The doctor completed a panoramic exam/x-ray and confirmed there was nothing pushing. The doctor did suggest she go to the ENT. She made an appointment with an ENT doctor for the following day, 08Apr2021, and the ENT put a camera down. She confirms she explained to them she just had the vaccine and she was googling information. She was told to not google anything and to let them check it out.  The caller states she explained to the ENT the reason she was there was because she was concerned, she is not a nose bleeder and nose bleeds never happened to her. Once blood clots started coming out that way, she was terrified. They didn't see anything alarming, but they wanted to make sure and do further research, so basically they planned to do a CT/CAT scan. She was scheduled for a CT/CAT scan on Monday, 12Apr2021, but she was allergic to the contrast and was sent home because they were not prepared for pre-medication. She is waiting for the doctor to schedule another appointment so she can go back. She felt she needed to report these nose bleeds because she has been seeing Johnson & Johnson had severe blood clots, but she took Pfizer's vaccine, and was also getting blood clots. Her nose bleeds just happened right after both vaccines. On an unspecified date, she had a little bump that went away. She had this big bump on her arm and a big rash developed. At first, the bump was the size of a quarter and then grew double in size. The bump finally went down, but the rash she can still see. The rash hasn't grown, it's just there- there is just a red blotch on her arm. She has not had another nose bleed since the one that occurred on 07Apr2021. She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. The outcome of events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: big bump on arm; rash/red blotch on arm; nose bleed, blood clots coming out of nose; nose bleed, blood clots coming out of nose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 (Batch/Lot Number: EW0151) as single dose, for covid-19 immunization. Medical history included ongoing sjogren's syndrome and ongoing lupus. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  07Apr2021, she started having a nose bleed. She explains she wasn't doing anything in particular, just talking on the phone, and blood just started pouring out of her nose. Blood clots started coming out as well. She ended up calling 911 and they sent an ambulance. The EMS helped her stop the bleeding. She didn't go to the ER or anything. However, she is getting implants done for her upper teeth so she wanted to double check and make sure nothing was pressing against her nasal cavity because the nose bleeds were so off/random. The doctor said there was no pushing. The doctor completed a panoramic exam/x-ray and confirmed there was nothing pushing. The doctor did suggest she go to the ENT. She made an appointment with an ENT doctor for the following day, 08Apr2021, and the ENT put a camera down. She confirms she explained to them she just had the vaccine and she was googling information. She was told to not google anything and to let them check it out.  The caller states she explained to the ENT the reason she was there was because she was concerned, she is not a nose bleeder and nose bleeds never happened to her. Once blood clots started coming out that way, she was terrified. They didn't see anything alarming, but they wanted to make sure and do further research, so basically they planned to do a CT/CAT scan. She was scheduled for a CT/CAT scan on Monday, 12Apr2021, but she was allergic to the contrast and was sent home because they were not prepared for pre-medication. She is waiting for the doctor to schedule another appointment so she can go back. She felt she needed to report these nose bleeds because she has been seeing Johnson & Johnson had severe blood clots, but she took Pfizer's vaccine, and was also getting blood clots. Her nose bleeds just happened right after both vaccines. On an unspecified date, she had a little bump that went away. She had this big bump on her arm and a big rash developed. At first, the bump was the size of a quarter and then grew double in size. The bump finally went down, but the rash she can still see. The rash hasn't grown, it's just there- there is just a red blotch on her arm. She has not had another nose bleed since the one that occurred on 07Apr2021. She just noticed when she had her first dose on 15Mar2021, the nose bleed happened within that week also. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm was sore; tired; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), 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.  The patient medical history and concomitant medications were not reported.  The patient experienced arm was sore and tired. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in both sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, intramuscular, administered in arm left on 18Mar2021 as single dose for covid-19 immunisation. Medical history included parkinson. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization that was probably 25 years ago and experience sinus blocked. The patient experienced pain in both sore arm on 18Mar2021 with outcome of recovered on 20Mar2021.  Patient stated that she had a very sore arm in her left arm that occurred with the first dose of COVID vaccine and stated that the arm soreness started 3 or 4 hours after the vaccine and lasted about 2 days. No AE require a visit to emergency room nor physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.