chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I'm not sleeping or able to even think because of the brain fog and fatigue; My thyroid blood work shows a 0.005 level of the needed hormone, prior to the shot I was at 3.6; My hair is falling out and creating bald spots; I'm not sleeping or able to even think because of the brain fog and fatigue; I'm not sleeping or able to even think because of the brain fog and fatigue; This is a spontaneous report from a contactable consumer (patient). A 26-year-old unspecified gender patient received the second dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration in Sep2021 (Lot Number: FF8839) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history included hashimotos, allergy to dairy, soy and yeast. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication included thyroid hormone, antibiotics for tooth infection. The patient previously received gluten and experienced allergy. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in Sep2021 (Lot Number: Fc3182) as single dose for COVID-19 immunization. The patient stated:"My thyroid blood work shows a 0.005 level of the needed hormone, prior to the shot I was at 3.6. This has been devastating to my health and condition, I have been living in a constant flare since the shots whereas before I was managing my condition well with the medicine and diet. My hair is falling out and creating bald spots. I'm not sleeping or able to even think because of the brain fog and fatigue." The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Herpes zoster, Immunisation, Off label use
Clinical narrative: had his third booster shot on 20Aug2021; had his third booster shot on 20Aug2021; got shingles; had a slight pain in the chest/ pain was on the patient's left chest and back; rash; pain was on the patient's left chest and back; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Aug2021 11:00 (At the age of 75 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy. Medical history included Kidney transplant (patient got his kidney transplant 11 years ago). Concomitant medications included tacrolimus (TACROLIMUS) and mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), both taken for an unspecified indication, start and stop date were not reported, high blood pressure medication, and cholesterol medication. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration, on 23Feb2021 (At the age of 74 years) as DOSE 1, SINGLE for covid-19 immunization and also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, on 16Mar2021 (At the age of 75 years) as DOSE 2, SINGLE for covid-19 immunization. Patient did not took other vaccination within 4 week of COVID vaccine. The patient had his third booster shot on 20aug2021 on 20aug2021, got shingles, had a slight pain in the chest/ pain was on the patient's left chest and back, rash, pain was on the patient's left chest and back on 2021. Event reported as, the patient had a slight pain in the chest area which is where the shingles started. The patient thought it was a back ache which began three days before the rash bloomed. The pain was on the patient's left chest and back. On 20Aug2021 the patient got the shot and he got the shingles medication on 26Aug2021. The patient clarified and confirmed that he had 3 doses total of the Pfizer covid vaccine. This event happened after the third dose. The patient said Aspercream helped a lot on the shingles. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of got shingles. At the time of reporting the outcome of the event shingles was recovering and for rest of the other events the outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had his third booster shot on 20Aug2021; had his third booster shot on 20Aug2021; got shingles; had a slight pain in the chest/ pain was on the patient's left chest and back; rash; pain was on the patient's left chest and back; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration, administered in Arm Left on 20Aug2021 11:00 (At the age of 75 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at Pharmacy. Medical history included Kidney transplant (patient got his kidney transplant 11 years ago). Concomitant medications included tacrolimus (TACROLIMUS) and mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), both taken for an unspecified indication, start and stop date were not reported, high blood pressure medication, and cholesterol medication. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration, on 23Feb2021 (At the age of 74 years) as DOSE 1, SINGLE for covid-19 immunization and also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, on 16Mar2021 (At the age of 75 years) as DOSE 2, SINGLE for covid-19 immunization. Patient did not took other vaccination within 4 week of COVID vaccine. The patient had his third booster shot on 20aug2021 on 20aug2021, got shingles, had a slight pain in the chest/ pain was on the patient's left chest and back, rash, pain was on the patient's left chest and back on 2021. Event reported as, the patient had a slight pain in the chest area which is where the shingles started. The patient thought it was a back ache which began three days before the rash bloomed. The pain was on the patient's left chest and back. On 20Aug2021 the patient got the shot and he got the shingles medication on 26Aug2021. The patient clarified and confirmed that he had 3 doses total of the Pfizer covid vaccine. This event happened after the third dose. The patient said Aspercream helped a lot on the shingles. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of got shingles. At the time of reporting the outcome of the event shingles was recovering and for rest of the other events the outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain in extremity, Product use issue
Clinical narrative: Arms are killing me; mildly headachy/tired; mildly headachy/tired; Product use for unapproved combination; Booster; This is a spontaneous report from a contactable consumer (patient). A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 01Nov2021 DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and influenza vaccine on 01Nov2021 as DOSE NUMBER UNKNOWN, SINGLE for Immunisation. The patient previously received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for covid-19 immunisation. Got Pfizer booster and flu shot yesterday (01Nov2021). Arms are killing me, feel mildly headachy/tired, but mostly just grateful to be benefiting from science in such a positive way. Outcome of the events was unknown.  No follow-up attempts are possible; information
Sex: U
Vaccine: COVID19
Symptoms: Coma, Myocardial infarction, Paralysis, Renal failure, Weight decreased
Clinical narrative: I was brought back only to remain in a coma for 11 days; it attacked my heart; I was paralyzed; I am on dialysis kidneys no longer function; 190 pounds of muscle when I left the hospital I was 150 pounds; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient stated: "I took the first Covid vaccine shot and it attacked heart. It killed me and I was brought back only to remain in a coma for 11 days when I woke from my coma I was  paralyzed from the waste down and had to do physical therapy to walk again. I am on dialysis cause my kidneys no longer function. Before the shot I worked out six days a week and was 190 pounds of muscle when I left the hospital I was 150 pounds of skin and bones. Now I have huge medical bills due to a shot". The outcome of coma was recovered in 2021. The outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Covid fog; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was not reported. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was none. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization and stomach began cramping, experienced extreme fatigue for 2 weeks and had a migraine with 24 hrs of the vaccine that lasted 24 hrs. On an unspecified date, the patient experienced extreme fatigue for 2 weeks. Now almost 3 weeks out from the 2nd shot the patient had Covid fog. The event resulted in disability or permanent damage. No treatment was received. The outcome of fatigue extreme was recovered. The outcome of other event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine
Clinical narrative: my stomach began cramping; migraine; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date at the age of 50-year-old as single dose for COVID-19 immunization. Medical history was not reported. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was none. First does within 15 min of the vaccine, the patient's stomach began cramping. He had a migraine with 24 hrs of the vaccine that lasted 24 hrs. The patient received the second dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and had extreme fatigue for 2 weeks. Now almost 3 weeks out from the 2nd shot he have Covid fog. The events resulted in disability or permanent damage. No treatment was received. The outcome of stomach cramps was unknown. The outcome of other event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor
Clinical narrative: loud tinnitus; unilateral tremor in hands; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (COVID19 VACCINE) via an unspecified route of administration on the left arm in Apr2021 at the age of 57-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. In Apr2021, the patient experienced unilateral tremor in hands developed after second vax and has not gone away. Also developed loud tinnitus after 2nd vax which has not gone away. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, General physical health deterioration, Injury, Investigation
Clinical narrative: Serious health crisis; Vaccine injury; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 21Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced serious health crisis and vaccine injury on an unspecified date (6 weeks later). Consumer reported her husband received his second does of the Pfizer Covid vaccine on 21Mar2021. About 6 week later he started developing symptoms that evolved as time went on. By the end of Jun, he was in a serious health crisis. After much bloodwork and testing, it was determines that he had a vaccine injury. His symptoms mirrored Covid long-haul yet he never had Covid. He tested negative for Covid and has no antibodies to Covid. We are looking for strategies to help him recover. The patient underwent lab tests and procedures which included blood test: he had a vaccine injury (After much bloodwork and testing, it was determines that he had a vaccine injury), investigation: he had a vaccine injury, sars-cov-2 test: negative (He tested negative for Covid and has no antibodies to Covid) on an unknown date. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Electrocardiogram, Full blood count, Headache
Clinical narrative: test (+) for Covid; Headache; L arm pain; tingling in L arm; This is a spontaneous report from a contactable other health care professional. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FD8448, Expiration date: Unknown), via intramuscular route of administration in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: FD8448) as dose 1, single (at the age of 54-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced test positive for COVID-19. On an unspecified date in 2021, the patient experienced headache, his arm pain and tingling in L arm. The patient underwent lab tests and procedures which included computerized tomogram: negative on 23Sep2021, electrocardiogram: possible enlarged L atrium on 23Sep2021, full blood count: negative on 23Sep2021, CMD: negative on 23Sep2021, SARS-COV-2 test: positive on 21Aug2021. It was reported that on 21Aug2021, the patient was tested positive for COVID-19, 19 days later he got second COVID-19 vaccine. He reported that headache started the next day and progressively got worse. He went to the emergency room visit for headache on 24Sep2021. On 27Sep2021, the reporter seen patient in his office for follow up emergency room visit plus persistent migraine Toredol 30mg/1ml intramuscular was given with dexamethasone 4 mg intramuscular. He also presented with L arm pain and tingling in L arm where injection was given,  on 11Oct2021. He continued to had headaches. The outcome of the event headache was not recovered. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: test (+) for Covid; Headache; L arm pain; tingling in L arm; This is a spontaneous report from a contactable other health care professional. A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FD8448, Expiration date: Unknown), via intramuscular route of administration in left arm on 19Aug2021 at 13:00 (Batch/Lot Number: FD8448) as dose 1, single (at the age of 54-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Aug2021, the patient experienced test positive for COVID-19. On an unspecified date in 2021, the patient experienced headache, his arm pain and tingling in L arm. The patient underwent lab tests and procedures which included computerized tomogram: negative on 23Sep2021, electrocardiogram: possible enlarged L atrium on 23Sep2021, full blood count: negative on 23Sep2021, CMD: negative on 23Sep2021, SARS-COV-2 test: positive on 21Aug2021. It was reported that on 21Aug2021, the patient was tested positive for COVID-19, 19 days later he got second COVID-19 vaccine. He reported that headache started the next day and progressively got worse. He went to the emergency room visit for headache on 24Sep2021. On 27Sep2021, the reporter seen patient in his office for follow up emergency room visit plus persistent migraine Toredol 30mg/1ml intramuscular was given with dexamethasone 4 mg intramuscular. He also presented with L arm pain and tingling in L arm where injection was given,  on 11Oct2021. He continued to had headaches. The outcome of the event headache was not recovered. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: as the mother of a son that had heart problems right after the first P shot. I'm fortunate that my son is still alive; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced as the mother of a son that had heart problems right after the first p shot. im fortunate that my son is still alive on an unspecified date, she also posted a link to this video of a father who says he lost his son to an adverse event after receiving the Pfizer. Event took place after use of product. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: a stroke in the eye; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNWON, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a stroke in the eye. Reporter reported that she knows someone who was paralyzed after getting the vaccine, someone who had a stroke in the eye. The outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No follow-up attempts are possible; No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Epstein-Barr virus infection reactivation, Lymphadenopathy, Scan
Clinical narrative: having reactivation of EBV virus after getting the vaccine; lymphadenopathy; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included Lymphoma, stem cell transplant, Epstein Barr virus infection. The concomitant medications were not reported. The patient experienced having reactivation of ebv virus after getting the vaccine, lymphadenopathy on an unspecified date. The patient underwent lab tests and procedures in 2021 which included biopsy: questionable for lymphoma questionable for lymphoma, that is her history, and another biopsy that was not lymphoma, that is her history, and biopsy: not lymphoma, positron emission tomogram: having lymphadenopathy months after receiving the Pfizer BioNTech COVID19 vaccine and it was all over her body internally, it showed in the PET scan/and caused lymphadenopathy on a PET scan. Stated she had 3 scans in the last 6 months. They don't know what it is, she had a history of lymphoma, and they jump to that conclusion, but they were looking at the scans and suggesting they did not think biopsy as it did not look suspicious enough for lymphoma, she had no symptoms. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, as dose 2, single for COVID-19 immunization. The patient's medical history includes Type 2 diabetes. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date, as dose 1, single for covid-19 immunization and experienced excessive sweating. The patient experienced chills. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Immunisation
Clinical narrative: blood sugar has been high/can't go below 200; dose received 3; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 34-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 02Nov2021 at 17:30 (at the age of 34-year-old) as dose 3 (booster), single for covid-19 immunization administered in pharmacy or drug store. The patient was not pregnant at time of vaccination. Patient's relevant medical history noted diabetes type 1 from an unknown date and unknown if ongoing. Patient's concomitant medications included included insulin (INSULIN) taken for unknown indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergy. Historical vaccination included, patient previously received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 (at the age of 34-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single both for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that she had no serious reactions to the first 2 shots. However, the booster shot which was received on 02Nov2021, made the patient feel much worse but patient was concerned because the blood sugar had been high for 5 days (event onset captured as 02Nov2021) at the time of this report (reported as now). Even without eating, the patient could not go below 200 even after taking lots of extra insulin. The patient received treatment with insulin. Hospitalization prolonged was noted as no. The patient underwent lab tests and procedures which included blood glucose increased resulted as high on 02Nov2021. Outcome of the event blood sugar has been high/can't go below 200 was not recovered.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dermatitis, Ocular hyperaemia, Pain, Polyarthritis
Clinical narrative: awoke to severe red eyes; have severe inflammation in my joints, neck, wrist, elbows, knees, hips; have severe inflammation in my joints, neck, wrist, elbows, knees, hips; the pain increased and actually became debilitation/EXTREMELY painful; the pain increased and actually became debilitation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 58 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 12:00 AM (Batch/Lot Number: FF2587) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hashimotos, hypothyroidism, erythema multiform, and covid prior vaccination. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine; liothyronine sodium (CYTOMEL) and vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3183), vaccinated at age of 58 years old, on 25Aug2021 in left arm for covid-19 immunisation. Three weeks after 2nd shot (28Sep2021), on 19Oct2021 08:00 AM, patient awoke to severe red eyes and started to have severe inflammation in her joints, neck, wrist, elbows, knees, hips. The pain increased and actually became debilitation. Patient needed help to do the smallest things. Extremely painful. Increased until she went for emergency help at a Hospital. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Treatment was received and treatment was corticosteroid shots+ 3 days IV Methylprednisolone. The patient was hospitalized for 3 days. The patient underwent lab tests and procedures which included Antigen SARS: negative blood test on 02Nov2021. The outcomes of events were unknown.  The events ocular hyperaemia, arthritis, dermatitis, pain and asthenia occurred in a location different from that of the reporter. This may be a duplicate report if another reporter from the location where the event occurred has submitted the same information to his/her local agency.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: awoke to severe red eyes; have severe inflammation in my joints, neck, wrist, elbows, knees, hips; have severe inflammation in my joints, neck, wrist, elbows, knees, hips; the pain increased and actually became debilitation/EXTREMELY painful; the pain increased and actually became debilitation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 58 years old, dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 12:00 AM (Batch/Lot Number: FF2587) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hashimotos, hypothyroidism, erythema multiform, and covid prior vaccination. The patient was not pregnant at time of vaccination. Concomitant medications included levothyroxine; liothyronine sodium (CYTOMEL) and vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3183), vaccinated at age of 58 years old, on 25Aug2021 in left arm for covid-19 immunisation. Three weeks after 2nd shot (28Sep2021), on 19Oct2021 08:00 AM, patient awoke to severe red eyes and started to have severe inflammation in her joints, neck, wrist, elbows, knees, hips. The pain increased and actually became debilitation. Patient needed help to do the smallest things. Extremely painful. Increased until she went for emergency help at a Hospital. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Treatment was received and treatment was corticosteroid shots+ 3 days IV Methylprednisolone. The patient was hospitalized for 3 days. The patient underwent lab tests and procedures which included Antigen SARS: negative blood test on 02Nov2021. The outcomes of events were unknown.  The events ocular hyperaemia, arthritis, dermatitis, pain and asthenia occurred in a location different from that of the reporter. This may be a duplicate report if another reporter from the location where the event occurred has submitted the same information to his/her local agency.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 21-year-old male patient received second dose bnt162b2 (COMIRNATY, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 25Feb2021 (age at vaccination: 21-year-old) as dose 2, single for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date as a dose 1 single for COVID-19 immunization. On 26Feb2021 (1 day after the vaccination also reported as within 48hours), patient experienced bell's palsy. The outcome was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Feeling abnormal, Gait disturbance, Lethargy
Clinical narrative: Unable to stand up straight or ambulate without help; Unable to stand up straight or ambulate without help; 102 temp; Nausea; Lethargy; Vertigo; Brain fog; Lack of visual field; Posterior mid back pain; Spent 3 days in bed with these symptoms; Hot to touch at injection site and very painful; Hot to touch at injection site and very painful; This is a spontaneous report from a contactable nurse (patient). This nurse reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot Number: EM9809, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation at a doctor's office/urgent care. Medical history included hypertension, hypercholesterolemia, hypothyroid, chronic lumber pain and glaucoma. Known allergies include statins. Historical vaccination information included the patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 28Jan2021 at 4pm (Batch/Lot Number: EL9261, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation. On an unspecified date in 2021 (after the second vaccine dose), the patient experienced 102 temperature, nausea, lethargy, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain. She spent 3 days in bed with these symptoms. The morning lethargy lasts till around noon then subsides. She also reported it was hot to the touch at injection site and very painful. The clinical outcome of the events 102 (unspecified units) temperature, nausea, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain, spent 3 days in bed with these symptoms, injection site was hot to touch and very painful was unknown.   Follow-up (12Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101487756 Same reporter/SD, potential/AE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Unable to stand up straight or ambulate without help; Unable to stand up straight or ambulate without help; 102 temp; Nausea; Lethargy; Vertigo; Brain fog; Lack of visual field; Posterior mid back pain; Spent 3 days in bed with these symptoms; Hot to touch at injection site and very painful; Hot to touch at injection site and very painful; This is a spontaneous report from a contactable nurse (patient). This nurse reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot Number: EM9809, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation at a doctor's office/urgent care. Medical history included hypertension, hypercholesterolemia, hypothyroid, chronic lumber pain and glaucoma. Known allergies include statins. Historical vaccination information included the patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 28Jan2021 at 4pm (Batch/Lot Number: EL9261, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation. On an unspecified date in 2021 (after the second vaccine dose), the patient experienced 102 temperature, nausea, lethargy, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain. She spent 3 days in bed with these symptoms. The morning lethargy lasts till around noon then subsides. She also reported it was hot to the touch at injection site and very painful. The clinical outcome of the events 102 (unspecified units) temperature, nausea, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain, spent 3 days in bed with these symptoms, injection site was hot to touch and very painful was unknown.   Follow-up (12Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101487756 Same reporter/SD, potential/AE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vertigo, Visual field defect
Clinical narrative: Unable to stand up straight or ambulate without help; Unable to stand up straight or ambulate without help; 102 temp; Nausea; Lethargy; Vertigo; Brain fog; Lack of visual field; Posterior mid back pain; Spent 3 days in bed with these symptoms; Hot to touch at injection site and very painful; Hot to touch at injection site and very painful; This is a spontaneous report from a contactable nurse (patient). This nurse reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose.  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot Number: EM9809, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation at a doctor's office/urgent care. Medical history included hypertension, hypercholesterolemia, hypothyroid, chronic lumber pain and glaucoma. Known allergies include statins. Historical vaccination information included the patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 28Jan2021 at 4pm (Batch/Lot Number: EL9261, at age 64-year-old at vaccination) as a single dose for COVID-19 immunisation. On an unspecified date in 2021 (after the second vaccine dose), the patient experienced 102 temperature, nausea, lethargy, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain. She spent 3 days in bed with these symptoms. The morning lethargy lasts till around noon then subsides. She also reported it was hot to the touch at injection site and very painful. The clinical outcome of the events 102 (unspecified units) temperature, nausea, unable to stand up straight or ambulate without help, vertigo, brain fog, lack of visual field, posterior mid back pain, spent 3 days in bed with these symptoms, injection site was hot to touch and very painful was unknown.   Follow-up (12Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101487756 Same reporter/SD, potential/AE
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: dose received 3; Swollen Lymph Nodes in the Armpit of the Injection site arm (after 3rd dose), lasting for at least 4 days; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 05Nov2021 at 09:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 24-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 (at the age of 24-year-old), both as single dose for COVID-19 immunisation. On an unknown date in Nov2021, the patient experienced swollen lymph nodes in the armpit of the injection site arm (after third dose), lasting for at least 4 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in the armpit of the injection site arm (after third dose) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Immunisation, Nausea
Clinical narrative: The patient received third/ booster dose of BNT162b2; Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); Patient experienced some known/expected side effects (fatigue, chills, pain in arm and fever); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); some unexpected side effects (nausea, GI distress, vomiting in the middle of the night); This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Nov2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medication included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as single doses for COVID-19 immunisation. On 07Nov2021, the patient experienced some known/expected side effects fatigue, chills, pain in arm and fever as well as some unexpected side effects; nausea, gastro intestinal (GI) distress and vomiting in the middle of the night. This only happened after the third shot in the night of and day after. No unexpected side effects happened after the second shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills, pain in arm, fever, nausea, GI distress and vomiting were resolved on an unknown date on Nov2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.