chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diverticulitis
Clinical narrative: Extreme constipation and diverticultis.; Extreme constipation and diverticultis.; This is a spontaneous report from contactable consumer (patient).   A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: 6206, expiry date: unknown) via unspecified route of administration, administered in left arm, on 07Apr2021 at 11:30 (age at vaccination: 61) as DOSE 2, SINGLE for Covid-19 immunisation. Patient took first dose of vaccination (lot number: 6198, expiry date: unknown), via unspecified route of administration, administered in left arm on 17Mar2021 at 11:15 AM (at the age of 62-years-old) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Apr2021, the patient experienced extreme constipation and diverticulitis. Treatment was given with antibiotics for the adverse events. Device date was reported as 23Jun2021. The outcome of events was not recovered.   Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: I have experienced Myocarditis symptoms; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, in left arm on 19May2021 16:00 (04:00 PM) (at the age of 31-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient had no Known allergies. The patient concomitant medication included omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8733), via an unspecified route of administration on 14Apr2021 16:00 (04:00 PM) (at the age of 31-year-old) as dose 1, single for COVID-19 immunization. The patient experienced myocarditis symptoms since a week after the second dose of the Pfizer vaccine on and off on an unspecified date. Patient was still experiencing them 7 weeks after his second dose. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not resolved.   Information on Lot/Batch number was available, additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: A patient that developed neck swelling 1-2 hours after receiving the first dose of the Pfizer Covid 19 Vaccine; Experienced injection site redness & pain; Experienced injection site redness & pain; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route administered, on an unspecified date, as Dose 1 single, for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient developed neck swelling 1-2 hours after receiving the first dose of the Pfizer COVID 19 Vaccine and the symptom lasted for about 2 days. On an unspecified date, the patient also experienced injection site redness and pain. Caller asking if the patient should receive the second dose of the Pfizer COVID 19 Vaccine or not. The outcome of all events was unknown.  Information on lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Tinnitus in right ear; Sore arm at injection site; This is a spontaneous report from a contactable Other Health Professional (patient).   A 62-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0191, Expiration date: unknown) via an unspecified route of administration on 08Apr2021 at 02:15 pm (at 62-year-old) in left arm as dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. patient did not have covid prior to the vaccination and was not tested for covid post vaccination. patient did not received any other vaccines in four weeks and other medications in two weeks. On 11Apr2021 at 06:00 AM, within 4 days of first dose the patient developed to tinnitus in right ear. There were no other symptoms other than a sore arm at injection site. The patient also developed a large red and swollen area on the injected arm but not at the injection site. This condition lasted 3 days, and then she lost at least 80 percent of her hearing in the right ear. As of 23Jun2021 she still had tinnitus in the right ear and still had a significant hearing loss. There had not been much improvement to either symptom since 29Apr2021. No treatment was received. The event tinnitus in right ear resulted in disability or permanent damage. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information had been requested.; Sender's Comments: Based on description given in the narrative, there is reasonable possibility of causal association between the event Tinnitus and the suspect BNT162B2.    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: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Having dizziness and muscle weakness in right arm.; Having dizziness and muscle weakness in right arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-years-old non-pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in right arm on an unspecified date as second dose, single for COVID-19 immunization. Previously, the patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number unknown), via an unspecified route of administration right arm on 10Apr2021 at 08:45 as first dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, 2weeks after the second dose, the patient developed dizziness and muscle weakness in right arm very unsettling, only gotten worse in right arm. It was reported that the primary care has done test and so far, they were inconclusive. The events were considered serious (disability). The outcome of the events was not recovered at the time of report.  Information on Lot/Batch number has been requested
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Erythema, Joint stiffness, Peripheral swelling, Tinnitus
Clinical narrative: developed a large red and swollen area on the injected arm but not at the injection site; developed a large red and swollen area on the injected arm but not at the injection site; not bend both thumbs for over 24 hours; lost at least 80 percent of my hearing in the right ear/significant hearing loss; tinnitus; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-years-old female (not pregnant) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0171, Pfizer NTEC), via an unspecified route of administration in left arm on 29Apr2021 at 08:00 as a single dose for COVID-19 immunization (at the age of 62-years-old). The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that after dose two on 29Apr2021, she could not bend both thumbs for over 24 hours. She also developed a large red and swollen area on the injected arm but not at the injection site. This condition lasted 3 days. She then lost at least 80 percent of my hearing in the right ear, the patient developed joint stiffness. As of 23Jun2021 she still had tinnitus in the right ear and still have a significant hearing loss. There has not been much improvement to either symptom since 29Apr2021. The patient did not receive any treatment. The clinical outcome for the events, lost at least 80 percent of my hearing in the right ear and tinnitus was not recovered whereas for events, not bend both thumbs for over 24 hours was recovered on 30Apr2021 and for event, developed a large red and swollen area on the injected arm but not at the injection site was recovered in May2021.  Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event: deafness and the administration of the vaccine 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Illness, Myocarditis, Pericarditis
Clinical narrative: Tired; Myocarditis; Pericarditis; Chest pain; sickness; Fever; Throwing up; This is a spontaneous report from a contactable consumer (patient parent). A 18-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0185 and expiration date was not reported), via unspecified route on 12May2021, as dose 2 single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included Somatropin (NORDITROPIN) and Letrozole. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, 14Apr2021 (Lot number EW0161 and expiration date was not reported), (age at vaccination 17-years-old), via unspecified route on as single dose for COVID-19 immunization.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date 2021, patient experienced chest pain and he did not know that was a side effect with the myocarditis and pericarditis, also he had normal sickness that he had fever and throwing up and tired. When He had the first shot, was 17 and he was 18 when he had the second one. The patient took Ibuprofen,  as treatment drug the next day after he had the shot. The outcome of all events were unknown   Information on Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Tired; Myocarditis; Pericarditis; Chest pain; sickness; Fever; Throwing up; This is a spontaneous report from a contactable consumer (patient parent). A 18-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0185 and expiration date was not reported), via unspecified route on 12May2021, as dose 2 single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included Somatropin (NORDITROPIN) and Letrozole. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, 14Apr2021 (Lot number EW0161 and expiration date was not reported), (age at vaccination 17-years-old), via unspecified route on as single dose for COVID-19 immunization.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date 2021, patient experienced chest pain and he did not know that was a side effect with the myocarditis and pericarditis, also he had normal sickness that he had fever and throwing up and tired. When He had the first shot, was 17 and he was 18 when he had the second one. The patient took Ibuprofen,  as treatment drug the next day after he had the shot. The outcome of all events were unknown   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/ hives on my legs; This is a spontaneous report from a contactable consumer reporting for a female patient (reporter's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number: Unknown, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer reported that she took her 1st Covid shot on Monday and it wasn't until the previous day afternoon and she was going to go to her doctor in few minutes, she noticed she had hives on her legs, and she haven't ever had that before until she took the shot. This must be a side effect to it because she actually talked to another friend of her, and she had the same thing happened to her. The patient just got up last night and took a very cold shower and iced the area with a bunch of ice and  called doctor, he told me to go and get over the counter medicine at any pharmacy. The patient went to and got Benadryl.You guys have it in the system. At right Aid, the patient told him. The patient  gave him the list of medication at the pharmacy it should be in the system. the patient take the medications that the patient take. Trust me, there was no side effect from my medications the system am having, you guys are having track of our information, track of our data and track of everyday its in the , the patient took the medication. Only side effects the patient am having are these hives. The patient have been taking these medications before the patient took the vaccine.the patient took the vaccine that was made by Pfizer. That is the only one and this is the only reaction that the patient was having.Reporter seriousness for hives was unspecified. The outcome of event was unknown.    Information related to batch/Lot no. was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021770729 Same reporter/product/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Pain in extremity, Vaccination site pain
Clinical narrative: I am not feeling well; all of sudden on my left arm which is where I received both of the shot started hurting on the site of the vaccination; I feel the same thing when I felt when I got vaccinated what's like the sore arm and like a kind of heavy that cannot be lifted; I feel the same thing when I felt when I got vaccinated what's like the sore arm and like a kind of heavy that cannot be lifted; This is a spontaneous report received from a contactable consumer (patient). A contactable consumer reported that:  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported; expiration date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 04May2021 as 2nd dose, single for COVID-19 immunization. Patient's medical history and concomitant medication were not provided.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported; expiration date: unknown), via an unspecified route of administration, on an unspecified date for Covid-9 immunization. On an unspecified date, the patient experienced all sudden on patient's left arm which was where the patient received both shots started hurting on the site of the vaccination and patient felt the same thing when patient felt when patient got vaccinated what's like the sore arm and like a kind of heavy that cannot be lifted, and the patient didn't know if that was normal. The patient had sore arm for one night and then now it came back, and patient didn't want to have later. Also. The patient was not feeling well. The outcome of events was unknown.   Follow up attempts are possible. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Experienced blood clots during her cycle after receiving her first dose of the Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable consumer, the patient via a Pfizer sponsor program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced experienced blood clots during her cycle after receiving her first dose of the pfizer covid-19 vaccine. Patient received her first dose of the Pfizer Covid-19 vaccine 17Apr2021. She experienced blood clots during her cycle. She had never experienced that before. She had not received her second dose. She was interested in finding out if she should get the second dose. The outcome of event was unknown.    Information upon lot number/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Period started on 12Apr2021 and did not stop until 15May2021; This is a spontaneous report from a contactable consumer(patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration in Arm Right on 07Apr2021 08:30 (Age at the time of vaccination: 47-years-old) (Batch/Lot Number: ER8729) as single for covid-19 immunization. Medical history included Cervical radiculopathy, perimemopausal, and GERD (Gastroesophageal reflux disease). Concomitant medications included Gabapentin 100 mg and multivitamin. The patient had allergic to drugs included amoxicillin and azithromycin. The patient had no other vaccines in four weeks before vaccination. As per the adverse event, it was reported that period started on 12Apr2021 and did not stop until 15May2021. Event was resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for event. The covid prior vaccination and post vaccination was mentioned as no. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain. Chest pain with breath.; This is a spontaneous report from a contactable pharmacist/patient. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jan2021(Age at vaccination-50 Years) 08:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension and hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) and losartan (LOSARTAN). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK5730 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 at 05:00 PM for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient was having no allergies. The patient was having no covid prior vaccination. The patient was not tested covid post vaccination.The patient experienced severe chest pain. chest pain with breath on 07Jan2021 at 18:00. The patient received no treatment. Outcome of the event was recovered on an unknown date.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Erectile dysfunction, Gout, Insomnia
Clinical narrative: Erectile dysfunction; Insomnia; Increased high anxiety levels; Diminished sex drive; Continuous joint aches; Possible gout build up; This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8753; Expiration date: Unknown) via an unspecified route of administration, in left arm on 22Apr2021 17:30 (age at vaccination 33-year-old) as dose 1, single, and patient received second dose via an unspecified route of administration, in left arm on 22Apr2021 (Batch/Lot Number: EW0173) as dose 2, single both for COVID-19 immunization. Medical history included joint injury and back pain from an unknown date and unknown if ongoing. Concomitant medications included fish oil (FISH OIL), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), loratadine (CLARITINE), fluticasone (FLUTICASONE) taken for an unspecified indication. Patient did the receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Apr2021 23:00 the patient experienced erectile dysfunction multiple times Continuous joint aches, insomnia, increased high anxiety levels, diminished sex drive, continuous joint aches, possible gout build up. Patient experienced diminished sex drive leading to erectile dysfunction multiple times continuous joint aches, that previously were not an issue, ever. Patient was hospitalized for 1 day. Hospitalization was not prolonged. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient had not received any treatment for adverse events. The outcome of all events was not recovered.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Libido decreased
Clinical narrative: Erectile dysfunction; Insomnia; Increased high anxiety levels; Diminished sex drive; Continuous joint aches; Possible gout build up; This is a spontaneous report from a contactable consumer (patient himself). A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8753; Expiration date: Unknown) via an unspecified route of administration, in left arm on 22Apr2021 17:30 (age at vaccination 33-year-old) as dose 1, single, and patient received second dose via an unspecified route of administration, in left arm on 22Apr2021 (Batch/Lot Number: EW0173) as dose 2, single both for COVID-19 immunization. Medical history included joint injury and back pain from an unknown date and unknown if ongoing. Concomitant medications included fish oil (FISH OIL), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), loratadine (CLARITINE), fluticasone (FLUTICASONE) taken for an unspecified indication. Patient did the receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Apr2021 23:00 the patient experienced erectile dysfunction multiple times Continuous joint aches, insomnia, increased high anxiety levels, diminished sex drive, continuous joint aches, possible gout build up. Patient experienced diminished sex drive leading to erectile dysfunction multiple times continuous joint aches, that previously were not an issue, ever. Patient was hospitalized for 1 day. Hospitalization was not prolonged. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient had not received any treatment for adverse events. The outcome of all events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Paraesthesia
Clinical narrative: Moderate to severe pain in the chest between rib bones; Pins and needles & numbness of extremities, limbs; Pins and needles & numbness of extremities, limbs; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0177, Expiration Date: not reported), via an unspecified route of administration in left arm on 23Jun2021 17:00 as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0187, Expiration Date: not reported), via an unspecified route of administration in left arm on 02Jun2021 16:00 for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Mental health issue, likely depression. Concomitant medication(s) included escitalopram and plantago ovata fibre (FIBER SUPPLEMENT). The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,the patient had not been tested for COVID-19. The patient experienced moderate to severe pain in the chest between rib bones (medically significant), pins and needles & numbness of extremities, limbs on 24Jun2021 03:00. Reported seriousness was non-serious. Device Date was 24Jun2021. It was unknown if patient received treatment or not. The outcome of the events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Hypomagnesaemia, Loss of consciousness, Syncope
Clinical narrative: 15 minutes after the shot I passed out in my car.; syncope; hypomagnesemia; abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0196), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jun2021 12:00 (age at the vaccination 32-year-old) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Jun2021, the patient had an adverse event which she described as "15 minutes after the shot I passed out in my car on 13Jun2021 12:15, syncope on 13Jun2021 12:15, hypomagnesemia on 13Jun2021 12:15, abnormal ekg on 13Jun2021 12:15."  Seriousness Criteria-Persistent, AE required visit to the emergency room. The patient underwent lab tests and procedures which included electrocardiogram: abnormal.  The outcome of the events was recovering.  Follow up attempts are completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 12:30 (Lot Number: ER8730) as dose 1, single for COVID-19 immunization at the age of 41-year-old. The vaccine was administered at pharmacy/drug store. Medical history included smoking from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 14Apr2021 and result was negative. The patient experienced tiredness on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021778305 Same patient/drug, different dose/event.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Chills, Crying, Dizziness
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 12:30 (Lot Number: ER8730) as dose 1, single for COVID-19 immunization at the age of 41-year-old. The vaccine was administered at pharmacy/drug store. Medical history included smoking from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 14Apr2021 and result was negative. The patient experienced tiredness on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021778305 Same patient/drug, different dose/event.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Fear, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 12:30 (Lot Number: ER8730) as dose 1, single for COVID-19 immunization at the age of 41-year-old. The vaccine was administered at pharmacy/drug store. Medical history included smoking from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 14Apr2021 and result was negative. The patient experienced tiredness on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021778305 Same patient/drug, different dose/event.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: She has not gotten her period since her first shot (beginning of April)/ had her second one she still hasn't had her period; This is a spontaneous report from a contactable consumer (patient's mother). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old), as a single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, at the age of 12-year-old) as a single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother was inquiring about the Pfizer BioNTech COVID19 vaccine. She mentions they all had it no problem. The last person who got it was her 12-year-old daughter. Her daughter has had her period for 2 years. Right before she got the vaccine, she was due for her period. She has not gotten her period since her first shot (beginning of April). Now she's also gotten her second shot and it still did not come. She feels like the only difference in the daughter's life was the vaccine. She wanted to have more information to know how to move forward. She says it's "out of the ordinary, nothing like this has happened since she's gotten her period". Mother wanted to know if we have any reports on the subject. What information was available regarding menstrual changes. There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This is not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. In teens, it is also important to note the natural variability in cycles due to the normal maturation process and the large range of normal menstrual cycles in the first few years after the onset of menses. Stress and weight changes, which have also occurred in many adolescents during the pandemic, can themselves cause these changes. COVID-19 vaccines can be used during puberty and that irregular periods are a common part of adolescence and usually have a wide normal range. The outcome of the event was reported as not resolved.  Information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac disorder
Clinical narrative: whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact; I think it was minor heart inflamation; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: ER8729) via an unspecified route of administration on 04May2021 at 15:00 (at the age of 23-years-old) in the left arm as dose 2, single for covid-19 immunisation. Facility of vaccination was workplace clinic. The patient medical history included mildly allergic to raw pineapple. Concomitant medications were not provided. The patient previously received first dose of BNT162B2 (Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 13Apr2021 at 15:00 (at the age of 23-years-old) as single dose for covid-19 immunisation with no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 the patient experienced "my whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact. It was for 3 days after the shot and then it resolved itself on its own. (I think it was minor heart inflammation)". No treatment was received for the events. Outcome of the events was recovered on an unknown date in May2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Back pain, Headache
Clinical narrative: Joint (mostly left knee) pain/Wrist pain (both); Back pain (upper & lower); Pain on left side of body; Sciatic nerve pain; Headaches; Weak hands; Nerve pain in second toe on right foot; Stomach pains; Pains on left side of abdomen; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female (non-pregnant) received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number EW0182) via an unspecified route of administration on 09Jun2021 at 05:15 AM administered in Left arm as dose 1, single for covid-19 immunization. Medical history included EPI, IBS, Subclinical Hyperthyroidism. Concomitant medications included the patient received within 2 weeks of vaccination: Dietary supplements, herbal supplement and teas. Known allergies included Lactose intolerant, shellfish, vicodin, tetracycline, doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jun2021, the patient experienced Joint (mostly left knee) pain, Back pain (upper & lower), Wrist pain (both), Pain on left side of body, Sciatic nerve pain, Headaches, Weak hands, Nerve pain in second toe on right foot, Stomach pains, Pains on left side of abdomen. The patient had a physician office visit due to the events. The patient did not take any treatment for the events. The outcome of the events was Recovered with lasting effects.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgia, Pain, Sciatica
Clinical narrative: Joint (mostly left knee) pain/Wrist pain (both); Back pain (upper & lower); Pain on left side of body; Sciatic nerve pain; Headaches; Weak hands; Nerve pain in second toe on right foot; Stomach pains; Pains on left side of abdomen; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female (non-pregnant) received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number EW0182) via an unspecified route of administration on 09Jun2021 at 05:15 AM administered in Left arm as dose 1, single for covid-19 immunization. Medical history included EPI, IBS, Subclinical Hyperthyroidism. Concomitant medications included the patient received within 2 weeks of vaccination: Dietary supplements, herbal supplement and teas. Known allergies included Lactose intolerant, shellfish, vicodin, tetracycline, doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jun2021, the patient experienced Joint (mostly left knee) pain, Back pain (upper & lower), Wrist pain (both), Pain on left side of body, Sciatic nerve pain, Headaches, Weak hands, Nerve pain in second toe on right foot, Stomach pains, Pains on left side of abdomen. The patient had a physician office visit due to the events. The patient did not take any treatment for the events. The outcome of the events was Recovered with lasting effects.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Seizure
Clinical narrative: cardiac arrest; seizures; his is a spontaneous report form a contactable consumer. This contactable consumer reported for a male patient (reporters brother).  A 34-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient experienced Cardiac arrest on 23Jun2021, Seizures on Jun2021 and patient was hospitalized for both the events and his status has gone out of control. The outcome of event was not recovered.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death, Vaccination complication
Clinical narrative: cardiac arrest; seizures; his is a spontaneous report form a contactable consumer. This contactable consumer reported for a male patient (reporters brother).  A 34-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 15Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient experienced Cardiac arrest on 23Jun2021, Seizures on Jun2021 and patient was hospitalized for both the events and his status has gone out of control. The outcome of event was not recovered.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Multiple sclerosis, SARS-CoV-2 antibody test, Vasculitis
Clinical narrative: a small brain bleed, possible stroke, and is being evaluated for multiple sclerosis.; possible stroke; multiple sclerosis; vasculitis; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 55 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, expiration date unknown), dose 1 intramuscular, administered in Arm Right on 22Jan2021 13:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included COVID-19 on 29Oct2020 (She stated that some of her symptoms started in November when she returned to work). The patient concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and it was unknown that the patient received other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. On 22Jan2021, the patient experienced vasculitis, small brain bleed, possible stroke, and is being evaluated for multiple sclerosis. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Oct2020. The patient visited doctor or other healthcare professional office/clinic. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cerebral haemorrhage, cerebrovascular accident and multiple sclerosis cannot be completely excluded based on information provided. The case will be reassessed if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Poor quality product administered, Product preparation error
Clinical narrative: injected the wrong solution, they used saline vs sodium chloride/ mistakenly used sterile water for injection; injected the wrong solution, they used saline vs sodium chloride/ mistakenly used sterile water for injection; I have something in my body; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she received the Pfizer COVID19 vaccine 1 week ago in Jun2021 and the vaccine site has contacted her to inform her they injected the wrong solution, they used saline vs sodium chloride (considered as wrong diluent used and poor quality vaccine administered). Caller was asking what is going to happen and how will this affect her health and felt a certain way, feel very unsafe. Mistakenly used sterile water for injection instead of sterile sodium chloride as the diluent for the Pfizer-BioNTech COVID-19 vaccine. After being advised to further consult with HCP as they may have ability to access additional information and provide better guidance for individual patient care she states that Pfizer was very secretive because do not provide more information. She further stated that due to no information being provided to the consumer this causes more panic mode. Now she had something in the body and she was calling Pfizer for help. She was trying to find the truth and protect her health. The outcome of events is unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she knows someone else who had COVID after having the COVID vaccine; she knows someone else who had COVID after having the COVID vaccine; This is a spontaneous report from a contactable consumer or other non-HCP.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the reporter knew, that someone else who had covid after having the covid vaccine. The outcome of the events was unknown.  Information on batch/lot number has been requested.