chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Palpitations, Tremor
Clinical narrative: my heart is racing; Cannot function with every day things that normal people do; Will take 10 steps before losing control of her legs and can't walk anymore; I am so exhausted from this vaccine; I am getting nervous; I feel like shit; this is not normal I do not feel good; feel horrible; Joint pain; my hand shake; shaking everything; This is a spontaneous report from a Pfizer sponsored program received from a Consumer (the patient).    A 42-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Sep2021 (Batch/Lot Number: F-3184) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced my heart is racing  (medically significant) on 2021 with outcome of unknown , cannot function with every day things that normal people do (medically significant) on 2021 with outcome of unknown , will take 10 steps before losing control of her legs and can't walk anymore  (medically significant) on 2021 with outcome of unknown , I am so exhausted from this vaccine  (non-serious) on 2021 with outcome of unknown , I am getting nervous  (non-serious) on 2021 with outcome of unknown , I feel like shit; this is not normal i do not feel good; feel horrible  (non-serious) on 2021 with outcome of unknown , joint pain (non-serious) on 2021 with outcome of unknown , my hand shake; shaking everything  (non-serious) on 2021 with outcome of unknown.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blister, Fatigue, Feeling abnormal, Oropharyngeal pain
Clinical narrative: sore throat, right side, blisters on right tonsil; sore throat, right side, blisters on right tonsil; sneezing and runny nose; sneezing and runny nose; felt bad overall/feels like the flu or strep; tiredness; body aches; slept most of the day; stomach pains; sore arm; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03Sep2021 at 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to events. No additional vaccines administered on same date of the Pfizer suspect. No relevant tests. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered on 13Aug2021 for covid-19 immunisation. Caller stated she had second Pfizer injection this past Friday (03Sep2021), stated she had a sore arm on 03Sep2021 and typical things, stated she works at local hospital, stated she was also administering the vaccine, states she was a registered nurse, stated on Saturday the day after the vaccine (04Sep2021) she was tired, with body aches, slept most of the day, states she then had a lot of stomach pain and felt bad overall, states she was still having stomach pains, yesterday (07Sep2021) it started getting worse, felt a sore throat, looked and saw blisters on right tonsil, states there was no fever. She also had been sneezing with a running nose on 04Sep2021, almost feels like the flu or strep. No investigation assessment. All events were not required a visit to Emergency Room or Physician Office. The outcome of event sore arm was recovering, of events tiredness, body aches, stomach pains, sore throat, right side, blisters on right tonsil, sneezing and runny nose was not recovered, of other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events is possible based on temporal association and known profile of the product.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea, Sneezing, Somnolence
Clinical narrative: sore throat, right side, blisters on right tonsil; sore throat, right side, blisters on right tonsil; sneezing and runny nose; sneezing and runny nose; felt bad overall/feels like the flu or strep; tiredness; body aches; slept most of the day; stomach pains; sore arm; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 03Sep2021 at 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to events. No additional vaccines administered on same date of the Pfizer suspect. No relevant tests. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered on 13Aug2021 for covid-19 immunisation. Caller stated she had second Pfizer injection this past Friday (03Sep2021), stated she had a sore arm on 03Sep2021 and typical things, stated she works at local hospital, stated she was also administering the vaccine, states she was a registered nurse, stated on Saturday the day after the vaccine (04Sep2021) she was tired, with body aches, slept most of the day, states she then had a lot of stomach pain and felt bad overall, states she was still having stomach pains, yesterday (07Sep2021) it started getting worse, felt a sore throat, looked and saw blisters on right tonsil, states there was no fever. She also had been sneezing with a running nose on 04Sep2021, almost feels like the flu or strep. No investigation assessment. All events were not required a visit to Emergency Room or Physician Office. The outcome of event sore arm was recovering, of events tiredness, body aches, stomach pains, sore throat, right side, blisters on right tonsil, sneezing and runny nose was not recovered, of other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events is possible based on temporal association and known profile of the product.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke like symptoms; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 03Sep2021 (batch/lot number was not reported) at the age of 42-year-old as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stroke like symptoms in Sep2021. The patient was hospitalized for 24 hours due to event. Outcome of event was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a Spontaneous report from a contactable consumer based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4056641-00). A 20-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via intramuscular route on 01Apr2021 (at the age of 19-year-old) as dose 1, single and second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via intramuscular route on 13Apr2021 (at the age of 19-year-old) as dose 2, single for covid-19 immunisation. Patient also take adalimumab (HUMIRA 40MG/0.4ML(ADALIMUMAB)) (HUMIRA; Solution for injection in pre-filled pen), via subcutaneous route from 2019 to 2021, 40 mg,1 in 7 days for crohn's disease. Medical history included crohn's disease from an unknown date and unknown if ongoing. There were no concomitant medications were not reported. Patient reported at a 19-year-old she experienced COVID on unspecified date in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Therapeutic measures were taken as a result of events which included Albuterol. At the time of this report, the outcome of event was not recovered. The reporter's causality for the event of COVID was not provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Rash macular
Clinical narrative: Redness; Broken out in a rash; A few small hives; Blotches on my left forearm; Experiencing itchy skin around my neck/ itchiness; Pain; Swelling; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), dose 2 via an unspecified route of administration in left arm on 03Sep2021 at 13:30 (Age at vaccination: 30-years-old) as dose 2, single for COVID-19 immunization. The patient had no known allergies. Medical history and concomitant medications were reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration in left arm on 13Aug2021 at 05:45PM (Age at vaccination: 30-years-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Sep2021 at 09:00 AM, the patient was experiencing itchy skin around her neck, had itchiness, pain, and swelling. On 08Sep2021, she woke to a few small hives and blotches on my left forearm. By 2pm, she had broken out in a rash and by 5pm, her entire upper body was covered in hives and redness. The adverse events result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Benadryl and Pepcid. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Redness; Broken out in a rash; A few small hives; Blotches on my left forearm; Experiencing itchy skin around my neck/ itchiness; Pain; Swelling; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), dose 2 via an unspecified route of administration in left arm on 03Sep2021 at 13:30 (Age at vaccination: 30-years-old) as dose 2, single for COVID-19 immunization. The patient had no known allergies. Medical history and concomitant medications were reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration in left arm on 13Aug2021 at 05:45PM (Age at vaccination: 30-years-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Sep2021 at 09:00 AM, the patient was experiencing itchy skin around her neck, had itchiness, pain, and swelling. On 08Sep2021, she woke to a few small hives and blotches on my left forearm. By 2pm, she had broken out in a rash and by 5pm, her entire upper body was covered in hives and redness. The adverse events result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Benadryl and Pepcid. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, Loss of consciousness
Clinical narrative: he is in the hospital with Covid pneumonia; he is in the hospital with Covid pneumonia; time did faint, passed out cold the day after his 2nd vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 64- year-old male patient 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 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received first dose of 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 1, SINGLE for covid-19 immunisation. The patient experienced covid pneumonia leading to hospitalization on an unspecified date, he is in the hospital with covid pneumonia causing drug ineffective on an unspecified date. The caller states that her step father who is the patient did faint, passed out cold the day after his 2nd dose of vaccine, he messed up his face and arm and busted his whole self up and now he is in the hospital with Covid pneumonia causing loss of consciousness on an unspecified date. Outcome of events covid-19 pneumonia and loss of consciousness was recovered on an unspecified date. Outcome of pneumonia causing drug ineffective was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood iron, Blood magnesium, Fatigue
Clinical narrative: Felt very tired; Did not have the right amount of energy; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 (Batch/Lot Number: EW0153) (at the age of 66-years-old) as SINGLE for covid-19 immunization at hospital. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 17Mar2021 (Batch/Lot number: EP6955) as SINGLE for covid-19 immunization from which the patient felt a little tired that evening, and then felt fine and only slept about 12 hours. Another historical vaccine included swine flu vaccine from which the patient had a  slight temperature and every muscle in his body ached. Patient does not have NDC, lot or expiry as it was years and years ago. Within 4 weeks prior to the COVID vaccine, the patient received regular flu shot, had one Sep2020 and got one yesterday. Patient medical history included, IBSD from Sep2016 and his gastrointestinal doctor put him on the special diet, scar tissue (some hamburger broke off in his throat in 2009 and caused scar tissue and he can't stand heat and his food has to be soft and cold, he can't eat warm foods) from 2009 to an unknown date, acid reflux and took that medication and had problem with his throat from an unknown date and unknown if ongoing. Patient denied for any concomitant medications. On an unspecified date in May2021, the patient felt very tired for about 3 months and he did not have the right amount of energy and stated that he got up at 7am and is retired and by 2pm was laid out and resulted in patient to visit Physician Office. On 15Jul2021, the patient underwent lab tests and procedures which included Sugar, Iron, , Thyroid, B12, red blood cell and white blood cell which was found to be normal and On an unspecified date iron and B12 was found to be low and on 28Jul2021, his magnesium was found to be normal. On an unspecified date in Aug2021, the outcome of events was recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count, Thyroid function test, Vitamin B12, White blood cell count
Clinical narrative: Felt very tired; Did not have the right amount of energy; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 (Batch/Lot Number: EW0153) (at the age of 66-years-old) as SINGLE for covid-19 immunization at hospital. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 17Mar2021 (Batch/Lot number: EP6955) as SINGLE for covid-19 immunization from which the patient felt a little tired that evening, and then felt fine and only slept about 12 hours. Another historical vaccine included swine flu vaccine from which the patient had a  slight temperature and every muscle in his body ached. Patient does not have NDC, lot or expiry as it was years and years ago. Within 4 weeks prior to the COVID vaccine, the patient received regular flu shot, had one Sep2020 and got one yesterday. Patient medical history included, IBSD from Sep2016 and his gastrointestinal doctor put him on the special diet, scar tissue (some hamburger broke off in his throat in 2009 and caused scar tissue and he can't stand heat and his food has to be soft and cold, he can't eat warm foods) from 2009 to an unknown date, acid reflux and took that medication and had problem with his throat from an unknown date and unknown if ongoing. Patient denied for any concomitant medications. On an unspecified date in May2021, the patient felt very tired for about 3 months and he did not have the right amount of energy and stated that he got up at 7am and is retired and by 2pm was laid out and resulted in patient to visit Physician Office. On 15Jul2021, the patient underwent lab tests and procedures which included Sugar, Iron, , Thyroid, B12, red blood cell and white blood cell which was found to be normal and On an unspecified date iron and B12 was found to be low and on 28Jul2021, his magnesium was found to be normal. On an unspecified date in Aug2021, the outcome of events was recovered.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal tenderness, Breast tenderness, Fibroadenoma of breast, Haemorrhagic breast cyst, Menstrual disorder
Clinical narrative: breast fibroids hemorrhagic cysts; breast fibroids hemorrhagic cysts; menstrual cycle changes; tenderness in abd and breast; tenderness in abd and breast; This is a spontaneous report from a contactable nurse (patient). A 27-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 17Feb2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. The patient medical history was not reported, and concomitant medications was none. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 22Jan2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. No other vaccine in four weeks. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. COVID prior vaccination and tested COVID post vaccination. On 17Feb2021, the patient experienced breast fibroids hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast. The adverse event resulted in doctor or other healthcare professional office clinic visit/emergency room department or urgent care, hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included binax resulted as negative on 02Aug2021 nasal swab. Treatment received was surgery and was recovered with lasting effects. The clinical outcome of the events was resolved with sequel as of unspecified date of 2021.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on strong temporal relationship the role of the vaccine BNT162B2 in triggering/contributing to the events breast fibroadenosis, hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast cannot be completely excluded. The case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: breast fibroids hemorrhagic cysts; breast fibroids hemorrhagic cysts; menstrual cycle changes; tenderness in abd and breast; tenderness in abd and breast; This is a spontaneous report from a contactable nurse (patient). A 27-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 17Feb2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. The patient medical history was not reported, and concomitant medications was none. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 22Jan2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. No other vaccine in four weeks. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. COVID prior vaccination and tested COVID post vaccination. On 17Feb2021, the patient experienced breast fibroids hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast. The adverse event resulted in doctor or other healthcare professional office clinic visit/emergency room department or urgent care, hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included binax resulted as negative on 02Aug2021 nasal swab. Treatment received was surgery and was recovered with lasting effects. The clinical outcome of the events was resolved with sequel as of unspecified date of 2021.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on strong temporal relationship the role of the vaccine BNT162B2 in triggering/contributing to the events breast fibroadenosis, hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast cannot be completely excluded. The case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; I was in Menopause and had not had a period or any bleeding for 15 months.  Exactly 3 weeks after my first dose, I got a period.; This is a spontaneous report from a contactable consumer (patient herself).   A 44-years-old non pregnant female patient 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, administered in Arm Left on 10Aug2021 at 14:45 (Age at vaccination 44-years-old) as single dose for COVID-19 immunisation (Pharmacy or Drug Store). The patient's medical history included multiple sclerosis, previous endometriosis from an unknown date and unknown if ongoing. The patient's concomitant medications included teriflunomide (AUBAGIO) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient was in menopause and had not had a period or any bleeding for 15 months. Exactly 3 weeks after my first dose, the patient got a period. The patient was not on any birth control on an unspecified date Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Aug2021 Nasal Swab. The patient did not receive treatment for the adverse event. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The patient had been COVID tested positive post vaccination. The outcome of event i was in menopause and had not had a period or any bleeding for 15 months was recovered on an unspecified date and rest other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Rash, Rash erythematous
Clinical narrative: broke out in a rash under the chest, stomach and back; blistering areas that bled; red rash under the skin that spread; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA7485), administered in the left arm on 02Sep2021 at 15:30 (at the age of 53-years-old) at dose number unknown, single for COVID-19 immunisation. Medical history included patient was allergic to multiple meds and foods, latex; polycystic ovarian syndrome (PCOS); endometriosis; arthritis and lupus; prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rabeprazole sodium (ACIPHEX) and metoprolol, both reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the 3rd day, on 05Sep2021, patient broke out in a rash under the chest, stomach and back; blistering areas that bled and a red rash under the skin that spread. Ended up in urgent care with prednisone and a steroid cream (which patient ended up having another reaction too). On day 7, the patient still had the rash after 3 days of meds. The events were reported as non-serious. The adverse event resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. A treatment was received for the adverse event and included steroid. The patient had not recovered from the events.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Magnetic resonance imaging, Speech disorder, Thrombosis
Clinical narrative: Speaking gibberish; Diagnosed with AFIB (new condition); TIA; Blood clot in brain shown by CT/MRI.; This is a spontaneous report from a contactable consumer (patient).  A 94-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at 15:00 as single dose for Covid-19 immunisation at the age of 94-year-old. Lot number was EL965. Medical history included bladder cancer, Pulmonary hypertension, Hypothyroidism. Concomitant medications included levothyroxine, timolol maleate (TIMOPTIC), cholecalciferol. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2020 at 15:00 for covid-19 immunisation at the age of 93-year-old. On 12Feb2021 at 05:00, the patient was speaking gibberish, the patient went to ER. The patient was diagnosed with atrial fibrillation (AFIB) (new condition) and transient ischemic attack (TIA). Spent night. On 12Feb2021, Computerised tomogram and Magnetic resonance imaging showed blood clot in brain. The patient visited Emergency room/ department or urgent care, and he was hospitalized for one day. The patient was treated for the events (XARELTO). The patient recovered with sequel from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Speaking gibberish; Diagnosed with AFIB (new condition); TIA; Blood clot in brain shown by CT/MRI.; This is a spontaneous report from a contactable consumer (patient).  A 94-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at 15:00 as single dose for Covid-19 immunisation at the age of 94-year-old. Lot number was EL965. Medical history included bladder cancer, Pulmonary hypertension, Hypothyroidism. Concomitant medications included levothyroxine, timolol maleate (TIMOPTIC), cholecalciferol. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2020 at 15:00 for covid-19 immunisation at the age of 93-year-old. On 12Feb2021 at 05:00, the patient was speaking gibberish, the patient went to ER. The patient was diagnosed with atrial fibrillation (AFIB) (new condition) and transient ischemic attack (TIA). Spent night. On 12Feb2021, Computerised tomogram and Magnetic resonance imaging showed blood clot in brain. The patient visited Emergency room/ department or urgent care, and he was hospitalized for one day. The patient was treated for the events (XARELTO). The patient recovered with sequel from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: results came back positive for COVID-19; results came back positive for COVID-19; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age 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 16Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was mentioned that caller, calling on behalf of her husband states that he received his 1st dose of the vaccine on 16Aug2021. He was scheduled to get his second dose of the vaccine 06Sep2021 but due to the holiday will be going tomorrow she states. In between his 1st dose and now, before receiving the 2nd dose of the vaccine, her husband had to be tested for COVID by his employer and the results came back positive for COVID-19 on an unspecified date in 2021. Caller would like to know if her husband can get his vaccination as scheduled tomorrow due to his recent diagnosis of COVID. Per the husband's place of employment, he was on quarantine until 02Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. Outcome of events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tinnitus
Clinical narrative: fluttering in ears like there is a bug going inside; numbness of the roof of her mouth; This is a spontaneous case received from a contactable consumer (patient himself). A 51-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FD8448), via an unspecified route of administration in left arm on 20Aug2021 13:00 (age at vaccination 51-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient's family medical history relevant to adverse event was reported as none. The patient historical vaccination included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: CU3399), via an unspecified route of administration in left arm on 27Jul2021 13:00 (age at vaccination 51-year-old) for COVID-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks were reported as none. Adverse events following prior vaccinations was reported as none. On 20Aug2021, the patient experienced fluttering in her ears, like there is a bug going in her ears and numbness in the roof of her mouth. He experienced both symptoms mentioned within 45 minutes of the second dose. He was having the symptoms right now. Adverse event does not require a visit to Emergency room/Physician office. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: tested positive for covid yesterday; tested positive for covid yesterday; I am so sick; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.   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 19Dec2020 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Sep2021 yesterday, the patient got that booster out and tested positive for covid and on an unspecified date in 2021 reported that patient was so sick and stated that we were no longer protected. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FC3182), on 17Aug2021 (at the age of 45-years-old) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a concern about getting the 2nd dose of BNT162b2 vaccine. She got the 1st dose on 17Aug2021 and then she tested positive for COVID on 18Aug2021 and did not know if she already had COVID by the time she got the 1st dose, so she got the results of the positive test for COVID on 18Aug2021; stated she missed the 2nd dose of the vaccine, that was scheduled for 07Sep2021, because of this and testing positive. Patient did not have smell, but she could taste; the doctor said it could take months to get rid of that. She would like to know when she could get the vaccine. Patient was getting conflicting information from her primary care doctor and another doctor and asked the pharmacist when she came in to get the 2nd dose and they said to call the company to get recommendations. Patient stated she just needed to know this information and was frustrated from being transferred around and declined to complete report. The outcome of the event was unknown.   Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Feeling hot, Headache, Peripheral swelling
Clinical narrative: Turned completely red.; Hot.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms; Started vomiting; Severe headache.; Rushed to ER for suspected anaphylactic reaction.; This is a spontaneous report from a contactable Nurse (patient).  A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 15:15 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Right arm on 18Aug2021 15:00 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Sep2021 (15:30), the patient turned completely red, hot, started swelling in the face, neck and arms, started vomiting and had severe headache; she rushed to ER for suspected anaphylactic reaction. The events resulted in emergency room/department or urgent care; medication and fluids were given as treatments of the events. Facility type vaccine: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Vomiting
Clinical narrative: Turned completely red.; Hot.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms.; Started swelling in the face, neck and arms; Started vomiting; Severe headache.; Rushed to ER for suspected anaphylactic reaction.; This is a spontaneous report from a contactable Nurse (patient).  A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 15:15 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Right arm on 18Aug2021 15:00 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Sep2021 (15:30), the patient turned completely red, hot, started swelling in the face, neck and arms, started vomiting and had severe headache; she rushed to ER for suspected anaphylactic reaction. The events resulted in emergency room/department or urgent care; medication and fluids were given as treatments of the events. Facility type vaccine: Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Computerised tomogram, Deafness, Fatigue, Upper respiratory tract infection
Clinical narrative: hearing loss; upper respiratory lungs; fatigue; asthma since Apr shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 02Apr2021, as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 on 27Feb2020 and 14Apr2020 (no testing yet, so unverified). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date in Apr2021, the patient experienced hearing loss, upper respiratory lungs, fatigue and asthma since April shot. The patient underwent lab tests and procedures which included computerised tomogram: cat got upper respiratory on Apr2021, computerised tomogram: cat shows shriveled air sacs on an unspecified date in 2021. All symptoms including that of lungs resolved over summer, at home. All were normal except asthma since April shot (hearing loss from original infection). In August, the patient steroids for both, lungs and energy was better. Therapeutic measures were taken as a result of the events. The outcome of the events hearing loss; asthma since April shot was not resolved. The outcome of events upper respiratory lungs; and fatigue was resolved on unspecified dates in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Two weeks later he tested positive for covid infection.; Two weeks later he tested positive for covid infection.; This is a spontaneous report from a contactable pharmacist (parent) via Pfizer-sponsored program.  A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the first dose of suspect vaccine; two weeks later, he tested positive for covid infection. The patient received REGENCOV antibodies. On unknown date, the patient resulted positive to sars-cov2 test. The outcome of the events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Toothache
Clinical narrative: I had severe Gum pain , especially around my molars.; I had severe Gum pain , especially around my molars.; This is a spontaneous report from a contactable consumer (patient himself).  This 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unspecified route of administration, on unknown date (at the age of 43-year-old) at single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8737), via an unspecified route of administration administered in the left arm, on 31Mar2021 10:00 (at the age of 43-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included chronic obstructive pulmonary disease (COPD) and asthma. Past drug history included allergy to celecoxib (CELEBREX). The patient reported she had severe gum pain, especially around her molars. The pain mostly went away by my 2nd shot, but lingered for a few months. Therapeutic measures taken as result of the event included 600 mg of ibuprofen a few times a day. Pre and Post vaccination COVID-19 tests were not performed. The patient had recovered with sequelae from the event.  The lot number for the vaccine (first dose), BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Extrasystoles, Heart rate, Heart rate decreased, Nausea
Clinical narrative: I felt as though I was going to faint several times a day; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; and the fluttering made me nauseous; My resting heart rate dropped; This is a spontaneous report from a contactable consumer (patient).   This 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo0153), via intramuscular administered in the left arm, on 04May2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo151) administered in the right arm, on 13Apr2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No known allergies. Relevant concomitant medications included metoprolol, cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), VITAMIN D3 and valsartan. The patient verbally reported 'on 16Jul2021, my heart fluttered, pounded, raced and skipped beats. My resting heart rate dropped and I felt as though I was going to faint several times a day, and the fluttering made me nauseous''. The events required physician office-visit. The patient was not treated for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.