chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Menstrual disorder, SARS-CoV-2 test, Scar
Clinical narrative: I have extremely painful period cramps and symptoms when I am supposed to have my period but no menstruation .; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; With both doses, I had a reaction on the right side of my face. Little bumps and "dents".; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:45(at the age of 48 years), (Batch/Lot Number: EN6207) as DOSE 1, SINGLE for covid-19 immunisation in hospital. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism, asthma from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid], vitamin d3 (VITAMIN D3),  (ELDERBERRY PLUS ), and biotin taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Sulfa and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient stated, with both doses, I had a reaction on the right side of my face. Little bumps and dents. It eventually went away. The main issue I was having was my period. I had my period before the 1st dose, March 9th. My second dose was on April 2nd, and I was due for my period on April 4. I get my period every 26 days. I was not on birth control. I had extremely painful period cramps and symptoms when I was supposed to have my period but no menstruation. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date in 2021 Nasal Swab. The clinical outcome of the event, with both doses, I had a reaction on the right side of my face, little bumps and dents was recovered on an unspecified date in 2021 and I have extremely painful period cramps and symptoms when I am supposed to have my period, but no menstruation was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101183910 same reporter/patient/product, different dose/event.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Burning sensation, Drug hypersensitivity, Swollen tongue
Clinical narrative: burning sensation; swollen tongue; allergy reaction; This is a solicited report based on information received by Pfizer from pharmaceutical company  (Manufacturer report number: CLO-2021-001324). A contactable 52-year-old female consumer reported that:   On 27Aug2021, this solicited report was received by biopharmaceutical(#) from a coustmer in the Country. A female patient, 52-years-old, had been treated with Rubraca (rucaparib) 500mg twice daily by mouth from an unspecified date in 2018 for malignant neoplasm of unspecified ovary. The patient's medical history was not reported. On an unspecified date, after the start of Rubraca, the patient was seen in the emergency room for an allergic reaction to the Pfizer COVID-19 Vaccine the patient experience the burning sensation and swollen tongue. Therapy with Rubraca was maintained. The outcome of the allergic reaction to Pfizer COVID-19 vaccine was unknown. Outcome attributed to adverse event: Other serious (Important medical events).  The patient assessed the causal relation between Rubraca and the allergic reaction as no related, providing the COVID-19 Vaccine to suggest an alternative casuality.  The adverse events in this Safety Report have been assessed against the he adverce event in the marketing authorisation  which is identical to the marketing authorisation . As a result, the listedness filled for the marketing authorisation  also captured the listed ness against the marketing authorisation .  Pharmaceutical Company comment: The serious event of allergy to vaccine is unlisted for Rubraca, as per the Safety Report, marketing authorisation, Regulatory Authority, and marketing authorisation . Considering the causality assessment provided by the patient, the causal relationship between Rubraca and Allergy to vaccine is assessed as not related. This single individual case report dose not change the benefit/ risk (BR) balance of this product. The company continues to monitor all adverse event and safety information individually and in aggregate on an ongoing basis.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event swollen tongue, burning sensation, drug hypersensitivity due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dysmenorrhoea, Heavy menstrual bleeding, Muscle spasms
Clinical narrative: Test: Nasal swab through CVS. Result: Positive; Test: Nasal swab through CVS. Result: Positive; The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass; My cycle ended on September 4th but today I started bleeding again; This period was very heavy and painful; cramping; This period was very heavy and painful; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received bnt162b2 (Comirnaty, Lot number: not reported, Expiration date: not reported, Age at vaccination: 42-year-old) via an unspecified route of administration in Left arm on 08Aug2021 03:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included PCOS. Concomitant medications were not reported. No other vaccine in four weeks. Other medications in two weeks was none. No covid was prior vaccination. Covid was tested post vaccination. Known allergies was none. On 29Aug2021, patient experienced Nasal swab through CVS: Positive (Drug ineffective and Covid-19), The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass, My cycle ended on September 4th but today I started bleeding again, This period was very heavy and painful (heavy period and period pains), cramping. Lab test included Nasal swab: positive on 29Aug2021. No treatment received for adverse events. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis, Vaginal haemorrhage
Clinical narrative: Test: Nasal swab through CVS. Result: Positive; Test: Nasal swab through CVS. Result: Positive; The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass; My cycle ended on September 4th but today I started bleeding again; This period was very heavy and painful; cramping; This period was very heavy and painful; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 42-year-old female patient received bnt162b2 (Comirnaty, Lot number: not reported, Expiration date: not reported, Age at vaccination: 42-year-old) via an unspecified route of administration in Left arm on 08Aug2021 03:00 PM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included PCOS. Concomitant medications were not reported. No other vaccine in four weeks. Other medications in two weeks was none. No covid was prior vaccination. Covid was tested post vaccination. Known allergies was none. On 29Aug2021, patient experienced Nasal swab through CVS: Positive (Drug ineffective and Covid-19), The first few days of my cycle had a lot of clotting. The clots were large and very painful to pass, My cycle ended on September 4th but today I started bleeding again, This period was very heavy and painful (heavy period and period pains), cramping. Lab test included Nasal swab: positive on 29Aug2021. No treatment received for adverse events. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, SARS-CoV-2 antibody test, Thrombosis
Clinical narrative: severe muscle pain in my arms, shoulders and my thighs; a golf ball size blood clot; I can not lift my arms over my head; my right hand has went numb due to it getting ahold of my ulnar nerve; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 30Apr2021 (Batch/Lot Number: ER8737) as dose 2, single for COVID-19 immunisation. Medical history included no spleen, asthma, arthritis, many broken bones, and allergies to penicillin, all from an unknown date and unknown if ongoing. Patient was not diagnosed with COVID prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm on 09Apr2021 (Batch/Lot Number: EP6955) as dose 1, single for COVID-19 immunization and experienced severe muscle pain in my shoulders, arms and back of thighs, hand is completely numb, and have no strength. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol xinafoate (ADVAIR); and naproxen sodium (ALEVE), all taken for unspecified indications, start and stop dates were not reported. The patient received the Pfizer vaccine (second dose) 30Apr2021. Patient stated "since then I have been put on disability, because I have severe muscle pain in my arms, shoulders and my thighs. I cannot lift my arms over my head, along with a golf ball size blood clot on an unspecified date. Now for the past month, my right hand has went numb due to it getting ahold of my ulnar nerve. I have seen 4 doctors no one knows what to do with it. My labs are good. I need help." Outcome of the events was unknown. SARS CoV-2 Antibody blood test on 29Jun2021 was positive.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hallucination, Hyperhidrosis, Muscle twitching, Pain in extremity, Tourette's disorder
Clinical narrative: tourette syndrome; hallucinations; tenderness in my left arm; sweating; neck twitching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient wrote to complain of the poor service the patient received when the patient became fully vaccinated on 11May2021. The side effects he underwent included tenderness in left arm, sweating, hallucinations and Tourette syndrome on an unspecified date. The patient's tics included neck twitching, a few swear words and one of them is the "K-word". People laugh at the patient's colorful language. The patient is a freshman in college where the patient is viewed as racist, homophobic, ableist and xenophobic due to the shot. The patient said that he/she paid for immunity to COVID-19 and not to get a disease. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid like symptoms; Covid like symptoms; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4067741-00). A contactable consumer (patient himself) reported that a 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; at the age of 64 years old), via intramuscular on 07Apr2021 (Batch/Lot number was not reported) as dose 2, singe; and via intramuscular on 10Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; and, adalimumab (HUMIRA; solution for injection in pre-filled pen, Batch/Lot number was not reported), via subcutaneous from an unspecified date to 28Aug2021, at an unknown dose and frequency, and via subcutaneous from 2021 (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date in 2021, it was reported that the patient experienced COVID like symptoms with humira (adalimumab) and covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient underwent laboratory test and procedures on unspecified date in 2021 which showed negative COVID test. The reporter's causality for the event(s) of COVID like symptoms was not provided. The action taken in response to the events for adalimumab was temporarily withdrawn. The outcome of the events was recovering.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Computerised tomogram, Dyspnoea, Pulmonary embolism
Clinical narrative: chest pain on left side; shortness of breath; left shoulder pain; showed a pulmonary embolism in my left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172), via an unspecified route of administration at the age of 30-year-old administered in arm left on 01Sep2021 13:00 at single dose for covid-19 immunisation. Medical history included crohn's disease. There was no covid prior vaccination and no known allergies. Concomitant medications included mesalazine (LIALDA); mercaptopurine in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) at the age of 30-year-old administered in arm left on 11Aug2021,01:00 PM for covid-19 immunisation. Woke up at 3am 08Sep2021 with chest pain on left side, shortness of breath and left shoulder pain. Went to (name) ER in (place name), a CT scan showed a pulmonary embolism in her left lung. She was admitted to hospital and put on blood thinners and pain meds. The events were resulted in Emergency room/department or urgent care and hospitalization. Days hospitalization was reported as one. The patient underwent lab tests included Nasal Swab: negative on 08Sep2021. The patient was treatment with Heparin, Morphine, Fetanol, Torodol. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chest pain on left side; shortness of breath; left shoulder pain; showed a pulmonary embolism in my left lung; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172), via an unspecified route of administration at the age of 30-year-old administered in arm left on 01Sep2021 13:00 at single dose for covid-19 immunisation. Medical history included crohn's disease. There was no covid prior vaccination and no known allergies. Concomitant medications included mesalazine (LIALDA); mercaptopurine in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) at the age of 30-year-old administered in arm left on 11Aug2021,01:00 PM for covid-19 immunisation. Woke up at 3am 08Sep2021 with chest pain on left side, shortness of breath and left shoulder pain. Went to (name) ER in (place name), a CT scan showed a pulmonary embolism in her left lung. She was admitted to hospital and put on blood thinners and pain meds. The events were resulted in Emergency room/department or urgent care and hospitalization. Days hospitalization was reported as one. The patient underwent lab tests included Nasal Swab: negative on 08Sep2021. The patient was treatment with Heparin, Morphine, Fetanol, Torodol. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Epistaxis
Clinical narrative: she thinks it could be ITP; platelets were a little lower on the second test; Dripping nose bleed; Fatigue/tired; Abdominal cramping; This is a spontaneous report from a contactable consumer (patient).  A 43-year-old female patient received first dose of BNT162B2 (lot number: EN6204) on 10Mar2021 11:45 (at age of 43-year-old) on right arm at single dose for COVID-19 immunization. Medical history and concomitant medications were none. Caller reports receiving her first vaccine dose in March. Caller is interested in receiving the second dose now and is asking if there would be an issue between the amount of time between first and second doses. Caller reports she experienced a "dripping" nosebleed, fatigue/tired, Abdominal cramping, the day after her first dose on 11Mar2021 and said she reported the safety event. She is scared to get the second dose and can't seem to get any clear information on if she should or not relative to these events. She can't be sure that the abdominal cramping is related to the Pfizer Covid-19 Vaccine because a lot of times she can have that anyway. Regarding the dripping nose bleed she felt like her nose was running so she checked with her hand and found her nose bleeding in a pretty good drip from one nostril; it came on sudden and stopped just as sudden but dripped for maybe a minute or so and filled up a tissue. She verified there has been no emergency room visit or hospitalization relative to these events. Caller verified that there are no relevant concomitant products or other medical conditions to provide for the report. She was not taking any medication at the time, she is on birth control now, but was not at that time. Part of her dilemma was that she got very scared about having the nosebleed. Her primary care physician at the time she called because she has a friend that's a doctor she thinks it could be ITP which is a bleeding disorder you can have from any vaccine. Patient asked her primary care physician for a blood test but he didn't listen; all of her interaction went to a nurse and it turns out they did wrong test for her which she was unaware of initially. They ordered just a regular CBC blood panel. She went to a new doctor for a different reason who looked up her blood panel and said the primary care physician didn't even do the correct panel for someone with a nosebleed, not the one the new doctor would have done. The test done was a basic CBC panel just got what caller guessed were her platelets, white blood cell count, typical tests with no notable results. Prior to having the Pfizer Covid-19 Vaccine she had baseline bloodwork done at her yearly physical so they had that to compare against the CBC done after onset of adverse events. The platelets were a little lower on the second test, the CBC, but still within a normal range. The outcome of event ITP and platelets were a little lower on the second test was unknown. The outcome of other events was recovered on 13Mar2021. The report was reported as non-serious.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy test
Clinical narrative: miscarriage; This is a spontaneous report from a contactable consumer. This 33-year old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot Ew0185) on 04Sep2021 07:30 AM at right arm for COVID-19 immunization. Age at vaccination: 33 years old. Medical history included Covid-19 and two healthy pregnancies with no issues. Concomitant drugs were not provided. The patient received the shot on 04Sep2021 and found out she was pregnant on 06Sep2021. She had five tests, all positive. On 10Sep2021 07:30 AM, she woke up bleeding and did not show a strong pregnancy line on the tests. The patient had miscarriage. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient needed to call doctor and see what to do next. Outcome of the event was unknown. Second Pfizer Covid-19 vaccine was scheduled for 25Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101190080 mother/baby case
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter did report a patient had an anaphylactic reaction to the Pfizer BioNTech Covid vaccine. The event was serious for being medical significant. The outcome of event was unknown.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Glomerulonephritis rapidly progressive
Clinical narrative: Necrotizing Crescentic Glomerulonephritis (ANCA); This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0167), via an unspecified route of administration on 16May2021 (46-year-old at time of vaccination) as single dose for COVID-19 immunization. Medical history included allergy to PCN. There were no concomitant medications (no other vaccine in four weeks; no other medications in two weeks). The patient experienced Necrotizing Crescentic Glomerulonephritis (ANCA) on 30Jul2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (5 days), and Disability or permanent damage. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the event and included Solumedrol 500 IV/ Rituximab IV. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received the second dose of bnt162b2 on 25Jan2021 (lot number: unknown) via unknown route of administration in Arm Right at single dose for COVID-19 immunization. Medical history and concomitant medications were reported none. Historical vaccine included the first dose of bnt162b2 on 04Jan2021 around 2Pm -3PM (lot number: unknown) for Covid-19 Immunization. Prior Vaccinations (within 4 weeks) there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE following prior vaccinations were reported as None. Family Medical History Relevant to AE was reported as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported None. Patient Had a problem and doctor told her to report this, did not know if it was related to the vaccine or not, wanted to know if there had been any other reports like this. Patient got pericarditis in mid Jun2021 that lasted until or around Aug2021. She did not know, maybe lasted until the second week in Aug2021. Clarified pericarditis started middle of Jul2021 on 16Jul2021. Patient did not have Pericarditis at the moment. Patient wanted to know whether it was ok to get the booster. Patient had No new medications, nothing changed in her life. Investigations included: Developed a positive Antinuclear Antibody, the autoimmune marker, around that time period after the pericarditis. First test was positive on 15Jun2021, repeat test was negative on 15Jun2021. The adverse event required a visit to Physician Office and Had tests done. The causality assessment between the event Pericarditis and the suspect drug was reported as unknown. The outcome of the event was recovered on 10Aug2021.  No follow-up attempts are possible; information about lot batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Pericarditis due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Impaired gastric emptying, Nausea, Vomiting
Clinical narrative: I believe the vaccine kick started her gastro paresis.; Nauseous; Periodic vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer (patient) reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0217) on 03Sep2021 08:30 AM single dose at right arm for COVID-19 immunization. Age at Vaccination: 55 years old. Medical history included Type 1 diabetic, stage 3 kidney disease, known allergies: Sulpha, talniflumate (ENSED), sulfamethoxazole, trimethoprim (BACTRIM). Concomitant drugs included unspecified medication. On the evening of 03Sep2021, 11:30 PM, she became nauseous. She has been nauseous, periodic vomiting, and diarrhea. After several days of treating this ourselves. Sometimes she has recovered on her own, she went to the emergency room on 09Sep2021. They started an IV of Saline, took blood, and gave her two shots of metoclopramide hydrochloride (REGLAN). Then they sent her home. They told her to come back in two or three days if she has not improved. She was still nauseous. The reporter believed the vaccine kick started her gastro paresis. The outcome of the events was not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer, Mammogram, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: a lump in her right breast/ they said the results came back as cancer; This is a spontaneous report from a contactable other-HCP. This 48-year-old female other-HCP (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose at left arm for COVID-19 immunisation on 14May2021. Relevant history included Internal Uterus Bleeding and COVID-19 since 11Mar2021 per PRL COVID 19 (Nasal Swab). Relevant concomitant drug included VITAMIN D NOS. The patient received the first dose of BNT162B2 for COVID-19 immunisation on 23Apr2021 (48-years old at the time of vaccination). The patient was not pregnant.  The patient had PRL COVID 19 (Nasal Swab) on 01Apr2021 with negative result. The patient felt a lump in her right breast since 26May2021 at 10:00 PM. She went to her primary doctor. They told her to do a mammogram. The patient did one in Jul2021. Then she saw a breast specialist. And then she did an ultra-sonogram. They told her the lump was looking big so they told her to do a biopsy. After she took the biopsy they said the results came back as cancer. At the reporting time the patient was in treatment. The patient would receive chemotherapy. The outcome of event was not resolved. The vent was reported as serious due to Medically significant.        The lot number for the vaccine, [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 event of breast cancer 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: passed out; convulse; dizziness; This is a spontaneous case from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via unspecified route in arm left on 07Sep2021 at 14:30 PM at patient age of 16-year-old, as single dose for COVID-19 immunisation. Medical history included COVID prior vaccination. No other medical history. 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 vaccine. On 08Sep2021 at 12:30 PM, it started with dizziness, then the patient passed out and when he fell to the ground he began to convulse. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received ibuprofen as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Electrocardiogram, Nausea, Palpitations, Tremor
Clinical narrative: May 13th 2021, left arm shaking with heart palpitations and nausea vomiting for 3-4 days September 13th 2021: Left arm shaking fluttering of heart with heart palpitations, also with nausea/vomiting for 9 days
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Vomiting
Clinical narrative: May 13th 2021, left arm shaking with heart palpitations and nausea vomiting for 3-4 days September 13th 2021: Left arm shaking fluttering of heart with heart palpitations, also with nausea/vomiting for 9 days
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Depression, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Headache that progressed in intensity for several days following the vaccination event.  Seizure/altered state of consciousness. Child's functioning was significantly affected for several days due to intense headaches.  He had to miss school and his testing for a week. After seizure event, the headaches ceased but he was left groggy, fatigued and depressed.  He stayed home to rest for several days.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Somnolence
Clinical narrative: Headache that progressed in intensity for several days following the vaccination event.  Seizure/altered state of consciousness. Child's functioning was significantly affected for several days due to intense headaches.  He had to miss school and his testing for a week. After seizure event, the headaches ceased but he was left groggy, fatigued and depressed.  He stayed home to rest for several days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Got Sick from Covid in September 2021; Got Sick from Covid in September 2021; Got Sick from Covid in September 2021; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 66-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration in left arm on 19Jan2021 00:00 as dose 1, single (at the age of 66-years-old) for COVID-19 immunization. The patient medical history reported as none. The concomitant medications included simvastatin (SIMVASTATIN) and candesartan (CANDESARTAN) taken within 2 weeks of vaccination for an unspecified indication, start and stop date were not reported. The patient got sick from covid in 06Sep2021. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with COVID-19 prior to vaccination. The patient tested for covid-19 after vaccination. The patient visited physician office visit for the events covid-19 and sickness. The patient was not taken any treatments for the events. The events were not leads to any death, Life threatening, prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 07Sep2021. The outcome of the events sick from covid was recovering.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise; Patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 10Apr2021 08:00 (at the age of 52-years) (Batch/Lot number was not reported) as dose 2, single and dose 1 intramuscular, administered in Arm Right on 20Mar2021 08:00 (at the age of 52-years) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included High cholesterol, high blood pressure, pre-diabetes, allergies to fruit with skins, some nuts and some vegetables. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient tested positive for covid-19 with symptoms on 09Sep2021 16:00, Fever, chills, body/muscle aches, malaise. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Sep2021 (Nasal Swab), sars-cov-2 test: negative on 10Sep2021 (Nasal Swab), sars-cov-2 test: positive on 10Sep2021 (Nasal Swab). Events results in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The events were assessed as non-serious by the reporter. Outcome of the event patient tested positively for COVID-19 with symptoms Fever, chills, body/muscle aches, malaise was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Neuropathy peripheral, Paraesthesia
Clinical narrative: developed neuropathy; pins and needles/ buzzing sensations in feet/lower legs to lower thighs; headaches; 4 days feeling dizzy; had substantial swelling of arm injection site.; overall bad; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female non pregnant patient received BNT162B2, dose 1 administered in Right arm on 02Aug2021 12:00 PM (lot number: EW0198) (at age of 64-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included might have rheumatoid arthritis, lupus, and or lyme disease and associated vector bacterial infections. Otherwise, healthy. Known allergies: One antibiotic once made sick, amoxicillin possibly. No COVID prior vaccination. On 12Aug2021 7:00 PM after receiving first dose, she had substantial swelling of arm injection site. 4 days feeling dizzy, headaches, overall bad, but no fever. Midway between 1st and second Pfizer vaccine, she developed neuropathy, pins and needles, buzzing sensations in her feet, lower legs to lower thighs. It is 24/7 but worse at night when laying. She had never had Neuropathy of any kind, prior to vaccine. To present date it persists. No COVID tested post vaccination. No treatments for the events. Outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: developed neuropathy; pins and needles/ buzzing sensations in feet/lower legs to lower thighs; headaches; 4 days feeling dizzy; had substantial swelling of arm injection site.; overall bad; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female non pregnant patient received BNT162B2, dose 1 administered in Right arm on 02Aug2021 12:00 PM (lot number: EW0198) (at age of 64-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included might have rheumatoid arthritis, lupus, and or lyme disease and associated vector bacterial infections. Otherwise, healthy. Known allergies: One antibiotic once made sick, amoxicillin possibly. No COVID prior vaccination. On 12Aug2021 7:00 PM after receiving first dose, she had substantial swelling of arm injection site. 4 days feeling dizzy, headaches, overall bad, but no fever. Midway between 1st and second Pfizer vaccine, she developed neuropathy, pins and needles, buzzing sensations in her feet, lower legs to lower thighs. It is 24/7 but worse at night when laying. She had never had Neuropathy of any kind, prior to vaccine. To present date it persists. No COVID tested post vaccination. No treatments for the events. Outcome of the events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Trouble getting and maintaining an erection; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0178) at single dose via an unknown route on 08Sep2021 14:00 at 29-year-old in right arm for Covid-19 immunization. Medical history was reported as "none". Patient had no known allergies. Concomitant drug was not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported event was trouble getting and maintaining an erection on 09Sep2021 12:00 AM. No treatment received.  Outcome of the event was not resolved. Since the vaccination, the patient had not been tested for COVID-19. The report was assessed as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on12Sep2021; Tested positive for COVID on 12Sep2021; Tested positive for COVID on12Sep2021; This is a spontaneous report from a contactable other health care professional (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EL3247, Expiration Date: not reported) via intramuscular route of administration, administered in right arm on 21Jan2021 at 14:30 as dose 1, single (at the age of 59 years) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number:EL3247, Expiration Date: not reported) via intramuscular route of administration on 21Jan2021 as dose 2, single (at the age of 59 years) at Workplace clinic for covid-19 immunisation. The patient medical history included hypertension. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient received other medication in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies. On 21Jan2021, the patient was administered two doses of bnt162b2 (Inappropriate schedule of vaccine administered). On 12Sep2021, the patient was tested positive for covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. The patient did not receive any treatment for the reported adverse event. Outcome of the event covid-19 was recovering.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Muscle tightness, Pain in extremity
Clinical narrative: Left arm pain and muscle tightness. Unable to close left hand.; Left arm pain and muscle tightness. Unable to close left hand.; Left arm pain and muscle tightness. Unable to close left hand.; This is a spontaneous report received from a contactable consumer (patient)  A 36-year-old male patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number: EW0186) on 20Aug2021 at 16:00 , via an unspecified route of administration, in Arm Left as single dose for COVID-19 immunisation.   Medical history included dust allergy and mycotic allergy.     On 21Aug2021 at 04:00 p.m. the patient experienced left arm pain and muscle tightness,  unable to close left hand with outcome of not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever after 24 hours; This is a spontaneous report from non- contactable consumer reported for herself that: A 34-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (at the age of 34-year-old) (Lot number was unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Past drug event and Known allergies included: Bactrim and morphine and was diagnosed with COVID-19 before vaccination. The patient was nonpregnant. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and colecalciferol vitamin d (COLECALCIFEROL). The patient experienced fever after 24 hours on 11Sep2021 with outcome of not recovered. Therapeutic medication was not administrated. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: Miscarriage; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 38 years old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 (Lot number: unknown, not available/provided to reporter at the time of report completion) administered in left arm as dose 1, single for COVID-19 immunization. No known allergies. No other vaccine in four weeks and no other medications in two weeks. The patient experienced miscarriage on 19Aug2021. The patient was hospitalized for miscarriage for 1 day. No COVID prior vaccination and was tested post vaccination. The patient underwent lab tests and procedures which included nasal swab/covid test: negative on 14May2021, Nasal Swab/covid test: negative on 24Aug2021. Therapeutic measures were taken as a result of miscarriage, treatment reported as "D and C". The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.