chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, SARS-CoV-2 test
Clinical narrative: shortness of breath; difficulty breathing; low heart rate; chest pain; Light headed; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Nov2021 00:30 (Lot number: 301S88A) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DVT left leg", start date: 2006 (unspecified if ongoing), notes: Other medical history: DVT left leg 2006. No other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Known allergies", notes: Known allergies: Naproxen. Vaccination history included: first dose of Bnt162b2 (lot number= EN6204) on 17Mar2021 at 10:30 AM administered in right arm, when the patient was 65 years old, for COVID-19 immunization; and second dose of Bnt162b2 (lot number= ER8737) on 07May2021 at 11:30 AM administered in right arm, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 03Nov2021 00:30, outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; DYSPNOEA (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "shortness of breath"; DYSPNOEA (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "difficulty breathing"; HEART RATE DECREASED (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "low heart rate"; CHEST PAIN (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "chest pain"; DIZZINESS (hospitalization) with onset 03Nov2021 14:30, outcome "not recovered", described as "Light headed". The patient was hospitalized for immunisation, dyspnoea, dyspnoea, heart rate decreased, chest pain, dizziness (hospitalization duration: 2 day(s)). The events "dose 3 (booster), single", "shortness of breath", "difficulty breathing", "low heart rate", "chest pain" and "light headed" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (03Nov2021) low; Nasal Swab: (11Nov2021) negative, notes: covid test post vaccination. Therapeutic measures were taken as a result of immunisation, dyspnoea, dyspnoea, heart rate decreased, chest pain, dizziness included Lidocaine patch, lovanox injection, heart monitor.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Malaise, Myocarditis
Clinical narrative: has not been feeling that great; terrible pain under right breast; Caller states she read that there could be inflammation of the lining of the heart, wondering if this could be that.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) at the age of 76 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Nov2021, outcome "unknown", described as "Caller states she read that there could be inflammation of the lining of the heart, wondering if this could be that."; BREAST PAIN (non-serious) with onset 15Nov2021, outcome "not recovered", described as "terrible pain under right breast"; MALAISE (non-serious), outcome "unknown", described as "has not been feeling that great". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Burning sensation, Condition aggravated, Eczema, Erythema
Clinical narrative: It is an exacerbation and worsening of an existing auto-immune disorder.; my hands, inner elbows and upper arms flared with eczema; it has gotten worse over five days, now involving my left shin and my face; It is red, burning, itching; It is red, burning, itching; It is red, burning, itching; Other vaccine same date veccine date 10Nov2021; Other vaccine same date veccine date 10Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 14:30 (Lot number: FH8028) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "eczema", start date: Oct2021 (unspecified if ongoing), notes: I recently had my first eczema episode, three weeks PRIOR to the vaccine). Concomitant medication(s) included: FLU, administration date 10Nov2021. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset 11Nov2021, outcome "not recovered", described as "It is an exacerbation and worsening of an existing auto-immune disorder."; ECZEMA (non-serious) with onset 11Nov2021, outcome "not recovered", described as "my hands, inner elbows and upper arms flared with eczema"; CONDITION AGGRAVATED (non-serious) with onset 11Nov2021, outcome "not recovered", described as "it has gotten worse over five days, now involving my left shin and my face"; ERYTHEMA (non-serious), BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 11Nov2021, outcome "not recovered" and all described as "It is red, burning, itching"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Nov2021 14:30, outcome "unknown" and all described as "Other vaccine same date veccine date 10Nov2021". Therapeutic measures were not taken as a result of autoimmune disorder, eczema, condition aggravated, erythema, burning sensation, pruritus. Additional information: Other medical history of Glaucoma, not related to this event. No known allergies. Facility type vaccine was pharmacy or drug store. Adverse event start time was 12:00 AM. Follow-up (17Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pruritus
Clinical narrative: It is an exacerbation and worsening of an existing auto-immune disorder.; my hands, inner elbows and upper arms flared with eczema; it has gotten worse over five days, now involving my left shin and my face; It is red, burning, itching; It is red, burning, itching; It is red, burning, itching; Other vaccine same date veccine date 10Nov2021; Other vaccine same date veccine date 10Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 14:30 (Lot number: FH8028) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing); "eczema", start date: Oct2021 (unspecified if ongoing), notes: I recently had my first eczema episode, three weeks PRIOR to the vaccine). Concomitant medication(s) included: FLU, administration date 10Nov2021. The following information was reported: AUTOIMMUNE DISORDER (medically significant) with onset 11Nov2021, outcome "not recovered", described as "It is an exacerbation and worsening of an existing auto-immune disorder."; ECZEMA (non-serious) with onset 11Nov2021, outcome "not recovered", described as "my hands, inner elbows and upper arms flared with eczema"; CONDITION AGGRAVATED (non-serious) with onset 11Nov2021, outcome "not recovered", described as "it has gotten worse over five days, now involving my left shin and my face"; ERYTHEMA (non-serious), BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 11Nov2021, outcome "not recovered" and all described as "It is red, burning, itching"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Nov2021 14:30, outcome "unknown" and all described as "Other vaccine same date veccine date 10Nov2021". Therapeutic measures were not taken as a result of autoimmune disorder, eczema, condition aggravated, erythema, burning sensation, pruritus. Additional information: Other medical history of Glaucoma, not related to this event. No known allergies. Facility type vaccine was pharmacy or drug store. Adverse event start time was 12:00 AM. Follow-up (17Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they confirmed him to be COVID positive; they confirmed him to be COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient's wife.   A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 27Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Chronic lymphocytic leukemia" (unspecified if ongoing). He was not taking any medication for his chronic lymphocytic leukemia (no immunosuppressants). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they confirmed him to be COVID positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: Before he got his 2nd dose, he got in contact with someone with COVID, and the doctor told him to proceed with the 2nd dose on 14May2021. After his 2nd dose, he never became well and continued to be ill and they confirmed him to be COVID positive. He received monoclonal antibodies on 20May2021.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Rash vesicular, SARS-CoV-2 test
Clinical narrative: Herpetic rash on fingers; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0170) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient had no Covid prior vaccination. The patient had Covid tested post vaccination. Concomitant medication(s) included: ZOLOFT; TRILEPTAL; WELLBUTRIN. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: RASH VESICULAR (hospitalization) with onset 28May2021, outcome "not recovered", described as "Herpetic rash on fingers". The patient was hospitalized for rash vesicular (hospitalization duration: 1 day(s)). The event "herpetic rash on fingers" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (04Aug2021) negative, notes: Nasal Swab; sars-cov-2 test: (13Aug2021) negative, notes: Nasal Swab. Therapeutic measures (Intravenous antibiotic) were taken as a result of rash vesicular.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Nausea, Pelvic discomfort, Pelvic pain, Presyncope
Clinical narrative: feeling going to vomit or faint; Immense pain during menstrual cycle; feeling going to vomit; heaviness in pelvic area; unusual pain and heaviness in pelvic area; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Sep2021 (Lot number: FC3184) at the age of 32 years (not pregnant) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications included vitamins, OTC pain reliever. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: FC3180, vaccine location: Left Arm), administration date: 06Aug2021, when the patient was 32 years old, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: PRESYNCOPE (medically significant) with onset 23Oct2021, outcome "unknown", described as "feeling going to vomit or faint"; DYSMENORRHOEA (non-serious) with onset 23Oct2021, outcome "unknown", described as "Immense pain during menstrual cycle"; NAUSEA (non-serious) with onset 23Oct2021, outcome "unknown", described as "feeling going to vomit"; PELVIC DISCOMFORT (non-serious) with onset 23Oct2021, outcome "unknown", described as "heaviness in pelvic area"; PELVIC PAIN (non-serious) with onset 23Oct2021, outcome "unknown", described as "unusual pain and heaviness in pelvic area". The events "feeling going to vomit or faint", "immense pain during menstrual cycle", "feeling going to vomit", "heaviness in pelvic area" and "unusual pain and heaviness in pelvic area" were evaluated at the physician office visit. Therapeutic measures were taken as a result of presyncope, dysmenorrhoea, nausea, pelvic discomfort, pelvic pain, which included Prescribed birth control, pain regimen. Covid was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Eye haemorrhage, Retinal vascular thrombosis
Clinical narrative: couldn't see out her central eye/lose total vision; some bleeding and or blood clot over her left eye, retina; blood clot over her left eye, retina; This is a spontaneous report received from a non-contactable reporter consumer from medical information team. The reporter is the patient. A female patient of an unspecified age received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA" (unspecified if ongoing), notes: on Plavix from TIA "years ago". Concomitant medication(s) included: PLAVIX taken for transient ischaemic attack. Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: unknown), for COVID-19 Immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "couldn't see out her central eye/lose total vision"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "some bleeding and or blood clot over her left eye, retina"; RETINAL VASCULAR THROMBOSIS (medically significant), outcome "unknown", described as "blood clot over her left eye, retina". The events "couldn't see out her central eye/lose total vision", "some bleeding and or blood clot over her left eye, retina" and "blood clot over her left eye, retina" were evaluated at the physician office visit. Reporter stated that 6-7 hours after the 2nd dose of the Pfizer BTC vaccine (12 and older formula, purple cap) she noticed some bleeding and or blood clot over her left eye, retina, she couldn't see out her central eye. She went to her regular eye Dr. and he dilated her eyes and then referred her to the specialist. After her eyes were dilated the blood made her lose total vision in her eye until the specialist operated on her eye and her peripheral vision came back. He stuck a needle in the white part of her eye. She had been on Plavix from TIA "years ago" and her primary Dr said it was up to the eye Dr. to stop the PLAVIX and the eye specialist said it was her primary HCP's responsibility because he knew her medical history much more in depth than the eye Dr. of the DRs told her to get the booster dose and this was not a reaction. It was too soon to be a side effect. She was a Medicare patient and they just want her to get the booster for the better of the country and not for the better of her health. Therapeutic measures were taken as a result of blindness, eye haemorrhage, retinal vascular thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant; double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant; This is a spontaneous report received from a contactable reporter (Consumer) reporting for friend from medical information team.  A female patient received COVID-19 VACCINE (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "double pneumonia in the both lungs, fully vaccinated and still got a  Delta variant". It was reported not sure which vaccine was given. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Delta variant.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101590157 same reporter/drug/event, different patient;US-PFIZER INC-202101590157 same reporter/drug/event, different patient
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Back pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier: 21K-163-4152682-00 (AbbVie). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single and via intramuscular, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "COVID-19"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Back pain". Clinical source as follows: In 2021, the patient experienced BACK PAIN and COVID.  PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of BACK PAIN with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of COVID-19 was not provided. Causality for bnt162b2: The reporter's causality for the events of BACK PAIN and COVID-19 with bnt162b2 both were possible. The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events drug ineffective, covid-19 and back pain (non-serious) and BNT162B2.  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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Pruritus, Skin plaque
Clinical narrative: itching left imprint of plaque; itching left imprint of plaque; ulcerative colitis flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4152990-00.  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single and intramuscular, administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2021, outcome "recovered" (2021), described as "ulcerative colitis flare up"; SKIN PLAQUE (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "itching left imprint of plaque". The action taken for adalimumab was unknown.  The reporter considered "ulcerative colitis flare up" and "itching left imprint of plaque" not related to bnt162b2.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for adalimumab: The reporter's causality for the events of itching left imprint of plaque unknown onset was not provided. The reporter's causality for the event of ulcerative colitis flare up with humira was no reasonable possibility.  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 information provided and plausible temporal association, the causality between BNT162B2 and Ulcerative colitis, Skin plaque, Pruritus cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue
Clinical narrative: black diarrhea; joint pain; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received bnt162b2 (COMIRNATY), administered in arm right (Lot number: FF8841) at the age of 62 years as dose 3, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications were one 50mg Valcyclovir; one multi-vitamin/ day. Vaccination history included: Comirnaty (product=COVID 19, lot number=EX. EN6205, number=1, vaccine location=left arm), COVID 19, lot number=EX. EL9266, number=2, vaccine location=left arm) for Covid-19 immunisation. The following information was reported: diarrhoea on the 3rd and 4th day following Pfizer 3rd booster; with outcome of recovered with sequel. The event joint pain, tiredness with onset 13Nov2021, outcome "not recovered"". Therapeutic measures were not taken as a result of. Diarrhoea and joint pain, tiredness.  Additional information: The patient had not received any other vaccine within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not hospitalized, case was assessed as non-serious,No treatment was taken.  No Follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric infection, Thrombosis
Clinical narrative: blood clot; infection in stomach; This is a solicited report from a contactable consumer (patient) via marketing program based on information received by Pfizer from Agency (Manufacturer Control Number#: 21K-163-4150638-00).   Solicited report by a consumer of a 43-years-old male with events of non-serious blood clot, shipping caused humira medication to come warm and infection in stomach with humira (adalimumab). There was no reported medical history. On unknown dates (2021), the patient experienced blood clot, shipping caused Humira medication to come warm and infection in stomach. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 15Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Causality for Humira(adalimumab) The reporter's causality for the event(s) of blood clot with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of shipping caused Humira medication to come warm and infection in stomach was not provided. The action taken in response to the events for adalimumab was unknown. The outcome of the event blood clot was not recovered, of  other event was unknown. Causality as per reporter for clot blood, incorrect product storage and gastric infection with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Thrombosis and Gastric infection cannot be completely excluded. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Stillbirth
Clinical narrative: three babies died one of them being stillborn and all 3 mother were vaccinated.; This is a spontaneous report from a contactable Other HCP. A female patient (pregnant) received BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced stillborn on unknown date. The mother was vaccinated. The outcome of event was unknown.     The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose was drawn up and administered after recommended 12-hour punctured Beyond Use Date (BUD) but before recommended 24-hour room temperature unpunctured BUD.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypersomnia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: 2 days I suffer severe body aches, bone and spinal ache hence most of time slept. Somewhat fever condition. Hence just tested and sleep most of time. Observed reddish swelling at injection site with somewhat still painful.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: 2 days I suffer severe body aches, bone and spinal ache hence most of time slept. Somewhat fever condition. Hence just tested and sleep most of time. Observed reddish swelling at injection site with somewhat still painful.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Anti-thyroid antibody, Antinuclear antibody positive, Biopsy skin abnormal
Clinical narrative: Massive hair shedding of scalp resulting in baldness. Symptoms started on 10/13/2021 and resulted in near baldness in 2 weeks.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin negative, Injury, Pregnancy test positive
Clinical narrative: LMP 9/15/2021 positive pregnancy test patient states heavy vaginal bleeding on 11/20/2021
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: LMP 9/15/2021 positive pregnancy test patient states heavy vaginal bleeding on 11/20/2021
Age: 61.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Fatigue, Herpes zoster, Pain, Rash
Clinical narrative: Starting 11/10/2021 - fatigue and general body aches. Starting 11/13/2021 - beginning signs of rash Starting 11/15/2021 - widespread rash, obvious signs of Shingles
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose was drawn up and administered after recommended 12-hour punctured Beyond Use Date (BUD) but before recommended 24-hour room temperature unpunctured BUD.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Chest discomfort, Chest pain, Electrocardiogram abnormal, Feeling abnormal
Clinical narrative: Approximately 20 minutes after receiving the vaccine (which was dose #2) I felt radiate down my arm. I went back to the pharmacy and advised the pharmacist. She advised me that other women have had the same effect, for unknown reasons. She advised me to go home and rest and go to the ER if I experience further problems over the next few days.  A few weeks later, I began feeling strong heart palpitations in the evening when at rest. I am still experiencing them now.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Approximately 20 minutes after receiving the vaccine (which was dose #2) I felt radiate down my arm. I went back to the pharmacy and advised the pharmacist. She advised me that other women have had the same effect, for unknown reasons. She advised me to go home and rest and go to the ER if I experience further problems over the next few days.  A few weeks later, I began feeling strong heart palpitations in the evening when at rest. I am still experiencing them now.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extreme itching all over body except for face and bottoms of feet that started gradually and progressed over two weeks. Took Claritin everyday and Benadryl every night x 1 week. Symptoms seem to have resolved.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose was drawn up and administered after recommended 12-hour punctured Beyond Use Date but before recommended 24-hour room temperature unpunctured Beyond Use Date.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Dizziness, Fatigue, Heavy menstrual bleeding, Immediate post-injection reaction
Clinical narrative: Instantly nauseas and exhausted, missed menstrual period. Once menstrual period arrived late, the bleeding has not stopped for 30+ days. Golf-ball sized clots are coming out of my uterus, I feel like I'm constantly going to pass out, and I'm soaking through more than 3 tampons per hour. I am struggling to take care of my kids and keep my job.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Menstruation delayed, Nausea, Thrombosis
Clinical narrative: Instantly nauseas and exhausted, missed menstrual period. Once menstrual period arrived late, the bleeding has not stopped for 30+ days. Golf-ball sized clots are coming out of my uterus, I feel like I'm constantly going to pass out, and I'm soaking through more than 3 tampons per hour. I am struggling to take care of my kids and keep my job.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Appendicitis perforated, C-reactive protein increased, Complicated appendicitis
Clinical narrative: Appendicitis symptoms started on 5/14/2021. Appendix ruptured and gone gangrene by the time symptoms were recognized. Patient had surgery on 5/19/2021.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, C-reactive protein increased, Computerised tomogram abdomen abnormal
Clinical narrative: On 11/14/2021 started complaining of lower right quadrant pain that got worse as the day went on and was not managed with ibuprofen or Tylenol. Eventually he could not stand up from a seated position without assistance or yelling in pain.  On 11/26/2021, he was admitted for a post-appendectomy abscess and is still being treated.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Pain, Postoperative abscess, Screaming, White blood cell count increased
Clinical narrative: On 11/14/2021 started complaining of lower right quadrant pain that got worse as the day went on and was not managed with ibuprofen or Tylenol. Eventually he could not stand up from a seated position without assistance or yelling in pain.  On 11/26/2021, he was admitted for a post-appendectomy abscess and is still being treated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Erythema, Immunisation, Pyrexia
Clinical narrative: Dose Number: 3; Verbally unresponsive; Temp of 101.9F; red face; Weakness; This is a spontaneous report received from contactable reporter (Pharmacist). A 78-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 (Lot number: FD0810) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: MS. Concomitant medications included: ACETAMINOPHEN; AMLODIPINE; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; ACETYLSALICYLIC ACID; BENAZEPRIL; DALFAMPRIDINE; DICLOFENAC SODIUM; FLUTICASONE; MELATONIN; OXYBUTYNIN; SENNA [SENNA ALEXANDRINA]; GLYCOLAX; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VITAMIN D [COLECALCIFEROL]; ATARAX [HYDROXYZINE HYDROCHLORIDE]; MILK OF MAGNESIA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Jan2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 28Oct2021, outcome "unknown", described as "Dose Number: 3"; UNRESPONSIVE TO STIMULI (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Verbally unresponsive"; PYREXIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Temp of 101.9F"; ERYTHEMA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "red face"; ASTHENIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Weakness". The patient was hospitalized for immunisation, unresponsive to stimuli, pyrexia, erythema, asthenia (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: body temperature: (28Oct2021) 101.9 Fahrenheit. It was unknown if therapeutic measures were taken as a result of unresponsive to stimuli, pyrexia, erythema, asthenia.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event unresponsive to stimuli, pyrexia, erythema and asthenia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Dose Number: 3; Verbally unresponsive; Temp of 101.9F; red face; Weakness; This is a spontaneous report received from contactable reporter (Pharmacist). A 78-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 (Lot number: FD0810) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: MS. Concomitant medications included: ACETAMINOPHEN; AMLODIPINE; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; ACETYLSALICYLIC ACID; BENAZEPRIL; DALFAMPRIDINE; DICLOFENAC SODIUM; FLUTICASONE; MELATONIN; OXYBUTYNIN; SENNA [SENNA ALEXANDRINA]; GLYCOLAX; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; VITAMIN D [COLECALCIFEROL]; ATARAX [HYDROXYZINE HYDROCHLORIDE]; MILK OF MAGNESIA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Feb2021, when the patient was 78 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Jan2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 28Oct2021, outcome "unknown", described as "Dose Number: 3"; UNRESPONSIVE TO STIMULI (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Verbally unresponsive"; PYREXIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Temp of 101.9F"; ERYTHEMA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "red face"; ASTHENIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Weakness". The patient was hospitalized for immunisation, unresponsive to stimuli, pyrexia, erythema, asthenia (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: body temperature: (28Oct2021) 101.9 Fahrenheit. It was unknown if therapeutic measures were taken as a result of unresponsive to stimuli, pyrexia, erythema, asthenia.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of event unresponsive to stimuli, pyrexia, erythema and asthenia cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Chills, Cough, Fatigue
Clinical narrative: He was admitted due to psychiatric issues. He reports feeling ill for 2-3 days prior to admission, with myalgias, fever, chills, mild cough, fatigue, generally improving.  He denies nausea, vomiting, diarrhea.SARS Coronavirus-2 infection: symptom onset around 11/23, with mild and improving symptoms. Chest X-ray was negative. Per history, vaccinated with recent booster dose.. Covid-19 positive. Denies N/V, fever, HA, dizziness, CP, SOB, DOB, abdominal pain, changes in bowel (diarrhea/constipation) or bladder habits.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Psychiatric symptom, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: He was admitted due to psychiatric issues. He reports feeling ill for 2-3 days prior to admission, with myalgias, fever, chills, mild cough, fatigue, generally improving.  He denies nausea, vomiting, diarrhea.SARS Coronavirus-2 infection: symptom onset around 11/23, with mild and improving symptoms. Chest X-ray was negative. Per history, vaccinated with recent booster dose.. Covid-19 positive. Denies N/V, fever, HA, dizziness, CP, SOB, DOB, abdominal pain, changes in bowel (diarrhea/constipation) or bladder habits.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Complement factor C4, Condition aggravated, Immune complex assay, Lip swelling, Swelling face
Clinical narrative: 11/24 12pm:   Booster dose of Pfizer mRNA after first two of Moderna (finished 5/5)] 11/26:   6:20pm - Photo evidence of hip welt?pretty sure it began there either 24th or 25th, but have no photos.   Left hip welt began to grow?.I thought it might go to face.  11/26 11:30pm:   Video - hip growing, spread and height, and appears to be non-pitting, blanching. 11/27 2:20am:   Facial swelling begins on the left side of lips - lower more prominent but upper had begun.  Took 20mg of Cetirizine quick dissolving tabs (2) 11/27 7:25am:   Facial swelling has spread to both sides of upper and lower lips and cheek/upper chin/Jowl on left side?maybe a little on right. 11/27 8:15am:   Blood draw for C1/C4 tests.  Needle goes in without issue?I?m sure there was latex gloves, but I don?t recall?rubbing alcohol, gauze and red wrap...nothing I'd think would cause a reaction. 11/27 1pm:   Slight itch at draw site has me notice the ?hive? around the draw site?PHOTOS 11/27 2:15pm:   Another 20mgs of quick dissolving Cetirizine  11/27 4:40pm:   Lips draining a little, cheeks still strong, especially the left one.  Draw site has really spread and raised.  Left hip welt is still present but might be going away a bit.  PHOTOS 11/28 2:15am:   Swelling is still present, but does seems to be getting better in lips?10mg of Cetirizine 11/28 10:30am:   Swelling is still present but is draining?left cheek is really still solid.   Took 10mg of Cetirizine.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 11/24 12pm:   Booster dose of Pfizer mRNA after first two of Moderna (finished 5/5)] 11/26:   6:20pm - Photo evidence of hip welt?pretty sure it began there either 24th or 25th, but have no photos.   Left hip welt began to grow?.I thought it might go to face.  11/26 11:30pm:   Video - hip growing, spread and height, and appears to be non-pitting, blanching. 11/27 2:20am:   Facial swelling begins on the left side of lips - lower more prominent but upper had begun.  Took 20mg of Cetirizine quick dissolving tabs (2) 11/27 7:25am:   Facial swelling has spread to both sides of upper and lower lips and cheek/upper chin/Jowl on left side?maybe a little on right. 11/27 8:15am:   Blood draw for C1/C4 tests.  Needle goes in without issue?I?m sure there was latex gloves, but I don?t recall?rubbing alcohol, gauze and red wrap...nothing I'd think would cause a reaction. 11/27 1pm:   Slight itch at draw site has me notice the ?hive? around the draw site?PHOTOS 11/27 2:15pm:   Another 20mgs of quick dissolving Cetirizine  11/27 4:40pm:   Lips draining a little, cheeks still strong, especially the left one.  Draw site has really spread and raised.  Left hip welt is still present but might be going away a bit.  PHOTOS 11/28 2:15am:   Swelling is still present, but does seems to be getting better in lips?10mg of Cetirizine 11/28 10:30am:   Swelling is still present but is draining?left cheek is really still solid.   Took 10mg of Cetirizine.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Confusional state, Multimorbidity, SARS-CoV-2 test positive
Clinical narrative: 71 y.o. female with a history of HTN, HLD, DMII, CVA, mild intermittent asthma, hyperactive bladder, GERD who recently tested + for COVID 19 w/o any pulmonary sx's p/w confusion and found to have + UA w/o dysuria/hematuria.  COVID 19 PNA, no pulm sx's. 11/29/21 ID physician's note: "Monoclonal Ab infusion: REGN-COV x1 given pt's age/comorbidities and high risk of progression   Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: 71 y.o. female with a history of HTN, HLD, DMII, CVA, mild intermittent asthma, hyperactive bladder, GERD who recently tested + for COVID 19 w/o any pulmonary sx's p/w confusion and found to have + UA w/o dysuria/hematuria.  COVID 19 PNA, no pulm sx's. 11/29/21 ID physician's note: "Monoclonal Ab infusion: REGN-COV x1 given pt's age/comorbidities and high risk of progression   Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: Undereye dermal filler from 6 months ago became swollen and painful on right side of face only.  The filler started hurting in the morning then became red and swollen by mid day. Vaccine was received on my right side. The filler under my left eye is unaffected.   By evening it is still swollen but seems to be going down. No treatment has been sought out yet.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph node in armpit of arm that was injected. Pain lasted about 4 days.
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Computerised tomogram abnormal, Dyspnoea, Fracture, Lymph node pain, Musculoskeletal chest pain
Clinical narrative: I received a Pfizer booster shot followed by senior Fluad shot, both left arm sane time. Which pharmacist saud shouldn't be a problem. Five days later very bad pain in left armpit lymph nodes which then moved  to include left clavicle area. Lasted over a week. Used heat and took pain reliever. Made breathing uncomfortable  as lung pressed against rib and thus against lymph nodes. After that pain subsided i had right rib pain. A CT showed a healing fracture AND multiple lung nodules. I'll be seeing a pulmonologist soon. I believe its possible the lung issue is related to the lymph node reaction.