chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment/Rebound COVID 2 days after testing negative; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Dec2022, outcome "not recovered", described as "COVID 19 Treatment/Rebound COVID 2 days after testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative, notes: Rebound COVID 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Illness, Interchange of vaccine products, Muscle spasms, Pain
Clinical narrative: Became sick with fever; Became sick with fever; body cramps and aches; body cramps and aches; Menstrual cycle started with immense pain; Moderna (two doeses) Pfizer (booster); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 at 13:30 as dose 3 (bivalent; booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: moderna (brand= Moderna ,, administration time= 04:45 PM,, dose number= 2,, vaccine location= Left arm.), administration date: 06Jun2021, when the patient was 24-year-old, for COVID-19 immunization; moderna (brand= Moderna,, administration date= 30Jun2021,, administration time= 04:45 PM,, dose number= 1,, vaccine location= Right arm.), administration date: 30Jun2021, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Dec2022 at 13:30, outcome "unknown", described as "Moderna (two doeses) Pfizer (booster)"; ILLNESS (non-serious), PYREXIA (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "Became sick with fever"; DYSMENORRHOEA (non-serious) with onset 03Dec2022 at 12:00, outcome "recovering", described as "Menstrual cycle started with immense pain"; MUSCLE SPASMS (non-serious), PAIN (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "body cramps and aches". Therapeutic measures were not taken as a result of illness, pyrexia, muscle spasms, pain, dysmenorrhea.  Additional information: No other vaccine in four weeks. No known allergies. The patient did not had covid prior vaccination. The patient was not tested for covid post vaccination. The patient received other vaccine in two weeks: Birth control. On 03Dec2022 at 12:00 AM, the patient became sick with fever, body cramps and aches. Menstrual cycle started with immense pain which is unusual. especially because I take birth control. The patient did not receive any treatment for the events.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Became sick with fever; Became sick with fever; body cramps and aches; body cramps and aches; Menstrual cycle started with immense pain; Moderna (two doeses) Pfizer (booster); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 at 13:30 as dose 3 (bivalent; booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: moderna (brand= Moderna ,, administration time= 04:45 PM,, dose number= 2,, vaccine location= Left arm.), administration date: 06Jun2021, when the patient was 24-year-old, for COVID-19 immunization; moderna (brand= Moderna,, administration date= 30Jun2021,, administration time= 04:45 PM,, dose number= 1,, vaccine location= Right arm.), administration date: 30Jun2021, when the patient was 24-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Dec2022 at 13:30, outcome "unknown", described as "Moderna (two doeses) Pfizer (booster)"; ILLNESS (non-serious), PYREXIA (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "Became sick with fever"; DYSMENORRHOEA (non-serious) with onset 03Dec2022 at 12:00, outcome "recovering", described as "Menstrual cycle started with immense pain"; MUSCLE SPASMS (non-serious), PAIN (non-serious) all with onset 03Dec2022 at 12:00, outcome "recovering" and all described as "body cramps and aches". Therapeutic measures were not taken as a result of illness, pyrexia, muscle spasms, pain, dysmenorrhea.  Additional information: No other vaccine in four weeks. No known allergies. The patient did not had covid prior vaccination. The patient was not tested for covid post vaccination. The patient received other vaccine in two weeks: Birth control. On 03Dec2022 at 12:00 AM, the patient became sick with fever, body cramps and aches. Menstrual cycle started with immense pain which is unusual. especially because I take birth control. The patient did not receive any treatment for the events.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body height, Decreased appetite, Mobility decreased, Nausea
Clinical narrative: she got at 8 am on a Sunday. At 5pm that same day, she couldn't move.; She had to lay down. She was so nauseous.; She wasn't eating. She never vomited.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 08:00 as dose 2, single (Lot number: EN6198) at the age of 68 years for COVID-19 immunization. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing), notes: She had issues with hot flashes; "menopause" (unspecified if ongoing); "Hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: FUROSEMIDE; LEVOTHYROXINE taken for hypothyroidism; LOSARTAN taken for hypertension. Past drug history included: Prempro for hot flashes, reaction(s): "Off label dosing", notes: she takes it every other day not every day. Vaccination history included: BNT162b2 (First dose, Lot-EN5318), administration date: 31Jan2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 21Feb2021 at 17:00, outcome "unknown", described as "She had to lay down. She was so nauseous."; MOBILITY DECREASED (non-serious) with onset 21Feb2021 at 17:00, outcome "unknown", described as "she got at 8 am on a Sunday. At 5pm that same day, she couldn't move."; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "She wasn't eating. She never vomited.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She does get a reaction to Pfizer's COVID shots though. She was fine after her first covid shot. Her second one three weeks later she got at 8 am on a Sunday. At 5pm that same day, she couldn't move. She had to lay down. She was so nauseous. She was in bed for 3 days. She wasn't eating. She never vomited. She just was unable to get out of bed for 2 days. And then she was fine.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: two Pfizer and two Moderna COVID-19 vaccine; she has been diagnosed with Covid-19; she has been diagnosed with Covid-19; 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.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient reported vaccine lot numbers (039TC20A and the second vaccination number as 006M20A) but she was not sure if it belongs to Pfizer COVID-19 Vaccine or the Moderna COVID-19 Vaccine. The patient's relevant medical history included: "Colds" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis. Past drug history included: Vicks nyquil for colds. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "two Pfizer and two Moderna COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has been diagnosed with Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection site soreness; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 17:30 as dose 4 (booster), single (Lot number: GJ3274) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "congenital heart disease" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: aspirin"; Ibuprofen, reaction(s): "Known allergies: ibuprofen". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 07Dec2022 at 09:00, outcome "recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2022 at 09:00, outcome "recovered", described as "Injection site soreness". Therapeutic measures were taken as a result of vaccination site pain, pain which included Tylenol.  Additional information: The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not had covid prior vaccination and not tested covid post vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive; (unspecified date) Positive; (06Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. If vaccine received: Yes. Other medication in 2weeks: No. Anti-viral details: On 27Nov2022 patient received Paxlovid for COVID 19 treatment till 01Dec2022. Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Sex: F
Vaccine: PNC20
Symptoms: Device leakage, Incorrect dose administered by product, Vaccination site extravasation
Clinical narrative: some leaked out but most went into her arm; some leaked out but most went into her arm; some leaked out but most went into her arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED BY PRODUCT (non-serious), DEVICE LEAKAGE (non-serious), VACCINATION SITE EXTRAVASATION (non-serious), outcome "unknown" and all described as "some leaked out but most went into her arm".  The reporter considered "some leaked out but most went into her arm" associated to pneumococcal 20-val conj vac (dipht CRM197 protein).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received Paxlovid as treatment from 03Dec2022 to 07Dec2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: she was prescribed with some antibiotics due to a sinus infection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: SINUSITIS (medically significant) with onset Dec2022, outcome "unknown", described as "she was prescribed with some antibiotics due to a sinus infection.". Therapeutic measures were taken as a result of sinusitis.  Clinical course: Reporter mentioned that his wife received the Pfizer-BioNTech Covid 19 Vaccine (gray cap bivalent) 2 days ago (on the 7th). And then she was prescribed with some antibiotics due to a sinus infection. He wanted to know if there would be a contraindication between the vaccine and the antibiotics she was prescribed. It was not clear if the infection was due to the Pfizer-BioNTech Covid 19 Vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: I had a severe menstrual cramps and had to go the emergency room on Tuesday from the booster I received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Dec2022 at 15:00 as dose number unknown (booster), single (Lot number: GJ6796), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number Unknown (Booster), Manufacturer Unknown), for COVID-19 Immunization.The following information was reported: DYSMENORRHOEA (non-serious) with onset 04Dec2022 at 09 :00, outcome "recovering", described as "I had a severe menstrual cramps and had to go the emergency room on Tuesday from the booster I received.". The events "i had a severe menstrual cramps and had to go the emergency room on tuesday from the booster i received." required emergency room visit. Therapeutic measures were taken as a result of dysmenorrhoea.  Additional information: Patient had not been received any other vaccine within four weeks and other medication within two weeks. Medication to help with the excruciating pain. Patient not had Covid prior vaccination and not been tested post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: her periods have not returned to a typical cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), administration date: 2021, for COVID-19 immunization, reaction(s): "periods are coming every 6+ weeks". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Jan2022, outcome "not recovered", described as "her periods have not returned to a typical cycle". The event "her periods have not returned to a typical cycle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient periods were coming every 6 plus weeks and really severe after the first booster in 2021. She had multiple boosters now and her periods have not returned to a typical cycle. The patient was COVID tested post vaccination. This report is not serious  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Dec2022 to 07Dec2022.  Clinical course: Reported as, symptoms improved but began again one day after ending treatment with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing), notes: HIV. 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 "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On an unknown date in Dec2022, the patient had COVID-19. The patient received as anti-viral for COVID-19 treatment from 02Dec2022 to 07Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Thrombosis
Clinical narrative: My niece took 2 Pfizer vaccines; she has 2 clots; She is sick all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "My niece took 2 Pfizer vaccines; she has 2 clots"; ILLNESS (non-serious), outcome "unknown", described as "She is sick all the time". Clinical course: "My niece took 2 Pfizer vaccines. She is only 18. She was forced to take it for her college and now she has 2 clots, and she is sick all the time. I am seeing what is happening, what Pfizer did to my 18-year-old niece who messed up her life and Pfizer is laughing at it. It is killing us, it is disgusting."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: my mom, who also took 2 Pfizer COVID shots; my mom has A-fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "my mom, who also took 2 Pfizer COVID shots; my mom has A-fib".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: my brother also took Pfizer. He has A-fib now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "my brother also took Pfizer. He has A-fib now".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid treatment from 30Nov2022 to 05Dec2022; Paxlovid treatment from 30Nov2022 to 05Dec2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LISINOPRIL; AMLODIPINE; LEVOTHYROXINE; TRAMADOL; GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Paxlovid treatment from 30Nov2022 to 05Dec2022". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  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 in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long covid symptom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability), outcome "unknown", described as "long covid symptom". The reporter stated that "the reasons for not being vaccinated are that I have 2 friends with long COVID symptoms after they were vaccinated. Neither had covid before but now they are battling with long COVID symptoms to the point of being disabled".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Long COVID symptoms after they were vaccinated /neither had COVID before; Long COVID symptoms after they were vaccinated /neither had COVID before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Long COVID symptoms after they were vaccinated /neither had COVID before".  Clinical course: The reporter have 2 friends with long COVID symptoms after they were vaccinated. Neither had COVID before but now they are battling with long COVID symptoms to the point of being disabled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: long COVID symptoms after they were vaccinated /neither had COVID before; long covid symptoms after they were vaccinated /neither had covid before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (Unknown).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown", described as "long COVID symptoms after they were vaccinated /neither had COVID before"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "long Covid symptoms after they were vaccinated /neither had covid before".  Additional Information: it was reported that it was not so much my interest as the feelings I got E the reasons for not being vaccinated are that reporter had 2 friends with long COVID symptoms after they were vaccinated. Neither had COVID before but now they are battling with long COVID symptoms to the point of being disabled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid infection; Covid infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 16 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jul2021 as dose 1, single (Lot number: 1C005A), on 24Jul2021 as dose 2, single (Lot number: FE1510) and on 05Feb2022 as dose 3 (booster), single (Lot number: FN0087) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2022, outcome "not recovered" and all described as "Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events "vaccination failure", "COVID-19".
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Rash, Swelling
Clinical narrative: Swelling in the left side of neck area; rash in upper chest and neck area; pain in arm and neck; pain in arm and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2022 at 14:30 as dose 1, single (Lot number: FR2583) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SWELLING (non-serious) with onset 09Dec2022 at 06:15, outcome "not recovered", described as "Swelling in the left side of neck area"; PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious) all with onset 09Dec2022 at 06:15, outcome "not recovered" and all described as "pain in arm and neck"; RASH (non-serious) with onset 09Dec2022 at 06:15, outcome "not recovered", described as "rash in upper chest and neck area". Therapeutic measures were not taken as a result of swelling, rash, pain in extremity, neck pain.  Additional information: Vaccine location was upper left arm. No other vaccine received in four weeks. Received multi-vitamins in two weeks. No covid prior to vaccination. Not tested for covid post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 25Nov2022 to 29Nov2022 for COVID 19.   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 available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Heart murmur" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: After taking the medication Patient experienced an extremely bitter taste in my mouth that does not go away after eating or brushing your teeth. The taste caused me to feel nauseous and Patient had difficulty sleeping. Patient also noticed that Patient was having pain in my gums and teeth after one 2 doses of the medicine. Patient decided after the fourth dose to discontinue the use as the adverse effects outweighed the Covid effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna; Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 013L20A), in left arm, on 16Feb2021 as dose 2, single (Lot number: 016M20A), on 03Nov2021 as dose 3 (booster), single (Lot number: 039P21A), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: 002MJ 2), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM SUPPLEMENT WITH VITAMIN D, start date: 01Jan2010; ROSUVASTATIN, start date: 24Apr2021, stop date: 29Nov2022. Past drug history included: Duricef, reaction(s): "Known allergies: Duricef".  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown", described as "Moderna; Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Nov2022 to  03Dec2022.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac" (unspecified if ongoing), notes: Celiac; "Known allergies: Penecillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). 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 "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had not received other medications in 2 weeks. Anti-viral details: Product=COVID-19 Treatment. Treatment start date=30Nov2022. Treatment stop date=05Dec2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna; Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Jan2022, outcome "unknown", described as "Moderna; Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative after 5 days of COVID and taking paxlovid; Positive, notes: Symptoms returns 6 days later and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Yes patient received vaccine. No other medication was taken in 2weeks. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 17:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Negative, notes: Tested negative on 05Dec and 06Dec; (06Dec2022) Negative, notes: Tested negative on 05Dec and 06Dec; (10Dec2022) Positive, notes: Tested positive 10Dec; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 29Nov2022 to 04Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: She has experienced issues with restriction of motion in her left arm; 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.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She has experienced issues with restriction of motion in her left arm".  Additional information: The patient reported that with her previous Pfizer BioNTech COVID-19 vaccinations and boosters she had issue with restriction of motion of her left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369373 same patient, drug, event, different dose;US-PFIZER INC-202201369370 same patient, drug, event, different dose;US-PFIZER INC-202201369372 same patient, drug, event, different dose;US-PFIZER INC-202201369371 same patient, drug, event, different dose;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "PCNs" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: coconut oil" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID AC; FLONASE [MOMETASONE FUROATE]. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Biaxin, reaction(s): "Known allergies: Bactrim"; Cephalexin, reaction(s): "Known allergies: Cephalexin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 30Nov2022 to 05Dec2022 for of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.