chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Feeling abnormal, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: I have 100.8 fever; Extreme pain; I feel awful; extreme swelling; redness and hot; redness and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old 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 included: "Asthma" (unspecified if ongoing), notes: Asthma. Concomitant medication(s) included: ADVAIR; THEOPHYLLINE; NEXIUM 24HR; SINGULAIR; XYZAL. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I have 100.8 fever"; PAIN (non-serious), outcome "unknown", described as "Extreme pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel awful"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "extreme swelling"; ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "redness and hot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Prevnar 20 Vaccine yesterday and yesterday morning and patient felt fine yesterday and now patient have 100.8 fever and the vaccine site was about 4 inches actually its probably about 5 inches in diameter and red and hot and swollen then patient feel awful and patient was just thinking my new vaccine have got many side effects and it feels like a COVID vaccine (Event captured as per Verbatim and COVID Vaccine captured as suspect conservatively). Stated, "Extreme pain, extreme swelling, redness and hot. I guess my question is, Is this an extreme reaction". Patient stated "You can't tell me about the fever I am experiencing extreme because I never had a fever because of the vaccine." Treatment: Consumer stated, "I have taken Advil and Ibuprofen and I think my arms (Sentence incomplete)."  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site warmth
Clinical narrative: I have 100.8 fever; Extreme pain; I feel awful; extreme swelling; redness and hot; redness and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old 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 included: "Asthma" (unspecified if ongoing), notes: Asthma. Concomitant medication(s) included: ADVAIR; THEOPHYLLINE; NEXIUM 24HR; SINGULAIR; XYZAL. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "I have 100.8 fever"; PAIN (non-serious), outcome "unknown", described as "Extreme pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I feel awful"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "extreme swelling"; ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "redness and hot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Prevnar 20 Vaccine yesterday and yesterday morning and patient felt fine yesterday and now patient have 100.8 fever and the vaccine site was about 4 inches actually its probably about 5 inches in diameter and red and hot and swollen then patient feel awful and patient was just thinking my new vaccine have got many side effects and it feels like a COVID vaccine (Event captured as per Verbatim and COVID Vaccine captured as suspect conservatively). Stated, "Extreme pain, extreme swelling, redness and hot. I guess my question is, Is this an extreme reaction". Patient stated "You can't tell me about the fever I am experiencing extreme because I never had a fever because of the vaccine." Treatment: Consumer stated, "I have taken Advil and Ibuprofen and I think my arms (Sentence incomplete)."  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 57-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 at 09:00 as dose 1, single (Lot number: EN6203), in left arm, on 18Mar2021 at 14:00 as dose 2, single (Lot number: EN6207), in left arm, on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 301458A), in left arm and on 06Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "benign prostatic hyperplasia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (14Jun2022) Negative, notes: initially tested negative one day after completion of treatment; (17Jun2022) Positive, notes: I initially tested negative one day after completion of treatment and then tested positive four days later. Therapeutic measures were taken as a result of covid-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing). Concomitant medication(s) included: CLONOPIN, start date: 09Sep2020; PROPRANOLOL, start date: 03Apr2022; EMGALITY [GALCANEZUMAB], start date: 01Oct2020; UBRELVY, start date: 01Oct2020 were also other medication in 2weeks product. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Flu shot, reaction(s): "Known allergies: Flu shot". The following information was reported: VACCINATION FAILURE (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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
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). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left 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: "Celiac dx" (unspecified if ongoing), notes: Celiac dx; "erosive arthritis" (unspecified if ongoing); "gluten intolerance" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Iron dextran iv, reaction(s): "known allergies: Iron dextran IV", notes: known allergies: Iron dextran IV. 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: (unspecified date) unknown results, notes: Treatment of COVID-19; (17Jun2022) Positive, notes: Return of symptoms and positive test six days after completing paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was not pregnant at the time of vaccination. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient had not received other medication in 2 weeks. Patient received COVID 19 Treatment as Paxlovid (Lot number- GA3567) from 07Jun2022 to 11Jun2022.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; 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 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Rash; "Rosacea" (unspecified if ongoing); "rash" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16Jun2022, Indication: Treatment of COVID-19, Administrator route: Oral.
Age: 36.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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) all with onset 04Jun2022, outcome "not recovered" and all described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: Tested positive on the morning of 04Jun; (10Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (11Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (12Jun2022) Negative, notes: tested negative on Friday June 10, 11, and 12; (17Jun2022) positive, notes: positive again on 17Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Aug2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right 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: "CLL" (unspecified if ongoing), notes: Other medical history: CLL. Concomitant medication(s) included: VENCLEXTA, start date: 05Jun2022, stop date: 09Jun2022; BENICAR, start date: 05Jun2022, stop date: 09Jun2022; CRESTOR, start date: 05Jun2022, stop date: 09Jun2022; AMBIEN, start date: 05Jun2022, stop date: 09Jun2022; XANAX, start date: 05Jun2022, stop date: 09Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 immunization. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient did not have any Known allergies. Antiviral details-Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jun2022, Treatment stop date: 09Jun2022, Indication: Treatment of COVID-19. Adverse event: I have had a rebound of Covid 19 after completing a 5-day course of Paxlovid. Symptoms include cough, low fever, headache. Adverse events start date: 13Jun2022, Adverse event start time: 04:45 PM, If patient recovered: Recovering, If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6207), on 14Apr2021 as dose 2, single (Lot number: EW0161), on 27Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 01May2022 at 18:30 as dose 4 (booster), single (Lot number: FM7553) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Lyme disease", start date: 2017, stop date: 2020; "adhd" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, covid-19.Product- COVID 19 Treatment, Brand- Paxlovid,Treatment start date- 26May2022,Treatment stop date- 31May2022,Indication- Treatment of COVID-19.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: positive covid test on 14Jun2022; positive covid test on 14Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (COMIRNATY), on 20Apr2021 as dose 1, single (Lot number: ER8731) and on 11May2021 as dose 2, single (Lot number: EW0165) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery", start date: 14May2022 (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 "positive covid test on 14Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14Jun2022) Positive, notes: Relevant Tests: None except positive covid test on 14Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Prior Vaccinations (within 4 weeks) was none. Patient medical history (including any illness at time of vaccination) was none pertinent or relevant per the caller. Family medical history relevant to AE(s) was none. Additional vaccines administered on same date of the Pfizer suspect reported as none. AE(s) did not require a visit to emergency room or physician office visit.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cataract, Eye haemorrhage
Clinical narrative: positive covid test on 14Jun2022; positive covid test on 14Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (COMIRNATY), on 20Apr2021 as dose 1, single (Lot number: ER8731) and on 11May2021 as dose 2, single (Lot number: EW0165) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "cataract surgery", start date: 14May2022 (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 "positive covid test on 14Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (14Jun2022) Positive, notes: Relevant Tests: None except positive covid test on 14Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Prior Vaccinations (within 4 weeks) was none. Patient medical history (including any illness at time of vaccination) was none pertinent or relevant per the caller. Family medical history relevant to AE(s) was none. Additional vaccines administered on same date of the Pfizer suspect reported as none. AE(s) did not require a visit to emergency room or physician office visit.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 4460704#1849-2117958061.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "endometrial cancer" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "heart problem" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; CYCLOBENZAPRINE HCL; METHOTREXATE SODIUM; ARAVA; DULOXETINE HCL; LISINOPRIL. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". Clinical information: Patient's past medical history included: multiple sites, encounter for observation for other suspected diseases.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Influenza like illness
Clinical narrative: Reactions from COVID vaccinations; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4429398-00 (AbbVie).  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (non-serious), outcome "recovered", described as "Reactions from COVID vaccinations"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The action taken for adalimumab was unknown.  Additional information: There was no reported medical history.It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The  reporter's causality for the event of REACTION FROM COVID VACCINATIONS with Pfizer biotech COVID-19 Vaccine (Tozinameran) was reported as probable. The reporter's causality for the event of REACTION FROM COVID VACCINATIONS with HUMIRA (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of FLU LIKE SYMPTOMS with HUMIRA was not provided.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: My brother has ckd and had 2 doses and 2 boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "My brother has ckd and had 2 doses and 2 boosters".  Clinical course: Reporter's brother had ckd and had 2 doses and 2 boosters. His gfr has gotten worse since last year. Reporter wanted to know if this is due to the vaccines.  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: Antibody test, Antibody test abnormal, Malaise
Clinical narrative: Clotting antibodies and spiked antibodies are extremely high, which means beyond safe normal levels; wellness is lacking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A female 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: ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "Clotting antibodies and spiked antibodies are extremely high, which means beyond safe normal levels"; MALAISE (non-serious), outcome "unknown", described as "wellness is lacking". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Case Category: Patient Assistance Programs. Do you publish reaction protocols for the covid 19 vaccine. My spouse was experiencing a prolonged reaction. Clotting antibodies and spiked antibodies are extremely high, which means beyond safe normal levels. It has taken 9 months to begin reducing them to "high" normal. Her wellness was lacking. Other symptoms are pronounced. Please advise.  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: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive today for Covid 19; tested positive today for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old female patient received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "unknown" and all described as "tested positive today for Covid 19". The patient underwent the following laboratory tests and procedures: Body temperature: (15Jun2022) low grade; SARS-CoV-2 test: (15Jun2022) Positive, notes: tested positive today for Covid 19.  Clinical information: I am writing to report that my spouse, a 36 year old female, tested positive today for Covid 19 after having had 2 PFE comirnaty shots, and a PFE comirnaty booster. Her symptoms include tight chest, sore throat, low grade fever and fatigue.  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: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-015841 (Moderna).  A female patient (not pregnant) received BNT162b2 (BNT162B2), 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 was not reported. Concomitant medication(s) included: METFORMIN; LYRICA; FARXIGA; LIPITOR; METOPROLOL; FENOFIBRATE; DICYCLOMINE; ZETIA; AMLODIPINE; SYNTHROID; CIMETIDINE; EDARBI; CORLANOR; REGLAN [METOCLOPRAMIDE]; PROTONIX [OMEPRAZOLE]. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient was treated with Benadryl.  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, Cough, Malaise, Productive cough, SARS-CoV-2 test
Clinical narrative: has a lot of phlegm when she coughs; has a lot of phlegm when she coughs; tested positive for Covid; tested positive for Covid; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8730), on 10Apr2021 as dose 2, single (Lot number: EP7553) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 14Jun2022, outcome "unknown", described as "not feeling well"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "unknown" and all described as "tested positive for Covid"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious), outcome "unknown" and all described as "has a lot of phlegm when she coughs". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Negative, notes: Started not feeling well Tuesday 16Jun2022, tested negative; (16Jun2022) Positive, notes: Tested positive this morning,16Jun2022. The reporter's friend tested positive for Covid today Pfizer Covid Vaccine. Symptoms: Started not feeling well Tuesday 14Jun2022, tested negative. The patient tested positive this morning, 16Jun2022. She felt terrible. No fever was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: has a lot of phlegm when she coughs; has a lot of phlegm when she coughs; tested positive for Covid; tested positive for Covid; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8730), on 10Apr2021 as dose 2, single (Lot number: EP7553) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 14Jun2022, outcome "unknown", described as "not feeling well"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "unknown" and all described as "tested positive for Covid"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious), outcome "unknown" and all described as "has a lot of phlegm when she coughs". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Negative, notes: Started not feeling well Tuesday 16Jun2022, tested negative; (16Jun2022) Positive, notes: Tested positive this morning,16Jun2022. The reporter's friend tested positive for Covid today Pfizer Covid Vaccine. Symptoms: Started not feeling well Tuesday 14Jun2022, tested negative. The patient tested positive this morning, 16Jun2022. She felt terrible. No fever was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Intraocular pressure increased, Intraocular pressure test, Weight, Weight increased
Clinical narrative: heart murmur; Eye pressure elevated; Gaining weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4618823.  A 71-year-old 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: CARDIAC MURMUR (non-serious), outcome "not recovered", described as "heart murmur"; INTRAOCULAR PRESSURE INCREASED (non-serious), outcome "not recovered", described as "Eye pressure elevated"; WEIGHT INCREASED (non-serious), outcome "not recovered", described as "Gaining weight". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Patient's concomitant medication included: was not reported. It was reported that: we have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with policies and procedures. On unknown date, patient started therapy with COVID-19 VACCINE for COVID-19. On unknown date, it was reported that patient experienced: Heart murmur, Eye pressure elevated, Gaining weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered". Additional information includes physician reported patient got Pfizer COVID-19 booster. She experienced headache and fatigue for 36 hours following booster. She was a female in her late fifties or early sixties. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Nasopharyngitis, Suspected COVID-19
Clinical narrative: Possibly had COVID; Possibly had COVID; experienced cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4432232-00.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1157153), oral for rheumatoid arthritis. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "experienced cold"; DRUG INEFFECTIVE (medically significant),SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Possibly had COVID". The action taken for upadacitinib was unknown.  Clinical course: On an unknown date, the patient experienced possibly had COVID. In 2022, the patient experienced cold. On an unknown date, possibly had COVID resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. Patient had a cold and possibly COVID. She felt good again. She got COVID booster right before getting the cold. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event (s) of possibly had COVID with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event (s) of cold was not provided.  The reporter considered "possibly had covid" and "experienced cold" related to BNT162b2.  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 the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult female 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid.  Clinical course: Reporter stated that she have an adult niece and an adult nephew who both recently tested positive for Covid. They had received the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200846772 Different patients, Same reporter, drug, event.;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Therapeutic product effect decreased
Clinical narrative: Drug effect decreased; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431075-00 (Agency).  A 42-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Oct2021 at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "COVID-19"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was unknown.  The reporter considered "covid-19" and "drug effect decreased" related to BNT162b2.  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 the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective, Drug effect decreased and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: vaccine helped him to recover from cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization; Bnt162b2 (Dose: 3/ First booster), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "vaccine helped him to recover from cancer".  Additional information: Caller's Concern: Caller is reporting a therapeutic effect regarding the COVID 19 vaccine. He mentioned that the vaccine helped him to recover from cancer. He also added that he got 2 vaccines and 2 booster shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was recently diagnosed Covid positive; was recently diagnosed Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 73-year-old patient received BNT162b2 (BNT162B2), 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 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 "was recently diagnosed Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12Jun2022) Positive.  Clinical course- The patient Primary Care Physician recommended  take the 5-day PAXLOVID medication. The patient just took first set of morning pills. Sunday tested positive and felt terrible (a 10 on the feeling bad chart). Today, Wednesday, the patient feeling better and am at a level 7 on the feeling bad chart.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune pancreatitis, Blood bilirubin, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound
Clinical narrative: SERONEGATIVE TYPE I AUTOIMMUNE PANCREATITIS; This is a literature report.  This case was the first case of suspected vaccine-induced seronegative Type I autoimmune pancreatitis (AIP) with IgG4-related disease occurring after a single dose of the Pfizer-BioNTech COVID-19 vaccine. A previously healthy 65-year-old male presented to a hospital with one week of jaundice. Two weeks prior, he had received his first dose of the COVID-19 vaccine. Admission labs demonstrated a cholestatic liver injury without eosinophilia. After initial imaging, an endoscopic ultrasound demonstrated a diffusely heterogenic pancreas with features of pancreatitis (lobularity, stranding). Endoscopic retrograde cholangiopancreatography (ERCP) demonstrated a 2cm distal common bile duct stricture. A sphincterotomy was performed and fully covered metal stent was placed (due to minor post-sphincterotomy bleeding). The patient's jaundice resolved, and he was discharged. He received his second dose of the COVID-19 vaccine shortly after hospitalization. The patient underwent the following laboratory tests and procedures: Blood bilirubin: 12 mg/dl, notes: 3 weeks post first vaccine dose; 2 mg/dl, notes: 6 weeks post first vaccine dose; 1 mg/dl, notes: 10 weeks post first vaccine dose; 4 mg/dl, notes: 12 weeks post first vaccine dose; 18 mg/dl, notes: 16 weeks post first vaccine dose (start of therapy); 12 mg/dl, notes: 18 weeks post first vaccine dose; 7 mg/dl, notes: 20 weeks post first vaccine dose; 2 mg/dl, notes: 24 weeks post first vaccine dose; 1 mg/dl, notes: 28 weeks post first vaccine dose; 1 mg/dl, notes: 34 weeks post first vaccine dose. Conclusion(s): We report a case of seronegative Type I AIP with IgG4-related disease in a previously healthy patient occurring after Pfizer-BioNTech COVID-19 vaccination. While this clinical presentation is typically associated with elevated serum IgG4 levels, our case implicates an alternate immunogenic trigger. Although such rare side effects of vaccination need to be recognized, they should not prevent physicians from recommending COVID-19 vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: exposed to 82.62 F for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event); IPOL was administered to 4 patients after excursion with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 years old female patient who experienced exposed to 82.62 f for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event) and ipol was administered to 4 patients after excursion with no reported adverse event while receiving vaccine Ipv (Vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect ipv (vero) lot T1871M, expiry date: 10-Oct-2022 (route, strength, formulation, frequency: unknown) in unknown administration site for Immunization.  On 03-SEP-2021 the patient developed non-serious events exposed to 82.62 f for 15 minutes/medication error due to temperature excursion exceeded the stability data (with no reported adverse event) (product storage error) and ipol was administered to 4 patients after excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events (product storage error and poor-quality product administered).  At time of reporting, the outcome was Unknown for both the events product storage error and poor-quality product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given outside of indication to an 18 mo old patient with no reported adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional.  This case involves a 18 months old of non-health care professional patient who received quadracel was given outside of indication to an 18 month old patient with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site as Prophylaxis (immunization).  On an unknown date the patient developed a non-serious event quadracel was given outside of indication to an 18 month old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (product administered to patient of inappropriate age).  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.