chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: puncturing skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 at 08:30 as dose 1, single (Lot number: EW0150), in left arm and on 22Apr2021 at 08:30 as dose 2, single (Lot number: EW0161), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "puncturing skin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the Pfizer doses for adults were so miniscule, the patient never felt any side effects. Normal one day arm injection site was not a side effect, it was a simply a normal physical response like she was completely disappointed in how little you put in the doses-you need to increase it 3Xs per dose like Moderna. It made her positive after all these years if she removed her mask, she wished they had higher dosage to protect better. You can also try to make it address future variant.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; cough; sore throat; body aches; nasal congestion; fatigue; low grade fever (99.5 F at its highest); This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 08:00 as dose 1, single (Lot number: EL9266), in right arm, on 14Mar2021 at 08:00 as dose 2, single (Lot number: EN6206), in right arm, on 30Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Mellitus Type 2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Stroke", start date: 2017 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "macular edema" (unspecified if ongoing); "cataracts" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; JANUVIA; TOUJEO; AMLODIPINE. The following information was reported: PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; PYREXIA (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "low grade fever (99.5 F at its highest)"; NASAL CONGESTION (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "sore throat"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.". The patient underwent the following laboratory tests and procedures: Body temperature: (06Jun2022) 99.5 Fahrenheit, notes: low grade at its highest; SARS-CoV-2 test: (07Jun2022) Positive, notes: Nasal Swab; (unspecified date) Negative. Therapeutic measures were taken as a result of cough, oropharyngeal pain, pain, nasal congestion, fatigue, pyrexia.  Clinical course: No other vaccine in four weeks, No covid prior vaccination, tested positive post vaccination. I took Advil and guaifenesin/dextromethorphan to treat the symptoms.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and suspected Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.; cough; sore throat; body aches; nasal congestion; fatigue; low grade fever (99.5 F at its highest); This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 08:00 as dose 1, single (Lot number: EL9266), in right arm, on 14Mar2021 at 08:00 as dose 2, single (Lot number: EN6206), in right arm, on 30Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF2593), in right arm and on 02Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Mellitus Type 2" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Stroke", start date: 2017 (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "macular edema" (unspecified if ongoing); "cataracts" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; JANUVIA; TOUJEO; AMLODIPINE. The following information was reported: PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "body aches"; COUGH (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; PYREXIA (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "low grade fever (99.5 F at its highest)"; NASAL CONGESTION (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 05Jun2022 at 12:00, outcome "not recovered", described as "sore throat"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 07Jun2022, outcome "unknown" and all described as "the symptoms continued so I took an at-home COVID (antigen) test which revealed a positive result.". The patient underwent the following laboratory tests and procedures: Body temperature: (06Jun2022) 99.5 Fahrenheit, notes: low grade at its highest; SARS-CoV-2 test: (07Jun2022) Positive, notes: Nasal Swab; (unspecified date) Negative. Therapeutic measures were taken as a result of cough, oropharyngeal pain, pain, nasal congestion, fatigue, pyrexia.  Clinical course: No other vaccine in four weeks, No covid prior vaccination, tested positive post vaccination. I took Advil and guaifenesin/dextromethorphan to treat the symptoms.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and suspected Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccinated and boosted, but still caught Covid earlier this year". Therapeutic measures were taken as a result of Covid-19, drug ineffective with Paxlovid. Clinical course: The patient was vaccinated and boosted, but still caught Covid earlier this year. The patient was prescribed Paxlovid and now the patient had rebounded twice. 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: COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID-19; tested positive for 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 48-year-old female patient 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 and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment, notes: started taking Paxlovid on Thursday morning a little bit before 10 AM,. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19". 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.
Age: 70.0
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) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 01:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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: "Breast Cancer" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: VALTREX oral. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Codeine, reaction(s): "known allergies: Codeine"; Lactose, reaction(s): "known allergies: Lactose". The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: The patient received other medication in 2weeks, Valtrex, via an oral route of administration. COVID 19 treatment was received with Paxlovid, Treatment start date: 06Jun2022, Administrator route: Oral. Pfizer BioNTech, vaccine lot unknown reason was misplaced or discarded.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn(s) Disease" (unspecified if ongoing), notes: Crohn(s) Disease. Concomitant medication(s) included: JUNEL, start date: 20Nov2020; STELARA, start date: 10Apr2020. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Anti viral details.  Patient received Other medication in 2 weeks Anti viral details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Limb injury
Clinical narrative: Ankylosing spondylitis; Left Shoulder operation; 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-163-4418110-00 (Abbvie).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 1 in 2 wk, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of administration: Intra-muscular.), administration date: 01Jan2021, for covid-19 vaccination. The following information was reported: LIMB INJURY (medically significant) with onset 2021, outcome "unknown", described as "Left Shoulder operation"; ANKYLOSING SPONDYLITIS (medically significant) with onset Aug2021, outcome "unknown". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of limb injury. Clinical course: The patient took first and second covid shot before shoulder surgery. In Aug2021, she experienced ankylosing spondylitis. It was unknown if she was enrolled in a covid-19 vaccine trial. The adverse events occurred prior to humira and did not worse on humira. Causality for Humira (Adalimumab): The reporter causality for the events of left shoulder surgery with humira (Adalimumab) was a reasonable possibility. The reporter's causality for the events of after second Pfizer shot patient was experiencing ankylosing spondylitis was not provided. Drug: Humira(adalimumab): Shoulder operation: Causality as per reporter (Drug/Vaccine): Probable, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Ankylosing spondylitis: Causality as per reporter (Drug/Vaccine): Not reported. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Abbive opinion is that there was no reasonable possibility that the events of left shoulder surgery and after second pfizer shot patient was experiencing ankylosing spondylitis are related to humira (Adalimumab).  The reporter considered "left shoulder operation" and "ankylosing spondylitis" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the reported events: "Limb injury", "Ankylosing spondylitis" and the suspect drug BNT162B2 cannot be completely excluded.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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-163-4420988-00.  A 26-year-old male patient 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Nov2017 (ongoing) (Batch/Lot number: unknown) at single (unk (citrate free)), subcutaneous for crohn's disease. The patient's relevant medical history included: "Moderate to Severe Adult Crohn's Disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovered" (2022) and all described as "COVID-19". The action taken for adalimumab was dosage not changed. Clinical course: The patient reported in May2022, the patient experienced Bowel obstruction and COVID-19. In 2022, the COVID-19 resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of bowel obstruction and COVID-19 with Humira (Adalimumab) was no reasonable possibility. Agency's opinion is that  there is no reasonable possibility that the events of bowel obstruction and COVID-19 are related to Humira (Adalimumab).  The reporter considered "covid-19" 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 information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and drug ineffective, Covid 19 cannot be completely excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Immune system disorder, Muscle disorder, Nervous system disorder
Clinical narrative: attacked my nervous system; attacked my muscles; attacked my bowel; it attacked my immune system; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Lot number: EW0167) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; ATORVASTATIN taken for blood cholesterol. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 05May2021, outcome "not recovered", described as "attacked my bowel"; MUSCLE DISORDER (non-serious) with onset 05May2021, outcome "recovering", described as "attacked my muscles"; NERVOUS SYSTEM DISORDER (medically significant) with onset 05May2021, outcome "recovering", described as "attacked my nervous system"; IMMUNE SYSTEM DISORDER (non-serious) with onset 05May2021, outcome "recovering", described as "it attacked my immune system". Therapeutic measures were taken as a result of nervous system disorder, muscle disorder, abdominal discomfort, immune system disorder.  Clinical course: The patient went, and I got the Olympus, that the Monoclonal Infusion (Intent Treatment) and next morning half symptoms were gone. When probed for permission to file the safety report consumer stated patient lost 13 months of life and patients bowel is not going to be right again. Patients husband got the same Vaccine. Consumer stated, they did not write Expiration date of Pfizer Covid-19 Vaccine, all they did was, they did not write it down on my card. The Consumer stated that Start date of event (nervous system attacked) was Immediately. The patient received treatment Chiropractor all the time, Chiropractor and the doctors were not interested because they said that the Vaccine is safe. Patient was not healthcare professional like Physician, Nurse, Pharmacist but consumer know her body. The patient just had a checkup. The patient did not receive any other vaccines.  Follow-Up (10Jun2022): Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in left arm 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 included: "known allergies: Sulfa drugs" (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 "Pfizer / BioNTech: Dose Number: 2; Pfizer: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: It was unknown whether patient took other medications in 2 weeks. The patient received Paxlovid from 10May2022 for treatment of COVID-19. On 11 May2022, the patient experienced swollen throat and horrible metallic aftertaste. The patient stopped Paxlovid 15May2022. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE; DESCOVY. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Treatment of COVID-19. 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: Linked Report(s) : US-PFIZER INC-202200810645 samer reporter/pt, different drug/event;
Age: 47.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years 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 had no relevant medical history. There were no concomitant medications. 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 22Apr2022 to 27Apr2022 for the treatment of COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 16:45 as dose 1, single (Lot number: EN6198), in left arm, on 06Mar2021 at 17:00 as dose 2, single (Lot number: EN6206), in left arm and on 12Nov2021 at 13:15 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes. Concomitant medication(s) included: METFORMIN, start date: 01Jun2019; RYBELSUS, start date: 01Mar2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: I tested positive 5 days later; (Jun2022) Negative, notes: tested negative on Day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Tested negative on Day 9, but then covid rebounded and She tested positive 5 days later. Her symptoms are milder now but she was stuck isolating again for 5 days. Patient received Paxlovid for 5 days as a treatment for the adverse event.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200813655 Same patient, same drug, different event, different dose;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Positive airway pressure therapy, SARS-CoV-2 test
Clinical narrative: Home antigen test was positive; Home antigen test was positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "s/p partial thyroidectomy" (unspecified if ongoing); "s/p cholecystectomy" (unspecified if ongoing); "he has OSA" (unspecified if ongoing), notes: he has OSA on CPAP; "obesity" (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 "Home antigen test was positive". The patient underwent the following laboratory tests and procedures: Positive airway pressure therapy: OSA, notes: he has OSA on CPAP; SARS-CoV-2 test: negative; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information:If vaccine received: Yes.Other medication in 2weeks: Unknown.Anti viral details:Product:COVID 19 Treatment, Brand:Paxlovid, treatment start date 27May2022,treatment stop date 31May2022, Indication:Treatment of COVID-19, administrator route:Oral. Adverse event: Patient took Paxlovid for 5 days and then tested negative on home antigen test. On Day 12, he developed nasal congestion and mild headache, no fever. Home antigen test was positive. Symptoms this time even milder than before.Adverse event start date: 07Jun2022 04:00 PM.If patient recovered: Recovering.If treatment ae: No.Known allergies: no.vaccine lot unknown reason: Not available/provided to reporter at the time of report completion for all suspect vaccine products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 37.0
Sex: M
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 38-year-old male patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (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; (07Jun2022) positive, notes: positive test result on 07Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
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) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 10:00 as dose 1, single (Lot number: 6N6199) and on 31Mar2021 at 09:00 as dose 2, single (Lot number: EP6955) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 071F21A), in right arm and on 18Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 0U8L21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: 09Jun2021; LOVASTATIN, start date: 01Apr2019, stop date: 28May2022.  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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient had no known allergies. COVID 19 Treatment with Plaxlovid from 28May2022 to 01Jun2022. It was reported 3 days after stopping the paxlovid patient had symptoms of flu and tested positive. Patient reported that he still have symptoms today. .
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Pyrexia
Clinical narrative: fever/He ran a temperature; a big knot came up under his arm; feeling really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever/He ran a temperature"; AXILLARY MASS (non-serious), outcome "recovered", described as "a big knot came up under his arm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling really bad".  Additional information: The patient had side effects when he got the first shot, that was fever and feeling really bad and a big knot came up under his arm, right arm. The second dose he experiencing face burning. Didn't get the booster shot. Then later on 2 weeks or a Month after the second dose his face started burning, like it's on fire and it won't stop. She said this has been going on for 3 months and this is ongoing. She said that done alright and then his face started burning. She said the knot and the fever went away after a while then his face started burning and never stopped. There were no additional vaccines administered on same date of the Pfizer Suspect If applicable. No AE(s) required a visit to Emergency Room and Physician Office. There were no Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient had no medical history, Family Medical History Relevant to AE(s). There were no relevant tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: 30155BA) 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: CONCERTA. 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: Negative, notes: I tested negative on multiple tests multiple days in a row before the rebound began; Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medication in 2 weeks was Concerta. The patient received Paxlovid (Antiviral, Lot number: GA3581) from 24May2022 to 30May2022 for COVID 19 treatment. Covid-19 rebound after completing Paxlovid treatment. The patient tested negative on multiple tests multiple days in a row before the rebound began.
Age: 54.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: unknown) at the age of 54 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: "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin, sulfa; "known allergies sulfa" (unspecified if ongoing), notes: known allergies penicillin, sulfa. The patient's concomitant medications were not reported. 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: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: it was unknown if other medication received in 2weeks. anti-viral details: product: COVID 19 Treatment, brand: Pfizer, treatment start date: 28May2022. treatment stop date: 02Jun2022. indication: Treatment of COVID-19. Patient experienced rebound covid on 07Jun2022. Patient did not received treatment. device timestamp: 08Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
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) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6206), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8734) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "known allergies: mango" (unspecified if ongoing), notes: known allergies: mango. There were no concomitant medications.  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; (08Jun2022) Positive, notes: Today's test came up strongly positive within 2 minutes' am using the iHealth brand test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: day 8 I had a very strong positive on rapid test.; day 8 I had a very strong positive on rapid test.; This is a spontaneous report received from 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 02Nov2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: "Gluten intolerance" (unspecified if ongoing); "high BP" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin"; Erythromycin, reaction(s): "known allergies erythromycin"; Penicillin, reaction(s): "known allergies Penicillin"; Levaquin, reaction(s): "known allergies levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "day 8 I had a very strong positive on rapid test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had a very strong positive on rapid test. Congestion headache and fatigue remain and it is now Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient seem to have had a rebound of COVID after taking Paxlovid. This was her first infection and she had two am doses of Moderna vaccine and one of Pfizer as her booster. Her symptoms were abating on day 6 and 7 and then on day 8 she had a very strong positive on rapid test. Congestion headache and fatigue remain and it is now Day 17. Perhaps a longer course of Paxlovid is needed! Thank you.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 at 13:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: VALACYCLOVIR HCL, start date: 01Feb2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022 at 12:00, 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) Positive, notes: COVID 19 treatment; (07Jun2022) Positive, notes: Still testing positive after completing all doses yesterday. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received treatment with Paxlovid for COVID-19 from 02Jun2022 to 07Jun2022, Lot number: GA8778.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Breaking out, had a rash; the pain in her arm was like something she never felt before; 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 female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 02Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in arm; influenza vaccine (FLU), on 02Jun2022 as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (1st booster), Lot/NDC/Expiry: Not provided, caller unwilling to complete report.), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Jun2022, outcome "unknown", described as "Breaking out, had a rash"; PAIN IN EXTREMITY (non-serious) with onset Jun2022, outcome "unknown", described as "the pain in her arm was like something she never felt before". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Ischaemic stroke, Thrombosis
Clinical narrative: atrial fibrillation; I suffered 2 small ischemic strokes; blood clots; 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), on 30Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9095) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "macular degeneration" (unspecified if ongoing); "PSVBs" (unspecified if ongoing), notes: PSVBs; "osteoporosis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: ACEBUTOLOL; TELMISARTAN; SYNTHROID; ALLEGRA; ALIGN. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Nov2021, when the patient was 76-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 06Feb2021, when the patient was 75-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 09Jan2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: ISCHAEMIC STROKE (hospitalization, medically significant) with onset 04Apr2022 at 18:30, outcome "recovering", described as "I suffered 2 small ischemic strokes"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 04Apr2022 at 18:30, outcome "recovering"; THROMBOSIS (hospitalization, medically significant) with onset 04Apr2022 at 18:30, outcome "recovering", described as "blood clots". The patient was hospitalized for atrial fibrillation, ischaemic stroke, thrombosis (hospitalization duration: 4 day(s)). The events "atrial fibrillation", "i suffered 2 small ischemic strokes" and "blood clots" required emergency room visit. Therapeutic measures were taken as a result of atrial fibrillation, ischaemic stroke, thrombosis. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 1984 (ongoing); "High cholesterol", start date: 1984 (ongoing); "Thrombophlebitis with Pulmonary Embolism", start date: 1972 (unspecified if ongoing), notes: Thrombophlebitis with Pulmonary Embolism; "Thrombophlebitis with Pulmonary Embolism", start date: 1972 (unspecified if ongoing), notes: Thrombophlebitis with Pulmonary Embolism. The patient's family history included: "Fibromyalgia", start date: 1984 (ongoing); "Diabetes" (ongoing); "Heart disease" (ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown".  Additional information: The patient did not receive any prior vaccination. There were no relevant test and specific relevant test for thromboembolic events with thrombocytopenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.