chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPVX, MENB, MNQ
Symptoms: Dysphonia, Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Neck pain; Headache; Arms and legs are painful; Hoarse voice; Fever; This is a spontaneous report received from non-contactable reporter (Nurse) from a sales representative.  An 11-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 02Mar2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; hpv vaccine (HPV VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 03Mar2022, outcome "unknown", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2022, outcome "unknown", described as "Arms and legs are painful"; HEADACHE (non-serious) with onset 04Mar2022, outcome "unknown"; DYSPHONIA (non-serious) with onset 04Mar2022, outcome "unknown", described as "Hoarse voice"; NECK PAIN (non-serious) with onset 04Mar2022, outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Hypersensitivity
Clinical narrative: I am allergic to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (174934). The reporter is the patient.  A 49-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 and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I am allergic to it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever; swollen arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Oedema peripheral
Clinical narrative: Arm with edema; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OEDEMA PERIPHERAL (non-serious), outcome "recovered", described as "Arm with edema". Therapeutic measures were not taken as a result of oedema peripheral.  Additional information: Edema Day after given PCV 13 which lasted for about a week. Patient did not take any medication but put cold packs on her arm with edema. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Arm soreness; It expired the day before its administration; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old male patient received BNT162b2 (BNT162B2), administration date, on 24Mar2022 as dose 2, single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 6 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: 16:05, Anatomical site: Right Deltoid, Route: Intramuscular, Batch/Lot : FL8094), administration date: 28Feb2022, when the patient was 6-year-old, for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 24Mar2022, outcome "unknown", described as "It expired the day before its administration"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  Additional information: Contact the manufacturer for information on the stability of the vaccine. If the manufacturer does not have data to support the stability of the vaccine, repeat the dose immediately (no minimum interval). Dose administered past the expiration/beyond-use date. Vaccination facility type: Doctor's Office/Urgent Care. patient had no Prior Vaccinations and no Concomitant Drugs and the patient's Medical History: None No Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia were None. Error due to miscalculation from Vacc. Arrival Patient notified no adverse reactions only normal side effects arm soreness. Vaccine vial expiration date Sep2021, from arrival to 6 week period expiration 23Mar2022  Follow-up attempts are completed. No further information is expected.  Follow-up (15Apr2022): This is a follow-up spontaneous report received from the same contactable Consumer. This Consumer reported in response to HCP letter sent via follow-up letter which included that:  Updated Information: Historical vaccine added, Primary reporter's occupation updated, Dose description Updated, Dose number, Route of administration, Anatomical location added, Vaccination facility Name, Address, City, State, Postal code, Phone number added, Event medically confirmed updated.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Allergy to chemicals
Clinical narrative: She stated having reactions to a Pneumonia vaccine in the past.; 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 pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "She stated having reactions to a Pneumonia vaccine in the past.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Immunisation, Off label use, Pyrexia
Clinical narrative: Covid test result= Positive; Covid test result= Positive; Fevers; Off label use; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2589), administration date: 22Oct2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 08Apr2022, outcome "unknown"; IMMUNISATION (medically significant) with onset 08Apr2022, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022, outcome "unknown" and all described as "Covid test result= Positive"; PYREXIA (non-serious) with onset 10Apr2022, outcome "unknown", described as "Fevers". The patient underwent the following laboratory tests and procedures: Body temperature: (10Apr2022) Unknown results; SARS-CoV-2 test: (10Apr2022) Positive, notes: Nasal Swab; (11Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia.  Clinical course: Facility type vaccine was Workplace clinic. It is unknown if the patient received other vaccine in four weeks. No covid prior vaccination. 08Apr22 got dose 4 COVID dose and then out to lunch and massage next day 09Apr22.- symptoms started Sunday night 10Apr22 fevers HA + ag test 10Apr night and 11Apr am. Treatment for AE was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The at risk events Off label use and immunisation assessed as NA.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result= Positive; Covid test result= Positive; Fevers; Off label use; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2589), administration date: 22Oct2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 08Apr2022, outcome "unknown"; IMMUNISATION (medically significant) with onset 08Apr2022, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022, outcome "unknown" and all described as "Covid test result= Positive"; PYREXIA (non-serious) with onset 10Apr2022, outcome "unknown", described as "Fevers". The patient underwent the following laboratory tests and procedures: Body temperature: (10Apr2022) Unknown results; SARS-CoV-2 test: (10Apr2022) Positive, notes: Nasal Swab; (11Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia.  Clinical course: Facility type vaccine was Workplace clinic. It is unknown if the patient received other vaccine in four weeks. No covid prior vaccination. 08Apr22 got dose 4 COVID dose and then out to lunch and massage next day 09Apr22.- symptoms started Sunday night 10Apr22 fevers HA + ag test 10Apr night and 11Apr am. Treatment for AE was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The at risk events Off label use and immunisation assessed as NA.
Sex: U
Vaccine: COVID19, PNC13
Symptoms: Dizziness, Malaise
Clinical narrative: I have been very sick for 7 days; I have been so dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 4 (booster), single (Batch/Lot number: unknown) for immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Previous immunization series complete, MANUFACTURER UNKNOWN); Covid-19 vaccine (DOSE 3 , MANUFACTURER UNKNOWN); Prevnar 13 (DOSE 1). The following information was reported: MALAISE (non-serious), outcome "recovering", described as "I have been very sick for 7 days"; DIZZINESS (non-serious), outcome "unknown", described as "I have been so dizzy". Additional information- It was reported that A week ago yesterday patient  went to the withheld pharmacist to receive my 4th shot, my second booster and the pharmacist said you can also get your second Prevnar, your pneumonia shot toady. I said really, she said yeah so I said okay and than about a minute later I said I dont think that's a really good idea today I'm just going to get one. He said why wouldn't you get it you haven't had a reaction have you? It wont hurt you. I have ben very sick for 7 days. I am feeling better today. I have been so dizzy because I did get the shot. I got two vaccines in both of my arms last week on Sunday I got my 4th covid shot and that Prevnar, my second." Note: The reporters/patients name was not provided on the phone call The following information was not provided during the call  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, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Covid positive 11Apr; Covid positive 11Apr; Cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old 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. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11Apr2022, outcome "unknown", described as "Cold like symptoms"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "Covid positive 11Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive.  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, UNK
Symptoms: Arthralgia, Thrombosis
Clinical narrative: Clot blood; Joint pain; 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-163-4348038-00 (AbbVie).  A 63-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3, (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history included: "pseudo gout" (unspecified if ongoing), notes: pseudo gout; "Interchange of vaccine products" (unspecified if ongoing), notes: Janssen COVID-19 vaccine/Pfizer BioNTech COVID-19 vaccine/ were also considered suspect. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Clot blood"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The action taken for risankizumab was unknown. Clinical coarse: Patient felt that blood clot was related to COVID vaccine but her physician did not agree. She stated Skyrizi (Risankizumab) calmed her arthritis but still she had the symptoms. The reporter causality for the event of blood clot and joint pain with Skyrizi (Risankizumab) was not provided. It was not known if the patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "clot blood" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 Vaccine: tested positive for Covid-19 after the booster dose; Covid-19 Vaccine: tested positive for Covid-19 after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 90-year-old female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 Vaccine: tested positive for Covid-19 after the booster dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Caller on the line who is concerned. She is 90 years old. She took Paxlovid yesterday. From yesterday until now, she is still tasting the medication. She mentioned that she is having diarrhea after taking the medication. She tested positive for Covid-19 after the booster dose of the Pfizer Covid -19 vaccine. Unable to clarify above details with caller. Caller is wanting to speak with a supervisor. She has been on the phone for over one hour. She wants a supervisor to call her back as soon as possible or her lawyer will call us. She cannot stay on this phone for over an hour. Caller disconnected abruptly after providing her phone number. Paxlovid: From taking the medication yesterday until now, she is still tasting the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: 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-163-4348488-00.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Apr2021, outcome "recovered" (05Apr2022). The action taken for adalimumab was unknown. Additional information: The patient also received second and booster dose on 21Apr2021 and 01Feb2022.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was possible. The reporter's assessment of the causal relationship of the events with the suspect product Humira (adalimumab) was not provided at the time of this report.  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 Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 06Apr2022 at 19:00, outcome "recovered" (11Apr2022) and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL8982), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN; AMLODIPINE; PROLIA.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical information: Known allergies: No.Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=09Apr2022, treatment stop date=11Apr2022.  No follow up attempts possible. No further information Is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID - 19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: lack of effect; COVID-19; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 13Apr2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FF2587, Expiration Date: 31Mar2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "lack of effect"; COVID-19 (medically significant), outcome "unknown". Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FF2587 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of  the reported events cannot be totally excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Home Ag: Positive; Home Ag: Positive; ST; mild cough; myalgias; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EP6955), on 07May2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 11Apr2022, outcome "unknown", described as "ST"; COUGH (medically significant) with onset 11Apr2022, outcome "unknown", described as "mild cough"; MYALGIA (medically significant) with onset 11Apr2022, outcome "unknown", described as "myalgias"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "Home Ag: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, oropharyngeal pain, cough, myalgia. Therapeutic measures were taken as a result of covid-19.  It was reported that it was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and Since the vaccination, the patient was been tested for COVID-19. It was reported that out with friends to escape room and dinner 09Apr then sx 11Apr late ST mild cough myalgias and positive Ag test 12Apr2022. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Home Ag: Positive; Home Ag: Positive; ST; mild cough; myalgias; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EP6955), on 07May2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 11Apr2022, outcome "unknown", described as "ST"; COUGH (medically significant) with onset 11Apr2022, outcome "unknown", described as "mild cough"; MYALGIA (medically significant) with onset 11Apr2022, outcome "unknown", described as "myalgias"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Apr2022, outcome "unknown" and all described as "Home Ag: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, oropharyngeal pain, cough, myalgia. Therapeutic measures were taken as a result of covid-19.  It was reported that it was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and Since the vaccination, the patient was been tested for COVID-19. It was reported that out with friends to escape room and dinner 09Apr then sx 11Apr late ST mild cough myalgias and positive Ag test 12Apr2022. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, COVID-19, Cough, Nasal congestion, Nasal discomfort
Clinical narrative: Nasal Swab; PCR: Positive; Nasal Swab; PCR: Positive; Throat irritation; Nose stuffiness; Nose irritation; Feels more like sinuses/upper respiratory irritation; Coughing; Reduced appetite; Have a strange rash pop up on my right arm; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Coughing"; RESPIRATORY TRACT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Feels more like sinuses/upper respiratory irritation"; RASH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Have a strange rash pop up on my right arm"; NASAL DISCOMFORT (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose irritation"; NASAL CONGESTION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose stuffiness"; APPETITE DISORDER (non-serious) with onset 10Apr2022, outcome "unknown", described as "Reduced appetite"; THROAT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "Nasal Swab; PCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive, notes: Covid test type post vaccination=Nasal swab Covid test name post vaccination=PCR; (unspecified date) Negative. It was unknown if therapeutic measures were taken as a result of throat irritation, nasal congestion, nasal discomfort, respiratory tract irritation, cough, appetite disorder, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Respiratory tract irritation, SARS-CoV-2 test, Throat irritation, Vaccination failure
Clinical narrative: Nasal Swab; PCR: Positive; Nasal Swab; PCR: Positive; Throat irritation; Nose stuffiness; Nose irritation; Feels more like sinuses/upper respiratory irritation; Coughing; Reduced appetite; Have a strange rash pop up on my right arm; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Coughing"; RESPIRATORY TRACT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Feels more like sinuses/upper respiratory irritation"; RASH (non-serious) with onset 10Apr2022, outcome "unknown", described as "Have a strange rash pop up on my right arm"; NASAL DISCOMFORT (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose irritation"; NASAL CONGESTION (non-serious) with onset 10Apr2022, outcome "unknown", described as "Nose stuffiness"; APPETITE DISORDER (non-serious) with onset 10Apr2022, outcome "unknown", described as "Reduced appetite"; THROAT IRRITATION (non-serious) with onset 10Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "Nasal Swab; PCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive, notes: Covid test type post vaccination=Nasal swab Covid test name post vaccination=PCR; (unspecified date) Negative. It was unknown if therapeutic measures were taken as a result of throat irritation, nasal congestion, nasal discomfort, respiratory tract irritation, cough, appetite disorder, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: sl loss of taste; sl loss of taste; Home Ag: Positive; Home Ag: Positive; congestion; HA; cough; chills; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Apr2022, outcome "unknown"; HEADACHE (non-serious) with onset 07Apr2022, outcome "unknown", described as "HA"; CHILLS (non-serious) with onset 07Apr2022, outcome "unknown"; NASAL CONGESTION (non-serious) with onset 07Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 07Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Home Ag: Positive"; AGEUSIA (non-serious), SALIVARY GLAND MASS (non-serious) all with onset 09Apr2022, outcome "unknown" and all described as "sl loss of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, headache, cough, nasal congestion, chills, ageusia, salivary gland mass.  Clinical information: The patient was receive any other vaccines within 4 weeks prior and prior to vaccination to the COVID vaccine and patient diagnosed with COVID-19 was unknown, since the vaccination the patient has been tested for COVID-19. Reported Event: to weekend 02Apr2022 to 03Apr2022 and then fatigue 06Apr2022, HA cough congestion chills 07Apr2022 and then tested positive 08Apr with home AG then sl loss of taste over 09Apr2022 w/e.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, SARS-CoV-2 test, Salivary gland mass, Vaccination failure
Clinical narrative: sl loss of taste; sl loss of taste; Home Ag: Positive; Home Ag: Positive; congestion; HA; cough; chills; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 28-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Apr2022, outcome "unknown"; HEADACHE (non-serious) with onset 07Apr2022, outcome "unknown", described as "HA"; CHILLS (non-serious) with onset 07Apr2022, outcome "unknown"; NASAL CONGESTION (non-serious) with onset 07Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 07Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "Home Ag: Positive"; AGEUSIA (non-serious), SALIVARY GLAND MASS (non-serious) all with onset 09Apr2022, outcome "unknown" and all described as "sl loss of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, fatigue, headache, cough, nasal congestion, chills, ageusia, salivary gland mass.  Clinical information: The patient was receive any other vaccines within 4 weeks prior and prior to vaccination to the COVID vaccine and patient diagnosed with COVID-19 was unknown, since the vaccination the patient has been tested for COVID-19. Reported Event: to weekend 02Apr2022 to 03Apr2022 and then fatigue 06Apr2022, HA cough congestion chills 07Apr2022 and then tested positive 08Apr with home AG then sl loss of taste over 09Apr2022 w/e.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Paxlovid/fully vaccinated. I've had 3 doses of the vaccine; Tested positive for Paxlovid/fully vaccinated. I've had 3 doses of the vaccine; 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 COVID-19 Vaccine - Manufacturer Unknown, 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: "Rheumatoid arthritis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Tested positive for Paxlovid/fully vaccinated. I've had 3 doses of the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: she tested positive for Paxlovid and started taking Paxlovid this sunday. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient stated this was not a complaint at all. However, patient would like to suggest a few things. The local doctors don't know how to prescribe the drugs correctly. Patient did her research before taking Paxlovid and I had to stop taking my statins and the drug she takes for her rheumatoid arthritis. Her regular internist didn't know they interacted with Paxlovid". "Local doctors on the ground need better education. It's like the wild west right now". Patient stated that she tested positive for Paxlovid and started taking Paxlovid this sunday. However, a couple of hours ago (12Apr2022) she noticed that her urine was turning a different color. Patient reported that she was fully vaccinated. She had 3 doses of the vaccine.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fowler's position
Clinical narrative: Client received her COVID Moderna Booster dose lot # 035C21A exp. 12.30.21 on 12.09.21. At 1257, client reported to EMT that she was feeling ?lightheadedness,? and he transported client to the anti-gravity chair in a semi-fowler position. PHN came to assist with the client. Client denied shortness of breath (SOB). At 1300, EMT took client?s vitals: BP 108/746, HR 66, R 17, O2 Sat. 99%, and client was alert and oriented x 4. At 1305, EMT took client?s vitals: BP 110/70, HR 72, O2 Sat. 99%, and client ate the crackers and juice provided by EMT. Client told she didn?t eat anything today. Client denied SOB or any other anaphylactic signs and symptoms. She denied any history of allergy or taking any medications. At 1328, EMT took client?s vitals: BP 110/76, HR 76, O2 Sat. 99%, and client said her ?lightheadedness? was 2/10. At 1330, client reported she was ?feeling better? and denied any ?lightheadedness? or any other symptoms. At 1330, PHN educated client on adverse reactions and when to seek EMS. At 1335, client declined to have her last vitals taken and left the vaccination site with a steady gait.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: patient  received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration; patients received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 1(tris), 0.2 ml single (Lot number: FL8094, Expiration Date: Sep2021) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: OVERDOSE (medically significant) with onset 12Apr2022, described as "patient  received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration"; PRODUCT PREPARATION ISSUE (medically significant) with onset 12Apr2022, described as "patients received the orange cap formulation of the Pfizer BioNTech Covid 19 vaccine that was not diluted before administration".Clinical information:  Reporter made a mistake today and the vaccines went out not diluted,  just discovered it happened, and four children received the vaccines, ages ranging from 8-10. Reporter  doesn't have dates of birth, height, weight or ethnicity to provide for these patients. Reporter provides age, sex, and initials for the four patients. Four patients received the undiluted vaccine as their first doses.; Sender's Comments: Based on the known safety profile of vaccine and the information available the Causal relation between the event and suspect drug is assessed as N/A,Linked Report(s) : US-PFIZER INC-202200566505 same reporter/drug/AE, different patient
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Herpes zoster, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Shingles; Eye infection; 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-163-4245187-00 (Company).  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years 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 included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of Administration: Intramuscular), administration date: 01Aug2021, when the patient was 62-year-old, for COVID-19 immunisation. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; EYE INFECTION (non-serious), outcome "unknown". The action taken for adalimumab was unknown. The reporters causality for the event(s) of shingles, rheumatoid arthritis flare up and eye infection was not provided for suspect Humira.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "shingles" and "eye infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events 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.