chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient received his first dose of the Moderna COVID-19 vaccines on 29-JUN-2022. He never received a second dose of the vaccine.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received his first dose of the Moderna COVID-19 vaccines on 29-JUN-2022. He never received a second dose of the vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received his first dose of the Moderna COVID-19 vaccines on 29-JUN-2022. He never received a second dose of the vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received his first dose of the Moderna COVID-19 vaccines on 29-JUN-2022. He never received a second dose of the vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received his first dose of the Moderna COVID-19 vaccines on 29-JUN-2022. He never received a second dose of the vaccine.).    No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: more than 36 days passed since patient received the first dose of primary series. Second dose has not been administered at the time of call; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (more than 36 days passed since patient received the first dose of primary series. Second dose has not been administered at the time of call) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (more than 36 days passed since patient received the first dose of primary series. Second dose has not been administered at the time of call) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (more than 36 days passed since patient received the first dose of primary series. Second dose has not been administered at the time of call) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (more than 36 days passed since patient received the first dose of primary series. Second dose has not been administered at the time of call).    No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid back in July 2022 with fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had covid back in July 2022 with fever) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced COVID-19 (had covid back in July 2022 with fever). At the time of the report, COVID-19 (had covid back in July 2022 with fever) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: BBIBP-CORV on 02-Oct-2021, BBIBP-CORV on 04-Nov-2021 and BBIBP-CORV on 03-Feb-2022. Past adverse reactions to the above products included No adverse event with BBIBP-CORV, BBIBP-CORV and BBIBP-CORV.    On 13-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine from a vial that had been punctured more than 12 hours ago.).    The patient received historical vaccines in a foreign country. The patient did not report any adverse reactions to the Covid-19 (Vero).  No concomitant medications was reported.  No treatment medications was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient had their first Moderna primary dose on 18Mar2022, and would to know what to do for the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient had their first Moderna primary dose on 18Mar2022, and would to know what to do for the second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient had their first Moderna primary dose on 18Mar2022, and would to know what to do for the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient had their first Moderna primary dose on 18Mar2022, and would to know what to do for the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient had their first Moderna primary dose on 18Mar2022, and would to know what to do for the second dose).    No concomitant medications were reported.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) and NO ADVERSE EVENT (no adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported. Dosage text of suspect Spikevax Bivalent was reported as Additional Booster.  Patient stated that she had the bivalent 22-Sep-2022, and wanted to know when she should get the next Moderna bivalent dose. She made an appointment and it was declined, stating that they couldn't do that. Patient stated that her friend who got the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.  No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: The next day I had red streaks left arm. It lasted for 3-4 days.; This spontaneous case was reported by a patient and describes the occurrence of RASH ERYTHEMATOUS (The next day I had red streaks left arm. It lasted for 3-4 days.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (The next day I had red streaks left arm. It lasted for 3-4 days.). At the time of the report, RASH ERYTHEMATOUS (The next day I had red streaks left arm. It lasted for 3-4 days.) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Reporter did not allow further contact
Age: 45.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was taken out of the refrigerator on 07-Apr-2023 at 8:20 am and administered to the patient on 10-Apr-2023 1:00 pm; no adverse event; Patient received bivalent vaccine exposed to room temperatures greater than 24 hours on 10-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent vaccine exposed to room temperatures greater than 24 hours on 10-Apr-2023), PRODUCT STORAGE ERROR (The vaccine was taken out of the refrigerator on 07-Apr-2023 at 8:20 am and administered to the patient on 10-Apr-2023 1:00 pm) and NO ADVERSE EVENT (no adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.   Concurrent medical conditions included Hypertension.    On 10-Apr-2023 at 1:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023 at 1:00 PM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent vaccine exposed to room temperatures greater than 24 hours on 10-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was taken out of the refrigerator on 07-Apr-2023 at 8:20 am and administered to the patient on 10-Apr-2023 1:00 pm). an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent vaccine exposed to room temperatures greater than 24 hours on 10-Apr-2023), PRODUCT STORAGE ERROR (The vaccine was taken out of the refrigerator on 07-Apr-2023 at 8:20 am and administered to the patient on 10-Apr-2023 1:00 pm) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received bivalent vaccine exposed to room temperatures greater than 24 hours on 10-Apr-2023) and PRODUCT STORAGE ERROR (The vaccine was taken out of the refrigerator on 07-Apr-2023 at 8:20 am and administered to the patient on 10-Apr-2023 1:00 pm).    No concomitant medications were reported.  Patient received first dose of Moderna COVID-19 vaccine monovalent on 12-Jan-2021 (lot number 25J20A), second dose on 09-Feb-2021 ((lot number 013L20A) and first booster dose on 03-Dec-2021 (lot number 037F21A).  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-719683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719683:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered vaccine after the 30 day beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 13-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No reported symptoms.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719719 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719719:2nd adult patient
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No Adverse Event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 14-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Bivalent Moderna COVID-19 vaccine instead of Monovalent first dose).    No concomitant medication were reported.  Reporter did not have patient information and was not a hundred percent sure about the date of the event. No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Drug ineffective, Headache, Suspected COVID-19, Vomiting
Clinical narrative: Covid; Covid; diarrhea; throwing up at the time; headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). Other Case identifier(s): US-ABBVIE-4134369 (Company).  A 74-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; VOMITING (non-serious) with onset 2022, outcome "unknown", described as "throwing up at the time"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "Covid". Clinical information: In Jul2022, the patient had covid. She was still recovering and getting her strength back. She was throwing up at the time as well as diarrhea and headache for eight days straight.  The reporter's assessment of the causal relationship of "covid", "diarrhea", "throwing up at the time" and "headache" 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.  The reporter's causality for the event(s) of Broke Hip, Blisters popped up on left leg, Covid/words that was trying to say was not coming out, Fell and Leg and foot swell up/right leg a bit swollen with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility. The reporter's causality for the event(s) of Covid/words that was trying to say was not coming out with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  Sender comment: Company's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: Event is more likely related to SARS CoV 2 global pandemic outbreak in this elderly age patient with underlying crohn's disease. Company's Alternative Etiology for Covid/words that was trying to say was not coming out with Adalimumab Solution for Injection: More likely related to concurrent covid infection in this elderly age patient.  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, a causal relationship between BNT162b2, and the events Suspected covid-19, drug ineffective, diarrhea, vomiting, and headache cannot be excluded.,Linked Report(s) : US-ABBVIE-4134369 Company;
Sex: F
Vaccine: COVID19
Symptoms: Body height, Immunisation reaction, Polymers allergy, Weight
Clinical narrative: PEG allergy; just now recovering from horrible symptoms of eruption from Pfizer vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "medication allergies: cabergoline, Midrol, Levaquin adverse tendon pain, Cipro, Penicillin " (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMERS ALLERGY (non-serious), outcome "unknown", described as "PEG allergy"; IMMUNISATION REACTION (non-serious), outcome "recovering", described as "just now recovering from horrible symptoms of eruption from Pfizer vaccination". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that the patient was oddly told to remain compliant by neurologist after Covid vaccinations as it turned out that patient have a PEG allergy and patient was just now recovering from horrible symptoms of eruption from Pfizer vaccination approximately 3 weeks after 1st jab. Other description: Aimovig 140mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Cells in urine, Neoplasm malignant, Precancerous condition, Urine cytology abnormal
Clinical narrative: Pre/cancer behind left ear, top right ear RT side of face, RT temple; Abnormal cell in urine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jun2015 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: CELLS IN URINE (non-serious) with onset Jul2015, outcome "unknown", described as "Abnormal cell in urine"; NEOPLASM MALIGNANT (medically significant) with onset Jan2016, outcome "unknown", described as "Pre/cancer behind left ear, top right ear RT side of face, RT temple". Therapeutic measures were taken as a result of neoplasm malignant. Additional information: Shot: Jun2015, Prevnar 13-Pneumonia (Withheld). Exams: 2009 Dermatology (Withheld) Pre/cancer skin; 2010 Dermatology (Withheld) Pre/cancer skin; 2011 Dermatology (Withheld) Pre/cancer skin; 2012 Dermatology (Withheld) Pre/cancer skin; 2014 Dermatology (Withheld) Pre/cancer skin ear; 2015 Dermatology (Withheld) Pre/cancer skin RT side face; Jun2015 Prostate (Withheld); Jul2015 Cyto (Withheld) Abnormal cell in urine; Jan2016 Dermatology (Withheld) per/cancer behind left ear, top right ear RT side of face, RT temple. 10Jul2018 Dermatology (withheld) surgery left side by ear on face.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Poor quality product administered, Product administration error, Tuberculosis
Clinical narrative: she had soreness; Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023; Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Apr2023 as dose number unknown (booster), 0.3 ml single (Lot number: GJ3270) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VARIVAX II taken for immunisation, on 10Apr2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 10Apr2023, outcome "unknown" and all described as "Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023"; PAIN (non-serious), outcome "unknown", described as "she had soreness". The patient underwent the following laboratory tests and procedures: Tuberculosis: Negative, notes: She was tested for TB which was negative in the week prior.  Additional information: A Pharmacist was calling to get additional information because there was a potential that they have given an expired Pfizer Covid-19 Bivalent Vaccine to a patient, Caller was trying to verify any recommendation afterwards if the patient supposed to get a repeat dose or if it was okay for the patient to get the expired Pfizer Covid-19 Bivalent Vaccine.  Beyond use date (BUD) was 04Apr and it was given on 10Apr, 6 days later. The patient received the Pfizer COVID Vaccine grey cap, bivalent on 10Apr2023 the vaccine beyond use date was on 04Apr2023 administered between 5.15-5.30pm. So, the vaccine was given passed its beyond use date. patient said she had soreness and that was it, she is fine.   Follow-up (11Apr2023 and 12Apr2023): This is a spontaneous follow-up report from a contactable Pharmacist.  Updated information included: Primary reporter (full address, alternative email address added). Patient age at vaccination, name and date of birth added. Other medical history added. Lab tests added. Concomitant drug 'Varivax' added. BNT162b2 Lot number, Dose description, anatomical location added. Event Soreness added.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough, Eye pain, Eye pruritus, Ocular hyperaemia
Clinical narrative: sinus issues; asthma; severe coughing; itchy red sore eyes; itchy red sore eyes; itchy red sore eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues"; ASTHMA (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "severe coughing"; EYE PRURITUS (non-serious), OCULAR HYPERAEMIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "itchy red sore eyes".  Additional information: The reporter and her husband have received the Covid vaccines. Since receiving them they both had serious sinus issues. The husband had been diagnosed with asthma. They both suffered with severe coughing, itchy red sore eyes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinus issues; asthma; severe coughing; itchy red sore eyes; itchy red sore eyes; itchy red sore eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), 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: SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues"; ASTHMA (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "severe coughing"; EYE PRURITUS (non-serious), OCULAR HYPERAEMIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "itchy red sore eyes".  Additional information: The reporter and her husband have received the Covid vaccines. Since receiving them they both had serious sinus issues. The husband had been diagnosed with asthma. They both suffered with severe coughing, itchy red sore eyes.  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: Headache, Migraine
Clinical narrative: headache; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 12Apr2023, outcome "unknown"; MIGRAINE (non-serious) with onset 12Apr2023, outcome "unknown". Additional information: she got her second shot of Pfizer covid vaccine on Monday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Oct2021 at 14:00 as dose 1, single (Lot number: FF8841), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Paxlovid was taken as therapeutic measure as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154565 same patient, different drug/event;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 at 09:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "Known allergies: Sulfa" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for treatment of COVID-19 on 11Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154632 same patient, different drug/event;US-PFIZER INC-202200035067 same patient, different vaccine dose /event;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the first two vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Allergic reaction to the first two vaccines". The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction to the first two vaccines".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300067780 same patient/drug/AE, different dose;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), single (Lot number: BIR5GJ6742) at the age of 52 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Apr2023 to 12Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154221 same reporter/patient,different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJ3275), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL9266), on 24Mar2021 as dose 2, single (Lot number: EN3518) and on 26May2022 at 13:00 as dose 3 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154212 Same reporter/patient,different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYMLOS, start date: Jan2022. Past drug history included: Erythromycin, reaction(s): "Drug Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient treated with paxlovid with start date 28Mar2023 and stop date 02Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154257 Same reporter/patient,different drug/AE.;
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 28 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), on 17Mar2021 as dose 2, single (Lot number: EN6208) and on 29Dec2021 as dose 3 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Petcus Excavatum" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Trazodone, reaction(s): "Known allergies: Trazodone", notes: Known allergies: Trazodone. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 01Apr2023 to 06Apr2023, were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hemochromatosis" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that treatment of COVID 19 with Paxlovid start date was 03Apr2023 and stop date was 08Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: EW015), on 29Oct2021 as dose 3 (booster), single (Lot number: EW0217) and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2011; FAMOTIDINE, start date: Jan2018; ALENDRONATE, start date: Jan2022. Past drug history included: Citalopram, reaction(s): "known allergies: citalopram". The following information was reported: VACCINATION FAILURE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 30Mar2023 to 04Apr2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, No adverse event, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: EW015), on 29Oct2021 as dose 3 (booster), single (Lot number: EW0217) and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Jan2011; FAMOTIDINE, start date: Jan2018; ALENDRONATE, start date: Jan2022. Past drug history included: Citalopram, reaction(s): "known allergies: citalopram". The following information was reported: VACCINATION FAILURE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 30Mar2023 to 04Apr2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), 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 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 26Mar2023 to 30Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.