chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HBV (Engerix B) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   On 27th December 2022, the patient received the 3rd dose of Engerix B. On 27th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose, 1st was in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th August 2021 with batch number 44DX9 and expiry date 28th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-DEC-2022  Reporter's Comments: The pharmacist reported that patient did not receive the 2nd dose of Shingrix.  The reporter enquired to repeat the series. The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested for Covid, Nasal Swab: postitve (18OCT2022); Tested for Covid, Nasal Swab: postitve (18OCT2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 51 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 at 12:00 as dose 1, single (Lot number: FN6204), in left arm, on 16Apr2021 at 12:00 as dose 2, single (Lot number: FP2533), in left arm, on 29Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 16Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history (no known allergies). The patient took concomitant medications (Probiotic). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Oct2022, outcome "unknown" and all described as "Tested for Covid, Nasal Swab: postitve (18OCT2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201398220 Same reporter/patient, same drug/different dose, different AE;US-PFIZER INC-202201397769 Same reporter/patient, same drug/different dose, different AE;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID; COVID; her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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 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"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.  Clinical course: My Husband was positive for Covid, not recently" and did not have any symptoms. The patient was not the reporter. Reporter type: Consumer or other non health professional (wife). COVID-19 vaccine was a Pfizer product. Paxlovid was a Pfizer product, Reason for no lot number: of Prevnar and unspecified flu shot, Moderna COVID-19 vaccine, COVID-19 bivalent vaccine: Caller unwilling to complete the report. Caller mentioned her husband also got the COVID-19 vaccines including three Moderna and two Pfizer, including bivalent, and her husband also had COVID and had mild symptoms. Agent reports caller mentioned that her husband's doctor also gave the medication, which agent is not sure which but he believes it was Paxlovid. Agent reports caller would like to know contraindicated drugs with Paxlovid. Documented as consumer, unable to verify with caller. Caller provides no further details about this medication. They both tested positive, and her husband had no symptoms whatsoever, but she had some, but they didn't test her for the flu so those could have been the flu. Pfizer COVID-19 vaccine/Pfizer COVID bivalent vaccine, Moderna COVID-19 vaccine: She and her husband got the COVID-19 vaccines including three Moderna and one Pfizer, also including a bivalent, and she and her husband had COVID, which her husband had no symptoms and she had some.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye operation
Clinical narrative: recently had eye surgery; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: GJ3375) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "discomfort in his arm"; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization, reaction(s): "discomfort in his arm". The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "recently had eye surgery".  Clinical course:  As per agent and confirmed by caller, caller is trying to figure out if the Pfizer covid vaccine he received was the vaccine for omicron. Agent provides lot # GJ3375. States someone suggested it wasnt the vaccine for Omicron but he didnt follow up. Caller clarifies details : he received a third dose of Pfizer covid vaccine on 25Oct2022. He thought he was getting the omicron vaccine as he heard on the news that it was available.  States he is in his mid 80s and recently had eye surgery. Caller unable to read information on his vaccination card upon request for information on the card.  Also states he felt no reaction whatsoever after he received the pfizer covid vaccine whereas with the first 2 covid 19 vaccine doses, he experienced discomfort in his arm for several days. States he is confused why he didnt experience any reactions with his last vaccine- he is wondering if he received a placebo.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time; I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GJ6796) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2022, outcome "unknown" and all described as "I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2022) positive; (26Dec2022) positive.  Clinical course: I am wondering if my last COVID vaccine was an older version. I was expecting one that it would provide protection against the most recent strains. I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time (24Dec2022 and still positive on 26Dec2022). This was very disappointing. My last vaccine was 12Nov2022 from #: GJ6796.  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 available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021010707 same reporter/patient, different dose/events;
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time; I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 5 (booster), single (Lot number: GJ6796) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2022, outcome "unknown" and all described as "I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Dec2022) positive; (26Dec2022) positive.  Clinical course: I am wondering if my last COVID vaccine was an older version. I was expecting one that it would provide protection against the most recent strains. I have had 5 vaccinations since 22Dec2020 and have just tested positive for COVID for the first time (24Dec2022 and still positive on 26Dec2022). This was very disappointing. My last vaccine was 12Nov2022 from #: GJ6796.  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 available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021010707 same reporter/patient, different dose/events;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2021 at 14:00 as dose 1, single (Lot number: EW0162) at the age of 52 years, in left arm, on 12May2021 at 14:00 as dose 2, single (Lot number: Ew0179) at the age of 52 years, in left arm, on 17Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 53 years, in left arm and on 30Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. 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 vaccination failure, covid-19. Clinical course: Patient received Paxlovid as COVID 19 treatment, from 15Dec2022 to 20Dec2022.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; SPIRONOLACTONE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive, notes: tested positive for COVID on Saturday 17Dec; (22Dec2022) Negative, notes: a rapid COVID test was negative; (26Dec2022) positive, notes: on monday 26Dec a rapid COVID test came back positive; (27Dec2022) unknown results, notes: did a follow up test on Tuesday 27Dec. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: Paxlovid taken that evening. Took all of the doses concluding in the morning of Thursday 22Dec, by which time my symptoms had resolved and a rapid COVID test was negative. On Sunday 25Dec my symptoms had returned (congestion, sore throat, cough - no fever) and in the evening on Monday 26Dec a rapid COVID test came back positive, as did a follow up test on Tuesday 27Dec.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna COVID-19 Vaccine dose 3 and Pfizer Vaccine dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Failure" (unspecified if ongoing); "pre-hypertension" (unspecified if ongoing); "Known allergy: Iodine as contrast dye" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "low testosterone" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown", described as "Moderna COVID-19 Vaccine dose 3 and Pfizer Vaccine dose 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid (lot number: unknown) on 17Dec2022 and stopped on 22Dec2022 for treatment of 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna Vaccine dose 4 and Pfizer vaccine dose 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diabetes, controlled by medication; "high blood pressure" (unspecified if ongoing), notes: high blood pressure controlled by medication. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2019; LOSARTAN, start date: Jan2019; FAMOTIDINE, start date: Jan2019; ROSUVASTATIN, start date: Jan2019, stop date: 10Dec2022. Past drug history included: Lisinopril, reaction(s): "known allergies lisinopril", notes: known allergies lisinopril. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Oct2022, outcome "unknown", described as "Moderna Vaccine dose 4 and Pfizer vaccine dose 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: still slight positive line on home COVID test; (19Dec2022) Negative, notes: Negative COVID home test on morning of 19Dec2022; (21Dec2022) Positive, notes: positive on home COVID test that evening. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Started 5-day dose of Paxlovid in evening of 11Dec2022, finished it morning of 16Dec2022. Negative COVID home test on morning of 19Dec2022. Developed repeat of initial COVID symptoms in afternoon of 21Dec2022, tested positive on home COVID test that evening. Doctor recommended no further meds, COVID symptoms currently thru 27Dec2022, still slight positive line on home COVID test. Have lost sense of smell and taste.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:15 as dose 5 (booster), 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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ENBREL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Feb2021 as dose 1, single (Lot number: 006M20A), in left arm, on 18Mar2021 as dose 2, single (Lot number: 038A21A), in left arm, on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Sep2022 as dose 5 (booster), single (Lot number: 017AOC), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cardiovascular disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Interchange of vaccine product"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 treatment with Paxlovid, treatment start date: 18Dec2022, treatment stop date: 23Dec2022. Patient had no known allergies.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)  The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: 655342) at the age of 45 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), on 28Apr2021 as dose 2, single (Lot number: ER8736) and on 18Nov2021 as dose 3 (booster), single (Lot number: FD0809) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Known allergies: Azithromycin", notes: Known allergies: Azithromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID rebound with positive Binax Now test result. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment/ Paxlovid Rebound; COVID 19 Treatment/ Paxlovid Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8727), in right arm and on 23Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/ Paxlovid Rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (COVID-19 treatment).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Somewhat overweight, otherwise, none" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 15Jan2015, stop date: 17Dec2022; OMEPRAZOLE, start date: 08Apr2016.  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. Clinical course: Five days after finishing paxlovid course my Covid symptoms returned. Same symptoms as before, sinus congestion, mild cough, headache. Patient took medication from 17Dec2022 to 21Dec2022. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN [LORATADINE]; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Dec2022) Positive, notes: Continue to test positive; (19Dec2022) Negative; (20Dec2022) Negative; (21Dec2022) Negative; (22Dec2022) Negative; (23Dec2022) Negative; (24Dec2022) Negative; (25Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Yes other medication in 2weeks and no known allergies.   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, COVID19
Symptoms: Condition aggravated, Dysgeusia, Herpes zoster, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Developed shingles; neuropathy in hands and feet became chronic; neuropathy in hands and feet became chronic; Experienced mild numbness in hands and feet; Immediate metal taste in mouth after both doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (prev dose brand unknown=False, is bivalent= False, prev dose lot number= ER8727, prev dose lot unknown= False, prev dose administration date= 29Mar2021, prev dose dose number=1, prev dose vaccine location=Right arm, Immediate metal taste in mouth after both doses), administration date: 29Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "metal taste in mouth"; Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: DYSGEUSIA (disability) with onset Apr2021, outcome "recovered with sequelae", described as "Immediate metal taste in mouth after both doses"; HYPOAESTHESIA (disability) with onset 14May2021, outcome "recovered with sequelae", described as "Experienced mild numbness in hands and feet"; NEUROPATHY PERIPHERAL (disability), CONDITION AGGRAVATED (disability) all with onset 14May2021, outcome "recovered with sequelae" and all described as "neuropathy in hands and feet became chronic"; HERPES ZOSTER (disability) with onset Aug2021, outcome "recovered with sequelae", described as "Developed shingles". The events "immediate metal taste in mouth after both doses", "experienced mild numbness in hands and feet", "developed shingles" and "neuropathy in hands and feet became chronic" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Therapeutic measures were taken as a result of dysgeusia, hypoaesthesia, herpes zoster, neuropathy peripheral, condition aggravated.  Clinical information: Patient did not took any other vaccine in four weeks. Other medications in two weeks: Ibuprofen 200mg. She was not having covid prior to vaccination and tested positive post vaccination. Immediate metal taste in mouth after both doses. She experienced mild numbness in hands and feet about 1 month later. Developed shingles 4 months later in Aug2021 (had Shingrix vaccine 2 dose in Jan2019) treated with antiviral and recovered but neuropathy in hands and feet became chronic. She received treatment of valACYclovir HCl 1 GM for adverse event. No known allergies were reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399442 similar report from same reporter;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Developed shingles; neuropathy in hands and feet became chronic; neuropathy in hands and feet became chronic; Experienced mild numbness in hands and feet; Immediate metal taste in mouth after both doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (prev dose brand unknown=False, is bivalent= False, prev dose lot number= ER8727, prev dose lot unknown= False, prev dose administration date= 29Mar2021, prev dose dose number=1, prev dose vaccine location=Right arm, Immediate metal taste in mouth after both doses), administration date: 29Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "metal taste in mouth"; Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: DYSGEUSIA (disability) with onset Apr2021, outcome "recovered with sequelae", described as "Immediate metal taste in mouth after both doses"; HYPOAESTHESIA (disability) with onset 14May2021, outcome "recovered with sequelae", described as "Experienced mild numbness in hands and feet"; NEUROPATHY PERIPHERAL (disability), CONDITION AGGRAVATED (disability) all with onset 14May2021, outcome "recovered with sequelae" and all described as "neuropathy in hands and feet became chronic"; HERPES ZOSTER (disability) with onset Aug2021, outcome "recovered with sequelae", described as "Developed shingles". The events "immediate metal taste in mouth after both doses", "experienced mild numbness in hands and feet", "developed shingles" and "neuropathy in hands and feet became chronic" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Therapeutic measures were taken as a result of dysgeusia, hypoaesthesia, herpes zoster, neuropathy peripheral, condition aggravated.  Clinical information: Patient did not took any other vaccine in four weeks. Other medications in two weeks: Ibuprofen 200mg. She was not having covid prior to vaccination and tested positive post vaccination. Immediate metal taste in mouth after both doses. She experienced mild numbness in hands and feet about 1 month later. Developed shingles 4 months later in Aug2021 (had Shingrix vaccine 2 dose in Jan2019) treated with antiviral and recovered but neuropathy in hands and feet became chronic. She received treatment of valACYclovir HCl 1 GM for adverse event. No known allergies were reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399442 similar report from same reporter;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed shingles; neuropathy in hands and feet became chronic; neuropathy in hands and feet became chronic; Experienced mild numbness in hands and feet; Immediate metal taste in mouth after both doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (prev dose brand unknown=False, is bivalent= False, prev dose lot number= ER8727, prev dose lot unknown= False, prev dose administration date= 29Mar2021, prev dose dose number=1, prev dose vaccine location=Right arm, Immediate metal taste in mouth after both doses), administration date: 29Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "metal taste in mouth"; Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: DYSGEUSIA (disability) with onset Apr2021, outcome "recovered with sequelae", described as "Immediate metal taste in mouth after both doses"; HYPOAESTHESIA (disability) with onset 14May2021, outcome "recovered with sequelae", described as "Experienced mild numbness in hands and feet"; NEUROPATHY PERIPHERAL (disability), CONDITION AGGRAVATED (disability) all with onset 14May2021, outcome "recovered with sequelae" and all described as "neuropathy in hands and feet became chronic"; HERPES ZOSTER (disability) with onset Aug2021, outcome "recovered with sequelae", described as "Developed shingles". The events "immediate metal taste in mouth after both doses", "experienced mild numbness in hands and feet", "developed shingles" and "neuropathy in hands and feet became chronic" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Therapeutic measures were taken as a result of dysgeusia, hypoaesthesia, herpes zoster, neuropathy peripheral, condition aggravated.  Clinical information: Patient did not took any other vaccine in four weeks. Other medications in two weeks: Ibuprofen 200mg. She was not having covid prior to vaccination and tested positive post vaccination. Immediate metal taste in mouth after both doses. She experienced mild numbness in hands and feet about 1 month later. Developed shingles 4 months later in Aug2021 (had Shingrix vaccine 2 dose in Jan2019) treated with antiviral and recovered but neuropathy in hands and feet became chronic. She received treatment of valACYclovir HCl 1 GM for adverse event. No known allergies were reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399442 similar report from same reporter;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dysgeusia, Herpes zoster, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Covid test date= 18Jan2022, covid test result= Positive; Covid test date= 18Jan2022, covid test result= Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8727), in right arm and on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Covid test date= 18Jan2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Additional information: facility type vaccine: Other. No other vaccine in four weeks. No covid prior vaccination. covid tested post vaccination. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399101 same reporter/patient, different dose/event;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Covid test date= 18Jan2022, covid test result= Positive; Covid test date= 18Jan2022, covid test result= Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8727), in right arm and on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Covid test date= 18Jan2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Additional information: facility type vaccine: Other. No other vaccine in four weeks. No covid prior vaccination. covid tested post vaccination. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399101 same reporter/patient, different dose/event;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test date= 18Jan2022, covid test result= Positive; Covid test date= 18Jan2022, covid test result= Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8727), in right arm and on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Covid test date= 18Jan2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Additional information: facility type vaccine: Other. No other vaccine in four weeks. No covid prior vaccination. covid tested post vaccination. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399101 same reporter/patient, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got sick but was ok now/also had COVID after COVID vaccine; got sick but was ok now/also had COVID after COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "asthma" (unspecified if ongoing), notes: her youngest child has asthma and several underlying conditions. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got sick but was ok now/also had COVID after COVID vaccine".  Clinical course: It was reported caller wanted to share her experience with COVID vaccine and say thank you for the privilege of having a vaccination. Caller declines to complete a report for her daughter or other family members, unable to confirm if caller meant her daughter or mother also had COVID after COVID vaccine, at risk report filed for caller's daughter and mother. No further details captured, reported, or documented at this time. COVID vaccine was a Pfizer product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse),   A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Dec2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 60 years 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 included: "Blood pressure high" (unspecified if ongoing), notes: Any other medical condition, consumer stated, "I only have high blood pressure. Concomitant medication(s) included: CARDIZEM [DILTIAZEM] taken for hypertension; TRIAMTERENE/HCTZ taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she took the Paxlovid on the 17th and also she got the COVID 19 vaccine and the booster shots". The events "she took the paxlovid on the 17th and also she got the covid 19 vaccine and the booster shots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results, notes: they just give me they took my blood pressure took care of everything the doctor team; SARS-CoV-2 test: (Dec2022) positive, notes: I think I have the COVID back. The way I feel, the way I am sick now, I am not going to do the test again; Weight: (unspecified date) 202 lbs. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: Reporter stated that she just reporting that she took Paxlovid for five days and had a rebound case and as per the caller she took the Paxlovid on the 17th and also she got the COVID 19 vaccine and the booster shots (Unspecified booster).  Consumer stated, she finished taking it and threw away the package.; Sender's Comments: Based on  available information, the causal association between the events Drug ineffective/Covid-19 and suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded.