chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; retested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 75 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 had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "not recovered", described as "retested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: On day 3 after testing positive for Covid-19 I started taking Paxlovid; (Aug2022) Positive, notes: On Day 5 after first positive test I again tested positive; (Aug2022) Negative, notes: On Days 7, and 10 I tested negative; (Aug2022) Negative, notes: On Days 7, and 10 I tested negative; (Aug2022) Positive, notes: Some mild symptoms remained and on Day 13 worsened a bit and I retested and was positive; (Aug2022) Positive, notes: Also positive test on Day 14.tested positive. On Day. Therapeutic measures were taken as a result of drug ineffective, covid-19 included treatment with Paxlovid from 16Aug2022 to 20Aug2022.  Clinical course: Patient received Multivitamin in 2 weeks. Rebound after Paxlovid treatment. On day 3 after testing positive for Covid-19 the patient started taking Paxlovid. On Day 5 after first positive test he again tested positive. On Days 7, and 10 he tested negative. Some mild symptoms remained and on Day 13 worsened a bit and the patient retested and was positive. Also positive test on Day 14.tested positive. Patient had no known allergies.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6198), in right arm, on 31Mar2021 as dose 2, single (Lot number: ER2613), in right arm and on 31Dec2021 as dose 3 (booster), single at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS"; "constipation". There were no concomitant medications (No other medication in 2weeks). Past drug history included: gabapentin, reaction: "known allergies: gabapentin". The following information was reported: vaccination failure (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID from 20Aug2022 to 24Aug2022. Patient also had rebound infection. Patient was tested positive on 28Aug2022 using a BinaxNow home test.  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: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: DOVATO; OLMESARTAN MEDOXOMIL. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: Known allergies: Levaquin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022 at 12:00, outcome "unknown" and all described as "COVID-19 Treatment". 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.  Additional information: other medication details: other medication in 2weeks product: Dovato, Viiv, Olmestartan medixomil and Accord.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Shingrix series complete, get shingles rash a few months later/ suspected vaccination failure; Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: Pharmacist states that he sometimes had patients who completed Shingrix series and then get shingles rash a few months later. The pharmacist did not have any patient specific information at time of reporting, just states that it had happened to several patients. The reporter consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting. This case had been linked with US2022AMR125956, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR125956:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after first Shingrix dose; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Aug-2022 Reporter's comment: The nurse reported that the patient had Shingles after first Shingrix dose. The patient was recovered on 25th August 2022. No additional details provided at that time. The consent to follow-up was granted.
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix administered to an 11 months old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   On 23rd August 2022, the patient received Havrix. On 23rd August 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter reported that, Havrix was administered to an 11 month old patient, he would turned one on 9th September 2022. Did not ask about follow-up. Additional Supportive Information: The reporter reported that, Havrix was administered to an 11 month old patient, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022; No Adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022).    No concomitant medication information was provided. The patient received 2nd dose (6-11 year) beyond 30 days in the refrigerator. It was reported that the vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day. Number of doses/vials were 3 doses/1 vial (6Y-11Y vial). The vial did not undergo any temperature excursion. No treatment medication was provided. This case is created for pediatric patient 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-636320, US-MODERNATX, INC.-MOD-2022-636327 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636320:Paediatric patient -1 US-MODERNATX, INC.-MOD-2022-636327:Paediatric patient -2
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Urticaria, Vaccination site reaction
Clinical narrative: got really sick like the flu; Moderna arm; hives and after the first dose it was worse; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (got really sick like the flu), VACCINATION SITE REACTION (Moderna arm) and URTICARIA (hives and after the first dose it was worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Moderna arm) and URTICARIA (hives and after the first dose it was worse). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (got really sick like the flu). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in 2021 at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (got really sick like the flu) and VACCINATION SITE REACTION (Moderna arm) outcome was unknown and URTICARIA (hives and after the first dose it was worse) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant drug was reported.  The two main shots in Spring 2021 and got the hives. After the first dose it was worse, and the second time it was better but they were taking Zyrtec before they went in, during and after.  Reporter said they wouldn't get a booster or give it to their kids.   This case was linked to MOD-2022-636333 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 038A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Got really sick like the flu) and URTICARIA (Hives after second dose) outcome was unknown. Concomitant product use was not provided by the reporter. It was reported that the hives got after second dose were better than the first time. Patient took Zyrtec before they went in, during and after vaccination. This case was linked to MOD-2022-636331 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B22A, 071F21A, 022M20A and 029L20A) for COVID-19 prophylaxis. The patient had no allergies to medications, food and other products. The patient had not had COVID + test or diagnosis.  Concurrent medical conditions included Hypertension Concomitant products included ATENOLOL and TRIAMTERENE for Hypertension. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, the patient experienced PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (soreness was in different places of her body), PAIN IN EXTREMITY (arms are still sore/soreness was also in the right arm), ARTHRALGIA (all joints are still sore/soreness in the joints) and VACCINATION SITE PAIN (left arm where the vaccine was administered was sore) had not resolved. The adverse events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient had not experienced a similar event in the past. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Respiratory arrest
Clinical narrative: stopped breathing; anxiety; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2), 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: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "stopped breathing"; ANXIETY (non-serious), outcome "unknown". The events "stopped breathing" and "anxiety" required physician office visit. Therapeutic measures were taken as a result of respiratory arrest. Clinical course: The consumer stated that he and his wife got their first dose of the Pfizer Covid 19 vaccine back on 17Jul to 21Jul (no year provided), when his wife stopped breathing. His wife has been on oxygen and has had anxiety ever since. Because of this his wife has not been able to get out of the house and that they had an upcoming doctor's appointment soon for her condition.     The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple myeloma" (unspecified if ongoing). Patient had no known allergies Concomitant medication(s) included: LENALIDOMIDE oral (Celgene Corporation), start date: Feb2022, stop date: 17Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 29Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 03Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. It was unknown if the patient had allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Positive, notes: testing positive for COVID 19 on Saturday 26Aug22. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started paxlovid on 18Aug2022 through 22Aug2022 and rebounded on 25Aug22, testing positive for COVID-19 on 26Aug2022.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid-19.  Tested positive on a take at home rapid antigen test kit.; Contracted Covid-19.  Tested positive on a take at home rapid antigen test kit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EJ1685), on 22Mar2021 as dose 2, single (Lot number: EK5730) and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Aug2022, outcome "recovering" and all described as "Contracted Covid-19.  Tested positive on a take at home rapid antigen test kit.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Aug2022) Positive, notes: Nasal Swab Siemens CliniTest: positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: There was no other vaccine in four weeks. Patient contracted Covid-19, tested positive on a take at home rapid antigen test kit on 27Aug2022. AE resulted in none of the above. There is no Covid prior vaccination. Covid tested post vaccination. Covid test type post vaccination: Nasal Swab Siemens CliniTest on 27Aug2022, was positive. There was no treatment AE. There was no known allergies or other medical history.
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Just loss total hearing in right ear; 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), 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. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization, reaction(s): "Just loss total hearing in right ear"; Bnt162b2 (2nd dose), for COVID-19 immunization, reaction(s): "Just loss total hearing in right ear". The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Just loss total hearing in right ear". Clinical course: Patient stated just loss total hearing in right ear. Read where Pfizer vaccine might cause this. I had all Pfizer Covid vaccinations and boosters. What do you know about this possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 at 12:30 as dose 1, single (Lot number: en6198), in left arm, on 27Mar2021 at 12:30 as dose 2, single (Lot number: er2613), in left arm, on 21Dec2021 at 12:30 as dose 3 (booster), single (Lot number: fh8028), in right arm and on 21Jul2022 at 13:15 as dose 4 (booster), single (Lot number: fp7135) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital syndrome" (unspecified if ongoing); "5 back surgeries" (unspecified if ongoing); "3 heart surgeries" (unspecified if ongoing); "Artificial heart valve" (unspecified if ongoing); "artificial aorta heart rhythm problems" (unspecified if ongoing), notes: artificial aorta heart rhythm problems associated with syndrome controlled by medicine.; "artificial aorta heart rhythm problems" (unspecified if ongoing), notes: artificial aorta heart rhythm problems associated with syndrome controlled by medicine. Patient has no known allergies. Concomitant medications included: DOFETILIDE (manufacturer: sun pharma), start date: Jan2019; METOPROLOL(manufacturer: rising), start date: Dec2013. Patient received Paxlovid from 18Aug2022 to 23Aug2022 for COVID-19 Treatment. Outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Drug ineffective, Electrocardiogram, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3181) at the age of 68 years, in arm 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), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown Results; Blood test: Unknown Results; Electrocardiogram: Unknown Results; SARS-CoV-2 test: Unknown Results. The report was not related to a study or programme. The patient said that with her first shot there was no reaction. The patient went to Pharmacy for both vaccines and she would not have known.  The patient wanted to know whether the first and second vaccines had different ingredients or the vaccines were different. The reporter was reading information from her vaccine card. The patient had Covid-19 in Jan2022. No additional vaccines were administered on same date of the Pfizer suspect.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3181) at the age of 68 years, in arm 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), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown Results; Blood test: Unknown Results; Electrocardiogram: Unknown Results; SARS-CoV-2 test: Unknown Results. The report was not related to a study or programme. The patient said that with her first shot there was no reaction. The patient went to Pharmacy for both vaccines and she would not have known.  The patient wanted to know whether the first and second vaccines had different ingredients or the vaccines were different. The reporter was reading information from her vaccine card. The patient had Covid-19 in Jan2022. No additional vaccines were administered on same date of the Pfizer suspect.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; on the fourth day I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2015, stop date: 20Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 28Aug2022 at 10:00, outcome "recovering", described as "on the fourth day I tested positive"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Aug2022) Positive, notes: my symptoms returned three days after ending the Paxlovid, and on the fourth day I tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Covid rebound: his symptoms returned three days after ending the Paxlovid, and on the fourth day he tested positive. Known allergies was reported as No. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 34-year-old female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06May2021 as dose 3 (booster), single (Lot number: FI4989), in left arm and on 19Nov2021 as dose 4 (booster), single (Lot number: FG3527) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lactose intolerant" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: YASMIN; FLONASE [FLUTICASONE PROPIONATE]; WELLBUTRIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: COVID 19 Treatment; (27Aug2022) Positive, notes: COVID rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 15Aug2022 to 19Aug2022 for treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; rebound after treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "rebound after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive, notes: rebound after treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any Other medication in 2 weeks. No known allergies. Anti-viral details: Product: COVID 19, Treatment Brand: Paxlovid, Treatment start date: 21Aug2022, Treatment stop date: 26Aug2022, Adverse event: rebound after treatment, Adverse event country: Adverse event start date: 29Aug2022, If patient recovered: Recovering, If treatment ae: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug BNT162B2 in the occurrence of the event  cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Influenza, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: 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 67-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he has cardiomyopathy or heart disease" (ongoing), notes: Reporter said he has cardiomyopathy or heart disease.; "arrhythmia" (ongoing); "he has cardiomyopathy or heart disease" (ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "nasty for 3 or 4 days"; DECREASED APPETITE (non-serious), outcome "recovered", described as "loss of appetite"; LETHARGY (non-serious), outcome "recovered", described as "for 3 or 4 days lethargic"; INFLUENZA (non-serious), outcome "recovered", described as "he did not have a good experience with this initial series like not a good flu and kept me out of work for the whole week"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "Couldn't do much/ stayed around the house". Additional information: It was reported that the patient would be 68 in a month. The patient has cardiomyopathy, arrhythmia and was on different medications because of these conditions. The patient was little concerned because of getting more shots. It was reported that, since Comirnaty was new and not tested properly he was a little concerned with his maladies. The patient did not visit his cardiologist about the next shot. Cardiologist was adamant about him getting the first shots because of his malady. The patient was more skeptical going forward. 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) : PFIZER INC-202201104406 Same patient/events, different dose;
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Influenza, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: 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 67-year-old male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "cardiomyopathy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "loss of appetite", "he did not have a good experience with this initial series like not a good flu and kept me out of work for the whole week", "for 3 or 4 days lethargic/Couldn't do much", "Couldn't do much/ stayed around home", "nasty for 3 or 4 days". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "nasty for 3 or 4 days"; DECREASED APPETITE (non-serious), outcome "recovered", described as "loss of appetite"; LETHARGY (non-serious), outcome "recovered", described as "for 3 or 4 days lethargic/Couldn't do much"; INFLUENZA (non-serious), outcome "recovered", described as "he did not have a good experience with this initial series like not a good flu and kept me out of work for the whole week"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "Couldn't do much/ stayed around home". Additional information: The patient would be 68 in a month. The patient has cardiomyopathy, arrhythmia and was on different medications because of these conditions. The patient was little concerned because of getting more shots. The patient did not visit his cardiologist about the next shot. Cardiologist was adamant about him getting the first shots because of his malady. The patient was more skeptical going forward. It was reported as since Comirnaty is new and not tested properly the patient was a little concerned with his maladies. When the time came the patient got first two shots and didn't go with booster because didn't had good reactions to first two shots. Not terrible, just felt nasty for 3 or 4 days.  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) : PFIZER INC-202201104375 Same patient/drug/event, different events;
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; disease recurrance; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 15Feb2021 as dose 1, single (Lot number: 013M20A), in left arm and on 15Mar2022 as dose 2, single (Lot number: 038A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA; TRUVADA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "recovering", described as "disease recurrance". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: felt completely better, started to test negative; (Aug2022) Positive, notes: positive rapid covid tests returned. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical Course:Initial COVID symptoms stopped, felt completely better, started to test negative, 48 hours after stopping Paxlovid, mild symptoms returned. 48 hours after that, positive rapid COVID tests returned.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "recovered", described as "Inflammatory reaction". Additional information: The patient had inflammatory reaction for three days after his covid-19 vaccine, but then was fine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201104380 same suspect vaccine, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: 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 patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2021 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: AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "got the COVID vaccination in May2021 and couldn't taste for 4 months". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient would like to know why the patient got the COVID vaccination in May2021 and could not taste for 4 months, got booster in Dec2021 and now still cannot taste 9 months later. The patient had never had COVID and test if the patient had symptoms and all negative, when will the patient get taste back. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of Vaccine products; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: Tested negative for two days after paxlovid treatment ended; (Aug2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID-19 Treatment from 20Aug2022 to 25Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Ear pain, Magnetic resonance imaging head, Pain in jaw
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old patient received BNT162b2 (BNT162B2), on 05Apr2022 at 16:39 as dose 4 (booster), single (Lot number: FP4554, Expiration Date: 30Jul2022) at the age of 63 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer", start date: Oct2019 (unspecified if ongoing); "R lower Lobectomy", start date: Feb2020 (unspecified if ongoing), notes: R lower Lobectomy; "Cholesterol" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing); "Rash-Herpes" (unspecified if ongoing). Concomitant medication(s) included: FAMVIR [FAMCICLOVIR] oral taken for herpes zoster, rash, start date: 1999 (ongoing); REPATHA subcutaneous taken for blood cholesterol, start date: 2021 (ongoing). Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); unknown manufacturer), for COVID-19 Immunization. The following information was reported: EAR PAIN (non-serious) with onset Apr2022, outcome "not recovered"; PAIN IN JAW (non-serious) with onset Apr2022, outcome "not recovered", described as "Jaw pain"; TOOTHACHE (non-serious) with onset Apr2022, outcome "not recovered", described as "Teeth pain". The events "teeth pain", "ear pain" and "jaw pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, ear pain, pain in jaw. Additional information: The patient did not receive prior vaccinations within four weeks. The patient underwent physical therapy in May2022 for jaw pain and acupuncture in Jun2022 for ear pain. The patient reported that pain started in Apr2022 and was still in pain. It was also reported that the patient went to physical therapy for ear, jaw, teeth pain and went to Chiropractor for acupuncture. The patient received treatment with steroids for the events.