chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Genital herpes, SARS-CoV-2 test
Clinical narrative: Had covid 1 month ago; genital herpes; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and Influenza. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and Influenza. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR JPI) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes). At the time of the report, COVID-19 (Had covid 1 month ago) and GENITAL HERPES (genital herpes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported. It was reported that patient had 5 or 6 shots. Most recent one was probably 7 months ago. Given 3 tablets by patient doctor for 5 days, starting 2 days after first experiencing symptoms. patient forget what they were called but it reduced the symptoms quickly. Starting the second day of symptoms patient got congested. Symptoms improved quickly after this medication started. Currently taste is a little off. patient had home test on 6th day after taking the pills which was negative for COVID-19. Most recent vaccine was probably pfizer, but contact is unsure. Contact has genital herpes and had not an outbreak of these since receiving the Moderna vaccines. There was one exception to this where patient had an outbreak on the back of his leg where patient took acyclovir and it went away within one day. This abnormal to his usual experience with his herpes.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature; No adverse event; poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    No concomitant medications was reported. The patient received the Moderna Primary series first dose on 24-Mar-2021 with lot number 031A21A in right arm, received second Moderna primary series dose on 21-Apr-2021 with lot number 047B21A in left arm and Moderna Monovalent booster dose on 8-Mar-2022 with lot number 027L21A in right arm. Expiration date was unknown. No adverse reaction was reported for the vaccine. No treatment drug details was reported.
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 22-Mar-2023 and was administered to patient on 24-Apr-2023; No adverse event; 75-year-old patient received Expired 5th dose Moderna COVID-19 Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (75-year-old patient received Expired 5th dose Moderna COVID-19 Bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 22-Mar-2023 and was administered to patient on 24-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (75-year-old patient received Expired 5th dose Moderna COVID-19 Bivalent vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 22-Mar-2023 and was administered to patient on 24-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (75-year-old patient received Expired 5th dose Moderna COVID-19 Bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 22-Mar-2023 and was administered to patient on 24-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (75-year-old patient received Expired 5th dose Moderna COVID-19 Bivalent vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 22-Mar-2023 and was administered to patient on 24-Apr-2023).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that the vial in carton of size 2.5 ml was not exposed to temperature excursion. It was also reported that there were three vials in carton and discarded all 3 but used 1 vial for 1 patient.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Dyspnoea, Fatigue
Clinical narrative: She can't drive.; achy; She walks very slow with help; She gets out of breath easy; Sore arm; headache; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and GAIT DISTURBANCE (She walks very slow with help) and DYSPNOEA (She gets out of breath easy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative. On an unknown date, Colonoscopy: Negative. On an unknown date, Computerised tomogram: Negative. On an unknown date, Magnetic resonance imaging: Negative.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient eventually had to quit her job. Patient had seen 23 doctors so far. Reporter could not recall dates of vaccination. He could confirm that patient received primary series. Reporter was also unsure if patient received any booster doses.  No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Impaired driving ability, Magnetic resonance imaging, Pain
Clinical narrative: She can't drive.; achy; She walks very slow with help; She gets out of breath easy; Sore arm; headache; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and GAIT DISTURBANCE (She walks very slow with help) and DYSPNOEA (She gets out of breath easy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative. On an unknown date, Colonoscopy: Negative. On an unknown date, Computerised tomogram: Negative. On an unknown date, Magnetic resonance imaging: Negative.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient eventually had to quit her job. Patient had seen 23 doctors so far. Reporter could not recall dates of vaccination. He could confirm that patient received primary series. Reporter was also unsure if patient received any booster doses.  No treatment medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She can't drive.; achy; She walks very slow with help; She gets out of breath easy; Sore arm; headache; fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), GAIT DISTURBANCE (She walks very slow with help), DYSPNOEA (She gets out of breath easy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, IMPAIRED DRIVING ABILITY (She can't drive.), PAIN (achy), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and GAIT DISTURBANCE (She walks very slow with help) and DYSPNOEA (She gets out of breath easy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative. On an unknown date, Colonoscopy: Negative. On an unknown date, Computerised tomogram: Negative. On an unknown date, Magnetic resonance imaging: Negative.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient eventually had to quit her job. Patient had seen 23 doctors so far. Reporter could not recall dates of vaccination. He could confirm that patient received primary series. Reporter was also unsure if patient received any booster doses.  No treatment medications was reported.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that had been left in a medical cooler with the temperature not monitored for 19 hours and 25 minutes).    No concomitant medications were provided. The patient received first dose of the Moderna primary series on 05-Mar-2021 with lot number 029A21A. Second dose on 08-Apr-2021 with lot number 027B21A. It was not known which arm patient received both first and second dose. First Moderna Monovalent booster dose on 20-Nov-2021 in left arm with lot number 939904. The expiration date was not known for first, second and first booster dose No other adverse reactions were reported after all 4 doses.  No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received a vaccine that had 5 different temperature excursions; No adverse event; Patient received a vaccine that had 5 different temperature excursions; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Patient has no allergy.  Concurrent medical conditions included Asthma (uncomplicated) and High cholesterol.    On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that had 5 different temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that had 5 different temperature excursions).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: After the first and 2nd shot, patient did not feel good; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 007B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (22 years ago).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-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 FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good). At the time of the report, FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported patient did not had any other vaccine at the same time as the DEC-2022 COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2023-721293 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023).    No concomitant medications was provided. No treatment medications was provided. HCP wanted dosing information on patients 6 Months of Age and Older Not Previously Vaccinated with a COVID-19 Vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-721294 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721294:(Patient 2 out of 2)
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144(15) or (B)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypercholesteraemia (not really, she just started taking meds for that) and Blood pressure high (not really, she just started taking meds for that). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient takes Plavix as blood thinner was needed. Patient received first dose on 24-Jan-2021 with lot number  042L20A, second dose on 26-Feb-2021 with lot number 001A21A, third dose on 22-Oct-2021 with lot number 048F21A, 1st booster on 22-Apr-2022 with lot number 065K21A. Patient had COVID over weekend last year. Patient cannot remember the exact dates. Patient stayed at home and took Paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 14:00 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 at 13:00 as dose 2, single (Lot number: EN6300), in left arm and on 02Sep2021 at 13:00 as dose 3 (booster), single (Lot number: EW0185) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2022 at 10:00 as dose 4 (booster), single (Lot number: 060H21A), in left arm and on 11Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Feb2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". 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: The patient received Paxlovid for COVID-19 treatment from 10Apr2023 to 15Apr2023.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, EM9809, fill lot EP8735, EM9807, and the formulated drug product lot EP8616, EM9805. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Lot provided as EN6300 is invalid as per SAP.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE), Interchange of vaccine products and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300165019 same reporter/patient, different product/AE;
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Tiredness; pain in joints; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: 3013513A) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "bipolar" (unspecified if ongoing), notes: Diagnosed 7 years ag. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0177, Expiration date: Unknown , Route of administration: Unknown), administration date: 18May2021, when the patient was 39-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE , Lot number: EW0196, Expiration date: Unknown , Route of administration: Unknown), administration date: 08Jun2021, when the patient was 39-year-old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in joints".  Additional information: Patient was tired for a while back. He was not happy enough walking and going to the beach. It was first the tiredness and then came the joint pain. Patient's joint pain started almost a year ago.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401449 same reporter/product, different patient/dose/event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 08May2021 as dose 2, single (Lot number: ER8836) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sinusitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Opoids, reaction(s): "known allergies: Opoids". Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Batch/Lot No: FW0169, Location of injection: Arm Left, Route of administration: Unknown , Expiration date: Unknown), administration date: 17Apr2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient was not sure when tinnitus began, but patient heard slight noise at first in her left ear at night when she layed down and it was real quiet. In the past couple of months the condition gotten louder where she heard it all the time. Patient came across an article telling people were experiencing this after Covid-19 shots. She haven't had any symptoms before. Patient haven't received any vaccine in four weeks.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: 053D22A) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FJ4989), 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: "Mild heart disease" (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 Apr2023, outcome "recovered" (17Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received other medication in 2weeks. It was reported that patient was treated with Paxlovid from 11Apr2023 to 15Apr2023. Took the full course of Paxlovid. Tested 2 days after completion and tested negative.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166762 same reporter/patient, different drug/AE;
Age: 59.0
Sex: F
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) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 59 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), 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: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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.  Clinical course: Symptoms returned and tested positive for Covid after 4 days, symptom free after 5 day paxlovid treatment.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 53 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166767 same reporter/patient, different drug/AE;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Sep2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Pork allergy" (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 Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with PAXLOVID from 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166921 same patient, different drug/AE;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 Batch/Lot No: GL0446; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Jan2023 as dose 1, single (Lot number: GL0446) at the age of 52 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Allergy". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 16Jan2023, outcome "unknown", described as "Dose Number: 1 Batch/Lot No: GL0446"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166986 same patient, different drug/events;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 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: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Negative; (21Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for COVID-19 Treatment from 12Apr2023 to 16Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166772 same reporter/patient, different drug/AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "liver issue" (unspecified if ongoing); "Known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as COVID-19 treatment from 12Apr2023 to 17Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167548 same patient, different drug/event (Paxlovid);
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: HUMALOG. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167782 Same reporter/patient,different drug/AE.;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Drug ineffective; COVID-19; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2021 as dose 2 (booster), single (Lot number: JC359), in right arm and on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jun2022 at 10:00 as dose 4 (booster), single (Lot number: 060A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pollen allergies" (unspecified if ongoing); "Grass allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering"; DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID 19 from 13Apr2023 to 18Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167757 same patient, different dose/events;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:00 as dose 6 (booster), single (Lot number: GH9694) at the age of 53 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "dry eye" (unspecified if ongoing); "DDD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Levaquin" (unspecified if ongoing); "Known allergies: Bactrim DS" (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 Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid from 12Apr2023 to 17Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167034 same patient, different drug/ event;
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain Left arm; Tingling; Burning pain; Pain in neck radiating to arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Burning pain"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Pain Left arm"; NECK PAIN (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Pain in neck radiating to arm"; PARAESTHESIA (non-serious) with onset 05Oct2022, outcome "not recovered", described as "Tingling". The events "pain left arm", "tingling", "burning pain" and "pain in neck radiating to arm" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, paraesthesia, pain, neck pain.  Additional Information: It was unknown if patient had other vaccine in four weeks. It was reported unknown if patient was tested for COVID post vaccination or had COVID prior vaccination.   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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: EW0158), in right arm, on 05May2021 as dose 2, single (Lot number: EW0167), in left arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FH8028), in right arm and on 10Aug2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received Paxlovid as Covid-19 treatment from 19Apr2023 to 22Apr2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166779 Same patient, different drug/AE;