chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Agitation, Cerebrovascular accident, Hyperglycaemia, Hypotension
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 12/25/2022 AGITATION I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 AGITATION I95.9 HYPOTENSION 12/25/2022 AGITATION J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 AGITATION G62.9 PERIPHERAL NEUROPATHY 12/25/2022 DM 2 W HYPERGLYCEMIA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 DM 2 W HYPERGLYCEMIA I95.9 HYPOTENSION 12/25/2022 DM 2 W HYPERGLYCEMIA J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 DM 2 W HYPERGLYCEMIA G62.9 PERIPHERAL NEUROPATHY 12/25/2022 AGE RELATED OSTEOPOROSIS I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 AGE RELATED OSTEOPOROSIS I95.9 HYPOTENSION 12/25/2022 AGE RELATED OSTEOPOROSIS J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 AGE RELATED OSTEOPOROSIS
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Type 2 diabetes mellitus
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 12/25/2022 AGITATION I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 AGITATION I95.9 HYPOTENSION 12/25/2022 AGITATION J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 AGITATION G62.9 PERIPHERAL NEUROPATHY 12/25/2022 DM 2 W HYPERGLYCEMIA I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 DM 2 W HYPERGLYCEMIA I95.9 HYPOTENSION 12/25/2022 DM 2 W HYPERGLYCEMIA J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 DM 2 W HYPERGLYCEMIA G62.9 PERIPHERAL NEUROPATHY 12/25/2022 AGE RELATED OSTEOPOROSIS I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 12/14/2022 AGE RELATED OSTEOPOROSIS I95.9 HYPOTENSION 12/25/2022 AGE RELATED OSTEOPOROSIS J96.00 ACUTE RESPIRATORY FAILURE 12/25/2022 AGE RELATED OSTEOPOROSIS
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Kinrix given to pt on 5/30/2023, it expired on 5/26/2023, no symptoms, no reactions.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Redness at injection site, fever, pain up the arm to the neck and down the arm to the hand, pain with shoulder movement.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Deep vein thrombosis
Clinical narrative: I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 11/9/2022 ATHEROSCLEROSIS OF AORTA
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Epilepsy, Glioblastoma multiforme, Intracranial mass
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 12/20/2022 BRAIN MASS J96.00 ACUTE RESPIRATORY FAILURE 12/20/2022 BRAIN MASS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 BRAIN MASS G40.909 EPILEPSY, UNSPECIFIED 12/20/2022 GLIOBLASTOMA MULTIFORME, BRAIN, UNSPECIFIED SITE J96.00 ACUTE RESPIRATORY FAILURE 12/20/2022 GLIOBLASTOMA MULTIFORME, BRAIN, UNSPECIFIED SITE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/20/2022 GLIOBLASTOMA MULTIFORME, BRAIN, UNSPECIFIED SITE
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Urinary tract infection
Clinical narrative: I95.9 HYPOTENSION 12/22/2022 UTI (URINARY TRACT INFECTION)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma, Hypoxia, Post procedural fever
Clinical narrative: Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------ HYPOXIA 10/11/2022 POSTOP FEVER HYPOXIA 10/11/2022 BILAT GLAUCOMA SUSPECT
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Resident admitted to facility on 5/23/2023 on Hospice Care. Resident received vaccine at approximately 1000 on 5/30 at PRIVACY Pharmacy. On 5/31 at 0420, staff found resident unresponsive, not breathing. Pronouncement of death 0420 on 5/31.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Femoral neck fracture, Neuropathy peripheral
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 8/6/2021 LEFT FEMORAL NECK UNSPECIFIED TYPE FX, INIT G62.9 PERIPHERAL NEUROPATHY 8/6/2021 COVID-19 DISEASE
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Back pain, Chills, Ear pain, Eye pain, Headache
Clinical narrative: excessive body aches, chills, internal organs aching, unbearable pain, muscle aches, inability to think and move , teeth pain, eye pain, ear pain, stabbing pain in back, headache, swollen throat, fever, chilled feet and hands
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Mental impairment, Mobility decreased, Myalgia, Pain, Peripheral coldness
Clinical narrative: excessive body aches, chills, internal organs aching, unbearable pain, muscle aches, inability to think and move , teeth pain, eye pain, ear pain, stabbing pain in back, headache, swollen throat, fever, chilled feet and hands
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pharyngeal swelling, Pyrexia, Toothache
Clinical narrative: excessive body aches, chills, internal organs aching, unbearable pain, muscle aches, inability to think and move , teeth pain, eye pain, ear pain, stabbing pain in back, headache, swollen throat, fever, chilled feet and hands
Age: 1.75
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event, administration error. Patient received TDaP instead of 4th dose of DTaP. Disease control was contacted and we were advised since this is the 4th dose in the DTaP series, the TDaP counts as the 4th dose and does not need to be repeated.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Ischaemic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 2/2/2023 ANEMIA
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Hypotension, Nausea, Nephrogenic anaemia, Vomiting
Clinical narrative: I95.9 HYPOTENSION 2/15/2023 NAUSEA AND VOMITING I95.9 HYPOTENSION 2/15/2023 ANEMIA DUE TO CKD I95.9 HYPOTENSION 2/15/2023 CELLULITIS
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic arteriosclerosis, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 ATHEROSCLEROSIS OF AORTA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 HYPOXIA ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 HYPOXIA  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 HYPOXIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 HYPOXIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/8/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE ACUTE ON CHRONIC RESPIRATORY FAILURE 11/8/2022 AMBULATORY OXYGEN THERAPY DEPENDENCE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/6/2023 AMBULATORY OXYGEN THERAPY DEPENDENCE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023 AMBULATORY OXYGEN THERAPY DEPENDENCE
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Medication error, Product administered to patient of inappropriate age
Clinical narrative: Pediatric HepA (Havrix) ordered by MD. Adult HepA (Havrix) administered by CMA. Error noted later during Inventory reconciliation.  MD notified parent of pediatric patient regarding  error made.  Per mother, intermittent diarrhea noted since 18 month visit on 4/19/23.  MD provided routine pediatric intermittent diarrhea treatment recommendations (dietary changes, probiotics, etc). Monitoring response.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Subsequently found out patient received the same Prevnar 20 dose on 5/26/23, we were not informed
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 14-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 43.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 43-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 19-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 74.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 75 year old patient is in a clinical trial and received BEXSERO; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 74-year-old female patient who received Men B NVS (Bexsero) (batch number m7455, expiry date 31-DEC-2022) for prophylaxis.   Concomitant products included MENQUADFI.   On 30-NOV-2022, the patient received the 1st dose of Bexsero. On 30-NOV-2022, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a 75 year old patient is in a clinical trial and received BEXSERO). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-MAY-2023 The registered pharmacist called to inform  that the elderly patient was in clinical trial and received Bexsero.  The patient also received Menquadfi last fall. The reporter also stated she believed that through the clinical trial patient could be receiving a complement inhibitor. The patient had not yet received the second dose of Bexsero. The reporter consented to follow-up. The patient received Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: it was given intradermally; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29-NOV-2024) for prophylaxis.   On 13-MAY-2023, the patient received Boostrix (intradermal). On 13-MAY-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: it was given intradermally). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 A medical assistant reported that a female patient received a dose of Boostrix that was given intradermally. The health care professionals (HCP) said it was given intradermally like a (tuberculosis) TB test. The vaccine administration facility was the same as primary reporter. The patient received Boostrix intradermally, which led to intramuscular formulation administered by other route. The reporter consented to follow-up via email.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore upper left deltoid; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (sore upper left deltoid) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 027B21A and 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced MYALGIA (sore upper left deltoid). At the time of the report, MYALGIA (sore upper left deltoid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had only the same symptom of sore upper left deltoid for all the other moderna vaccines.    No treatment medications were reported.   This case was linked to MOD-2023-725757 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: I got rebound Covid. Chills, runny nose, aches and pains; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got rebound Covid. Chills, runny nose, aches and pains) in a  patient of an unknown age and gender 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.     Previously administered products included for Drug use for unknown indication: Iodine and Sulfa (Sulfa). Past adverse reactions to the above products included Allergy with Iodine and Sulfa.   On 28-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. On 08-May-2023 at 11:00 AM, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 16-May-2023, the patient experienced COVID-19 (I got rebound Covid. Chills, runny nose, aches and pains). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in May 2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I got rebound Covid. Chills, runny nose, aches and pains) had not resolved.            Patient wasn't taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient had received Moderna dose 1 on 29Jan202, Lot No: 932L20A in left arm, Dose 2 on 26Feb2021, Lot No. 022N20A in right arm, Dose 3 in 29Oct2021, Lot No. 932F21A in left arm and dose 4 8Apr2022, Lot No. 046L21A in right arm.  Patient wasn't hospitalized.
Sex: U
Vaccine: COVID19-2
Symptoms: Acute febrile neutrophilic dermatosis
Clinical narrative: have developed Sweet Syndrome; This spontaneous case was reported by a patient and describes the occurrence of ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: COVID-19 Vaccine (Dose 2, received 2 COVID vaccines), COVID-19 Vaccine (Dose 1 and received 2 COVID vaccines). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine and COVID-19 Vaccine.    On an unknown date, the patient received third 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 ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) (seriousness criterion medically significant). At the time of the report, ACUTE FEBRILE NEUTROPHILIC DERMATOSIS (have developed Sweet Syndrome) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment- This spontaneous case concerns a patient of unknown gender and age with no medical history reported who experienced the serious unexpected (medically significant) event acute febrile neutrophilic dermatosis after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. It was reported that after receiving 2 COVID vaccines and one booster patient developed Sweet Syndrome. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose given on 16Feb2021 and 2nd dose on 27Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Adhesive tape allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021).    No concomitant medication information was reported. On 01-Dec-2022, the patient received third dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with route of administration as unknown, dose as unknown and lot number as unknown. On 03-May-2023, received fourth dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with route of administration as unknown and vaccination site deltoid, dose as 0.5 and lot number as AS7173B. No treatment medication information was reported.   This case was linked to MOD-2023-724026 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 doses of Moderna bivalent vaccine was administered ; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered ).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-726446 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726446:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD.).    Concomitant medication details not reported by the reporter. Pharmacist stated that they had 6 patients dosed with the bivalent vaccine which were administered one and two days beyond the BUD. The lot number of the vaccine is AS7173B, the date it was pulled out of the freezer was 24-Apr-2023. 4 doses were administered on 25-May-2023 and 2 doses on 26-May-2023 Treatment details was not reported by the reporter. This case contains information about 1st patient out of 6   This case was linked to US-MODERNATX, INC.-MOD-2023-726808, US-MODERNATX, INC.-MOD-2023-726807, US-MODERNATX, INC.-MOD-2023-726806, US-MODERNATX, INC.-MOD-2023-726805, US-MODERNATX, INC.-MOD-2023-726799 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726808:Patient 6 US-MODERNATX, INC.-MOD-2023-726806:Patient 4 US-MODERNATX, INC.-MOD-2023-726805:Patient 3 US-MODERNATX, INC.-MOD-2023-726807:Patient 5 US-MODERNATX, INC.-MOD-2023-726799:Patient 2
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 2 doses of Moderna bivalent vaccine was administered BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-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 (2 doses of Moderna bivalent vaccine was administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent vaccine was administered BUD).    Concomitant product use was not provided by the reporter.  It was reported that 2 doses of Moderna bivalent vaccine was administered BUD.  Treatment information was not provided.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726786:patient 2
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Callers nephew had a 26 year old friend of his that received the second dose of the vaccine. Died two days later; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Callers nephew had a 26 year old friend of his that received the second dose of the vaccine. Died two days later) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 26-May-2023 The patient died on 26-May-2023. The cause of death was not reported. An autopsy was not performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact; Reporter's Comments: This fatal spontaneous case concerns a 26-year-old patient of an unknown gender, with no medical history reported, who received the second dose of mRNA-1273 vaccine and died two days later (death and medically significant). No details of previous doses were provided. The reported cause of death was not reported. An autopsy was not performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; inadvertently administered an expired dose of the bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) 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. 050D22A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (1st dose, batch ; 025J20-2A) on 05-Jan-2021, MODERNA COVID-19 VACCINE (2nd dose, batch ; 011M20A) on 02-Feb-2021, MODERNA COVID-19 VACCINE (3rd dose, batch ; 007C21A, route: Intramuscular) on 02-Sep-2021, MODERNA COVID-19 VACCINE (4th dose, batch ; 033K21-2A and route: Intramuscular) on 11-Apr-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 25-May-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) .5 milliliter. On 25-May-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 (inadvertently administered an expired dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of the bivalent vaccine).    It was reported that there was no record of patient's medical history.    No concomitant medication was reported. The patient did not had any AE after the administration. No treatment medication was reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: The problem got worst recently; Had hives; Had an immune response to the vaccine a skin rash; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 016M20A and 041L20A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash). The patient was treated with CETIRIZINE at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (The problem got worst recently), URTICARIA (Had hives) and RASH (Had an immune response to the vaccine a skin rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. A few weeks after the first booster patient had hives and rash and had to go to the emergency room. They gave strong antihistamine. At the emergency room they told to go see an allergist. The allergist told that patient had an immune response to the vaccine a skin rash. Now patient had been taking Cetirizine for two years. It had been helping now the problem got worst recently. The allergist recommended more medication and increase dosage.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Product administration interrupted
Clinical narrative: cardiologist didn't receive his second dose, because he had bad Chest-pain.; cardiologist didn't receive his second dose, because he had bad Chest-pain.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.). At the time of the report, CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: I got the vaccine and I'm very sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got the vaccine and I'm very sick) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got the vaccine and I'm very sick). At the time of the report, ILLNESS (I got the vaccine and I'm very sick) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Pyrexia, Tremor
Clinical narrative: Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high; Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and Coronavac. Past adverse reactions to the above products included No adverse event with Coronavac and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me). At the time of the report, DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2023-726767 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2023: Live Follow up received historical vaccine updated.
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Peripheral swelling, Pyrexia
Clinical narrative: Upper arm swelling; High fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Upper arm swelling) and PYREXIA (High fever) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Upper arm swelling) and PYREXIA (High fever). At the time of the report, PERIPHERAL SWELLING (Upper arm swelling) and PYREXIA (High fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High fever.         Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Feeling hot, Peripheral swelling, Tenderness
Clinical narrative: My arm is swelling down into my forearm. It's hot and sore to the touch. I've been back to Dr's office twice today and They were not very reassuring on what to do.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy rectum normal, Colonoscopy, Rectal haemorrhage
Clinical narrative: The next day and for two weeks, the patient experienced significant rectal bleeding in the toilet with each bowel movement.  There was no pain.  The patient went to Urgent Care to be examined, and had a colonoscopy after the bleeding ceased.  The colonoscopy yielded material for biopsy, which came out negative.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Second Bivalent booster given. Clinic was unaware of 10/2022 bivalent booster that the patient had received and mom did not disclose until a follow up phone call was made 5 days later to discuss lab results (unrelated to patient's vaccine). It was during this phone call that mom disclosed patient's vaccine that she received.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness and swelling from shoulder to elbow
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: HCP was not aware of new Bivalent vaccine available administered Monovalent after recommended date by the State.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: HCP was not aware of new Bivalent vaccine available administered Monovalent after recommended date by the State.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Interchange of vaccine products, Tinnitus
Clinical narrative: chills; left ear totally plugged up with tinnitus symptoms/Flushing out of ear; left ear totally plugged up with tinnitus symptoms; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose number unknown (booster), single (Lot number: GJ3277) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Propylene glycol, reaction(s): "Known Allergies: propylene glycol"; Thimerasol for Known allergies: thimerasol. Vaccination history included: moderna (vaccine brand: Other,, vaccine brand other: Moderna,, vaccine brand unknown: False,, vaccine administration date: 26May2023,, vaccine lot number: O45H22A,, vaccine lot unknown: False,, vaccine dose number: 2,, vaccine dose number unknown: False,, vaccine location: Left arm), administration date: 26May2023, when the patient was 82-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE Unknown manufacturer), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Oct2022, outcome "unknown"; CHILLS (non-serious) with onset 15Oct2022, outcome "not recovered"; TINNITUS (non-serious) with onset 15Oct2022, outcome "not recovered", described as "left ear totally plugged up with tinnitus symptoms"; EAR DISCOMFORT (non-serious) with onset 15Oct2022, outcome "not recovered", described as "left ear totally plugged up with tinnitus symptoms/Flushing out of ear". Therapeutic measures were taken as a result of chills, ear discomfort, tinnitus.  additional information: 2 days after Pfizer injection had chills, during night left ear totally plugged up with tinnitus symptoms/Flushing out of ear (on 15Oct2022 at 12:00 AM) with the treatment of antibiotics, Flonaseuse. Symptoms have continued since Pfizer injection. Injection Pfizer GJ3277 bivalent. Given left arm 13Oct2022, known allergies: propylene glycol, thimerasol. Patient did not receive any other medication in 2 weeks.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Nausea, Pyrexia
Clinical narrative: before I have very bad arthritis; Now I am very nauseous; Joint pain; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25May2023 as dose number unknown (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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset May2023, outcome "unknown", described as "Fever"; ARTHRALGIA (non-serious) with onset May2023, outcome "unknown", described as "Joint pain"; NAUSEA (non-serious) with onset May2023, outcome "unknown", described as "Now I am very nauseous"; ARTHRITIS (non-serious) with onset May2023, outcome "unknown", described as "before I have very bad arthritis".  Additional information: Patient had a Pfizer Bivalent COVID Vaccine today and had reactions to them, before patient has very bad arthritis so, patient has joint pain and fever but now patient is very nauseous and was wondering, patient has a prescription for Zofran. Patient wanted to know if it can be taken or not. It is an antiemetic kind of medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 15:00 as dose 5 (booster), single (Lot number: GJ3274) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6298), in left arm, on 27Mar2021 at 11:00 as dose 2, single (Lot number: ER8732), in right arm, on 13Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 13Jul2022 at 15:00 as dose 4 (booster), single (Lot number: FP7135), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2017, stop date: 18May2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204080 same reporter/patient, different drug/event.;