chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Encephalitis
Clinical narrative: flare sign encephalitis; This spontaneous case was reported by a physician and describes the occurrence of ENCEPHALITIS (flare sign encephalitis) in a male patient of an unknown age 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. On an unknown date, the patient experienced ENCEPHALITIS (flare sign encephalitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (flare sign encephalitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that a young man after receiving the second dose of Moderna Vaccine experienced flare sign encephalitis.  No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Encephalitis (reported as flare sign encephalitis). The event occurred on an unknown date after receiving the second dose of mRNA-1273. Presenting symptoms, clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient also experienced vestibulitis (unspecified anatomic location) after the first dose but the etiology and disease course were not specified. There is insufficient information to assess whether the reported illnesses were related and if caused by the same infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-589814.; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Encephalitis (reported as flare sign encephalitis). The event occurred on an unknown date after receiving the second dose of mRNA-1273. Presenting symptoms, clinical course, diagnostic procedures conducted and treatment details were not provided in the case. The patient also experienced vestibulitis (unspecified anatomic location) after the first dose but the etiology and disease course were not specified. There is insufficient information to assess whether the reported illnesses were related and if caused by the same infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 13-Jun-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 13-Jun-2022) in a 64-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 13-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 13-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated they had a vaccine they moved from freezer to fridge on 10-May-2022. And according to information sheet they were good for 30 days, but it looked like there had been a couple of doses given this week. The vaccine should had been discarded on 10-Jun-2022 but the patient was given a second dose of the series on 13-Jun-2022. The dose was administered after 30-day Use by Date. It was also reported that the vial had not undergone any temperature excursions and the patient had not called to report any side effects.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Hallucination, Memory impairment
Clinical narrative: A bunch of issues suddenly with memory and hallucinations; A bunch of issues suddenly with memory and hallucinations; This spontaneous case was reported by an other health care professional and describes the occurrence of HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) (seriousness criterion medically significant) and MEMORY IMPAIRMENT (A bunch of issues suddenly with memory and hallucinations). At the time of the report, HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) and MEMORY IMPAIRMENT (A bunch of issues suddenly with memory and hallucinations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received a COVID booster last week but brand of product was unknown.  No additional adverse events. No product quality complaints.  No treatment medications was reported.  Company comment: This spontaneous case concerns an elderly patient of unspecified gender  ,with no medical history reported, who experienced the unexpected serious (medically significant) event of Hallucination which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly patient of unspecified gender  ,with no medical history reported, who experienced the unexpected serious (medically significant) event of Hallucination which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was administered to a patient as a booster dose past the published expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported no adverse events were reported   This case was linked to MOD-2022-590949 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Carditis, Eye inflammation
Clinical narrative: Carditis; Eye inflammation; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Carditis) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a week. In November 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CARDITIS (Carditis) (seriousness criterion medically significant) and EYE INFLAMMATION (Eye inflammation). At the time of the report, CARDITIS (Carditis), EYE INFLAMMATION (Eye inflammation) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment This spontaneous case concerns a 50-year-old male patient with concomitant medication Adalimumab indicated for Rheumatoid arthritis, who experienced the unexpected serious, medically significant event of carditis and non-serious events of COVID-19 (AESI) and eye inflammation. The patient received a dose of mRNA-1273 on an unknown date, thus latency between vaccination and the event cannot be assessed. Adalimumab could lead to pericarditis. The medical history of Rheumatoid arthritis is associated with abnormal immunity and chronic inflammation that could be a contributory risk factor for carditis and eye inflammation. The event COVID-19 could also contribute to carditis and eye inflammation if their temporal relationship is known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 50-year-old male patient with concomitant medication Adalimumab indicated for Rheumatoid arthritis, who experienced the unexpected serious, medically significant event of carditis and non-serious events of COVID-19 (AESI) and eye inflammation. The patient received a dose of mRNA-1273 on an unknown date, thus latency between vaccination and the event cannot be assessed. Adalimumab could lead to pericarditis. The medical history of Rheumatoid arthritis is associated with abnormal immunity and chronic inflammation that could be a contributory risk factor for carditis and eye inflammation. The event COVID-19 could also contribute to carditis and eye inflammation if their temporal relationship is known. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired 2nd booster beyond 12 hours after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd booster beyond 12 hours after puncture) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B and 027A21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022 at 9:44 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022 at 9:44 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd booster beyond 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd booster beyond 12 hours after puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter was not sure of the First and Second Dose brand, dates, and lot numbers. No concomitant medication were reported.  The vial was initially stored in the refrigerator on 16-JUN-2022. The vial was first punctured on 16-JUN-2022 at 1:20PM. Post puncture the vial was stored in Refrigerator. The vial did not undergo any temperature excursions. The vial was not exposed to room temperature range (8° to 25°C= 46° to 77°F) and was in the refrigerator. Number of doses/vials were 1 dose/ 1 vial. No treatment information was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Sleepy; Felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (Felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 034F21A, 031M20A and 013L20H) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: influenza (Other vaccine given within 1 month prior to Moderna COVID-19 vaccine: Influenza probably). Past adverse reactions to the above products included No adverse event with influenza. Concurrent medical conditions included Allergic to cats (Cat allergy), Hypertension (No recent change in status such as improvement or worsening.), Alcoholism (No recent change in status such as improvement or worsening.), Kidney failure (No recent change in status such as improvement or worsening.) and Gastric disorder. Concomitant products included OMEPRAZOLE for Gastric disorder, AMLODIPINE for Hypertension.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (Felt tired). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (Felt tired) had not resolved.     Patient did not seek any medical care and experienced a similar event in the past.  After Second booster patient drank whiskey on 16-Jun-2022, on 17-Jun-2022, felt tired, sleepy and did not know if had fever. No treatment had been given for symptoms.   This case was linked to MOD-2022-590911, MOD-2022-591120 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR LOSS AFTER COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT). At the time of the report, ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) had not resolved.     Concomitant medications were not reported.  It was unknown if the patient was enrolled in the COVID-19 vaccine trail.  The reporter causality for the event ALOPECIA (HAIR LOSS AFTER COVID BOOSTER SHOT) with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) was no reasonable possibility.  Treatment information was not reported.   This case was linked to MOD-2022-591492 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 15-JAN-2021 and 2nd dose was administered on 15-APR-2021) outcome was unknown.            No concomitant medication information provided.  It was unknown if patient was enrolled in Covid-19 vaccine trial.  No treatment information provided.   This case was linked to MOD-2022-591448 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Solid organ transplant.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough COVID-19) (seriousness criterion hospitalization). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive for severe COVID-19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BREAKTHROUGH COVID-19 (Breakthrough COVID-19) to be related.    Company comment: This is a literature-non-study case concerning a male  patient of an unknown age with medical history of solid organ transplant, who experienced the serious (hospitalization) unexpected event of Breakthrough COVID-19, on an unknown date after the  second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Clinical course and hospitalization details were not provided. Patient received non-monoclonal antibody therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitants and treatment were reported. Patient not received third dose. Patient received non-monoclonal antibody therapy. The only variable associated with presenting with severe disease was a shorter time from vaccination to diagnosis.   This case was linked to MOD-2022-590482 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2022: Live follow up received by safety on 16-Jun-2022 has Email with FTA and contains significant information includes significant information reporters details, literature information, medical history, lab data, hospitalization were updated.; Sender's Comments: Company comment: This is a literature-non-study case concerning a male  patient of an unknown age with medical history of solid organ transplant, who experienced the serious (hospitalization) unexpected event of Breakthrough COVID-19, on an unknown date after the  second dose of mRNA-1273 vaccine. SARS-CoV-2 test was performed with positive result. Clinical course and hospitalization details were not provided. Patient received non-monoclonal antibody therapy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MOD-2022-590482:(Case-1: 11 patients cluster case)
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: swelling on her hands and arms; had a red rash on her hands and arms; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   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, 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 PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms). At the time of the report, PERIPHERAL SWELLING (swelling on her hands and arms) and RASH ERYTHEMATOUS (had a red rash on her hands and arms) outcome was unknown.            It was reported that patient had received 3rd and 4th boosters. No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diabetic neuropathy, Dizziness, Pain in extremity
Clinical narrative: Diabetes neuropathy in Feet; Felt Light headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIABETIC NEUROPATHY (Diabetes neuropathy in Feet), DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication.    No medical history was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIABETIC NEUROPATHY (Diabetes neuropathy in Feet), DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DIABETIC NEUROPATHY (Diabetes neuropathy in Feet) was resolving and DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant drugs were not reported.  The patient had diabetes neuropathy in feet and trouble sleeping due to neuropathy.  The reporter's causality for the events of Diabetes neuropathy in feet and sore arm with LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT) was no reasonable possibility. The reporter's causality for the event of felt lightheaded was not provided.  Treatment details were not given.  It was unknown whether the patient was enrolled in a covid-19 vaccine trial.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction
Clinical narrative: Drug side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Drug side effect) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Drug side effect). At the time of the report, ADVERSE DRUG REACTION (Drug side effect) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Causality for co-suspect product (HUMIRA) was reported as probable.  No concomitant medication information was provided. No treatment medication were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient states all doses have been bad; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient states all doses have been bad) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 037B21A and 004C21A) for COVID-19 prophylaxis.     The patient had no Allergies (medications, food and other products).  The patient never had COVID test or diagnosis previously.  Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal, AMLODIPINE and METOPROLOL for Blood pressure abnormal.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient states all doses have been bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Patient states all doses have been bad) was resolving.            No medical history information reported.   This case was linked to MOD-2022-591722 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging
Clinical narrative: some issues with her arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (some issues with her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 028d21a) for COVID-19 prophylaxis.     The patient never had COVID-19 positive test or diagnosis. The patient had no history relating to mentioned and both Acute and Chronic illnesses at the time of vaccination. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Treazodone).   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (some issues with her arm). At the time of the report, LIMB DISCOMFORT (some issues with her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: result not reported Result not reported.         No concomitant medications were reported. The patient was not sure if she experienced a similar event in the past. The adverse event was ongoing with no improvement but instead the symptoms worsened. Treatment included Cortisol and also to do therapy by an orthopedic doctor, no one seemed to understand to why she had this issues.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arms are sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arms are sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced PAIN IN EXTREMITY (arms are sore). At the time of the report, PAIN IN EXTREMITY (arms are sore) outcome was unknown.            Patient took second booster dose of Moderna COVID-19 Vaccine. No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-592045 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Overdose, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician and Nurse) from medical information team. The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), on 31May2022 at 15:00 as dose 4 (booster), 1.8 ml single (Lot number: FK9729) at the age of 61 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, NDC number, lot number, expiration date: EP6955), administration date: 12Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (2nd dose:, NDC number, lot number, expiration date: PR8734), administration date: 02Apr2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (3rd dose:, NDC number, lot number, expiration date: FF2590), administration date: 24Oct2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: OVERDOSE (non-serious) with onset 31May2022, described as "receiving 1.8mL of the Pfizer COVID-19 Vaccine/ given an overdose of the vaccine, given a 1.8ml dose of the vaccine each, the whole vial, so 6 times what the dose should have been which should have been .3ml only"; PYREXIA (non-serious), described as "fever"; CHILLS (non-serious); INFLUENZA LIKE ILLNESS (non-serious), described as "like having the flu"; ASTHENIA (non-serious), described as "weakness". Additional information: Patient was received a 1.8ml dose of the vaccine, the whole vial, so 6 times what the dose should have been which should have been .3ml only. Emergency Room: No, Physician Office No, Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No, Other Conditions: No, Other Products: No. The type of medication error was overdose. The stage of medication error was preparation and administration. The contributing factors to the medication error was a floater between offices and thought that it wasn't a multidose vial and gave the whole vial. It was her first time giving the Pfizer Covid vaccine. The patient and they are doing well with no issues. Follow-up (17Jun2022):  This is a spontaneous follow-up report received from a contactable consumer (Practice manager). This consumer (Practice manager) reported in response to Non-HCP letter sent which included that: Updated information included: Reporter information added, Product coding updated. Clinical information added in narrative. Sender's Comments: Linked Report(s) : PFIZER INC-202200794834 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Diabetes mellitus, Endocrine ophthalmopathy, Hip arthroplasty, Mammoplasty
Clinical narrative: Crohn's disease; Rheumatoid arthritis flare up; thyroid eye disease; Psoriasis flare up; breast reduction; diabetes; Hip replacement; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not available). The reporter is the patient. Other Case identifier(s): 22K-163-4421982-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (non-serious) with onset 2021, outcome "recovered", described as "Hip replacement"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "not recovered", described as "diabetes"; MAMMOPLASTY (non-serious) with onset Mar2022, outcome "recovered", described as "breast reduction"; CROHN'S DISEASE (medically significant), outcome "not recovered"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "not recovered", described as "thyroid eye disease"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "hip replacement" and "breast reduction" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events and the suspect drug BNT162b2   cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Rheumatoid arthritis
Clinical narrative: Crohn's disease; Rheumatoid arthritis flare up; thyroid eye disease; Psoriasis flare up; breast reduction; diabetes; Hip replacement; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not available). The reporter is the patient. Other Case identifier(s): 22K-163-4421982-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (non-serious) with onset 2021, outcome "recovered", described as "Hip replacement"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "not recovered", described as "diabetes"; MAMMOPLASTY (non-serious) with onset Mar2022, outcome "recovered", described as "breast reduction"; CROHN'S DISEASE (medically significant), outcome "not recovered"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "not recovered", described as "thyroid eye disease"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "hip replacement" and "breast reduction" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events and the suspect drug BNT162b2   cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 03Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti viral product, Paxlovid, treatment start date: 06Jun2022 and treatment stop date: 11Jun2022. Indication: Treatment of COVID-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Dyspnoea exertional, Feeling abnormal, Heavy menstrual bleeding, Impaired work ability
Clinical narrative: Brain fog is so bad i can't remember things anymore prior to the shot I was clear thinking and never forgot a thing. This has severely impacted my day-to-day life. I can't find a normal job due to the fact that my memory is basically nonexistent.   My periods have also been affected. I was regular every 4 weeks, lasting no more than 4 days with light to moderate flow, now I'm bleeding heavily, and lasting sometimes 2 weeks with excruciating cramping for the full duration.  Also, i was also very energetic, now i struggle to climb a set of stairs without wanting to pass out due to feeling short of breath.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment
Clinical narrative: Brain fog is so bad i can't remember things anymore prior to the shot I was clear thinking and never forgot a thing. This has severely impacted my day-to-day life. I can't find a normal job due to the fact that my memory is basically nonexistent.   My periods have also been affected. I was regular every 4 weeks, lasting no more than 4 days with light to moderate flow, now I'm bleeding heavily, and lasting sometimes 2 weeks with excruciating cramping for the full duration.  Also, i was also very energetic, now i struggle to climb a set of stairs without wanting to pass out due to feeling short of breath.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysmenorrhoea, Feeding disorder, Heavy menstrual bleeding, Loss of personal independence in daily activities
Clinical narrative: Unable to eat without wanting to vomit after every meal. Gone from being a healthy kid who ate heaps to now unable to eat small amounts without wanting to vomit. Lack of energy. Gone from an energetic teen to a kid who struggles to get out of bed. Her periods prior to vax, normal 4-week cycle, 4-5 day regular flow. Now she has severe cramping and has been hospitalized for pain relief, on 1 occasion. Her bleeding is now lasting, since the shot, 3 weeks, and changing her pads hourly. This has badly impacted to the ability to stay in mainstream school.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Mobility decreased, Nausea
Clinical narrative: Unable to eat without wanting to vomit after every meal. Gone from being a healthy kid who ate heaps to now unable to eat small amounts without wanting to vomit. Lack of energy. Gone from an energetic teen to a kid who struggles to get out of bed. Her periods prior to vax, normal 4-week cycle, 4-5 day regular flow. Now she has severe cramping and has been hospitalized for pain relief, on 1 occasion. Her bleeding is now lasting, since the shot, 3 weeks, and changing her pads hourly. This has badly impacted to the ability to stay in mainstream school.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; headache; muscle aches; intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), 1 day after the suspect product(s) administration, outcome "recovered"; HEADACHE (non-serious), 1 day after the suspect product(s) administration, outcome "recovered"; MYALGIA (non-serious), 1 day after the suspect product(s) administration, outcome "recovered", described as "muscle aches"; FATIGUE (non-serious), 1 day after the suspect product(s) administration, outcome "recovered", described as "intense fatigue". Additional information: the patient reported experiencing 1 day of chills and 5 days of headache, muscle aches and intense fatigue beginning the day after receiving her first booster (3rd Pfizer vaccine shot) 8 months after completing her primary vaccination course of two doses of the Pfizer COVID-19 vaccine. On the sixth day after receiving her booster shot, the patient awoke feeling normal with all symptoms resolved. She had experienced similar symptoms 1 day after each of the two doses of Pfizer vaccine that lasted only for 1 day each during her primary vaccination sequence of dosing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202200820919 same product/ patient/event, different dose;PFIZER INC-202200813752 same product/ patient/event, different dose;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: wag19821), on 06Mar2021 as dose 2, single (Lot number: wag19821), on 07Oct2021 as dose 3 (booster), single (Lot number: wag19821) and on 15Apr2022 as dose 4 (booster), single (Lot number: wag19821) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "lastose allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: It was reported that after treatment ended, virus came back, still fighting it 2 weeks later.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 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: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive, notes: COVID symptoms returned after 5 days. Positive antigen test; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. The patient did not receive any other medication in 2weeks. The covid symptoms returned after 5 days on 15Jun2022 at 12 PM. Positive antigen test. The patient took Paxlovid for Covid 19 treatment. The treatment start date was reported as 05Jun2022 and stop date was 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Lethargy, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 7-year-old male patient received BNT162b2 (COMIRNATY), on 15Jun2022 at 19:00 as dose 3 (booster) single (Lot number: FL8094) at the age of 7 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, Second dose , 05Dec2021, Lot: FK5618, Expiry: Unknown, Site: Left arm), administration date: 05Dec2021, when the patient was 7-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, First dose: , 09Nov2021, Lot: FK5127, Expiry: Unknown, Site: Left arm is his guess.), administration date: 09Nov2021, when the patient was 7--old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Jun2022 at 12:00, outcome "not recovered"; LETHARGY (non-serious) with onset 16Jun2022 at 12:00, outcome "not recovered", described as "his son is extremely lethargic"; PYREXIA (non-serious) with onset 16Jun2022 at 12:00, outcome "not recovered", described as "low grade fever"; FEELING ABNORMAL (non-serious) with onset 16Jun2022 at 12:00, outcome "not recovered", described as "son feels not like himself". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The AE(s) require a visit to Physician Office or Emergency Room. The patient was not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none.