chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case contains information for patient 18 out of 25 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported. This case belongs to patient no 19 out of 25 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case belongs to patient no 7 out of 25 patients.  Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case belongs to patient no 21 out of 25 patients.  Concomitant medications were not reported.  No adverse event was reported patient.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow-up contains significant information. Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Master case
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for patient.  Treatment medications were not reported.  This case contains information for patient 20 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766: (Master Case)
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 9 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had sore arm after vaccination. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737041 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737041:Bivalent case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Hives; Rash; Welts; Itching/very bad itching and scratching; Very bad itching and scratching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), RASH (Rash), URTICARIA (Welts), PRURITUS (Itching/very bad itching and scratching) and SCRATCH (Very bad itching and scratching) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 016B22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product CETIRIZINE HYDROCHLORIDE (ZYRTECNO) for an unknown indication.    Concomitant products included ACICLOVIR (ACYCLOVIR DENK), ESCITALOPRAM and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 25-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient started CETIRIZINE HYDROCHLORIDE (ZYRTECNO) (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (Hives), RASH (Rash), URTICARIA (Welts), PRURITUS (Itching/very bad itching and scratching) and SCRATCH (Very bad itching and scratching). At the time of the report, URTICARIA (Hives), RASH (Rash), URTICARIA (Welts) and PRURITUS (Itching/very bad itching and scratching) had not resolved, and SCRATCH (Very bad itching and scratching) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter did not provide any causality assessments.   The patient did not experience any additional symptoms/events. It was reported that patient visited urgent Care first time and received a steroid shot. There were no lab data/results available. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: New event was added.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Cardiovascular symptom, Dyspnoea exertional, Hypersensitivity, Limb discomfort
Clinical narrative: Lost 8 pounds since the adverse event; has no energy; trouble breathing upon exertion; her arm was left sore and uncomfortable; She stated she was feeling heart failure symptoms at the time; allergic reactions; hives; her arm was left sore; itching; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy) and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no.) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives. Concomitant products included ACRIVASTINE (BENADRYL OTC) for Hives, CORTISONE for an unknown indication.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), DYSPNOEA EXERTIONAL (trouble breathing upon exertion), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time). The patient was treated with TRIAMCINOLONE DIACETATE (PROCTOSTEROID) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives) was resolving, WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time) outcome was unknown and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss.         It was reported that patient had to go to urgent care for these symptoms. The urgent care physician prescribed her a steroid injection and tablets to take for the week. She stated she was feeling heart failure symptoms at the time.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pruritus, Urticaria, Weight decreased
Clinical narrative: Lost 8 pounds since the adverse event; has no energy; trouble breathing upon exertion; her arm was left sore and uncomfortable; She stated she was feeling heart failure symptoms at the time; allergic reactions; hives; her arm was left sore; itching; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy) and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no.) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives. Concomitant products included ACRIVASTINE (BENADRYL OTC) for Hives, CORTISONE for an unknown indication.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), DYSPNOEA EXERTIONAL (trouble breathing upon exertion), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time). The patient was treated with TRIAMCINOLONE DIACETATE (PROCTOSTEROID) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm was left sore), PRURITUS (itching), HYPERSENSITIVITY (allergic reactions) and URTICARIA (hives) was resolving, WEIGHT DECREASED (Lost 8 pounds since the adverse event), ASTHENIA (has no energy), LIMB DISCOMFORT (her arm was left sore and uncomfortable) and CARDIOVASCULAR SYMPTOM (She stated she was feeling heart failure symptoms at the time) outcome was unknown and DYSPNOEA EXERTIONAL (trouble breathing upon exertion) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss.         It was reported that patient had to go to urgent care for these symptoms. The urgent care physician prescribed her a steroid injection and tablets to take for the week. She stated she was feeling heart failure symptoms at the time.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: A Moderna bivalent vaccination was given one day after determined BUD. BUD was 8/28 and was given 8/29; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna bivalent vaccination was given one day after determined BUD. BUD was 8/28 and was given 8/29) 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Aug-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 29-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna bivalent vaccination was given one day after determined BUD. BUD was 8/28 and was given 8/29) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Moderna bivalent vaccination was given one day after determined BUD. BUD was 8/28 and was given 8/29) 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 (A Moderna bivalent vaccination was given one day after determined BUD. BUD was 8/28 and was given 8/29).    No concomitant medication information was reported. BUD was 28-Aug-2023. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live follow up has been appended.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 4 (booster), single (Lot number: Gj3270) at the age of 62 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: "Just some age related low thyroid output" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 25Oct2018; LEVOTHYROXINE, start date: 01Nov2021; ESTRADIOL, start date: 01May2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative, notes: I tested negative to Covid and went back to work; (Aug2023) Positive, notes: I had a fever and a positive Covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment start date 14Aug2023 and stop date 19Aug2023. Patient reported that Covid rebounded. She took all 5 days of Paxlovid and felt much better. She tested negative to Covid and went back to work. Four days later, she started feeling excessively tired. Two days after that it was clear she was sick. She had a fever and a positive Covid test and said it was rebound Covid. I'm back in quarantine. She was not suffering much at that time but wanted to be part of the data.
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic herpes simplex, Slit-lamp examination
Clinical narrative: herpes simplex keratitis; This is a literature report.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "amblyopia" (unspecified if ongoing), notes: of his left eye. The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES SIMPLEX (medically significant) with onset 22Feb2021, outcome "recovered" (2021), described as "herpes simplex keratitis". The event "herpes simplex keratitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Slit-lamp examination: discreet area of, notes: central edema with keratic precipitates and stromal haze. Therapeutic measures were taken as a result of ophthalmic herpes simplex. Clinical course: Several physicians in our practice noted a cohort of patients presenting with keratitis in temporal proximity to their COVID-19 vaccinations. We hypothesize that the intense immunological reaction following LNP-formulated mRNAbased COVID-19 vaccinations may have triggered or reactivated keratitis. A 60-year-old man with a significant past ocular history of amblyopia of his left eye was referred to the clinic for 2 months of decreased vision in his right eye, which began approximately 2 weeks after his first Pfizer COVID-19 vaccination. Slit-lamp examination of his right cornea revealed a discreet area of central edema with keratic precipitates and stromal haze. Based on the examination, a diagnosis of herpes simplex keratitis and endotheliitis was made. He was prescribed prednisone forte four times a day as well as valacyclovir 1 g twice daily with improvement in vision and examination by 3-month follow-up. Six months later, the patient was seen with no signs of inflammation or infection and no observed infiltrate.; Sender's Comments: Based on the temporal relationship, the association between the event ophthalmic Herpes simplex with BNT162b2 can not be completely 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,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster, Slit-lamp examination
Clinical narrative: Recurrent Keratitis/ herpes zoster keratitis; This is a literature report for the following literature source(s).  A 32-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes zoster keratitis" (unspecified if ongoing), notes: of his left eye 4 months earlier. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Mar2021, for COVID-19 immunisation. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant) with onset 03Apr2021, outcome "recovering", described as "Recurrent Keratitis/ herpes zoster keratitis". The patient underwent the following laboratory tests and procedures: Slit-lamp examination: two new subepithelial infiltrates. Therapeutic measures were taken as a result of ophthalmic herpes zoster. Clinical course: A 32-year-old man with a history of herpes zoster keratitis of his left eye 4 months earlier, which was progressively improving, presented for a routine follow-up. He reported pain and pruritis in his left eye. Slit-lamp examination of his left cornea revealed two new subepithelial infiltrates. He had received his second dose of the Pfizer COVID-19 vaccination 3 days prior to the onset of symptoms. He was started on loteprednol twice a day and valacyclovir 1 g daily with progressive improvement of the symptoms at 1-month and 2-month follow-up visits.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported event Bacterial enteritis.Case will be reviewed on receipt of FU information. 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,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chest pain
Clinical narrative: ACUTE NON ST ELEVATION MI 5/1/2023 CHEST PAIN
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Basal ganglia stroke, Ischaemic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/12/2023 ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 4/12/2023 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Arteriosclerosis coronary artery, Coronary artery disease, Lipids increased
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 3/24/2023 ACUTE NON ST ELEVATION MI CAD WO ANGINA DUE TO LIPID RICH PLAQUE
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Arthritis, Condition aggravated, Immune system disorder
Clinical narrative: Almost full loss of taste and smell post covid vaccination due to increased risk of illness because of lowered immunity. Tried many different neurological receptor improvement supplements and breathing treatments with essential oils. Only minor improvements took place over time. Arthritis flare-ups happened in the past month or so. Specifically my left pointer finger.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Deep vein thrombosis
Clinical narrative: I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/12/2023 ACUTE NON ST ELEVATION MI I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 4/12/2023 ACUTE NON ST ELEVATION MI
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Insomnia, Sleep apnoea syndrome
Clinical narrative: INSOMNIA W SLEEP APNEA 11/30/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Bone pain, Eczema, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: ABOUT 5 -6 HOURS AFTER RECEIVING THE INJECTION PATIENT HAD SWELLING WITH WEEPING WELTS ON HER RIGHT UPPER ARM AND SHOULDER (INJECTIONS WERE BOTH IN THE LEFT DELTOID). ABOUT 8-10 HOURS AFTER THE INJECTIONS, PATIENT EXPERIENCED BONE PAIN ON HER LEFT SIDE FROM HER NECK TO HER ELBOW. HER ARM IS STILL NUMB AND SHE CANNOT LIFT HER LEFT ARM UP WITHOUT EXTREME PAIN. HER FACE BROKE OUT WITH WELTS WHICH TURN TO ECZEMA. HER FACE IS HEALING AFTER ONE WEEK AFTER USING HER OWN PREVIOUSLY PRESCRIBED TOPICAL STEROIDS.  SHE STILL HAS TROUBLE SLEEPING WITH PAIN ON HER LEFT NECK AND SHOULDER AND NUMBNESS IN HER LEFT ARM.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Insomnia, Neck pain, Pain, Pain in extremity
Clinical narrative: ABOUT 5 -6 HOURS AFTER RECEIVING THE INJECTION PATIENT HAD SWELLING WITH WEEPING WELTS ON HER RIGHT UPPER ARM AND SHOULDER (INJECTIONS WERE BOTH IN THE LEFT DELTOID). ABOUT 8-10 HOURS AFTER THE INJECTIONS, PATIENT EXPERIENCED BONE PAIN ON HER LEFT SIDE FROM HER NECK TO HER ELBOW. HER ARM IS STILL NUMB AND SHE CANNOT LIFT HER LEFT ARM UP WITHOUT EXTREME PAIN. HER FACE BROKE OUT WITH WELTS WHICH TURN TO ECZEMA. HER FACE IS HEALING AFTER ONE WEEK AFTER USING HER OWN PREVIOUSLY PRESCRIBED TOPICAL STEROIDS.  SHE STILL HAS TROUBLE SLEEPING WITH PAIN ON HER LEFT NECK AND SHOULDER AND NUMBNESS IN HER LEFT ARM.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Peripheral swelling, Skin weeping, Urticaria
Clinical narrative: ABOUT 5 -6 HOURS AFTER RECEIVING THE INJECTION PATIENT HAD SWELLING WITH WEEPING WELTS ON HER RIGHT UPPER ARM AND SHOULDER (INJECTIONS WERE BOTH IN THE LEFT DELTOID). ABOUT 8-10 HOURS AFTER THE INJECTIONS, PATIENT EXPERIENCED BONE PAIN ON HER LEFT SIDE FROM HER NECK TO HER ELBOW. HER ARM IS STILL NUMB AND SHE CANNOT LIFT HER LEFT ARM UP WITHOUT EXTREME PAIN. HER FACE BROKE OUT WITH WELTS WHICH TURN TO ECZEMA. HER FACE IS HEALING AFTER ONE WEEK AFTER USING HER OWN PREVIOUSLY PRESCRIBED TOPICAL STEROIDS.  SHE STILL HAS TROUBLE SLEEPING WITH PAIN ON HER LEFT NECK AND SHOULDER AND NUMBNESS IN HER LEFT ARM.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Hypertensive heart disease, Obstructive sleep apnoea syndrome
Clinical narrative: G47.33 OBSTRUCTIVE SLEEP APNEA 4/18/2023 HYPERTENSIVE HEART DISEASE WITH HEART FAILURE
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic herpes simplex, Physical examination, Slit-lamp examination
Clinical narrative: herpes simplex keratitis causing corneal decompensation; This is a literature report.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "open-angle glaucoma" (unspecified if ongoing); "uveitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES SIMPLEX (medically significant) with onset 14Feb2021, outcome "recovered", described as "herpes simplex keratitis causing corneal decompensation". The patient underwent the following laboratory tests and procedures: examination: she had a significant decrease in her vision from, notes: baseline in her left eye; Slit-lamp examination: she was found to have corneal edema, notes: with Descemet folds as well as microcystic edema. Therapeutic measures were taken as a result of ophthalmic herpes simplex. Clinical course: An 81-year-old woman with a past ocular history significant for open-angle glaucoma as well as uveitis presented with severe pain and decreased vision in her left eye 1 week after receiving her first dose of the Pfizer COVID-19 vaccine. On examination, she had a significant decrease in her vision from baseline in her left eye. On slit-lamp exam, she was found to have corneal edema with Descemet folds as well as microcystic edema. She had no signs of iritis. The patient was diagnosed with herpes simplex keratitis causing corneal decompensation and was started on valacyclovir as well as topical prednisolone. The diagnosis was made based on her acute presentation and history. In follow-up visits at 2, 4, 8, and 12 weeks, the patient showed no improvement despite medical management. She was not on any prostaglandin analogues leading up to or during this period. Due to unresolving vision loss that was affecting the patient's functioning, a Descemet stripping automated endothelial keratoplasty was successfully performed 3 months after the onset of symptoms. At post-op month #1, the corneal transplant was clear, and the patient's vision improved.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event ophthalmic herpes simplex and BNT162B2 is considered possible. 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.,Linked Report(s) : US-PFIZER INC-PV202300145291 Same article/ drug/event and different patient;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Acute polyneuropathy, Acute respiratory failure, Demyelinating polyneuropathy
Clinical narrative: G61.0 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY 4/21/2023 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Discomfort, Fatigue, Hypersomnia
Clinical narrative: About 1-2 days after second Pfizer shot in series, I became very sick, achy, almost went to the ER because it felt like I was having a very bad reaction that felt like a heart attack. Sore body aches and pain; feeling very weak and uncomfortable for about 3 days. In bed and slept for about 2 days straight.  Very tired and lethargic. Still have joint aches and always tired.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: About 1-2 days after second Pfizer shot in series, I became very sick, achy, almost went to the ER because it felt like I was having a very bad reaction that felt like a heart attack. Sore body aches and pain; feeling very weak and uncomfortable for about 3 days. In bed and slept for about 2 days straight.  Very tired and lethargic. Still have joint aches and always tired.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: body aches, arm pain at injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD