chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster).    Concomitant product use was not provided by the reporter. This case was for patient 14 of 16. Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:master case(same reporter)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster).    Concomitant product use was not provided by the reporter. This case was for patient 13 of 16. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:master case((same reporter)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 2nd of 16 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  16 patients were administered pediatric monovalent vaccines instead of bivalent boosters on 21DEC2022.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 3rd of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 16th of 16 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  16 patients were administered pediatric monovalent vaccines instead of bivalent boosters on 21DEC2022.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 5th of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 6th of 16 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  16 patients were administered pediatric monovalent vaccines instead of bivalent boosters on 21DEC2022.   Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 7 of 16 adult patients described by the reporter No concomitant information was reported. Patient was administered pediatric monovalent vaccine instead of bivalent booster on 21DEC2022. No symptoms reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    This case contains information for the 08 of 16 patients described by the reporter.  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) outcome was unknown and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters).    Reporter reported that 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters on 21-Dec-2022. Doses were administered by IM injection. No symptoms were reported . 1 patient was 15 years old while were 15 adult patients.  No concomitant medication reported. No treatment medication reported.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 4th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Pain in arm/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm/arm soreness) 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. 042h22a) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 14-Nov-2020.    On 14-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Dec-2022, the patient experienced VACCINATION SITE PAIN (Pain in arm/arm soreness). At the time of the report, VACCINATION SITE PAIN (Pain in arm/arm soreness) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received 1st dose on 06-Apr-2021, lot number: 031b21a, 2nd dose on 04-May-2021, lot number: 014c21a and 1st booster on 01-Dec-2021, lot number: 027h21b.  Following vaccination with the booster since the first day, patient experienced arm soreness, moderate pain in the left arm, uncomfortable pain. Now it had been a week with constant arm soreness. Patient had not received any treatment.   This case was linked to (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation reaction, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: I could not drive; severe reaction/ it was ugly; It was horrible; hardly any sleep; I was unfunctional for two weeks. I couldn't do anything.; tired; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired). At the time of the report, IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   No concomitant medications were reported.  Patient was enrolled in a FLU vaccine trial and patient got a severe reaction.  It was reported you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown. It was reported patient not happy with what happened. patient went nine days with hardly any sleep patient was literally fit to be tied. patient went another couple of days before patient could start. Getting some sleep. I mean, it took like two weeks out of my life with this vaccine. It was horrible and patient only did this because patient had been very happy with Moderna. Patient protected with the Moderna Flu vaccine trial. And patient had been never had a reaction to a flu shot. And it was ugly. It was reported the care was Horrendous. And patient mean over the weekend, and then by Monday.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I could not drive; severe reaction/ it was ugly; It was horrible; hardly any sleep; I was unfunctional for two weeks. I couldn't do anything.; tired; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired). At the time of the report, IMPAIRED DRIVING ABILITY (I could not drive), IMMUNISATION REACTION (severe reaction/ it was ugly), FEELING ABNORMAL (It was horrible), SLEEP DISORDER (hardly any sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was unfunctional for two weeks. I couldn't do anything.) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   No concomitant medications were reported.  Patient was enrolled in a FLU vaccine trial and patient got a severe reaction.  It was reported you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown. It was reported patient not happy with what happened. patient went nine days with hardly any sleep patient was literally fit to be tied. patient went another couple of days before patient could start. Getting some sleep. I mean, it took like two weeks out of my life with this vaccine. It was horrible and patient only did this because patient had been very happy with Moderna. Patient protected with the Moderna Flu vaccine trial. And patient had been never had a reaction to a flu shot. And it was ugly. It was reported the care was Horrendous. And patient mean over the weekend, and then by Monday.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vial was initially stored in the refrigerator:07Dec20226. Date(s) and time(S) vial was first punctured*:08Dec2022 11AM. Date(s) and time(s) of administration of vaccine*: 27Dec2022).    Vaccine coordinator reported that a nurse put a vial of Moderna back in the fridge after puncturing it and administered a dose 3 weeks later. More than 12 hours post puncture dose was administered. Individual vials or unbroken cartons were 1 vial. Vial size was 2.5 mL 10 dose. The vial was initially stored in the refrigerator on 07-Dec-2022. Vial was first punctured on 08-Dec-2022. The vial was stored in fridge post puncture. The vial does not undergo any temperature excursions. It was reported that they pulled the dose for the patient and put it back in the fridge. No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional.   Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ the product reached a highest temperature of 9C" and Vaxelis was not applicable.  Further information is expected.  For reference purposes this case is linked to MCM-004173, MCM-004202 and MCM-004204.
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age.; A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age.; This non-serious spontaneous safety report, case ID 02294724 (Interaction number 02294722), was received by partner, on 30Nov2022 and forwarded on 01Dec2022 from a physician.  Due to the nature of the event, he causal relationship between Vaxelis and the reported event "A physician told the representative that he used Vaxelis to vaccinate a patient at two months of age. Physician used Pentacel to vaccinate the same patient at 4 months of age" was not applicable.  Further information is expected.
Sex: U
Vaccine: DTAPHEPBIP, DTPPVHBHPB
Symptoms: Interchange of vaccine products
Clinical narrative: A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis; A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis; This non-serious spontaneous safety report, Case ID: 02302242/Interaction Number 02302233, was received by partner, on 13DEC2022 and forwarded on 14DEC2022 from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "A pediatric patient received Vaxelis at 2 months of age and Pediarix at 4 months of age in place of a second dose of Vaxelis".  Further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event NOS; This serious initial spontaneous safety report was received by Novavax on 27-DEC-2022 from a consumer via web portal.   A male of 55 year-old  was vaccinated with intramuscular Novavax Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 27-DEC-2022.  The following medical history was reported: Cerebral haemorrhage due to Physical assault (1992), Dust allergy, Food allergy and Seizure. It was also reported the individual received unspecified drugs on an unspecified date in SEP-2022.  The following concomitant medications were reported: Keppra (levetiracetam), ibuprofen and penicillin NOS.  On 27-DEC-2022, after vaccination, the individual experienced adverse event NOS (PT: Adverse event) (Serious: Disability and Life-Threatening). Adverse event details were reported as, "Looking for medical test too participate in and get paid. SARS COVID 14. Black Tar. Crack and medical test."   Treatment for the adverse event was reported as "No."  At the time of reporting, the event outcome of Adverse event was recovered with sequelae.  Lot number was not provided in the report.; Sender's Comments: This 55 year-old male experienced: Adverse event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Adverse event was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported event is considered Possible.
Age: 29.0
Sex: F
Vaccine: 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient had levothyroxine in 2 weeks. Patient received anti-viral treatment with Paxlovid from 06Dec2022 to 11Dec2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Rhinorrhoea, Sneezing
Clinical narrative: her eye is also like red; Sneezing; Runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 16Dec2022, outcome "not recovered", described as "Runny nose"; SNEEZING (non-serious) with onset 16Dec2022, outcome "not recovered"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "her eye is also like red".  Additional information: Reporter stated, I am calling in reference to my sister, we had her, have her COVID vaccine booster (clarified as Pfizer COVID-19 vaccine booster), the 4th one on Friday, this past Friday the 16th and as soon as she got the booster she started sneezing, I thought that was going to pass but she still sneezing, sneezing a lot and like runny nose. So I thought it was going to stop in a day or whatever but it was still going on. So I am concerned about that and now her eye was also like red. Reporter further stated, was that like Normal, was that something I should worried about.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Ill-defined disorder, Investigation, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.; experiencing extreme fatigue and weakness in the muscles; he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.; experiencing extreme fatigue and weakness in the muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), in Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, He had received all the COVID vaccines from Pfizer), for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), FATIGUE (non-serious) all with onset Jul2022, outcome "not recovered" and all described as "experiencing extreme fatigue and weakness in the muscles"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), ILL-DEFINED DISORDER (non-serious) all with onset Jul2022, outcome "not recovered" and all described as "he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot.". The events "he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot." and "experiencing extreme fatigue and weakness in the muscles" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the reporter assessed the events as non-serious. They have consulted doctors but hadn't found the cure. They had made tests and RMIs, but the brain looks normal. She wanted to know if Pfizer recommends a treatment or a specialist to consult this case. The patient was older than 12 years. She described that they are almost sure that this was caused by the vaccine because the symptoms started the next day after vaccination. Now he cannot run, cannot exercise, and the situation has turned severe because his life has been affected a lot. The patient took the last booster dose from Pfizer and he had taken all the COVID vaccines from Pfizer and it was the bivalent grey cap formulation.  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: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 10:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Malaise, Myalgia
Clinical narrative: dizzy; weak; feeling terrible; at injection site hurts/injection site pain is in her right upper arm; muscle pain; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 26Jan2021, Lot number: unknown, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose Pfizer COVID-19 Vaccine:, Date Received: 17Feb2021, Lot number: EN6201, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (3rd dose Pfizer COVID-19 Vaccine:, Date Received: 13Oct2021, Lot number: 30155ISA, Route of Administration: Intramuscular), administration date: 13Oct2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (4th dose Pfizer COVID-19 Vaccine:, Date Received: 22Apr2022, Lot number: FM9992, Route of Administration: Intramuscular), administration date: 22Apr2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Dec2022, outcome "not recovered", described as "at injection site hurts/injection site pain is in her right upper arm"; DIZZINESS (non-serious) with onset 20Dec2022, outcome "not recovered", described as "dizzy"; MALAISE (non-serious) with onset 20Dec2022, outcome "not recovered", described as "feeling terrible"; PYREXIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "fever"; MYALGIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "muscle pain"; ASTHENIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other conditions was noted as no. Vaccination facility type was noted as clinic. Patient was calling about third Booster Bivalent COVID-19 Vaccine. She had the booster yesterday (19Dec2022) and today (20Dec2022) when she woke up, she was feeling terrible and have not had that reaction to her previous Pfizer vaccines. She was dizzy, weak, at injection site hurts, muscle pain, and fever. These started on 20Dec2022 (today) when she woke up. These symptoms were still ongoing and were about the same. Patient clarified the injection site pain is in her right upper arm. Adverse events require visit to emergency room and physician's office were noted as no. Investigations was noted as no.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: dizzy; weak; feeling terrible; at injection site hurts/injection site pain is in her right upper arm; muscle pain; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN. Vaccination history included: BNT162b2 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 26Jan2021, Lot number: unknown, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (2nd dose Pfizer COVID-19 Vaccine:, Date Received: 17Feb2021, Lot number: EN6201, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (3rd dose Pfizer COVID-19 Vaccine:, Date Received: 13Oct2021, Lot number: 30155ISA, Route of Administration: Intramuscular), administration date: 13Oct2021, when the patient was 73-year-old, for Covid-19 immunization; BNT162b2 (4th dose Pfizer COVID-19 Vaccine:, Date Received: 22Apr2022, Lot number: FM9992, Route of Administration: Intramuscular), administration date: 22Apr2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Dec2022, outcome "not recovered", described as "at injection site hurts/injection site pain is in her right upper arm"; DIZZINESS (non-serious) with onset 20Dec2022, outcome "not recovered", described as "dizzy"; MALAISE (non-serious) with onset 20Dec2022, outcome "not recovered", described as "feeling terrible"; PYREXIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "fever"; MYALGIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "muscle pain"; ASTHENIA (non-serious) with onset 20Dec2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other conditions was noted as no. Vaccination facility type was noted as clinic. Patient was calling about third Booster Bivalent COVID-19 Vaccine. She had the booster yesterday (19Dec2022) and today (20Dec2022) when she woke up, she was feeling terrible and have not had that reaction to her previous Pfizer vaccines. She was dizzy, weak, at injection site hurts, muscle pain, and fever. These started on 20Dec2022 (today) when she woke up. These symptoms were still ongoing and were about the same. Patient clarified the injection site pain is in her right upper arm. Adverse events require visit to emergency room and physician's office were noted as no. Investigations was noted as no.