chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product use in unapproved indication
Clinical narrative: Shingrix given to a patient with active shingles; This case was reported by a pharmacist via call center representative and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug use for unapproved indication. On an unknown date, the outcome of the drug use for unapproved indication was unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The pharmacist stated that the first dose of Shingrix was given to a patient with active shingles. The reporter declined to provide contact details and rushed off the phone before specialist could attempt to collect further details.  No further information available. The reporter did not consent to follow-up. Additional supportive information: The patient received a dose of Shingrix with active shingles, which led to drug use for unapproved indication.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the diluent CWY of the vaccine; Received only the diluent CWY of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA677A, expiry date 31st March 2024) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: The patient received a partial dose of Menveo as patient received only the diluent CWY of the vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the diluent CWY of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number abxb36aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: Register medical assistance reported that the patient was administrated an expired dose of Bexsero. No adverse event was reported. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received Bexsero expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: The health care professional reported that a dose of Bexsero was given to the patient and it was already expired. The reporter did not consent to follow up. Additional Supportive Information: The use of Bexsero dose which was already expired on 30th June 2022, which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix expired administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's Comments: The nurse reported that patient was administered Twinrix on 9th Aug 2022, that was expired on 07th AUG 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix vaccine, which led to expired vaccine used.
Sex: M
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: PREMATURE BIRTH; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of an unspecified race and ethnicity. The patient's mother was enrolled in a non-company sponsored study: COVID 19 Vaccines Pregnancy Exposure Registry. The patient's weight, height, and medical history were not reported. On 09-AUG-2021, The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported and expiry: Unknown) dose was not reported, 1 total administered for COVID-19 immunisation. The drug start period and drug last period 81 days. The batch number was not reported and has been requested. No concomitant medications were reported. 09-AUG-2021, the patient experienced fetal exposure during pregnancy. On 29-OCT-2021, the patient experienced premature birth. The reaction first time and last time for  the event premature birth was 82 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 29-OCT-2021, and the outcome of premature birth was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and premature birth, and fetal exposure during pregnancy as not related. Company causality between covid-19 vaccine ad26.cov2.s, and premature birth was related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20211148570.; Sender's Comments: V0: 20220809205-covid-19 vaccine ad26.cov2.s-Premature birth. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.  20220809205-covid-19 vaccine ad26.cov2.s-fetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: pneumonia (30 years ago had pneumonia real bad like for a year), and concurrent conditions included: ex-smoker (Quit smoking). The patient had no history and was pretty healthy overall. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 in total was administered on 03-MAY-2021 to right arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. No concomitant medications were reported. The patient received non-company booster of Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 07-NOV-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2).  The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was reported that on 03-AUG-2022, the patient tested positive for covid-19 and also mentioned on the same day, a little earlier the symptoms had begun. The patient mentioned the symptoms was just not feeling well (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: covid-19 virus test positive (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000244954. This case, involving the same patient is linked to 20220823011.; Sender's Comments: V0: 20220807187- covid-19 vaccine ad26.cov2.s - confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 22 year old white (caucasian) male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and drug allergy (Unspecified) and other pre-existing medical conditions included: The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 at 14:00 on left arm for covid-19 prophylaxis. Age at time of vaccination 21 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUL-2022, the patient tested positive for covid-19 which led to confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered on 31-DEC-2021 at 14:00 on left arm for covid-19 prophylaxis.  On 02-JUL-2022 Patient tested positive for (confirmed covid-19 infection) Covid on (Saturday) (dose number in series 2). Laboratory data included: COVID-19 virus test Positive The patient received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 02-JUL-2022 till 06-JUL-2022 for covid-19 treatment. Patient had a paxlovid prescription and just over 6 months after receiving the booster patient took it for 4 days. After that point patient had been feeling much better. On JUL-2022, after testing negative twice (on 09-JUL-2022 COVID-19 virus test negative and SARS-CoV-2 test negative) over the following 3 days. After then getting symptoms again patient tested positive (nearly instantly with the rapid test, COVID-19 rapid POC (point of care) test Positive). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and paxlovid was drug withdrawn on 06-JUL-2022. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246036.; Sender's Comments: V0:20220820796-COVID-19 VACCINE Ad26.COV2.S- confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; EXPOSED TO COVID-19; This spontaneous report received from a patient via a other company (Pfizer, Inc) concerned a 75 year old male. Initial information processed with additional information received on 11-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (unspecified). The patient had previously received 2 doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose and start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total administered in left arm on an unspecified date in FEB-2022 at 12:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 75 years old. Concomitant medications included lovastatin, and metoprolol. On an unspecified date in 2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient exposed to covid-19 (Dose number in series: 2). On 20-JUL-2022, Laboratory data included: COVID-19 virus test Negative. The patient was quarantined from 20-JUL-2022 to till present. On 22-JUL-2022, the patient tested positive which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. On 23-JUL-2022, the patient received non-company co suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, for treatment of COVID-19. Paxlovid last administration date was 27-JUL-2022. On 29-JUL-2022, the patient still tested positive. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and exposed to covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246040.; Sender's Comments: V0: 20220820808- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Faeces hard
Clinical narrative: STOOLS HARD/FIRM; DIARRHEA; This spontaneous report received from a patient via other manufacturer concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included polycarbophil calcium (Fibercon) for an unknown indication.  On an unspecified date, the patient experienced stools hard/firm and diarrhea (Dose number in series 1). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported and expiry: unknown) dose, frequency, and therapy date were not reported for moderate to severe ulcerative colitis.  The patient additionally received two doses of Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, intramuscular, batch number was not reported and expiry: unknown) dose was not reported (1 in 1 once), administered on an unspecified dates for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of Moderna covid-19 vaccine (Dose number in series 2). The patient received two booster doses of Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin, intramuscular, batch number was not reported and expiry: unknown) dose was not reported (1 in 1 once), administered on an unspecified dates for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of Pfizer biontech covid-19 vaccine (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from diarrhea, and the outcome of stools hard/firm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient is also a health care professional. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: OFF LABEL DOSING FREQUENCY; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: pneumonia (30 years ago had pneumonia real bad like for a year), and concurrent conditions included: ex-smoker (Quit smoking). The patient had no history and was pretty healthy overall. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 in total was administered on 03-MAY-2021 to right arm for covid-19 prophylaxis. No concomitant medications were reported. The patient received non-company booster of Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 07-NOV-2021 for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2).  The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (dose number in series 3). The drug was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 03-AUG-2022, the patient tested positive for covid-19 (confirmed clinical vaccination failure, dose number in series 1) and also mentioned on the same day, a little earlier the symptoms had begun. The patient mentioned the symptoms was just not feeling well (confirmed covid-19 infection) (dose number in series 1 and dose number in series 3). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of off label dosing frequency was not reported. This report was non-serious.  This case, involving the same patient is linked to 20220807187 (dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: MUSCULOSKELETAL DISORDER (RIGHT HAND STILL BOTHERING); This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced musculoskeletal disorder (right hand still bothering). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of musculoskeletal disorder (right hand still bothering) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Headache, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had any problem before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-AUG-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the patient experienced chest pain, and headache. On AUG-2022, the patient experienced covid positive. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chest pain and covid positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246109.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Urticaria
Clinical narrative: AFTER RECEIVED THE VACCINE DO NOT KNOW EXACTLY WHAT WAS IN FOOD; BREAK OUT IN HIVES (ZIP LIKE KIND OF PINS AND NEEDLES IN THE BACK OF TRUCK AND THEN GOING DOWN TOWARD ENTIRE BODY); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced after received the vaccine do not know exactly what was in food, and break out in hives (zip like kind of pins and needles in the back of truck and then going down toward entire body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the after received the vaccine do not know exactly what was in food and break out in hives (zip like kind of pins and needles in the back of truck and then going down toward entire body) was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain assessment, Vomiting
Clinical narrative: CONSTANT BILATERAL TEMPLES HEADACHE (8 HOURS POST VACCINATION); ON/OFF NAUSEA AND NOT CONSTANT; VOMITING (ONE EPISODE BETWEEN 4:00- 5:00, CONTENTS WERE UNDIGESTED FOOD); This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to pet dander (causes itchy eyes and sneezing). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2022 for covid-19 prophylaxis. Age at time of vaccination 18 years old. No concomitant medications were reported.  On 11-AUG-2022 at 04:00, the patient experienced constant bilateral temples headache (8 hours post vaccination). On 11-AUG-2022 04:00, the patient experienced on/off nausea and not constant. On 11-AUG-2022 04:00, the patient experienced vomiting (one episode between 4:00- 5:00 contents were undigested food). Laboratory data included: Pain scale 6/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant bilateral temples headache (8 hours post vaccination) and on/off nausea and not constant, and the outcome of vomiting (one episode between 4:00- 5:00 contents were undigested food) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased immune responsiveness
Clinical narrative: IMMUNITY IS WANING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced immunity is waning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunity is waning was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Back pain, Blood test abnormal, Computerised tomogram, Deep vein thrombosis
Clinical narrative: - Acute Saddle Pulmonary Embolism. - Deep Vein Thrombosis, lower extremity, proximal, acute, left. Shortness of breath started 04/25/2022 and got progressively worse along with mid and lower back pain until left leg started swelling up on 06/08/2022 which sent me to the ER where they diagnosed the Acute Saddle PE and Left Leg DVT. Placed on IV blood thinner while in hospital. Released and put on prescription of ELIQUIS 5 MG tablets twice per day for at least one year for treatment of unprovoked PE and DVT events. No prior history of Blood Clots and subsequent blood work showed no genetic predisposition to blood clots. Had seasonal Flu vaccine and 1st dose of Shingles Vaccine on 01/10/2022. Had 2nd dose of Shingles vaccine on 06/04/2022 and the left leg pain started on 06/05/2022 and continued with leg swelling starting 06/08/2022 which is when I went to the ER as I suspected I had a blood clot in my leg. It was a surprise to find out I had the PE as well.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Pain in extremity, Peripheral swelling, Pulmonary embolism
Clinical narrative: - Acute Saddle Pulmonary Embolism. - Deep Vein Thrombosis, lower extremity, proximal, acute, left. Shortness of breath started 04/25/2022 and got progressively worse along with mid and lower back pain until left leg started swelling up on 06/08/2022 which sent me to the ER where they diagnosed the Acute Saddle PE and Left Leg DVT. Placed on IV blood thinner while in hospital. Released and put on prescription of ELIQUIS 5 MG tablets twice per day for at least one year for treatment of unprovoked PE and DVT events. No prior history of Blood Clots and subsequent blood work showed no genetic predisposition to blood clots. Had seasonal Flu vaccine and 1st dose of Shingles Vaccine on 01/10/2022. Had 2nd dose of Shingles vaccine on 06/04/2022 and the left leg pain started on 06/05/2022 and continued with leg swelling starting 06/08/2022 which is when I went to the ER as I suspected I had a blood clot in my leg. It was a surprise to find out I had the PE as well.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, X-ray
Clinical narrative: - Acute Saddle Pulmonary Embolism. - Deep Vein Thrombosis, lower extremity, proximal, acute, left. Shortness of breath started 04/25/2022 and got progressively worse along with mid and lower back pain until left leg started swelling up on 06/08/2022 which sent me to the ER where they diagnosed the Acute Saddle PE and Left Leg DVT. Placed on IV blood thinner while in hospital. Released and put on prescription of ELIQUIS 5 MG tablets twice per day for at least one year for treatment of unprovoked PE and DVT events. No prior history of Blood Clots and subsequent blood work showed no genetic predisposition to blood clots. Had seasonal Flu vaccine and 1st dose of Shingles Vaccine on 01/10/2022. Had 2nd dose of Shingles vaccine on 06/04/2022 and the left leg pain started on 06/05/2022 and continued with leg swelling starting 06/08/2022 which is when I went to the ER as I suspected I had a blood clot in my leg. It was a surprise to find out I had the PE as well.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Infant irritability, Pyrexia
Clinical narrative: This is a 4-month-old male with no chronic medical history parents at bedside presenting with persistent fever x1 day.  Father states that patient received two 4-month vaccines yesterday.  Parents gave patient a dose of Tylenol prior to vaccines and have repeated Tylenol every 4 hours since vaccines yesterday.  Patient had similar postvaccine fever in June post 2-month vaccines and decided to split 4-month vaccines into 2 sessions.  Second 4-month vaccines are scheduled in 2 weeks.  Patient is bottle-fed and parents report normal appetite, wet diapers and bowel movements.  No diarrhea, vomiting.  Patient is not pulling at his ears and besides increased fussiness is otherwise acting appropriately.  Last dose of Tylenol was at 6 AM.  T-max of 102.2 at home.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling that started approximately 24 hours after vaccine. Self resolved. No hives, wheezing, vomiting, or other symptoms. The swelling improved over the course of the day but returned the following morning and then resolved again.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: PATIENT WAS GIVEN A DOUBLE DOSE OF VARICELLA DUE TO RECEIVING PROQUAD AND VARIVAX. NO AFTER EFFECTS FROM DOUBLE DOSE.
Age: 11.0
Sex: M
Vaccine: DT, MNQ
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever 100-101 Achy Sore throat
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Hot flush, Pain in extremity, Rash
Clinical narrative: Started feeling pain in my arm and shoulder and it never went away. Then 2 weeks later I started getting various rashes on my body. The rashes were hot and spread sporatically. Started getting hot flashes that still remains. Gets dizzy a lot. Participant has been trying to get his PCP to take him seriously, but doesn't feel like they have. Has started taking pictures of the rashes.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Started feeling pain in my arm and shoulder and it never went away. Then 2 weeks later I started getting various rashes on my body. The rashes were hot and spread sporatically. Started getting hot flashes that still remains. Gets dizzy a lot. Participant has been trying to get his PCP to take him seriously, but doesn't feel like they have. Has started taking pictures of the rashes.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 11.0
Sex: F
Vaccine: HEPA, MMRV, MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: N/A Patient's mother reported no adverse events.on  8/8/22 via telephone call.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: The night of receiving the vaccine 7/28/22  I had a low grade fever , next day felt very fatigued, nauseous & had headache.   I considered this normal reaction. However,  these went on for a week, w/the addition of my legs feeling weird, which seemed like too long for side effects.  These symptoms did improve a a bit over the week, & on Sat 8/6/22 during the day I felt like I was finally almost normal. However, Sat evening I suddenly felt very dizzy, had vertigo & was very nauseous.  I had vertigo again on 8/11 and am still very fatigued, with headaches, sinus congestion and leg muscles still feel weird.  Not even close to being able to do normal activities. So I guess I think the adverse event occurred 8/6/22 & forward, but just that the side effects went on so long was also adverse.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Nausea, Pyrexia, SARS-CoV-2 test negative, Sinus congestion
Clinical narrative: The night of receiving the vaccine 7/28/22  I had a low grade fever , next day felt very fatigued, nauseous & had headache.   I considered this normal reaction. However,  these went on for a week, w/the addition of my legs feeling weird, which seemed like too long for side effects.  These symptoms did improve a a bit over the week, & on Sat 8/6/22 during the day I felt like I was finally almost normal. However, Sat evening I suddenly felt very dizzy, had vertigo & was very nauseous.  I had vertigo again on 8/11 and am still very fatigued, with headaches, sinus congestion and leg muscles still feel weird.  Not even close to being able to do normal activities. So I guess I think the adverse event occurred 8/6/22 & forward, but just that the side effects went on so long was also adverse.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: The night of receiving the vaccine 7/28/22  I had a low grade fever , next day felt very fatigued, nauseous & had headache.   I considered this normal reaction. However,  these went on for a week, w/the addition of my legs feeling weird, which seemed like too long for side effects.  These symptoms did improve a a bit over the week, & on Sat 8/6/22 during the day I felt like I was finally almost normal. However, Sat evening I suddenly felt very dizzy, had vertigo & was very nauseous.  I had vertigo again on 8/11 and am still very fatigued, with headaches, sinus congestion and leg muscles still feel weird.  Not even close to being able to do normal activities. So I guess I think the adverse event occurred 8/6/22 & forward, but just that the side effects went on so long was also adverse.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Interchange of vaccine products, Pain, Sneezing
Clinical narrative: Patient called Pharmacy STORE 1842 on 8/12/22 @  6:30pm. to report chills, sneezing, cough and body aches ONE DAY after receiving her MODERNA BOOSTER vaccine (administered on 8/11/22). The symptoms started at 2pm on 8/12/22 and continued and she took a Tylenol tablet OTC to reduce her symptoms
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine administered under doctor's orders; patient was too young to receive Pfizer 5-11.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: pain and redness at injection site, headache and fatigue
Age: 48.0
Sex: F
Vaccine: COVID19, HEPAB
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Developed red painful rash on lower right leg, hot to the touch.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash
Clinical narrative: Here today for concern for immunization reaction. She received MMR and Tdap to her right arm on 8/5/22.  Starting Sunday night, she started to notice some red, mildly painful spots to both hands and feet. Had evaluation at urgent care following, didn't think it was HFMD.  No fevers.  Today she has 2 spots to left hand, 2 spots to right hand, 10 spots to left foot, 5 spots to right foot. These continue to be mildly painful. Have not changed since first noticed: no papule development or blister formation.  Typically participates in gymnastics: they stayed at home in case of HFMD.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Parent signed up patient as a walk-in at pediatric clinic. The covid-19 mass vaccination form was filled out with patients name, date, DOB, chart number, indicating they wanted 2nd vaccine. This nurse was one of two nurses giving immunizations. I did verify the E.H.R. to see if any other immunizations were due. I did not verify that it had been three weeks since the last covid shot. The age appropriate covid vaccine was administered. When I was entering the covid vaccine, I then realized that it had only been two weeks since the last shot.  First dose was received 7/29/2022. Parent was then informed that patient received too soon.
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Oedema peripheral, Pain
Clinical narrative: 08/11/2022 09:35:01 AM >Patient reports the following:  -yesterday (8/10/22) received  Monkeypox (JYNNEOS) 0.5 mL  -side effects noticed immediately after receiving injection  -c/o of the following: major swelling on posterior Left arm; hot to the touch; painfull; erythema; left pinky and ring fingers are numb since this AM -patient declines SOB and any other concerning s/s at this time -patient is not administering OTC pain medications, does not have thermometer at home to check today's temp -RN verbalized patient can apply cool compress, continue to monitor s/s, if worsening patient to be seen promptly, and educated upon most common side effects  Pictures attached to OV 8/10/22 for PCP to review and advise. 08/11/2022 04:44:15 PM > appreciate above and agree with your recommendations: cold compresses, Tylenol and/or NSAIDs. Please report to VAERS  and FU with pt tomorrow on symptoms. 08/12/2022 04:50:42 PM > patient reports the following is still occurring of Left upper extremity post 1st MonkeyPox vaccine:  -pain is 4/10  -edema below the left deltoid has decreased -erythema is still present; this has not increased -declines fever, chills at this time -still c/o numbness/tingling of left pinky and ring finger  plan: patient will continue to monitor s/s, TV with PCP on 8/19/22 to f/u on s/s.   RN submitted VERAS report
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: 08/11/2022 09:35:01 AM >Patient reports the following:  -yesterday (8/10/22) received  Monkeypox (JYNNEOS) 0.5 mL  -side effects noticed immediately after receiving injection  -c/o of the following: major swelling on posterior Left arm; hot to the touch; painfull; erythema; left pinky and ring fingers are numb since this AM -patient declines SOB and any other concerning s/s at this time -patient is not administering OTC pain medications, does not have thermometer at home to check today's temp -RN verbalized patient can apply cool compress, continue to monitor s/s, if worsening patient to be seen promptly, and educated upon most common side effects  Pictures attached to OV 8/10/22 for PCP to review and advise. 08/11/2022 04:44:15 PM > appreciate above and agree with your recommendations: cold compresses, Tylenol and/or NSAIDs. Please report to VAERS  and FU with pt tomorrow on symptoms. 08/12/2022 04:50:42 PM > patient reports the following is still occurring of Left upper extremity post 1st MonkeyPox vaccine:  -pain is 4/10  -edema below the left deltoid has decreased -erythema is still present; this has not increased -declines fever, chills at this time -still c/o numbness/tingling of left pinky and ring finger  plan: patient will continue to monitor s/s, TV with PCP on 8/19/22 to f/u on s/s.   RN submitted VERAS report
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac monitoring, Chest X-ray, Chest pain
Clinical narrative: The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chondritis, Computerised tomogram, Dizziness, Ear discomfort, Echocardiogram
Clinical narrative: The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.