chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles, received both doses/  Suspected vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported by medical assistant. The patient received 2 doses of Shingrix about 4 years ago from reporting. At the time of reporting the patient had active Shingles outbreak. The reporter was not sure why or how this happened but would like more information on that. The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100475:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have shingles, had vaccination years ago/Suspected vaccination failure; shingles, lower back to belly button; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had shingles vaccination many years ago.  The patient had shingles at the time of reporting affecting lower back going to the belly button . The patient stated that, it was absolutely awful and Keep him/her in prayers .  The patient further stated that, guess he/she should have taken another one. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 06-AUG-2022, 2nd dose on 19-jun-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7524T, expiry date 13th July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th August 2020, (batch number CL335 and expiry date 23rd May 2022)).   On 19th June 2022, the patient received the 2nd dose of Shingrix. On 19th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's comment: Pharmacist reported that the patient forgot to get second dose, so it was not administered until 19th June 2022. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administration of Havrix 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 patient who received HAV (Havrix) (batch number unknown, expiry date 24th May 2022) for prophylaxis.   On 27th June 2022, the patient received Havrix. On 27th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-Jun-2022 Reporters comment: An expired Havrix vaccines was administered to the patient. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: told clinic this would be his first dose/ actually had first dose just two weeks prior; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 27-Jun-2022 Reporters comment: Nurse reported patient came in and received Shingrix vaccine. He told clinic this would be his first dose, however after it was administered, they realized he actually had first dose just two weeks prior. Reporter did not want to provide any further details. Reporter does not want to be contacted for follow-up. Nurse declined to provide any information additional information. Did not consent to follow-up. Additional Supportive Information: The patient received two doses of Shingrix, 2 weeks apart, which led to shortening of vaccination schedule.
Age: 70.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first two doses in 2016, third 28-JUN-2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received HAB (Twinrix adult) 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.   Previously administered products included Twinrix adult (the patient received his first two doses of Twinrix in 2016).   On 28th June 2022, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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:28-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose of Twinrix adult later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered expired Havrix (exp:6/20/22) dose to a pt on 6/27/2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix adult) (batch number unknown, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 27th June 2022, unknown after receiving Havrix adult and Havrix 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: 28-JUN-2022 Reporter's Comments: The pharmacist reported that they inadvertently administered a dose of Havrix was given to the patient and it was already expired. The pharmacist inquired how to proceed with revaccination. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 20th June 2022, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose which expired on 14-JUN-2022 was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix and Havrix 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: 28-JUN-2022 Reporter's Comments: The physician assistant reported that a dose of Havrix was given to the patient and it was already expired. The reporter did not consent to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 14th June 2022, which led to expired vaccine used.
Age: 0.67
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Havrix to an 8 month old pt; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported by medical assistant. The reporter stated that last month another employee administered Havrix to an 8 month old patient instead of to a 2 year old patient. The reporter did not have additional details at time of call. The reporter consented to follow up via email. Additional Supportive Information: The reporter stated that 8 month old patient was administered Havrix instead of to a 2 year old patient which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally administered third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2022, the patient received the 3rd dose of Shingrix. On 29th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comment: The pharmacy intern reported that the patient was accidentally administered third dose of Shingrix on 29th June 2022, at approximately noon. The reporter did not consent to follow-up. Additional Supportive Information: The patient was accidentally administered with third dose which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2.5 years before, not received dose two; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two and a half years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022  Reporter's comment: The reporter was the concerned patient. The physician reported that he received first dose of Shingrix two and a half years before this report and had not received dose two. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked to the case US2022099886, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099886:Same reporter
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose was given which had an expiration date of 14Jun2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 28th June 2022, the patient received the 1st dose of Havrix. On 28th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comments:  The reporter stated that the patient was administered Havrix, which had an expiration date of 14th June 2022. At the time of reporting, dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received dose, the dose had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Havrix and Havrix 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: 29-Jun-2022. Reporter's Comments: The pharmacist reported that a dose of Havrix was given to the patient and it was already expired.  The vaccine administration facility was the same as primary reporter.  The reporter did not consent to follow up. Additional Supportive Information: The patient received Havrix dose, which was already expired on 18th June 2022, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Social problem
Clinical narrative: 3rd dose administered  after 6 month  due to COVID pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient did not receive the 3rd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The pharmacist reported about administration of 3rd Engerix-B vaccine after 6 month for several employees due to COVID pandemic delayed.  The reporter consented to follow up. No additional details were given regarding employees who have had delayed Engerix-B vaccinations.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose a year ago, has not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment:  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The vaccine administration facility was the same as primary reporter which corresponded to the 1st dose as 2nd dose was not administered. This case is linked to the case US2022099156, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099156:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 12/07/2020 and never received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The patient self-reported the case. The reporter stated that he intended to get 2nd dose as soon as possible. The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The details corresponded to the 1st dose as 2nd dose was not administered.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysgeusia
Clinical narrative: COVID-19 INFECTION; METALLIC TASTE; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ADHD (Attention-deficit/hyperactivity disorder) and unspecified allergy. The patient previously 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 at left leg on 02-MAR-2021 for prophylactic vaccination. Age at time of vaccination was 28 years. The batch number was not reported and has been requested. Concomitant medications included methylphenidate hydrochloride for drug used for unknown indication. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received non-company suspect vaccine included: Spikevax (elasomeran) (form of admin and route of admin were not reported, batch number: unknown expiry: unknown) dose was not reported, administered at left arm on 22-OCT-2021 for prophylactic vaccination (dose number in series 2). On an unspecified date, patient experienced covid-19 infection (dose number in series 2). On 21-JUN-2022, patient took non-company suspect drug Pfizer-Paxlovid (form of admin and route of admin were not reported, batch number GC4026 expiry: unknown) dose was not reported, administered for treatment of Covid-19.  On 21-JUN-2022 at 22:00, the patient experienced metallic taste 2 hours after first dose of Paxlovid  (dose number in series 2). Date of last administration of Paxlovid was 21-JUN-2022.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from metallic taste, and outcome of covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: OVER TIRED THE NEXT DAY; HEADACHE IN THE FOLLOWING DAYS; This spontaneous report received from a patient who is a nurse concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient is a nurse. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in 2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, in 2020, the patient experienced over tired the next day, and headache in the following days (Dose number in series 1). The outcome of the over tired the next day and headache in the following days was not reported. The patient received additional covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Carbon dioxide, Feeling abnormal
Clinical narrative: FELT CRUDDY; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 309 pounds, and height was 65 inches. The patient's past medical history included: covid-19 infection (Patient stated that back in SEP-2020 he went to the hospital and almost died, CO2 level were through the roof. He sat down and looked at his hospital record and it said he had COVID. He assumed he had it.), and covid-19 infection (Patient stated he got Covid again in DEC-2020. Patient stated he still was not vaccinated either time), and concurrent conditions included: non-smoker, and non-alcoholic, and other pre-existing medical conditions included: The patient had no known allergies to vaccine, drug or food. The patient had no drug abuse or illicit drug usage. Patient did not have family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported. On SEP-2020, Laboratory data included: CO2 Patient reported his CO2 level was through the roof. On 05-MAY-2021, the patient experienced felt cruddy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cruddy. This report was non-serious. This case, involving the same patient is linked to 20220638632.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dysgeusia, Muscle tightness, Myalgia
Clinical narrative: BITTER TASTE; MUSCLE ACHE; MUSCLE TIGHTNESS; DIARRHEA; This spontaneous report received from a patient via Pfizer Inc. concerned a 60 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was not pregnant at the time of reporting. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment (vaccine). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered at left arm on 19-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 60 years. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s.  The patient additionally received non-company suspect covid-19 vaccine tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported, administered on 12-JUN-2022 for prophylactic vaccination and end date of therapy was 16-JUN-2022. Duration was 4 days. Age at the time of vaccination was 60 years.  On 15-JUN-2022, third day of vaccination, the patient experienced muscle tightness, and diarrhea (Dose number in series 2). On 16-JUN-2022, fourth day of vaccination, the patient experienced muscle ache (Dose number in series 2). On 17-JUN-2022, fifth day of vaccination, the patient experienced bitter taste (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from muscle tightness, bitter taste, diarrhea, and muscle ache. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Off label use, SARS-CoV-2 test, Vomiting
Clinical narrative: CONFIRMED COVID-19 INFECTION; VOMITING; DIARRHEA; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other company (Pfizer) concerned a 64 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: unknown) dose was not reported, 1 in total, administered on 22-MAR-2021 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported, 1 in total, administered on 02-SEP-2021 on left arm for prophylactic vaccination which was an off label dosing frequency (dose number in series 2). The drug was associated with Off label use. Age at time of vaccination 64 years old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. The patient received third dose of non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 3) (form of admin, route of admin were not reported, batch number: FK9896 and expiry: unknown) dose was not reported, administered on 07-FEB-2022 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced nasal congestion/runny nose (coded as confirmed covid-19 infection) (dose number in series 3). The patient received Paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 07-JUN-2022 to 12-JUN-2022 for the treatment of covid-19. On 13-JUN-2022, the patient tested negative for Covid-19. On 16-JUN-2022, the patient experienced vomiting, and diarrhea (dose number in series 3). Vomiting and diarrhea were not part of original symptoms and the patient had no fever. On 17-JUN-2022, Laboratory data included: COVID-19 virus test was resulted positive. The action taken with tozinameran was not applicable. The patient had not recovered from vomiting, diarrhea, and confirmed covid-19 infection. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 SYMPTOMS; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (drug not reported). The patient previously took covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start date was not reported administered for prophylactic vaccination. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 28-APR-2021 for prophylactic vaccination which was off label use (off label dosing frequency) (Dose number in series 2). Age at time of vaccination 30 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JUN-2022, the patient initiated the treatment with paxlovid for COVID-19 and completed the treatment on 10-JUN-2022. On an unspecified date in JUN-2022, the patient experienced covid-19 symptoms after treatment with paxlovid (Dose number in series 2). On an unspecified date in JUN-2022, Laboratory data included: COVID-19 virus test Positive (the patient had strong positive at home test). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug discontinued. The patient had not recovered from covid-19 symptoms, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with product quality complaint: 90000238707.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK; This spontaneous report received from a patient via a company representative concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy. 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 prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220651820.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAINS; This spontaneous report received from a consumer via a company representative via Social media concerned a male of unspecified age, race and ethnic origin. 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, batch number and expiry were not reported) dose, start therapy date were not reported 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient (reporter's nephew) experienced chest pains, and was hospitalized (date unspecified). Number of days hospitalized and discharge information was not reported. As per the reporter, "My nephew is in the hospital today for chest pains following the Johnson and Johnson vaccine that was required by a potential employer" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pains was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220661521-COVID-19 VACCINE AD26.COV2.S-chest pains. The event(s) has an unknown/unclear 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 unassessable.
Age: 51.0
Sex: M
Vaccine: 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 52 year old male. 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 not reported, batch number: 207A21A, expiry: 18-FEB-2022) dose was not reported, 1 total administered to left arm on 12-AUG-2021 for prophylactic vaccination. Age at time of vaccination 51 years old. No concomitant medications were reported.  On 26-JAN-2022, the patient had a COVID-19 PCR (polymerase chain reaction) test, which resulted positive (coded as confirmed covid-19 infection and clinical vaccination failure). The Patient was given with an infusion after he tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239971.; Sender's Comments: V0: 20220700574 -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. 20220700574 -Covid-19 vaccine ad26.cov2.s -confirmed covid-19 infection. 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 unassessable.
Age: 23.0
Sex: M
Vaccine: 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 consumer concerned a 24 year old, male. Initial information was processed along with additional information received on 01-JUL-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: unknown) dose was not reported, 1 in total was administered to right arm on 15-JUL-2021 for prophylactic vaccination. Age at time of vaccination 23 years old. No concomitant medications were reported.  On 21-JUN-2022, the patient had bad cough and headache. On mid last week, week before 26-JUN-2022, patient started feeling sick and also had strep throat (confirmed covid-19 infection). On 26-JUN-2022, Laboratory data included: COVID-19 virus test Positive (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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: 90000240652. This case, from the same reporter is linked to 20220702424.; Sender's Comments: V0: 20220702322-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: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: SNEEZING OCCASIONALLY; This spontaneous report received from a patient 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 not reported, batch number: 1808609 expiry: 04-FEB-2022) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2022, Laboratory data included: COVID-19 rapid POC test Negative. On an unspecified date, the patient experienced sneezing occasionally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sneezing occasionally. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Influenza like illness; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (Influenza like illness) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Covid arm). At the time of the report, IMMUNISATION REACTION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided Treatment medication was not provided by the reporter  Patient had experienced Covid arm from The Moderna
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Extra dose administered
Clinical narrative: I got reinfected with COVID; Extra dose administered; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got reinfected with COVID) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 treatment.     Concurrent medical conditions included Crohn's disease, Hashimoto's disease, Drug allergy (Sulf), Penicillin allergy and Drug allergy (Remicade). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN D [VITAMIN D NOS] and VITAMIN B12 NOS for an unknown indication.   On 26-Feb-2021 at 12:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022, received sixth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 26-Jun-2022, the patient experienced COVID-19 (I got reinfected with COVID). At the time of the report, COVID-19 (I got reinfected with COVID) was resolving and EXTRA DOSE ADMINISTERED (Extra dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient historical condition included Lupus.  Patient concurrent medication included Plaquenil, Pepcid, P.  Patient had no hospitalization prolonged.  Patient had not taken treatment for the adverse reaction. Device Date : 29Jun2022  Company Comment: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (I got reinfected with COVID) unspecified 13 days after receiving a dose of mRNA-1273 vaccine. Extra dose administered was noted in this case. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (I got reinfected with COVID) unspecified 13 days after receiving a dose of mRNA-1273 vaccine. Extra dose administered was noted in this case. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Embolism
Clinical narrative: passed away via embolism shortly; This spontaneous case was reported by an other health care professional and describes the occurrence of EMBOLISM (passed away via embolism shortly) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EMBOLISM (passed away via embolism shortly) (seriousness criteria death and medically significant). The patient died in May 2021. The reported cause of death was passed away via embolism shortly. It is unknown if an autopsy was performed.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  It was reported that patient's brother was looking to understand that his sister passed at a fairly young age as patient was extremely strong and healthy at the time it was reported and  She was unexpectedly passed away within 2 weeks of the last dose.  Company Comment: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine. The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter. Cause of death was reported as embolism. Autopsy report was not provided. Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old female patient with no reported medical history, who experienced the unexpected, serious (fatal and medically significant) adverse event of special interest Embolism on an unknown date after receiving the second dose of mRNA-1273 vaccine.  The event occurred within two weeks of vaccination and led to a fatal outcome shortly thereafter.  Cause of death was reported as embolism. Autopsy report was not provided.  Patient received the first dose of mRNA-1273 vaccine 33 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: passed away via embolism shortly