chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider ordered DTAP and pt is 7 years old. DTAP can only be under age 7. MA administered DTAP. Re educated MA about age indications. Handouts given on vaccine age limits. Provider also informed
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: MA had inafnt patients for COVID vaccines in the morning and did not realize a different vaccine is needed for the afternoon as that age group is 5-11 years ols. MA gave the 5 year old a Pfizer vaccine that is reccomended for 6months-4 years old. Per CDC dose will need to be repeated if parent wants to due to low dose given. Parent aware and agrees to bring pt back. Informed MA about COVID vaccines for different age groups. Showed her handout on dosing schedule for COVID vaccines
Age: 7.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: RN was doing a nurse visit and updating vaccines for child. The RN read the box of the given vaccine which states up to 7 years old and pulled the DTAP. This vaccine is only reccomended for children up to 7. Since this child is 7, the vaccine he should have got was TDAP as this one is for ages 7 and over. EMR and other system acceped this vaccine and child will not need to repeat. Spoke with RN and informed her of checking the right medication for patients age and informed her to always check as there are different recomendations for each vaccine. The vaccine box does have wording unclear but reinforced 5 rights of med admin.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Exactly one week after vaccination, my entire body broke out in hives/rash.  Nothing like this has ever happened before.  The hives lasted for 2 days before I set up a virtual appointment with my healthcare provider. They said I was experiencing an allergic reaction and prescribed me with a steroid (prednisone, 10mg) that I took for four days. It helped while I was taking it and then I started getting hives again, but not as intense.  It's been almost 10 months since I got the shot and I still take allergy meds at least once a week because I start to itch randomly.  I know it's because of the vaccine because nothing else in my life has changed at all and I have never experienced an allergic reaction to anything before.  I have done plenty of research online and there is a whole community that has been experiencing chronic urticaria from the Moderna booster.  I also think it's worth nothing that I was fine after I received my initial two vaccinations.  By the time I got the booster though, I had gotten covid twice despite being fully vaccinated.  The allergic reaction began after the booster, not the original vaccinations.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Fear, Pyrexia
Clinical narrative: My daughter received the flu vaccine 45 minutes after she received the Bivalent vaccine from another facility.  On our way out of the building, she verbalized that she wanted to cough but can't & started complaining of dyspnea/ shortness of breath, & chest tightness. She was scared, tearful, & didn't want to talk. I didn't not hear any wheezing from her. We walked to the ER, vital signs were stable. It took about 20 minutes before she felt better & I checked her out without being seen by MD. No lingering symptoms were noted the next day except for fever & fatigue.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder, Tearfulness
Clinical narrative: My daughter received the flu vaccine 45 minutes after she received the Bivalent vaccine from another facility.  On our way out of the building, she verbalized that she wanted to cough but can't & started complaining of dyspnea/ shortness of breath, & chest tightness. She was scared, tearful, & didn't want to talk. I didn't not hear any wheezing from her. We walked to the ER, vital signs were stable. It took about 20 minutes before she felt better & I checked her out without being seen by MD. No lingering symptoms were noted the next day except for fever & fatigue.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse events
Age: 43.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizzyness
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram normal
Clinical narrative: I had previous 4 covid vaccines (initial series, 2 boosters, all Pfizer) with no side effects at all.  Recently had Moderna (becausethat is what the facility was offering)  Felt normal the day of vaccination, woke up the next morning with Left hip pain that strongly resembled sciatica that I had had 5 years prior due to herniated disk on my right side. Pain became more severe throughout the day. 11/23 /2022 went to ER in town I was visiting.  I remembered that I had the Moderna vaccine 2 days prior but that I had also been doing strenuous activity. A CT Scan was ordered which showed no cause for the pain I was experiencing.  No other side effects experienced (sore arm, fever, fatigue, etc)
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W002561, expiration date reported and established as 07-OCT-2023 (strength, dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. Prior to administration, the dose experienced temperature excursions of 1 hour at 9.13 degrees Celsius and 37 hours 15 minutes at minimum of -8.45 degrees Celsius (product storage error). There were no previous temperature excursions.  No additional adverse event (AE) information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: Reporter states that patient had a sharp pain on the right side of his rib cage and on October 12th, 2022 patient was diagnosed with Shingles; Reporter states that the injection was administered "way too high in the shoulder area." Reporter states that this caused pain and soreness on the shoulder area; This spontaneous report was received from the patient's spouse and refers to a male patient of unknown age. The patient's medical history included ""old shingles vaccine" administration. Concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2018 and in October 2018, the patient was vaccinated with the first and the second dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis in right arm (dose, strength, lot #, expiry date, and route of administration were not provided). Reporter stated that the injection was administered "way too high in the shoulder area" and this caused pain and soreness on the shoulder area. Still this day, the patient has pain in the shoulder. The outcome of the event was reported as not resolved.  On 12-OCT-2022, the patient had a sharp pain on the right side of his rib cage and was diagnosed with shingles. The patient sought medical attention. Treatment included valacyclovir. The outcome of the event was unknown.  The causal relationship between the shoulder pain, shingles and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called in and reported that an expired dose of VARIVAX was administered on 10/31/2022. Caller did not report any temperature excursion. Caller reports the vaccines expired on 10/05/2022. No further information was provided to further clarify any; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unspecified date, the first and second dosages of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, indication, lot number and expired date were no reported). On 31-OCT-2022, the patient was vaccinated with an expired vaccine third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral liquid, third dose, Lot #1742084, expiration date: 05-OCT-2022 (strength, route of administration, and indication were not reported). It was specified that no mention of any temperature excursion was made, and no further information was provided to further clarify any. No adverse event was reported. At the time of reporting, the outcome of the event not reported.  The action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) regarding the event was not reported  The causal relationship between the event and the suspect vaccine was not reported.; Sender's Comments:  US-009507513-2211USA000276
Sex: F
Vaccine: HEP
Symptoms: Syringe issue, Wound
Clinical narrative: punctured a medical assistant's thumb / medical assistant noticed pain in her thumb while administering the vaccination and realized a piece of the finger flange broke off during the injection of a patient.; RECOMBIVAX HB broke; This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-NOV-2022, the patient noticed pain in her thumb while she was administering hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) injection (lot number W016842 which has been verified to be valid, expiration date reported and validated as 19-NOV-2023) as prophylaxis (dosage, route of administration, and anatomical site of injection were not reported); and realized a piece of the finger flange broke off during the vaccination and punctured her thumb (wound and syringe issue). The patient sought medical attention, and as treatment the wound was cleaned, and glass was removed. On 18-NOV-2022, the patient recovered from the event.   The causal relationship between wound and hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) was not provided.    This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2211USA006547:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP calling in to report that a patient was inadvertently administered an expired dose of PROQUAD.; No additional AEs/no PQCs; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 04-NOV-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (1 dose) (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U009259, with an expiration date of 19-SEP-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: "I had shingles vac. ten years ago; do I need one again? And if you already had shingles, can you get it again?"; This spontaneous report has been received from a consumer, regarding to itself, a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On an unspecified date in 2012 (reported as ten years ago), the patient was vaccinated with a dose of Zoster Vaccine Live (ZOZTAVAX) subcutaneous injections (reported as shingles vaccine) as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported).  On an unspecified date, the patient experienced shingles (Herpes zoster). The patient was inquiring if another dose was needed. The outcome of herpes zoster was not reported.  The causal relationship between herpes zoster and Zoster Vaccine Live (ZOZTAVAX) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reported an adverse event. Caller explained GARDASIL 9 was administered after the expiry date. Caller said the GARDASIL 9 administration occurred on 14NOV2022 and the date of expiration was 25AUG2022.; This spontaneous report has been received from a pharmacist concerning to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 14-NOV-2022,the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number 1687292 that was verified to be valid with an expiration date reported and established as 25-AUG-2022) for prophylaxis (expired product administered).  By the reporting time, the caller confirmed that the suspect vaccine had no history of temperature excursions.   No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: SMALLMNK
Symptoms: Monkeypox, Polymerase chain reaction positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004664, is a spontaneous case report initially received from a phycisian (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient's medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 645 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, reported as six days after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) six days after the first dose of Jynneos vaccine was administered. Monkeypox is unlisted. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) six days after the first dose of Jynneos vaccine was administered. Monkeypox is unlisted. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the full course of vaccination has not been yet completed at the time of confirmed monkeypox infection via PCR the case is considered not related to vaccine.
Sex: U
Vaccine: SMALLMNK
Symptoms: HIV test negative, Monkeypox, Orthopoxvirus test positive, Polymerase chain reaction positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004667, is a spontaneous case report initially received from a healthcare professional (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history was not provided.   The patient's concomitant medication was not provided.  On an unspecified date, the patient was negative to human immunodeficiency virus (HIV).  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On unspecified date, reported as one week after second Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown demographics received the first and second doses of Jynneos, applied on unknown dates for monkeypox prevention. Reportedly, a week after the second dose, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted for Jynneos. Medical history was not specified. Patient was negative for HIV. Concomitant medications were unknown. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, the event is assessed as not related to Jynneos. According to the insert for MVA-BN, vaccination with the product may not result in protection in all cases.; Sender's Comments: A patient of unknown demographics received the first and second doses of Jynneos, applied on unknown dates for monkeypox prevention. Reportedly, a week after the second dose, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted for Jynneos. Medical history was not specified. Patient was negative for HIV. Concomitant medications were unknown. Considering that the full protection may not have been reached after 1 week after the second dose, this case is considered not related to vaccine.
Sex: U
Vaccine: SMALLMNK
Symptoms: CD4 lymphocytes, Monkeypox, Polymerase chain reaction positive
Clinical narrative: PCR confirmed Monkeypox; Case reference number US-BN-2022-004668, is a spontaneous case report initially received from a healthcare professional via Communications (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV) with CD-4 lymphocytes, at 631 (units not provided).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox. As reported, the patient received the first Jynneos dose during illness but that was not confirmed.  At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and as possibly related to Jynneos vaccination.   Additional information received from the physician via Med Communications on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004665, US-BN-2022-004666, US-BN-2022-004667 and US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown demographics received the first dose of Jynneos, applied on an unknown date for monkeypox prevention. It was reported that the patient received this dose of Jyneos during illness, but no further details were clarified. On an unknown date, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the labeling for Jynneos. Medical history included HIV, with CD4 lymphocytes level at 631. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, the event is assessed as not related to Jynneos. Furthermore, the patient developed the infection before being able to complete the vaccination course.; Sender's Comments: A patient of unknown demographics received the first dose of Jynneos, applied on an unknown date for monkeypox prevention. It was reported that the patient received this dose of Jyneos during illness, but no further details were clarified. On an unknown date, the patient developed the serious (medically significant) event of monkeypox, confirmed via PCR test. Monkeypox is unlisted per the labeling for Jynneos. Medical history included HIV, with CD4 lymphocytes level at 631.  Considering that the patient developed the infection before being able to complete the full vaccination course of 2 doses this case is considered not related to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them now. Dr. told me the same thing about the covid vaccines/Suspected vaccination failure; I have them now; 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.   The patient's past medical history included covid-19. Previously administered products included Covid-19 vaccine (received 1st, 2nd and 3rd dose on an unknown date).   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: 16-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that he/she had them now.  It had been a month. The patient's doctor told him/her the same thing about the covid vaccines.  The patient had three. He/she almost died from Covid. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of 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: Herpes zoster, Vaccination failure
Clinical narrative: vaccination failure/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the GSK shingles vaccine. The patient developed shingles despite of shingles shot. The shingles was not as bad as it would be. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: 2 patients received an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, 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: 14-NOV-2022 Reporters comment: Doctor reported that the patient received a dose of Havrix that expired 5 weeks earlier. The health care professional did not provide patient identifiers, lot number or exact expiration date of product. The reporter consented to follow-up. Additional Supportive information: The patient received a dose of Havrix that expired 5 weeks earlier, which led to expired vaccine used. This case had been linked to the case US2022AMR171880 reported by the same reporter. This case was linked to the cases US2022AMR163515, US2022AMR163547, US2022163626 and US2022AMR164695.; Sender's Comments:  US-GSK-US2022AMR171880:Same reporter. Patient 2 of 2 US-GSK-US2022AMR163515:Same reporter US-GSK-US2022AMR163547:Same reporter US-GSK-US2022163626:Same reporter US-GSK-US2022AMR164695:Same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient only got the the adjuvant; Patient only got the the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix. On 11th November 2022, unknown after receiving Shingrix, 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: 14-NOV-2022 Reporter's comment: The reporter was the patient's son who stated that his mother got her first Shingrix vaccine. However, the nurse just let him know that she did not reconstituted the vaccine and so the patient only got the adjuvant.  The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the patient had received only the adjuvant part, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: No 2nd dose due to COVID pandemics, 1st dose 2019; This case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (patients were vaccinated on 2019 or 2020 with the first dose).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.    Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A health care professional had reported that several patients did not had receive the second dose at the time of reporting, due to the COVID pandemics. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2022AMR168777:Same reporter. 2020 case.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of expired Havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Havrix. On 17th October 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: 14-NOV-2022 Reporter's comments: A nurse had reported that the patient had received a dose of expired Havrix vaccine, which was expired on 09 August 2022. The reporter had consent to follow up.  Additional supportive information: The patient had received an expired dose of Havrix, which had led to expired vaccine used. This case was linked with US2022168181 which was reported by same reporter.; Sender's Comments:  US-GSK-US2022168181:Same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm; Constant fever between 99 and 102 degrees; Constant headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th November 2022, 3 hrs after receiving Shingrix, the patient experienced pain in arm, fever and headache. On an unknown date, the outcome of the pain in arm, fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: The reporter was the patient and had received her first Shingrix vaccine in the left arm. She had experienced  a very sore arm since the day she had received the Shingrix. She had a constant fever that was being fluctuated between 99 and 102 degrees Farhenit.  The reporter also had reported that she has had a constant headache, except for maybe two hours since receiving the vaccine. The reporter did not consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 29Sep2022, 2nd on 10Nov2022/ Administering the Second Dose of Shingrix at Less than the Minimum Recommended Interval; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number AR335, expiry date 11th February 2024) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 10th November 2022, the patient received the 2nd dose of Shingrix. On 10th November 2022, 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: 14-NOV-2022 Reporter's comments: The nurse had called to report that the patient who was not immunocompromised patient had received his first dose on 29 September 2022, lot number-23YG7 and expiration date 10 December 2023. but then, on 10 November 2022 he was administered with a Shingrix second dose. The reporter had consent to follow up via email. Additional supportive information: The patient had received the second dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash
Clinical narrative: rash; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and diarrhea. On an unknown date, the outcome of the rash and diarrhea were unknown.   It was unknown if the reporter considered the rash and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced a rash and diarrhea. The patient did not provide any demographics. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Myocardial infarction
Clinical narrative: MASSIVE HEART ATTACK; BLOOD CLOT IN DAMAGED APEX; This spontaneous report received from a consumer (wife) via a company representative through social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have heart problem prior vaccination. 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 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-DEC-2021, the patient experienced massive heart attack, and blood clot in damaged apex. It was reported as "Bless your wife. My husband had a massive heart attack after the vaccine still with us but lots of damage and still has a blood clot in damaged Apex. This was December 7, 2021. No prior heart problems ever". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in damaged apex, and the outcome of massive heart attack was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221139543.  It was determined that 20221139543 was a duplicate of this case. All relevant information regarding Manufacturer Report Number 20221139543 will be submitted under 20221139393.; Sender's Comments: V0: 20221139393-massive heart attack. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221139393- blood clot in damaged Apex. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Death, Hospitalisation, Off label use
Clinical narrative: HOSPITALIZATION; OFF LABEL DOSING FREQUENCY; DEATH; This spontaneous report received from a parent through social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on OCT-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on NOV-2021 for covid-19 prophylaxis. The drug was associated with Off label use (Off label dosing frequency). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On unspecified dates in 2022, the patient was hospitalized in and out of the hospital (reason and duration unspecified) (Dose number in series 2). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. On 25-APR-2022, the patient experienced death and died from an unknown cause of death (Dose number in series 2). It was unknown if an autopsy was performed or not. It was reported as "...My son got 2 covid shots, 1 in October of last year, another in November of last year!!! He was in and out of the hospital about 5 times the first 4 months of this year!!! He passed April 25th of this year !!!!" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization and off label dosing frequency was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221139847-Death and Hospitalization. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company representative through social media and concerned a patient of unspecified age and sex. 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, 1 total, start therapy date were not reported for covid-19 prophylaxis. 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 experienced heart attack. The reporter stated that "My daughter had a stroke and her friend had heart attack after their shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221146283.; Sender's Comments: V0-20221143337- Heart Attack. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER; This spontaneous report received from a consumer via a company representative via social media concerned a male 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 experienced cancer. The reporter stated that " my boyfriend and best friend, both developed 2 different cancers after receiving the shot. Weird, Coincidence or is the shot what some say it is, It sure was not tested long after it was made". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221143605.; Sender's Comments: V0: 20221146108- Cancer. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative via social media 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, 1 total start therapy date were not reported for covid-19 prophylaxis. 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 experienced stroke. It was reported that, "My daughter had a stroke". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221143337.; Sender's Comments: 20221146283- stroke. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS ALL THRU BODY TWICE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age race and ethnicity. 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 date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 experienced blood clots all thru body twice. It was reported as "I talked with a woman at a place that told me from her shot she got many blood clots all thru her body twice" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots all thru body twice was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221146373- Blood clots all thru body twice. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: DIED; MASSIVE HEART ATTACK; This spontaneous report received from a consumer by a company representative via social media concerned a 34 year old male of an unspecified race and ethnicity. 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 date were not reported) dose, start therapy date was not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 4 decade old. 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 experienced massive heart attack and he died from unknown cause of death. It was reported as "My family member got it and had a massive heart attack and died he was only 34". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221147298-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221147298- massive heart attack. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: BECAME SO NERVOUS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously 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, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, following vaccination with second dose the patient became so nervous, had to hold glass with both hands in order to drink (Dose number in series 2). It was reported as "After receiving my second j j shot, I became so nervous had to hold my glass with both hands in order to drink, still that way. No more shots for me." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from became so nervous. This report was non-serious.