chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dehydration, Hypersensitivity, Mobility decreased, Vomiting
Clinical narrative: vomited for 15 hours straight about 80 times; almost killed/I almost died/feel myself dying within 24 hours; could not move; dehydrated; lost 10 lbs in 24 hours; severe allergic reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of impending doom in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included healthy patient.   On 10-DEC-2024, the patient received the 1st dose of Shingrix. On 10-DEC-2024, less than a day after receiving Shingrix, the patient experienced impending doom (Verbatim: almost killed/I almost died/feel myself dying within 24 hours). On 11-DEC-2024, the patient experienced vomiting (Verbatim: vomited for 15 hours straight about 80 times). In DEC-2024, the patient experienced mobility decreased (Verbatim: could not move), dehydration (Verbatim: dehydrated), weight loss (Verbatim: lost 10 lbs in 24 hours) and allergic reaction (Verbatim: severe allergic reaction). The outcome of the impending doom, mobility decreased, weight loss and allergic reaction were unknown and the outcome of the dehydration and vomiting were resolved.   It was unknown if the reporter considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix.     It was unknown if the company considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2024 and 13-DEC-2024 The patient self-reported this case. The patient was aggressive and raising her voice and had received 1st dose of Shingrix and on the next day she woke up at 5:30 am in the morning and had uncontrollable vomiting about 80 times for 15 hours straight. The patient lost 10 pounds in one night was so dehydrated the doctor said she would had been dead in another hour, because she guessed she had a really severe allergic reaction and said your shot almost killed her in 24 hours (within a day). She was pissed beyond belief and asked what was her life worth to you and said apparently nothing since you knowingly sell these shots that can kill a person in a day. She got no information from her doctor about anything to expect. She reported it to healthcare professional and stated HCP office was rude and did not care and she would not be seeing HCP, so no HCP consent.  She was posting on social media how Shingrix could kill people and that GSK did not care.  She also stated she was getting a lawyer. The case US2024157516 was identified as follow-up of case US2024157513. The case US2024157516 was deleted due to being created in error and all future correspondence would be added in the present case US2024157513 which stands as case of record.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: vomited for 15 hours straight about 80 times; almost killed/I almost died/feel myself dying within 24 hours; could not move; dehydrated; lost 10 lbs in 24 hours; severe allergic reaction; This non-serious case was reported by a consumer via call center representative and described the occurrence of impending doom in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included healthy patient.   On 10-DEC-2024, the patient received the 1st dose of Shingrix. On 10-DEC-2024, less than a day after receiving Shingrix, the patient experienced impending doom (Verbatim: almost killed/I almost died/feel myself dying within 24 hours). On 11-DEC-2024, the patient experienced vomiting (Verbatim: vomited for 15 hours straight about 80 times). In DEC-2024, the patient experienced mobility decreased (Verbatim: could not move), dehydration (Verbatim: dehydrated), weight loss (Verbatim: lost 10 lbs in 24 hours) and allergic reaction (Verbatim: severe allergic reaction). The outcome of the impending doom, mobility decreased, weight loss and allergic reaction were unknown and the outcome of the dehydration and vomiting were resolved.   It was unknown if the reporter considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix.     It was unknown if the company considered the impending doom, mobility decreased, dehydration, vomiting, weight loss and allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2024 and 13-DEC-2024 The patient self-reported this case. The patient was aggressive and raising her voice and had received 1st dose of Shingrix and on the next day she woke up at 5:30 am in the morning and had uncontrollable vomiting about 80 times for 15 hours straight. The patient lost 10 pounds in one night was so dehydrated the doctor said she would had been dead in another hour, because she guessed she had a really severe allergic reaction and said your shot almost killed her in 24 hours (within a day). She was pissed beyond belief and asked what was her life worth to you and said apparently nothing since you knowingly sell these shots that can kill a person in a day. She got no information from her doctor about anything to expect. She reported it to healthcare professional and stated HCP office was rude and did not care and she would not be seeing HCP, so no HCP consent.  She was posting on social media how Shingrix could kill people and that GSK did not care.  She also stated she was getting a lawyer. The case US2024157516 was identified as follow-up of case US2024157513. The case US2024157516 was deleted due to being created in error and all future correspondence would be added in the present case US2024157513 which stands as case of record.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; they got an episode of shingles; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 75-year-old female 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: they got an episode of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-JAN-2025. The reporter had a patient that received 2 doses of the Shingrix vaccine in year 2019.  In 2023, patient had an episode of shingles.  The reported asked the patient to repeat the series of Shingrix vaccine.  Reporter tried to check CDC and this website but was not able to find answer. The reporter asked information regarding this. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: very sore injection site for over a week/then less sore but able to use arm; itching at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Dec2024 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PRURITUS (disability) with onset 20Dec2024 at 16:00, outcome "recovering", described as "itching at the injection site"; VACCINATION SITE PAIN (disability) with onset 20Dec2024 at 16:00, outcome "recovering", described as "very sore injection site for over a week/then less sore but able to use arm". Therapeutic measures were taken as a result of vaccination site pain, vaccination site pruritus. Additional information: very sore injection site for over a week. Then less sore but able to use arm. Then itching at the injection site. This is the very worst injection i have ever received.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Autoimmune disorder, COVID-19, Condition aggravated, Drug ineffective
Clinical narrative: she had Covid; she had Covid; autoimmune disease reactivated; autoimmune disease reactivated; Is it similar ingredients to Pfizer Covid Vaccine because she is allergic to them; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had Covid"; AUTOIMMUNE DISORDER (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "autoimmune disease reactivated"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Is it similar ingredients to Pfizer Covid Vaccine because she is allergic to them". Clinical course: She said that she had the Pfizer Covid-19 vaccine before. After a year, she had Covid and her autoimmune disease reactivated.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he just had Covid 19, he went to the ER; he just had Covid 19, he went to the ER; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he just had Covid 19, he went to the ER". The event "he just had covid 19, he went to the er" required emergency room visit. The patient stated he just had Covid 19. He went to the ER and the doctor would not give him nirmatrelvir, ritonavir (PAXLOVID) because he said the patient had all of his vaccinations and was updated on his boosters. The physician said recent study's showed it would be more detrimental to take nirmatrelvir, ritonavir.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient got vaccinated past fall. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT; ABILIFY. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2025, outcome "unknown" and all described as "Got Covid after having been vaccinated". The event "got covid after having been vaccinated" required physician office visit. The patient went to the doctor on Friday 03Dec2024. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2025) Positive; Weight: (unspecified date) 160 lbs, notes: Could be a little more. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started PAXLOVID on Saturday 04Jan2025. The patient was already on fourth day of taking her medication. Clinical course: On Monday night last week (30Dec2024), the patient got exposed to covid. She didn't test until 03Jan2025 and it came back positive.   The lot number for BNT162b2 omicron (kp.2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Got Covid after receiving Covid Vaccine; Got Covid after receiving Covid Vaccine; This is a spontaneous report and received from Consumer or other non HCPs.  A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN taken for low density lipoprotein; FLOMAX [TAMSULOSIN HYDROCHLORIDE] taken for prostatic disorder, bladder disorder; DUTASTERIDE taken for prostatic disorder. Past drug history included: Covid-19 vaccine for COVID-19 immunization, notes: DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2024, outcome "unknown" and all described as "Got Covid after receiving Covid Vaccine". Clinical course: The patient (reporter's husband) was exposed to COVID on 30Dec2024. It was confirmed that the patient was vaccinated with the Pfizer COVID vaccine (vaccinated again in the fall). The patient developed COVID after receiving the COVID vaccine. The reporter stated that the patient he had to "come off" of atorvastatin. The patient was treated with nirmatrelvir, ritonavir. The patient had finished the nirmatrelvir, ritonavir dose the night before the initial report. The patient also had to make a modification of tamsulosin hydrochloride; he had to reduce the dose. The patient was attempting to see if still he was still testing positive.  Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Got Covid after having been vaccinated; Got Covid after having been vaccinated; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2024, outcome "unknown" and all described as "Got Covid after having been vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate dose of vaccine administered; This is a spontaneous report received from an Other HCP, Program ID.  A 36-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Mar2020 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "asplenia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (Dose 1; single), administration date: Sep2013, for immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Mar2020, outcome "unknown", described as "Inappropriate dose of vaccine administered". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: developed rash all over his body from his neck to his genital area; hives with red rash with dotted red spots; hives with red rash with dotted red spots; Initial information received on 06-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 9 months old male patient who developed rash all over his body from his neck to his genital area, hives with red rash with dotted red spots after receiving poliomyelitis vaccine (INACTIVATED) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Jan-2025, the patient received 0.5 ml of dose 1  dose of IPV (VERO) Suspension for injection with standard strength (expiry date- 31-Oct-2026 and lot X1C891M) once via intramuscular route in the right vastus lateralis as Immunization.  On 04-Jan-2025 the patient developed rash all over his body from his neck to his genital area (rash) and hives with red rash with dotted red spots (urticaria) (rash macular) (latency- 1 day) following the administration of IPV (VERO).  Reportedly, the mother of the patient mentioned that the rashes went away on their own. No other vaccines. The next once was supposed to be on 31-Jan-2025.   Action taken was not applicable.  No corrective treatment was received for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in January 2025 for the events.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: administered this Fluzone prior to being aware that there had been a temperature excursion (with no reported adverse event); Initial information received on 18-Dec-2024 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves an unknown age and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD] prior to being aware that there had been a temperature excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), Conocmitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength) with lot UT8437AA and expiry date 30-Jun-2025 via unknown route in unknown administration site for immunization prior to being aware that there had been a temperature excursion (with no reported adverse event) (poor quality product administered) (Latency same day).  Reportedly, reporter stated that one of our work clinics refrigerators was out of range for a while before it was discovered. Total time out of range:  261 hours (10 days 21 hours) Highest Temp:  12.7C.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: UNK
Symptoms: Lip disorder, Lip erythema, Lip pruritus, Mass, Nausea
Clinical narrative: Queasy; Skin rashes; Got breakout; Pea-sized bumps on biceps, stomch, back side of arm, bottom lip; Bumps on bottom lip, they were itchy; Bumps on bottom lip, they were pink; Sleepy; This spontaneous case initially received on 31-Dec-2024, was reported by a non health professional and concerns an elderly female patient.  At the time of the event the patient had diabetes.  Concomitant medication: refer to appropriate report section, Zenofibrate.  Administration of company suspect drug(s): On 26-Dec-2024, the patient received Fluad (TIV) for Influenza immunization, Dose regimen: .5 ml, route of administration and anatomical location were not reported. Lot number: 388477.  Non-company suspect drugs: Benadryl (Diphenhydramine hydrochloride), Indication: Bumps on bottom lip, they were itchy, Bumps on bottom lip, they were pink, Got breakout, Pea-sized bumps on biceps, stomch, back side of arm, bottom lip, Skin rashes.  Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Skin rashes (outcome: Not recovered / Not resolved), Got breakout (outcome: Not recovered / Not resolved), Pea-sized bumps on biceps, stomch, back side of arm, bottom lip (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were itchy (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were pink (outcome: Not recovered / Not resolved). On 30-Dec-2024, the patient experienced Queasy (outcome: Not recovered / Not resolved). On Dec-2024, the patient experienced Sleepy (outcome: Not Reported).  Patient had breakouts and a rash. Patient had pea-sized bumps on biceps, stomach, back side of arm, the one in the front and back of the neck were painful and the size of 50cent pieces. Patient had bumps on my bottom lip, they were itchy, pink, and in the middle they get redder and redder, it was not really like a blister. Patient talked to the Pharmacy, they recommended Benadryl but made patient sleepy. Patient spoke to the doctor, and they wanted patient to got to the emergency room (ER), but patient didn't do that. The patient woke up about 3 o'clock. Patient had to put Caladryl on her neck. Patient was feeling a bit queasy last night (30-Dec-2024).  Fluad (TIV) action taken: Not Applicable Treatment medication: Benadryl, Caladryl  Reporter's assessment: The reporter considered the events as non-serious and causality was not reported. ; Reporter's Comments: All events were considered related.
Sex: F
Vaccine: UNK
Symptoms: Rash, Somnolence
Clinical narrative: Queasy; Skin rashes; Got breakout; Pea-sized bumps on biceps, stomch, back side of arm, bottom lip; Bumps on bottom lip, they were itchy; Bumps on bottom lip, they were pink; Sleepy; This spontaneous case initially received on 31-Dec-2024, was reported by a non health professional and concerns an elderly female patient.  At the time of the event the patient had diabetes.  Concomitant medication: refer to appropriate report section, Zenofibrate.  Administration of company suspect drug(s): On 26-Dec-2024, the patient received Fluad (TIV) for Influenza immunization, Dose regimen: .5 ml, route of administration and anatomical location were not reported. Lot number: 388477.  Non-company suspect drugs: Benadryl (Diphenhydramine hydrochloride), Indication: Bumps on bottom lip, they were itchy, Bumps on bottom lip, they were pink, Got breakout, Pea-sized bumps on biceps, stomch, back side of arm, bottom lip, Skin rashes.  Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Skin rashes (outcome: Not recovered / Not resolved), Got breakout (outcome: Not recovered / Not resolved), Pea-sized bumps on biceps, stomch, back side of arm, bottom lip (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were itchy (outcome: Not recovered / Not resolved), Bumps on bottom lip, they were pink (outcome: Not recovered / Not resolved). On 30-Dec-2024, the patient experienced Queasy (outcome: Not recovered / Not resolved). On Dec-2024, the patient experienced Sleepy (outcome: Not Reported).  Patient had breakouts and a rash. Patient had pea-sized bumps on biceps, stomach, back side of arm, the one in the front and back of the neck were painful and the size of 50cent pieces. Patient had bumps on my bottom lip, they were itchy, pink, and in the middle they get redder and redder, it was not really like a blister. Patient talked to the Pharmacy, they recommended Benadryl but made patient sleepy. Patient spoke to the doctor, and they wanted patient to got to the emergency room (ER), but patient didn't do that. The patient woke up about 3 o'clock. Patient had to put Caladryl on her neck. Patient was feeling a bit queasy last night (30-Dec-2024).  Fluad (TIV) action taken: Not Applicable Treatment medication: Benadryl, Caladryl  Reporter's assessment: The reporter considered the events as non-serious and causality was not reported. ; Reporter's Comments: All events were considered related.
Sex: U
Vaccine: FLUX
Symptoms: Acoustic stimulation tests abnormal, Hearing aid user, Hypoacusis
Clinical narrative: Lost 60 percent hearing in the left ear / To day hearing is now 56% loss; This spontaneous case initially received on 04-Jan-2025 (with additionally information also received on 06-Jan-2025 and 07-Jan-2025), was reported by a non health professional and concerns a patient of unknown age/gender.  No medical history or concomitant medications were reported.  Administration of company suspect drug(s): On 09-Oct-2024, the patient received Influenza virus vaccine for an unknown indication, dose regimen not reported, route of administration and anatomical location not reported, Lot number: not reported but will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 13-Oct-2024, the patient experienced Lost 60 percent hearing in the left ear / To day hearing is now 56% loss (Medically Significant, outcome: Not Reported).  The patient stated that on 09-Oct had the vaccination as noted. Four days later (13-Oct-2024) lost 60 percent hearing in the left ear. To day of notification (04-Jan-2025), hearing was now 56% loss. Have gained 20% back. May the patient would get it all back when vaccine left the immune system which would be Mar-2025 or Apr-2025. Currently spent thousands today on hearing aids. At ENT 03-Jan-2025. Hearing aids. As of 06-Jan-2025 would not work out for patient. Planned to return them. Hearing test done. Remarkably had come up 20% in injured ear. From 36% hearing to now 56 %. Quite curious in 8 weeks. Felt when vaccine left immune end of Mar-2025 may receive the hearing back The patient was waiting flu vaccine leaving immune system and also said that never again would take it. No more vaccines.  Influenza virus vaccine action taken: Not Applicable  Non-medication treatment: hearing aid  Reporter assessment: the reporter did not provide a seriousness and causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes.Related due to plausible temporal relationship of 4 days post vaccination.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Injection site erythema, Product administered to patient of inappropriate age
Clinical narrative: Redness at the injection site; inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a below 12-months-old patient, gender was not provided.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On an unknown date, at the age of below 12 months (Inappropriate age at vaccine administration), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y010372, with expiration date not provided but upon internal validations established as 05-JUN-2026).   On an unknown date, the patient experienced redness at the injection site (Injection site erythema). It was not reported if the patient sought medical attention, received any treatment, or if the patient had laboratory diagnostics or studies performed for this adverse event. At the time of the reporting, the outcome of the event was unknown.   The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live therapy type (M-M-R II) was not provided.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: Child spiked high fevers 104 over next 24-hrs headache stomach ache malaise dizziness poor appetite
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory viral panel, Viral test negative
Clinical narrative: Child spiked high fevers 104 over next 24-hrs headache stomach ache malaise dizziness poor appetite
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: immune thrombocytopenia
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Patient reports that on 12/29 she developed a blood clot that went to her lungs. She was admitted to the hospital on 12/29 and was treated for a pulmonary embolism with a heparin drip and then discharged on 12/31/24.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of Pfizer COVID-19 vaccine in error
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Nausea, Pyrexia, Rash
Clinical narrative: Patient said 10 to 14 days after receiving the Shingrix vaccine he had a rash develop on his arm and trunk, high fever with chills, nausea, and was unable to work for 3 to 5 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event just didn't need an additional dose.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Discomfort, Dizziness, Erythema, Facial pain
Clinical narrative: Administered vaccine to client, then one to her younger sister. Completed documentation, then went to front desk to hand over paperwork. Heard younger sister crying and returned to room to find client slumping over a chair, with her dad assisting her. Dad said she had stood up, said she felt dizzy, and then slumped over. Dad assisted client onto exam table. Client crying and said the right side of her face hurt; slight redness noted there.  She complained of no other injuries . Over the next 20 minutes, head of exam table was raised gradually, and client was given a bottle of water. Cold pack also given for face, although client said it was uncomfortable and took it off after a few minutes.  After about half an hour, client walked to waiting area accompanied by dad and myself. She sat down for another 5 minutes, then left.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Posture abnormal
Clinical narrative: Administered vaccine to client, then one to her younger sister. Completed documentation, then went to front desk to hand over paperwork. Heard younger sister crying and returned to room to find client slumping over a chair, with her dad assisting her. Dad said she had stood up, said she felt dizzy, and then slumped over. Dad assisted client onto exam table. Client crying and said the right side of her face hurt; slight redness noted there.  She complained of no other injuries . Over the next 20 minutes, head of exam table was raised gradually, and client was given a bottle of water. Cold pack also given for face, although client said it was uncomfortable and took it off after a few minutes.  After about half an hour, client walked to waiting area accompanied by dad and myself. She sat down for another 5 minutes, then left.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, patient given adult dose instead of child dose. Patient has tolerated fine.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Anal incontinence, Atrial fibrillation, Electrocardiogram, Fatigue, Lymphadenopathy
Clinical narrative: After receiving Abrysvo vaccination the patient reported feeling tired and then sick. He laid down and eventually became nauseous but could not move himself to the bathroom, so he used a nearby trashcan instead. Pt reported having to go to the bathroom 25 times which unfortunately resulted in him soiling himself. He called the hospital. His son recommended that he get there via ambulance for his safety. Pt stated that he felt his life was in danger. At the hospital pt discovered that he was experiencing atrial fibrillations due to severe vomiting. Pt was put on fluids. Pt is currently laying down in bed recovering.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Malaise, Mobility decreased, Nausea, Vomiting
Clinical narrative: After receiving Abrysvo vaccination the patient reported feeling tired and then sick. He laid down and eventually became nauseous but could not move himself to the bathroom, so he used a nearby trashcan instead. Pt reported having to go to the bathroom 25 times which unfortunately resulted in him soiling himself. He called the hospital. His son recommended that he get there via ambulance for his safety. Pt stated that he felt his life was in danger. At the hospital pt discovered that he was experiencing atrial fibrillations due to severe vomiting. Pt was put on fluids. Pt is currently laying down in bed recovering.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Covid Comirnaty vaccine (12yr and up) given to patient that is 10years old.  Once realized, patient's father notified and he stated that she is fine, not having any adverse symptoms and he was not concerned.  Pt is 10years old and  weighs  around 170lbs
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event, but second vaccine given in error
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-GAD antibody, Autoantibody test, Blood glucose, Decreased appetite, Fatigue
Clinical narrative: Weight loss, increased thirst, trouble staying awake, fatigue, decreased appetite, frequent urination, difficulty sleeping.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glycosylated haemoglobin, Insomnia, Pollakiuria, Somnolence, Thirst
Clinical narrative: Weight loss, increased thirst, trouble staying awake, fatigue, decreased appetite, frequent urination, difficulty sleeping.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Weight loss, increased thirst, trouble staying awake, fatigue, decreased appetite, frequent urination, difficulty sleeping.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Within a few hours of receiving the Shingrix vaccine in her left deltoid she felt  a bit ill with fevers and chills. The next day she initially felt a little bit better. Later that night she woke up with a burning pain on the medial side of her right arm around the elbow. There was a small  palpable epitrochlear lymph node. Skin on the arm was extremely sensitive to light touch but no rash developed on her arm. The following day, she developed a rash on the right lateral ribs. Rash was a cluster of vesicles on erythematous base in a single dermatome on the side of the chest.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash vesicular, Sensitive skin
Clinical narrative: Within a few hours of receiving the Shingrix vaccine in her left deltoid she felt  a bit ill with fevers and chills. The next day she initially felt a little bit better. Later that night she woke up with a burning pain on the medial side of her right arm around the elbow. There was a small  palpable epitrochlear lymph node. Skin on the arm was extremely sensitive to light touch but no rash developed on her arm. The following day, she developed a rash on the right lateral ribs. Rash was a cluster of vesicles on erythematous base in a single dermatome on the side of the chest.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Tenderness
Clinical narrative: patient complained of redness and tenderness in arn
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: RSV Arexvy vaccine was administered to a 34 week 1 day pregnant female that was due on 2/19/25. Physician was immediately informed, patient was informed, patients OB GYN was informed. next OB appt is 1/23/25 No adverse effects noted Pregnancy Hx G2 Estimated date of delivery 2/19/25
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Flank pain
Clinical narrative: Abdomen right side pain; Flank area pain; 1st dose on 02Jul2024 and the 2nd on 14Aug2024 of Engerix B; This non-serious case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 49-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B with an associated reaction of abdominal pain (received 1st dose on 02-JUL-2024, for tolerance of 1st dose of Engerix B , refer case US2024156174).   On 14-AUG-2024, the patient received the 2nd dose of Engerix B. On 14-AUG-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 02Jul2024 and the 2nd on 14Aug2024 of Engerix B). On an unknown date, the patient experienced abdominal pain (Verbatim: Abdomen right side pain) and flank pain (Verbatim: Flank area pain). The outcome of the abdominal pain, flank pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2024156174   Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that patient had received Engerix B in an urgent care facility but he did not know the lot number and expiry dates  The right side pain in abdomen and flank area came back after receiving second dose of Engerix B The patient received 2nd dose of Engerix B later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2024156174:1 st dose
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED PAIN AND SWOLLENESS IN HER LEFT UPPER ARM 3 WEEKS AFTER ADMINISTRATION OF VACCINES
Sex: U
Vaccine: COVID19, FLU3, HEPA, HPV9, MENB, MMR, MNQ, TDAP, VARCEL, MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; HCP calling to report that a patient inadvertently received an expired dose of MMR II.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On 08-JAN-2025, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X000177, with expiration date on 02-JAN-2025) (Expired product administered). There was no adverse effect reported.
Sex: U
Vaccine: COVID19, FLU3, HEPA, HPV9, MENB, MMR, MNQ, TDAP, VARCEL, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP calling to report that a patient inadvertently received an expired dose of MMR II.; This spontaneous report was received from a nurse referring to a patient, age and gender was not provided.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On 08-JAN-2025, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X000177, with expiration date on 02-JAN-2025) (Expired product administered). There was no adverse effect reported.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Received HEPLISAV-B while pregnant; Initial report received on 27-Nov-2024.    The report was initially received from the HEPLISAV-B Pregnancy Registry. A pharmacist reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.     Medical history, allergies, and concomitant medications were not reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported.   On an unknown date, the patient received an unknown dose of HEPLISAV-B (lot #, expiration date, NDC #, site and route not reported) while pregnant.   No other details were specified.    The outcome of the event was unknown.    The pregnancy registry was closed to new patients at the time of reporting.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Discomfort
Clinical narrative: Gave a Dose of HEPLISAV-B Which was Diluted with a Dose of MMR2; Injection "Felt Heavy"; Initial report received on 09-Dec-2024.  A pharmacist reported that a 22-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been diluted with a dose of measles, mumps, and rubella vaccine (MMR2) and then said the injection "felt heavy."  No medical history or concomitant medications were reported.  On 08-Dec-2024,  the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (lot number 943008, expiration date 20-Sep-2025, and NDC number 43528-0003-05)] intramuscularly in the left deltoid. The dose of HEPLISAV-B that had been diluted with a dose of  MMR2. The patient stated that the injection "felt heavy" after injection.   No other information was available.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Discomfort, Erythema, Mass, Pruritus, Skin warm
Clinical narrative: 3-4" round skin discoloration (red), a bit "hot" to touch; the red area is itchy and a little bit uncomfortable; there is a lump under the skin where the skin is red.  This redness and lump have not resolved as of today (1/10/2025) -- 11 days and counting.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Albumin globulin ratio decreased, Antiphospholipid antibodies negative, Antithrombin III
Clinical narrative: A month after taking my second dose of Pfizer Covid-19 Vaccine I noticed a brown spot on the right lower leg. I thought that this was just a discoloration, or possibly a skin issue. These brown spots kept growing over time and they started apearing on the left leg too. I got pregnant with my second baby in august and I discussed my concern of the legs with my OBG/YN but he said they are not very noticeable and it could be nothing. However, these brown spots kept growing and I started having inflammation on my lower legs, therefore after the delivery in June 2022, I talked again to my OBGYN that I need to see some doctor regarding at this time swollen, inflamed spots and brown patches all over my lower legs. My OBGYN referred me to see Dr. (a vein specialist) and I was able to see him in December 2022. His assessment said that I had Superficial Vein Thrombosis and he suggested that I get an assessment from a hematologist since the SVT were very large for a young patient like me, and that he suspected occult malignancy. I was seen by Hematology in June 2023, they have done a series or Labs and a Doppler bilateral which revealed left peroneal vein thrombosis. I was put on Eliquis 5MG  twice a day for 3 months and repeated the left leg doppler in 3 months. After three months there were no improvements, therefore I was recommended to stop Eliquis and get seen by my vein specialist. After going back to the vein doctor, I was suggested to get another assessment by hematology as well as take Xarelto 20mg, and I was referred to M.D. I saw Dr in December 2023. He suggested that I do some more labs and get a CAT Scan, also treat my DVT with XARELTO 20mg for 1 year. I got my CAT Scan done in December 26, 2023 3hich showed no obvious evidence of any malignancy.  There was a small groundglass opacity in the right upper lobe. The hematologist recommended that I repeat my CAT Scan in 2024, which i did. The second CAT Scan done in October 2024 showed a growing groundglass opacity in the right upper lobe. At this time the hematologist suggested that I get seen by a Pulmonology immediately, and that I stop Xarelto in a month. I saw a pulmonary specialist the after three days, and he advised me to have a ION lung bronchoscopy done as soon as possible, and find out what is on my lung. I had my lung bronchoscopy done in 11/20/24 at clinic which revealed a lung infection due to unknown reason. The pulmonary specialist said that this infection could have been caused by a virus, but the biopsy cannot defy if a virus is the underlying reason. However, I have always suspected that my blood clots on my superficial veins and later deep vein thrombosis was a result of the COVID-19 Vaccine as I noticed the brown spots which turned to be clots right after i took the Covid-19 vaccine. I have expressed this concern with my OBG/YN doctor, with the vein specialist and later with my hematologist.