chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV
Symptoms: Limb discomfort, Malaise, Systemic lupus erythematosus
Clinical narrative: affected balance, eyes, hands; affected balance, eyes, hands; affected balance, eyes, hands; every bone in body hurts; triggered an attack on lupus; triggered an attack on lupus; This is a spontaneous report received from a Consumer or other non HCP.  A 91-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Lupus", start date: 2023 (ongoing), notes: under the care of a dermatologist, doing fine; "Covid-19", start date: 2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant, disability) with onset 2024, outcome "not recovered", SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant, disability), outcome "not recovered" and all described as "triggered an attack on lupus"; BALANCE DISORDER (disability), EYE DISORDER (disability), LIMB DISCOMFORT (disability), outcome "not recovered" and all described as "affected balance, eyes, hands"; BONE PAIN (disability), outcome "not recovered", described as "every bone in body hurts". Clinical course: The patient got lupus 2 years ago (2023) when got covid (2023), but she has been under the care of a dermatologist. The patient was doing fine and the day after thanksgiving she got RSV vaccination shot, and patient has been sick ever since. The RSV shot triggered an attack on lupus, the shot also affected her balance, eyes, hands and every bone in body hurts. Patient stated that Pfizer was going to say the age, 91, had a lot to do with it but that's not true. Now patient was suffering from these debilitating side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Familia Mediterranean Fever (FMF)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Pyrexia
Clinical narrative: Patient experience fever; site reaction ( bump); site reaction (red ); site reaction ( hard); This spontaneous case, initially received on 12-Jan-2025, was reported by a non health professional and concerns a(n) Other child female patient.  Past medical history included Immunization.  Administration of company suspect drug(s): On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 12-Jan-2025, the patient experienced Patient experience fever (outcome: Recovered / Resolved, stop date: Jan-2025), site reaction ( bump) (outcome: Recovered / Resolved), site reaction (red ) (outcome: Recovered / Resolved), site reaction ( hard) (outcome: Recovered / Resolved).  Non-drug treatment/Other action taken:  INN Flu Vaccine Seasonal action taken: Not Applicable; Reporter's Comments: The events were considered related
Sex: F
Vaccine: UNK
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Influenza A; Influenza A; This spontaneous case, initially received on 20-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age.  Medical history and concomitant medications were unknown.  Administration of company suspect drug: On 10-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, dose regimen: 0.5 ml, route of administration and anatomical location: not reported,  Lot number: 946618.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 06-Jan-2025, the patient experienced Influenza A (Medically Significant, outcome: Unknown), Influenza A (outcome: Not reported).  The patient reported that was administered Flucelvax 2024-2025 (Lot #946618) on 10-Oct-2024 at Pharmacy. On Monday 06-Jan-2025 the patient was diagnosed with Influenza A (by point-of-care testing Influenza A rapid) at Urgent Care.  It was unknown if patient was hospitalized. Treatment measures associated with event: Unknown  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect/vaccination failure can generally be expected for any medicinal/drug product/vaccine as a 100% success rate cannot be reasonably assumed in every patient treated.
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Influenza, Influenza virus test positive, Pain, Pyrexia
Clinical narrative: Diagnosed with flu; Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024; Fever; Aches and pains; Fatigue; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a male patient of unknown age.  Concomitant Medications: Unknown Medical History: Unknown  Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: 0.5 ml, 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 19-Jan-2025, the patient experienced Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024 (Medically Significant, outcome: Unknown). On 19-Jan-2025, the patient experienced Diagnosed with flu (Medically Significant, outcome: Unknown). Associated symptoms included: Fever, Aches and pains, Fatigue.  The patient reported that had tested positive for the flu on Sunday 19-Jan-2025. He received a Flucelvax vaccine on 29-Oct-2024. Side effects he had had were fever, aches and pains and fatigue. Patient reported that he was diagnosed with flu (influenza) after taking Flucelvax.  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient incorrectly received HIB in place of ordered Menveo vaccine. No adverse outcome noted. Patient remains stable with no medical intervention required.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling abnormal, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache, fever, sore throat, sneezing, runny nose, tiredness, overall feeling bad.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Headache, fever, sore throat, sneezing, runny nose, tiredness, overall feeling bad.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the pt did not have an adverse event, however, this medication was given a dose that was not indicated or considered necessary. Pt received an Arexvy vaccine on 01/27/2025, however, the pt had received a previous Arexvy vaccine on 11/14/2023 as well.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Presyncope
Clinical narrative: had lightheadedness on way out of clinic and had vasovagal event
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives on opposite arm a couple hours after injection, followed by outbreak of hives and swelling in forehead that have lasted more than 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: Patient stated that her arm swelled up with a lump like a golf ball.  Did not seek medical treatment.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Breath holding, Computerised tomogram head normal, Crying, Haemoglobin decreased, Human rhinovirus test positive
Clinical narrative: Patient presented to the clinic for 12 month well child exam.  After the exam she was given the first two vaccines (Hep A and Prevnar.)  She immediately started crying and appeared to have a breath holding spell.  MOm picked her up off of the exam table when she would not catch her breath and then the patient started seizing.  The patient had generalized tonic clonic movements for about 15 minutes after the vaccines.  An ambulance was called but the infant stopped seizing without medication by the time that paramedics arrived.  She was transferred to a local emergency room for evaluation.  She had a normal CT scan and tested positive for rhinovirus.  She will be evaluated by Neurology as an outpatient.  She was sent home with Diastat in the case that she has more seizure activity.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC20
Symptoms: Immediate post-injection reaction, Seizure, Tonic clonic movements
Clinical narrative: Patient presented to the clinic for 12 month well child exam.  After the exam she was given the first two vaccines (Hep A and Prevnar.)  She immediately started crying and appeared to have a breath holding spell.  MOm picked her up off of the exam table when she would not catch her breath and then the patient started seizing.  The patient had generalized tonic clonic movements for about 15 minutes after the vaccines.  An ambulance was called but the infant stopped seizing without medication by the time that paramedics arrived.  She was transferred to a local emergency room for evaluation.  She had a normal CT scan and tested positive for rhinovirus.  She will be evaluated by Neurology as an outpatient.  She was sent home with Diastat in the case that she has more seizure activity.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: After patient was vaccinated it was realized that pt had just been vaccinated with just the diluent.  the shingrix vaccine was never reconstituted
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Firm, painful swelling at the injection site, notably warm to the touch.   Noticed within the first 48 hours after receiving the vaccine.  Slowly enlarged in size until approximately 1.5 cm in diameter.  It has been 20 days since the vaccination was administered.  Both the size of the swelling and the pain level have decreased, but are still present.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: 1 day after vaccine developed pruritic hives on his chest and arms.  Seen in clinic the next day and hives were covering 90% of his arms, chest, back, buttocks and thighs.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Arrhythmia, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: I'm filling this out the same day of the shot.  Within two minutes of the shot, I notices prickly feelings in my left arm, hand, and fingers.  I sat in my car for about 20 minutes after the shot.  When I was driving away from the pharamcy, within the first hour of the shot, I felt two arrhythmia feelings: one at about 1/4 mile from the pharmacy where I got the shot, and one a bit further as I was entering the grocery parking lot (named for timing/distance from the pharmacy).  It's within 8 hours of receiving the shot, and I'm feeling prickly, needle-like feelings still in my left arm in various places, including under my arm, as well.  I'm also feeling the prickly and numb sensations on both sides of my neck, on my ears, as well as my temples, up to the top of my head where I also have a headache sensation.  It seems the prickly feeling is spreading to more than my arm and hand throughout the day.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood glucose, Electrocardiogram, Fall, Head injury, Loss of consciousness
Clinical narrative: after HPV vaccine administration, patient had syncope episode. Patient had LOC for about a minute, fell on floor and hit head. Patient regained consciousness. Vital signs monitored, blood sugar taken. Patient taken to ER, observed, EKG done. Patient had a follow up appointment the next day at the clinic patient reported feeling well, ambulating normal, and pain.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pain, Syncope
Clinical narrative: after HPV vaccine administration, patient had syncope episode. Patient had LOC for about a minute, fell on floor and hit head. Patient regained consciousness. Vital signs monitored, blood sugar taken. Patient taken to ER, observed, EKG done. Patient had a follow up appointment the next day at the clinic patient reported feeling well, ambulating normal, and pain.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain in arm (Left) Limited motion in left arm - patient states she can't lift arm above shoulder
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Small fiber neuropathy" (unspecified if ongoing); "adrenergic dysautonomia" (unspecified if ongoing); "POTS" (unspecified if ongoing); "ataxia" (unspecified if ongoing); "downbeating nystagmus" (unspecified if ongoing); "superventicular tachycardia" (unspecified if ongoing); "severe dysmotility issues" (unspecified if ongoing); "left atrial inflammation x4" (unspecified if ongoing); "ocular rosacea" (unspecified if ongoing); "blephiritis" (unspecified if ongoing); "polyneuropathy" (unspecified if ongoing); "immune deficiency" (unspecified if ongoing); "macrocytosis without anemia" (unspecified if ongoing); "elevated liver enzymes" (unspecified if ongoing), notes: gone; "gone-acute fatty liver- gone" (unspecified if ongoing), notes: gone; "Igg3 subclass deficiency" (unspecified if ongoing); "left arm swelled to wrist and halfway down back" (unspecified if ongoing); "Still hurts" (unspecified if ongoing); severe dysmotility issues; b cells tanking wbc. 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 "COVID". Clinical course: First shot. Not safe or effective. Still got Covid a year and a half later.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient had chest pain and fevers after gardasil. Seen at Medical Center and diagnosed with myocarditis and flown to another Medical Center for eval and diagnosed with myocarditis
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Grunting, Malaise
Clinical narrative: Patient had chest pain and fevers after gardasil. Seen at Medical Center and diagnosed with myocarditis and flown to another Medical Center for eval and diagnosed with myocarditis
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Myopericarditis, Troponin increased
Clinical narrative: Patient had chest pain and fevers after gardasil. Seen at Medical Center and diagnosed with myocarditis and flown to another Medical Center for eval and diagnosed with myocarditis
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chest pain, Laboratory test, Myocarditis, Pyrexia
Clinical narrative: Patient had chest pain and fevers after gardasil. Seen at Medical Center and diagnosed with myocarditis and flown to another Medical Center for eval and diagnosed with myocarditis
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: his dermatologist recommended he get the vaccine because he is experiencing warts in his hands/pharmacist refused to administer the vaccine to him because he was over the age of indicated use; No additional AE; This spontaneous report was received from a consumer and refers to a male patient over 50 years of age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  Patient report that his dermatologist recommended, he get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection because he was experiencing warts in his hands. He was scheduled to receive the first dose of vaccine on 16-JAN-2025 (also reported as today) but the pharmacist refused to administer the vaccine to him because he was over the age of indicated use and the pharmacist was worried, she would be audited, even though his insurance agreed to pay for it ((Product prescribing issue).  No additional adverse events were reported.  Additional information is not expected.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2501USA004808: US-009507513-2501USA004808:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Malaise, Vaccination failure
Clinical narrative: Suspected vaccination failure; it burns /sick/ frequent outbreaks; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: it burns /sick/ frequent outbreaks). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that it burned and reported not to get fooled by the vaccine. Both injections made patient sick as a dog and the patient had more frequent outbreaks. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding 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  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered only the lyophilized hib component of pentacel and used sterile water to dilute it with no reported adverse event; Initial information received on 23-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age / gender patient who was administered only the lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and used sterile water to dilute it with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Jan-2025, the patient received an unknown dose of lyophilized HIB component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site and used sterile water to dilute it with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, they wanted to know if the HIB dose counted as a dose. They had a follow up question with what they should do about the DTaP-IPV component.   Information on the batch number was requested corresponding to the one at time of event occurrence.   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: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had their pre-exposure in 1999 but the patient only had 1 dose with no reported adverse event; Initial information received on 24-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who had her pre-exposure in 1999 but the patient only had 1 dose of rabies (HDC) vaccine [Imovax Rabies] with no reported adverse event .   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient had their pre-exposure in 1999 but the patient only had 1 dose with an unknown dose of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).   Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, patient received the vaccine from a different brand which the she could not remember.  Patient told the specialist that her titers dropped and she would need a booster so she was asking on the number of shots that she should receive for the booster dose of Rabavert    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.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy kidney, Biopsy lung, Dialysis, End stage renal disease, Goodpasture's syndrome
Clinical narrative: I was diagnosed with a rare autoimmune disease anti gbm good pasture now a proven side effect of covid vaccine.  There are other proven cases.  I have end stage renal disease and am on dialysis.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transfusion
Clinical narrative: I was diagnosed with a rare autoimmune disease anti gbm good pasture now a proven side effect of covid vaccine.  There are other proven cases.  I have end stage renal disease and am on dialysis.
Sex: F
Vaccine: HPV4
Symptoms: Inability to afford medication, Off label use, Product prescribing issue
Clinical narrative: My doctor has prescribed me the Gardasil vaccine, however, I am outside of the normal recommended age to receive it. She has seen a great benefit to older women with my condition who have gotten Gardasil.; inability to afford medication; No additional AE; This spontaneous report was received from a consumer regarding herself, a female patient of unspecified age (reported as outside of the normal recommended age to receive Quadrivalent Human Papillomavirus [Types 6,11,16,18] Recomb. Vaccine [GARDASIL]).  The patient's medical history, historical drugs, known drug allergies, and concomitant therapies were not reported. Her concurrent conditions included an unspecified condition.   On an unknown date, the physician prescribed her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, outside of the normal recommended age to receive this vaccine, as she had seen a great benefit to older women with her condition who have gotten it (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) (Off label use). The physician was willing to give it her at her office, but her insurance would not pay for it. Local pharmacies won't even give her the vaccine. She had been told it was well over $500 dollars for each vaccine and there were three of them. That was very costly for her at this time. She had checked out the company's patient assistance programs but her income was over the limits. So she asked if there was anything the company could do to provide some assistance to lower the cost of the vaccine for her, as she would have to decide to not to get the vaccines if she was unable to receive some assistance, stating it was very troubling when decisions about her health had to come down to price (Inability to afford medication). No additional events were reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient who was administered improperly stored VARIVAX following a TE; This spontaneous report was received from an other reporter referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 28-JAN-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # Y011019, expiration date: 18-JUN-2026; strength, dose, anatomical location and route of administration were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 11 degree Fahrenheit (F)/ 6F to 14F (the time frame was 30 Minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: Allergic to vaccine). The outcome of the allergy to vaccine was not reported.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine.   Additional Information: GSK receipt Date: 31-DEC-2024 This case was reported by a patient via interactive digital media. The  Patient was allergic to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of illness (received 1st dose of Shingles vaccine on an unknown date, refer linked case US2025AMR004636).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2025AMR004636   Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick.; Sender's Comments:  US-GSK-US2025AMR004636:same patient
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis.   On 02-JAN-2025, the patient received Infanrix. On 02-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JAN-2025 The health care professional reported that  a seven years and ten  months old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness starting upper arm travels down to hand  Numbness happens many times a day
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site vesicles, Peripheral swelling, Skin warm
Clinical narrative: Mother has pictures. Seen 1/21/25 for 4 year old well child care, got DTap/IPV and MMR/Varicella. Her arm got swollen and red, it was warm to the touch no fevers. Then developed a little blister at the injection site. Left arm No interventions, redness is better but still present. Has scab
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: I received RSV "AREXVY" vaccination in my left arm, Tuesday 12-10-2024 at 4:30 pm at pharmacy. I did not feel the needle shot when it was given to me. I asked the lady if I needed to stay after the shot. She said, no. I walked to the car. I then felt a stinging in my left arm shot area. But it soon went away. So I drove home.--about 20 miles. The next day the arm was sore when I rubbed it. At bedtime I noticed the arm was also red with fever in the upper arm area-- about a 3 inch area and slightly swelled. I took 1/2 Tylenol pill when I went to bed. I was able to sleep at night. (I took my temperature by mouth when I had the reaction to RSV vaccination and my body temperature was around 97.7 degrees. I did not have a fever other than the 3 inch area at the site of the vaccination.) Thursday at 3:30 am, I woke up and went to the bathroom. The arm was still sore and red and had fever in the same area. I then took 1/2 Tylenol pill and went back to bed and back to sleep. Thursday morning I was concerned that I should be doing something about the reaction since it was no better--still about the same. I called Medical Group where my family doctor, is located at 8:49 am. I left a mesage for the nurse to call me back.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Injection site bruising, Product administered at inappropriate site
Clinical narrative: The adverse reaction to my forearm is that it was bruised dark purple and deep blue color for 3wks. at clinic under doctor  requests for blood work. Therefore, no pneumonia or shingle shot was ever given upon my request but flu shot. Right -forearm
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Dysphonia, Feeling hot, Feeling jittery
Clinical narrative: Vaccine given at approximately 3:15 PM. By 3:20 PM, patient reported dry mouth and warm, tingling sensation in mouth/throat, with some nausea. Denied swelling, shortness of breath, itching, redness, hives, or difficulty swallowing. Offered Pt some water.  At 3:30 PM, patient reported also feeling jittery/dizzy; no other new symptoms. Pt declined offer to call ambulance but ate a cookie. Vitals normal for patient, as noted below. By 3:35 PM, noted that jitteriness, nausea, and tingling were gone. Still denied swelling or SOB. (Called patient's PCP at 3:39 PM and discussed reaction with receptionist; was transferred to nurse line voicemail. Attempted to call back to discuss live at 3:42 PM but again was unable to connect with nurse at this time, so left voicemail with my and the patient's cell numbers.) Patient noted feeling better at check-ins at 3:55 PM and 4:03 PM, with just some remaining warmth and some voice change. Still denied swelling and shortness of breath. Pt was comfortable leaving pharmacist care at 4:15 PM--only warmth in mouth remaining. Counseled to call 911 immediately if SOB, swelling, or dizziness developed. Pt noted she has medical alert pendant at home and cell phone with her. Called patient to follow-up at 5:47 PM; reported only having warm tongue at this point; did not have diphenhydramine available at home. Reinforced when to call 911 and advised to contact PCP if symptoms remained by next morning. Staff from PCP office called back when she received message at 8:47 AM on 1/30/25. I provided an update on the course of events since the initial voicemail; she planned to call the patient to check-in today and notify the physician.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Vaccine given at approximately 3:15 PM. By 3:20 PM, patient reported dry mouth and warm, tingling sensation in mouth/throat, with some nausea. Denied swelling, shortness of breath, itching, redness, hives, or difficulty swallowing. Offered Pt some water.  At 3:30 PM, patient reported also feeling jittery/dizzy; no other new symptoms. Pt declined offer to call ambulance but ate a cookie. Vitals normal for patient, as noted below. By 3:35 PM, noted that jitteriness, nausea, and tingling were gone. Still denied swelling or SOB. (Called patient's PCP at 3:39 PM and discussed reaction with receptionist; was transferred to nurse line voicemail. Attempted to call back to discuss live at 3:42 PM but again was unable to connect with nurse at this time, so left voicemail with my and the patient's cell numbers.) Patient noted feeling better at check-ins at 3:55 PM and 4:03 PM, with just some remaining warmth and some voice change. Still denied swelling and shortness of breath. Pt was comfortable leaving pharmacist care at 4:15 PM--only warmth in mouth remaining. Counseled to call 911 immediately if SOB, swelling, or dizziness developed. Pt noted she has medical alert pendant at home and cell phone with her. Called patient to follow-up at 5:47 PM; reported only having warm tongue at this point; did not have diphenhydramine available at home. Reinforced when to call 911 and advised to contact PCP if symptoms remained by next morning. Staff from PCP office called back when she received message at 8:47 AM on 1/30/25. I provided an update on the course of events since the initial voicemail; she planned to call the patient to check-in today and notify the physician.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Extra dose administered, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Patient received an extra dose by mistake of Arexvy. First dose was received 12/15/23 and second dose was received 1/29/25. Patient has a sore arm, some fatigue and slight sore throat. No other adverse effects reported by patient. Called patient to discuss incident at 10:20am on 1/30/25
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Body temperature fluctuation, Fatigue, Headache, Heart rate increased, Tremor
Clinical narrative: shakes, lack of temperature control, headache, fatigue, increased heart rate - lasting for about 6 hours, eventually subsided, did not result in hospital/ER visit. Pt used tylenol, rested and increased fluid intake
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Burning sensation, Muscle spasms
Clinical narrative: States she took a diphenhydramine 25 mg pill on 01/29/2025 at 2:30 pm and then took a nap. States that at about 4:30 pm on same day she woke up with a burning sensation at her left upper thigh and right leg "muscle spasms" in her calf and foot. States lasted about 15 minutes and then went away with no reoccurrence since that time. Stated  she just wanted to report it as she had received vaccines on 01/27/2025 and had never had anything like that happen before.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Magnetic resonance imaging joint, Rotator cuff syndrome, X-ray limb
Clinical narrative: Teammate received the Flu vaccine at the Pharmacy on 12/3/24 and has had left shoulder pain since. Had physical therapy x 3 with no improvement. Saw Occ Health doctor who ordered MRI and X- ray and referred pt to Orthopedic doctor. Teammate stated MRI showed rotator cuff damage. Teammate stated orthopedic doctor recommended surgery.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient has had arm pain since shot was given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: pinkeye
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: Starting immediately, after the 2nd dose, patient has been experiencing severe headaches, cold chills, and stomach cramps. These are intermittent and come and go. Patient says she has never felt like this before and does not feel like herself.  She has been take Aleve to combat these effects, but it's not working.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate Immunization of Arexvy - previously vaccinated 12/18/2023
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness postural, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient received 2 IM vaccines in left deltoid at 0805. Patient stood up without issue and went and sat in another chair.  Do dizziness with standing. 3 minutes later patient states he felt dizzy. Eyes rolled back and his head fell to the side. Patient was pale and sweaty. His mother was standing next to him and supported his head. Patient regained consciousness within 30 seconds. No nausea or vomiting. Elevated patient's feet and had him sit for 15 minutes. He then was able to stand without issue afterwards and reported no dizziness or nausea. was able to ambulate out of clinic without issue
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Posture abnormal
Clinical narrative: Patient received 2 IM vaccines in left deltoid at 0805. Patient stood up without issue and went and sat in another chair.  Do dizziness with standing. 3 minutes later patient states he felt dizzy. Eyes rolled back and his head fell to the side. Patient was pale and sweaty. His mother was standing next to him and supported his head. Patient regained consciousness within 30 seconds. No nausea or vomiting. Elevated patient's feet and had him sit for 15 minutes. He then was able to stand without issue afterwards and reported no dizziness or nausea. was able to ambulate out of clinic without issue
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: BUD 1/21/2025 vaccine given 1/27/2025
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt given incorrect vaccine at time of visit, Pt needed Boosterix and received Bexsero from misread error on vaccine order. No adverse side effects reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: I developed vitiligo which is not present amongst 7 siblings with no history of vitiligo
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Blood test normal, Coagulation test normal, Epistaxis, Generalised oedema, Haematoma
Clinical narrative: Medically significant 30 minute nose bleed on 12/07/04.  Multiple spontaneous hematomas and vascular inflammation in lower extremities verified via MRI Generalizes swelling on left side of body. No injection site reaction
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: Medically significant 30 minute nose bleed on 12/07/04.  Multiple spontaneous hematomas and vascular inflammation in lower extremities verified via MRI Generalizes swelling on left side of body. No injection site reaction
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient came to pharmacy on 1/28/25 reporting severe arm pain in the vaccinated arm.  Controlled by frequent doses of 600mg ibuprofen.  She did not say when the issue initially started, just that is was after she had the vaccine.  I recommended that she continue with the ibuprofen at 600mg up to 4 times a day and that she also report this issue to her doctor to see if additional follow up is necessary.  Patient did state that she has bursitis issues in that arm already.
Age: 48.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Patient reporting  itching on left arm ,under left arm, neck and under left back side the day of the vaccination 01/27/2025, low fever (38 degree)  and taking parasetamol unknown dose, 01/28/2025 patient taking benadryl 20 mg  for itching and redness at side of the vaccination.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Dermatitis bullous, Injection site erythema, Injection site vesicles
Clinical narrative: Pt was given the MMR/VAR vaccine  on 1/28/25. Remarkable PE shows a cluster of bullous rash surrounded by erythema on her right thigh.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ambulatory, Electrocardiogram normal, Hypoaesthesia, Malaise, Palpitations
Clinical narrative: Have had L hand tingling and numbness in 3 fingers since the second vaccination in 2021. First experienced palpitations after the Moderna vaccination in 2022. Had very mild COVID symptoms in July 2022. Saw PCP in August for continued palpitations and he recommended cardiology. Cardiology was seen, Holter monitor was placed, cannot recall dates but it was in 2023. After Holter monitor, Tilt table test was performed in June 2023. EKG in PCP office in August 2022 was normal. Subsequent EKGs from cardiology office have been abnormal ever since.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test positive
Clinical narrative: Have had L hand tingling and numbness in 3 fingers since the second vaccination in 2021. First experienced palpitations after the Moderna vaccination in 2022. Had very mild COVID symptoms in July 2022. Saw PCP in August for continued palpitations and he recommended cardiology. Cardiology was seen, Holter monitor was placed, cannot recall dates but it was in 2023. After Holter monitor, Tilt table test was performed in June 2023. EKG in PCP office in August 2022 was normal. Subsequent EKGs from cardiology office have been abnormal ever since.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: A Boostrix vaccine was administered within a 14-day interval form the previous dose of Boostrix given on 01/14/2025 to a 25-year-old patient who is 30 weeks pregnant, with an estimated due date of 04/10/2025.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered 51 days after last COVID-19 vaccination
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: The patient was given a second dose of RSV vaccine outside of CDC guidelines. The patient received the vaccine for the first time on 11-19-2023. The patient reports adverse events of fatigue, redness, soreness, and stiffness in the arm where the vaccine was administered.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal stiffness
Clinical narrative: The patient was given a second dose of RSV vaccine outside of CDC guidelines. The patient received the vaccine for the first time on 11-19-2023. The patient reports adverse events of fatigue, redness, soreness, and stiffness in the arm where the vaccine was administered.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: Within a week of getting the flu shot I began having severe muscle cramps all over my body. This is unrelieved by Motrin. It required two ER visits. On the second ER visit i was unable to shower nor get dressed without my wifes help. These symptoms are still present. I am now on high dose steroids (Prednisone) with extreme difficulty weaning off the steroids. Several of my doctors are very suspicious of the flu shot triggering an autoimmune response. I am now under the care of Neurology, Rheumatology,Spine Doctor, and primary care doctor.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Ultrasound lymph nodes
Clinical narrative: Patient had localized redness, swelling, pain at injection site and presumed regional lymphadenopathy although axillary ultrasound report was normal.  This occurred 2 days after injection and resolved spontaneously within a week. No further concerns.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: none
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Persistently sore arm (now 4+ months later).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: I grabbed the under 65 influenza vaccine from the fridge and administered the vaccine. It wasn't until afterwards that I realized the patient should have gotten the over 65 influenza vaccine.
Age: 1.5
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: 18mo patient was seen here today for her well visit. Due to her sickle cell disease, due for a dose of MCV4. A Menveo 1-vial presentation was given instead of the Menveo 2-vial presentation. All parties involved in patient care aware of error. No immediate reactions noted for patient.