chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: FLUX, VARZOS
Symptoms: Erythema
Clinical narrative: Angry Red Shoulder; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of localized erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patients received Shingrix (unknown arm) and Flu vaccine. On an unknown date, an unknown time after receiving Shingrix and Flu vaccine, the patients experienced localized erythema (Verbatim: Angry Red Shoulder). The outcome of the localized erythema was resolved.   The reporter considered the localized erythema to be related to Shingrix. It was unknown if the reporter considered the localized erythema to be related to Flu vaccine.     The company considered the localized erythema to be related to Shingrix. It was unknown if the company considered the localized erythema to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 18-JUL-2025 A Population Health Pharmacist at a top 200 healthcare system wanted to know if certain patients had a genetic predisposition to experience more severe local reactions with Shingrix.  She shared that some patients experienced an angry red shoulder, while others could barely tell where the vaccination had been given.  She had seen the same thing when patients received an adjuvanted flu vaccine.  When asked about the age of the patients in whom she had noticed this difference more often, she shared that it was usually not the elderly, but patients in their 40s and 50s.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Skin lesion, Vaccination failure
Clinical narrative: mild shingles outbreak two months ago; suspected vaccination failure/Lack of drug effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included polymyalgia rheumatica (experienced 20 years ago, treated with one round of Prednisone and it resolved.). Previously administered products included Prednisone (polymyalgia rheumatica treated with one round of Prednisone). Concurrent medical conditions included hypercholesterolemia and atrial fibrillation. Concomitant products included lovastatin and apixaban (Eliquis).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) and the 1st dose of Shingrix (intramuscular, unknown deltoid). In MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: mild shingles outbreak two months ago). In MAY-2025, the outcome of the shingles was resolved. The outcome of the vaccination failure was not reported.   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: 23-JUL-2025 The patient reported that he had received both doses of Shingrix about 10 years ago, stating it had been confirmed to be "the new vaccine." He experienced a mild shingles outbreak two months prior. He had only a few lesions on his right back and side, accompanied by tingling on the right side and right front of his trunk. This was treated and resolved quickly. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 09-AUG-2022, the patient received the 2nd dose of Shingrix. On 12-MAR-2022, the patient received the 1st dose of Shingrix. On 21-JUL-2025, 1077 days after receiving Shingrix and 1227 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with mupirocin (Bactroban). 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: 30-JUL-2025 The patient received first and second dose of Shingrix and a week ago (Monday from reporting date), the patient developed shingles.  The rash was on his left side near his hip and on his left side center back.  His doctor prescribed an antiviral and Bactroban (mupirocin) ointment 2 percent. This case was considered as suspected vaccination failure as details regarding 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 about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 39.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: had two outbreaks of shingles since then and one in July; Suspected vaccination failure; had two outbreaks of shingles since then One in March; 39 years patient received Shingrix;  This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 39-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included renal disease.   In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 years patient received Shingrix). In MAR-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two outbreaks of shingles since then One in March). In JUL-2025, the patient experienced shingles (Verbatim: had two outbreaks of shingles since then and one in July). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUL-2025 The patient received the Shingrix vaccine in December and had two outbreaks of shingles since then which was one in March and one in July. The patient was very disappointed.  The patient thought it was supposed to prevent future outbreaks and had to go on medication for them and was not supposed to take it because of his/her kidney disease. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in his fingers started this morning; numbness and tingling in his fingers started this morning; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis. Concomitant products included Cyclobenzaprine hydrochloride (Cyclobenzaprine), Duloxetine hydrochloride (Duloxetine), Tamsulosin hydrochloride (Tamsulosin), Tadalafil and Tadalafil (Cialis) for an unknown indication.   On 31-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 01-Aug-2025, the patient experienced HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning). At the time of the report, HYPOAESTHESIA (numbness and tingling in his fingers started this morning) and PARAESTHESIA (numbness and tingling in his fingers started this morning) had not resolved.      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The HCP was not aware of any other vaccines administered 4 weeks prior to Spikevax.   The patient received most of his vaccines and had some pain medications at the pharmacy.   The HCP enquired about a side effect one of their patients experienced after receiving the COVID-19 vaccine the previous day. On the morning of 01-Aug-2025, a patient contacted the pharmacy to report experiencing numbness in their fingers following administration of the COVID-19 vaccine the previous day. The pharmacist spoke with the patient over the phone. The HCP believed the numbness and tingling in his fingers began that same morning and had not yet resolved. After conducting some research, the HCP was unable to find substantial information on this side effect and sought to learn whether similar cases had been reported. She was particularly interested in understanding the outcomes of those cases and whether there is a typical timeline for resolution.  It was unknown if the patient experienced any additional symptoms or events.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Fluzone HD on 7/22/25 and again on 8/4/25. Patient reports no adverse events or side effects.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Peripheral swelling
Clinical narrative: Patient describes waking up the next morning with a swollen arm, with two knots at the injection site, the entire area red and hot to touch. She reports that the two knots when the injections were given disappeared the next day. This morning she contacted the pharmacy to report that her arm was still red from the shoulder to elbow and hot to touch.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Back to school event, 9 yr. old was given Pfizer (6 mths-4yrs) vaccine. Minor sent to post vaccination observation and after 15 minutes monitoring minor was dismissed.Noticed the vial closely when entering vaccine information to database, wrong vaccine was given,notified clinic lead on site.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: resident passed away
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: 7/29/25 at 1200pm patient received his 3rd Twinrix vaccine. Administered into right deltoid with a 25G x1 inch safety hypodermic needle. As this RN was pushing in vaccine, employee stated it was painful compared to the other 2 doses. Complained of continued pain while in health center. Employee given Ibuprofen 200 mg (2 tablets) at 1207pm. Advised to keep arm moving. Denied any numbness or tingling. Employee stated he had minimal discomfort and left department at 1218pm.  8/5/25 1339 employee came back into health center complaining of right arm pain. "I can raise my arm to about shoulder height, then I have to push through the pain. And it gets stiff, and I have to work it out to loosen it up." Reports taking Ibuprofen 200 mg x3 tabs twice a day. Denies any pain into shoulder or down into bicep/arm. Recommended alternate ice/heat, alternate Tylenol/Ibuprofen and follow package direction.
Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: Product container issue
Clinical narrative: the vial of the glass breaking while we were giving the vaccine; the vial of the glass breaking while we were giving the vaccine; administered to the patient; This is a spontaneous report received from a Consumer or other non HCP.  A 6-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2025 as dose number unknown, single (Lot number: LP4946, Expiration Date: Aug2026) at the age of 6 months intramuscular, in left vastus lateral. for immunisation, Device Lot Number: LP4946, Device Expiration Date: Aug2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine"; POOR QUALITY DEVICE USED (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine; administered to the patient".  Additional information: Reporter stated that medication issue they had this morning(31Jul2025) of a vial breaking while giving a vaccine. Packaging sealed and intact. It was administered to the patient and the patient got the full vaccine. Lab working (Past 2 week) was Unknown. The "lab was no" but reporter was not sure.   Causality for "the vial of the glass breaking while we were giving the vaccine" and "the vial of the glass breaking while we were giving the vaccine; administered to the patient" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Loss of consciousness, Mobility decreased
Clinical narrative: 12+ hours after receiving the vaccine patient reported that she began to feel like she couldn't move, also felt like she was having trouble breathing.  Father states she lost consciousness briefly. Symptoms resolved, then the following day, 8/5/25 around 3:00pm patient stated she began feeling like she couldn't move her arms and legs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: [ICH-Unidentifiable patient]. Upon receipt of follow-up information on (24Jul2025), this case now contains all required information to be considered valid.  This is a literature report.  A 26-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 07Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 3 (booster), single and on 27Mar2023 as dose 4 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "dysfunctional uterine bleeding" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "Attention-deficit hyperactivity disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypogonadism" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for insomnia; LEVONORGESTREL taken for contraception; TESTOSTERONE taken for hypogonadism; BUSPIRONE taken for anxiety; SERTRALINE taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "recovered" (14Apr2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: There is not a reasonable possibility that the reported event covid-19 was related to the suspect product event most likely due to patient underlying contributory factors.,Linked Report(s) : US-PFIZER INC-PV202500078537 Same article, drug, event and different patient;
Vaccine: PNC20
Symptoms: Product container issue
Clinical narrative: this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle.".  Additional information: The reporter stated, all the liquid was still in the vaccine. The vaccine was not administered to any patient, as they got another dose and we used that to administer the dose.  The reporter considered "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "this vaccine broke as we were like administering it basically and the tip just came off where you would like to attach the needle." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Product Quality Group provided investigational results on 01Aug2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Infection; COVID 19 Infection; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 24Jul2025, this case now contains all required information to be considered valid.  This is a literature report.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; nvx cov 2373 (NVX COV 2373), on 12Jul2022 as dose 4 (booster), single and on 30Mar2023 as dose 5 (booster), single, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "chronic low back pain" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "depression" (unspecified if ongoing); "gastroesophageal reflux disease" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "irritable bowel syndrome" (unspecified if ongoing); "Migraine without aura" (unspecified if ongoing); "Nausea associated with migraines" (unspecified if ongoing); "Peripheral sensory neuropathy" (unspecified if ongoing); "Muscle pain" (unspecified if ongoing); "Headache" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease; PROCHLORPERAZINE taken for anxiety; SUMATRIPTAN taken for migraine without aura; CLONAZEPAM taken for depression; INTRAUTERINE CONTRACEPTIVE DEVICE taken for contraception; DESVENLAFAXINE taken for depression; GABAPENTIN taken for depression; EPTINEZUMAB taken for migraine without aura, headache; PARACETAMOL taken for myalgia; NAPROXEN taken for myalgia; BREXPIPRAZOLE taken for depression. Past drug history included: Bactrim, reaction(s): "bactrim allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Apr2023, outcome "recovered" (01May2023) and all described as "COVID 19 Infection". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter considered "covid 19 infection" related to BNT162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event covid-19 based on the known safety profile and temporal association.,Linked Report(s) : US-PFIZER INC-202500156631 Same article, drug, event and different patient;
Sex: M
Vaccine: HEP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adacel was administered to a newborn instead of hepatitis b with no reported adverse event; adacel was administered to a newborn instead of hepatitis b with no reported adverse event; Initial information received on 01-Aug-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 1 day old male patient who was administered to Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to a newborn instead of Hepatitis B Vaccine  with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Aug-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (Lot U8274AA, expiry date 31-Aug-2026, strength standard and frequency once)  via intramuscular route in unknown administration site for Immunisation and it was administered to a newborn instead of Hepatitis B Vaccine  with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered)  (latency same day).   Action taken was not applicable.  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: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose;  This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis.   On 28-JUL-2025, the patient received Infanrix. On 28-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUL-2025 A Nurse Practitioner mentioned he did not realize that he gave a Infanrix vaccine that was a little bit past the expiration date which led to expired vaccine used.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; I contracted covid 4 times, I stopped taking vaccines as it was not protecting me; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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), outcome "unknown" and all described as "I contracted covid 4 times, I stopped taking vaccines as it was not protecting me". 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: Depressed mood, Feeling abnormal
Clinical narrative: About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad; Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me; 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)), in Jul2025 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: DEPRESSED MOOD (non-serious), outcome "unknown", described as " About like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed/I have been a little sad"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Can't stop thinking about putting this hamster in my butt hole; I felt like getting my hamster doing that and it's been bothering me".  Additional information patient went to get the vaccine (Pfizer COVID-19 Vaccine) about like two weeks ago and afterwards like about 3 or 4 days afterwards I just got really-really depressed and I think they are related. Consumer stated, Ever since I, this is very related to the vaccine. So, I told you ever since I got the vaccine (Pfizer COVID-19 Vaccine), I have been a little sad but along or soon I also kind of feel like I have hamster and for some reason I had it (hamster) for years and he's just been a really pet of mine and I loved them but I got this vaccine shot for COVID about two weeks ago and ever since then I can't stop thinking about putting this hamster in my butt hole, so weird, I don't know have you had any report about that or I might be the only one? I felt like getting my hamster doing that and it's been bothering me, and I feel like it has to do with the vaccine (Pfizer COVID-19 Vaccine) Consumer stated, I am sorry, I have 'pauperism autism' (further not clarified). So, some times I say retracted things.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: MNP
Symptoms: Headache, Pain in extremity
Clinical narrative: having like under other arm she did not get injection, she felt heavy on her other arm; sore arm; Having headache everyday; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received meningococcal group abcwy vaccine (PENBRAYA), in Jul2025 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jul2025, outcome "unknown", described as "Having headache everyday"; LIMB DISCOMFORT (non-serious) with onset Jul2025, outcome "recovered" (2025), described as "having like under other arm she did not get injection, she felt heavy on her other arm"; PAIN IN EXTREMITY (non-serious) with onset Jul2025, outcome "unknown", described as "sore arm".  Additional information: The reporter stated, "Yes, my daughter get a vaccine for Penbraya the meningitidis vaccine like a week ago and then she had, at the beginning the first two days sore arm which is normal and then while she took the vaccine, she was on her menstrual period too, right and then she started having like under other arm she did not get injection, she felt heavy on her other arm and then for one or two days and it went away but after her period was over and like Sunday, on Sunday last week after that she started having headache every day. So, I was wondering is this related to the Penbraya vaccine or?" When paraphrased the above concern: Reporter stated, "Last Wednesday and then she was having sore arm under that she got the shot and then the first two days and then next two days she started having the other arm feeling heavy."  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: got covid; got covid; 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid". The clinical course was reported as follows: The patient was diagnosed with COVID-19 and he found a pack of nirmatrelvir;ritonavir (PAXLOVID) dates Sep2022 and he also got Pfizer COVID-19 vaccines shot twice before but still got COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me; This is a spontaneous report received from a Consumer or other non HCP,.  A 79-year-old female 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 included: "Cataracts" (unspecified if 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 "I've always used the Pfizer shots; The doctor just prescribed Paxlovid for me". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, "The doctor just prescribed Paxlovid for me. I got COVID. I can't afford the medicine, Paxlovid. I have cataracts, and I am old. Well, I do want to say that I do like the Pfizer medication program. I've always used the Pfizer shots, and all that stuff, I can appreciate this."    The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had the vaccine 6 times, and the last one being in October, and this is the first time having COVID". The events "she had the vaccine 6 times, and the last one being in october, and this is the first time having covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was vaccinated 6 times against COVID, counting the recommended boosters. The last one was on 15Oct2024 and it would be one year since the last COVID vaccination. It was the patient's first time having COVID. Doctor ordered a prescription at a pharmacy and was told that she would be given a voucher for Paxlovid.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient reported to pharmacy #5619 where she received her vaccination 2 days ago, and showed that her upper left arm around the vaccination site was visibly red and bruised. Reported that there was pain and a burning sensation that's been progressing since she received her vaccine. Patient was advised to treat any symptoms and discomfort with ibuprofen and/or acetaminophen and to ice around the site, and that the pharmacist will check with her tomorrow and see how she is feeling. Will also reach out to her physician if anything progresses.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin irritation
Clinical narrative: Pharmacy was contacted by physician stating patient's left arm was irritated and itchy
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Retching, Tremor
Clinical narrative: In the middle of the night after receiving the vaccine, patient started getting shakes, dray heaves, and felt freezing cold. Symptoms lasted for about 2 days
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles a week after the Covid 19 vaccine. It was early onset (I was in my young 40s) and I believed it to be directly related to the vaccine. I?ve heard from others that shingles activation is not uncommon.
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Fatigue, Incorrect route of product administration, Injected limb mobility decreased, Injection site warmth
Clinical narrative: vaccination site movement impairment; it was administered subcutaneously  rather than intramuscularly; warmth at the injection site; fatigue; weakness in legs; a little soreness, but less pain; still a bit red; rash; This spontaneous report was received from a consumer regarding a 56-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 16-JUL-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered subcutaneously in the left arm for vaccination (strength, dose, vaccination scheme, lot number, and expiration date were not reported) (Incorrect route of product administration).  Later that evening, the patient experienced warmth at the injection site (Vaccination site warmth), and began to have fatigue (Fatigue), weakness in legs (Muscular weakness), it was not easy to lift her arm (Vaccination site movement impairment), and she broke out in a rash on hear arm that spread (Vaccination site rash). Her doctor prescribed her antibiotics. On an unknown date in July 2025, the patient also experienced a little soreness, but less pain (Pain) and reported that she was still a bit red (Erythema), but much smaller surface area remaining affected. At the time of the reporting, the patient was getting better from the events (recovering).  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Sex: F
Vaccine: PNC21
Symptoms: Muscular weakness, Pain, Rash
Clinical narrative: vaccination site movement impairment; it was administered subcutaneously  rather than intramuscularly; warmth at the injection site; fatigue; weakness in legs; a little soreness, but less pain; still a bit red; rash; This spontaneous report was received from a consumer regarding a 56-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 16-JUL-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered subcutaneously in the left arm for vaccination (strength, dose, vaccination scheme, lot number, and expiration date were not reported) (Incorrect route of product administration).  Later that evening, the patient experienced warmth at the injection site (Vaccination site warmth), and began to have fatigue (Fatigue), weakness in legs (Muscular weakness), it was not easy to lift her arm (Vaccination site movement impairment), and she broke out in a rash on hear arm that spread (Vaccination site rash). Her doctor prescribed her antibiotics. On an unknown date in July 2025, the patient also experienced a little soreness, but less pain (Pain) and reported that she was still a bit red (Erythema), but much smaller surface area remaining affected. At the time of the reporting, the patient was getting better from the events (recovering).  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other AE; HCP calling to report a patient who received HEPTAVAX-II (RECOMBIVAX HB) in (withheld) on 27MAY2024 and second dose on 25JUN2025 would like to receive her 3rd dose here in (withheld). She will be receiving a 3rd dose in the form of ENGERIX-B today 28JUL2025.; This spontaneous report was received from a pharmacist and refers to a(n) 37-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 27-May-2024, in another country, the patient was vaccinated with the first dose of with Hepatitis B Vaccine (Recombinant) (HEPTAVAX-II) (RECOMBIVAX HB). On 25-Jun-2025, the patient received the second dose of with Hepatitis B Vaccine (Recombinant) (HEPTAVAX-II) (RECOMBIVAX HB) (Inappropriate schedule of vaccine administration). Both doses were administered by Unknown route as prophylaxis (anatomical site, lot # and expiration date were not reported).  On 28-Jul-2025, she would receive her 3rd dose in the reporter's country, but in the form of ENGERIX-B. No other information provided. No other AE/No PQC.  Lot number is being requested and will be submitted if received.
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Erythema, Feeling hot, Peripheral swelling
Clinical narrative: My arm is completely swollen, red and very hot; My arm is completely swollen, red and very hot; My arm is completely swollen, red and very hot; some kind of allergy; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose number unknown, 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: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "My arm is completely swollen, red and very hot"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "some kind of allergy".  Additional information: Patient received last fall, the Pfizer COVID vaccine Comirnaty, that one and patient had a reaction in the other arm. The arm was completely swollen, red and very hot. So, patient need to know what if, ingredients were the same in those vaccines, also asked if anything in there. Because patient definitely have some kind of allergy. The COVID patient got last fall, Oct2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Hepatitis B antibody positive, Laboratory test normal, Rash pruritic, Sexually transmitted disease test, Skin discolouration
Clinical narrative: At the early months of 2024, I observed a few purplish bumps on both of my arms, sometimes they're itchy. I went to facility, where I had all STD tests, but everything came out clean. I went to health center, where more lab tests was done, and everything yet came out clean. The doctor referred me to a dermatologist and went to few and then a dermatology center, where I was prescribed BETAMETHASONE DIPROPIONATE OINTMENT USP (AUGMENTED), 0.05%, which had an effect on the bumps. But every time the ointment runs out the bumps came out in large numbers and on all parts of my body...
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Intra-uterine contraceptive device insertion
Clinical narrative: Reported Symptoms: 10005103:BLEEDING; 10027334:MENSTRUATION ABNORMAL; Narrative: "She tells me she had a continuous period for about 6-8 weeks after she took the Moderna covid shot, so she does not want any more vaccines. She was on oral contraceptives at the time and had to switch her birth control to IUD after this happened." Other Relevant HX: Other: prolonged menses
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other:
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Reported Symptoms: 10042674:SWELLING; 10046735:URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA; SWELLING
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: An 88yo female with PMH which included hypothyroidism, HTN, HLD, chronic anxiety, chronic GERD, HX of smoking 40+ years. The patient recently moved from (withheld) and presented to clinic on March 26, 2025 to get her medication refilled (transferred from another clinic) and established care. During the visit the PCC - RN's note included "vaccine discussed and patient informed to bring in immunization status" The RN also reported the patient had a historical ADR of Influenza vaccine induced anaphylaxis. No other detailed information was provided regarding the vaccine type (mfc, lot # exp) when, where and by whom it was administered. Other Relevant HX: Other: ANAPHYLAXIS
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Vomiting
Clinical narrative: Reported Symptoms: 10047700:VOMITING; 10049800:NUMBNESS IN FEET; Narrative: Other Relevant HX: Other: VOMITING; NUMBNESS in feet
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Myocardial infarction
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10028596:MYOCARDIAL INFARCTION; Narrative: Patient received influenza vaccination earlier in the day. Patient's spouse reported patient experienced a "heart attack" later in the day and passed away Other Relevant HX: Other: myocardial infarction
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms:  10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: the infant did not experience any adverse issues or side effects from the administered vaccines; VAXELIS, VAXNEUVANCE, and ROTATRIX were all inadvertently administered to a 6-day-old infant; This spontaneous report was received from a physician and refers to a 6-day-old patient of unknown gender.   The patient was a full-term baby (born at a gestation of 37 weeks). The patient's medical history or concomitant therapies were not reported.   On 04-AUG-2025, the patient was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection, pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection and rotavirus vaccine live oral 1v (ROTARIX), administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported) (Product administered to patient of inappropriate age). The patient did not experience any adverse issues or side effects from the administered vaccines and was otherwise doing well.   Lot# is being requested and will be submitted if received.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: more pain in my arm. First shot, my arm ached for days; This serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: more pain in my arm. First shot, my arm ached for days) (serious criteria other: Serious as per reporter). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     The company considered the pain in arm to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2025 The patient had bad reaction (arm ached for days) from first shot and opted out of second one.; Sender's Comments: The company considers that there was no reasonable possibility that the event Pain in extremity may have been caused by Shingrix. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 38.0
Sex: F
Vaccine: PNC21
Symptoms: Aphasia, Blood culture, Chest pain, Computerised tomogram head, Computerised tomogram heart
Clinical narrative: Heart rate ranging from 170-180s, pain in chest, dizziness. Paralysis of hand, arms and legs, slurring/aphasia. EMS call with two doses of IV Adenosine  administered without success en route to hospital. Defibrillator pads administered, unused. IV administration of Magnesium and Potassium in emergency room upon arrival. Spiked fever and was treated for sepsis with Vancomycin and Azteronam. Heart rate lowered to 150s once admitted to the hospital but required further medication to lower resting HR. Anti clot injections administered. Vomiting and diarrhea treated with Zofran and fluids. SVT as a result of elevated heart rate.