chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles/had a mild case; am still dealing with neuropathy pain in my right hand; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 85-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In NOV-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles/had a mild case) and post herpetic neuralgia (Verbatim: am still dealing with neuropathy pain in my right hand). The outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the first shingles shot, never went back for the 2nd dose. The patient reported that he/she had shingles the first part of November 2024, he/she still dealing with neuropathy pain in his/her right hand. The reporter reported that he/she had a mild case. They requested get the vaccine both of them.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix probable intramuscular administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix probable intramuscular administration). The outcome of the subcutaneous injection formulation administered by other route 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: 17-MAR-2025 A pharmacist wanted to know what would happen if Priorix was administered intramuscularly. The agent asked if this administration had already occurred, which led subcutaneous injection formulation administered by other route but the health care provider only commented that he did not have confirmation till the time of reporting and therefore could not provide the adverse event data.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: booster was not administered; received on 15-SEP-2021; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 49TM3, expiry date 28-MAY-2022) for prophylaxis.   Concurrent medical conditions included immunocompromised and multiple allergies.   On an unknown date, the patient did not received the 2nd dose of Infanrix. On 15-SEP-2021, the patient received the 1st dose of Infanrix. On 15-SEP-2021, not applicable after receiving Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received on 15-SEP-2021). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: booster was not administered). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were 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: 17-MAR-2025 The nurse reported that a patient who was in here for her well check and she was immunocompromised and allergies had drawn titers and recommended she had have another DTAP, now she was out of the age range and asked for provided multiple times if this was the vaccine that we should give and they said yes but they just wanted to make sure that this would, that she was still within the parameters for that vaccine. The health care professional confirmed that the patient completed the Infanrix schedule. The heath care professional did not have dates or lot numbers of all the vaccines administered but provided the first one administered on September 15th, 2021. Patient was immunocompromised and the booster was not administered. Till the time of reporting, the patient did not receive 2nd dose of Infanrix, which led to incomplete course of vaccination. The patient received a dose of Infanrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: they were only given the diluent, it wasn't reconstituted with the antigen component; Only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   On 14-MAR-2025, the patient received Priorix. On 14-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: they were only given the diluent, it wasn't reconstituted with the antigen component) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 18-MAR-2025 A nurse called to informed that they have a patient that was given the MMR vaccine, Priorix, and they were only given the diluent, it was not reconstituted with the antigen component, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.  The vaccine administration facility was the same as primary reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Pain in extremity, Polymyalgia rheumatica, Suspected COVID-19
Clinical narrative: polymyalgia rheumatica/stiff shoulders / everything was stiff; Patient reported the temporal arteritis and GCA they are all the same field; felt like Covid; legs hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field). In 2021, the patient experienced SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt). The patient was treated with Tocilizumab (Actemra) at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica/stiff shoulders / everything was stiff), GIANT CELL ARTERITIS (Patient reported the temporal arteritis and GCA they are all the same field), SUSPECTED COVID-19 (felt like Covid) and PAIN IN EXTREMITY (legs hurt) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient reported that it had all started after getting the Covid shot on 11-Jan-2021 (Moderna), with the second one on 08-Feb-2021 (Moderna), before taking Actemra.   The patient reported that she hadn't been taking anything and had been perfectly healthy, but within 6 months of getting the second Moderna Covid shot, her shoulders and legs had become stiff, everything had felt stiff, and it had felt like Covid.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Product storage error
Clinical narrative: Menquadfi was administered post temperature excursion with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]  post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation; and MENINGOCOCCAL VACCINE B (MENB) for Immunisation.  On 19-Mar-2025, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot U8369BA and expiry date- 31-MAR-2028) via intramuscular route in the right arm for Immunisation post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Max/low temperature reached: lowest temp of negative 0.6°C and max temp of 6.3°CDuration: 25 hrs  Previous Excursion- NONE, Human error- Unknown, Administered- YES, Does extended stability data cover the excursion- NO.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.  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.; Sender's Comments:  US-SA-2025SA086554:02460337 US-SA-2025SA087172:02460523
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: 60 year old patient received an expired dose of TENIVAC today with no reported adverse event; Initial information received on 25-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 60 years old male patient received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 25-Mar-2025, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) lot U7679AA, Expiry date : 21-Mar-2025 (expired product administered) via intramuscular route in the right deltoid for Immunization with no reported adverse event (strength was unknown) (latency : same day).  Reportedly, Caller requested information regarding any detrimental effects to the patient for administration of TENIVAC 4 days post expiration date. The caller was not aware of any adverse reactions at the time of the call.   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.
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: Pharmacist inquiring if a 45-year-old patient with low titers can receive a booster of MMRII.; This spontaneous report was received from a pharmacist and refers to a 45-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, vaccination site, route of administration, lot # and expiration date were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection.  On an unknown date, the patient had low titers (antibody test negative). The pharmacist was inquiring if a 45-year-old patient with low titers can receive a booster of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The caller stated that the patient would like a booster shot. It was unknown if the dose was administered. No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was reported. At the reporting time, the outcome of the adverse event was not provided.   The causal relationship between the adverse event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Product use in unapproved indication, Skin warm, Tenderness
Clinical narrative: CAPVAXIVE Provider treated patient for cellulitis; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; Patient presented arm that was swollen, ,doubled in size, and was red, hot, and tender.; This spontaneous report was received from a 60s female patient via company representative referred to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route, anatomical site, dose form, lot # and expiration date were not reported) for cellulitis (product use in unapproved indication).  On 12-Mar-2025, the patient experienced side effect with arm that was swollen, doubled in size, and was red, hot, and tender (peripheral swelling, erythema, feeling hot, pain in extremity). It was reported that treatment was given for the events. The outcome of all events was not reported. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable.   The causal relationship between all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.   The reporter considered the events of peripheral swelling, erythema, feeling hot and pain in extremity to be medically significant.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: died after taking the vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "died after taking the vaccines". The cause of death on her death certificate also says it was the vaccine that killed her. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 89-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, in 2025 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2025, outcome "unknown" and all described as "Covid". The event "covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2025) Positive. The caller just had a six month appointment with her doctor today (20Mar2025), and she hasn't been feeling well this week, and the doctor took the test and she had Covid. All her Covid shots were Pfizer. When she had her last Booster, well they didn't give her a booster they just gave her a shot this year a couple of weeks ago, they gave it to her, and all of a sudden now she got Covid. While the caller mentioned all their COVID shots were Pfizer, they were not sure if the last shot was Pfizer or not.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered MENQUADFI post temperature excursion with no reported AE; Max/low temperature reached at lowest temp of negative 0.6°C and max temp of 6.3°C for 25 hrs with no adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked with US-SA-2025SA086720 and US-SA-2025SA086554.  This case involves a 16 years old male patient where for the Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reporter reported max/low temperature reached at lowest temp of negative 0.6°c and max temp of 6.3°c for 25 hrs with no adverse event and vaccine was administered post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Mar-2025, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot U8369BA and expiry date- 31-MAR-2028) via intramuscular route in the right arm for Immunisation post temperature excursion with no reported ae (poor quality product administered) (latency- same day).  On an unknown date in 2025 the reporter reported max/low temperature reached at lowest temp of negative 0.6°c and max temp of 6.3°c for 25 hrs with no adverse event (product storage error) (unknown latency).  Reportedly, Previous Excursion- NONE, Human error- Unknown, Administered- YES, Does extended stability data cover the excursion- NO.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.  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.; Sender's Comments:  US-SA-2025SA086720:02460523 US-SA-2025SA086554:02460337
Age: 4.0
Vaccine: MMR, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to unknown amount of patients. HCP is unable to provide patient information or dates of administration at this time.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.   On 04-NOV-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (Lot No. X011441 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 19-APR-2025 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error); that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (Lot N., expiration date, route and anatomical location of administration were not provided), after a temperature excursion of 9.2 degree Celsius (C) during a time frame of 13 minutes. No previous temperature excursion was reported. No additional adverse event (AE) was reported. (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : X011441 HL , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; breakout of shingles to forehead, face and around the eyes; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 15 years ago).   In AUG-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, the patient received the 1st dose of Shingrix. On 19-FEB-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: breakout of shingles to forehead, face and around the eyes). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure and facial herpes zoster to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the 1st vaccine of Shingrix in June 2024 and 2nd vaccine in August 2024, was unsure of exact date. Patient stated that she had a breakout of shingles that had improved and breakout was to forehead, face and around the eyes. Had to see eye doctor too. This case was considered as suspected vaccination failure as details of 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,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Peg 3350, reaction(s): "Allergy: PEG 3350", notes: PEG, 3350 or something; Miralax, reaction(s): "allergy to Miralax". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine".  Additional information: The patient received 3 doses. The patient had an allergy to ingredient in COVID-19 vaccine, clarified a PEG 3350 or something allergy, an allergy to MiraLAX (said the ingredient in Miralax was also in the vaccine).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500063102 Same patient, product, different dose number and event;US-PFIZER INC-202500063399 Same patient, product, different dose number and event;
Age: 83.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Gait inability
Clinical narrative: she had severe joint pain in her back/pain; I cannot walk; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 18Mar2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 83 years, in right arm for immunisation. The patient's relevant medical history included: "very long time diabetic" (unspecified if ongoing), notes: well controlled; "sciatic" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The patient also took other concomitant therapy. The following information was reported: GAIT INABILITY (non-serious) with onset Mar2025, outcome "unknown", described as "I cannot walk"; ARTHRALGIA (non-serious) with onset 18Mar2025, outcome "unknown", described as "she had severe joint pain in her back/pain". Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient stated she was a very long time diabetic and on a few medications, but generally in pretty good health and her diabetes was well controlled. She had the pneumococcal 20 vaccine in the afternoon on Tuesday 18Mar2025. When she got home, she was fine and then in the evening, she had pain/severe joint pain in her back and the bottom of her back on the right side. She stated she thought it was possibly a sciatic which she had before and she just kind of ignored it. The next day, she was in extreme pain and she had never had the pain like that. She took a couple of TYLENOL which started to ease it. Caller states by Thursday the pain started on the left side which she had never had before and it has continually gotten worse. She took quite a few TYLENOL in the beginning which she shouldn't because she was on ELIQUIS (so she was very concerned about taking the Tylenol), but she took it anyway because the pain was so severe and now she was taking them sporadically and she was in terrific pain and it was not helping. She took from Wednesday to Thursday (19Mar2025 to 20Mar2025) about five TYLENOL. On Thursday afternoon, Thursday night it went to the other side from the right side to the left side which she never had before and now, she took some more TYLENOL, and she stopped taking them on Friday (21Mar2025), because she did not want to take anymore. On Sunday 23Mar2025, it was so bad that she had to start taking another TYLENOL at 6pm and she had to have another one in the morning (24Mar2025). The pain was so terrible that she cannot walk, and was in severe pain. She stated this all went on over the weekend. Other than the injection she had no idea why she was in such pain, but she looked at the website and saw that the side effect was joint pain. She was perfectly fine before the vaccination.    The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm/achy the next day or two/sore arm, feeling kind of spacey and a little funny the first day or two, like achy; accidentally got Prevnar 20 shot twice in a year; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Mar2025 as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 20 (dose 1), administration date: 2024, for immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2025, outcome "unknown", described as "Sore arm/achy the next day or two/sore arm, feeling kind of spacey and a little funny the first day or two, like achy "; INCORRECT DOSE ADMINISTERED (non-serious) with onset Mar2025, outcome "unknown", described as "accidentally got Prevnar 20 shot twice in a year".  Additional information: The patient got Prevnar 20 last summer and then got the same one in Mar2025 (a week before 24Mar2025). Forgot already got it. The patient had normal reaction that she had with all the vaccine she got in. Sore arm and kind of achy the next day or two and the patient was feeling normal no other concerning side effects. And also reported as the patient was just fine, had normal side effects, sore arm, feeling kind of spacey and a little funny the first day or two, like achy and just nothing serious at all.  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: Covid after Vaccine; Covid after Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Vaccine". Additional information: The caller stated "I'm speaking with my local doctor here, in the next little while, possibly by tomorrow morning, you know, so I'll have the full written prescription from him". When discussing the process of online enrollment, the caller stated "I feel like I have a really bad cold. I've never had Covid before, this is the first time. I dodged all of this and then I go see my grandson and they both have snotty noses and sure enough. He's 6 months old. He got Covid. We all got Covid God, I never get sick, it's so weird" After the manual FPL check was done, the caller mentioned they were going to enroll their wife and stated "I think she is speaking with her endocrinologist, cause she wanted to verify kidney function or something". After obtaining the voucher processing details, the caller stated "It's crazy, like I said when you don't get sick, you just go what the heck is going on It's been such a weird thing that you know, how are we supposed to feel or not feel. I've had all my vaccinations, so" While the caller was enrolling their spouse online, they stated " I'm half delirious as it is".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: for 24 hours after the shot I had no pain and the following week I had very little pain, that's happened every time I've taken the Pfizer vaccine or the boosters; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "horribly allergic to a lot of things" (unspecified if ongoing); "Constant pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "for 24 hours after the shot I had no pain and the following week I had very little pain, that's happened every time I've taken the Pfizer vaccine or the boosters".  Additional information: She had a mild case of Covid at the time and so she didn't take the medicine because of the listed side effects. She was horribly allergic to a lot of things and so she wasn't going to chance it, and it was a very mild case because she had had all the boosters and the vaccines. She was the only person that she knows that the next 24 hours after the Pfizer vaccine, she had absolutely no pain in her body. She was 80 years old now and she lived with constant pain, so for 24 hours after the shot she had no pain. The following week, she had very little pain and that's happened every time she had taken the Pfizer vaccine or the boosters. She didn't know what's in the Pfizer thing, but it worked for her. On 10Jan2024, she was diagnosed as positive with the Covid. She went to the ER on 08Jan with COVID but was negative on the Tuesday (09Jan2024). On Wednesday, the 10Jan2024, she was already positive, but it was a very mild case just like a little cold. She got the Paxlovid, but she ended up not using it because of side effects. She decided she was not doing any kind of drugs except for her normal regimen just because she doesn't want to end up in the ER. She had a list of 20 do not give her medicines including Benadryl. She stays away as much as possible from drugs of any kind. She was on 3 blood thinners at this point so there were two of them that were blood thinners still. Many of these drugs come with a fear of that.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500035385 same patient/drug, different event/dose;
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: On 3/11, arm became red.  On 3/12, arm became swollen.  Pt seen in ED on 3/14 and given benadryl.  Pt seen again 3/17 in clinic, diagnosed with cellulitis and started on Augmentin.  Also had vaccines on 3/3/2025: dtap/IPV-Sanofi-2CA54C3 right arm MMRV-Merck-Y018163- left arm Hep A-Merck-Y013274-left arm
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Blood glucose normal, Burning sensation, Chest X-ray, Dizziness, Heart sounds abnormal
Clinical narrative: after member received the vaccine the following started: nausea, dizziness, pain in the shoulder blade, tingle in the fingers, cold extremities, paleness, tachycardia, high blood pressure, extremities weakness, body tremors, numb tongue, speech difficulty. at first doctors taught it was a diabetic emergency but blood sugars were normal range, Emergency Doctor auscultate mu heart and found the S2 delayed.   After the event patient still has the following symptoms. Numbness of the arms and neck, tingle of the fingers, burning sensation on the shoulder blade.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Hypertension, Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Muscular weakness
Clinical narrative: after member received the vaccine the following started: nausea, dizziness, pain in the shoulder blade, tingle in the fingers, cold extremities, paleness, tachycardia, high blood pressure, extremities weakness, body tremors, numb tongue, speech difficulty. at first doctors taught it was a diabetic emergency but blood sugars were normal range, Emergency Doctor auscultate mu heart and found the S2 delayed.   After the event patient still has the following symptoms. Numbness of the arms and neck, tingle of the fingers, burning sensation on the shoulder blade.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Musculoskeletal pain, Nausea, Pallor, Paraesthesia, Peripheral coldness
Clinical narrative: after member received the vaccine the following started: nausea, dizziness, pain in the shoulder blade, tingle in the fingers, cold extremities, paleness, tachycardia, high blood pressure, extremities weakness, body tremors, numb tongue, speech difficulty. at first doctors taught it was a diabetic emergency but blood sugars were normal range, Emergency Doctor auscultate mu heart and found the S2 delayed.   After the event patient still has the following symptoms. Numbness of the arms and neck, tingle of the fingers, burning sensation on the shoulder blade.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Speech disorder, Tachycardia, Tremor
Clinical narrative: after member received the vaccine the following started: nausea, dizziness, pain in the shoulder blade, tingle in the fingers, cold extremities, paleness, tachycardia, high blood pressure, extremities weakness, body tremors, numb tongue, speech difficulty. at first doctors taught it was a diabetic emergency but blood sugars were normal range, Emergency Doctor auscultate mu heart and found the S2 delayed.   After the event patient still has the following symptoms. Numbness of the arms and neck, tingle of the fingers, burning sensation on the shoulder blade.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Abdominal wall mass, Computerised tomogram abnormal, Culture negative, Drain placement, Leukocytosis
Clinical narrative: is a 15 m.o. female who presents to the office with her parents.  A couple of hours ago parents noticed a lump on LL abdomen and walking and fine and some times standing with left knee bent. Had her 15 month WCC yesterday  and had vaccines in both legs and 2 vaccines in the left thigh and one in the right thigh. Had Dtap Hib and Prevnar.  The lump is on the left side in the diaper area Parent concern since pt on January 19,  2025 admitted for Bilateral inguinal node abscesses and admitted for 3 days. I and  D IV clindamycin MSSA. On 01/20/25.  D/C to home for 14 day course of Keflex. On 01/28/25 need I and D on the right side. Consulted with Dr and then called ER as call to expect the pt. Parents drove directly to  pediatric ER.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Psoas abscess, Shift to the left, Swelling, Ultrasound scan abnormal, White blood cell count increased
Clinical narrative: is a 15 m.o. female who presents to the office with her parents.  A couple of hours ago parents noticed a lump on LL abdomen and walking and fine and some times standing with left knee bent. Had her 15 month WCC yesterday  and had vaccines in both legs and 2 vaccines in the left thigh and one in the right thigh. Had Dtap Hib and Prevnar.  The lump is on the left side in the diaper area Parent concern since pt on January 19,  2025 admitted for Bilateral inguinal node abscesses and admitted for 3 days. I and  D IV clindamycin MSSA. On 01/20/25.  D/C to home for 14 day course of Keflex. On 01/28/25 need I and D on the right side. Consulted with Dr and then called ER as call to expect the pt. Parents drove directly to  pediatric ER.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Rash erythematous, Scab
Clinical narrative: DONOR PRESENTS WITH RED BUMPS WITH SCABS TO THE LEFT FOREARM AND BICEP. DENIES ANY ITHCINESS AT THIS TIME.
Age: 0.17
Sex: M
Vaccine: PNC15
Symptoms: Tremor
Clinical narrative: one week after receiving vaccine infant began having tremor like hand movements that have continued for two months
Age: 70.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient inadvertently given PRIORIX IM. No adverse event noted or reported
Age: 42.0
Sex: F
Vaccine: IPV
Symptoms: Dysgeusia, Paraesthesia, Sensory disturbance
Clinical narrative: Immediately after Polio vaccine, patient reported feeling a "weird" feeling in her arm, stomach then a "weird" taste in mouth. Then a tingly feeling in arm. No respiratory issues reported by patient. Patient was observed for 15-20 mins, she said the "weird" feeling and taste was gone.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Alcohol use, Arthralgia, Dizziness, Fatigue, Lymph node pain
Clinical narrative: I worked here and this was my former employer.  24 hours later I began to feel really faint and tired.  I believe that I asked to go home.  That evening, I developed a severe throat and swallowing pain around my neck lymph nodes that persisted for the next five days.  I also had general internal infection-like reactions of a mild fever and aching joints and muscles that could be somewhat alleviated by alternating 800 mg doses of ibuprofen and 1000 mg doses of Tylenol every four hours.  I got a test done at the doctor's office, and I had neither strep nor Covid-19, yet was not tested for the flu.  I was woken every night for those five nights in immense pain as the either previous dose of ibuprofen or Tylenol wore off.  After being wretchedly sick for five days, I decided that I was not going to miss a planned weekend trip in the golden leaf-changing trees, and so I went and took even more ibuprofen and Tylenol and still drank plenty of whiskey talking with friends old and new around the fire before passing out in the trunk of my friend's car camper for the night.  I believe I shocked my system back to normalcy, because the next morning I awoke feeling wonderful and had no further problems.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Odynophagia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I worked here and this was my former employer.  24 hours later I began to feel really faint and tired.  I believe that I asked to go home.  That evening, I developed a severe throat and swallowing pain around my neck lymph nodes that persisted for the next five days.  I also had general internal infection-like reactions of a mild fever and aching joints and muscles that could be somewhat alleviated by alternating 800 mg doses of ibuprofen and 1000 mg doses of Tylenol every four hours.  I got a test done at the doctor's office, and I had neither strep nor Covid-19, yet was not tested for the flu.  I was woken every night for those five nights in immense pain as the either previous dose of ibuprofen or Tylenol wore off.  After being wretchedly sick for five days, I decided that I was not going to miss a planned weekend trip in the golden leaf-changing trees, and so I went and took even more ibuprofen and Tylenol and still drank plenty of whiskey talking with friends old and new around the fire before passing out in the trunk of my friend's car camper for the night.  I believe I shocked my system back to normalcy, because the next morning I awoke feeling wonderful and had no further problems.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder, Streptococcus test negative
Clinical narrative: I worked here and this was my former employer.  24 hours later I began to feel really faint and tired.  I believe that I asked to go home.  That evening, I developed a severe throat and swallowing pain around my neck lymph nodes that persisted for the next five days.  I also had general internal infection-like reactions of a mild fever and aching joints and muscles that could be somewhat alleviated by alternating 800 mg doses of ibuprofen and 1000 mg doses of Tylenol every four hours.  I got a test done at the doctor's office, and I had neither strep nor Covid-19, yet was not tested for the flu.  I was woken every night for those five nights in immense pain as the either previous dose of ibuprofen or Tylenol wore off.  After being wretchedly sick for five days, I decided that I was not going to miss a planned weekend trip in the golden leaf-changing trees, and so I went and took even more ibuprofen and Tylenol and still drank plenty of whiskey talking with friends old and new around the fire before passing out in the trunk of my friend's car camper for the night.  I believe I shocked my system back to normalcy, because the next morning I awoke feeling wonderful and had no further problems.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: Inflammation and  pain on inside of left wrist. Same arm as injection
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling jittery, Gait inability, Influenza like illness, Loss of consciousness
Clinical narrative: During the night following the vaccine, I started feeling flu like symptoms and was unable to sleep.  I was also very jittery.  When I started to feel as if I was going to vomit or pass out, I tried to get to the bathroom but was unable to walk once I got from the bedroom to the hallway.  I fell to the floor and called to my husband.  He rushed to my side, and I blacked out, went stiff, started breathing very heavily, then was not breathing.  This lasted approximately 10 seconds.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Respiratory arrest, Sleep disorder
Clinical narrative: During the night following the vaccine, I started feeling flu like symptoms and was unable to sleep.  I was also very jittery.  When I started to feel as if I was going to vomit or pass out, I tried to get to the bathroom but was unable to walk once I got from the bedroom to the hallway.  I fell to the floor and called to my husband.  He rushed to my side, and I blacked out, went stiff, started breathing very heavily, then was not breathing.  This lasted approximately 10 seconds.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Disturbance in attention, Dizziness, Tremor
Clinical narrative: Body trimmers, 100 degree fever, dizzy, unable to focus
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient did not report a vaccine reaction.  the age of the patient was the concern as the age requirement was not met.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Burning sensation, Computerised tomogram, Crying
Clinical narrative: Body aches, burning sensations, numbness in face and back of neck, hair is GONE from all her skin, muscle loss, looks like she is a skeleton, pain all the time. Dr does nothing for her , we are trying a new DR
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle atrophy, Pain
Clinical narrative: Body aches, burning sensations, numbness in face and back of neck, hair is GONE from all her skin, muscle loss, looks like she is a skeleton, pain all the time. Dr does nothing for her , we are trying a new DR