chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Face injury, Fall, Head injury, Loss of consciousness, Somnolence
Clinical narrative: Fainted; Vision went out (said he saw black); really sleepy; fell to the floor; hit head on floor and required stitches for face injury; hit head on floor and required stitches for face injury; This serious case was reported by a consumer via sales rep and described the occurrence of fainting in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac).   On 03-JAN-2025, the patient received the 1st dose of Menveo (right arm) and the 1st dose of Boostrix (left arm). On 03-JAN-2025, less than a day after receiving Menveo and Boostrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria hospitalization and GSK medically significant), blackout (Verbatim: Vision went out (said he saw black)) (serious criteria GSK medically significant), sleepiness (Verbatim: really sleepy), fall (Verbatim: fell to the floor), face injury (Verbatim: hit head on floor and required stitches for face injury) and head injury (Verbatim: hit head on floor and required stitches for face injury). The outcome of the fainting was resolving and the outcome of the blackout, sleepiness, fall, face injury and head injury were not reported.   It was unknown if the reporter considered the fainting, blackout, sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix.     The company considered the fainting and blackout to be unrelated to Menveo and Boostrix. It was unknown if the company considered the sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix.   Additional Information: GSK receipt date: 03-JAN-2025 The patient was said he was really sleepy, his vision went out (said he saw black) and then fell to the floor off exam table. The patient fainted after vaccines and hit head on floor and required stitches for injury on face.; Sender's Comments: Syncope is a listed event which, due to the following criteria (concurrent anxiety) is considered unrelated to GSK vaccine Menveo and Boostrix. Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Menveo and Boostrix.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Suture insertion, Syncope
Clinical narrative: Fainted; Vision went out (said he saw black); really sleepy; fell to the floor; hit head on floor and required stitches for face injury; hit head on floor and required stitches for face injury; This serious case was reported by a consumer via sales rep and described the occurrence of fainting in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included fluoxetine hydrochloride (Prozac).   On 03-JAN-2025, the patient received the 1st dose of Menveo (right arm) and the 1st dose of Boostrix (left arm). On 03-JAN-2025, less than a day after receiving Menveo and Boostrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria hospitalization and GSK medically significant), blackout (Verbatim: Vision went out (said he saw black)) (serious criteria GSK medically significant), sleepiness (Verbatim: really sleepy), fall (Verbatim: fell to the floor), face injury (Verbatim: hit head on floor and required stitches for face injury) and head injury (Verbatim: hit head on floor and required stitches for face injury). The outcome of the fainting was resolving and the outcome of the blackout, sleepiness, fall, face injury and head injury were not reported.   It was unknown if the reporter considered the fainting, blackout, sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix.     The company considered the fainting and blackout to be unrelated to Menveo and Boostrix. It was unknown if the company considered the sleepiness, fall, face injury and head injury to be related to Menveo and Boostrix.   Additional Information: GSK receipt date: 03-JAN-2025 The patient was said he was really sleepy, his vision went out (said he saw black) and then fell to the floor off exam table. The patient fainted after vaccines and hit head on floor and required stitches for injury on face.; Sender's Comments: Syncope is a listed event which, due to the following criteria (concurrent anxiety) is considered unrelated to GSK vaccine Menveo and Boostrix. Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Menveo and Boostrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had shingles on my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: I had shingles on my face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolved (duration 9 days).   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles on his/her face. He/she bought a bottle of everclear 190 at the liquor store and used Q tips to put it on his/her face. Dry it up and gone in 9 days. Never had it again. The patient never had shingles before till he/she got the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Bad shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Bad shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. Patient have had 2 shingle shots and still get bad shingles. For some reason, it just did not seem to help the patient. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. Patient reported that vaccine was a scam.  He/she had the shots and got shingles 2 months later.  And while taking acyclovir twice a day too. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure 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 Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JAN-2024 This case was reported by a patient via interactive digital media. The patient received the vaccine but still had Shingles. It lasted for about two and a half months and it was very painful. Would not wish it on anyone. Was not mild. Had to go on heavy duty pain medication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided 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 Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: had shingles that is driving me nuts three years later; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had shingles that is driving me nuts three years later). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-JAN-2025 This case was reported by a patient via interactive digital media. The patient stated that his/her shingles vaccine was very painful and two weeks later he/she had shingles that was driving him/her nuts three years later.
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Double hep B dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 10-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 77J49) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 42B22) for prophylaxis.   On 16-DEC-2024, the patient received the 1st dose of Pediarix and the 1st dose of Engerix B. On 16-DEC-2024, an unknown time after receiving Pediarix and Engerix B, the patient experienced overdose (Verbatim: Double hep B dose). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-DEC-2024. The reporter reported that the following incident that happened on 16-Dec-2024, reporter had a patient come in for her immunization and she received a Pediarix but also received a separated hep B vaccination (Engerix-B) on the same day, which led to overdose. .
Age: 47.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix 2nd dose on Sep 5th 2023 and 3rd dose on Dec 20th 2023; Twinrix 1st dose taken on Aug 30th 2023 and 2nd dose on Sep 5th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too short in a 47-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 20-DEC-2023, the patient received the 3rd dose of Twinrix. On 05-SEP-2023, the patient received the 2nd dose of Twinrix. On 05-SEP-2023, not applicable after receiving Twinrix, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced drug administration duration too short (Verbatim: Twinrix 1st dose taken on Aug 30th 2023 and 2nd dose on Sep 5th 2023). On 20-DEC-2023, the patient experienced drug administration duration too short (Verbatim: Twinrix 2nd dose on Sep 5th 2023 and 3rd dose on Dec 20th 2023). The outcome of the drug administration duration too short and drug administration duration too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-DEC-2024 A pharmacist mentioned she had a patient that received three doses of Twinrix at different intervals. 1st dose received on 30 Aug 2023. The patient received 2nd and 3rd dose early which led to shortening of vaccinations schedule. The pharmacist asked for recommendations on this situation.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: only received one dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received first dose of Bexsero on 26th July 2023).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: only received one dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2024  The nurse reported that the patient that would come into their facility on the day of reporting who had only received one dose of Bexsero and asked information to make clinical decision about administering a second dose during patient´s visit.  The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive the second dose of Bexsero which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: pain at the injection site; fever; nausea; severe body aches; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 23-DEC-2024, the patient received Bexsero. On 23-DEC-2024, 4 hrs after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain at the injection site), fever (Verbatim: fever), nausea (Verbatim: nausea) and general body pain (Verbatim: severe body aches). On 24-DEC-2024, the outcome of the injection site pain, fever, nausea and general body pain were resolved (duration 1 day).   It was unknown if the reporter considered the injection site pain, fever, nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, fever, nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-DEC-2024 The physician reported that the patient received the Bexsero vaccine.  Four hours  after the vaccination the patient began to experience severe body aches, nausea, fever of 101.6 Fahrenheit and pain at the injection site.  The physician reported all the symptoms resolved the following day. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31-OCT-2019 with batch number 54A2T and lot expiry 11-DEC-2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024 The pharmacist reported that a patient received a first dose and had not received a second dose yet.  The patient was asking for a second dose today and pharmacist calls to request information to make clinical decision. Health care professional stated the first dose given to the patient happened at a different facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, 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 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15-JAN-2021, the patient received the 2nd dose of Shingrix. On 18-SEP-2020, the patient received the 1st dose of Shingrix. On 23-DEC-2024, 1438 days after receiving Shingrix and 1557 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter was the patient. The patient developed Shingles even though she received the full vaccination with Shingrix. The patient received the first dose of Shingrix on 18th September 2020, and the second dose on 15th January 2021. The lot number provided for the first dose was 35943 and expiration was 26th January 2022 and the lot number for the second dose was EV4TD and expiration was 4th January 2022. Both the lot numbers provided do not correspond Shingrix. The patient began experiencing pain on 23rd December 2024, and developed a rash (no blisters) on 26th December 2024. The pain had started on the left flank, then her back, lower abdomen, groin area and thigh. The rash was developed on the out aspect of the left thigh. The patient stated she has never had Shingles (disease) before, and that she did not receive Zostavax prior to receiving Shingrix. The patient was also a nurse and self-diagnosed the Shingles. 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, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2)
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Incomplete course of vaccination, Malaise
Clinical narrative: Got ill; the patient never went back to receive the second dose; Death; This serious case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 29-OCT-2024, between 5 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Death) (serious criteria death and GSK medically significant). On an unknown date, the patient experienced illness (Verbatim: Got ill) and incomplete course of vaccination (Verbatim: the patient never went back to receive the second dose). The outcome of the illness and incomplete course of vaccination were unknown. The patient died on 29-OCT-2024. The reported cause of death was unknown.   The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the illness to be related to Shingrix.     The company considered the unknown cause of death and illness to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter reported that patient received his first dose of Shingirx, she thinks, in April 2024 and the patient never went back to receive the second dose which leads to incomplete course of vaccination, patient got ill after receiving the Shingrix vaccine, and died. The reporter also reports that the patient did receive another vaccine that same day in the opposite arm, but cannot remember what the name of the other vaccine was.  The reporter states that the death had nothing to do with the Shingrix Vaccine. This case is linked with US2025003275, reported by same reporter.; Sender's Comments: Death and Illness are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025003275:Same reporter/Different patient; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; 3 year old received the Pfizer vaccine 12 and plus; 3 year old received the Pfizer vaccine 12 and plus; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A 3-year-old 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: PYREXIA (non-serious), outcome "unknown", described as "fever"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "3 year old received the Pfizer vaccine 12 and plus".  Additional information: Two children (3 year old and 1 year old) received the Pfizer vaccine 12 and plus and they are having a fever. The reporter is the children's parent. They went to the doctor to get the vaccine, and they received a call that the vaccine that was administered to both patients is the Pfizer vaccine for age 12 and older. The patients have fevers at the time of the report. The reporter was asking if the children should be taken to the ER/hospital.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500008909 same reporter/suspect vaccine/event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: fever; rash; fatigue; 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: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; RASH (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  Additional information: Patient received the second Pfizer COVID vaccine recently with side effects of fever, rash, and fatigue.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: for three days her arm hurt quite a lot but then right now can move it but it is still; for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more; for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more; redness went away but came back/4 inch round red mark and it is a little more warmer than the rest of the skin; felt tired; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Jan2025 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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "for three days her arm hurt quite a lot but then right now can move it but it is still"; MOVEMENT DISORDER (non-serious), MOBILITY DECREASED (non-serious), outcome "not recovered" and all described as "for three days her arm hurt quite a lot but then right now can move it but it is still/arms movement back but at the site it flared up more"; ERYTHEMA (non-serious), outcome "not recovered", described as "redness went away but came back/4 inch round red mark and it is a little more warmer than the rest of the skin"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Additional information: Patient noticed today maybe a 4 inch round red mark and it is a little more warmer than the rest of the skin. Originally it was red it seems to go away and patient noticed in the shower, when is feeling it now it is slightly warmer than the rest of arm.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: I've had Covid three times; I've had Covid three times; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "Covid", start date: 2020 (unspecified if ongoing), notes: first one is before the vaccine; "lost twenty pounds" (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 had Covid three times". The event "i've had covid three times" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: lost twenty pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient tested positive for covid and got a prescription of Paxlovid. The patient had covid 3 times; the first time was before the vaccine. The second time he had it, the patient went to urgent care, and he got Paxlovid for free. The patient felt a lot better than he did the first time he had Covid when he had pneumonia and lost twenty pounds. The patient had covid after Paxlovid.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: contracted Guillain Barre Syndrome after a Covid Shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "contracted Guillain Barre Syndrome after a Covid Shot". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Abscess limb, Acute kidney injury, Sepsis
Clinical narrative: Abscess limb; Acute kidney injury; Sepsis; Initial information received on 06-Jan-2025 regarding an unsolicited valid serious Courtesy case received from a consumer/non-healthcare professional.  This case involves a 60 years old female patient who said to experienced abscess limb, acute kidney injury and sepsis after receiving Influenza USP trival A-B subvirion no preservative vaccine [Fluzone], Boostrix, Novavax Covid-19 vaccine.  The patient's past medical history included Asthma, Tobacco user, Hypertension, Bipolar disorder and Drug hypersensitivity.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing bacterial rhinosinusitis and Fungal skin infection.  Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair); Salbutamol (Albuterol); Azelastine, Buprenorphine, Mirtazapine (Mirtazepine Teva); Olanzapine, Oxybutynin, Propranolol and Venlafaxine.  On 29-Oct-2024, the patient received a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UT8506KA via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication and received a dose of suspect novavax covid-19 vaccine injection not produced by Sanofi Pasteur lot 602MF013 via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication and received a dose 1 of suspect Boostrix not produced by Sanofi Pasteur lot 5YB5G via intramuscular route in unknown administration site (strength and expiration date: not provided) for drug used for unknown indication.  On 06-Nov-2024 the patient developed abscess limb, acute kidney injury and sepsis (latency- 8 days). These events was assessed as medically significant and life-threatening and the patient was hospitalized for these events.  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 Recovered / Resolved on an unknown date for all the events.; Sender's Comments: Sanofi Company Comment dated 17-Jan-2025: This case involves a 60 years old female patient who said to experienced abscess limb, acute kidney injury and sepsis after receiving Influenza USP trival A-B subvirion no preservative vaccine [Fluzone], Boostrix, Novavax Covid-19 vaccine, with latency of 8 days following vaccination. Further information regarding  previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, concomitant use of multiple vaccines remains as confounding factor and the role of individual suspect vaccine cannot be assessed.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received 2nd dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75F74, expiry date 31-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 12-JAN-2024 from batch number PS2CK with expiry date 10-JUL-2025).   On 19-DEC-2024, the patient received the 2nd dose of Arexvy. On 19-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received 2nd dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 19-DEC-2024 Pharmacist reported that patient received a dose of Arexvy and then was administered with an extra dose of Arexvy, which led to an extra dose administered. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Sudden death; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA369389 (Sanofi), AE-017381 (BioNTech SE).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), 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: SUDDEN DEATH (death, medically significant), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 omicron (kp.2) is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Unknown cause of death
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dust allergy, Illness
Clinical narrative: Same initial onset of symptoms after vaccine, my anxiety keeps amplifying with symptoms; Very sensitive to dust/inhale any amount of dust, get severely sick; Very sensitive to dust/inhale any amount of dust, get severely sick; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0170) at the age of 32 years for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the first administration of BNT162B2. The patient's relevant medical history included: "Gerd" (ongoing); "Sleep apnea" (ongoing); "heart attack/heart issues" (ongoing); "heart attack/heart issues" (ongoing); "Pneumonia" (ongoing). The patient is not allergic to any previous vaccination, medications, food all other products. There were no concomitant medications. The patient was not taking any other medications within 2 weeks prior to the event onset. The following information was reported: ANXIETY (hospitalization), outcome "not recovered", described as "Same initial onset of symptoms after vaccine, my anxiety keeps amplifying with symptoms"; DUST ALLERGY (non-serious), ILLNESS (non-serious), outcome "not recovered" and all described as "Very sensitive to dust/inhale any amount of dust, get severely sick". The event "very sensitive to dust/inhale any amount of dust, get severely sick" required physician office visit. Therapeutic measures were taken as a result of dust allergy, illness.  Clinical course: After the vaccine, the patient was very sensitive to dust. If he inhales any amount of dust, he gets severely sick. This resulted to multi-doctor/multi-lung specialists visits and the patient was prescribed with an inhaler (ongoing use). It was also reported that the patient has same initial onset of symptoms after vaccine, his anxiety keeps amplifying with symptoms. The patient's anxiety resulted to hospitalization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400329270 same reporter/patient/suspect vaccine; different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Dermatitis, Post-acute COVID-19 syndrome, Urticaria
Clinical narrative: hyper auto immune system; dermatitis; hives burning, itchy in the body; long term Covid; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2023 as dsoe 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "hyper auto immune system"; DERMATITIS (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives burning, itchy in the body"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long term Covid". The event "long term covid" required physician office visit. Clinical course: Caller wanted to report a reaction after vaccines and long term Covid which has been to many doctors they told her she had dermatitis and hyper auto immune system with hives burning, itchy in the body after Covid vaccine 2 years ago.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Peripheral swelling, Product administered at inappropriate site, Ultrasound scan
Clinical narrative: Patient states she had arm swelling, neck and shoulder pain and had to see a doctor. She said they completed an ultrasound and the vaccine was administered too high and too forward in the arm. Patient was prescriber cyclobenzaprine for the pain. The pain finally just went away after 3 months.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: Cold and flu-like symptoms such as stuffy nose, headache, body aches, fatigue, excessively tired, that has, so far, lasted 8 days (and counting).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I experienced, and am still experiencing chronic hives from the vaccine.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received covid vaccines pfizer for 12 yrs + instead of 5yr-11yrs
Age: 12.0
Sex: M
Vaccine: HPV9, MMR, MNQ, VARCEL
Symptoms: No adverse event
Clinical narrative: No signs or symptoms of adverse reaction, no treatment required
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Immune-mediated arthritis, Joint swelling
Clinical narrative: Since receiving the moderna covid vacccine, my neuropathic symptoms associated with my right ankle (post surgical neuropathy 2016) progressively worsened and ultimately spread bilaterally to my lower back and left foot. These symptoms were accompanied by fatigue, malaise, and persistent joint swelling, headaches, congestion, and rhinitis. i was recently diagnosed with immune related arthritis in those areas and other major joints. None of these neurologic and immune related conditions are conventional and only arose/worsened following the covid vaccination
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Neuropathy peripheral, Respiratory tract congestion, Rhinitis
Clinical narrative: Since receiving the moderna covid vacccine, my neuropathic symptoms associated with my right ankle (post surgical neuropathy 2016) progressively worsened and ultimately spread bilaterally to my lower back and left foot. These symptoms were accompanied by fatigue, malaise, and persistent joint swelling, headaches, congestion, and rhinitis. i was recently diagnosed with immune related arthritis in those areas and other major joints. None of these neurologic and immune related conditions are conventional and only arose/worsened following the covid vaccination
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Local reaction, Musculoskeletal chest pain, Swelling
Clinical narrative: PT HAD A LOCAL REACTION . SWELLING ABD UT GOT INFECTED, PT ALSO SAID HER RIBS WERE HURTIN
Age: 57.0
Sex: M
Vaccine: PNC21
Symptoms: Blood test, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: patient had pain in injection site, headache starting night after vaccination, fever and nausea and vomiting starting that evening.
Age: 57.0
Sex: M
Vaccine: PNC21
Symptoms: Vomiting
Clinical narrative: patient had pain in injection site, headache starting night after vaccination, fever and nausea and vomiting starting that evening.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lethargy, Weight bearing difficulty
Clinical narrative: Per mother: lethargic, unable to bear weight, swelling and redness at both injection sites, warmth at R thigh.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Feeling hot, Injection site paraesthesia, Injection site pruritus, Injection site warmth, Paraesthesia
Clinical narrative: patient had a reaction to the capvaxive vaccine, came back a few minutes (maybe 5) after the vaccine and said her arm that she got the capvaxive in started itching at the injection site and getting warm/tingling, then that feeling traveled down her arm, across her chest and to her entire body. She waited by the pharmacy for about a half an hour before she left, she said when she left she did still have the feeling but it was getting better. A few hours later her side effects subsided completely
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient previously vaccinated with Arexvy 10/25/2023, and he should not have been vaccinated again.  He has experienced no adverse reactions.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Extreme continuous pain in exact area where injection of vaccine was given.  Never had this type of problem with any other vaccine ever!
Age: 54.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a Gardasil vaccine that he did not request. No adverse reaction.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Frequent bowel movements, Haematochezia, Vaccine positive rechallenge
Clinical narrative: Presented with blood in stool on 1/2. 9 days after getting her 3rd rotavirus vaccine. Parents report they noted change in her stools with increased frequency following the vaccine. This occurred with prior immunization of rotavirus as well. Pt admitted to hospital after 4 attempts at air enema, ultimately successful.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Extra dose administered
Clinical narrative: patient got AREXY 2023 - the system didn't upload it to vaccine registry. In 2025 he asked for AREXVY, vaccine registry was checked and wasn't on there so patient was given a second dose.  He did not have any adverse events , just some redness on his arm.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Accidentally diluted COVID 6 mon-4 yrs vaccine with sterile water instead of correct sodium chloride diluent. Vials were replaced with a different cap by pharmacy and the wrong diluent was grabbed and used. No apparent injury/reaction currently.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tinnitus
Clinical narrative: FEVERS, FATIGUE - WITHIN 1 DAY - NOTABLE LEFT SIDED TINNITUS THAT HAS NOT RESOLVED NEARLY 4 YEARS LATER.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Low grade fever, muscle aches, headache, and fatigue last 5 hours