chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Drug Exposure During Pregnancy; Drug Exposure During Pregnancy; Extra dose; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis.   On 20-SEP-2024, the patient received the 2nd dose of Boostrix. On 03-SEP-2024, the patient received the 1st dose of Boostrix. On 20-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Extra dose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy) and vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were not applicable.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in second trimester Pregnancy Exposure (Boostrix): To mother in second trimester Estimated Delivery/Due date: 02-DEC-2024 Pregnancy Outcome: Pregnancy was ongoing   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: 24-SEP-2024 The reporter had a patient, who was pregnant, and who received the Tdap on 03-SEP-2024, and then another one on 20-SEP-2024, and reporter need to know if GSK had any research or data that know like any effects or anything like that. The reporter mentioned that both vaccines where administer during the 2nd pregnancy trimester of the patient. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Boostrix during pregnancy, which led to extra dose administered.   Upon internal review the case was updated on 10-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant woman in her 36.1 week of pregnancy, receive the Boostrix; already had the Boostrix during this pregnancy; However, looking back the woman already had the Boostrix during this pregnancy,; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24-SEP-2024, the patient received the 2nd dose of Boostrix (intramuscular). On an unknown date, the patient received the 1st dose of Boostrix. On 24-SEP-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: However, looking back the woman already had the Boostrix during this pregnancy,). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant woman in her 36.1 week of pregnancy, receive the Boostrix) and vaccine exposure during pregnancy (Verbatim: already had the Boostrix during this pregnancy). The outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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: 24-SEP-2024 The health care professional reported that a pregnant patient in her 36.1 week of pregnancy, received the Boostrix on the day of reporting, which led to vaccine exposure during pregnancy. However, looking back the women already had Boostrix during this pregnancy, which led vaccine exposure during pregnancy and extra dose administered. The reporter was unsure of the date due to computer being down, no symptoms.   Upon internal review the case was updated on 11-FEB-2025 The report type was updated from PMS to Spontaneous. Summary of changes: Report type, product details and narrative were updated.
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Hiberix + only diluent given; Hiberix + only diluent given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Hib (Hiberix) (batch number 395JH) for prophylaxis.   On 15-JAN-2025, the patient received Hiberix. On 15-JAN-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix + only diluent given) and inappropriate dose of vaccine administered (Verbatim: Hiberix + only diluent given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JAN-2025 The nurse reported that the diluent portion of Hiberix vaccines was administered to a patient without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Product prescribing error
Clinical narrative: Drug prescribing error; The patient received the first dose of Shingrix in 2022 and 2nd in May 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2022).   In MAY-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient did not receive the 3rd dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the first dose of Shingrix in 2022 and 2nd in May 2024). On an unknown date, the patient experienced drug prescribing error (Verbatim: Drug prescribing error). The outcome of the drug dose administration interval too long and drug prescribing error were unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025 The pharmacist reported that she had a prescription for a patient for Shingrix, but it will be the patient's 3rd dose which led to drug prescribing error.  The patient received the first dose of Shingrix in 2022 and 2nd in May 2024.  The pharmacist thinks the physician may have forgotten the patient received the 1st dose in 2022 and that's why the 3rd dose was prescribed.  The patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: A 4 months old female patient received a dose of Kinrix; Kinrix was administered for the 2nd dose of DTaP and IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 4 months old female patient received a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was administered for the 2nd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 04-FEB-2025 The reporter reported that a 4 months old patient received Kinrix and Kinrix was administered for the 2nd dose of DTaP and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. And wanted to know if there was anything if they should do.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: A 55 years old male patient received a dose of manevo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 55-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis.   On an unknown date, the patient received Menveo (subcutaneous). On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: A 55 years old male patient received a dose of manevo). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 05-FEB-2025 The pharmacist reported that they administered a dose of Menveo (1 vial) subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The reporter was ask what was the recommendations to follow.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: sore muscles; fever; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-FEB-2025, the patient received Shingrix (intramuscular). On 06-FEB-2025, 1 days after receiving Shingrix, the patient experienced muscle soreness (Verbatim: sore muscles), fever (Verbatim: fever) and rash (Verbatim: rash). The outcome of the muscle soreness, fever and rash were unknown.   It was unknown if the reporter considered the muscle soreness, fever and rash to be related to Shingrix.     It was unknown if the company considered the muscle soreness, fever and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-FEB-2025 The reporter reported that a patient received his Shingrix vaccination and reporting day morning he awoke with fever, muscle aches and rash on his stomach and arms.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: Only adjuvant portion; Only adjuvant portion; late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number HA5HA, expiry date 13-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17-MAY-2024).   On 04-FEB-2025, the patient received the 2nd dose of Shingrix. On 04-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant portion), inappropriate dose of vaccine administered (Verbatim: Only adjuvant portion) and drug dose administration interval too long (Verbatim: late 2nd dose ). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 06-FEB-2025 The health care professional reported that he/she asked regards the Shingles vaccine (Shingrix), if a patient was given just the diluent only and not the vaccine it self, when was safe to get the dose of vaccine, which led to inappropriate preparation of medication and inappropriate doseof vaccine administered. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 13-month-old patient instead of Pediarix; Kinrix was administered to a 13-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 28-JAN-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 28-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was administered to a 13-month-old patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 13-month-old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 06-FEB-2025 The reporter reported that the Kinrix was administered to a 13-month-old patient instead of Pediarix which led to, wrong vaccine administered and inappropriate age at vaccine administration. The reporter stated that they had always re-vaccinated after 30 days an in because it was considered an invalid dose but their stated, they did not had to re-vaccinate because it was the same dose. The vaccine administration facility was the same as primary reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20-APR-2023).   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: received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2025 The pharmacist stated a patient received the first dose of Shingrix almost 2 years ago and did not return for the 2nd dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2018187736:same reporter
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received a first dose of Twinrix in Aug 7th 2024 and second dose was given today Feb 7th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old female patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 07-AUG-2024, batch number 2553X, expiry date 25-SEP-2026).   On 07-FEB-2025, the patient received the 2nd dose of Twinrix. On 07-FEB-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a first dose of Twinrix in Aug 7th 2024 and second dose was given today Feb 7th 2025). The outcome of the drug dose administration interval too long 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: 07-FEB-2025 A pharmacist reported that a patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule The pharmacist asked if series should be re started
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: patient started the Havrix series in 2019 but never received the second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: patient started the Havrix series in 2019 but never received the second 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: 07-FEB-2025 The pharmacist reported that a patient started the Havrix series in 2019 but never received the second dose. Till the time of reporting, the patient did not receive the 2nd dose of Havrix, which led to an incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose increased, Pain in extremity
Clinical narrative: sore arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY ("sore arms") in a 60-year-old female patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection.     Concurrent medical conditions included Diabetes.    On 04-Feb-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) 1 dosage form. On 05-Feb-2025,  after starting mRNA-1345 (mRESVIA), the patient experienced PAIN IN EXTREMITY ("sore arms"). At the time of the report, PAIN IN EXTREMITY ("sore arms") outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2025, Blood glucose: high blood sugar of 185..     The action taken with mRNA-1345 (mRESVIA) (Intramuscular use) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2025-782121 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Pain in extremity
Clinical narrative: "sore arms"; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY ("sore arms") in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 04-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 05-Feb-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY ("sore arms"). At the time of the report, PAIN IN EXTREMITY ("sore arms") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2025, Blood glucose increased: high blood sugar of 185.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-782124 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-782124:mRESVIA RSV Vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID.  A 60-year-old female patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for COVID-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2022 (unspecified if ongoing). There were no concomitant medications. Past drug history included: Paxlovid, start date: Jul2022, for COVID-19 treatment. Vaccination history included: COVID-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization; Moderna (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Weight: About 155. The patient had nirmatrelvir/ritonavir (PAXLOVID) before and then she started with a couple of years ago and that she got all her boosters. The patient guesses that she can get COVID-19 again. So, she had PAXLOVID before and she has COVID-19 and PAXLOVID again. Therapeutic measures included nirmatrelvir/ritonavir (300/100 mg), oral, at 3 tablets, twice daily, for 5 days from 06Feb2025 (ongoing).
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: the most painful shot I have ever gotten; near it's swollen and red where at the site of the injection; near it's swollen and red where at the site of the injection; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Feb2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) at the age of 61 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the most painful shot I have ever gotten"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "near it's swollen and red where at the site of the injection".  Additional information: Consumer stated that patient actually got a Prevnar 20, 0.5 milliliter shot 05Feb2025 (yesterday) in the morning and it was the most painful shot patient had ever gotten and patient was just been living like because patient just do and may be patient should not have but right but patient have, near it's swollen and red where at the site of the injection so, patient was concerned about that. Patient did not know if there was something patient should do about it. Consumer was requested to visit nearest Health Care Professional or Pharmacist in case of emergency.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, COVID-19, Drug ineffective, Malaise
Clinical narrative: I got COVID; I got COVID; I haven't been feeling well and the different symptoms I am having; pain in the right side of my back; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: this is the second time I have covid, but the first time I did not have any symptoms I didn't know I had it but when I got tested it shows that I had covid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID"; MALAISE (non-serious), outcome "not recovered", described as "I haven't been feeling well and the different symptoms I am having"; BACK PAIN (non-serious), outcome "not recovered", described as "pain in the right side of my back". The events "i got covid" and "i haven't been feeling well and the different symptoms i am having" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: I have the antibodies; SARS-CoV-2 test: I got COVID; I had covid.  Clinical course: The reporter stated that, "The doctor told me last night, you know, because he hasn't been feeling well and the different symptoms  this is the second time he has covid, but the first time did not have any symptoms he didn't know he had it but when I got tested it shows that he had covid had to be quarantined but this time had vaccinations,. Reporter stated" I've had two vaccinations and I have the bloodwork showing that I have the antibodies but then I got the covid test I got Covid from a family member had a baby, I was kind of helping the baby, and somehow I get the COVID, and I started the symptoms, and like the Covid and yesterday I went to the ER (emergency room) you know I have to get an (inaudible) because I've been having a pain in the right side of my back and the lung doctor was saying I need to get the medication because it's going to help (inaudible) down so it doesn't make the symptoms worse so I can get better. "  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: SARS-CoV-2 test
Clinical narrative: I got COVID; I got COVID; I haven't been feeling well and the different symptoms I am having; pain in the right side of my back; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: this is the second time I have covid, but the first time I did not have any symptoms I didn't know I had it but when I got tested it shows that I had covid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID"; MALAISE (non-serious), outcome "not recovered", described as "I haven't been feeling well and the different symptoms I am having"; BACK PAIN (non-serious), outcome "not recovered", described as "pain in the right side of my back". The events "i got covid" and "i haven't been feeling well and the different symptoms i am having" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: I have the antibodies; SARS-CoV-2 test: I got COVID; I had covid.  Clinical course: The reporter stated that, "The doctor told me last night, you know, because he hasn't been feeling well and the different symptoms  this is the second time he has covid, but the first time did not have any symptoms he didn't know he had it but when I got tested it shows that he had covid had to be quarantined but this time had vaccinations,. Reporter stated" I've had two vaccinations and I have the bloodwork showing that I have the antibodies but then I got the covid test I got Covid from a family member had a baby, I was kind of helping the baby, and somehow I get the COVID, and I started the symptoms, and like the Covid and yesterday I went to the ER (emergency room) you know I have to get an (inaudible) because I've been having a pain in the right side of my back and the lung doctor was saying I need to get the medication because it's going to help (inaudible) down so it doesn't make the symptoms worse so I can get better. "  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Gait disturbance, Malaise, Vomiting
Clinical narrative: he was very sick; vomiting; difficulty breathing; couldn't walk 10 feet to the bathroom; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he was very sick"; VOMITING (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "couldn't walk 10 feet to the bathroom". Additional information: he was very sick and was vomiting, had difficulty breathing, and couldn't walk 10 feet to the bathroom after receiving rsv vaccine.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: stated her daughter's friend got flublok and she wasn't 18 yet with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who had received Influenza Trivalent Recombinant Vaccine [Flublok TIV] and she wasn't 18 yet with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the less than 18 years old patient received a unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly: "Caller refused to provide event information without her friend's approval."  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects post vaccination. Pt was given Dtap instead of Tdap.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT STARTED EXPERIENCING ITCHING AND HIVES A DAY AFTER THE VACCINE AND STILL HAD THEM 5 DAYS AFTER THE VACCINE.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate vaccine given
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Protein total increased
Clinical narrative: Following Pfizer her protein levels started to rise and then she was diagnosed with autoimmune hepatitis
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Apathy, Arthralgia, Arthritis, Brain fog
Clinical narrative: Chronic runny nose, crippling arthritis, pain in joints, brain fog, memory loss, lack of motivation, growths appearing with pain on multiple locations, blurred vision, osteoarthritis, health determination has occurred at rapid speed since being vaccinated. Shortness of breath, unable to carry item with little weight feels like an elephant is sitting on my chest.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dyspnoea, General physical health deterioration, Osteoarthritis, Pain
Clinical narrative: Chronic runny nose, crippling arthritis, pain in joints, brain fog, memory loss, lack of motivation, growths appearing with pain on multiple locations, blurred vision, osteoarthritis, health determination has occurred at rapid speed since being vaccinated. Shortness of breath, unable to carry item with little weight feels like an elephant is sitting on my chest.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea, Skin mass, Vision blurred
Clinical narrative: Chronic runny nose, crippling arthritis, pain in joints, brain fog, memory loss, lack of motivation, growths appearing with pain on multiple locations, blurred vision, osteoarthritis, health determination has occurred at rapid speed since being vaccinated. Shortness of breath, unable to carry item with little weight feels like an elephant is sitting on my chest.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Patient submitted to receive her second dose a week after her first. This was flagged in our corporate system and I was notified to verify the patient's records to determine if she received the first dose. Upon investigation on state shots, it was determined the patient received 3 doses of hepA/hepB (twinrix) back in 2012 and 2013 to complete the series. The dose she recently received on 2/7/25 was a revaccination that the guidelines do not recommend at this time.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient experienced no adverse effects but received a second dose of vaccine when only one dose is required
Age: 62.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient had Boostrix and Prevnar 20 on 02/04/2025 on his left deltoid . Patient called and informed us that he had big redness and swelling on his arm since 02/05 and it spreading more each day, today after 7 days the redness is round 8  inches, some pain but  mostly redness and  itching around the area. We informed his MD. MD order  steroid medication for him to help with the symptoms. Patient picked up his medication on 02/11/25 and we advised patient to contact us or his MD within 3 days if the condition doesnt improve or get worse.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A TOTAL OF 4 SHINGRIX SHOTS (FIRST IN 2020 AT PHARMACY, SECOND, THIRD AND FOURTH AT DIFFERENT PHARMACY IN 2022, 2023 AND NOW 2025) PATIENT AND PRESCRIBER WERE NOTIFIED IMMEDIATELY AND THUS FAR PATIENT EXPERIENCING NO ILL-EFFECT (5 HOURS POST VACCINE)
Age: 21.0
Sex: F
Vaccine: JEV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT WAS ADMINISTERED AN ADDITIONAL DOSE OF JEV INSTEAD OF THE INTENDED VACCINE OF HPV. NO REACTIONS ACCURED
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles, Scar
Clinical narrative: Blisters in 2? by 1? area where varicella vaccine was given. Still a scare on his leg.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC15, RV5
Symptoms: Eye swelling
Clinical narrative: Left eye swelling when woke at 5 am the following morning, which resolved. Mother had photo of eye. Swelling resolved that day, no rash, no cough
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous report received from a health care professional concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced death. (Dose series 1). The patient died on June 2, 2024 after taking the shot. The action taken with janssen covid-19 vaccine was not applicable.  It was unknown if an autopsy was performed.  Reported cause of death was unknown cause of death.  The patient died on 02-Jun-2024.  This report was serious (death).; Sender's Comments: V0: janssen covid-19 vaccine  -Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Hypocalcaemia
Clinical narrative: Hypocalcemia; This serious case was reported by a other health professional via sales rep and described the occurrence of hypocalcemia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hypocalcemia (Verbatim: Hypocalcemia) (serious criteria hospitalization). The outcome of the hypocalcemia was resolved.   It was unknown if the reporter considered the hypocalcemia to be related to Shingrix.     The company considered the hypocalcemia to be unrelated to Shingrix.   Additional Information: GSK receipt date: 28-JAN-2025 Other HCP reported that patient was in hospital for Hypocalcemia from unknown date. Expiry Date of Shingrix were not known. Reporter did not know whether it was 1st or 2nd dose of Shingrix.; Sender's Comments: Hypocalcaemia  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: both shingles and the shingles vaccine can put you in hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization 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 hospitalization (Verbatim: both shingles and the shingles vaccine can put you in hospital) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that both shingles and the shingles vaccine can put you in the hospital. Patient said that he/she know from their experience, he/she took the 2 part vaccine as a preventative, also stated it was a big mistake. The follow-up could not be possible as no contact details were available.; Sender's Comments: Hospitalisation is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: You can't sit, you can't lie down; it hurts to even wear clothes.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased 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 mobility decreased (Verbatim: You can't sit, you can't lie down) and pain (Verbatim: it hurts to even wear clothes.). The outcome of the mobility decreased and pain were not reported.   It was unknown if the reporter considered the mobility decreased and pain to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient received Shingles vaccine and could not sit, could not lie down, it hurt to even wear clothes. This by far the worst vaccination patient ever had, however after seeing his/her mother, sister and husband live through this. There was no way patient would not keep up to date on vaccinations.
Age: 0.17
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; 2-month old patient, was suppose to get VAXELIS but she was administered FLUZONE (pf) instead with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was suppose to get diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Vaxelis] but she was administered fluzone (pf) instead with no reported adverse event and inappropriate age at vaccine administration after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Feb-2025, the patient received 0.5 mL of suspect influenza usp trival a-b subvirion no preservative vaccine, Suspension for injection (lot UT8419CA, expiry date 30-Jun-2025; strength standard)  via unknown route in unknown administration site for Immunization and Vaxelis not produced by Sanofi Pasteur (lot number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and 2-month old patient was suppose to get vaxelis but she was administered fluzone (pf) instead with no reported adverse event (wrong product administered),inappropriate age at vaccine administration (latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Hearing aid user, Tinnitus
Clinical narrative: loss of hearing; now have constant ringing in my ears; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss 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 hearing loss (Verbatim: loss of hearing) (serious criteria GSK medically significant) and ringing in ears (Verbatim: now have constant ringing in my ears). The outcome of the hearing loss and ringing in ears were not resolved.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingles vaccine.     The company considered the hearing loss to be unrelated to Shingles vaccine. It was unknown if the company considered the ringing in ears to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-FEB-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and had severe reactions and loss of hearing.  Now (at the time of reporting), the patient had constant ringing in his/her ears and require hearing aids.  The patient asked to review the side effects of the vaccine. Further patient said if he/she had known about the side effects he/she might have passed on the vaccine.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: RVX
Symptoms: Constipation, Pain
Clinical narrative: has not pooped in 16 hours and has screamed in pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of constipation in a female patient who received Rotavirus vaccine for prophylaxis.   On 31-MAY-2024, the patient received Rotavirus vaccine. On an unknown date, less than a day after receiving Rotavirus vaccine, the patient experienced constipation (Verbatim: has not pooped in 16 hours and has screamed in pain). The outcome of the constipation was not resolved.   The reporter considered the constipation to be related to Rotavirus vaccine.     The company considered the constipation to be related to Rotavirus vaccine.   Additional Information: GSK Receipt Date: 04-FEB-2025 This case was reported via interactive digital media. Severe cases of rotavirus were very rare, and the prior vaccine of Rotarix had complications with intestinal blockage that it was removed from the market and put back in a couple of years later. If your child got the virus, the biggest risk was dehydration.  The reporter's two cents this vaccine wasn't needed if they had access to medical care.  If they were out in rural areas, the reporter  would have had child get it.  The reporter had friends whose babies developed the very symptoms it was supposed to prevent.  The reporter chose to get it for the patient. The reporter were 50/50 on it knowing it was unnecessary but decided to do it because the side effects were pretty low and it contained no aluminum.  The patient has not pooped in 16 hours and had screamed in pain for the first time (we got it the day before) from constipation. The follow-up could not be possible as no contact details were available.