chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV5
Symptoms: Product preparation issue
Clinical narrative: Pentacel given on 10/11/24 was given only the DTAP-IPV component.  Missing the ActHIB component.  No reconstitution happened.  Waiting on State guidelines for next steps to ensure patient is fully vaccinated.  Upon hearing from the state our office will reach out to parent/guardian with next steps.
Age: 0.17
Sex: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: wrong diluent administered
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received low dose Flu vaccine by accident instead of 65+ dose.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-SEP-2024, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (1 dose, lot #Y003891 was valid, expiration date: 06-FEB-2026, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). Temperature excursion (TE) of 10.2 F for 1 hour and 30 minutes was reported. No previous TE . No other AE (No adverse event). No product quality complaint (PQC).  This is one of few reports from the same reporter.; Sender's Comments:  US-009507513-2410USA001590:MSD US-009507513-2410USA001407:MSD US-009507513-2410USA001596:MSD US-009507513-2410USA001583:MSD US-009507513-2410USA001624:MSD US-009507513-2410USA001630:MSD US-009507513-2410USA001312:MSD US-009507513-2410USA001318:MSD US-009507513-2410USA001454:MSD
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error; No AE; This spontaneous report was received from a nurse and refers to an 1-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (1st dose, lot #X026666 was valid for formulation pre-filled syringe, expiration date: 29-MAY-2025, administered intramuscularly in left thigh) for prophylaxis (Product storage error). Temperature excursion (TE) of 8.8 degree Celsius (C) for 4 minutes and 45 seconds was reported. No previous TE. No side effects reported (No adverse event). No additional information/clarification provided. No additional AE/no PQC. ; Sender's Comments:  US-009507513-2408USA009052:MSD
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to report that the patient has received an extra dose of VAQTA. No further information was provided. No additional AE/ no PQC.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-OCT-2024, the patient was vaccinated with an extra dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 31-OCT-2025, administered for prophylaxis (Extra dose administered) (strength, dose, dose number, lot #, and route of administration were not provided). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No Additional AE; TE where products were administered after stored improperly; This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 03-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), 0.5 milliliter, lot #Y012074, expiration date: 05-JAN-2026, administered for prophylaxis (anatomical location and route of administration were not provided) after being improperly stored (Product storage error). Details of temperature excursion were as follows: 0 hours 30 minutes 0 seconds -11.25 C (prior), 0 hours 30 minutes 0 seconds -11.63 C (prior), 0 hours 44 minutes 0 seconds -8.69 C (prior), 0 hours 36 minutes 0 seconds -9.63 C (prior), and 0 hours 44 minutes 0 seconds -8.25 C (current). No additional information were provided.; Sender's Comments:  US-009507513-2410USA003525:MSD US-009507513-2410USA003167: US-009507513-2410USA003188:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer reported patient administered GARDASIL 9 after product experienced a temperature excursion. TE filed: 02687250.  No symptoms reported. See related AE cases: 02687255, 02687306 and 02687307. Consent to correspond granted.  No additional AE/No; Customer reported patient administered GARDASIL 9 after product experienced a temperature excursion. TE filed: 02687250.  No symptoms reported. See related AE cases: 02687255, 02687306 and 02687307. Consent to correspond granted.  No additional AE/No; This spontaneous report was received from a nurse practitioner regarding a patient of unspecified age and gender. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 07-OCT-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #Y000205, expiration date: 23-SEP-2026, administered for prophylaxis (strength, and route of administration were not provided) that had gone through a temperature excursion at 31.7 F for 18 minutes (Product storage error). But no symptoms were reported. No additional adverse events or product quality complaints.  No previous excursions.   This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2410USA003745: US-009507513-2410USA004053: US-009507513-2410USA004100:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant calling to report inadvertently administering ROTATEQ vaccines after experiencing a temperature excursion. Products were supported. See TE case# 02687734 filed. Permission to contact HCP was granted. No additional information provid; no adverse event; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #2003174, expiration date: 14-SEP-2025, administered orally for prophylaxis (strength, dose were not not provided). The vaccine was inadvertently administered after experiencing a temperature excursion. (temperature 10.3C  for 2 Hours 14 Minutes 0 Seconds)(incorrect product storage). There was no previous temperature excursion. No additional adverse event reported (no adverse event).; Sender's Comments:  US-009507513-2410USA004231:MSD US-009507513-2410USA004327:MSD
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant calling to report inadvertently administering ROTATEQ vaccines after experiencing a temperature excursion.; No additional AE/PQC reported; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender.  The patient's medical history, previous drug allergies or reactions, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #2003138, expiration date: 29-APR-2025, valid per internal review), administered for prophylaxis (strength, and route of administration were not provided) vaccine that was exposed to a temperature excursion of 10.3 Celsius degrees for 2 hours and 0 seconds (Product storage error). No adverse events were provided.  This is one of 3 reports from  the same reporter.; Sender's Comments:  US-009507513-2410USA004327:MSD US-009507513-2410USA004047:MSD
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Smear cervix abnormal
Clinical narrative: abnormal pap smears; patient received GARDASIL 9 four times; second dose in 2017, and third and fourth doses in 2022  / an alternate dosing schedule; first dose in 2014, second dose in 2017 / an alternate dosing schedule; This spontaneous report was received from Physician and refers to a 25-year-old female.  The patient's medical history, previous drug allergies or reactions and current conditions and concomitant therapies were not reported.  On an unspecified date in 2014, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On an unspecified date in 2017, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). On an unspecified date in 2022, she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration) and also on an unspecified date in 2022, she was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (extra dose administered).  On an unknown date, the patient experienced abnormal pap smears but no further information regarding on what was specifically abnormal (Smear cervix abnormal ).  The causal relationship between abnormal pap smears and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: RVX
Symptoms: Cough, Nasopharyngitis, Pyrexia
Clinical narrative: Have severe cold; Low grade fever; cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cold (Verbatim: Have severe cold), low grade fever (Verbatim: Low grade fever) and cough (Verbatim: cough). The outcome of the cold and low grade fever were not reported and the outcome of the cough was not resolved.   It was unknown if the reporter considered the cold, low grade fever and cough to be related to RSV vaccine.     It was unknown if the company considered the cold, low grade fever and cough to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 02-OCT-2024 This case was reported by a patient via interactive digital media. The patient received the RSV vaccine shot a few weeks ago and has severe cold with low grade fever and continued cough going on 10 days.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This serious case was reported by a consumer via other manufacturer and described the occurrence of anaphylaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anaphylaxis. Previously administered products included Covid-19 vaccine (took 2 doses of Pfizer Covid 19 vaccine (unclear it was Comirnaty and/or Pfizer-BioNTech Covid-19 vaccine 2024-2025 formula) and had limited reaction that came out) and Covid-19 vaccine with an associated reaction of no adverse event (received 3rd dose of Pfizer Covid 19 vaccine last year (unclear it was Comirnaty and/or Pfizer-BioNTech Covid-19 vaccine 2024-2025 formula) and had did not have reaction). Concurrent medical conditions included autoimmune disorder (had autoimmune and took Epi-pen), asthma (has a Asthma type 2) and latex allergy (had type 1 latex allergy and natural rubber latex allergy). Concomitant products included cetirizine hydrochloride (Zyrtec).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: anaphylaxis) (serious criteria GSK medically significant). The outcome of the anaphylaxis was not reported.   The reporter considered the anaphylaxis to be related to Shingrix.     The company considered the anaphylaxis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient self-reported this case. She had a reaction but a limited reaction for the first two Pfizer covid 19 vaccines that came out. 7 years ago, the patient took one pill, after taking it she got several blocks away and she went into anaphylaxis, nothing related to GlaxoSmithKline. The patient was on steroids, pepcid and cetirizine, it's like zyrtec. The reporter said it was same medication, but a different manufacturer. The patient said 6 percent of the population had latex allergy it was not a small amount. She had type 1 and immune disorder and asked that she should have covid 19 vaccine and the flu vaccine together. The patient received the Shingrix vaccine, and she got into anaphylaxis this one had a reconstituting liquid, that caused her to go into anaphylaxis it was not the Shingrix itself. Not just the rubber stopper, also the liquid in it or on it. She stated that the GlaxoSmithKline showing did not dilute this and no contamination during reconstituting it was the reconstitution product that caused the reaction with her Shingrix.; Sender's Comments: Anaphylactic reaction is a listed event which, due to the following criteria (past medical history included anaphylaxis) is considered unrelated to GSK vaccine Shingrix.
Sex: M
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 male 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 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: 09-OCT-2024 This case was reported by a patient's wife via interactive digital media. The patent's wife reported that vaccine did not work for the patient . This case was considered as suspected vaccination failure since the details regarding completion of  primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case had been link with US2021AMR203558, reported by the same reporter for herself.; 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. US-GLAXOSMITHKLINE-US2021AMR203558:for female patient
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient was administered pediarix rather than kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9P329, expiry date 06-MAR-2026) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Infanrix (Infanrix was given as the first dose as the DTaP series) and DTaP.   On 29-JUL-2024, the patient received the 5th dose of Pediarix (intramuscular). On an unknown date, the patient received Kinrix. On 29-JUL-2024, an unknown time after receiving Pediarix and not applicable after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Patient was administered pediarix rather than kinrix). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Follow up information received on 17-SEP-2024 The nurse reported that the patient was administered Pediarix rather than Kinrix which led to wrong vaccine administered. Summary of changes: General tab, patient details, event details and narrative were updated.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration, Underdose
Clinical narrative: adult patient received the paediatric dose of Engerix b; adult patient received the paediatric dose of Engerix b; Expired vaccine used; Hepatitis B vaccines on May 1st 2000, August 2nd 2000, January 11th 2002; Hepatitis B vaccines on May 1st 2000, August 2nd 2000; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a infant female patient who received HBV (Engerix B pediatric) (batch number NT9X3, expiry date 09-SEP-2024) and (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis b (received 1st dose on 01-MAY-2000). Concomitant products included Hepatitis b vaccine (Hepatitis b).   On 20-SEP-2024, the patient received Engerix B pediatric .5 ml. On 11-JAN-2002, the patient received the 3rd dose of Hepatitis B vaccine. On 02-AUG-2000, the patient received the 2nd dose of Hepatitis B vaccine. On 02-AUG-2000, not applicable after receiving Engerix B pediatric and Hepatitis B vaccine and an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: Hepatitis B vaccines on May 1st 2000, August 2nd 2000). On 11-JAN-2002, the patient experienced drug dose administration interval too long (Verbatim: Hepatitis B vaccines on May 1st 2000, August 2nd 2000, January 11th 2002). On 20-SEP-2024, the patient experienced underdose (Verbatim: adult patient received the paediatric dose of Engerix b), adult use of a child product (Verbatim: adult patient received the paediatric dose of Engerix b) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the drug dose administration interval too long, drug dose administration interval too long, underdose, adult use of a child product and expired vaccine used were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2024 The clinical manager explained that they gave a pediatric dose (0.5 milliliters) to a 24 year old patient today (on the day of reporting), which led to underdose and adult use of a child product. The patient received prior Hepatitis B vaccines, the interval for 2nd and 3rd vaccines was more than the recommended time interval, which led to lengthening of the vaccination schedule. On 23-AUG-2024, the patient received Hepatitis B vaccine. The reporter did not had brand name, lot number or expiration date for the first 3 doses of Hepatitis B vaccines which were received in 2000 and 2002.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Erythema, Pain, Rash
Clinical narrative: dealing with pain; elbow hurts; redness on my arm; had rash on both arms (no itching); This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 23-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included pain in arm and shoulder pain. Concurrent medical conditions included migraine.   On 30-SEP-2024, the patient received Influenza vaccine (intramuscular, right arm). On 30-SEP-2024, less than a day after receiving Influenza vaccine, the patient experienced rash (Verbatim: had rash on both arms (no itching)). On an unknown date, the patient experienced pain (Verbatim: dealing with pain), pain in elbow (Verbatim: elbow hurts) and erythema of extremities (Verbatim: redness on my arm). The outcome of the rash was not resolved and the outcome of the pain and pain in elbow were not reported and the outcome of the erythema of extremities was resolved.   It was unknown if the reporter considered the rash, pain, pain in elbow and erythema of extremities to be related to Influenza vaccine.     It was unknown if the company considered the rash, pain, pain in elbow and erythema of extremities to be related to Influenza vaccine.   Additional Information: GSK Receipt Date: 30-SEP-2024 and 01-OCT-2024 The patient had GlaxoSmithKline (GSK) flu vaccine and patient had rash on both arms (no itching) The vaccine administration facility was the same as primary reporter. The patient had an allergic reaction yesterday (at the day of reporting) to a flu shot, but the redness on him arms and went away. The patient said his arm and shoulder was already hurting before he/she had a flu shot should had never used his right arm but he/she was dealing with pain which might be associated with my migraines. The patient said his elbow hurts right now. The reporter said did not know how migraines are associated with other body parts on a restriction for ibuprofen. The reporter said he/she cant had it more than 2 times a week due to rebound migraines he/she use topical analgesics like Bio Freeze and if pain worsens his migraine situation makes them feel worse.
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product use issue
Clinical narrative: the administration of Arexvy in a pregnant woman; administration of Arexvy in a pregnant woman; administration of Arexvy in a pregnant woman who gave birth; This non-serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: the administration of Arexvy in a pregnant woman), product use in unapproved population (Verbatim: administration of Arexvy in a pregnant woman) and live birth (Verbatim: administration of Arexvy in a pregnant woman who gave birth). The outcome of the vaccine exposure during pregnancy, product use in unapproved population and live birth were not applicable.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacy assistant contact GlaxoSmithKline requesting information about the administration of Arexvy in a pregnant woman (patient) who gave birth, which led to, vaccine exposure during pregnancy and product use in unapproved population. Less than a year after received Arexvy, the patient experienced live birth. The reporter wanted to know if the newborn had to be revaccinated. The vaccine administration facility was the same as primary reporter.  No more information was provided.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose was given early or in less than recommended interval; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received MMR (Priorix) (batch number 4ZC23) for prophylaxis.   Concomitant products included Priorix.   On 24-SEP-2024, the patient received the 2nd dose of Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced drug dose administration interval too short (Verbatim: The second dose was given early or in less than recommended interval). The outcome of the drug dose administration interval too short was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2024 The physician reported that the patient received the 2nd dose early or in less than recommended interval which led to shortening of vaccinations schedule. The patient received 1st dose on 3rd September 2024. The vaccine was given by a nurse practitioner who stated it was given early for international travel based on CDC guidelines.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: pateint did not recive 2nd dose yet/received 1st dose of Twinrix vaccine in 2022 or 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix vaccine in 2022 or 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: pateint did not recive 2nd dose yet/received 1st dose of Twinrix vaccine in 2022 or 2023). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-OCT-2024 The reporter reported that the patient had received at least one Twinrix vaccine, unsure of exact time of dose of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter stated that patient records were not complete in their database, the lot number, expiration date and administration dates for Twinrix vaccine were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: eye swollen; her eye was itching; shingles next to her eye; diagnosed with shingles next to her eye and on the top of her head; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Shingrix (intramuscular) and RSV vaccine. On 02-SEP-2024, an unknown time after receiving Shingrix and RSV vaccine, the patient experienced eye pruritus (Verbatim: her eye was itching). On 03-SEP-2024, the patient experienced eye swelling (Verbatim: eye swollen). In SEP-2024, the patient experienced ophthalmic herpes zoster (Verbatim: shingles next to her eye) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles next to her eye and on the top of her head). The outcome of the ophthalmic herpes zoster and shingles were not resolved and the outcome of the eye pruritus and eye swelling were not reported.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, eye pruritus and eye swelling to be related to Shingrix and RSV vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingrix and RSV vaccine. It was unknown if the company considered the shingles, eye pruritus and eye swelling to be related to Shingrix and RSV vaccine.   Additional Information: GSK receipt date: 08-OCT-2024 The patient reported that she received two vaccinations approximately 3 weeks ago. She described them as she thinks on of them was for shingles, and the other was for that RSV vaccine. The reporter did not know what manufacturer's RSV vaccine it was. She stated that her eye was itching and was swollen. Then she visited her doctor on 07th September 2024 and was diagnosed with shingles next to her eye and on the top of her head. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK  vaccine Shingrix and RSV vaccine.
Sex: F
Vaccine: RVX
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This serious case was reported by a physician via call center representative and described the occurrence of cardiac arrest in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 2 weeks after receiving RSV vaccine, the patient experienced cardiac arrest (Verbatim: Cardiac arrest) (serious criteria GSK medically significant). The outcome of the cardiac arrest was unknown.   It was unknown if the reporter considered the cardiac arrest to be related to RSV vaccine.     The company considered the cardiac arrest to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-OCT-2024 The physician had a patient who went into cardiac arrest two weeks after her RSV vaccination, reporter was unsure if patient received Arexvy but reporter would like to know if cardiac pulmonary risks were associated with post vaccination of Arexvy.; Sender's Comments: Cardiac arrest  is an unlisted event which is considered unrelated to GSK  vaccine RSV vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: experiencing symptoms of a shingle's rash; rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-SEP-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: experiencing symptoms of a shingle's rash) and rash (Verbatim: rash). The outcome of the shingles and rash were not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK receipt date: 09-OCT-2024 The reporter reported that patient had received 1st dose of Shingrix vaccine and about the timing of Shingrix 2nd dose administration patient was still experiencing symptoms of a shingle's rash. At the time of the call the patient did not received 2nd dose of Shingrix. The reporter reported that the patient did not had immunocompromised conditions.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little bit of sore arm) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingles Vaccine (First Dose) on 31-Jan-2022 and Shingles Vaccine (Second Dose) on 27-Apr-2022. Past adverse reactions to the above products included No adverse effect with Shingles Vaccine and Shingles Vaccine. Concomitant products included Celecoxib (Celexal) and Pantoprazole sodium sesquihydrate (Protonix) for an unknown indication.    On 24-Jan-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of sore arm). The patient was treated with Ibuprofen (Advil) at a dose of when needed. At the time of the report, PAIN IN EXTREMITY (little bit of sore arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the first four or five that she had just breezed right through/ whizzed through that with no problem at all, just a little bit of a sore arm. which did not bother her. The patient insisted that for those vaccines, she did not have any problems except the sore arm.   This case was linked to MOD-2024-774810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live non-significant follow-up received included reference numbers added. On 08-Oct-2024: Live significant follow-up received included narrative updated. On 08-Oct-2024: Live non-significant follow-up received included reference numbers added.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Lacunar stroke
Clinical narrative: stroke/lacunar infarct stroke; COVID twice; This spontaneous case was reported by a patient and describes the occurrence of LACUNAR STROKE (stroke/lacunar infarct stroke) in an 85-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    The patient's past medical history included COVID-19.   On 04-Oct-2022, the patient received fourth dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2022, the patient experienced LACUNAR STROKE (stroke/lacunar infarct stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COVID-19 (COVID twice). At the time of the report, LACUNAR STROKE (stroke/lacunar infarct stroke) had resolved with sequelae and COVID-19 (COVID twice) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.; Reporter's Comments: The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fatigue, Vaccination site swelling
Clinical narrative: anaphylactic reaction/difficulty breathing/severe allergic reaction; Vaccination site swelling; fatigue; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction/difficulty breathing/severe allergic reaction) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction/difficulty breathing/severe allergic reaction) (seriousness criterion medically significant), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction/difficulty breathing/severe allergic reaction), VACCINATION SITE SWELLING (Vaccination site swelling) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient had anaphylactic reaction that was not real. That was really not good reaction. Patient meant, she understood fatigue and she understood swelling of the injection site. But it was also reported that when tongue started swelling, she had difficulty breathing. Patient had an interaction of an anesthesia to the updated Spikevax 2024-2025 vaccine because patient will be having a surgery on 21-OCT-2024 and patient need anesthesia.  Patient also asked for additional medicines like Synthroid and Atorvastatin. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774963 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of SPIKEVAX 2024-2025 KP.2 PFS vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774963:same patient with different product
Age: 77.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: patient that received a dose of Bexsero and a dose of Menveo in 28/Jun/2024 hadn't received the 2nd dose of neither of the vaccines yet; Inappropriate age.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On 28-JUN-2024, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On an unknown date, the patient did not receive the 2nd dose of Bexsero. On 28-JUN-2024, an unknown time after receiving Bexsero and Menveo and not applicable after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age.). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: patient that received a dose of Bexsero and a dose of Menveo in 28/Jun/2024 hadn't received the 2nd dose of neither of the vaccines yet). The outcome of the incomplete course of vaccination 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: 24-SEP-2024 A pharmacist called to inform that a patient that received a dose of Bexsero and a dose of Menveo in 28/Jun/2024 hadn't received the 2nd dose of neither of the vaccines yet, which led to incomplete course of vaccination. The 77 year old patient received Bexsero and Menveo, which led to inappropriate age at vaccine administration. Also, reporter mentioned that the patient was on the complement inhibitor Ultomiris. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210489:SAME REPORTER
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. Clinical course: A female caller previously administered with Pfizer covid-19 vaccine had experienced myocarditis after previous booster vaccination. Now, she was hesitant of the new vaccine. As she was asking the likelihood of occurrence of developing myocarditis. Needless to say, it affected her heart function that's why she was hesitant of getting the vaccine. Her last vaccination was last year and she already had 4 doses of Pfizer COVID vaccine. When referred to her HCP, she added the information that she already talked to her primary care physician and cardiologist. However, they would like to know the likelihood of myocarditis recurrence to make an informed decision since there was only minimum amount of information available to public.  Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy palms and soles of feet; slight rash on wrists and tops of feet; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Oct2024 at 09:30 as dose 1, single (Lot number: LM2212) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN.  The following information was reported: PRURITUS (non-serious) with onset 10Oct2024 at 07:00, outcome "not recovered", described as "Itchy palms and soles of feet"; RASH (non-serious) with onset 10Oct2024 at 07:00, outcome "not recovered", described as "slight rash on wrists and tops of feet". Therapeutic measures were taken as a result of pruritus, rash.  Additional information: Vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines on the same date as the suspect vaccine. Patient did not receive any other vaccines within 4 weeks prior to the suspect vaccine. Patient was taking other medications within 2 weeks of the event starting. Patient received Benadryl as suggested by pharmacist for the adverse event.  No follow-up attempts are possible.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 10Oct2024, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea. Additional information: The patient received the vaccine at about 1:15 to 1:30. She has not taken any medication for the diarrhea because she did not know if it would mix since she just took the shot.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Neoplasm malignant
Clinical narrative: stage IV of cancer as a result of receiving the Pfizer vaccinations.; health is declining; 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "stage IV of cancer as a result of receiving the Pfizer vaccinations."; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "health is declining". Clinical details: The customer stated that her husband's health is declining and that he now has stage IV of cancer as a result of receiving the Pfizer vaccinations. The reporter considered event as caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400131856 same product, reporter, different events and patient.;US-PFIZER INC-PV202400131857 same product, reporter, different events and patient.;US-PFIZER INC-PV202400131858 same product, reporter, different events and patient.;US-PFIZER INC-PV202400131859 same product, reporter, different events and patient.;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A 40-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Additional information: The patient reported she did not have a reaction to either of the shots last year when she had them done on the same day, except for a sore arm.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did not work; did not work; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NUS2024US165813_OS.  A 70-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did not work". The regular Covid vaccines which patient was taking religiously did not work.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.