chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Biliary tract disorder, Biopsy bile duct abnormal
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, Blood lactate dehydrogenase increased, Cholangitis, Hepatic necrosis
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Hypertransaminasaemia, Liver injury
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Biopsy liver abnormal, Blood alkaline phosphatase increased
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Blood bilirubin increased, C-reactive protein normal, Exposure to communicable disease, Faeces discoloured, Jaundice
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Respiratory symptom, Serum ferritin increased
Clinical narrative: Pt noticed jaundice, clay colored stools ~2/09/23. Bilirubins up to 20s, hospitalized at Hospital /transferred to Medical Center. No pain, fevers. Liver biopsy showed autoimmune hepatitis
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Gout
Clinical narrative: inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places; Arthritis flare; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient received vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroid disorder.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare). At the time of the report, INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant and treatment medications were not reported. Company Comment This spontaneous case concerns a 61-years-old-male patient, with   medical history of  Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroid disorder who experienced the unexpected AESI of arthritis, the unexpected event of inflammation unknown days after 4th.  dose of  mRNA- 1273 bivalent vaccine. The medical history of osteoarthritis is a confounder for the events. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-713977 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713977:Dose 1 and Dose 2
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Arthritis, Condition aggravated, Inflammation
Clinical narrative: inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places; Arthritis flare; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient received vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroid disorder.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare). At the time of the report, INFLAMMATION (inflammatory problem going throughout his whole body (hand, wrists, leg, feet, elbow, and knee)/lot of inflammation in a lot of different places) and ARTHRITIS (Arthritis flare) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant and treatment medications were not reported. Company Comment This spontaneous case concerns a 61-years-old-male patient, with   medical history of  Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroid disorder who experienced the unexpected AESI of arthritis, the unexpected event of inflammation unknown days after 4th.  dose of  mRNA- 1273 bivalent vaccine. The medical history of osteoarthritis is a confounder for the events. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-713977 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713977:Dose 1 and Dose 2
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Caller was Pharmacist. Caller reported AE for Patient.   As confirmed by Caller at current call time, Patient who was administered 1st GARDASIL 9 Dose 'a year ago' for Corresponding 3 Dose GARDASIL 9 Series had not yet been administered Correspondi; No adverse event; This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  In February 2022 (reported as "a year ago"), 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) for prophylaxis (route, lot number and expiration date were not reported), for corresponding 3 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series. By the time of reporting, the patient had not yet been administered corresponding 2nd hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose.    No adverse events were reported.
Sex: F
Vaccine: PNC15, PNC15
Symptoms: Injury associated with device, Limb injury, Product physical issue, Skin laceration, Syringe issue
Clinical narrative: cutting the nurse; leaving glass scraps on her fingers; leaving glass scraps on her fingers; VAXNEUVANCE PFS appear super fragile and keep shattering; syringe found broken; This spontaneous report was received from a registered nurse via company representative concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023,  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W021510, expiration date: 08-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided); appeared super fragile and they had three different lot numbers that kept shattering (product physical issue). One pre-filled syringe was found broken in tray and it was unknown where it was broken or which lot number was affected. Additionally, it was reported that on the same date, the sixth pre-filled syringe broke (syringe issue) as one of the nurses was screwing on the needle, cutting the nurse (Skin laceration) and leaving glass scraps on her fingers (limb injury) (injury associated with device). Furthermore, it was reported that they had multiple syringes break while screwing the needles and taking them out of the box. The first one broke while taking it out of the box on 13-JAN-2023 and it was the very first one that was going to be used (Lot#: W021510). Second broke on 15-JAN-2023 while screwing on the needle, (same lot number W021510). The third one broke on 27-JAN-2023, as it was placed on the counter (Lot #: W021510). Fourth one broke on 02-FEB-2023, when a nurse screwed on the needle (Lot#: W027250). Fifth one broke on 03-FEB-2023 and it rolled onto the floor (Lot # W021510).  The outcome of the events of skin laceration, limb injury, and injury associated with device was not reported.   The causal relationship between the events of skin laceration, limb injury, and injury associated with device and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event reported; Nurse reports a patient was administered a third dose of GARDASIL 9 too soon on 22-FEB-2023.; The patient received first dose of Gardasil 9 on 18-DEC-2002 and second dose on 05-JAN-2023; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     The patient was vaccinated with a first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on 18-DEC-2022, 05-JAN-2023 and 22-FEB-2023 respectively,  lot # W028573 for dose 3, expire date 06-JAN-2025, for prophylaxis (dose, lot # for dose 1 and 2, expire date for dose 1 and 2 and route were not reported) (inappropriate schedule of product administration). No additional adverse event and nor product quality complain were reported.
Age: 0.5
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; Nurse explained she has a patient who went to another country in Nov 2022 and at the time was 6 months old. The patient received a dose of MMR II and VAQTA prior to going to Ethiopia.; This spontaneous report has been received from a nurse concerning to a 6-month-old patient of an unknown gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, (strength, route of administration were not provided lot number W006214 that was verified to be valid, expiration date reported and established as 04-MAR-2023); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, once ( lot number U039548 that was verified to be valid, expiration date reported and established as 14-DEC-2023) (strengths and routes of administration were not provided)  for prophylaxis, which was reconstituted with sterile diluent (dose, strength, route of administration and formulation were not reported ;lot number W017640 that was verified to be valid, expiration date: reorted and establisedh as 06-NOV-2024).  No additional adverse events (AEs) reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows.; This spontaneous report was received from a medical assistant concerning a male patient currently 12 years old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-AUG-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U028825, expiration date: 02-NOV-2023, administered as prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient developed complete hair loss on the body and scalp which includes facial hair, scalp hair, pubic hair, eye lashes and eye brows (Alopecia). At the time of reporting, the patient had not recovered from the event of alopecia. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was reported as discontinued.   The causal relationship between the event of alopecia and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 65.0
Sex: M
Vaccine: PNC15
Symptoms: Burning sensation
Clinical narrative: a burning sensation on their arms after the VAXNEUVANCE injection/ slight burning sensation few minutes/trival burning sensation; This spontaneous report has been received from a nurse referring refers to 65-year-old male patient. The information on the patient's concurrent conditions, concomitant therapies or pertinent medical history was not provided.  On 26-JAN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) a dose of 0.5 ml, administered intramuscularly (IM) in right deltoid, lot# W021512, expiration date 10-AUG-2023 for prophylaxis.  On 26-JAN-2023, the patient complained of a slight (also reported as trivial) burning sensation on his arm after the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection for few minutes. The event resolved within 10 minutes. There was no medication error.  The nurse reported that the event was attributable to the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA009692:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Their super painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included itchy rash, shingles, blister and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-MAR-2023 Reporter Comment: This case was reported by the patient via interactive digital media. The patient got them in 2002, started as a itchy rash, she/he called her/him mother to ask her what to put on it she said get you some aveeno oatmeal bath powder, that'll work so she/he did. The warm water did soothe and made it feel better however afterword about 30mins later, that rash turned into blisters that were extremely painful wearing a shirt to the hospital and driving myself a nightmare its noooo joke. Those shingles injections are worth it. The only drawback their super painful afterwards for about 2 weeks. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered/gave an expired Hep A vaccine; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 6th February 2023) for prophylaxis.   On 24th February 2023, the patient received Havrix. On 24th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The nurse (licensed vocational nurse) just gave an expired Hepatitis A vaccine (Havrix). The health care professional (HCP) had no details about patient. The reporter gave consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix given instead of Kinrix; Boostrix administered to 4 years-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, 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: 27-FEB-2023 Reporter's Comments: Office manager reported that a 4 years old patient, supposed to be receiving Kinrix as part of the 4th Dtap-IPV vaccination and received Boostrix by mistake. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The 4 years old patient received Boostrix instead of Kinrix by mistake, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 27-Feb-2023 Reporter's Comments: A certified medical assistant reported that a patient was erroneously given an expired dose of Havrix. Information found in medical information about vaccination and patient were disclosed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5Jan2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 5th January 2022, with batch number 53936 and expiry 1st April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The patient did not receive the 2nd dose yet. The reporter did not consent to follow-up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 28-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Havrix vaccine on 28th February 2023 which was expired on 16th February 2023. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 18Nov2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comments: The registered pharmacist (RPH) reported two patient had not yet received their second doses of Shingrix (second dose not yet given). The health care professional (HCP) unable to provide additional adverse event details at this time. The  HCP gives consent for safety team follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023032800, reported by same reporter.; Sender's Comments:  US-GSK-US2023032800:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 08Sep2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comments: The registered pharmacist (RPH) reported two patient had not yet received their second doses of Shingrix (second dose not yet given). The health care professional (HCP) unable to provide additional adverse event details at this time. The  HCP gave consent for safety team follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023032799, reported by same reporter.; Sender's Comments:  US-GSK-US2023032799:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Both doses in 2019-2020, recently shingles/ Suspected Vaccination failure; Shingles; Soreness in  arm; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain in arm. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)), steroids nos (Steroids) and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the vaccination failure and pain in arm were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comments: The reporter was the patient. The patient had received both doses of Shingrix in 2019 or in 2020. The patient recently came down with a case of Shingles. The reporter stated that after receiving Shingrix, he had a little bit of soreness in the arm that he received the shot.  The reporter was taking antibiotics (undefined), steroids, and a cream to treat the shingles.  Reporter gave consent to follow up with healthcare professional (pharmacy). The reporter had consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT LIKE SYMPTOMS; This spontaneous report received from a health care professional via other manufacturer (Moderna) concerned an adult patient of unspecified sex, age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072 expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced blood clot like symptoms (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot like symptoms was not reported. The patient additionally received booster dose of non-company vaccine included: Moderna covid-19 Vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 Vaccine (elasomeran) (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230314384-blood clot like symptoms. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 47-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment medication was reported.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided.  No treatment information was provided.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment medication was provided.   Reporter did not allow further contact
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Feb-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact