chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took shingrix, still got herpes zoster/Suspected vaccination failure; severe herpes zoster; This case was reported by a physician via other manufacturer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included upadacitinib (Rinvoq) tablet for rheumatoid arthritis.   The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Rinvoq (oral) 15 mg once daily (15 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant and other: other medically important cond) and herpes zoster (serious criteria other: other medically important cond). The action taken with Rinvoq was unknown. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix vaccine for shingles but still got very severe herpes zoster with Rinvoq. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Rinvoq. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient got vaccinated and 4 to 6 weeks later had shingles. The reporter stated that, the vaccine was not safe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had multiple outbreak of shingles, first as a teenager in the 1950's).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had an outbreak of shingles a total of 8 times, the first as a teenager in the 1950's diagnosed by their family doctor. The patient was told that it was an impossibility to have it as a teenager. The patient had both shots and had an outbreak after each shot. At the time of reporting, the patient was 80 years old and the patient was going through an outbreak. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling bad and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, feeling bad and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, feeling bad and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient got a Shingles shot after the first shingles occurrence and experienced shingles second time. They felt like being burned with fire and stabbed with a knife at the same time. Second shingles occurrence was much less severe and did not lasted as long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she felt like he/she was dying with their 1st shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Fully vaccinated, have a shingles outbreak/Suspected vaccination failure; Have a shingles outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had been fully vaccinated with Shingrix vaccine but had shingles outbreak. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Given only the grey vial; Given only the grey vial; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The age at vaccination was not reported. The patient received only the grey vial of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: my arm is sore; feeling little sick; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.  Additional details were provided are as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine day before vaccination and his/her arm was sore and feeling little sick. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness; Swelling; Redness; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, swelling and erythema. On an unknown date, the outcome of the pain, swelling and erythema were unknown.   It was unknown if the reporter considered the pain, swelling and erythema to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and it was the first one to give soreness, swelling and redness. The patient also reported that it had put a big hole in his/her pocketbook. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: sores; This case was reported by a consumer via interactive digital media and described the occurrence of skin ulcer in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin ulcer. On an unknown date, the outcome of the skin ulcer was unknown.   The reporter considered the skin ulcer to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and it caused him/ her to get like sores. The patient would like to question the vaccine. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: still feel lousy / feel bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient experienced very mild case of shingles 3 or 4 years ago from reporting date).   On 9th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine 2 days ago from reporting date and still feel lousy. The patient stated that she did not want to imagine what a bad shingles case would feel like. Gladly feel bad for a couple days to hopefully never get it again. The follow-up would not possible as no contact details were available. The case had been linked to US2021AMR254583, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254583:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: still feel lousy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient's wife had a very mild case of shingles 3 or 4 years ago from reporting date).   On 9th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got his 2nd shot of Shingles vaccine two days ago from reporting date and he still feeling lousy.  The follow up would not possible as no contact details were available. The case had been linked to US2021AMR254580, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254580:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: under the weather; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the first Shingles shot was not too bad, was fairly under the weather for a week. The second shot was needed before 6 months. The patient enquired if the shots must be working. The follow-up would not possible as no contact details were available. This case was linked with US2021AMR254592, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254592:Same reporter, same product, same patient, case for different dose
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had the shingles shots / shingles in eye/s uspected vaccination failure; shingles in eye / excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and still got shingles in the eye. It was excruciating even with antiviral and antibiotic. The patient stated that he/she thought that the shots prevented shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received an expired dose of Shingrix. The follow-up could not be possible as no contact details were available.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 37-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis. Concurrent medical conditions included breast feeding (had been breastfeeding for 5 months). On 9th December 2021, the patient received Shingrix. On 9th December 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional details were provided as follows: Health care professional(HCP) reported a 37 year old breastfeeding woman received the Shingrix inadvertently instead of a varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. No reactions reported. HCP mentioned that she had been breastfeeding for 5 months. The consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: got half a dose; medication spill outside the body; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4r9r, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental underdose and syringe leak. On an unknown date, the outcome of the accidental underdose and syringe leak 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 details were provided as follows: The child patient only got half a dose of Pediarix vaccine before they accidently hit the syringe and the rest of medication spill outside the body, which led to accidental underdose and syringe leak. Interpretation of "outside the body" was outside the body of the syringe. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX) and oxycodone. On 30th October 2021, the patient received the 2nd dose of Shingrix. On 30th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced stomach pain and headache. The patient was treated with prednisone. On an unknown date, the outcome of the stomach pain and headache were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the stomach pain and headache to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix and had been experiencing headaches, and severe stomach aches. The patient received the dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient had an electronic visit for his (primary care physician) PCP on 8th December 2021, as a result and was prescribed prednisone. The reporter did not consent to follow-up. The reporter did not consent to health care professional contact, but did consent to personal contact.; Sender's Comments: US-GLAXOSMITHKLINE US2021AMR253640:same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose less than one month interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number D49FM, expiry date unknown) for prophylaxis.   The patient's past medical history included hepatitis b (might have Hepatitis B infection, but was not sure as there was no other information or medication details on the record). Previously administered products included Shingrix (received 1st dose on 7th October 2021, batch number B4Z44, expiry date 27th December 2023).   On 20th October 2021, the patient received the 2nd dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Adult failure to thrive
Clinical narrative: was administered a pediatric dose of Engerix-B inadvertently; was administered a pediatric dose of Engerix-B inadvertently; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 24-year-old male patient who received HBV (Engerix B pediatric) (batch number 25N39, expiry date 16th March 2024) for prophylaxis.   On 10th December 2021, the patient received the 2nd dose of Engerix B pediatric. On 10th December 2021, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient inadvertently administered a pediatric dose of Engerix B, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to the pandemic, hasn't received her second dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 or early 2020). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, due to the pandemic, the patient did not receive 2nd dose of Shingrix, which led to social problem . The reporter did not consent to follow up. This case was linked with case US2021254883, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254883:same reporter, other patient
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: has not received the second dose yet due to the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019 or in early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, due to the pandemic, the patient did not receive 2nd dose of Shingrix, which led to social problem . The reporter did not consent to follow up. This case was linked with case US2021254878, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254878:same reporter, other patient
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 month old patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The practice manager reported that, the patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. Note:In narrative the patient age was reported as 15 months, however it get autocaptured as per date of birth and vaccination date, hence captured as autocalculated.
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th December 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th December 2021, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/ not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Bexsero in her arm and had immediate pain in that arm. The reporter suspected that injection was given too high up the arm, which led to vaccine administered at inappropriate site. The pain was continued. Limited details were available. The reporter consented to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th March 2020 in left deltoid(0.5 ml, intramuscular), batch number K9R97, expiry date 15th November 2021). On an unknown date, the patient received 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 details were provided as follows: The reporter was the patient. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called to ask about the efficacy of getting the second dose later then 6 months past the second dose and if should get the second dose. The reporter did not consent to follow up. This case was linked with case US2021254899, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021254899:same reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first shingrix vaccine 8/8/2018 / has not yet received the second dose; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 8th August 2018, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The patient had shingles since getting the first vaccine of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021254895, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254895:same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   On 14th December 2021, the patient received Engerix B. On 14th December 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The medical assistant reported that on the day of reporting, patient received dose of Engerix-B that was already got expired, which led to expired vaccine used. The Health care professional (HCP) did not had any information on adverse events details.  The Health care professional gave consent for safety team to follow up. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered at inappropriate site
Clinical narrative: This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: muscle mass on arms or thighs. The patient experienced severe reactions in arm when treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine given into gluteal muscle, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given into gluteal muscle and off label use was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hot flush, Nervousness, Pain
Clinical narrative: THROMBOCYTOPENIA; ACHE ALL OVER; HOT FLASHES EXACERBATED; NERVOUSNESS; JUST FELT SICK LIKE GOING TO HAVE A VIRUS; FATIGUE; This spontaneous report received from a patient concerned a 65 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ITP (Immune thrombocytopenia), penicillin allergy, hypoglycemia, and Hashimoto's disease. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number, expiry: UNKNOWN) dose was not reported, dose number in series was 1, administered on 07-APR-2021 to left arm for prophylactic vaccination.  On an unspecified date after vaccinated with covid-19 vaccine ad26.cov2.s, the patient was little sick for 6 to 7 days (fatigue, low grade aching and low grade chills) (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, (dose number in series was 2), administered on 22-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination, for about 15 days, the patient had experienced fatigue, ache all over and had exacerbated hot flashes. The patient stated that she felt sick like she was just going to have a virus. She On 23-NOV-2021, the blood platelet fell from 74 (when she got the booster that is on 22-OCT-2021) to 34. 8 days later, on 03-DEC-2021, they dropped 4 more points to 30. She had thrombocytopenia. All side effects after booster mostly recovered but the platelets are still dropping and the nervousness is still present. The patient stated that nervousness is possibly platelets related. She also said that she will follow up with her primary care doctor.  Laboratory data included: Platelet count (NR: not provided) 74. On 23-NOV-2021, Laboratory data included: Platelet count (NR: not provided) 34. On 03-DEC-2021, Laboratory data included: Platelet count (NR: not provided) 30. (dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, hot flashes exacerbated, and just felt sick like going to have a virus, and had not recovered from thrombocytopenia, and nervousness. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211215290.(dose number in series was 1 case).  .; Sender's Comments: V0-20211214362- covid-19 vaccine ad26.cov2.s-Thrombocytopenia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia
Clinical narrative: THROMBOCYTOPENIA; ACHE ALL OVER; HOT FLASHES EXACERBATED; NERVOUSNESS; JUST FELT SICK LIKE GOING TO HAVE A VIRUS; FATIGUE; This spontaneous report received from a patient concerned a 65 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ITP (Immune thrombocytopenia), penicillin allergy, hypoglycemia, and Hashimoto's disease. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number, expiry: UNKNOWN) dose was not reported, dose number in series was 1, administered on 07-APR-2021 to left arm for prophylactic vaccination.  On an unspecified date after vaccinated with covid-19 vaccine ad26.cov2.s, the patient was little sick for 6 to 7 days (fatigue, low grade aching and low grade chills) (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, (dose number in series was 2), administered on 22-OCT-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After vaccination, for about 15 days, the patient had experienced fatigue, ache all over and had exacerbated hot flashes. The patient stated that she felt sick like she was just going to have a virus. She On 23-NOV-2021, the blood platelet fell from 74 (when she got the booster that is on 22-OCT-2021) to 34. 8 days later, on 03-DEC-2021, they dropped 4 more points to 30. She had thrombocytopenia. All side effects after booster mostly recovered but the platelets are still dropping and the nervousness is still present. The patient stated that nervousness is possibly platelets related. She also said that she will follow up with her primary care doctor.  Laboratory data included: Platelet count (NR: not provided) 74. On 23-NOV-2021, Laboratory data included: Platelet count (NR: not provided) 34. On 03-DEC-2021, Laboratory data included: Platelet count (NR: not provided) 30. (dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, hot flashes exacerbated, and just felt sick like going to have a virus, and had not recovered from thrombocytopenia, and nervousness. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211215290.(dose number in series was 1 case).  .; Sender's Comments: V0-20211214362- covid-19 vaccine ad26.cov2.s-Thrombocytopenia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 40 year old female. Initial information was processed along with the additional information received on 08-DEC-2021 and 10-DEC-2021. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no significant medical history. Patient always wore a mask, prior to and after vaccination whenever left the house. On 23-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 23-AUG-2021) dose was not reported, 1 total, administered to left arm for prophylactic vaccination (dose number in series: 1). Concomitant medications for unknown indication included ascorbic acid, multivitamin [vitamin NOS], and zinc.  On 26-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A and expiry: Unknown) dose was not reported, 1 total, dose number in series: 2, administered to left arm for prophylactic vaccination. On 27-NOV-2021, the patient experienced body pains. (Subsumed under confirmed COVID-19 infection event) On 28-NOV-2021, she experienced cough. (Subsumed under confirmed COVID-19 infection event) On 29-NOV-2021, the patient lost sense of smell. (Subsumed under confirmed COVID-19 infection event) On 30-NOV-2021, PCR test was performed which showed positive for covid-19 (coded as Confirmed COVID-19 Infection and Confirmed Clinical Vaccination Failure) (dose number in series 2). The reporter noted that the lab had called the patient to report positive covid-19. They also mentioned in report detected antibodies (Ab). Laboratory data included: COVID-19 PCR test was positive. On 01-DEC-2021, a second PCR lab test was performed to verify the results, which also produced a positive covid-19 result. Laboratory data included: COVID-19 PCR test was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205874. Confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. This case, involving the same patient is linked to 20211217766.; Sender's Comments: V0:20211217118-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Stress
Clinical narrative: SHOT WAS STRESS; POUNDING HEART/ THREE EPISODES OF HEART PALPITATION; This spontaneous report received from a parent concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included: congestive heart failure, and other pre-existing medical conditions included: Patient wears an implanted heart rate monitor to record heart rate. The patient reported that the symptoms of heart palpitations were still ongoing due to existing congestive heart failure, but the frequency of episodes is now similar to what it was prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metoprolol for congestive heart failure, hydrochlorothiazide for drug used for unknown indication, and venlafaxine for drug used for unknown indication. On 03-AUG-2021, the patient experienced pounding heart/ three episodes of heart palpitation. On an unspecified date, the patient experienced shot was stress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pounding heart/ three episodes of heart palpitation, and the outcome of shot was stress was not reported. This report was non-serious.