chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: two doses of Shingrix in 2017, diagnosis of shingles November 2021/ suspected Vaccination failure; diagnoses of shingles, November 2021; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1st outbreak refer link case US2021246376). Previously administered products included Zostavax (received one dose in 2012).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In November 2021, more than 2 years 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 age at vaccination was not reported. The patient received two doses of Shingrix in 2017 and the patient had diagnosed shingles. No further details provided. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021246376:1st outbreak
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Had the shingles vaccine, got shingles/suspected vaccination failure; shingles in eye; shingles in ear; shingles. Scalp, ear and down left side.; This case was reported by a consumer via (Facebook) 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), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine and got shingles on scalp, eye, ear and down left side.  The patient said still glad, as he/she got the shot, might had been worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: can feel pain a Little; 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. The patient was treated with calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain 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 dose of Shingles vaccine and still felt little pain but no rash. The patient stated that he/she used a lot of calaming lotion it helped. The follow-up would not possible as no contact details were available.; Sender's Comments: still can feel pain a Little but no rash
Sex: U
Vaccine: VARZOS, 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got shingles. The patient got vaccinated and was told a month after the second shot the patient had a mild case of shingles. The patient stated that the vaccine did not solve the problem. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them / mild case; painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that, he/she had shingles after getting the Shingles shot. The patient said it was a mild case because of the shot.  The patient said, he/she did not ever want a bad case. It was soo painful. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer  interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingles vaccine.  The case was reported by the patient. The age at vaccination was not reported. The patient had chicken pox really bad as a child, so the patient was at risk. The patient just got 1st of 2 shingles vaccine. The injection really hurt and arm was very sore for a couple of days, well worth it if he/she could avoid the pain. The reporter said a good friend of his/her had shingles and was still fighting it several months later, the patient's friend was going through physically exhausted physically restless. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, 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), shingles, pain in arm and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain in arm and rash were unknown. It was unknown if the reporter considered the vaccination failure, shingles, pain in arm and rash to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles on the arm after the Shingles shot. The patient's arm was sore and had rash. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 50.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: first Shingrix on 9/29/2021, second 11/24/2021; injection site was sore; Headache; fever; body aches; Chills; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and COVID-19 VACCINE. In November 2021, 24 hrs after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced headache, fever, general body pain, chills and tiredness. On 24th November 2021, the patient experienced injection site pain and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain, headache, fever, general body pain, chills and tiredness were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the headache, fever, general body pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient and employee. The age at vaccination was not reported. The patient got his first Shingrix vaccine on 29th September 2021, 0.5 ml intramuscular in left arm. The patient received his second shingrix vaccine and Covid booster on the same day. He got his shingrix vaccine in his left arm and his covid booster in his right arm.  The reporter advised to tell patients not to get the shingrix vaccine and Covid booster on the same day. The reporter stated that immediately after getting the Shingrix vaccine, the injection site was sore and lasted 24 hours.  About 24 hours post getting his shingrix and covid vaccine, the patient developed a headache, fever, body aches, chills, and tiredness. The symptoms lasted for about 48 hours. All the symptoms had resolved. The patient received 2nd dose 5 days short of 2 months which led to shortening of vaccination schedule. The patient received all of his vaccines at his local pharmacy. The patient was unsure if his symptoms were related to the shingrix vaccine, covid booster, or a combination of both.  The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: first Shingrix on 9/29/2021, second 11/24/2021; injection site was sore; Headache; fever; body aches; Chills; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and COVID-19 VACCINE. In November 2021, 24 hrs after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced headache, fever, general body pain, chills and tiredness. On 24th November 2021, the patient experienced injection site pain and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain, headache, fever, general body pain, chills and tiredness were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the headache, fever, general body pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient and employee. The age at vaccination was not reported. The patient got his first Shingrix vaccine on 29th September 2021, 0.5 ml intramuscular in left arm. The patient received his second shingrix vaccine and Covid booster on the same day. He got his shingrix vaccine in his left arm and his covid booster in his right arm.  The reporter advised to tell patients not to get the shingrix vaccine and Covid booster on the same day. The reporter stated that immediately after getting the Shingrix vaccine, the injection site was sore and lasted 24 hours.  About 24 hours post getting his shingrix and covid vaccine, the patient developed a headache, fever, body aches, chills, and tiredness. The symptoms lasted for about 48 hours. All the symptoms had resolved. The patient received 2nd dose 5 days short of 2 months which led to shortening of vaccination schedule. The patient received all of his vaccines at his local pharmacy. The patient was unsure if his symptoms were related to the shingrix vaccine, covid booster, or a combination of both.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Arthritis, Coeliac disease, Herpes zoster, Inflammation, Pain
Clinical narrative: celiac disease; pain for one year; inflammation for over one year; arthritis; diagnoses of shingles, April 2021; two doses of Shingrix in 2017, diagnosis of shingles April 2021/ suspected vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis and COVID-19 VACCINE PFIZER for prophylaxis.   Previously administered products included Zostavax (received one dose in 2012).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, COVID-19 VACCINE PFIZER, COVID-19 VACCINE PFIZER and COVID-19 VACCINE PFIZER. In April 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced celiac disease (serious criteria GSK medically significant), pain, inflammation and arthritis. On an unknown date, the outcome of the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis were unknown.   It was unknown if the reporter considered the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a dispensing pharmacist and immunizer and reported this case for herself. The age at vaccination was not reported. The patient received two doses of Shingrix in 2017. The patient had celiac disease and arthritis.  The patient had appointment with a rheumatologist to identify arthritis type was in December 2021. The patient had pain and inflammation on her right side for over one year.  The patient had 2 diagnoses of shingles in April 2021 and November 2021.  The patient had received 3 doses of COVID 19 vaccine Pfizer in 2021. The patient asked, would revaccination with Shingrix be recommended for based on the medical/ clinical data available. It was unknown if the reporter considered the celiac disease, shingles and arthritis to be related to COVID 19 vaccine Pfizer. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked to the case US2021AMR247056 for 2nd Shingrix outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR247056:2nd outbreak
Sex: F
Vaccine: COVID19, COVID19, COVID19, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: celiac disease; pain for one year; inflammation for over one year; arthritis; diagnoses of shingles, April 2021; two doses of Shingrix in 2017, diagnosis of shingles April 2021/ suspected vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis and COVID-19 VACCINE PFIZER for prophylaxis.   Previously administered products included Zostavax (received one dose in 2012).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, COVID-19 VACCINE PFIZER, COVID-19 VACCINE PFIZER and COVID-19 VACCINE PFIZER. In April 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced celiac disease (serious criteria GSK medically significant), pain, inflammation and arthritis. On an unknown date, the outcome of the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis were unknown.   It was unknown if the reporter considered the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a dispensing pharmacist and immunizer and reported this case for herself. The age at vaccination was not reported. The patient received two doses of Shingrix in 2017. The patient had celiac disease and arthritis.  The patient had appointment with a rheumatologist to identify arthritis type was in December 2021. The patient had pain and inflammation on her right side for over one year.  The patient had 2 diagnoses of shingles in April 2021 and November 2021.  The patient had received 3 doses of COVID 19 vaccine Pfizer in 2021. The patient asked, would revaccination with Shingrix be recommended for based on the medical/ clinical data available. It was unknown if the reporter considered the celiac disease, shingles and arthritis to be related to COVID 19 vaccine Pfizer. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked to the case US2021AMR247056 for 2nd Shingrix outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR247056:2nd outbreak
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine had 3 previously reported temperature excursions; expired dose was administered; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-month-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug and expired vaccine used 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 age at vaccination was not reported. The patient received expired dose of INFANRIX with expiration date of 26th November 2021, which led to expired vaccine administered to patient. No other information was provided. Lot number was not available. He was also advised that the vaccine had 3 previously reported temperature excursions, the last being reported to GlaxoSmithKline on 21st December 2021. He wanted additional information on what to do after administration of expired vaccine. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th November 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 16th November 2021, the patient experienced injection site erythema. On 17th November 2021, the patient experienced injection site warmth and injection site swelling. The patient was treated with steroids nos (Steroid (Not Specified)) and antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the injection site warmth, injection site swelling and injection site erythema were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site warmth, injection site swelling, injection site erythema and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient is the reporter. The age at vaccination was not reported. The patient received her first Shingrix dose on 15th November 2021 and immediately had arm pain at the injection site. The patient stated the pain had lessened and she only had injection site arm pain if her arm was bumped. On 16th November 2021 she also had redness at the injection site. On 17th November 2021 she also had swelling and hot skin at the injection site. She went to an urgent care facility and was prescribed a steroid and antibiotic. The redness, swelling and hot skin resolved 4 to 5 days later. She had nothing else to report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on July 2020, didn´t received 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on July 2020).   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 age at vaccination was not applicable for this report. The patient didn´t received second dose of shingrix at the time of reporting which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired Drug Used; 1 year and 8 days old patient got Hiberix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received Hib (Hiberix) (batch number TF4EB, expiry date 26th September 2021) for prophylaxis.   Concomitant products included MMRV.   On 30th November 2021, the patient received Hiberix (intramuscular) .5 ml. On 30th November 2021, unknown after receiving Hiberix and an unknown time after receiving MMRV, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were reported as follows: The reporter reported that the patient had administered an expired Hiberix and MMRV vaccine, which led to expired vaccine used. Base on the information given, the patient was 1 year and 8 days old on the day of reporting, which led to inappropriate age at vaccine administration. The reporter did not know the number of doses out of 4 dose series that the patient received. The MMRV was a non- GSK vaccine (Merck). The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix vaccine (1st dose received on 6th September 2019 from batch number TE493, expiry date 19th October 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 reported as follows: The VAERS details were reported for the 1st dose. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient called pharmacy on the day of reporting, to ask about receiving 2nd dose, but it had not yet been administered. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 4-year-old male 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 an unknown date, the patient received Kinrix (intradermal) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site rash to be related to Kinrix and Kinrix 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 reported as follows: The age at vaccination was not reported. The nurse on duty who reported that the Kinrix vaccine might have been administered inappropriately to the patient. The vaccine was administered into his leg but which leg was unknown. It was reported that the nurse might have used a needle that was too small therefore given the vaccine intradermally rather than intramuscularly, which led to intramuscular formulation administered by other route. The patient to whom the vaccine was administered experienced the bullseye rash at the site of administration. The time of onset of the rash or if it had resolve, could not be provided by the reporter. THe voice mail had been left for the medical provider to get additional information on the scenario. The date of vaccine administration, exact site of administration, dose, exact route given, when did the symptoms started, had they resolved unknown. The reporter did not consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number ZH327, expiry date 1st April 2023) for prophylaxis. On 20th October 2021, the patient received Shingrix. On 20th October 2021, unknown after receiving Shingrix, 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 were reported as follows: The reporter reported that patient received the Shingrix which was reconstituted with saline, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Incorrect dose administered, Occupational exposure to product, Syringe issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, occupational exposure to product and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a patient. Caller states her first dose of the Shingrix vaccine leaked out a lot wetting on her arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.   Caller had since received her second dose and states that went fine. Caller inquiring if she should have a third dose to compensate for the first dose that leaked out.  There was no pain or reaction after the injection. The reporter consented to follow up. No additional details were provided by the reporter.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received second dose, 49 years old; received fiirst dose, 49 years old; 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 49-year-old female patient who received Herpes zoster (Shingrix) (batch number B93K4, expiry date 7th May 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7323T, expiry date 6th May 2022) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 18th September 2020, the patient received the 1st dose of Shingrix. On 18th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 1st December 2020, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received 1st and 2nd dose of Shingrix at 49 years of age, which led to inappropriate age at vaccine administration. The health care professional mentioned that the patient she did not had immunosuppressive diseases.  The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose received 07/2021. Second dose not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 1st July 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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 age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination. The reporter consent to follow up.
Age: 78.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of underdose in a 78-year-old female patient who received HAV (Havrix 720) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 30th November 2021, the patient received the 2nd dose of Havrix 720 (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 nurse reported that the adult patient received the pediatric presentation of HAVRIX 720ELU/0.5ML (Pre-Filled Syringe) yesterday (day before reporting) rather than the adult strength (1440 ELU) product, which led to underdose and adult use of a child product. The reporter consented to follow up. This case has been linked with case US2021226689, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021226689:same reporter
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult pt received pediatric dose; Adult pt received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 59-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 HCP reported that the 59 year old patient received pediatric dose of the Engerix-B, which led to underdose and adult use of a child product. No reactions reported. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: SEVERE LEG PAIN; TINGLING IN FEET, LEGS, ARMS, HANDS; NUMBNESS; SHOULDER PAIN; SUDDEN ARM PAIN/ CONSTANT PAIN/ HURT WHEN RECEIVED THE SHOT; ENLARGED LEFT SHOULDER/ SWELLING; STIFFNESS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was left handed. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Dose number in series was 1. Concomitant medications were not reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced severe leg pain, tingling in feet, legs, arms, hands, and numbness for at least 3 months. The patient stated the vaccination did not go well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe leg pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.  On 22-OCT-2021, the patient received additional non-company suspect vaccine mRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. Dose number in series was 2. As per the report, in the evening on 22-OCT-2021, following vaccination with mRNA 1273, the patients arm suddenly was in pain and had stiffness (not numbness). The patient stated that it hurt very much when patient received a shot. The patient remained in constant pain with an enlarged left shoulder. The patient did go to the physician and had an x-ray (results not reported). Per patient, the pain was in my shoulder and arm. At the time of this report, the patient was in too much pain.  The action taken with mRNA 1273 was not applicable. The patient had not recovered from sudden arm pain/ constant pain/ hurt when received the shot, shoulder pain, and enlarged left shoulder/ swelling, and the outcome of stiffness was not reported. This report was non-serious
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, X-ray
Clinical narrative: SEVERE LEG PAIN; TINGLING IN FEET, LEGS, ARMS, HANDS; NUMBNESS; SHOULDER PAIN; SUDDEN ARM PAIN/ CONSTANT PAIN/ HURT WHEN RECEIVED THE SHOT; ENLARGED LEFT SHOULDER/ SWELLING; STIFFNESS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was left handed. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Dose number in series was 1. Concomitant medications were not reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced severe leg pain, tingling in feet, legs, arms, hands, and numbness for at least 3 months. The patient stated the vaccination did not go well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe leg pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.  On 22-OCT-2021, the patient received additional non-company suspect vaccine mRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. Dose number in series was 2. As per the report, in the evening on 22-OCT-2021, following vaccination with mRNA 1273, the patients arm suddenly was in pain and had stiffness (not numbness). The patient stated that it hurt very much when patient received a shot. The patient remained in constant pain with an enlarged left shoulder. The patient did go to the physician and had an x-ray (results not reported). Per patient, the pain was in my shoulder and arm. At the time of this report, the patient was in too much pain.  The action taken with mRNA 1273 was not applicable. The patient had not recovered from sudden arm pain/ constant pain/ hurt when received the shot, shoulder pain, and enlarged left shoulder/ swelling, and the outcome of stiffness was not reported. This report was non-serious
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH THAT COMES AND GOES; This spontaneous report received from a patient concerned a 61 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: blindness. The patient had no known drug allergies.  The patient received covid-19 vaccine (Janssen dose series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 03-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, he started having Shortness of Breath that comes and goes (dose series 1). The patient did not have any symptoms until about 3 weeks or a month ago from the time of reporting on 05-NOV-2021. He would have Shortness of Breath for couple of hours in the afternoon and it went away. The patient stated he was having Shortness of Breath at the time of reporting. He called to inquire on how long would this last for and if it would go away. He did not have any other symptoms. He had not consulted with a doctor.  On 02-NOV-2021, the patient received the Moderna Booster and he reported having the Shortness of Breath that comes and goes (dose series 1) before getting the Moderna Shot (Non-company dose series 2).   The action taken with covid-19 vaccine was not applicable.  The patient had not recovered from shortness of breath that comes and goes.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Chills, Diarrhoea, Discomfort, Feeling abnormal
Clinical narrative: DIARRHEA, WENT TO THE BATHROOM 4 TIMES; NAUSEA; BODY WAS UNCOMFORTABLE; FEELING OF 5TH DIMENSION, LIKE FLOATING IN THE SKY; DID NOT FEEL LIKE DOING ANYTHING; CHILLS AS DAY WENT ON; WOKE UP WITH NOT FEELING WELL/ GENERAL MALAISE; This spontaneous report received from a patient concerned an 83 year old white male of unspecified ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine(dose number in series 1) (suspension for injection, route of admin not reported, and batch number were not reported) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No adverse event reported following vaccination with covid-19 vaccine. The patient received covid-19 vaccine (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 04-NOV-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021 Patient began to experience side effects. woke up not feeling well 12th at night, chills as day went on, nausea, but no vomiting. Claimed that he did not feel body pain, but stated that body was uncomfortable. Patient felt that he was in a 5th dimension, like he was floating in the sky. He did not feel like doing anything that day. On 06-NOV-2021, nausea and chills stopped, but general malaise continued. Night from Saturday 06-NOV-2021 to Sunday 07-NOV-2021, patient had diarrhea an went to the bathroom 4 times. He had not taken anything to stop the diarrhea and the diarrhea is resolving itself. Nothing else was taken to relieve other symptoms. The action taken with covid-19 vaccine was not applicable. The patient recovered from body was uncomfortable, and feeling of 5th dimension, like floating in the sky, and chills as day went on, and nausea on 06-NOV-2021, was recovering from diarrhea, went to the bathroom 4 times, had not recovered from woke up with not feeling well/ general malaise, and the outcome of did not feel like doing anything was not reported. This report was non-serious.