chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller stated that GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in prefilled syringe, lot # 1691180, expiration date: 15-NOV-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced a temperature excursion of 9 degrees Celsius to 25 degrees Celsius (9.92 degrees Celsius) for 1 hour and 21 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA000845: US-009507513-2105USA000846:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller stated that GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in prefilled syringe, lot # 1691180, expiration date: 15-NOV-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced a temperature excursion of 9 degrees Celsius to 25 degrees Celsius (9.92 degrees Celsius) for 1 hour and 21 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; Devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA000775:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional adverse effect reported; Caller stated that ROTATEQ that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1707447, expiration date: 20-FEB-2022, orally (exact dose was not provided) for prophylaxis.  The administered vaccine experienced a temperature excursion of 9 degrees Celsius to 25 degrees Celsius (9.92 degrees Celsius) for 1 hour and 21 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA000775:
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: bullous pemphigoid; Information has been received regarding a case in litigation from a lawyer referring to an elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: bullous pemphigoid. The outcome of the event bullous pemphigoid was unknown.  Upon internal review, bullous pemphigoid was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no further information provided/no further AEs reported; inadvertently administered an expired dose; This spontaneous report has been received from a physician referring to a 4-month-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 04-MAY-2021, the patient was inadvertently vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 injection orally for prophylaxis (strength was not reported; lot # 1660999, expiration date was reported and validated as 03-MAY-2021) (expired product administered). No further information or adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional adverse events; the dose of GARDASIL 9 expired on 04/29/2021 and was administered today on 05/05/2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The reporter was calling to verify if the potency of a dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was still supported that expired on 29-APR-2021. The reporter stated the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) expired on 29-APR-2021 and was administered on 05-MAY-2021 (0.5 ml, lot # R017134, expiration date 29-APR-2021; route was not reported) for prophylaxis (expired product administered).    The reporter stated there was no previous temperature excursions reported on this dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). This expired dose was found supported by memo. No additional adverse events were reported. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017134; expirationdate: 29-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MEN
Symptoms: Arthralgia, Haemophagocytic lymphohistiocytosis
Clinical narrative: HLH; joint pain; This spontaneous report was received from a physician via a company representative and refers to a 16-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-SEP-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, via intramuscular route (injection site, lot # and expiration date were not reported) as cancer prevention. On the same day, she was vaccinated with influenza virus vaccine live (unspecified) (exact dose, injection site, route of administration, lot # and expiration date were not reported). On an unknown date in 2020 (reported as "sometime in the fall"), the patient was vaccinated with meningococcal b vaccine (unspecified) (exact dose, injection site, route of administration, lot # and expiration date were not reported).      On 03-SEP-2020, the patient experienced joint pain and has been diagnosed with haemophagocytic lymphohistiocytosis (HLH). The patient sought medical attention and was under the care of a hematologist. It was unknown if any treatment was given for the events or if any lab diagnostics were performed. The patient has not received any subsequent doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the events was unknown.  There was no causality assessment provided by the reporter.  Upon internal review, the event of haemophagocytic lymphohistiocytosis was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This case was received via VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 17-Mar-2021 due to VOMITING. At the time of the report, VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was vomiting , she was on the floor, and she called the EMS twice. The second time was taken to the hospital. Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This case was received via FDA VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Apr-2021 The patient died on 01-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptom Text : Death reported to Health department from Medical Examiner office, no further details provided Company comment:This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med history and no concomitant medication were provided. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med hx and no conmeds were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Expired product administered
Clinical narrative: Feel little dizziness; Ingested one dose of an expired Vivotif; Spontaneous report received on 28APR2021. Additional information was received on 04MAY2021.  A pharmacist reported that a 72-year-old male consumer "ingested one dose of an expired Vivotif" (PT: Expired product administered) and "feel little dizziness" (PT: Dizziness) following the administration of Vivotif. The consumer was receiving oral Vivotif (expiry date: Nov 2020) for immunisation. On 28APR2021 in the morning, the consumer ingested one dose of an expired Vivotif. On the same day, the consumer felt little dizziness after taking Vivotif. On 04MAY2021, the pharmacist stated that the patient had also followed up with the physician. The patient did not take any medication for dizziness, it resolved on its own. It was reported that the patient ended up receiving the injection for typhoid vaccine since Vivotif was unavailable. Action taken with Vivotif with respect to the reported events "feel little dizziness" and "ingested one dose of an expired Vivotif" was not applicable. The consumer had recovered from the reported event "feel little dizziness" while the outcome of the reported event "ingested one dose of an expired Vivotif" was unknown.  The pharmacist stated that as per their pharmacy profile, the patient did not have any medical history. In addition, he was not on any other medications.  Company Comment: A consumer took one dose of an expired Vivotif (expired product administered) and then felt dizziness which was resolved on its own. Since Vivotif was unavailable to the consumer, he ended up receiving typhoid vaccine injection. Dizziness is a known effect with Vivotif, and the causality is assessed as possible. The causality of expired product administered is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took one dose of an expired Vivotif (expired product administered) and then felt dizziness which was resolved on its own. Since Vivotif was unavailable to the consumer, he ended up receiving typhoid vaccine injection. Dizziness is a known effect with Vivotif, and the causality is assessed as possible. The causality of expired product administered is assessed as not applicable to Vivotif due to the nature of the event.
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS SHOT for prophylaxis.   Concomitant products included allopurinol, vitamin d, telmisartan, amlodipine, icosapent (Vascepa) and vitamins nos (Multivitamin).   On an unknown date, the patient received Shingrix and TETANUS SHOT. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix and tetanus shot, the patient experienced sore arm. It was unknown if the reporter considered the pain in arm to be related to TETANUS SHOT.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: received 2 doses of shinrix and had/ shingles 2 years after the second dose/Suspected vaccination failure; had a breakthrough case of shingles; have a spreading rash; This case was reported by a physician via sales rep and described the occurrence of Suspected vaccination failure in a adult 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, 2 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient received 2 doses of Shinrix and had a breakthrough case of shingles 2 years after the 2nd dose. The physician stated that it was mild case with no pain but did had a spreading rash. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpes zoster were not provided. This case has been linked with case US2021AMR066664, as reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066664:Same reporter, different patient
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; three years later, I still have symptoms; i may have to resort to a lifetime of gabapentin pills to get relief; I had double vaccination / three years later, I still have symptoms and flare ups; I may have to resort to a lifetime of gabapentin pills to get relief; Suspected vaccination failure; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 27th April 2018, less than a year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, vaccination failure, shingles and pain were unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, vaccination failure, shingles, pain, shingles and pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received dose of Shingles vaccine previously and the reporter stated that  on 27th April 2018 patient had worst most deep pain and he/she not a complainer and also stated that vaccine was rendered ineffective and patient was in so much pain. The patient also received the two doses of Shingles vaccine later and patient experienced pain and shingles. The reporter stated that as soon as patient was mostly asymptomatic he/she had the double vaccination. The reporter stated that even three years later the patient still had symptoms and flare ups in the shingles location. The reporter stated that he/she might have to resort to a lifetime of gabapentin pills to get relief. The patient advised to people that to get the shingles vaccination. This case was considered as suspected vaccination failure since the time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure'; got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and a few months later got the shingles. The patient further stated that it was awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Therapeutic response unexpected
Clinical narrative: Unexpected benefit / Shingrix vaccine series helped with his "herpes simplex."; Shingrix shot "knocked the heck" out of him / he was "down for 3 days"; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis.   The patient's past medical history included genital herpes. Previously administered products included Valtrex with an associated reaction of dizziness (had been taking Valtrex 500 mg every day for years and was prescribed 20 years ago, refer case US2021AMR099395). Concurrent medical conditions included pain (goes from his side to his hip) and herpes simplex (Painful upper right side kidney area outbreaks of herpes simplex).   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced feels awful and unexpected therapeutic effect. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the feels awful and unexpected therapeutic effect were recovered/resolved.   It was unknown if the reporter considered the feels awful and unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself.  The age at vaccination was not reported.  The patient received Shingrix vaccine in unknown deltoid. The patient stated that the Shingrix shot knocked the heck out of him and he was down for 3 days. Recently the patient had been taking Valtrex daily to prevent what he calls herpes simplex outbreaks that he gets on his upper right side (kidney area) and the physician said that it was classic shingles.  The patient was told by his physician that he no longer had to take Valtex every day because the Shingrix would help prevent his upper right side outbreaks, so the patient stopped taking Valtrex and wanted to report the unexpected benefit of having Shingrix prevent him from getting another episode of the upper right side outbreaks which he refers to as herpes simplex. The patient wanted GlaxoSmithKline to know that the Shingrix vaccine series helped with his herpes simplex. The patient stated he took a massive amount of Valtrex and it (shingles) went away after 3 to 4 days of Valtrex. The reported did not want to share his physician information. The reporter did not consent to follow up. This is 1 of 3 cases reported by the same reporter. For tolerance with 2nd dose of Shingrix, refer case US2021097933.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR099395:Same reporter. Valtrex case. US-GLAXOSMITHKLINE-US2021097933:Same reporter. Shingrix 2nd dose case. US-GLAXOSMITHKLINE-US2021AMR099395:Same reporter. Valtrex case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: was vaccinated still got them / Suspected vaccination failure; was vaccinated still got them; was sore last night; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. In May 2021, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the vaccination failure and shingles 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 patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient was vaccinated but he/she still got shingles and was sore last night from the reporting date and was not sore on the day of reporting. 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. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: having muscle cramping; This case was reported by a consumer via (Shingrix Chatbot) interactive digital media and described the occurrence of muscle cramp in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle cramp. On an unknown date, the outcome of the muscle cramp was unknown.   It was unknown if the reporter considered the muscle cramp to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had been having muscle cramping since vaccination. The patient was asked if was this something to worry about.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19 pneumonia, Herpes zoster
Clinical narrative: I was in hospital with covid pneumonia. I had already had one shot; I got shingles / I had already had one shot; This case was reported by a consumer and described the occurrence of covid-19 pneumonia 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 covid-19 pneumonia (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 pneumonia and shingles were unknown.   It was unknown if the reporter considered the covid-19 pneumonia and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and experienced shingles on butte when was in hospital with covid pneumonia. The patient had already had one shot but it was not quite time to get second one so now have to wait 6 months to get second one.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Pain
Clinical narrative: tired; body aches; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 17-year-old male 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 27th February 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th February 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and general body pain 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 as follows: The case was reported by the mother of the patient. The patient received his dose of Bexsero and the next day he felt tired and had body aches but they subsided quickly. The reporter consented to follow up. For tolerance after 2nd dose refer case US2021099742.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021099742:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Hot flush
Clinical narrative: Have headaches / 6 months later and still have them; Hot flashes / 6 months later and still have them; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot with an associated reaction of no adverse event (received 1st dose on an unknown date, 2 months ago from the 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced headache and hot flashes. On an unknown date, the outcome of the headache and hot flashes were not recovered/not resolved.   It was unknown if the reporter considered the headache and hot flashes to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The patient received 2nd Shingles shot and had headache and hot flashes. The reporter stated that 6 months later, he or she still had the events.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Incomplete course of vaccination
Clinical narrative: Never got the second one; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received in October 2017, it was just one shot), shingles vaccine with an associated reaction of adverse drug reaction (received 1st shot in June 2019) and flu shot with an associated reaction of adverse drug reaction (received on an unknown date, refer case id: US2021AMR100337).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 patient had reported the case for himself/herself. The age at vaccination was not applicable. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had a reaction to 1st Shingles shot and till the time of reporting he/she never got the second one, which led to incomplete course of vaccination. The reporter reported he/she just very unlucky with shots had same thing happened with the flu shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100337:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Got my 2nd shot on a Friday & was miserable for a week; This case was reported by a consumer via  interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th April 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she got the shot on a Friday and was miserable for a week. The reporter stated that before getting these shots, it should be read what they can cause and only good for 4 years.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and still got shingles/ Suspect vaccination failure; shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a adult 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 patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got 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 target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles/and I ha had shingles shots/ Suspect vaccination failure; I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 1st dose of COVID 19 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: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got shingles after 1st dose of Covid vaccine and also he or she had received the Shingles shots. The patient stated that, he or she would not take the 2nd dose of Covid. It was unknown if the reporter considered the shingles to be related to Covid vaccine. 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.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: continues to break out in shingles around her waistline/ shingles around her eyes; She never received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female 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 1st dose of Shingles vaccine (intramuscular) .5 ml and the 2nd dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. Many years ago, the patient received shingles vaccine on an unknown arm. She was unsure if it was the Shingrix vaccine or Zostavax. The patient stated that about 6 months after her vaccination, she broke out in shingles around her eyes and she continued to break out in shingles around her waistline about every 2 months since first break out.   Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The reporter declined to provide healthcare professional's information. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain/ Aching at injection site; Redness at injection site; Swelling at injection site; Chills/ Shivering; Fever; Myalgia; Fatigue; Headache over her right eye; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On 2nd May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and headache were not recovered/not resolved and the outcome of the shivering, myalgia and fatigue were recovered/resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient did not experience any adverse events following the first dose of vaccine. Upon receiving the second vaccine, the patient immediately experienced pain, redness, swelling and achiness at the injection site. Approximately 12 hours following the second vaccine, the patient had chills (shivering), fever up to 101 degrees Fahrenheit, myalgias, fatigue. On 2nd May 2021, less than a day after vaccination, the patient experienced headache. At the time of reporting, shivering, myalgias and fatigue have subsided. The patient continued to have a headache over her right eye, redness, swelling and achiness at the injection site. The reporter consented to follow up. The customer provided consent to follow-up with her directly via phone. She provided GlaxoSmithKline consent to follow-up with the pharmacy where she received the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Migraine, Myalgia, Pyrexia
Clinical narrative: Pain/ Aching at injection site; Redness at injection site; Swelling at injection site; Chills/ Shivering; Fever; Myalgia; Fatigue; Headache over her right eye; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On 2nd May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and headache were not recovered/not resolved and the outcome of the shivering, myalgia and fatigue were recovered/resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient did not experience any adverse events following the first dose of vaccine. Upon receiving the second vaccine, the patient immediately experienced pain, redness, swelling and achiness at the injection site. Approximately 12 hours following the second vaccine, the patient had chills (shivering), fever up to 101 degrees Fahrenheit, myalgias, fatigue. On 2nd May 2021, less than a day after vaccination, the patient experienced headache. At the time of reporting, shivering, myalgias and fatigue have subsided. The patient continued to have a headache over her right eye, redness, swelling and achiness at the injection site. The reporter consented to follow up. The customer provided consent to follow-up with her directly via phone. She provided GlaxoSmithKline consent to follow-up with the pharmacy where she received the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the first dose of  shingrix, 2.5 yrs ago , never went back for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2.5 years ago).   On an unknown date, the patient received 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: Age at vaccination was not applicable for this report.  The patient got the first dose and never went back for the 2nd dose, which led to incomplete course of vaccination.  The patient received first dose in another state. They wanted to know if they have to start over. No other information of vaccine available . The reporter consented to follow up. This case has been linked with US2021097932 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097932:SAME REPORTER
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Havrix on july 5th, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old patient who received HAV (Havrix) 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 (received Havrix on 5th July 2019, batch number E9G4E, expiry date 29th November 2021).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of Havrix till the time of reporting, which lead to incomplete course of vaccination. The batch number for 1st dose was reported as E9C74E which was corrected to E9G4E as per sales data sheet. The reporter did not consented to follow up. This case has been linked to US2021097941, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097941:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early second dose / 1st: 12/02/2020  2nd: 01/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, unknown after receiving Shingrix and an unknown time 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 information was provided as follows:  The age at vaccination was not reported. The patient received 1st dose on 2nd December 2021. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant was administered; only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult 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 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 information was provided as follows:  The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.