chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 045C21A, 043B21A and 037A21B) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetes and Hypothyroidism. Concomitant products included METFORMIN, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and LORATADINE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:00 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:00 AM,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Total 5 vials were affected. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past.   No treatment medication was reported by reporter.  Patient was never diagnosed with COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022; No adverse event; administer a expired vaccine to more than 40 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients), PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 022C21A and 040B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Apr-2021 at 9:09 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 13-May-2021 at 8:08 AM, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jun-2022 at 10:52 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 10:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients), PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients) and PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022).    Concomitant medications were not reported. They thought that Moderna had an extension like Pfizer, and they though it would expired on the 13Jul2022 but it was expired on the 13May2022, they realize this on the 8Jun2022. The total Number vials reported as 5 vials. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: no adverse event; Caller is a medical assistant who reports that PROQUAD and VARIVAX were inadvertently administered to a patient concomitantly today; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2022, the patient was inadvertently vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 mL once, lot #U033046, expiration date: 21-OCT-2023) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin (rHA))  (PROQUAD) (0.5 mL, lot #U016976, expiration date: 24-NOV-2022) administered for prophylaxis (strength, anatomical location and route of administration were not provided) (accidental overdose) with sterile diluent (MERCK STERILE DILUENT). The patient had no adverse effects or symptoms from receiving these doses (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided. No PQC.; Nurse calling in to report an AE for a patient that was administered a dose of MMR-II reconstituted with expired STERILE DILUENT. Per caller the patient was administered the dose of MMR-II today 19JUL2022 and the STERILE DILUENT expired 1JUL2022.; Nurse calling in to report an AE for a patient that was administered a dose of MMR-II reconstituted with expired STERILE DILUENT. Per caller the patient was administered the dose of MMR-II today 19JUL2022 and the STERILE DILUENT expired 1JUL2022.; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 19-JUL-2022, the patient was administered with a dose of 0.5 mL measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # U019291, expiration date 18-JUN-2023; strength was not reported), reconstituted with expired sterile diluent (STERILE DILUENT) (lot # S037027, expiration date 01-JUL-2022; strength was not reported) subcutaneously for prophylaxis (expired product administered, product preparation issue). No additional adverse event (AE) details were provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Alopecia
Clinical narrative: Ptient developed hair loss after receiving a form of GARDASIL.; This spontaneous report has been received from a nurse through a company representative, and refers to an approximately 36-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, when the patient was an approximately 14-15 years old, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (The reporter was not sure which vaccine was administered) injection, administered intramuscular (strengths exact, dosages, vaccination schemes frequency, anatomical sites of injection, lots number, and expiry dates were not reported) as prevention of human papillomavirus infection HPV (prophylaxis).  On an unspecified date (approximately between 2001 and 2002) the patient experienced hair loss (alopecia). No treatment was received. Subsequently, on an unknown date, the patient recovered from alopecia.   The causality assessment between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report has been received from an office manager via company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter (lot# T018669, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 29-MAY-2022) for prophylaxis (Expired product administered).  No adverse event was reported.; Sender's Comments:  US-009507513-2207USA007049: US-009507513-2207USA007043:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; VARIVAX and MMRII administered after a TE; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concomitant medications, concurrent conditions, previous drug reactions and allergies were not provided.  On 25-JUL-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number U030161 which has been verified to be valid, expiration date reported and validated as 28-SEP-2023) and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number U028163 which has been verified to be valid, expiration date reported and validated as 09-SEP-2023); both administered as prophylaxis (doses, routes of administration and anatomical sites of injection were not reported). The administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of - 10 degrees Celsius (C) up to 8 C, during an unspecified time frame; and 3.4 C, during a time frame of 10 hours. The administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) was stored at a temperature of 23.8 C, during a time frame of 9 hours and 45 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-JUL-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U030161, expiration date: 28-SEP-2023, administered subcutaneously for prophylaxis (strength was not provided), after a temperature excursion of 2 hours and 45 minutes at a temperature of 41.5F (product storage error). No previous temperature excursions were reported. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; a patient was inadvertently administered a dose of MMR II after the labeled expiration date. Caller stated the vaccine expired on 30-JUL-2022 but was administered to the patient today, 2-AUG-2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 02-AUG-2022, the patient was inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T025930, expiration date: 30-JUL-2022, (strength, and route of administration were not provided) administered for prophylaxis (Expired product administered). The caller confirmed the vaccine did not experience any temperature excursions. The caller was provided the supported disclaimer based on the Post Expiry Memo. No additional adverse event (AE) reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No known patient adverse reactions or side effects; 1 dose of GARDASIL 9 was administered on 7/26/2022 / Temperature excursion; This spontaneous report was received from an Office Manager/Vaccine Coordinator referring to a 12-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  The Office Manager/Vaccine Coordinator reported that there was a temperature excursion just discovered, it occurred between 11-JUL-2022 and 15-JUL-2022. Vaccines involved in the excursion were Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (Captured in MARRS case # 2208USA003006), and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The vaccine undergo a temperature excursion of above 47 degrees Fahrenheit (F) (55.2F) for a period of 5 hours, and above 47 degrees Fahrenheit (F) (53F) for a period of 30 minutes (Product storage error). The vaccine did not underwent a previous temperature excursion.  On 26-JUL-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml intramuscular (IM), administered as prophylaxis, lot number was verified to be U032636 with expiration date of 26-OCT-2023. There were no known patient adverse reactions or side effects (No adverse event).  An excursion on 26-JUL-2022 was already reported.  This was one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2208USA003006:
Sex: F
Vaccine: RV5
Symptoms: Adverse reaction, Surgery
Clinical narrative: Legal Issue Involved - AE sent to Legal Caller is a Merck employee reporting an AE for ROTATEQ that she received on 8/5/2022 via email. Caller states the email was sent from a consumer who stated his daughter received; This spontaneous report was received from the patient's mother via company representative on an email, referring to a female patient of unknown age. The patient's medical history, current conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, dose, vaccination scheme, lot #, and expiry date were not provided).  On an unknown date, the patient develop an adverse reaction that almost killed her, and due to that adverse reaction she had to have an emergency surgery to saved her life. At the reporting time, the outcome of the event was not provided.  The causality assessment between the adverse reaction and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was reported as related.  Upon, an internal review the adverse reaction was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Nurse reporting AE for improperly stored PROQUAD administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot #W002783 and expiration date: 24-JUL-2023; strength, dosage regimen, anatomical location, and route of administration were not provided) that had underwent a temperature excursion of -14.2 degree for 40 minutes with previous temperature excursion of -14.5 celsius degrees during 10 minutes (product storage error). The vaccine was administered as prophylaxis. No adverse event was reported.  This is one of the several cases reported from the same reporter.; Sender's Comments:  US-009507513-2208USA004029:Case # 02220597
Sex: U
Vaccine: COVID19, COVID19, COVID19, FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had 2 mild cases since double shingle shot/ Suspected vaccination failure; had 2 mild cases; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   Concurrent medical conditions included thyroid disorder.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, Flu vaccine, COVID-19 VACCINE, the 2nd dose of COVID-19 VACCINE and the 1st dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, not applicable after receiving Flu vaccine and an unknown time after receiving COVID-19 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. It was unknown if the reporter considered the shingles to be related to Flu vaccine.     Additional Information: RA Receipt Date: 6-Aug-2022 Reporter's comment: The patient self reported the case via RA page. The patient had 2 mild cases of shingles since the double shingle shots. The patient had always gotten their flu shot and had 2 Covid dose and one booster dose. The patient stated that he/she would not get another covid booster dose. The patient stated that that it messed up his/her thyroid meds and doctor/pharmacist said that they thought covid booster had caused all the problems. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Renal disorder, Vaccination failure
Clinical narrative: Shingles/Suspected vaccination failure; Shingles all over my back; Went to a visit at Hospital for my kidney; This case was reported by a consumer via interactive digital media and described the occurrence of 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 renal disorder. On an unknown date, the outcome of the vaccination failure, shingles and renal disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and renal disorder to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient was vaccinated and got the shingles. The patient never felt one thing and stated that he/she was blessed he/she did not even realize he/she had them all over the back until he/she went to a visit at hospital for the kidney and they flipped out and said the patient had shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the shot but just got shingles/Guess this vaccine doesn't work; Got the shot but just got shingles/shingles again on my right hip and butt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles many years ago just below right breast and across back).   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles many years ago just below his/her right breast and across his/her back.  The patient stated that he/she was awful but never missed a day of work.  The patient got the shot a couple of years ago but just got shingles again on his/her right hip and butt. The patient stated miserable but he/she was retired now so did not have had to put clothes on.  The patient guessed this vaccine did not work either. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots last year, have the shingles/suspected vaccination failure; Shingles on face, hair and around eye/ for 2 months; This case was reported by a consumer via interactive digital media and described the occurrence of 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date:29-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got both of the shots last year and guess what he/she have had shingles. The patient never ever had felt to bad.  The patient stated that they were on the face in his/her hair and around his/her eye. The patient stated that they said the patient was lucky, did not had a bad case. If this was not bad the patient did not want any worse. The patient have had been dealing with them for 2 months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got both vaccine, have gotten shingles a few times; Shingles a few times, flare ups, stress brings it on; Stress brings it on for me; This case was reported by a consumer via interactive digital media and described the occurrence of 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient stated that no side affects from shot, he/she was happy thinking that would be the last of shingles, sadly it was not, just not as server.  The patient got both the vaccine and still had gotten shingles/flare ups few times after. The patient stated that just not as bad, stress brings them on for him/her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had shingles shots, had shingles on spinal area; Shingles on her spinal area; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter remember that the patient had shingles on her spinal area. The reporter stated guess what, the patient had her shingles shots as recommended by her doctor. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder
Clinical narrative: Bad intestinal side effects; This case was reported by a consumer via interactive digital media and described the occurrence of gastrointestinal disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown.   The reporter considered the gastrointestinal disorder to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reported had asked that why anyone would not tell us the efficacy of taking just one of the 2 shots. The patient had bad intestinal side effects and thought it to be from the first shot. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a mild case of shingles in April (year unspecified)).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR116813   Additional Information: GSK Receipt Date: 06-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had mild case of shingles, so they recommended after that, the patient got the series of two shingles vaccines. After the first dose patient experienced a sore arm for a couple of days. Additional Supportive Information: Follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR116813, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR116813:Same reporter.
Sex: U
Vaccine: HPV2
Symptoms: Incomplete course of vaccination
Clinical narrative: only received 2 out of 3 doses; This case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received HPV 16-18 (Cervarix) for prophylaxis.   Co-suspect products included human papilloma type 16 + 18 vaccine + as04d pre-filled syringe device (Cervarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Cervarix (received 1st and 2nd dose on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Cervarix and Cervarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Cervarix and Cervarix 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 Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The nurse reported that the patient initiated HPV series with Cervarix while traveling but claimed that the patient only received 2 out of 3 doses in series. No additional information was provided. No additional adverse event or product quality complaint was reported at the time of call. The reporter consented to follow up. Additional Supportive Information: The patient received 2 out of 3 doses in series which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac disorder, Herpes zoster
Clinical narrative: Shingles 2 weeks after 2nd dose; it did something to my heart; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of tachycardia. Concurrent medical conditions included cardiac valve leak.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and heart disorder. On an unknown date, the outcome of the shingles and heart disorder were unknown.   It was unknown if the reporter considered the shingles and heart disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-Aug-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The reporter was just saying that on another post, caught a Shingles on 2 weeks after the second vaccine and somebody said they did also. The reporter also believed that something to his/her heart had leaky heart value. After Covid vaccine heart been beating like on a rollercoaster. Follow-up would not possible, as no contact, details were available; Sender's Comments:  US-GSK-US2022AMR117009:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot 5 years ago, never got second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 5 years ago from reporting).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 08-AUG-2022 Reporter's comment: This case was received from patient via interactive digital media. The patient never got second Shingles shot. The reporter wanted to know can patient get second dose now. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 17th June 2022) for prophylaxis.   On 28th July 2022, the patient received Havrix. On 28th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comment: The reporter was a practice administrator. The reporter reported that the patient was administered an expired dose of the Havrix vaccine inadvertently. The reporter consented to follow up.  Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received three years before from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The reporter stated that there had been three years since the first dose of Shingrix and could he/she get the second now after three years. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got really sick after his/her shingles shot. The patient stated could not do another one. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR117816:Same reporter US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117821:Same reporter US-GSK-US2022AMR117819:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR117819:Same reporter US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117821:Same reporter US-GSK-US2022AMR117801:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117801:Same reporter US-GSK-US2022AMR117816:Same reporter US-GSK-US2022AMR117821:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Medication error, Product preparation error
Clinical narrative: received dosis reconstituted with sterile water; received Menveo dosis reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA5H94, expiry date 23rd May 2023) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular) .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The reporter reported that the vaccine was possibly reconstituted with sterile water instead of appropriate diluent. Error was discovered and reported when staff thought an empty box was in refrigerator. The date issue was identified was 8th June 2022 The patient could have received inappropriately reconstituted vaccine. Centers for disease control and prevention/GlaxoSmithKline advised to reimmunize the patient. It was a medication error without harm. The reporter consented to follow-up. Additional supportive information: The patient received the inappropriately reconstituted Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This is 1 of 5 linked case, reported by same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091409:Same reporter US-GSK-US2022AMR117819:Same reporter US-GSK-US2022AMR117816:Same reporter US-GSK-US2022AMR117801:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; achy arm sore as heck; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness and pain in arm were unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and patient felt tired and experienced achy arm sore as heck. The patient asked did anyone had any side effects and if so what were symptoms. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Influenza
Clinical narrative: got so sick/she got sick with the flu; like she had the flu/she got sick with the flu; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness and influenza. On an unknown date, the outcome of the sickness and influenza were unknown.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reported stated that he/she knew someone that had got Shingle vaccine and got so sick like she had the flu and the reporter could not understand why the patient got sick with the flu. Additional supportive information: Follow-up would not possible, as no contact details were available.