chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA, HIBV, RV5, UNK
Symptoms: Product storage error
Clinical narrative: no patients experienced symptoms; unspecified patients were administered improperly stored doses of PEDVAX HIB, ROTATEQ and VAQTA; This non-valid spontaneous report was received from a healthcare professional and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On or after 16-APR-2020,  the patients were vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (units not provided), lot # S032358 with expiration date 11-JAN-2021 intramuscularly (dose, frequency and anatomical location were not provided); Hemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S007079 with expiration date 24-JAN-2022 or lot number S023219 with expiration date 03-MAR-2022 intramuscularly (dose and anatomical location were not provided and, rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # S017642 with expiration date 28-FEB-2021 orally (dose was not provided) all the vaccines were administered for prophylaxis. No patients experienced symptoms. Administered doses of vaccines experienced the temperature excursion of 47.3 degrees Fahrenheit for 1 hour and 22 minutes (also reported as multiple excursions). Digital data logger was involved. There were no previous excursions reported.  This report is non-valid due to lack of patients' identifiers. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HIBV, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported an unspecified number of unspecified patients received improperly stored PEDVAXHIB, PNEUMOVAX 23 and ROTATEQ.; No additional adverse effects were reported; This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown ages and gender. The patients' pertinent medical histories, concurrent conditions and previous drug reactions/allergies were not reported.  On unspecified dates, the patients were vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) routes of administration, dosage regimens, and anatomical locations were not reported; (lot number R021076 which has been verified to be valid, expiration date reported and validated as 11-JUN-2021), pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) routes of administration, dosage regimens, and anatomical locations were not reported; (lot number S036811 which has been verified to be valid, expiration date reported and validated as 02-AUG-2021) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  administered orally (lot number 1660952 which has been verified to be valid, expiration date reported and validated as 28-MAR-2021). All the vaccines administered as prophylaxis. No additional adverse effects were reported.   The temperatures and time frames reported were: lowest temperature below 36 degrees Fahrenheit (F) (34.2 F) for 34 minutes; lowest temperature below 36 degrees F (34 F) for 37 minutes. Previous temperature excursion were reported: on 05-DEC-2019, lowest temperature below 36 degrees F (32.9 degrees F) for 900 minutes; 07-DEC-2019, lowest temperature below 36 degrees F (34.2 degrees F) for 130 minutes; 10-DEC-2019, lowest temperature below 36 degrees F (33.3 degrees F) for 66 minutes. A data logger was used.  This case has been considered as non-valid due to unspecified number of unspecified patients
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: subsequent to ZOSTAVAX inoculation, plaintiff was treated for shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2011, pt was inoculated with zoster vaccine live (ZOSTAVAX) by unknown route, as prescribed and/or administered by a pharmacist at a local pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, she was treated by a physician for shingles (herpes zoster). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medication, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At reporting time, pt was not recovered from herpes zoster and it was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly stored expired VARIVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information was provided regarding the patient's concurrent conditions, concomitant medications and medical history.      On 21-APR-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and on 26-APR-2020, was vaccinated with an improperly varicella virus vaccine live (oka/merck)(VARIVAX) with lot # S005077 and expiration date 19-FEB-2021 for prophylaxis (route of administration and dose was not reported).  The administered dose of the vaccine experienced a temperature excursion 50 degrees Fahrenheit on 20-MAR-2020 for 40 minutes.   There was no adverse effect reported.  This call was because of a data logger with no previous temperature excursion.
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis bacterial, Herpes zoster, Rash, Rash vesicular
Clinical narrative: shingles; septic arthritis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from septic arthritis in the shoulder, and a painful blistering rash. As a result of these symptoms, the patient was seen and treated by medical providers, diagnosed with shingles and septic arthritis. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, septic arthritis was considered to be medically significant. The lawyer considered both events to be disability.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called reporting possibly administered doses of improperly stored VARIVAX to unspecified patients.; Nurse called reporting possibly administered doses of improperly stored VARIVAX to unspecified patients.; No adverse affects reported.; This spontaneous report was received from a nurse, referring to an unspecified number of patients of unknown ages and gender. The patients' pertinent medical histories, concurrent conditions, previous drug reactions/allergies, and concomitant medications were not reported.  On unspecified dates, the patients were possibly vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S019462, which has been verified to be valid, expiration date reported and validated as 24-JUN-2021), as prophylaxis (routes of administration, dosage regimens and anatomical locations were not reported) (circumstance or information capable of leading to medication error and product storage error). The administered dose of the vaccine experienced a temperature excursion of 5.7 degrees Fahrenheit for 25 minutes, as recorded by a data logger. There was a previous temperature excursion, however if was not specified. No adverse effects reported.  This case has been considered as non-valid due to unspecified number of unspecified patients.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; patient, date of birth 6/29/2019, received the third dose of ROTATEQ on 5/6/2020/after age of 8 months; patient, date of birth 6/29/2019, received the third dose of ROTATEQ on 5/6/2020/after age of 8 months; This spontaneous report has been received from a nurse and refers to a 10-month-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 06-MAY-2020 (after age of 8 months), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S005875, expiration date: 30-NOV-2020) dose 3, administered at a dose of 2 milliliters, once, orally as prophylaxis.         No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 01-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 02-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: had experienced fatigue; stiffness in the injected arm; loss of appetite; FEVERISH; NAUSEA; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, limbs stiffness, decreased appetite, fever and nausea. On an unknown date, the outcome of the fatigue, limbs stiffness, decreased appetite, fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fatigue, limbs stiffness, decreased appetite, fever and nausea to be related to Shingrix.  Additional details were reported as follows: The patient was a neighbor of the reporter. The age at the vaccination was not reported. The patient received Shingrix and experinced fatigue, nausea, feverish, loss of appetite and stiffness in the injected arm. The Symptoms lasted a week. Reporter did not consent to follow up. This case has been linked with case US2020077689, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles outbreak; PHN; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Six months ago from the date of the date of reporting the patient received Shingrix and had shingles outbreak and was treated for PHN in November 2019.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 03-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: my husband and I got the Shingrix shots last year / he came down with Shingles 2 days ago/ Suspected vaccination failure; he came down with Shingles 2 days ago; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had when patient was child).   On an unknown date, the patient received Shingrix at an unknown dose. In May 2020, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but could be 70 or 71 years old. The patient received vaccine before a year of reporting and experienced shingles 2 days before from date of reporting. Thephysician said he was the first person they had treated that had the vaccine. The reporter wanted to know did this happen often. This case was considered as suspected vaccination failure as details regarding vaccination schedule was unknown at the time of reporting.  The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Electrocardiogram normal, Pruritus, Sleep disorder
Clinical narrative: Chest pain; itching; because it occurs at night now waking her up; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included itchy rash (noted 5 to 6 years ago a rash with itching that eventually went away, the cause was unknown.). Previously administered products included Shingrix with an associated reaction of chest pain (received 1st dose in June 2019, refer case US2020AMR076066.).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced chest pain, pruritus and sleep disturbance. The patient was treated with camphor, levomenthol, phenol (Sarna), non-drug therapy (Ice Pack (No Medication)) and topical steroid nos (Steroid Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chest pain was recovered/resolved and the outcome of the pruritus and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the chest pain, pruritus and sleep disturbance to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left arm and had chest pain. She stated it was the same location, EKG (Electrocardiogram) was negative again and resolved quickly. She noted with the second dose she also had itching on her back from the neck to her buttocks and in the front from her neck to the top of her legs. She has seen a Dermatologist, who has prescribed steroid cream that helps but the itching returns. She feels the itching was getting worse, because it occurs at night at the time of reporting waking her up. She stated that she gets temporary relief with Sarna and ice packs. This past Saturday night she was in tears with the itching.  The reporter consented to follow up. Emergency room visit required. The caller was open to receiving authorization form, she wanted to think about it and did not provide HCP info with this call. There is discrepancy between the outcome reported in the structured field of database (not recovered) and the outcome reported in the source document (RESOLVED WITH SEQUEL).      Lab Comments: lab test performed on unknown date.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: Incomplete course of vaccination; possible low grade fever; fatigue; achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th July 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, fatigue and pain. On an unknown date, the patient experienced incomplete course of vaccination. On 15th July 2019, the outcome of the fever, fatigue and pain were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fever, fatigue and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced possible low grade fever, fatigue and achiness. Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. The patient planned to follow-up with her physician on an unknown date. Consented to follow up. This case has been linked with case US2020075688 and US2020075693, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Pain, Swelling
Clinical narrative: swelling in her left arm pit the size of an egg near her chest area; black and blue with a streak from the bottom of her armpit to her shoulder; drew her to tears and hurt like hell; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2020, the patient received the 2nd dose of Shingrix. On 27th April 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and exacerbation of pain. On 28th April 2020, the patient experienced local swelling and injection site bruising. On an unknown date, the outcome of the local swelling was not recovered/not resolved and the outcome of the injection site pain, injection site bruising and exacerbation of pain were unknown.   It was unknown if the reporter considered the local swelling, injection site pain, injection site bruising and exacerbation of pain to be related to Shingrix.  Additional details were reported as follows: The patient received her second dose of Shingrix and reported that the injection caused her pain at the injection site and it drew her to tears and hurt.   The next day, she had swelling in her left arm pit the size of an egg near her chest area.   She was black and blue with a streak from the bottom of her armpit to her shoulder which was an inch wide.   Days went by and the black and blue coloring went to yellow and purple and was now fading but the area had gone down to the bottom of her bra.   The swelling has pretty much subsided in the armpit but a little bit of swelling was remaining today.   The patient had a concern that the pharmacist possibly did not inject the vaccine intramuscularly. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and warmth
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to unknown number of patients of unknown age and gender. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  In 2019 (reported as since 20-JUN-2019), the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # N034411, expiration date 04-DEC-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023960, expiration date 01-SEP-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 9 Celsius degrees for 15 minutes. The storage temperature of varicella virus vaccine live (oka/merck) (VARIVAX) was 9 Celsius degrees to 25 Celsius degrees for 15 minutes. There was no previous temperature excursion for both vaccines. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Data logger was involved for both vaccines.   This case was considered non-valid due to lack of patient identifiers.  Follow up information was received from a medical assistant on 12-MAY-2020. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. The male patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 14-AUG-2019.; Sender's Comments:  US-009507513-2005USA003627:Original Case : 1911USA003982 US-0095075132-005USA003625:Original Case : 1911USA003982 US-009507513-2005USA003619:Original Case : 1911USA003982
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of ROTATEQ on 2/25/2020 that bad been improperly stored; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On 25-FEB-2020, the patient was inadvertently vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S006050 has been verified to be a valid lot number, expiration date 12-DEC-2020 (exact dose and dose number were not provided) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion above 47 degrees Fahrenheit (50.9 degrees Fahrenheit) for 30 minutes on 08-FEB-2020 and above 47 degrees Fahrenheit (52.7 degrees Fahrenheit) for 15 minutes on 25-FEB-2020. It was also reported that administered dose of vaccine was exposed to the temperature excursion above 47 degrees Fahrenheit (50.7 degrees Fahrenheit) for 25 minutes on 03-MAR-2020 (after vaccine administration). Data logger was involved. There was no previous temperature excursions.  No additional adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to a male patient of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 24-SEP-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin (rHA)) (M-M-R II) lot # N034411, expiration date 04-DEC-2019 (vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was above 9 Celsius degrees for 15 minutes. There was no previous temperature excursion  reported. No adverse effects reported. No product quality complaint (PQC) was involved in this case. Digitial data logger was involved.; Sender's Comments:  US-009507513-1911USA003982:Original Case : 1911USA003982 US-009507513-2005USA003625: US-009507513-2005USA003625:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 07-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Chest pain, Electrocardiogram normal, Neuralgia
Clinical narrative: nerve related; breast pain; Pain in her chest that went through her left breast; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced nerve pain, chest pain and breast pain. On an unknown date, the outcome of the nerve pain, chest pain and breast pain were recovered/resolved.   It was unknown if the reporter considered the nerve pain, chest pain and breast pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced pain in her chest that went through her left breast.  She went to the doctor and had an EKG that was negative.  She stated that they think it was nerve related and it resolved within 24 hours.   For tolerances of 2nd dose, refer case US2020075636, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: very bad sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 2019, refer case US2020077722.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced sore arm but not as bad as after the first shot.  Sore arm has at the time of reporting resolved. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and had arm pain and she knew she was not alone because others have too.  The pain lasted for a couple weeks and was significant. She had no reactions after the second dose. The reporter did not consent to follow up. The HCP did not wish to provide any further information regarding this.  She declined to provide any further information since she knows this was an expected adverse event following Shingrix administration. This case linked with US2020078036 and US2020078030, reported by same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Colorectal cancer metastatic, Guillain-Barre syndrome, Rectal cancer stage IV
Clinical narrative: Guillain Barre syndrome; colorectal cancer stage IV; Colorectal cancer; rnetatastatic colorectal cancer; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information was received on 29 April 2020 via medical records (The case was medically confirmed). The patient had ingested GSK suspect Shingrix vaccination on 21 May 2018. As per date noted in medical records, 13 September 2018 the patient had metastatic colorectal cancer and the patient was admitted in June 2018 following a previous admission in May 2018 where he was diagnosed with Guillain-Barre syndrome. The patient had colorectal cancer dated on 19 July 2018. On 21 February 2019, the patient had stage 4 rectal cancer  The patient suffered Guillain Barre syndrome (also diagnosed with metastatic colorectal cancer (stage IV).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2019, the patient received the 2nd dose of Shingrix. On 1st August 2019, less than a day after receiving Shingrix, the patient experienced chills and fever. On 2nd August 2019, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional information was provided as follows: The case was reported by the wife of the patient. The age at the vaccination was not reported. The patient experienced low grade fever and chills. The reporter consented to follow up. Limited information was provided of the patient. This case linked with US2020075686 and US2020075693, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Sleep disorder
Clinical narrative: fatigue; chills; not feeling well; during the night woke her up; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue, chills, feeling unwell and sleep disturbance. On an unknown date, the outcome of the fatigue, chills, feeling unwell and sleep disturbance were recovered/resolved.   It was unknown if the reporter considered the fatigue, chills, feeling unwell and sleep disturbance to be related to Shingrix.  Additional information was provided as follows: The reporter reported for her sister. The age at the vaccination was not reported. The batch details and injection date not available. The patient received Shingrix a year ago and experienced fatigue, chills, and not feeling well which during the night woke her up.  The symptoms resolved within 48 hours. The reporter did not consent to follow up. Medical doctor follow up consent was not provided. This case is linked to the case US2020075692, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Urticaria
Clinical narrative: Patient with mild hives on hands bilaterally with 1st vaccine.  2nd vaccine (listed above), started with blister like rash starting on hands/arm, spreading to back and then trunk.  Rash eventually all over upper part of body, but not legs.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: redness, swelling and hardness of entire upper, outer left arm
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Agitation, Fatigue, Malaise, Pyrexia, Restlessness
Clinical narrative: The evening after his vaccination, patient developed a low grade fever 100.2F, agitation and restlessness while trying to sleep, fatigue and malaise.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder
Clinical narrative: GI Grade3 beginning 4 hours after shot lasting 24 hours
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site rash
Clinical narrative: Within 1 day of injection, patient noted a red rash over the site (LD) of injection with area of induration under skin.  Rash is described as red papules with no pruritis
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash, Rash pustular
Clinical narrative: localized pustular rash
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 22-OCT-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # N034411, expiration date 04-DEC-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The measles, mumps, and rubella (rHA) (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. The storage temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was above 9 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects was reported. No product quality complaint (PQC) was involved in this case. Digital data logger was involved.; Sender's Comments:  US-009507513-2005USA003619: US-009507513-1911USA003982: US-009507513-2005USA003627:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to a female patients of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 20-JUN-2019, the patient was vaccinated with improperly stored doses varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023960, expiration date 01-SEP-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The storage temperature of varicella virus vaccine live (oka/merck) (VARIVAX) was 9 Celsius degrees to 25 Celsius degrees for 15 minutes. There was no previous temperature excursion reported. No adverse effects was reported. No product quality complaint (PQC) was involved in this case. Digital data logger was involved.; Sender's Comments:  US-009507513-2005USA003625: US-009507513-1911USA003982: US-009507513-2005USA003619:
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Herpes zoster, Rash, Rash erythematous
Clinical narrative: acute hearing loss in her right ear and was diagnosed with profund sensorineural hearing loss; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-JAN-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an acute hearing loss in her right ear and was diagnosed with profound sensorineural hearing loss. She also suffered a painful and red rash on the right side of her abdomen and chest. The rash was diagnosed as shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of acute hearing loss in her right ear diagnosed as profound sensorineural hearing loss was considered to be medically significant. Both events were considered to be disabling.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 08-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 09-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Wheezing
Clinical narrative: Soreness in both arms, both thighs; Soreness in both thighs; Began to wheeze; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2020, between 4 and 5 months after receiving Shingrix, the patient experienced pain in extremity, back pain and wheezing. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the pain in extremity, back pain and wheezing were not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity, back pain and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and he reported that about 1 month ago from the date of reporting he began to experience soreness in both arms, lower back, in both thighs and wheeze. The patient was reporting that events were getting worse.   The patient contacted their provider via telehealth and the patient was prescribed an unspecified muscle relaxant which did not improve symptoms. Reporter consented to follow up.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/13/2020 Patient called in (by phone) to report her upper right arm in the back is swollen, red, and warm to the touch.  Patient reported this started yesterday (5/12/2020).  Advised to apply cold compresses and keep monitoring.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; a patient was administered an expired PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 11-MAY-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (lot number: R021045, expiration date: provided as 11-MAY-2020, but upon internal validation established 14-APR-2020) (exact dose and route of administration was not reported). No additional adverse event was provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021045; expirationdate: 14-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability