chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; No additional AE; This spontaneous report was received from an unspecified reporter (reported as "other"), referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T005406, which has been verified to be valid, expiration date reported and validated as 12-AUG-2021) as prophylaxis. The vaccine administered experienced a temperature of -9.5 degrees Celsius for 8 hours and 53 minutes, and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion. No additional adverse events were reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Colonoscopy, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Very sleepy, feeling faint to almost passing out, severe abdomen pain, feeling like she couldn't breathe, after 2 sleep study tests she's been diagnosed with Narcolepsy, IBS. I couldn't get NO ONE TO LISTEN TO ME!! SHES 25 and it took YEARS for a doctor to listen.  I asked him to test her for HEAVY METALS but he said he hasn't ever done one of those test before and DIDN'T DO IT!! THIS VACCINE IS THE CAUSE OF MY DAUGHTERS HEALTH ISSUES!
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Irritable bowel syndrome, Narcolepsy, Presyncope, Sleep study abnormal, Somnolence
Clinical narrative: Very sleepy, feeling faint to almost passing out, severe abdomen pain, feeling like she couldn't breathe, after 2 sleep study tests she's been diagnosed with Narcolepsy, IBS. I couldn't get NO ONE TO LISTEN TO ME!! SHES 25 and it took YEARS for a doctor to listen.  I asked him to test her for HEAVY METALS but he said he hasn't ever done one of those test before and DIDN'T DO IT!! THIS VACCINE IS THE CAUSE OF MY DAUGHTERS HEALTH ISSUES!
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Pending
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving VARIVAX states that there have been administered doses.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No additional information regarding patients' medical history, concomitant medication and concurrent condition was provided.  It was reported that temperature excursion was intermittent beginning from 28-JUL-2020, but not previously reported. Since 30-JUL-2020, the patient was administered with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002843, expiration date 23-JAN-2022, exact dose and route of administration were not reported; and lot # S032357, expiration date 14-OCT-2021, 0.5 ml, route of administration were not reported for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as from minus 14 Celsius degree to minus 10 Celsius degree (maximum minus 9.5 Celsius degree) for 38 hours and 30 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 02-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician assisstant for shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 include care for hospitalization, physician care, monitoring, treatment, medications, 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles and postherpetic neuralgia was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 include care for hospitalization, physician care, monitoring, treatment, medications, 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 will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no furlher AE; Dose/Frequency: 0.5 mL IM; Caller reported that the data logger report that was run on 21 Sep 2020 noted that the stock of frozen vaccines experienced a temp excursion on 16 Sep 2020 due to hurricane.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-SEP-2020, it was noted that the stock of frozen vaccines experienced a temperature excursion (product storage error).  On 18-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 5 milliliters (ml), administered intramuscularly (incorrect route of product administration) (formulation, strength, vaccination scheme and anatomical site of vaccination were not reported; lot number T010288, which has been verified to be valid, expiration date reported and validated as 20-SEP-2021) as prophylaxis.  On 21-SEP-2020, the caller reported that, the data logger was run, and the vaccine administered experienced a temperature excursion of 28.6 degrees Fahrenheit (F) for a time frame of 2 hours and 22 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; No additional AE; This spontaneous report was received from an unspecified reporter (reported as "other"), referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), admisitered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S038702, which has been verified to be valid, expiration date reported and validated as 01-DEC-2021) as prophylaxis. The vaccine administered experienced a temperature of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008353: US-009507513-2009USA008520:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter, referring to a patient of 1 year old and unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S038702, expiration date 01-DEC-2021) given as prophylaxis. The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event (AE) details were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008555: US-009507513-2009USA008675: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an a physician referring to a patient of currently 1-year-old of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported), lot number S038702, expiration date 01-DEC-2021, given as prophylaxis.   The improperly stored dose vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008675: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804: US-009507513-2009USA008870:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No known adverse effects.; On 09/17/2020, a patient received a dose of PROQUAD that was reconstituted with an expired diluent.; On 09/17/2020, a patient received a dose of PROQUAD that was reconstituted with an expired diluent.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions, or allergies and concomitant medications were not reported.   On 17-SEP-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T013537, which has been verified to be valid, expiration date reported and validated as 17-OCT-2021) as prophylaxis, however; it was reconstituted (medication dilution) with an expired sterile diluent(MERCK STERILE DILUENT) (formulation, strength, dose, frequency and route of administration were not reported; lot number N029881, which has been verified to be valid, expiration date reported and validated as 24-MAY-2020) (expired product administered and product preparation issue). It was not known any adverse effect.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2009USA007780:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report has been  received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.         On 21-SEP-2020,  the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) Lot # T013539, expiration date 17-OCT-2021 for prophylaxis (dosage regimen  was not reported). The storage temperature was reported  to had been  between 6°F to 14°F, specifically at 11.7°F  for 25 minutes.            There was digital data logger involved and  no previous temperature excursion was reported.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Caller reports patient received an extra dose of MMR II; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 21-SEP-2020,  the patient was vaccinated with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA)  formulation was not reported but defaulted to subcutaneous injection, 0.5 ml, Lot# S020160, expiration date 30-JUN-2021 for prophylaxis.   No additional adverse events details were available.
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; Pharmacist reported that on 9/21/2020, the unspecified 11 year old patient was inadvertently administered a third dose of MMRII; This spontaneous report has been received from nurse practitioner and a pharmacist concerning a 11 years-old patient of unknown gender. The patient's historical drugs included the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), also reported as ¨ the second dose had been administered seven years ago.¨. The patient's concurrent conditions, medical history and concomitant therapies were not reported.          On 21-SEP-2020, the patient was inadvertently vaccinated with a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage regimen, Lot # and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Medical assistant calling to check and see if there is any information on extend expiration for VARIVAX that was expired and was administered today.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patients' pertinent medical history, current condition, previous drug reactions or allergies, and concomitant medications were not reported.   On 22-SEP-2020, the patient received an expire dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number R026548, which has been verified to be valid, expiration date reported and validated as 17-SEP-2020) as prophylaxis. It was reported that no temperature excursion occurred.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an Improperly stored administered PROQUAD; This spontaneous report was received from a licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (PROQUAD) (dosage regimen not provided) lot number T013539, expiration date 17-OCT-2021, recombinant human albumin (rHA) given as prophylaxis.   The improperly stored dose experienced a temperature excursion between 6 degree Fahrenheit (°F) and 14°F (average temperature of 11.7°F) for 25 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008944: US-009507513-2009USA008968: US-009507513-2009USA008968: US-009507513-2009USA008941: US-009507513-2009USA009048: US-009507513-2009USA009094:
Sex: F
Vaccine: HPV4
Symptoms: Crohn's disease
Clinical narrative: patient was diagnosed with Crohn's disease; This spontaneous report was received from a medical assistant via a company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter.      In 2017, the patient received 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis, an later, at unspecified date, she was diagnosed with Crohn's disease. The patient's mother, who was a registered nurse, believed that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused the patient's Crohn's disease but the prescriber did not feel it was related. It was unknown if patient received treatment for the adverse experience, if any laboratory study was performed or if medical attention was sought. At reporting time, patient was not recovered from Crohn's disease. The causality assessment was not reported.  Upon internal review, Crohn's disease was considered a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported an improperly stored administered PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-SEP-2020, it was administered to the patient an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) as prophylaxis. The vaccine administered experienced a temperature of 6 degrees Fahrenheit (F) to 14F (11.7F), for 25 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: F
Vaccine: FLUX
Symptoms: Exposure via skin contact, No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: the vaccine dripped down patient's arm as it was not administered properly/no AE; the vaccine dripped down patient's arm as it was not administered properly/no AE; the vaccine dripped down patient's arm as it was not administered properly/no AE; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a physician via other employee.  This case involves a female patient (age unspecified) who received INFLUENZA VACCINE [Flu shot] which dripped down to her arm as it was not administered properly (underdose, exposure via skin contact and wrong technique in product usage process).   Medical history, medical treatment, vaccination and family history were not provided. At the time of the event, the patient was on IMMUNOTHERAPY. Concomitant medication if any, not reported.  On 26-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of vaccine underdose, exposure via skin contact and actual medication error due to wrong injection technique. (Latency: at the same time of vaccination). The patient did not get the usual bump on her arm  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: a small headache; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who experienced a small headache (headache), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. It was reported that the patient took flu vaccine from Sanofi every year with very little side effect of headache.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (reported as Sanofi vaccine) (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a small headache (headache) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient had recovered from headache (it was reported as headache for a day).  There will be no information available on the batch number for this case.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: two round, fairly large swollen areas on lower portion of upper arm. Reaction is lower than where I remember receiving the flu shot.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient came in stating he needed to receive a Shingles vaccine and that he had been advised to get vaccinated during a visit to MD. Proir to administration pharmacist reviewed with the patient vaccine regiment and side effects, then administered. On the patient's way out, the pharmacist reiterated that he would want to come back within 2-6 months for the completion of the course (shot #2). It was at this point that the patient stated that he had had at least 1 shingrix vaccine in the past and just figured he was due for another. The pharmacist researched and discovered that the patient had indeed received 2 previous shingles shots on 11/14/19 & 2/9/20. At this point the pharmacist contacted GSK to see if there was any data on 3 vaccines. GSK said that while they do not recommend more than 2 shots, that they had done studies on a 3 shot regimen in immuno-compromised patients. In pertaining to side effects, GSK stated that side effects that were reported were the same as after shot 1 & 2 (pain at injection site, lethargy, fatigue) with no serious or long term effects. This information was communicated to the patient. MD also informed
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Right shoulder pain, and decreased range of motion.  SIRV injury.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Ear discomfort, Ear swelling, Tinnitus
Clinical narrative: Starting at approximately 2200 hours noticed ringing in right ear, stuffy feeling in both ears. Continued through out the night. Next morning at 0730 hours upon awaking louder ring in right ear and lower ringing in left ear with swelling feeling in both ears. Nasal passages feel clear, no drainage, no other S/S.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: distal and medial  to injection site (about 7 cm away) developed a raised, red, warm slightly tender/slightly itchy papule 15 mm by 4 mm with 2 separate smaller (several mm each)  similar areas distal
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth
Clinical narrative: distal and medial  to injection site (about 7 cm away) developed a raised, red, warm slightly tender/slightly itchy papule 15 mm by 4 mm with 2 separate smaller (several mm each)  similar areas distal
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site reaction - redness, swelling at injection site, warm to touch
Age: 70.0
Sex: F
Vaccine: MENB
Symptoms: Injection site haemorrhage, Off label use, Vaccine positive rechallenge
Clinical narrative: when took bandage off of left arm saw big spot of blood approximately the size of a nickel where she received the Bexsero vaccination; she was told to get the Menveo, Bexsero, Prevnar 13 and Haemophilus influenzae type B (HIB) vaccine after her surgery; This case was reported by a consumer via call center representative and described the occurrence of injection site bleeding spot in a 70-year-old female patient who received Men B NVS (Bexsero) (batch number ABX797AB, expiry date 30th September 2020) for prophylaxis.   The patient's past medical history included spleen operation. Previously administered products included Bexsero with an associated reaction of contusion (1st dose received on 22nd June 2020, refer case US2020186261), Menveo with an associated reaction of contusion (2nd dose received on 22nd June 2020, refer case US2020186261), Haemophilus influenzae type B vaccine with an associated reaction of contusion (received Haemophilus influenzae type B vaccine on an unknown date) and Prevenar 13 with an associated reaction of contusion (received Prevenar 13 vaccine on an unknown date). Concurrent medical conditions included appendix cancer and platelet count high. Concomitant products included acetylsalicylic acid (Baby Aspirin).   On 15th September 2020, the patient received the 2nd dose of Bexsero. On 15th September 2020, less than a day after receiving Bexsero, the patient experienced injection site bleeding spot and off label use. On an unknown date, the outcome of the injection site bleeding spot and off label use were unknown.   It was unknown if the reporter considered the injection site bleeding spot to be related to Bexsero.  Additional details were provided as follows: The patient reported for herself. The patient mentioned that she is on a daily baby aspirin because her platelets were high from the spleen surgery. The patient received Menveo and Bexsero vaccinations on 22nd June 2020 and was supposed to get the second dose 60 days later.  The patient received her second dose of Bexsero on 15th September 2020 however, she never received her second dose of Menveo.  On 15th September 2020, when patient took her bandage off of her left arm, she saw a big spot of blood approximately the size of a nickel on her arm where she had received the Bexsero vaccination.  The patient could not recall which two vaccines she had received in her left arm in June 2020.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186261:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Soreness at injection site; injection site which she said was her hip; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced injection site soreness after the dose of Shingrix. The reporter mentioned that the injection site was hip and the patient moved when she was injected and she beleived that, this was why she experienced pain. As per the patient, the injection was given on hip instead of deltoid, which led to vaccine administration at inappropriate site. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Mass, Rash pruritic
Clinical narrative: numerous small blister like, itchy lumps on my arms and legs; numerous small blister like, itchy lumps on my arms and legs; numerous small blister like, itchy lumps on my arms and legs; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox when patient was in thirties).   On 14th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced blister, itchy rash and mass. On an unknown date, the outcome of the blister, itchy rash and mass were unknown.   It was unknown if the reporter considered the blister, itchy rash and mass to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for themself. The age group was not reported but was selected as adult as per vaccine indication. The patient had Shingles vaccine two days before the date of reporting and since then had numerous small blister like, itchy lumps on arms and legs.  The patient asked if patient was contagious and reported that It looked exactly as it did when patient had chicken pox in thirties. The consent to contact the reporter was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Rash
Clinical narrative: Rash around her trunk area of the; Chills; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash and chills. On an unknown date, the outcome of the rash and chills were unknown.   It was unknown if the reporter considered the rash and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection to a local pharmacy and did not know if it was 1st or 2nd dose 3 to 4 months ago and reported a rash with chills around her trunk area of the body.  The Doctor had just left the office but took her laptop with her that had more information such as date of birth, patient initials and maybe if other Vaccinations were recommended that day.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: High fever (101-101.4); Headaches; Body aches; received the first dose of the Shingrix vaccine on 8/2/2020 /  second dose on 9/2/2020/ Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 2nd August 2020, refer case US2020AMR186080).   On 2nd September 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 2nd September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, headache, general body pain and drug dose administration interval too short. The patient was treated with IBUPROFEN (ADVIL). On 4th September 2020, the outcome of the fever, headache and general body pain were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient reported for herself. Patient received the flu shot at the same time as the second Shingrix vaccine. The patient experienced high fever (101-101.4), headaches, and body aches within 12 hours of receiving the second dose on 2nd September 2020.  The patient received 1st dose on 2nd August 2020 and 2nd dose on 2nd September 2020 which led to shortening of vaccination schedule. On 3rd September 2020, patient took three Advil 200mg tablets to help reduce the fever and the fever reduced. On 3rd September 2020 at night (around 6pm) patient took two to three more Advil tablets.  All information was not available. Lot number and expiry was unavailable.  HCP was not yet aware of the adverse events, but patient would be following-up with them. Patient gave permission to follow-up with their HCP and provided the contact information. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR186080:same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: First dose of Shingrix vaccine on 2/24/20 / Not received the second dose yet; Rash on legs/ from knee down to ankle; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 25th February 2020, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and the day after receiving Shingrix, the patient experienced rash on front of both of legs from knee down to ankle. The rash lated for 3 days and then resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: kin rash almost like a chickenpox breakout; experiencing an itching rash in the tronqueal area /  along the extremities, on arms and legs; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2020, 1 days after receiving Shingrix, the patient experienced itchy rash. On 3rd September 2020, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash and itchy rash were unknown.   It was unknown if the reporter considered the varicella-like rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the following day the patient started experiencing an itching rash in the tronqueal area. On the 2nd day post 1st dose, the rash continued along the extremities, on arms and legs, the skin rash almost like a chickenpox breakout.  The injection had been administered by the intramuscular route on the left deltoid muscle. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: itchy welts/rash as similar to hives; rash which was itchy/80% of her torso from her neck to her upper thighs/rash went down her legs behind her knees and under her arms/rash in the area of her body that sweats; redness; finally able to sleep; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypersensitivity (has a history of sensitivity to breaking out in rashes).   On 11th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2020, 3 days after receiving Shingrix, the patient experienced red rash and difficulty sleeping. On 14th September 2020 15:00, the patient experienced itchy rash. On 14th September 2020 23:00, the patient experienced urticaria. The patient was treated with ibuprofen and antihistamines for topical use. Shingrix was interrupted. On 15th September 2020, the outcome of the urticaria, red rash and difficulty sleeping were recovered/resolved. On an unknown date, the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the itchy rash, urticaria, red rash and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient has a history of sensitivity to breaking out in rashes. The patient received 1st dose of Shingrix and 3 days later on monday she started to break out in a rash which was itchy and changed over time. The patient reported that the rash started around 15:00 and at 23:00 it covered approximately 80 percent of her torso from neck to her upper thighs and described the rash was as similar to hives with redness and itchy welts. The rash went down to legs behind knees and under arms. By 15:00 the rash had calmed down and was finally able to sleep and the following morning everything mostly disappeared. The rash would present itself in pieces and would be very itchy for a short while and then it would die down and some time later it would reappear in another area. The patient took Ibuprofen, stayed calm and applied antihistamine lotion which would help calm the area in 20 minutes. The patient had experienced a slight reappearance of the rash in the area of her body that sweats. Because of her experienced she did not think that she would get the 2nd dose of Shingrix vaccine. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: hardness at the injection site; itchiness. and hardness at the injection site; heaviness in the injected arm; sweating at her hairline; feeling of being hot; pain, redness and swelling at the injection site; redness and swelling at the injection site; swelling at the injection site; tiredness; muscle aches; feeling feverish; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 19th September 2020 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced tiredness, muscle pain and fever. On 19th September 2020, the patient experienced injection site pain, injection site erythema and injection site swelling. On 20th September 2020, the patient experienced injection site induration, injection site itching, heaviness in arm, sweating and feeling hot. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On Saturday at 01:00 pm, the patient received Shingrix on right arm. In the evening, less than a day after receiving Shingrix, the patient experienced pain, redness and swelling at the injection site. The patient experienced tiredness, muscle aches and felt feverish in the early hours of Sunday morning. One day after receiving Shingrix, the patient experienced heaviness in the injected arm and the itchiness and hardness at the injection site. A day before reporting, the patient also had sweating at her hairline and an overall feeling of being hot. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Limb discomfort, Myalgia
Clinical narrative: hardness at the injection site; itchiness. and hardness at the injection site; heaviness in the injected arm; sweating at her hairline; feeling of being hot; pain, redness and swelling at the injection site; redness and swelling at the injection site; swelling at the injection site; tiredness; muscle aches; feeling feverish; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 19th September 2020 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced tiredness, muscle pain and fever. On 19th September 2020, the patient experienced injection site pain, injection site erythema and injection site swelling. On 20th September 2020, the patient experienced injection site induration, injection site itching, heaviness in arm, sweating and feeling hot. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On Saturday at 01:00 pm, the patient received Shingrix on right arm. In the evening, less than a day after receiving Shingrix, the patient experienced pain, redness and swelling at the injection site. The patient experienced tiredness, muscle aches and felt feverish in the early hours of Sunday morning. One day after receiving Shingrix, the patient experienced heaviness in the injected arm and the itchiness and hardness at the injection site. A day before reporting, the patient also had sweating at her hairline and an overall feeling of being hot. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: hardness at the injection site; itchiness. and hardness at the injection site; heaviness in the injected arm; sweating at her hairline; feeling of being hot; pain, redness and swelling at the injection site; redness and swelling at the injection site; swelling at the injection site; tiredness; muscle aches; feeling feverish; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 19th September 2020 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced tiredness, muscle pain and fever. On 19th September 2020, the patient experienced injection site pain, injection site erythema and injection site swelling. On 20th September 2020, the patient experienced injection site induration, injection site itching, heaviness in arm, sweating and feeling hot. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site induration, injection site itching, tiredness, muscle pain, fever, heaviness in arm, sweating and feeling hot to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. On Saturday at 01:00 pm, the patient received Shingrix on right arm. In the evening, less than a day after receiving Shingrix, the patient experienced pain, redness and swelling at the injection site. The patient experienced tiredness, muscle aches and felt feverish in the early hours of Sunday morning. One day after receiving Shingrix, the patient experienced heaviness in the injected arm and the itchiness and hardness at the injection site. A day before reporting, the patient also had sweating at her hairline and an overall feeling of being hot. The reporter consented to follow up.