chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Insomnia, Myalgia
Clinical narrative: injection site pain; right arm sore; right arm swollen; could not sleep; muscle aches; feels exhausted; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019 14:00, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, 16 hrs after receiving Shingrix, the patient experienced exhaustion. On 20th May 2019, the patient experienced injection site pain, pain in arm, injection site swelling, insomnia and muscle pain. On an unknown date, the outcome of the injection site pain, pain in arm, injection site swelling, insomnia, muscle pain and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, injection site swelling, insomnia, muscle pain and exhaustion to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at around 2 pm and 1 second after vaccination the patient experienced injection site pain. The patient reported that about 4 hours later, her arm became swollen at the injection site and was sore.  Ten hours after vaccination, the patient reported that she had difficulty sleeping due to muscles aches all night.  On 21st May 2019, the patient felt exhausted. The reporter did not consent to follow-up. Lot number was not known at time of report.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: injection site pain; right arm sore; right arm swollen; could not sleep; muscle aches; feels exhausted; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019 14:00, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, 16 hrs after receiving Shingrix, the patient experienced exhaustion. On 20th May 2019, the patient experienced injection site pain, pain in arm, injection site swelling, insomnia and muscle pain. On an unknown date, the outcome of the injection site pain, pain in arm, injection site swelling, insomnia, muscle pain and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, injection site swelling, insomnia, muscle pain and exhaustion to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix at around 2 pm and 1 second after vaccination the patient experienced injection site pain. The patient reported that about 4 hours later, her arm became swollen at the injection site and was sore.  Ten hours after vaccination, the patient reported that she had difficulty sleeping due to muscles aches all night.  On 21st May 2019, the patient felt exhausted. The reporter did not consent to follow-up. Lot number was not known at time of report.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient came in on 5/28 letting us know that he had gotten a rash which starting from the stomach and raps around the back. He also says he noticed a small rash on the left arm. Advised patient to call the Dr and make an appointment. Per package insert Shingrix can cause a rash as a side effect however, we would like him to get that check by Dr to ensure that is from the Shingrix and not from a bug bite. Spoke with patient again on 5/30 he said he is doing fine and will go to see the Dr the next day.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Fatigue, Febrile convulsion, Hypersomnia, Pyrexia
Clinical narrative: the day after immunization mother reported 103 fever and febrile siezure, taken to ED , sent home with fever reducer and the following day spike fever of 105,  continues to be fatigued and sleeping more
Age: 44.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: Developed  hives  hours later in the evening following administration. patient took 25 mg Benadryl  at time of eruption . Reported no difficulty breathing.Treated next day by urgent care with prednisone 20mg x 5 days.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Immunosuppression, Renal transplant
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. The patient's concurrent condition, concomitant medications, medical history, past drugs, allergies and reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dosage schedule was not reported). On an unknown date, the patient experienced drug allergy to ZOSTAVAX (drug hypersensitivity). The drug allergy reaction was reported as kidney transplant (renal transplant) and immunosuppression. The reporter considered renal transplant, drug hypersensitivity and immunosuppression to be related to ZOSTAVAX. Upon internal review, the event immunosuppression and renal transplant was considered to be medically significant. This is one of the two reports.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: wide spread rash on arms and trunk; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   On 28th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced a wide spread rash on her arms and trunk.  The rash had totally subsided, at the time of reporting. No further details were provided.
Sex: U
Vaccine: RV1
Symptoms: Oral administration complication, Regurgitation
Clinical narrative: Spit up; This case was reported by a nurse via call center representative and described the occurrence of regurgitation in a patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, immediately after receiving Rotarix, the patient experienced regurgitation. On an unknown date, the outcome of the regurgitation was recovered/resolved.   It was unknown if the reporter considered the regurgitation to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient spit up vaccine during administration. No additional details were provided. The reporter stated that no details were provided when requested.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO adverse reactions noted or reported after the immunization. Patient was over 6 and medication is recommended for up to 6 years.
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Injection site rash
Clinical narrative: Persistent rash to SPV site 7 weeks after vaccine
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, WARM TO TOUCH.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Full blown shingles outbreak
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Rash generalised, Rash pruritic
Clinical narrative: Minor swelling and pain at injection site for 2-3 days. Days 7-9 rash broke out beginning with ears, face, and neck then spreading to chest, shoulders, and upper back. Itchy when touched, worsened with heat.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: sever shivering all night
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia, Feeling abnormal, Hypokinesia, Injection site pain, Injection site swelling
Clinical narrative: Fever 102.4, malaise, severe pain in joints, decreased ROM in right arm , tender to touch at injection site with swelling,  Slowed responses in general and delayed swallowing.  I felt pretty awful,  which persisted into the next day with fever down to 100.4 but otherwise about the same
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever 102.4, malaise, severe pain in joints, decreased ROM in right arm , tender to touch at injection site with swelling,  Slowed responses in general and delayed swallowing.  I felt pretty awful,  which persisted into the next day with fever down to 100.4 but otherwise about the same
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given a Hep A on 5-29-19 but the vaccine expired on 5-27-19. Patient had no adverse reaction. This dose will not count as part of patient's immunization schedule. Patient mother has been contacted and is aware that this dose is invalid due to being expired and that patient will need another dose in 6 months.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 23-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 19-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided.   On or about 24-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.        On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 86 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-JUN-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 17-MAY-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old male patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or around 13-DEC-2016 (at the age of 62 years), the patient was vaccinated with ZOSTAVAX by a pharmacist at a pharmacy (lot #, expiration date, dose and route of administration were not specified). On an unspecified date, the patient experienced hearing loss. On an unspecified date, the patient was treated by a healthcare provider at an Ears, Nose, and Throat (ENT) group for hearing loss. The outcome of the event was not reported. The reporter considered the event to be related to ZOSTAVAX. Upon internal review, the event hearing loss was determined to be medically significant.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: left arm soreness; Shoulder pain; left arm swelling; redness left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2019, 3 days after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist at calling to report adverse event for a customer who reported that the patient received Shingrix and reported swelling and redness three days after receiving of the vaccine in her left arm, which had resolved.  The patient reports left arm pain radiating to the shoulder which started couple of days after receiving the vaccine and continued to experience this pain.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Product supply issue
Clinical narrative: small outbreaks of blisters/shingles; Blisters; Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced shingles, blister and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced after 1st dose of Shingrix 1 to 2 small outbreaks of blisters or shingles since receiving the 1st dose at an unknown date. The 1st dose of Shingrix received approximately 9 months ago and was unsuccessful at receiving 2nd dose at his local pharmacy due to availability. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness, headache, muscle aches, chills, nausea and exhaustion for two full days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Dizziness, headache, muscle aches, chills, nausea and exhaustion for two full days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: swallon arm and pain for 3 days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing, runny nose, flu-like symptoms, extreme fatigue, headache
Age: 1.58
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Balance disorder, Crying, Cytogenetic analysis
Clinical narrative: It started with him showing emotional distress. He cried all the time and only sat in one place. His speech started to lose speech. He had learned words and was communicating well with us about his needs to not  being able to say those words and reverted to crying.He had development delays start to show in Gross motor abilities and balance
Age: 1.58
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Emotional distress, Gross motor delay, Mobility decreased
Clinical narrative: It started with him showing emotional distress. He cried all the time and only sat in one place. His speech started to lose speech. He had learned words and was communicating well with us about his needs to not  being able to say those words and reverted to crying.He had development delays start to show in Gross motor abilities and balance
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Headache, Hyperhidrosis, Vaccine positive rechallenge
Clinical narrative: Headache (throbbing), cold/hot, shivers/sweats; possibly mild fever (did not measure); same symptoms as with first dose, given in January 2019
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient reports a rash that covers her torso up to her scalp. Patient states that it is itchy, and she taking Zyrtec to treat symptoms. The rash appeared the day after vaccination. As of two days after vaccination, the rash has not yet resolved.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy report was received from a family nurse practitioner and refers to a currently 20-year-old female patient. The patient medical history included fetal anomaly and one previous pregnancy with elective termination. The patient had no concurrent medical condition.  On 15-APR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot no. R024264 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 29-OCT-2019 (exact dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The patient's last menstruation period (LMP) was on 09-APR-2019, the estimated date of conception was 23-APR-2019 and the estimated due date (EDD) was reported as 14-JAN-2020. Gestation period at exposure could not be calculated as the vaccine was administered before the estimated date of conception.  The pregnancy outcome was outcome pending.; Sender's Comments:  US-009507513-1905USA008649: US-009507513-1905USA008648:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided.  On or about 01-MAY-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 54 years old male patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a family nurse practitioner for Herpes Zoster. The outcome of Herpes Zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 88 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Liver function test increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 72 year old female patient. Information on patient's concurrent conditions, medical history and concomitant medications were unknown. On 03-APR-2019, the patient was vaccinated with PNEUMOVAX 23 1 dosage form (lot/batch, expiry date were unknown) in the upper left arm for prophylaxis. On 23-APR-2019, the patient was vaccinated with SHINGRIX (dosage schedule, lot/batch, expiry date were unknown) in the right arm for prophylaxis. On an unknown date (reported as after receiving SHINGRIX), the patient experienced reaction on the left arm which was further specified as redness, swelling at site and fever. On an unknown date, the patient had liver and kidney function test which revealed elevated kidney function levels and elevated liver function test. The patient also had sedimentation rate test which showed a value of 150 with unspecified units. The patient did not received treatment for the events. The outcome of the events was reported as recovered. The causality assessment was not reported. No product quality complaint (PQC) was involved. Upon internal review, the event renal impairment was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Renal function test abnormal, Renal impairment
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 72 year old female patient. Information on patient's concurrent conditions, medical history and concomitant medications were unknown. On 03-APR-2019, the patient was vaccinated with PNEUMOVAX 23 1 dosage form (lot/batch, expiry date were unknown) in the upper left arm for prophylaxis. On 23-APR-2019, the patient was vaccinated with SHINGRIX (dosage schedule, lot/batch, expiry date were unknown) in the right arm for prophylaxis. On an unknown date (reported as after receiving SHINGRIX), the patient experienced reaction on the left arm which was further specified as redness, swelling at site and fever. On an unknown date, the patient had liver and kidney function test which revealed elevated kidney function levels and elevated liver function test. The patient also had sedimentation rate test which showed a value of 150 with unspecified units. The patient did not received treatment for the events. The outcome of the events was reported as recovered. The causality assessment was not reported. No product quality complaint (PQC) was involved. Upon internal review, the event renal impairment was determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: has tested positive for an unspecified HPV; This spontaneous report was received from a patient's mother and refers to her daughter, female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On an unknown date, the patient completed the vaccination series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as prevention of HPV). On an unknown date, the patient had an unspecified human papilloma virus test performed, whose result was positive. The outcome of the event was reported as not recovered.  The relatedness between human papilloma virus test positive and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Muscle fatigue
Clinical narrative: muscle tiredness; Headache; Injection site swelling; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in November 2018, refer case US2019GSK089494).   On 1st May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced muscle fatigue, headache, injection site swelling and injection site erythema. The patient was treated with ibuprofen (Advil) and non-drug therapy (Cold Pack). On an unknown date, the outcome of the muscle fatigue, headache, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the muscle fatigue, headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second injection for shingles the day before reporting. The patient had the majority of side symptoms except for upset stomach.  The patient asked for Advil to alleviate the muscle tiredness, headache etc. and asked for does cold pack also help to alleviate the swollen redness of the injection site. Discrepancy has been provided for the start date of vaccine, as 30th April 2019 should not be yesterday (the day before reporting) date.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: muscle tiredness; Headache; Injection site swelling; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received in November 2018, refer case US2019GSK089494).   On 1st May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced muscle fatigue, headache, injection site swelling and injection site erythema. The patient was treated with ibuprofen (Advil) and non-drug therapy (Cold Pack). On an unknown date, the outcome of the muscle fatigue, headache, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the muscle fatigue, headache, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second injection for shingles the day before reporting. The patient had the majority of side symptoms except for upset stomach.  The patient asked for Advil to alleviate the muscle tiredness, headache etc. and asked for does cold pack also help to alleviate the swollen redness of the injection site. Discrepancy has been provided for the start date of vaccine, as 30th April 2019 should not be yesterday (the day before reporting) date.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Increased tendency to bruise, Pain in extremity, Skin warm, Urticaria
Clinical narrative: arm  welts; arm  warmth to touch; arm  tenderness; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced welts, skin warm and pain in arm. On an unknown date, the outcome of the welts, skin warm and pain in arm were recovering/resolving.   It was unknown if the reporter considered the welts, skin warm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced welts on her arm, and her arm was warm and tender to the touch after receiving Shingrix. On 22nd May 2019, the patient went to see her doctor for treatment of welts, warmth, and tenderness. The welts, warmth, and tenderness were improving, but had not resolved. On 21st May 2019, the patient was in bed all day, the day after she received the vaccine. The healthcare professional did not have lot number or expiration date to provide. This case has been linked with US2019092213, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain, Pain of skin, Pyrexia, Screaming
Clinical narrative: Fever; diarrhea; Felt like 1000 needles under her skin; Woke up screaming during the night; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On 10th May 2019, less than a day after receiving Shingrix, the patient experienced fever, diarrhea, pain of skin, screaming and pain. On 12th May 2019, the outcome of the screaming was recovered/resolved. On 14th May 2019, the outcome of the fever and diarrhea were recovered/resolved. On an unknown date, the outcome of the pain of skin and pain were recovered/resolved.   It was unknown if the reporter considered the fever, diarrhea, pain of skin, screaming and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient was administered Shingrix and for 3 to 4 days, the patient experienced diarrhoea, 102 degree F fever, felt like 1000 needles under her skin, woke up screaming 2 nights in a row with horrific pain.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 16-year-old female patient who received ENGERIX B adult (batch number 94S22, expiry date 4th September 2020) for prophylaxis. On 22nd May 2019, the patient received ENGERIX B adult (intramuscular). On 22nd May 2019, less than a minute after receiving ENGERIX B adult, the patient experienced passed out (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant) and light headedness. On 22nd May 2019, the outcome of the passed out, convulsion and light headedness were recovered/resolved. It was unknown if the reporter considered the passed out, convulsion and light headedness to be related to ENGERIX B adult. Additional details were reported as follows: The patient received an adult dose as a booster of the Engerix-B vaccine in left deltoid. Within a minute of receiving the vaccine, the patient indicated that they felt light-headed. Right after that, the patient passed out and started to have convulsions. The reporter indicated that this did not last very long. The patient woke up after the convulsions. The reporter was unable to provide additional details, including what dose in the series this was.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had fever, swelling, redness at the injection site that made her report to urgent care for evaluation. Upon examination today, the patient also had some bruising on her arm around the inject site.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Breast mass, Hypophagia, Morbillivirus test positive, Oral infection, Papule
Clinical narrative: Paient was also given DTAP  Tripedia brand, but that was not an option.  Had fever on May 8 and 9 after receiving MMR, Varicella and DTaP on May 1.  One emesis.  No bloody stools; decreased po intake.  Seen in acute care clinic and diagnosed with viral illness.  No acute asthma exacerbation; using controller meds daily.  Rash: diffuse, rough, macular papular 1-3 mm rash that started on abdomen: little on face, more on extremities and torso. Right arreolar mass for months to right of nipple is a 2 mm waxy papule with some discoloration. Rash started May 11, 2019.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash macular, Rash papular, Respiratory viral panel
Clinical narrative: Paient was also given DTAP  Tripedia brand, but that was not an option.  Had fever on May 8 and 9 after receiving MMR, Varicella and DTaP on May 1.  One emesis.  No bloody stools; decreased po intake.  Seen in acute care clinic and diagnosed with viral illness.  No acute asthma exacerbation; using controller meds daily.  Rash: diffuse, rough, macular papular 1-3 mm rash that started on abdomen: little on face, more on extremities and torso. Right arreolar mass for months to right of nipple is a 2 mm waxy papule with some discoloration. Rash started May 11, 2019.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Paient was also given DTAP  Tripedia brand, but that was not an option.  Had fever on May 8 and 9 after receiving MMR, Varicella and DTaP on May 1.  One emesis.  No bloody stools; decreased po intake.  Seen in acute care clinic and diagnosed with viral illness.  No acute asthma exacerbation; using controller meds daily.  Rash: diffuse, rough, macular papular 1-3 mm rash that started on abdomen: little on face, more on extremities and torso. Right arreolar mass for months to right of nipple is a 2 mm waxy papule with some discoloration. Rash started May 11, 2019.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Blood test, Chills, Computerised tomogram head, Deafness bilateral
Clinical narrative: Very high fever with rigors, severe left sided uncontrollable headaches, dizziness, nausea, severe vomiting  unable to keep food down x 5 days, double vision-still persistent till date, insomnia, hearing loss worse on the left ear, ringing in the ear both ears, worse on the left still persist, and unresolved till date, numbness of left side of the body, and face.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Dizziness, Electrocardiogram, Headache, Hypoaesthesia
Clinical narrative: Very high fever with rigors, severe left sided uncontrollable headaches, dizziness, nausea, severe vomiting  unable to keep food down x 5 days, double vision-still persistent till date, insomnia, hearing loss worse on the left ear, ringing in the ear both ears, worse on the left still persist, and unresolved till date, numbness of left side of the body, and face.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Laboratory test, Migraine, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Very high fever with rigors, severe left sided uncontrollable headaches, dizziness, nausea, severe vomiting  unable to keep food down x 5 days, double vision-still persistent till date, insomnia, hearing loss worse on the left ear, ringing in the ear both ears, worse on the left still persist, and unresolved till date, numbness of left side of the body, and face.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmological examination, Pyrexia, Tinnitus, VIth nerve paralysis, Vomiting
Clinical narrative: Very high fever with rigors, severe left sided uncontrollable headaches, dizziness, nausea, severe vomiting  unable to keep food down x 5 days, double vision-still persistent till date, insomnia, hearing loss worse on the left ear, ringing in the ear both ears, worse on the left still persist, and unresolved till date, numbness of left side of the body, and face.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Chills, Death, Pyrexia, Sudden infant death syndrome
Clinical narrative: Fever chills DIED a week after.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: redness, rash and inflammation at injection site, unknown which vaccine caused. mother requested this be submitted to VAERS
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Malaise, Throat tightness
Clinical narrative: After leaving our office, pt went home and reported SOB/feeling like his throat was closing up. Felt sick for 2 weeks following vaccine.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: patient was given pediatric dose of hep A, not adult dose for their second dose. Given hep b peds for first dose.
Age: 53.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient came in on 5/29/19 with hives on his body and itching. He showed me pictures. I recommended hydrocortisone cream and zyrtec, but he said he would try the cream. I said if it persists, to go to the doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified), for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received improperly stored PROQUAD; This spontaneous report was received from registered nurse and refers to an approximately 4-year-old patient (reported as most likely around 4 years) of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 28-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) from lot # R026351 with expiry date 15-MAR-2020 for prophylaxis (dose, route, and anatomical location were not reported) (product storage error). Concomitant therapy included properly stored sterile diluent (lot # S000130, expiry date: 23-AUG-2021). The vaccine was exposed to a temperature excursion of 6 degree Fahrenheit (F) to 14 F (6.4 F) for 1 hour and 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality compliant (PQC) was reported.  This is one of the three reports received from the same reporter.
Sex: M
Vaccine: HPVX
Symptoms: Asthenia, Cerebrovascular accident, Wheelchair user
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 12 or 13 years old male patient. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported. On unknown date in 2016, the patient was vaccinated with a dose of GARDASIL 9 or with a dose of GARDASIL (dose, lot #, expiration date and route were not reported) for prophylaxis. On unknown date, the patient experienced a "stroke" (cerebrovascular accident). The patient sought medical attention and he received unspecified medical treatment from an unspecified Healthcare Provider. Also, the patient was experiencing "debilitating issues and needs to use a wheelchair" (asthenia). At the time of the report, the outcome of cerebrovascular accident and asthenia was reported as not resolved. The relationship between cerebrovascular accident, asthenia and GARDASIL 9 or GARDASIL was not reported.  Cerebrovascular accident and asthenia were considered to be disabling by the nurse due to the patient was in a wheelchair. Upon internal review, cerebrovascular accident was determined to be medically significant.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash; High temperature; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number YD5RS, expiry date 30th August 2019) for prophylaxis.   On 8th April 2019, the patient received Pediarix (intramuscular) .5 ml. On 11th April 2019, 3 days after receiving Pediarix, the patient experienced generalized rash and high temperature. On an unknown date, the outcome of the generalized rash and high temperature were unknown.   It was unknown if the reporter considered the generalized rash and high temperature to be related to Pediarix.  Additional details were provided as follows:  The patient was administered Pediarix in left deltoid. The patient developed a rash on his forehead and now he was completely covered with rash from forehead to his toes.  Patient had a temperature of 99.3 degrees F. Patient visited the doctor's office on 12th April 2019 for his rash. No further details were provided. There is discrepancy in vaccination date, as per field it was mentioned as 8th April 2019 however in source document narrative it is 4th April 2019. In worst case scenario we are considered as 8th April 2019 with lesser TTO.
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in their mouth; This case was reported by a pharmacist via call center representative and described the occurrence of taste metallic in a adult 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 taste metallic. On an unknown date, the outcome of the taste metallic was unknown.   It was unknown if the reporter considered the taste metallic to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  As the patient received Shingrix, they experienced a metallic taste in their mouth. The reporter had no further information and at the time of reporting was not at work.