chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Pain, Swelling
Clinical narrative: Swollen lymph nodes in armpit of arm that received the shot.  Pain and swelling started 23 hours after booster and continued for 2 weeks with decreasing pain and swelling.  Pain and swelling noticed in contralateral armpit 3 days after booster and continued for 2 weeks  with decreasing pain  and swelling.  Sporadic pain continues through today around the tricep and shoulder of arm contralateral to shot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: Extreme fatigue lasting 6 days, dizziness, numbness in arm
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Twelve-year-old patient was given pediatric Pfizer BioNTech which is indicated for ages 5-11.  The administrating nurse noted at the top of the consent form that the parent wanted the pediatric dose even though her child was out of the indicated age range.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Pruritus, Urticaria
Clinical narrative: Since November 27th, itchy hives have been appearing every day, all over the body in small groups (1-2 hives at a time). They last for anywhere between 30 minutes and an hour before each cluster of hives resolves. However, without intervention, another small cluster of hives will develop before the previous has resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen painful thigh which was noticed the following evening and worsened, which looked like a cellulitis.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Mobility decreased, Pain
Clinical narrative: SIRVA-partial  rotator cuff tear and frozen shoulder. Pain when doing daily activities such as dressing and driving.  Physical Therapy  sessions to attempt to regain mobility.  Using prescription diclofenac sodium topical gel.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Rotator cuff syndrome, Shoulder injury related to vaccine administration, X-ray limb abnormal
Clinical narrative: SIRVA-partial  rotator cuff tear and frozen shoulder. Pain when doing daily activities such as dressing and driving.  Physical Therapy  sessions to attempt to regain mobility.  Using prescription diclofenac sodium topical gel.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Swollen arm,   painful at injection site and surrounding area
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dyspnoea, Palpitations, Pyrexia
Clinical narrative: fever shortness of breath heart palpitations  chest pain swollen chest/underarm sever pain
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: fever shortness of breath heart palpitations  chest pain swollen chest/underarm sever pain
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Depressed level of consciousness, Dizziness, Headache, Injection site pain
Clinical narrative: -soreness at injection site approximately 2 hours after injection. -headache approximately 10-12 hours after injection. -high temperature (38.5+/101.5) 12 hours after injection lasting 4-5 hours. -chills, shivering -some dizziness before fever, dizziness and reduced alertness during fever. -night sweats after fever broke.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Night sweats, Pyrexia
Clinical narrative: -soreness at injection site approximately 2 hours after injection. -headache approximately 10-12 hours after injection. -high temperature (38.5+/101.5) 12 hours after injection lasting 4-5 hours. -chills, shivering -some dizziness before fever, dizziness and reduced alertness during fever. -night sweats after fever broke.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Dosage administered was what the vial had labeled as 0.5ml. It was a booster dose that was supposed to be 0.25ml. No adverse effects or treatment required.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered dosage labeled on the vial. This was a booster shot that was supposed to be 0.25ml. No adverse reaction or treatment required.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered dosage labeled on the vial of 0.5 ml. This was a booster dose that was supposed to be 0.25ml. no adverse reactions or treatment required.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered dosage listed on the vial of 0.5 ml. This was a booster dose that was supposed to be 0.25ml. No adverse reaction or treatment needed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered dosage listed on the vial of 0.5 ml. This was a booster dose that was supposed to be 0.25ml. No adverse reaction or treatment required.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered dose labeled on the vial of 0.5ml. This was a booster vaccine which should have been 0.25ml. No adverse reaction or treatment required.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: other zoster-related conditions; Developed painful shingles, itching, blisters/shingles and other zoster-related conditions; This spontaneous report as received from a physician and a pharmacist refers to a 69-year-old female patient with allergy to meloxicam and tetanus. The patient was enrolled in the Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain and a completed form was received on 10-SEP-2012. The patient's medical history included allergic rhinitis and art (as reported). The patient had no recent exposure to chickenpox and shingles.  On 28-AUG-2012 (also reported as 31-AUG-2012) the patient was vaccinated subcutaneously in the left arm with 0.65 ml dose of zoster vaccine live (ZOSTAVAX) (lot number 671901/0421AE, expiration date 21-MAR-2013). Concomitant medications included hydrochlorothiazide, fluticasone furoate (VERAMYST), estrogens, conjugated, methyltestosterone, cyanocobalamin (reported as B12) and ranitidine hydrochloride (ZANTAC). The pharmacist reported that on an unknown date in 2012 the patient developed painful shingles after receiving zoster vaccine live (ZOSTAVAX). She developed rash under her arms, breasts, chest and back, itching and blisters identified as herpes zoster. No treatment was given for the event. Medical attention was sought for the event, the patient called the pharmacist. On 07-SEP-2012 a nasal swab specimen was collected and was sent to the laboratory on 10-SEP-2012 for Varicella Zoster Virus (VZV) Strain Identification Polymerase Chain Reaction (PCR). Results were pending at the time of this report. The outcome was reported as not recovered at the time of this report.  Follow up (FU) information was recieved on 15-OCT-2012. On 11-SEP-2012 final PCR specimen results identified the presence of VZV wild type strain.  Additional information has been requested.  FU information was received on 07-FEB-2022 from a lawyer regarding the case in litigation. It was reported that on or about 31-AUG-2012, the patient (pt) was vaccinated by a pharmacist at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster/related conditions. Subsequently, on an unknown date, the pt was treated by a physician for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided (hence, the outcome remained not recovered/not resolved as previously reported for the event of shingles, and was considered unknown for the newly added event of other zoster-related conditions). The lawyer considered both events to be related to zoster vaccine live (ZOSTAVAX).  FU information has been received on 16-FEB-2022 via pharmacy records. It was reported that zoster vaccine live (ZOSTAVAX) injection subcutaneous (SQ) was dispensed (sold) to the pt on 31-AUG-2012.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: other zoster-related conditions; Developed painful shingles, itching, blisters/shingles and other zoster-related conditions; This spontaneous report as received from a physician and a pharmacist refers to a 69-year-old female patient with allergy to meloxicam and tetanus. The patient was enrolled in the Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain and a completed form was received on 10-SEP-2012. The patient's medical history included allergic rhinitis and art (as reported). The patient had no recent exposure to chickenpox and shingles.  On 28-AUG-2012 (also reported as 31-AUG-2012) the patient was vaccinated subcutaneously in the left arm with 0.65 ml dose of zoster vaccine live (ZOSTAVAX) (lot number 671901/0421AE, expiration date 21-MAR-2013). Concomitant medications included hydrochlorothiazide, fluticasone furoate (VERAMYST), estrogens, conjugated, methyltestosterone, cyanocobalamin (reported as B12) and ranitidine hydrochloride (ZANTAC). The pharmacist reported that on an unknown date in 2012 the patient developed painful shingles after receiving zoster vaccine live (ZOSTAVAX). She developed rash under her arms, breasts, chest and back, itching and blisters identified as herpes zoster. No treatment was given for the event. Medical attention was sought for the event, the patient called the pharmacist. On 07-SEP-2012 a nasal swab specimen was collected and was sent to the laboratory on 10-SEP-2012 for Varicella Zoster Virus (VZV) Strain Identification Polymerase Chain Reaction (PCR). Results were pending at the time of this report. The outcome was reported as not recovered at the time of this report.  Follow up (FU) information was recieved on 15-OCT-2012. On 11-SEP-2012 final PCR specimen results identified the presence of VZV wild type strain.  Additional information has been requested.  FU information was received on 07-FEB-2022 from a lawyer regarding the case in litigation. It was reported that on or about 31-AUG-2012, the patient (pt) was vaccinated by a pharmacist at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster/related conditions. Subsequently, on an unknown date, the pt was treated by a physician for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided (hence, the outcome remained not recovered/not resolved as previously reported for the event of shingles, and was considered unknown for the newly added event of other zoster-related conditions). The lawyer considered both events to be related to zoster vaccine live (ZOSTAVAX).  FU information has been received on 16-FEB-2022 via pharmacy records. It was reported that zoster vaccine live (ZOSTAVAX) injection subcutaneous (SQ) was dispensed (sold) to the pt on 31-AUG-2012.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no advere event; expired product administered; caller reports the products was involved in a atemperature excursion; This spontaneous report was received from a nurse and refers to a 67-year-old patient.    The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 20-JAN-2022, the patient was inadvertently vaccinated with 0,5 milliliter of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T024556 with expiration date 08-JAN-2022) for prophylaxis. The vaccine was involved in a temperature excursion of 48.4 degrees Farenheit for 40 minutes. There was no additional adverse event reported (expired product administered, no adverse event and product storage error).
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Took her 1st dose a year ago and had not received her 2nd dose yet; No additional AE reported; This spontaneous report was received from a pharmacist regarding a patient who was currently 21-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unspecified date in February 2021, reported as "a year ago" the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, anatomical location, route of administration, lot number and expiration date were not reported).   It was reported that the patient missed her second dose and at the reporting date she had not received. No additional adverse event was reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 15-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot number U024221, expiration date 04-OCT-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 39.55 degrees Fahrenheit for 10 hours. No previous temperature excursions were detected.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; I have had both the zostravax vaccination in 2015, both doses of the shingrix vaccination in 2020, yet I recently developed shingles; This spontaneous report was received from a patient of unknown gender, who would be 66 years old at the reporting time. The patient's medical history, concurrent condition and concomitant medication were not provided.  The patient have had both the zoster vaccine live (ZOSTAVAX) vaccination in 2015 (extra dose administered), both doses of the varicella zoster vaccine rge (cho) (SHINGRIX) vaccination in 2020 (strength, dose, frequency, route, lot# and expiration date were not provided), yet the patient recently developed shingles (herpes zoster and vaccination failure). The outcome of all events were unknown.    The reporter considered vaccination failure to be related to suspect products of zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (cho) (SHINGRIX) vaccination. The causality between shingles and suspect products was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: they both knocked me off; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional deatils were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had shingles shot and it knocked off the patient for a day. The reporter stated that, it was well worth the actual shingles. For the tolerence of 2nd dose refer case US2022AMR028369 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR028369:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: they both knocked me off; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (1st dose received on an unknown date, refer case US2022AMR028356).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR028356  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt knocked him/her off his/her butt for a day but well worth the actual shingles. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR028356:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: been vaccinated for shingles, and got it last week/suspected vaccination failure; got it last week; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.  The age at vaccination was not reported. The patient had been vaccinated with Shingles vaccine and got shingles last week. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never got the 2nd one; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.  The patient asked could he/she had the vaccine shot again. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Neck pain, Vaccination failure
Clinical narrative: got two shots, then got internal shingles/suspected vaccination failure; internal shingles; pain in neck; numbness in ear; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles, neck pain and numbness. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neck pain was not recovered/not resolved and the outcome of the numbness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, neck pain and numbness to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient got the two Shingle shots in 2020 and then got internal shingles 6 months later.  The patient reported that her/his physician too believed of getting shingles in 2021. The patient's ear went numb for two months before he/she realized that he/she had shingles.  Therefore, patient was late getting the antivirals and took Valtrex as prescribed. The patient hoped that his/her pain in neck goes away soon. The patient had no rash, but severe neck pain that kept coming back.. The patient still had month later neck pain. This case was considered as suspected vaccination failure since the details regarding completion of laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia
Clinical narrative: Experienced a red arm; Experienced fever; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and fever. On an unknown date, the outcome of the erythema of extremities and fever were unknown.   It was unknown if the reporter considered the erythema of extremities and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had red arm and fever after vaccination with 1st dose of Shingrix. The reporter described fever as light. No additional information provided. No lot number, expiration date, patient date of birth, or full health care professional contact details provided.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: female patient received a pediatric dose; female patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up. Note: There is a discrepancy regarding the reported suspect vaccine information, query was raised for the same and meanwhile suspect start date, batch number and expiry date was kept blank for Engerix B as all information seems to be for Havrix.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced minor sore arm after receiving his Shingrix vaccine The reporter did not consent to follow up. The reporter provided limited information and reporter did not wish to provide personal information. This case is 1 out of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026668:same reporter
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: administration of expired dose; 15 month old received boostrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   On 11th February 2022, the patient received Boostrix. On 11th February 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: Medical assistant reported that an expired dose of Boostrix administered to a 15 months old patient, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 2, 5 days before 6 months; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 7-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was unknown. The reporter was the patient's grandmother. The patient received 2nd dose of Havrix, 5 days before the 6 month period, which led to shortening of vaccination schedule. The reporter wanted to know if the series had to be started again. The patient was referred the healthcare professional. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; worsening of his shingrix outbreaks; worsening of his shingrix outbreaks; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (before the vaccine, the patient would break out in a small spot in the same place).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and condition aggravated. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and condition aggravated to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received both Shingrix vaccines about a year ago from the date of reporting, exact dates were unknown. The patient received 2nd dose in an unknown deltoid. The patient stated that, ever since getting the vaccines, he had worsening of his shingles outbreaks. The patient would break out in a small spot in the same place before the vaccine.  Since the vaccine, the shingles had spread throughout the body. No lot number or expiration date was known for vaccines. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding, laboratory confirmation of shingles was not provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: half dose left out the syringe /  didn't receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 13th April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2021, from batch number G4CY5).   On 14th February 2022, the patient received the 2nd dose of Shingrix. On 14th February 2022, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: Registered pharmacist reported that, during administration of 2nd dose of Shingrix, half dose left out the syringe, so the patient did not receive full dose, which led to underdose. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: whole body was itching; RASH ON PALMS OF HANDS; This case was reported by a physician via sales rep and described the occurrence of generalized pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced generalized pruritus and rash. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the generalized pruritus was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced rash on the palm of his hands and 15-20 minutes later his whole body was itching for which he took an anti-histamines.  The anti-histamines resolved the issues but then rash returned 2 months later. The reporter did not have vaccine facility details. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose approximately 14 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 14 months ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter stated that, the second dose was late due to the patient residing in different states throughout the year and not due to supply issue.  The reporter was calling from home and did not have patient details or lot number and expiration date details. The reporter consented to follow up. Healthcare professional gave permission for follow up, but declined to provide mailing address. This case is linked with US2022027784, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027784:same reporter, diffrent patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose approximately 16 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 16 months ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter stated that, the second dose was late due to the patient residing in different states throughout the year and not due to supply issue.  The reporter was calling from home and did not have patient details or lot number and expiration date details. The reporter consented to follow up. Healthcare professional gave permission for follow up, but declined to provide mailing address. This case is linked with US2022027781, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027781:same reporter, different patient
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient being vaccinated with a dose that expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the registered nurse. The reporter stated that, the patient was vaccinated with a dose of expired Twinrix vaccine, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on 2020 hasn't received the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st December 2020, Batch number- N972X).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter called in to inquire and report for Shingrix and asked if the patient should repeat the dose, start over or continue the series. The reporter did not consent to follow up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: HCP used an expired vaccine  in a patient; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the Healthcare professional administered an expired Kinrix vaccine to the patient, which led to expired vaccine used. The reporter learned of this adverse event about 1 hour ago from the time of reporting. No other information was known. The reporter consented to follow up. Gave the reporter the Medical information number and time for the Healthcare professional to call.  The reporter gave permission for GlaxoSmithKline to contact them.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered pregnant patient; Infanrix administered to 28 y/o patient; Infanrix was given instead of Boostrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 28-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th January 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 24th January 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the care co-ordinator. The reporter stated that, Infanrix was administered to the pregnant patient instead of Boostrix, which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. The Healthcare professional gave permission for safety to follow up. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Dyspnoea, Erythema, Influenza like illness
Clinical narrative: redness of the arm; flu like symptoms; anxiety; sore throat; weakness; irritability; trouble breathing; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had her a dose of Shingrix about a month ago and afterwards she began to experience redness of the arm, flu like symptoms, anxiety, sore throat, weakness, irritability, trouble breathing, and trouble sleeping.  The patient was referred to health care professional and gave her medical disclaimer, advised as per package insert content.  Provided medical informer phone number for health care professional reference and offered after call survey. The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Irritability, Oropharyngeal pain
Clinical narrative: redness of the arm; flu like symptoms; anxiety; sore throat; weakness; irritability; trouble breathing; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, influenza-like symptoms, anxiety, sore throat, weakness, irritability, difficulty breathing and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had her a dose of Shingrix about a month ago and afterwards she began to experience redness of the arm, flu like symptoms, anxiety, sore throat, weakness, irritability, trouble breathing, and trouble sleeping.  The patient was referred to health care professional and gave her medical disclaimer, advised as per package insert content.  Provided medical informer phone number for health care professional reference and offered after call survey. The reporter consented to follow-up.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Infant received adult dose; Infant received adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-week-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received an adult dose of the Engerix-b, which led to overdose and adult product administered to child. No reactions were reported.  The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up via email.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Dizziness, Malaise, Tunnel vision
Clinical narrative: I went shopping 7-8 hours after receiving my Pfizer booster shot, and when I went to leave the store, I started to not feel well, and then I got tunnel vision. I had my boyfriend pull the car around to the front of the store, and went I got into the car, everything went black, and I couldn?t hear anything. After I got home, every time I stood up I got the same lightheaded feeling.