chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site vesicles, Pain
Clinical narrative: 1 small Blister near injection site and cluster of bisters on the nose. Painful and sore, started to heal and scab over after 6 days.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Oligomenorrhoea
Clinical narrative: I 'm on the 27 th day of my period. A lot lighter than I usually experience but not light enough to be considered spotting filling 2 regular sized tampons a day. Opposed to my usual periods having to change a regular tampon every hour or two. Also no usual cramps or back pain, no blood clots that I usually experience. in a lot of ways it's the easiest period I've ever had except for the fact that it is on day 27. I'm very tired all the time which is usual when on my period but not for 27 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash appeared same day and is still there.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Groin pain, Laboratory test, Pain
Clinical narrative: Back and body ache, legs groin chest, kidneys, throw up and fever. Went to emergency, Doctors took many many test
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Renal pain, Vomiting
Clinical narrative: Back and body ache, legs groin chest, kidneys, throw up and fever. Went to emergency, Doctors took many many test
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Suicidal ideation
Clinical narrative: Child developed a massive PANDAS OCD Flare and possibly cytokine storm.   He ended up in the hospital asking to die because OCD thoughts became over whelming.  Child has had PANDAS for 6 years and never had an incident like this.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Blood thyroid stimulating hormone decreased, Goitre, Hypothyroidism
Clinical narrative: After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain.  Swallowing was painful, and my neck ached only on the left side.  I went to an urgent care center after work that day and was told to see my PCP.  I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound.  The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid.  The left nodule was larger.  I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations.  I was referred to an endocrinologist and saw her on 3/24.  She prescribed me atenolol, which eliminated my symptoms.  On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis.  I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic.  I was taken off of the atenolol and started on levothyroxin 50mg qd.  After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly.  I am scheduled for a follow-up thyroid ultrasound in two weeks.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Neck pain, Nodule, Odynophagia, Oropharyngeal pain
Clinical narrative: After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain.  Swallowing was painful, and my neck ached only on the left side.  I went to an urgent care center after work that day and was told to see my PCP.  I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound.  The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid.  The left nodule was larger.  I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations.  I was referred to an endocrinologist and saw her on 3/24.  She prescribed me atenolol, which eliminated my symptoms.  On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis.  I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic.  I was taken off of the atenolol and started on levothyroxin 50mg qd.  After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly.  I am scheduled for a follow-up thyroid ultrasound in two weeks.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia, Thyroid gland scan abnormal, Thyroid mass, Thyroiditis
Clinical narrative: After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain.  Swallowing was painful, and my neck ached only on the left side.  I went to an urgent care center after work that day and was told to see my PCP.  I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound.  The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid.  The left nodule was larger.  I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations.  I was referred to an endocrinologist and saw her on 3/24.  She prescribed me atenolol, which eliminated my symptoms.  On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis.  I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic.  I was taken off of the atenolol and started on levothyroxin 50mg qd.  After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly.  I am scheduled for a follow-up thyroid ultrasound in two weeks.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free increased, Tremor, Tri-iodothyronine decreased
Clinical narrative: After experiencing left supraclavicular lymph node pain for a few days, on 3/8 I woke up with a noticeable goiter and severs left neck/throat pain.  Swallowing was painful, and my neck ached only on the left side.  I went to an urgent care center after work that day and was told to see my PCP.  I was able to see her on 3/10, and had thyroid labs drawn and a thyroid ultrasound.  The ultrasound showed two nodules > 3.5mm, one on each side of my thyroid.  The left nodule was larger.  I went for more labs on 3/17, and within two days I began experiencing tachycardia, tremors, anxiety, agitation, and palpitations.  I was referred to an endocrinologist and saw her on 3/24.  She prescribed me atenolol, which eliminated my symptoms.  On 4/1 I underwent a radioactive nucleotide reuptake exam and was diagnosed with thyroiditis.  I took the atenolol for about a month and had more labs drawn, which showed I was now hypothroidotic.  I was taken off of the atenolol and started on levothyroxin 50mg qd.  After taking that for two months I had repeat labs that were on the high side of normal, and my dose of levothyroxin was increased slightly.  I am scheduled for a follow-up thyroid ultrasound in two weeks.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: I read on an App that DR. has 2 patients who have developed Lupus and after the Pfizer vaccine. He is still studying the cases closely to report them; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medication were not reported. On unspecified date, patient has developed Lupus after the vaccine. Treatment received was unknown. Reporter informed that has 2 patients who have developed Lupus after the Pfizer vaccine and was still studying the cases closely to report them. The outcome of event was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; temperature excursion: -14.7 C; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.  On 12-MAY-2021, the patient was vaccinated with incorrectly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, exact dose, route of administration were not reported; lot number reported as S03870 verified to be not valid, expiry date reported as 31-MAY-2022) for prophylaxis.  The suspect vaccine was stored in the temperature from -50 degrees Celsius (C) to -15 C (-14.7C) for 45 minutes, in the temperature of -10.29 C for 45 minutes and in the temperature of -1.81 C for 3 hours and 30 minutes. There was previous temperature excursion of -14.7 C for 45 minutes. Digital data logger was involved. No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event reported; Administration of VARIVAX and MMR II (Stored in Freezer) that underwent a temperature excursion to a patient; This spontaneous report was received from a licensed vocational nurse and refers to a 1 year old male patient.  The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.   On 20-MAY-2021, the patient was vaccinated with an incorrect storage dose of  varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, 0.5 ml, lot # T027305, expiration date 12-AUG-2022 for prophylaxis. On the same date, the patient also received an incorrect storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II). subcutaneously, 0.5 ml, lot # S037497, expiration date 20-NOV-2021 for prophylaxis. The vaccines were exposed at 19.3 Fahrenheit (F) for 1 hour and 31 minutes. There was no previous temperature excursion. The call was made due to "data logger". No other adverse events were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported at this time; temperature excursion on ROTATEQ; This spontaneous report has been received from a health care professional referring to a 4 months old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-MAY-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, strength and anatomical location were not provided; lot# 1741376 has been verified to be a valid lot number, expiration date reported as 06-MAR-2022), orally for prophylaxis (product storage error). The vaccine underwent temperature excursion at 48.2 Fahrenheit (F) for 15 minutes. The previous temperature excursion was at 46.2 F for 15 minutes. The digital data logger was involved in recording excursion details. At the time of report, there was no additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA000779: US-009507513-2106USA000757: US-009507513-2106USA000712: US-009507513-2106USA000591: US-009507513-2106USA000663: US-009507513-2106USA000689: US-009507513-2106USA000988:
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE details were available; inadvertent concomitant administration of VARIVAX and PROQUAD to a patient; This spontaneous report has been received from a medical assistant referring to a 1-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 28-MAY-2021, the patient was inadvertent concomitantly vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # T025944, expiration date: 30-JUL-2022; strength and route were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) (0.5 mL, lot # T029099, expiration date: 23-FEB-2022; strength and route were not reported) for prophylaxis (inappropriate schedule of product administration). The reporter was requesting any information on what to look for with the patient. No additional adverse event details were available.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: product experienced a temperature excursion; no adverse event; This spontaneous report as received from a pharmacist (also reported as costumer) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S028737 expiration date 03-APR-2022 for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided).  No adverse effects were reported. Temperature excursion was registered by Digital Data Logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired GARDISIL 9; This non-valid spontaneous report was received from a physician via office manager and refers to a patient of an unknown age and gender.  On 03-JUN-2021, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # R026716 was valid for formulation vial, expiration date 30-MAY-2021 (route of administration and anatomical location were not provided) for prophylaxis. The reporter inquired viability of administered dose. No additional adverse events reported.  This case is non-valid due to lack of patient's identifiers.  Follow up information was received form an unspecified source at the physician office on 15-JUN-2021.  The reporter stated if they could get more information regrading the patient. However, more information was not able to be provided as it was not available.
Age: 18.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Vaqta and Gardasil 9 were administered to a patient on 6/2/21 prior to discovering temperature excursion; This spontaneous report was received from a medical assistant and refers to a 18-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-JUN-2021, the patient was vaccinated with an improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022, at a dose of 0.5 milliliter, intramuscularly and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T025370, expiration date 01-DEC-2022, at a dose of 0.5 ml, intramuscularly for prophylaxis (anatomical locations were not provided). The temperature excursion was below 2 Celsius degrees (1,1 Celsius degrees) for 14 hours. There were no previous excursions reported. The digital data logger was involved. No additional adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired GARDASIL 9 was administered to a patient; This spontaneous report has been received from a pharmacist referring to a consumer, of unknown age and gender patient.   No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were provided.  On 04-JUN-2021, the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) of 0.5 milliliter for prophylaxis, lot # R021634, expiration date 08-MAY-2021. (anatomical location and route of administration were not provided). The reporter stated that the vaccine had no prior temperature excursions. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021634; expirationdate: 08-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: additional adverse event reported; called about a temperature excursion and a improper storage; This spontaneous report has been received from a medical assitant, referring to a patient of unknown age and gender.The patient's concurrent medications, pertinent medical history, drug reactions or allergies were not reported.  On 04-JUN-2021, the patient was vaccinated with an improperly stored  the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) 0.5 milliliter , intramuscular , lot number S028738 , expiration date : 03-APR-2022 ,as prophylaxis  The vaccine was exposed to a temperature excursion of 50.9 °degree F for a time frame of 2 hours and 49 minutes, which were detected by the Digital Data Logger. There was no previous temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: who missed a dose of GARDASIL 9; No additional AE reported; This spontaneous report was received from a pharmacy technician and refers to a 17-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, lot # 1621934, expiration date 29-JAN-2022 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. On an unknown date, the patient missed a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event was reported. The outcome of the event was unknown.  The relatedness between the suspect therapy and the event was not provided  This is one of 2 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEP, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported; an expired dose of RECOMBIVAX HB was inadvertently administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 10-JUN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R031056, expiration date: 04-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse event was reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R031056; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Hypoaesthesia, Muscle spasms
Clinical narrative: full body cramping; numbness in limbs; extreme weakness; This spontaneous report as received from a registered nurse refers to a 14-year-old female patient. The patient's concomitant vaccine included unspecified Covid vaccine. There was no information about the patient's concurrent conditions or medical history provided.  On 10-JUN-2021, 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) 0.5 mg, intramuscularly, lot # T008151, expiration date: 21-JUN-2022 (anatomical location was not reported) for prophylaxis.   On the same day, reported as 3 minutes after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had full body cramping, extreme weakness and numbness in limbs. The patient sought medical attention and was transported to hospital via ambulance as a treatment.  The outcome of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008151; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of GARDASIL 9 one year ago and did not complete the series at that time; No other AE/PQC reported; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On an unknown date in 2020, reported as one 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) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient did not complete the series at that time.  Non-valid due to no patients identifiers.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Alopecia, Anaemia, Heavy menstrual bleeding
Clinical narrative: heavy bleeding; female problems; became anemic; had hair loss; This spontaneous report as received from an office manager via a company representative refers to a 17-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (employee was unable to verify) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.     On an unknown date, reported as 1 month after receiving suspected vaccine, the patient started having female problems, heavy bleeding, became anemic and had hair loss. It was unknown if the patient sought medical attention or if she received any treatment.  The outcome of the events was unknown. Causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Product administration error
Clinical narrative: No additional AE reported; a consumer was inadvertently administered the PNEUMOVAX 23 vaccine/The consumer was not scheduled to receive this vaccine; This spontaneous report as received from an unspecified reporter, reported as other refers to a 53-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-JUN-2021, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, lot # T031820, expiration date: 10-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. The patient was not scheduled to receive this vaccine and had not previously been vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: The patient suffered herpes zoster. As a result of these symptoms, was seen and treated by medical providers and is still under their care.; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was considered to be not recovered. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No AE reported; expired dose of PROQUAD was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 14-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S017256, expiration date 01-DEC-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse event (AE) was reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional AEs; expired dose of RECOMBIVAX HB was administered on 11JUN2021; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-JUN-2021, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 1 time dose, lot # R034547, expiration date 09-JUN-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further information is available; patient received an expired VAQTA; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-JUN-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 1 dose, lot # T008698, expiration date 04-JUN-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Rash, Rash morbilliform
Clinical narrative: measles; morbilliform rash over trunk, face and some extremities; This spontaneous report was received from a consumer via a company representative and refers to a 14 year old patient of unknown gender. The patient's medical history included stem cell transplant and it was reported the patient was well. No information regarding the patient's concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, frequency, route and site of administration, lot number and expiration date were not provided).  On an unknown date, 7 days after the vaccination, the patient developed morbilliform rash over trunk, face and some extremities. It was stated that it looked like measles. It was unknown if there was any treatment given for the adverse events. The patient was being seen by the dermatology team and would have a biopsy. The outcome of the events was not provided.  The reporter was concerned that the events were related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  Upon internal review, the event of measles was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The physician told the field employee that a patient experienced syncope after receiving her second dose of GARDASIL 9; This spontaneous report was received from a physician via company representative, referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.     On 11-JUN-2021, 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) (route, strength, lot # and expiration date were not provided) for prophylaxis.         The physician stated that, on the same date, the patient experienced syncope. The patient recovered on the same date after "seconds or a few minutes" later. The patient sought for medical attention, however it was unknown if any treatment was provided.  The physician spoke with the patient's family on 14-JUN-2021 (reported as "yesterday"), and the informed the patient was doing fine. Causality between the reported event and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, syncope was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Herpes zoster
Clinical narrative: Congestive heart failure; Herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster and congestive heart failure. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of congestive heart failure and herpes zoster were considered to be disabling.  Upon internal review, the event of congestive heart failure was determined to be medically significant.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Muscle fatigue, Muscular weakness, Sleep disorder
Clinical narrative: SEVERE pain/ in shoulder , limp elbow; tiredness in shoulder , limp elbow; limp elbow and hand; I've waked at 3 am; This case was reported by a consumer and described the occurrence of shoulder pain in a 74-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th June 2021 21:00, the patient received Shingles vaccine. In June 2021, 6 hrs after receiving Shingles vaccine, the patient experienced shoulder pain, muscle fatigue, mobility decreased and sleep disturbance. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the shoulder pain, muscle fatigue, mobility decreased and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain, muscle fatigue, mobility decreased and sleep disturbance to be related to Shingles vaccine.  Additional information was provided as follows: On 9th June 2021, the patient had Shingles vaccination in evening about 9 pm. On 10th June 2021 about 3 am, the patient woke up in severe pain and tiredness in shoulder, limp elbow and hand. The patient applied ice and took two Tylenol. The patient asked what else should be done.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: made my arm sore for days; I never felt good..; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.  Additional case was reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received a updated Shingle shot and had arm sore for days and never felt good and had receive another in 30 days, but it was better then shingles. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: got the shot 3 days later he was dead; This case was reported by a consumer via media and described the occurrence of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by reporter for a friend's husband. The patient was in perfect shape but passed away 3 days after his shingles shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR131309:Same reporter.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt only received the diluent part of the mcv4; Pt only received the diluent part of the mcv4; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient only received the diluent part of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine. The reporter consented to follow up. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: I am 48 years old / I have a prescription to get the shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (Shingles on face).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: This case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient was 48 years old at the time of reporting and had a horrible case of shingles on face and had a prescription to get the shingrix vaccine, which led to intercepted drug prescribing error. The patient added that, he/she could not find anyone to give it since the patient was under 50 years of age had insurance and also insurance says they will not pay until the patient became 50 and the patient could not afford the vaccines The reporter did not consent to follow up.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix 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 GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130439:Same reporter. Patient #3 of 3.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix 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 GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130437:Same reporter. Patient #2 of 3. US-GLAXOSMITHKLINE-US2021130439:Same reporter. Patient #3 of 3.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix 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 GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130437:Same reporter. Patient #2 of 3.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose / to a patient / 3rd dose in the series; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 9794C, expiry date 13th June 2021) for prophylaxis.   Previously administered products included Engerix B (1st dose and 2nd dose of Engerix B received on an unknown date).   On 15th June 2021, the patient received the 3rd dose of Engerix B. On 15th June 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Engerix B which was already expired on 13th June 2021. The reporter did not feel completely comfortable sharing patient information but mentioned they would provide that in the follow-up. The reporter consented to follow up.