chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number - EN6206) on 08-Mar-2021, Pfizer (2nd dose and Lot number - ER8730) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Was given the vaccine which was slightly outside the 12 hour recommended period/administered Moderna booster doses to 2 patients from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  The vial was initially stored in the refrigerator on 06 Jan 2022 at 8 am and the vial was first punctured on the same day at 10 am.  The vaccine was administered on 07 Jan 2022 at 10 am and 10:15 am. The vial was stored in refrigerator after puncture. The vial did not undergone any temperature excursion.   This case was linked to MOD-2022-445137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Added reporter. Updated suspect product details.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Computerised tomogram head, Impaired work ability, Magnetic resonance imaging
Clinical narrative: TEMPORARY DISABILITY; INFLAMMATION OF THE BRAIN; MILD COGNITIVE IMPAIRMENT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had an adverse reaction from the vaccine and seeking assistance from J and J. On an unspecified date in JUN-2021, the patient was under physician's care, after receiving the vaccine. The patient experienced temporary disability and not able to go back to the current job. On 03-JAN-2022, the patient was diagnosed with mild cognitive impairment due to the inflammation of the brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary disability, inflammation of the brain and cognitive impairment was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220114664 -Covid-19 vaccine ad26.cov2.s- Temporary disability, inflammation of the brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Mobility decreased, Myalgia, Neuralgia, Pain
Clinical narrative: TEMPORARY DISABILITY; INFLAMMATION OF THE BRAIN; MILD COGNITIVE IMPAIRMENT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had an adverse reaction from the vaccine and seeking assistance from J and J. On an unspecified date in JUN-2021, the patient was under physician's care, after receiving the vaccine. The patient experienced temporary disability and not able to go back to the current job. On 03-JAN-2022, the patient was diagnosed with mild cognitive impairment due to the inflammation of the brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary disability, inflammation of the brain and cognitive impairment was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220114664 -Covid-19 vaccine ad26.cov2.s- Temporary disability, inflammation of the brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: TEMPORARY DISABILITY; INFLAMMATION OF THE BRAIN; MILD COGNITIVE IMPAIRMENT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had an adverse reaction from the vaccine and seeking assistance from J and J. On an unspecified date in JUN-2021, the patient was under physician's care, after receiving the vaccine. The patient experienced temporary disability and not able to go back to the current job. On 03-JAN-2022, the patient was diagnosed with mild cognitive impairment due to the inflammation of the brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary disability, inflammation of the brain and cognitive impairment was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220114664 -Covid-19 vaccine ad26.cov2.s- Temporary disability, inflammation of the brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Disability, Noninfective encephalitis
Clinical narrative: TEMPORARY DISABILITY; INFLAMMATION OF THE BRAIN; MILD COGNITIVE IMPAIRMENT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had an adverse reaction from the vaccine and seeking assistance from J and J. On an unspecified date in JUN-2021, the patient was under physician's care, after receiving the vaccine. The patient experienced temporary disability and not able to go back to the current job. On 03-JAN-2022, the patient was diagnosed with mild cognitive impairment due to the inflammation of the brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temporary disability, inflammation of the brain and cognitive impairment was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments 20220114664 -Covid-19 vaccine ad26.cov2.s- Temporary disability, inflammation of the brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: GI Bleed
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: GI Bleed
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Angiogram cerebral normal, Aspartate aminotransferase increased, Blood bilirubin increased, Haematuria
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Headache, Immune thrombocytopenia, Immunoglobulin therapy, Magnetic resonance imaging head normal
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia, Urine analysis abnormal, Venogram normal
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Chromaturia, Computerised tomogram head, Headache, Laboratory test
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Pain, Platelet disorder, Pyrexia, Red blood cell abnormality
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Transfusion, Ultrasound scan
Clinical narrative: after the covid 19 vaccine shot. my daughter started with fever and headache. I gave her Tylenol and the following day i did not send her to school due that she was in a lot of pain on her harm, fever, headache.  On statuary 1/8/2022 i spotted blood clot on her lip and inside her mouth which I thought it was from the fever and her urine started changing color. Sunday morning 1/9/2022  i had to call her pediatrician and i explain to her what was happening to my daughter.  i told her that she had more blood clots in her body and her urine look like blood. She told me to go straight to the emergency room.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had the 1st shot then got covid the following week; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (had the 1st shot then got covid the following week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had the 1st shot then got covid the following week). At the time of the report, COVID-19 (had the 1st shot then got covid the following week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient wanted to confirm if the second dose could be taken as the patient had event over 9 months ago.  Treatment medications were not provided by the reporter. COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (After the second dose his whole hand got inflamed for a week) and RASH (like skin rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 054C21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.  The patient's past medical history included Splenectomy (it was removed after a car accident when he was 19 years old.). Concomitant products included SILDENAFIL CITRATE (VIAGRA) for an unknown indication.   On 07-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (After the second dose his whole hand got inflamed for a week) and RASH (like skin rash). In March 2021, PERIPHERAL SWELLING (After the second dose his whole hand got inflamed for a week) and RASH (like skin rash) had resolved.            No treatment drug was provided by reporter.  Patient was not had a history of myocarditis/pericarditis.   This case was linked to MOD-2022-445684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Non-significant FU: This report was received to quality complaint team under QE-014043, QE-014044, and QE-014045.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, 1 total, administered on 19-JUN-2021 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-AUG-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered  (Dose number in series 2). No concomitant medications were reported.  On 01-JAN-2022 or 02-JAN-2022 (2-3 days ago), the patient's symptoms started. The patient had symptoms of fever, cold and pain in the body. On 03-JAN-2022, the patient tested COVID positive using a lab test antigen test (suspected covid-19 infection) (Dose number in series 2). On 03-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided. On 15-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot number T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments: US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE'S; Temperature excursion involving administered PROQUAD vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical and drug history, current conditions, and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (lot number reported as U022726 expiration date 16-JAN-2023 ; dose, vaccination scheme, route of administration,and anatomical site of vaccination were not reported).     The medical assistance reported that on 13-DEC-2021 temperature excursion involving administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) vaccines (product storage error).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) were reported.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a other health professional nurse practitioner, concerning a 6-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies. On 28-DEC-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, at a dose of 0.5 milliliter (ml) (lot number T030749, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 16-MAR-2023) (route of administration and anatomical location were not reported), as prophylaxis (product use issue). No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs or PQC reported; VARlVAX given IM instead of SQ; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.      On 27-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (mL), lot# reported as 1017685 is not valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 21-MAY-2022) via intramuscular (IM) instead of subcutaneous (SQ) route for prophylaxis (incorrect route of product administration). No other information provided. No additional adverse event (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse referring to a 4-year-old patient of unreported gender. The patient's relevant medical history and concomitant medications were not provided. On 29-DEC-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5ml (lot number reported as U019286, expiration date 15-DEC-2022; vaccination scheme frequency, route of administration were not reported) for prophylaxis. On 28-DEC-2021, Improperly stored the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product storage error) as follows: minus 10.6 (-10.6) degree Celsius (C) for 30 minutes. The product has no previous excursions.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 28-DEC-2021, the patient was vaccinated with improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # T031202 with expiration date: 14-JUN-2022, dose: 0.5 milliliter (strength, dose number and route of administration were not reported) for prophylaxis (Product storage error). No additional adverse events were reported. Administered dose of Hepatitis A Vaccine, Inactivated (VAQTA) was stored improperly in the temperature 50.5 Fahrenheit (F) for 57 minutes. There was no previous temperature excursions.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; balance issues; Information has been received from a lawyer regarding a case in litigation and referring to a patient (pt) of unknown age and gender. Information about the pt's concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as after receiving zoster vaccine live (ZOSTAVAX), the pt suffered postherpetic neuralgia and balance issues. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the suspect product, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of post herpetic neuralgia and balance disorder were considered to be disabling.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; 2 patients were administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.      On 04-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter/1 time dose (expired product administered) (lot number T033510 and expiration date 28-DEC-2021) for prophylaxis.    No additional event (no adverse event) was reported. No PQC was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history and concomitant therapy were not reported. On 04-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) lot # S039319, expiration date: 04-DEC-2021 0.5 milliliter for prophylaxis. (dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported). No additional AE, PQC nor additional information was provided.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous has been received from a consumer, concerning a currently 8-year-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not reported. On unknown date, the patient was vaccinated with a dose of (recombinant)(RECOMBIVAX HB) (anatomical location, lot number and expiration date were not reported) for prophylaxis. On unknown date, the patient's titer was negative after receiving all the 3 doses of (recombinant)(RECOMBIVAX HB) (hepatitis b surface antibody negative). At the reporting time, the outcome was unknown. The causal relationship between hepatitis b surface antibody negative and (recombinant)(RECOMBIVAX HB) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication.  On or about 29-DEC-2014, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), at a pharmacy as recommended for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, the patient was treated by providers for the following injuries resulting from patient' vaccine use: herpes zoster and postherpetic neuralgia. The outcome of herpes zoster and postherpetic neuralgia was unknown.  The reporter considered herpes zoster and post herpetic neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: MMR
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No additional AE reported; during administration the patient moved and the needle came out of the skin/no medication leaked from the injection site, but there was still 0.1mL left in the syringe that the patient did not receive/patient only received 0.4mL of the MMR Il vaccin; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's medical history and concomitant medications were not provided.  On 07-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II), 0.4 milliliter (lot # T029550 and expiration date reported as 01-SEP-2022) for prophylaxis. During administration the patient moved, and the needle came out of the skin, nurse confirmed no medication leaked from the injection site, but there was still 0.1mL left in the syringe that the patient did not receive. Nurse stated the patient only received 0.4mL of the MMR Il vaccine (accidental underdose). No additional information provided. No additional AE reported. No PQC reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: This spontaneous report was received from a healthcare business professional who was an office manager referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the reporter stated that it was unable to confirm if patient was previously administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (circumstance or information capable of leading to medication error). On 03-JAN-2022, the patient had missed a scheduled measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and another missing on 07-JAN-2022 (product dose omission issue). No additional AE reported. No PQC.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Medication error
Clinical narrative: The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name; Injection site tenderness; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from LLP-Biontech SE [Other Case identifier(s): US-BNTAG-1581 (BNTAG), license party for Comirnaty].  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Injection site tenderness".  Additional information:  On 17Nov2021, a dose was drawn up by the pharmacist for a subject in study BNT162-17. The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name and DOB per site process. The dose of BNT162b2 was then administered to a non-study patient, not in the study. (The patient was on site for a Covid-19 vaccine booster dose). The patient that was not trial participant was observed post dose and had been followed up via phone calls for monitoring of any symptoms. The originally intended trial participant received the correct dose according to randomization assignment. The patient that inadvertently had received study medication/vaccine with phone calls and the non-study patient has had only an expected post injection site tenderness. At time of reporting, the events have resolved with date of 17Nov2021. No further information was available at that time. Additional information had been requested.  Reporter comment: The reporting physician considers the event to be non-serious. The company agrees to the physician's assessment. Hence, the case was assessed as unexpected on case level. The reporting physician assessed the event as related to treatment with BNT162b2. The sponsor agreed to the investigator's assessment as injection site pain was expected for parent vaccine BNT162b2 (Comirnaty). Medication error was not considered an adverse drug reaction in this case, as only consequences of medication error are considered to be adverse drug reactions. Therefore, seriousness, expectedness and causality are assessed as not applicable.  The benefit-risk profile of BNT162b2was not affected by this event and no change in the reference safety information was required at that time.  Causality Assessments: Drug: COMIRNATY Injection site tenderness, Medication error Per Reporter: Possible Per Company (BioNTech SE): Possible. Bnt162b2 (COMIRNATY) is under agreement with Biontech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: got the stupid shot / got shingles/ suspected vaccination failure; very bad nerve pain; shingles; 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 GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and got the shingle lasted 3 months and still had very bad nerve pain. The patient stated he/she the Shingles shot did not keep from getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles break out; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had when was young) and shingles (had shingles break out in one place by buttocks (common in women) when in late 30's).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had chicken pox when the patient was young and had shingles break out in one place by his/her buttocks which was common in women when in his/her late 30's. The patient had them chronically in that area for over 24 years, also had 2 of the Shingles vaccines with no results. At the time of reporting, the patient was 58-year-old and had to take an antiviral for them to stay under control. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash macular, Vaccination failure
Clinical narrative: had both of the injections and still get shingles; still get shingles; Spots aren't as large but still here; 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and spot-like rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the spot-like rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and spot-like rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that the patient received both of the shingles injections and still get shingles. Spots were not as large but still here. The case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: nerve pain / worst pain ever; still hurt; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain 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 nerve pain and pain. The patient was treated with medication unknown (Nerve Medication). On an unknown date, the outcome of the nerve pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and pain 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 went on 5 weeks and was the worst pain ever the nerve pain was horrible and took nerve medicine and still hurt. The patient had the first vaccine when it came out and suggested to get the vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had the shot, 1 year later had shingles/ suspected vaccination failure; shingles in both eyes; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that the patient had the shingles shot, 1 year later the patient had shingles in both eyes, it was been 4 years, still fighting it off and on. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, and laboratory confirmation of shingles was not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pruritus, Urticaria
Clinical narrative: Shivering all over; Headache; Muscles aches all over; Welt on her upper arm that was itchy; Welt on her upper arm that was itchy; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2021, 12 hrs after receiving Shingrix, the patient experienced shivering, headache, generalized muscle aches, urticaria and pruritus. On an unknown date, the outcome of the shivering, headache, generalized muscle aches, urticaria and pruritus were recovered/resolved.   It was unknown if the reporter considered the shivering, headache, generalized muscle aches, urticaria and pruritus to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. She stated that she received her dose of Shingrix last Wednesday. She reported that approximately 12 hours after the shot, she began to experience shivering, headache, muscle aches all over and a welt on her upper arm that covered about 12 inches into 8 inches and that it was itchy.  No lot number or expiration date for vaccine was known. The reporter did not consent to follow up. Declined to provide health care professional information.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered
Clinical narrative: patient received 4 doses of Shingrix; patient received 4 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 97PL2, expiry date unknown) for prophylaxis.   Previously administered products included shingrix (received 1st dose intramuscularly on unknown arm on 13th November 2019, batch number: 2CP9B) and shingrix (received 2nd dose intramuscularly on unknown arm on 17th April 2020, batch number: 73E59).   On 4th January 2022, the patient received the 4th dose of Shingrix (intramuscular). On 5th January 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 5th January 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 4th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The reporter was the retail pharmacist. The reporter stated that patient received 4 doses of Shingrix and all were given on arm intramuscularly at the same pharmacy which led to extra dose administered. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002784:same reporter US-GLAXOSMITHKLINE-US2022002785:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 4 doses of Shingrix; patient received 4 doses of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 97PL2, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 17th April 2020, Batch number- 73E59, intramuscularly on an unknown arm) and Shingrix (received 1st dose on 13th November 2019, Batch number- 2CP9B, intramuscularly on an unknown arm).   On 4th January 2022, the patient received the 4th dose of Shingrix (intramuscular). On 5th January 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 5th January 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 4th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: This case was reported by the retails pharmacist. The patient received 4 doses of Shingrix on an unknown arm, which led to extra dose administered. All the doses were given at the same pharmacy. The reporter consented to follow up. This case is one of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002782:same reporter US-GLAXOSMITHKLINE-US2022002785:same reporter