chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nasopharyngitis, Product storage error
Clinical narrative: Pt was given a dose from a vial that was >12 hour post puncture. Vial was left at room temp at 6pm and pt was given dose at around 10:20am. Pt was informed of error and pt reported feeling "bad" after receiving shot. She states cold like symptoms, fever, chills, headache started the same evening (Friday) that she received the shot and was gone by Sunday evening, except for the headache. Headache has not gone away and has been ongoing 24/7. Pt has an upcoming appointment with her physician in about a week.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Pt was given a dose from a vial that was >12 hour post puncture. Vial was left at room temp at 6pm and pt was given dose at around 10:20am. Pt was informed of error and pt reported feeling "bad" after receiving shot. She states cold like symptoms, fever, chills, headache started the same evening (Friday) that she received the shot and was gone by Sunday evening, except for the headache. Headache has not gone away and has been ongoing 24/7. Pt has an upcoming appointment with her physician in about a week.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Laboratory test, Liver function test, Pruritus, Renal function test
Clinical narrative: Intense itching all over body, mainly in palm of hands.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, COVID-19, Chills
Clinical narrative: I had very little side effects from the booster shot compared to the second covid vaccine I had received approximately 8 months prior. I just had a mild headache and mild ache at injection site vs. chills, headache, joint pain, body aches, severe pain at injection site.  3 weeks later, I was feeling under the weather, but would test negative when using an at home covid test kit. Then, my boyfriend, whom I live with, tested positive for covid and we did not isolate him nor avoid direct contact. I was feeling ill for over a week and tested every other day but continued to test negative. Finally, on Jan 9, 2022, I lost my sense of smell and taste and got a covid positive result
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Injection site pain, Malaise, Pain
Clinical narrative: I had very little side effects from the booster shot compared to the second covid vaccine I had received approximately 8 months prior. I just had a mild headache and mild ache at injection site vs. chills, headache, joint pain, body aches, severe pain at injection site.  3 weeks later, I was feeling under the weather, but would test negative when using an at home covid test kit. Then, my boyfriend, whom I live with, tested positive for covid and we did not isolate him nor avoid direct contact. I was feeling ill for over a week and tested every other day but continued to test negative. Finally, on Jan 9, 2022, I lost my sense of smell and taste and got a covid positive result
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had very little side effects from the booster shot compared to the second covid vaccine I had received approximately 8 months prior. I just had a mild headache and mild ache at injection site vs. chills, headache, joint pain, body aches, severe pain at injection site.  3 weeks later, I was feeling under the weather, but would test negative when using an at home covid test kit. Then, my boyfriend, whom I live with, tested positive for covid and we did not isolate him nor avoid direct contact. I was feeling ill for over a week and tested every other day but continued to test negative. Finally, on Jan 9, 2022, I lost my sense of smell and taste and got a covid positive result
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dyspnoea, Feeling jittery, Genital rash
Clinical narrative: Day 1: Fingertips numb & tingly Day 2: Vaginal area swollen & painful. Left labia very enlarged. Could not tell if the pain was from a bump(s) on the inner genitals or vaginal opening as area was so swollen. Extremely painful & sensitive to touch. Lasted several weeks. Bumps returned in Jan 2022 -painful & burning sensation. Day 5: Felt like wind was knocked out of her. Pain in mid area below chest. Day 15: Very shaky & jittery. Note: Same painful vaginal issues appeared 3 months after 2nd Pfizer vaccine shot.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Labia enlarged, Paraesthesia, Tenderness, Tremor
Clinical narrative: Day 1: Fingertips numb & tingly Day 2: Vaginal area swollen & painful. Left labia very enlarged. Could not tell if the pain was from a bump(s) on the inner genitals or vaginal opening as area was so swollen. Extremely painful & sensitive to touch. Lasted several weeks. Bumps returned in Jan 2022 -painful & burning sensation. Day 5: Felt like wind was knocked out of her. Pain in mid area below chest. Day 15: Very shaky & jittery. Note: Same painful vaginal issues appeared 3 months after 2nd Pfizer vaccine shot.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal infection, Vulvovaginal pain
Clinical narrative: Day 1: Fingertips numb & tingly Day 2: Vaginal area swollen & painful. Left labia very enlarged. Could not tell if the pain was from a bump(s) on the inner genitals or vaginal opening as area was so swollen. Extremely painful & sensitive to touch. Lasted several weeks. Bumps returned in Jan 2022 -painful & burning sensation. Day 5: Felt like wind was knocked out of her. Pain in mid area below chest. Day 15: Very shaky & jittery. Note: Same painful vaginal issues appeared 3 months after 2nd Pfizer vaccine shot.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Feeling jittery, Heavy menstrual bleeding
Clinical narrative: Day 1: Jittery after coffee (unusual. Lasted for 1 month). Fatigue for approx 1 week. Day 2: Very sleepy.  Day 5: Menstrual - very heavy for 3 days. Day 6: Very sleepy. Pain in buttocks & pelvic area lots of pressure. Stomach problems. Still very sleepy. Left wrist pain started (sharp, achy, constant).  Pain similar to doing too many handstands. Day 7: Wrist pain progressively worse. Has not done anything to aggravate arm. Day 8: Pain in wrist now has traveled to elbow. Day 15: Pain in left arm is now from elbow to fingers. Not swollen. Pain pretty constant. Day 16: Pain in arm = level 8. Day 24: Wrist sensitivity lingers. Can't put pressure on arm. Bowel movement irregular (not solid, color off) - lasted for at least 1 month. 2 Months: Menstrual heavy w/ clumps. Sore throat. Low-grade fever. 1 week later - dry cough. 3 Months: Tired & dizzy. No appetite.   Painful bumps appeared in vaginal area as had previously appeared after 1st vaccine dose. Painful to touch. Low-grade fever with sore throat. Sore neck.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain in extremity, Pelvic pain, Somnolence
Clinical narrative: Day 1: Jittery after coffee (unusual. Lasted for 1 month). Fatigue for approx 1 week. Day 2: Very sleepy.  Day 5: Menstrual - very heavy for 3 days. Day 6: Very sleepy. Pain in buttocks & pelvic area lots of pressure. Stomach problems. Still very sleepy. Left wrist pain started (sharp, achy, constant).  Pain similar to doing too many handstands. Day 7: Wrist pain progressively worse. Has not done anything to aggravate arm. Day 8: Pain in wrist now has traveled to elbow. Day 15: Pain in left arm is now from elbow to fingers. Not swollen. Pain pretty constant. Day 16: Pain in arm = level 8. Day 24: Wrist sensitivity lingers. Can't put pressure on arm. Bowel movement irregular (not solid, color off) - lasted for at least 1 month. 2 Months: Menstrual heavy w/ clumps. Sore throat. Low-grade fever. 1 week later - dry cough. 3 Months: Tired & dizzy. No appetite.   Painful bumps appeared in vaginal area as had previously appeared after 1st vaccine dose. Painful to touch. Low-grade fever with sore throat. Sore neck.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood urine present, Chromaturia, Cold sweat
Clinical narrative: 1. During the night after the shot--Severe stomach pain woke me up and couldn't sleep 2. During the night after the shot--lots of blood in the pee, Pee was in dark brown color 3. Next morning---heart raising, cold sweat, couldn't move, dizziness, extremely week, severe stomach pain 4. urine test showed blood inside 5. Doctor diagnosed for kidney bleeding 6. Kidney kept bleeding for a month 7. Had to do urine test repeatedly 8. Stomach pain sometimes
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Movement disorder, Palpitations, Renal haemorrhage, Sleep disorder
Clinical narrative: 1. During the night after the shot--Severe stomach pain woke me up and couldn't sleep 2. During the night after the shot--lots of blood in the pee, Pee was in dark brown color 3. Next morning---heart raising, cold sweat, couldn't move, dizziness, extremely week, severe stomach pain 4. urine test showed blood inside 5. Doctor diagnosed for kidney bleeding 6. Kidney kept bleeding for a month 7. Had to do urine test repeatedly 8. Stomach pain sometimes
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: 1. During the night after the shot--Severe stomach pain woke me up and couldn't sleep 2. During the night after the shot--lots of blood in the pee, Pee was in dark brown color 3. Next morning---heart raising, cold sweat, couldn't move, dizziness, extremely week, severe stomach pain 4. urine test showed blood inside 5. Doctor diagnosed for kidney bleeding 6. Kidney kept bleeding for a month 7. Had to do urine test repeatedly 8. Stomach pain sometimes
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since 20 December she has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body and typically occur at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. Her symptoms led her to be seen in the ER on 24 Dec where she was treated with oral antihistamines and oral corticosteroid with transient relief of symptoms. Since that time she has been treated with two courses of oral corticosteroids. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 9 December, 11 days prior to onset of symptoms. She has used oral antihistamines with control of symptoms. She denies constitutional symptoms. UCT score today is 16 (2, 4, 3, 2, 1, 1, 1, 2).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure via breast milk, Pyrexia, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash), PYREXIA (Fever), DIARRHOEA (Diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) in a 4-month-old female infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A), while the mother received the product for COVID-19 vaccination. The patient's past medical history included Maternal exposure during breast feeding on 20-Dec-2021. On 20-Dec-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Dec-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding). On an unknown date, the infant was diagnosed with RASH (Small rash), PYREXIA (Fever) and DIARRHOEA (Diarrhea). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred  on 10-Aug-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 20-Dec-2021, EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) had resolved. At the time of the report, RASH (Small rash), PYREXIA (Fever) and DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown. Patient mother stated that she and her baby were reacting to the Moderna COVID 19 vaccine. Reporter's baby was 4.5kg when mother received the 1st dose of Moderna vaccine, her baby had a small rash (it was not over a lot of the body), fever and diarrhea. mother was younger, so she was not worried. Topical steroid were used for treatment of rashes, once they stop the steroid for a day, the symptoms came back. Reporter visited the pediatrician and allergist and they prescribed steroid. It was also reported that this was day three that they stopped the steroids and patient was having the symptoms again, that was the third time reporter tried to stop the steroid. No concomitant medication were provided. This case was linked to MOD-2022-507351 (Parent-Child Link). This case was linked to MOD-2022-506803 (Patient Link). See case MOD-2022-507351 for details regarding the Parent case.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Inflammation, Tinnitus
Clinical narrative: Consistently hearing a light ringing tone that sounds like the phone is off the hook in my left ear.
Sex: U
Vaccine: COVID19
Symptoms: Muscle discomfort
Clinical narrative: shot has effected the mussel in my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization. The following information was reported: MUSCLE DISCOMFORT (non-serious), outcome "unknown", described as "shot has effected the mussel in my arm".  Additional information: Caller stated that, shot has affected the mussel in arm. When brushing teeth arm falls. He cannot hold arm up good. It has done something to the mussel in that arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Vertigo
Clinical narrative: had a feeling of being dragged down; I am confused; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0167) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREDNISONE (ongoing). Vaccination history included: Bnt162b2 (1st dose of the Pfizer COVID Vaccine on 05Apr2021 with lot ER8737), administration date: 05Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "I am confused", "a bit of weakness and felt weak". The following information was reported: CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "I am confused"; VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "had a feeling of being dragged down".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine; 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 13-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose, lot # U024221, expiration date reported as 04-OCT-2023, but upon internal validation established as 04-AUG-2023 (dose number and exact route of administration were not provided) for prophylaxis (Product storage error). The vaccine had been improperly stored in the temperature of 39.55 Fahrenheit degrees (F) for 10 hours with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse, referring to a patient of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 31-JAN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation prefilled syringe, lot # U010534 with expiration date: 31-OCT-2022, 0.5 milliliter, strength unknown), intramuscularly for prophylaxis after temperature excursion (product storage error). No additional information provided.   Administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion below 49. 1 Fahrenheit degrees (F) for 5 hours and 9 minutes; 56.3F for 14 hours and 7 minutes; 49.6F for 35 hour and 9 minutes. There was no previous temperature excursions reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report has been received from a nurse prescriber referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not reported.   On 27-JAN-2022, 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) 1 dose (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U008315 has been verified to be valid, expiration date reported and established as 15-AUG-2023) for prophylaxis.  The vaccine was exposed to a temperature excursion of 0.5 degrees Celsius (C) during a time frame of 168 hours (product storage error). There was no previous temperature excursion, and no other adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA003842: US-009507513-2202USA003879: US-009507513-2202USA003908: US-009507513-2202USA003856:
Sex: M
Vaccine: PPV
Symptoms: Emphysema
Clinical narrative: WAS DIAGNOSED WITH EMPHYSEMA IN MAY 2021; This spontaneous report was received from a consumer (patient's wife) and refers to a male patient of unspecified age. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On an unknown date in 2010 (reported as "12 years ago"), the patient received one dose (reported as "1 dose") of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (concentration, scheme vaccination frequency, route of administration, anatomical site of application, lot number and expiration date were not provided) as prophylaxis.  On an unspecified date in May 2021, the patient was diagnosed with emphysema.  The outcome of the event was not reported. The causality assessment between the emphysema event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was reported as no connection (not related).
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PROQUAD had expired on 2/7/2022 and was administered to a patient on 2/18/2022.; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On 18-FEB-2022, the patient the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status rHA) (PROQUAD) lot #T027116 was confirmed to be valid, expiration date: 07-FEB-2022, administered for prophylaxis (exact dose, route of administration, anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired dose of MMR II; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 21-FEB-2022, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot #: T001212, expiration date: 12-JAN-2022, albumin status: recombinant human albumin (rHA) (site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
Age: 1.33
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported. No PQC; V ARlV AX was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a 16-months-old patient of an unknown gender. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diluent (STERILE DILUENT). Patient's concurrent conditions, medical history and drug allergies were not provided.  On 22-FEB-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot# U016065, expiration date 20-MAY-2023, at a dose 0,5 milliliter (route of administration and dose number were not provided) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored diluent (STERILE DILUENT) on the same day. The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at temperature 9.9F for 1 hour 22 minutes. No previous temperature excursion involved. No additional AE was reported. No PQC reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional information provided; an improperly stored dose of varivax was administered to a patient on 17-FEB-2022; This spontaneous report was received from a 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 17-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot # U010400, expiration date 01-APR-2023 (formulation, dose number, site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 293 hours and 14 minutes. No previous temperature excursions reported. No additional information provided (no adverse event).; Sender's Comments:  US-009507513-2202USA007938: US-009507513-2202USA008270: US-009507513-2202USA007865:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Adinistration of on expired PRODUCT to a patient; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 25-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot # not reported and expiration date reported as 29-JAN-2022) 1 dose, for prophylaxis (expired product administered). Vaccine had no prior temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose was inadvertantly administered to a patient after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient 's patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 28-FEB-2022, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rha) (M-M-R II) 0.5 ml/ once (lot # t006166 was valid and expiration date was 19-FEB-2022, anatomical location and vaccination scheme were not reported) for prophylaxis. The caller confirmed the MMR II dis not experience any temperature excursions prior administration. No additional AE nor PQC reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around May 2017, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles (herpes zoster). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of 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 had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event herpes zoster was considered as not recovered. The reporter considered the event of herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; postherpetic neuralgia; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around November 2014 the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles (herpes zoster), and post herpetic neuralgia. As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of 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 had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event herpes zoster and post herpetic neuralgia was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Vaccines were administered after temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions were not reported.   On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot # U017140, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided).  Concomitant medications included sterile diluent. However no adverse effects reported.   Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion above 6 Fahrenheit grades to 14 Fahrenheit grades for 4 hours 0 minutes 0 seconds. There were no previous temperature excursions reported.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pedriatic dose to a 20-year-old patient; pedriatic dose to a 20-year-old patient; no additional AE reported; Spontaneous information has been received from a nurse via company representative, referring a 20-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On an unknown date, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) as prophylaxis (dose, route, lot # and expiration date were not provided) (Incorrect dose administered, Product administered to patient of inappropriate age). No additional adverse event reported.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; GARDASIL 9 was accidently administered to a two month old patient on Mar 3, 2022; This spontaneous report was received from certified medical assistant and refers to a 10-week-old patient (also reported as 2-month-old). The patient's concurrent condition, medical history and concomitant medications were not provided.  On 03-MAR-2022, the patient was accidently vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age), lot number: 1780867, expiration date 08-AUG-2023, dose/frequency reported as "once" (route of administration and injection site were not reported) for prophylaxis. No adverse event (AE) and product quality complaint (PQC) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; vaccine was administered after temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 06-NOV-201, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA)) (PROQUAD) 0,5 millilter, lot#U017140, expiration date: 28-NOV-2022 (route of administration  was not reported) for prophylaxis (Product storage error). The vaccine was reconstituted with properly strored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 6 up to 14 degrees Fahrenheit for 4 hours and 14 up to 46 degrees Fahrenheit for 4 hours and 45 minutes. There were no previous excursions reported. There was no adverse effect reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001841:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; HBP in charge of vaccine storage calling to report that MMR II and VARIVAX were administered to a patient today 3/4/2022; This spontaneous report was received from an other health professional referring to a 57-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-MAR-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U006485, expiration date 26-FEB-2023 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number U022320, expiration date 15-JUL-2023 (doses and routes of administration not reported) both for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Needle issue, No adverse event, Product storage error
Clinical narrative: a needle was attached to a GARDASIL 9; no other adverse events reported; This spontaneous report has been received from a nurse referring a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies and drug allergies or reactions were not reported.   On 01-FEB-2022, a needle was attached to a HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe (product storage error) but was not administered to the patient until 25-FEB-2022 (exact dose and route were not reported, with a valid lot # T036444 and expiration date on 09-APR-2023) as prophylaxis. There were no other patients involved as a result of the attached needle. No other adverse events reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; nurse calling to report a temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U026796, expiration date 28-JAN-2023 (dose and route of administration not reported) as prophylaxis, which had undergone a temperature excursion of 48.8 Fahrenheit for 96 hours. No adverse event was reported.  No previous temperature excursions were reported.  This is one of 4 cases received by the same reporter. ; Sender's Comments:  US-009507513-2203USA000257: US-009507513-2203USA002143: US-009507513-2203USA002144:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; nurse calling to report a temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U026796, expiration date 28-JAN-2023 (dose and route of administration not reported) as prophylaxis, underwent a temperature excursion of 48.8 Fahrenheit for 96 hours. No adverse event was reported.  No previous temperature excursions were reported.  This is one of 4 cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA002142: US-009507513-2203USA000257: US-009507513-2203USA002144:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; nurse calling to report a temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U026796, expiration date 28-JAN-2023 (dose and route of administration not reported) as prophylaxis, underwent a temperature excursion of 48.8 Fahrenheit for 96 hours. No adverse event was reported.  No previous temperature excursions were reported.  This is one of 4 cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA002142: US-009507513-2203USA002143: US-009507513-2203USA000257:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of VAQTA was administered after its labeled expiry date; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.       On 02-MAR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T017179, expiration date 26-OCT-2021 for prophylaxis (dose #, exact dose, route of administration and anatomical location were not provided) (expired vaccine used).The vaccine did not experience any temperature excursions. The reporter provided the non-supported disclaimer based on the post expiry memo. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 05-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, once, lot number U022321, expiration date 15-JUL-2023 for prophylaxis (route of administration not reported) No adverse event was reported.  The vaccine underwent a temperature excursion of -8.1 degrees Celsius for 4 hours. No previous temperature excursions were reported.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: date of vaccination (Approx.): 2015, 2016; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1705USA014981), concerning an approximately 63-year-old female patient. The patient's medical history, concurrent condition and concomitant medication were not reported.  On an unknown date in 2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported). On an unknown date in 2016, the patient was vaccinated with another dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1705USA014981:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 27-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursion included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003335: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003311: US-009507513-2203USA003321:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 13-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003335: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003310: US-009507513-2203USA003321:
Age: 18.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Nauseous; Headache; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On 23rd February 2022, the patient received Menveo, Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine. On an unknown date, less than a week after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device and unknown after receiving HPV vaccine, the patient experienced dizziness, nausea and headache. On an unknown date, the outcome of the dizziness, nausea and headache were unknown.   It was unknown if the reporter considered the dizziness, nausea and headache to be related to Menveo, Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine. 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 case was reported by patient's mother. The patient after vaccination started complaining of dizziness, was nauseous and had headache.  The patient also received the HPV vaccine. The mother said all 3 vaccines (Menve, Bexsero, HPV) were given at the same time.  The reporter not sure which product was causing adverse event. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: dose in October 2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired Kinrix was given; This case was reported by a other health professional via other manufacturer and described the occurrence of expired vaccine used in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The patient received expired dose of Kinrix. No additional details or product quality complaint were reported.