chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Within approximately 2 minutes of getting the shot I started to feel clammy and warm. Then started to sweat heavily. This lasted for about 5 minutes. 7 days after my shot I developed a red itchy bump at the injection site.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Fatigue, Headache, Intensive care
Clinical narrative: Headache, shortness of breath, difficulty breathing, fatigue from 6/12-6/18.  Pulmonary embolism diagnosis on 6/18
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Headache, shortness of breath, difficulty breathing, fatigue from 6/12-6/18.  Pulmonary embolism diagnosis on 6/18
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Intense nausea and vomiting starting at 5 AM, intense achiness and headache. Vomiting intermittent throughout the day, with 20-30 occurrences between 5 AM and 10PM. Ondansetron 4mg RX administered at approx 9 AM and 8 PM.   No improvement after morning dose, contents promptly thrown back up. Brief period of improvement late afternoon until early evening on 06/29/2021. Water and crackers and toast administered during improvement. Child was vomiting bile by 10PM.   As of this report, not yet resolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival oedema, Conjunctivochalasis, Eye irritation, Ophthalmological examination
Clinical narrative: In less than a week and a half after the second dose, I started experiencing eye irritation - which was recently diagnosed as Conjunctival Chalasis.   Extreme eye irritation and occasional cystic swelling of conjuntiva in my right eye.    My eye was been treated with steriod drops, and am now being treated with Prolensa.  I can no longer wear a contact in my right eye.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Occasional bouts of dizziness
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin hypopigmentation, Tenderness, Unevaluable event
Clinical narrative: Hypopigmentation in the shape of a circle, the size of the bandaid was noticed around May 18th. It coincidentally happened to appear after I stuck a round magnet on my arm after hearing the theory that Covina vaccines were magnetic. The magnet did not stick but the day following my arm was tender and it was shortly after I noticed the round circle appear. Photos are available.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Loss of consciousness
Clinical narrative: Child passed out day after
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint swelling, Laboratory test, Magnetic resonance imaging, Pain
Clinical narrative: Inflammation in hip/leg. Unable to wLk. Excrutiating pain
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, X-ray
Clinical narrative: Inflammation in hip/leg. Unable to wLk. Excrutiating pain
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: Chest pain 3 days after 2nd Pfizer Covid vaccination.  Worse lying down, improved sitting up High Sensitivity Troponin 2340 ng/l
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Headache, Insomnia, Memory impairment
Clinical narrative: Headaches, brain fog, lack of sleep, trouble remembering things
Age: 24.0
Sex: M
Vaccine: ADEN_4_7, HPV9
Symptoms: Focal segmental glomerulosclerosis, Nephrotic syndrome, Proteinuria
Clinical narrative: Diagnosed with FSGS, nephrotic syndrome and proteinuria
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Headache, Herpes zoster
Clinical narrative: I had a severe shingles outbreak which I believe wasrelated to Pfi zer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. Inaddition, I had severe headaches for several days. I'm 38 and I've never had shingles before (although I likelyhad chickenpox in my childhood). An urgent care nurse prescribed me Acyclovir 800MG tablets 5 times a dayand TRIAMCINOLONE 0.1% cream 2-4 times a day. Now 2 weeks later the rash looks much better however Istill feel annoying burning.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Headache, Herpes zoster, Rash, Skin burning sensation
Clinical narrative: I had a severe shingles outbreak which I believe wasrelated to Pfi zer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. Inaddition, I had severe headaches for several days. I'm 38 and I've never had shingles before (although I likelyhad chickenpox in my childhood). An urgent care nurse prescribed me Acyclovir 800MG tablets 5 times a dayand TRIAMCINOLONE 0.1% cream 2-4 times a day. Now 2 weeks later the rash looks much better however Istill feel annoying burning.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Pain, Pericarditis
Clinical narrative: Stabbing Chest Pain, Myocarditis or Pericarditis
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea; Severe lightheadedness and diziness; This is a spontaneous report received from a contactable other health professional (patient, self-reported). A 42-year-old female patient (age at vaccination: 42 year) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 24Mar2021 09:15 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes, osteoarthritis, fibromialgya, and arthritis. The patient was not allergies to medications, food, or other products. Concomitant medications included tetanus vaccine toxoid (TETANUS-VACCIN, in right arm) within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 24Mar2021 at 12:15 AM, she had severe lightheadedness and diziness. Due to dizziness, she couldn't stay stand. The patient also had nausea on an unspecified date. She couldn't guide; therefore, she couldn't go to the hospital. The patient did not receive treatment for the adverse event. Outcome of the events not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event dizziness and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided.  On 27-APR-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) with lot number T002845 and expiration date 23-JAN-2022 (both verified as valid) for prophylaxis (dose, vaccination scheme, route and anatomical location of administration were not reported). Varicella virus vaccine live (oka/merck) (VARIVAX)  was improperly stored at a temperature of -14 degrees Celsius for a time frame of 35 hours and 43 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2106USA001746: US-009507513-2106USA001761: US-009507513-2106USA001914: US-009507513-2106USA001941: US-009507513-2106USA001959:
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Off label use, Pain in extremity, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: he was in a lot of pain in her arm and believed the doctor hit her bone after the administration of MMR II.; daughter was administered MMR II via intramuscularly via subcutaneously; Doctor informed her that new research states that it is better to give MMR II via intramuscularly; This spontaneous report was received from a pharmacist referring to her daughter a 25 year old female patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 21-APR-2021 and 02-JUN-2021, the patient was vaccinated with the first and second dose, respectively, of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) 0.5 milliliters (ml) on her arm, intramuscularly instead of subcutaneously (lot number S020161 and expiration date: 30-JUN-2021) for prophylaxis even though paperwork said the vaccine was administered subcutaneously On 02-JUN-2021 the patient experienced a lot of pain in her arm (vaccination site pain) and believed the doctor hit her bone after the administration of the above mentioned vaccine (incorrect route of product administration). The patient self-medicated with (paracetamol) TYLENOL and recovered from the event. The patient contacted the physician and the physician informed her that new research stated that it is better to give  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) II vaccine via intramuscularly instead o subcutaneously but wouldn't provide the patient with information (off label use).  The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the vaccination site pain was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: no other AEs reported; needle malfunction caused a patient to receive a smaller than recommended dose of PROQUAD (0.3ml as opposed to 0.5ml).; needle malfunction; This spontaneous report was received from a registered 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 15-JUN-2021, when the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T025509 expiration date 23-JAN-2022 (route of administration was not provided) for prophylaxis, the needle had a malfunction (product quality issue) causing that the patient to receive 0.3 milliliter instead of 0.5 milliliters as the recommended dose (underdose). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; an improper stored dose  of PNEUMOVAX23 was administered today / the product was frozen upon removal from the refrigerator; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-JUN-2021, the patient was vaccinated with an improper stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, intramuscularly, lot# T034630, expiration date 22-JUN-2022, for prophylaxis (strength and frequency were not reported). Temperature excursion details were not provided; however, the product was frozen upon removal from the refrigerator. A digital data logger was not involved. No additional adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no adverse events; Administration of an expired dose of PNEUMOVAX23; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-JUN-2021, the patient was vaccinated with an expired dose of (PNEUMOVAX23) 1 injection, lot# S024808, expiration date 02-JUN-2021, for prophylaxis (strength, route and frequency were not reported). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 14-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Sex: U
Vaccine: VARCEL
Symptoms: In vitro fertilisation, No adverse event
Clinical narrative: Improperly stored VARIVAX was administered; no adverse event; This spontaneous report was received from a nurse (also reported as office manager) and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025947, expiration date 30-JUL-2022 (administration route, dose and frequency were not reported) for prophylaxis.   The improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) experienced multiple excursions as they were stored from -50 Celsius degrees (C) to -15C, with an average temperature of -12.8C for 40 minutes, and also with an average of -12.7C during 1 hour. There was a previous temperature excursion with an average temperature of -12.8C, for 40 minutes (reported twice). The call was because of a data logger.No additional adverse event or product quality complaint (PQC) were involved.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional adverse event; Patient was administered VARIVAX via intramuscular route, instead of subcutaneous route; This spontaneous report was received from a nurse and refers to a 29 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025942,  expiration date 30-JUL-2022, intramuscularly (instead of subcutaneous route) for prophylaxis (dose and frequency not reported). No additional adverse events were reported.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; the patient had already completed the GARDASIL 9 series, so today he received a fourth dose; This spontaneous report was received from a nurse referring to a 21 year old male patient. Information regarding the patient's concurrent conditions, pertinent medical history and concurrent conditions was not provided.     On 24-JUN-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot # T026323, expiration date 22-FEB-2023) dose, route of administration and anatomical location were not reported for prophylaxis. The reporter stated that she did not realize that the patient had already completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination series 10 years prior, so the patient received a fourth dose (extra dose administered). No additional adverse event or product quality concern was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: no adverse reactions; didn't realized it was MMR-11 and varicella combined; accidently gave a 4 year old patient an expired dose of VARlVAX.; It was also reported that the staff member gave PROQUAD but meant to give MMR-II and didn't realized it was MMR-II; both VARlVAX and PROQUAD were given intramuscularly rather than subcutaneously; Information has been received from a medical assistant, referring to a 4 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2021, the patient was vaccinated by accident with an expire dose of varicella virus vaccine live (oka/merck)(VARIVAX), (lot number and expiration date were not reported) intramuscularly for prophylaxis. It was also reported that the patient was also vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot number and expiration date were not reported) instead of measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). n addition, the reported confirmed that both vaccines (varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)) were given intramuscularly rather than subcutaneously. Per reporter, the patient did not have any adverse reactions.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Improperly stored PNEUMOVAX23 was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.      On 14-JUN-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # T016159, expiration date 28-FEB-2022) 0.5 ml, intramuscular route, anatomical location was not reported for prophylaxis. The reporter stated that the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) administered was improperly stored, as they had a power outage and the temperature reached was unknown but she reported that the product was out of range for one day. No previous temperature excursion was reported it was unspecified if the call was beacuse of a data logger. No additional adverse events reported, no product quality complaint. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Shingrix cause swelling in axillary lymph nodes; This case was reported by a consumer via interactive digital media and described the occurrence of axillary lymph nodes enlarged in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. The patient received Shingrix and had swelling in axillary lymph nodes. The patient asked if this could be the side effect of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I got it after my shot.; 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got shingles after the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: I got the shingles shot twice. Both times I got the shingles/ suspected vaccination failure; Got them twice after the shots/ got the shingles; This case was reported by a consumer via (Facebook) 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles shot twice and both times got the shingles. The reporter stated that, shingles were one of the many side effets from the covid shot and this was the reason why the patient's doctor advised not to take the covid shot. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting. This case is linked with the case- US2021AMR139339, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139339:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: My friend got them three more times after being vaccinated/ Suspected vaccination failure; My friend got them three more times; 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.   The patient's past medical history included shingles.   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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient got shingles three more times after being vaccinated, so they could save it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Bell's palsy
Clinical narrative: got Bell's palsy within a day or two after I gave the flu shot a few years ago; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a adult patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a week after receiving Influenza vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Influenza vaccine.  Additional details were provided as follows: The patients was 65 years old at the time of reporting. The case was reported by a physician during a Medical information chat. More than 12 to 13 years ago the patient received flu shot and got Bell's palsy within a day or two after the vaccination. The reporter had no vaccination records.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: DIFFICULTY WITH THE RIGHT SIDE OF NECK; RIGHT SIDE MUSCLE ATROPHY DOESN'T REALLY SHOW, EXCEPT FOR BUTTOCKS; HURTS DOWN THROUGH SHOULDER BLADE; LIMBS FELT HEAVY; MUSCLES AND BRAIN ON STRIKE, BRAIN HAD A HARD TIME COMING UP; MAJOR MUSCLE  FATIGUE/ DIFFICULT DEALING WITH THE MUSCLE FATIGUE; TWINGES; ABLE TO SPEAK MORE CLEARLY, MORE MOBILITY IN LEGS AND ARMS, LESS PAIN IN THE RIGHT SIDE OF THE BODY MORE ANKLE MOVEMENT AND READ JUST JOINTS; CHILLS; WOKE UP WITH SLIGHT HEADACHE; ACHY MUSCLE; TIRED; FEVER; RIGHT ARM NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hemorrhagic stroke associated with pain, and concurrent conditions included seizures, felt like a chain mail sock on up to thigh, arm was standstill, and felt like arm had more soft tissue (padding) than muscle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced right arm numb. On 15-MAY-2021, the subject experienced chills. On 15-MAY-2021, the subject experienced woke up with slight headache. On 15-MAY-2021, the subject experienced achy muscle. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints. On 25-MAY-2021, the subject experienced twinges. On 26-MAY-2021, the subject experienced limbs felt heavy. On 26-MAY-2021, the subject experienced muscles and brain on strike, brain had a hard time coming up. On 26-MAY-2021, the subject experienced major muscle fatigue/ difficult dealing with the muscle fatigue. On 17-JUN-2021, the subject experienced difficulty with the right side of neck. On 17-JUN-2021, the subject experienced right side muscle atrophy doesn't really show, except for buttocks. On 17-JUN-2021, the subject experienced hurts down through shoulder blade. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achy muscle, and fever on 15-MAY-2021, and woke up with slight headache, had not recovered from major muscle fatigue/ difficult dealing with the muscle fatigue, and the outcome of able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints, right arm numb, tired, twinges, difficulty with the right side of neck, hurts down through shoulder blade, right side muscle atrophy doesn't really show, except for buttocks, limbs felt heavy and muscles and brain on strike, brain had a hard time coming up was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Therapeutic response unexpected
Clinical narrative: DIFFICULTY WITH THE RIGHT SIDE OF NECK; RIGHT SIDE MUSCLE ATROPHY DOESN'T REALLY SHOW, EXCEPT FOR BUTTOCKS; HURTS DOWN THROUGH SHOULDER BLADE; LIMBS FELT HEAVY; MUSCLES AND BRAIN ON STRIKE, BRAIN HAD A HARD TIME COMING UP; MAJOR MUSCLE  FATIGUE/ DIFFICULT DEALING WITH THE MUSCLE FATIGUE; TWINGES; ABLE TO SPEAK MORE CLEARLY, MORE MOBILITY IN LEGS AND ARMS, LESS PAIN IN THE RIGHT SIDE OF THE BODY MORE ANKLE MOVEMENT AND READ JUST JOINTS; CHILLS; WOKE UP WITH SLIGHT HEADACHE; ACHY MUSCLE; TIRED; FEVER; RIGHT ARM NUMB; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hemorrhagic stroke associated with pain, and concurrent conditions included seizures, felt like a chain mail sock on up to thigh, arm was standstill, and felt like arm had more soft tissue (padding) than muscle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced right arm numb. On 15-MAY-2021, the subject experienced chills. On 15-MAY-2021, the subject experienced woke up with slight headache. On 15-MAY-2021, the subject experienced achy muscle. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced fever. On 18-MAY-2021, the subject experienced able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints. On 25-MAY-2021, the subject experienced twinges. On 26-MAY-2021, the subject experienced limbs felt heavy. On 26-MAY-2021, the subject experienced muscles and brain on strike, brain had a hard time coming up. On 26-MAY-2021, the subject experienced major muscle fatigue/ difficult dealing with the muscle fatigue. On 17-JUN-2021, the subject experienced difficulty with the right side of neck. On 17-JUN-2021, the subject experienced right side muscle atrophy doesn't really show, except for buttocks. On 17-JUN-2021, the subject experienced hurts down through shoulder blade. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achy muscle, and fever on 15-MAY-2021, and woke up with slight headache, had not recovered from major muscle fatigue/ difficult dealing with the muscle fatigue, and the outcome of able to speak more clearly, more mobility in legs and arms, less pain in the right side of the body more ankle movement and read just joints, right arm numb, tired, twinges, difficulty with the right side of neck, hurts down through shoulder blade, right side muscle atrophy doesn't really show, except for buttocks, limbs felt heavy and muscles and brain on strike, brain had a hard time coming up was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. Laboratory data (dates unspecified) included: Covid-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint (PQC).; Sender's Comments: V0: 20210642713-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy
Clinical narrative: FOGGY FEELING, FEELING LIKE TAKEN AN HALLUCINOGENIC; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the subject experienced foggy feeling, feeling like taken an hallucinogenic. On 15-JUN-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from foggy feeling, feeling like taken an hallucinogenic, and lethargic. This report was non-serious. This case, from the same reporter is linked to 20210651147.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Depressed mood, Feeling hot, Insomnia
Clinical narrative: PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. This event(s) is considered unassessable. The event(s) 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(s).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, Sweating fever
Clinical narrative: PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. This event(s) is considered unassessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Thrombosis
Clinical narrative: BODY ACHES; PAIN IN ARM; BLOOD CLOT; This spontaneous report received from a patient who reported on social media via a company representative concerned a patient of unspecified age, sex, 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, intramuscular, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 21-JUN-2021, the patient had blood clot and reported that arm was killing (pain in arm). On 22-JUN-2021, in the morning, the patient got body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm, body aches and blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651546-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) 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(s).