chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Got Covid on 31Dec2022.; got Covid on 31Dec2022.; she got the J and J as dose 1/Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose 2 (booster), single (Lot number: EW0186) at the age of 65 years, in arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "she got the J and J as dose 1/Pfizer COVID booster"; DRUG INEFFECTIVE (medically significant) with onset 31Dec2022, outcome "unknown", described as "Got Covid on 31Dec2022."; COVID-19 (medically significant) with onset 31Dec2022, outcome "unknown", described as "got Covid on 31Dec2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive, notes: got COVID virus on 31Dec2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19, interchange of vaccine products.The patient had no other medical conditions. Indication for the Pfizer booster was also mentioned as general health guidelines as a good citizen. Reporter stated that she wanted to alert that she had an adverse reaction to the booster shot. In 2021, when she was 64 as soon as she was eligible in Mar2021, she got the J and J and had a good night's sleep and was fine. In Nov2021, 7-8 months later the J and J was not available so she got the Pfizer booster vaccine. Patient mentioned that she would like to get another booster but does not know if there has been any research done on individuals who suffered from myocarditis after the Pfizer shot and asked if ther was a vaccine recommended for that demographic. There may be clinical research done and they may share that with her. She mentioned that she did get Covid three weeks ago because she did not know which vaccine to take. She did not go to a physician. She did not know if she still has it and she will be tested for Covid tomorrow. She still has some effects. It was further specified that patient received Pfizer COVID booster on 20Nov2021 and got COVID virus on 31Dec2022.; Sender's Comments: Linked Report(s) : PFIZER INC-202300036615 same reporter, product and patient, different event.;
Age: 62.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE STORAGE TEMP ISSUE, HEALTH DEPARTMENT ADVISED TO REPEAT.
Age: 62.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Product storage error
Clinical narrative: VACCINE STORAGE TEMP ISSUE, HEALTH DEPARTMENT ADVISED TO REPEAT.
Age: 42.0
Sex: U
Vaccine: FLUA4, FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 55.0
Sex: U
Vaccine: FLUA4, FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product distribution issue, Product reconstitution quality issue, Product storage error
Clinical narrative: No symptomatic side effects reported; the product was frozen and was inadvertently administered to patients; a shipment of DILUENT arrived a day later than it's "receive by" date.; Product reconstitution quality issue; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 21-DEC-2022, a shipment of sterile diluent (STERILE DILUENT) Solution for injection/infusion (lot# W000447, expiration date 07-MAY-2024; strength, dose, route of administration and anatomical location were not reported) arrived a day later than it's "receive by" date (product distribution issue) and had a "freeze" indicator that stated the product was frozen (product storage error) which was not quarantined and was inadvertently administered to the patient, and reconstituted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot# W026326, expiration date 18-FEB-2024; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product reconstitution quality issue). No symptomatic side effects reported. No additional adverse events details or product quality complaint (PQC).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Corrective lens user, Diplopia, Disorientation, Eye disorder
Clinical narrative: On July 29, 2022, five days after receiving my 2nd Covid Booster (received on July 24, 2022), I started to experience double vision while driving and extreme eye fatigue.  The double vision then persistent while simply looking at a distance, while walking, watching television, and computer work. I contacted my ophthalmologist who diagnosed me with strabismus (appt was during the week of August 22, exact day not remembered as they gave me an appointment almost immediately due to my symptoms) and planned to refer me to a specialist. That referral was never processed therefore I consulted with my primary care physician who processed a referral to Neuro-Ophthalmologist.  By the time I was able to be seen by Dr., it was 10/26/2022.  Prior to receiving the 2nd Covid Booster, I did not have any vision issues.  My only vision prescription was a progressive prescription for reading and computer only.  This 2nd booster was also the only vaccine that also caused the chills and headache the following day and I was unable to go to work.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Strabismus, Vision blurred
Clinical narrative: On July 29, 2022, five days after receiving my 2nd Covid Booster (received on July 24, 2022), I started to experience double vision while driving and extreme eye fatigue.  The double vision then persistent while simply looking at a distance, while walking, watching television, and computer work. I contacted my ophthalmologist who diagnosed me with strabismus (appt was during the week of August 22, exact day not remembered as they gave me an appointment almost immediately due to my symptoms) and planned to refer me to a specialist. That referral was never processed therefore I consulted with my primary care physician who processed a referral to Neuro-Ophthalmologist.  By the time I was able to be seen by Dr., it was 10/26/2022.  Prior to receiving the 2nd Covid Booster, I did not have any vision issues.  My only vision prescription was a progressive prescription for reading and computer only.  This 2nd booster was also the only vaccine that also caused the chills and headache the following day and I was unable to go to work.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itchiness on arms, trunk, and neck
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Extreme fatigue; Dizziness; Orthostatic intolerence; autonomic dysfunction; Severe and constant headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), severe and persistent headache, autonomic nervous system imbalance, orthostatic intolerance, dizziness, and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007498: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Extreme fatigue; Dizziness; Orthostatic intolerence; autonomic dysfunction; Severe and constant headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), severe and persistent headache, autonomic nervous system imbalance, orthostatic intolerance, dizziness, and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007498: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), and dizziness.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007498: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic intolerence; Autonomic Nervous System Imbalance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007498: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic intolerence; Autonomic Nervous System Imbalance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to female patient (pt) of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007498: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE details available.; received a 3rd dose of GARDASIL 9 when she did not need to.; This spontaneous report was received from the patient's mother concerning an 18-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 17-OCT-2016, when the patient was 12 years old, she received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported).   On an unspecified day in May 2017, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported), which aligned with the 2 dose regimen according to the patient's age at that moment.   On 16-JAN-2023, when the patient was 18 years old, her gynecologist told her that she should get a third dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and administered the vaccine for prophylaxis when she did not need to (dose, route of administration, injection anatomical location, lot # and expiration date were not reported) (Extra dose administered). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2009 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS). The outcome of the event was not provided. The reporter stated that the event were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; dizziness; fatigue; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2011 following vaccination, the pt experienced Postural orthostatic tachycardia syndrome (POTS), dizziness, headache, and fatigue. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin, CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Meningitis/ The patient was currently hospitalized with "VZV meningitis"; pleocytosis; This spontaneous report has been received from a physician, referring a 13-year-old female patient. The patient's medical history included asthma, allergies were reported as none. The patient's concurrent conditions and concomitant medications were not provided.  On 06-AUG-2010, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 0224Zhas been verified to be a valid lot number, expiry date 28-JAN-2012) (strength, dose, and frequency were not reported) On 05-AUG-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 5002316 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)) (strength, dose, frequency, lot number, and expiry date were not reported) both vaccines were indicated as prophylaxis.  On 09-JAN-2023, the patient experienced arm pain; on 16-JAN-2023, the patient experienced herpes zoster skin rash, and was admitted to the hospital on 19-JAN-2023 for VZV meningitis (herpes zoster meningitis) and pleocytosis. The patient was described as "healthy and not immunocompromised". On the same date, diagnostical testing were performed: cerebral spinal fluid (CSF) was available for testing with protein 74 mg/dL red blood cells (RBC) <1000 (units not provided), glucose 56 mg/dL, and white blood cells (WBC) 269 (units not provided) (16% neutrophils, 70% lymphocytes, and 14% monocytes) with the results of meningitis panel and encephalitis PCR panel: with VZV PCR positive, and a sample from a skin lesion.  The outcome of the events herpes zoster meningitis and pleocytosis was not provided. It was stated that the patient is still hospitalized.  The causality assessment was not provided.  Upon internal review, the event herpes zoster meningitis was determined to be medically significant, and reported as life-threatening by the reporter.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Herpes zoster meningitis, Laboratory test, Lymphocyte percentage, Monocyte percentage decreased
Clinical narrative: Meningitis/ The patient was currently hospitalized with "VZV meningitis"; pleocytosis; This spontaneous report has been received from a physician, referring a 13-year-old female patient. The patient's medical history included asthma, allergies were reported as none. The patient's concurrent conditions and concomitant medications were not provided.  On 06-AUG-2010, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 0224Zhas been verified to be a valid lot number, expiry date 28-JAN-2012) (strength, dose, and frequency were not reported) On 05-AUG-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 5002316 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)) (strength, dose, frequency, lot number, and expiry date were not reported) both vaccines were indicated as prophylaxis.  On 09-JAN-2023, the patient experienced arm pain; on 16-JAN-2023, the patient experienced herpes zoster skin rash, and was admitted to the hospital on 19-JAN-2023 for VZV meningitis (herpes zoster meningitis) and pleocytosis. The patient was described as "healthy and not immunocompromised". On the same date, diagnostical testing were performed: cerebral spinal fluid (CSF) was available for testing with protein 74 mg/dL red blood cells (RBC) <1000 (units not provided), glucose 56 mg/dL, and white blood cells (WBC) 269 (units not provided) (16% neutrophils, 70% lymphocytes, and 14% monocytes) with the results of meningitis panel and encephalitis PCR panel: with VZV PCR positive, and a sample from a skin lesion.  The outcome of the events herpes zoster meningitis and pleocytosis was not provided. It was stated that the patient is still hospitalized.  The causality assessment was not provided.  Upon internal review, the event herpes zoster meningitis was determined to be medically significant, and reported as life-threatening by the reporter.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Neutrophil percentage increased, Pain in extremity, Pleocytosis, Rash, Skin lesion
Clinical narrative: Meningitis/ The patient was currently hospitalized with "VZV meningitis"; pleocytosis; This spontaneous report has been received from a physician, referring a 13-year-old female patient. The patient's medical history included asthma, allergies were reported as none. The patient's concurrent conditions and concomitant medications were not provided.  On 06-AUG-2010, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 0224Zhas been verified to be a valid lot number, expiry date 28-JAN-2012) (strength, dose, and frequency were not reported) On 05-AUG-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 5002316 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)) (strength, dose, frequency, lot number, and expiry date were not reported) both vaccines were indicated as prophylaxis.  On 09-JAN-2023, the patient experienced arm pain; on 16-JAN-2023, the patient experienced herpes zoster skin rash, and was admitted to the hospital on 19-JAN-2023 for VZV meningitis (herpes zoster meningitis) and pleocytosis. The patient was described as "healthy and not immunocompromised". On the same date, diagnostical testing were performed: cerebral spinal fluid (CSF) was available for testing with protein 74 mg/dL red blood cells (RBC) <1000 (units not provided), glucose 56 mg/dL, and white blood cells (WBC) 269 (units not provided) (16% neutrophils, 70% lymphocytes, and 14% monocytes) with the results of meningitis panel and encephalitis PCR panel: with VZV PCR positive, and a sample from a skin lesion.  The outcome of the events herpes zoster meningitis and pleocytosis was not provided. It was stated that the patient is still hospitalized.  The causality assessment was not provided.  Upon internal review, the event herpes zoster meningitis was determined to be medically significant, and reported as life-threatening by the reporter.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella meningitis, Varicella virus test positive
Clinical narrative: Meningitis/ The patient was currently hospitalized with "VZV meningitis"; pleocytosis; This spontaneous report has been received from a physician, referring a 13-year-old female patient. The patient's medical history included asthma, allergies were reported as none. The patient's concurrent conditions and concomitant medications were not provided.  On 06-AUG-2010, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 0224Zhas been verified to be a valid lot number, expiry date 28-JAN-2012) (strength, dose, and frequency were not reported) On 05-AUG-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection on the left arm (lot number 5002316 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)) (strength, dose, frequency, lot number, and expiry date were not reported) both vaccines were indicated as prophylaxis.  On 09-JAN-2023, the patient experienced arm pain; on 16-JAN-2023, the patient experienced herpes zoster skin rash, and was admitted to the hospital on 19-JAN-2023 for VZV meningitis (herpes zoster meningitis) and pleocytosis. The patient was described as "healthy and not immunocompromised". On the same date, diagnostical testing were performed: cerebral spinal fluid (CSF) was available for testing with protein 74 mg/dL red blood cells (RBC) <1000 (units not provided), glucose 56 mg/dL, and white blood cells (WBC) 269 (units not provided) (16% neutrophils, 70% lymphocytes, and 14% monocytes) with the results of meningitis panel and encephalitis PCR panel: with VZV PCR positive, and a sample from a skin lesion.  The outcome of the events herpes zoster meningitis and pleocytosis was not provided. It was stated that the patient is still hospitalized.  The causality assessment was not provided.  Upon internal review, the event herpes zoster meningitis was determined to be medically significant, and reported as life-threatening by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse Practitioner called and reported that a dose of VAQTA expired on 14JAN2023 and was administered on 25JAN2023. The product had no temperature excursions through date of administration. No additional AE reported. No PQC reported. No additional in; This spontaneous report was received from a nurse prescriber regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot #U021561, expiration date: 14-JAN-2023) (Expired product administered) for prophylaxis (strength, dose, dose number, anatomical location and route of administration were not provided). It was  reported that the product had no temperature excursions and no additional adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 28-DEC-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 28-DEC-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150600, 20230150423, 20230150157, 20230149982, 20230150588 and 20230150716.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Migraine, Vision blurred
Clinical narrative: STROKE; DIZZINESS; BLURRY VISION; MIGRAINES; This spontaneous report received from a patient concerned an adult male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had optimal body weight, lifestyle and diet. The patient had no history of heart or other health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 1 administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. Following vaccination with covid-19 vaccine ad26.cov2.s on an unspecified date in APR-2021, the patient suffered from dizziness, blurry vision and migraines for three weeks. On 28-APR-2021, the patient had a stroke which affected right side and speech which was diagnosed by a cardiologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, blurry vision, and migraines, and the outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230152916- Stroke-The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 31-MAR-2021 for covid-19 prophylaxis. The patient did not experience any adverse event with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on 03-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JAN-2022, the patient experienced covid-19 test positive. The patient did not have any symptoms like fever, cough, congestion, chills. Laboratory data included: COVID-19 virus test Positive. On 01-FEB-2022, Laboratory data included: COVID-19 virus test showed a slight marker (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 test positive. This report was non-serious. This case, from the same reporter is linked to 20230157110.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Left testicle hurts; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TESTICULAR PAIN (Left testicle hurts) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (Left testicle hurts). At the time of the report, TESTICULAR PAIN (Left testicle hurts) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first Moderna vaccine on 8/4/2022 and his second Moderna vaccine on 11/30/2022.).    Concomitant medication was not reported.  Bivalent booster was administered on 6-Jan-2023.  Treatment medication was not reported.   This case was linked to MOD-2023-695514 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series; pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series; No adverse reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 IMMUNISATION (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series), INTERCHANGE OF VACCINE PRODUCTS (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series) and NO ADVERSE EVENT (No adverse reaction) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine (Three Pfizer maroon cap doses). Past adverse reactions to the above products included No adverse event with Comirnaty and Pfizer-BioNTech COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series), INTERCHANGE OF VACCINE PRODUCTS (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, COVID-19 IMMUNISATION (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series), INTERCHANGE OF VACCINE PRODUCTS (pediatrician gave a Moderna bivalent booster dose accidently to 2 y/o child after Pfizer's primary series) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.            It was reported that the patient (2-year-old) was accidentally given a Moderna booster by pediatrician after patient completing the Pfizer series. There was three months between her third pfizer dose and the moderna bivalent booster.  Concomitant medications and treatment medications were not reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260: case
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037E21A, 019B21A and 027A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)