chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV
Symptoms: Pruritus, Pustule, Pyrexia
Clinical narrative: Parent reports child had high fevers of 104F since vaccination along with pox and itchiness. Pox were reported on trunk, face, ears, arms, and buttocks. Fevers resolved after administering both Tylenol and ibuprofen.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: extreme body pain
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Patient would not stop crying after he got his vaccines at 10:45 AM, lasted about 2-3hrs, by 4:27 PM mom stated patient was doing better and no concerns.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hypotension, Syncope
Clinical narrative: PT HAS VACCINE DONE WITH NO COMPLICATIONS. PT AND MOTHER WAITIED IN LOBBY AFTER VACCINE ADMIN FOR ~5 MINUTES. PT EXCITED AND THEN WAITED OUTSIDE FOR 1-2 MINUTES. THEN HAD A SYNCOPAL EVENT LASTING A FEW SECONDS. PT HAD NO TRAUMA, AND MOTHER CAUGHT PATIENT PRIOR TO HITTING GROUND. CODE CALLED. PT WAS FOUND TO BE HYPOTENSIVE WITH BP 70/50 AND HR 65. AFTER SEVER MINUTES BLOOD PRESSURE RETURNED TO NORMAL TENSIVE. PT WAITED WITH MOTHER AND CODE STAFF FOR APROXIMATELY 15 MINUTES. PT REPORTED THEY FEEL BETTER AND WERE ALLOWED TO LEAVE AMBILATING WITH MOTHER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: headache, myalgia, fatigue, shivering, fever, and gastrointestinal symptoms characterized as nausea.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: headache, myalgia, fatigue, shivering, fever, and gastrointestinal symptoms characterized as nausea.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number DZ747, expiry date 12-JUL-2024) for prophylaxis.   On 16-JUL-2024, the patient received Engerix B adult. On 16-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUL-2024 The patient received an dose of Engerix B today (on the day of reporting) that expired on Friday, which led to expired vaccine used.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red rash; raised rash; white spot on stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUN-2024, the patient received the 1st dose of Shingrix (right deltoid). On 14-JUL-2024, 17 days after receiving Shingrix, the patient experienced red rash (Verbatim: Raised red rash), raised rash (Verbatim: raised rash) and rash (Verbatim: white spot on stomach). The outcome of the red rash, raised rash and rash were not resolved.   It was unknown if the reporter considered the red rash, raised rash and rash to be related to Shingrix.     It was unknown if the company considered the red rash, raised rash and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2024 Reporter was the patient who was currently on vacation.  The reporter stated that she received her first Shingrix vaccine in her right deltoid and on 14 July 2024 her stomach broke out in a red raised rash with little white spots and symptoms had not resolved.  She treated rash with Cort cream. Reporter did not have lot number of suspect product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: yet to receive shot 2.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th November 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: yet to receive shot 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-JUL-2024 The patient received Shingrix shot 1 but has yet to receive shot 2, which led to incomplete course of vaccination. Did not consent to follow-up.
Age: 85.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received the first dose of Twinrix on Sept 18, 2023 (2nd dose was due October 16, 2023) and did not get the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th September 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received the first dose of Twinrix on Sept 18, 2023 (2nd dose was due October 16, 2023) and did not get the 2nd dose.). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-JUL-2024 The pharmacist state a patient received the first dose of Twinrix and 2nd dose was due October 16, 2023, but did not get the 2nd dose, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric third dose (Engerix-B); Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   Previously administered products included Hepatitis B vaccine (On 04-MAR-2023, received 1st dose with batch number- W036194) and Hepatitis B vaccine (On 05-AUG-2023, received 2nd dose with batch number-W036194).   On 17-JUL-2024, the patient received the 3rd dose of Engerix B pediatric .5 ml. On 17-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: pediatric third dose (Engerix-B)) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 17-JUL-2024 The adult patient received Engerix-B pediatric dose, which led adult use of a child product and underdose. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered an extra dose of Boostrix on 15-JUL-2024; inadvertently administered an extra dose of Boostrix on 12-JUL-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received on 25-OCT-2013).   On 15-JUL-2024, the patient received Boostrix. On 12-JUL-2023, the patient received Boostrix. On 12-JUL-2023, not applicable after receiving Boostrix and an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: inadvertently administered an extra dose of Boostrix on 12-JUL-2023). On 15-JUL-2024, the patient experienced extra dose administered (Verbatim: inadvertently administered an extra dose of Boostrix on 15-JUL-2024). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 17-JUL-2024 The patient was inadvertently administered an extra dose of Boostrix on 12-Jul-2023 and 15-Jul-2024, which led extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult was inadvertently given a pediatric dose of Engerix-B; adult was inadvertently given a pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via sales rep and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult was inadvertently given a pediatric dose of Engerix-B) and accidental underdose (Verbatim: adult was inadvertently given a pediatric dose of Engerix-B). The outcome of the adult use of a child product and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2024 The medical assistant reported that an adult was inadvertently given a pediatric dose of Engerix-B vaccine, which led to adult use of a child product and accidental underdose. The reporter asked for advice and said that the patient had left the office and should the patient be recalled and given the adult dose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: Two adjuvant administration same patient (adjuvant alone + full correct dose) same visit; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug administration error in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7YE7T, expiry date 18-AUG-2024) for prophylaxis.   On 25-JUN-2024, the patient received Shingrix (unknown arm). On 25-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug administration error (Verbatim: Two adjuvant administration same patient (adjuvant alone + full correct dose) same visit). The outcome of the drug administration error was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2024 The nurse called and asked what to do as the patient that was given a full dose in one arm and a dose with the adjuvant alone (different arms) on the same vaccination date and on same visit, which led to drug administration error. The nurse did not know any detail (lot number, expiration date) on the adjuvant alone dose.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: developed an itchy rash after receiving the Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced itchy rash (Verbatim: developed an itchy rash after receiving the Shingrix vaccine). The outcome of the itchy rash was resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUL-2024 The patient self-reported this case. She developed an itchy rash after receiving the Shingrix vaccine and the rash had been present for 2 weeks. The reporter did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: the patient was supposed to get the MenACWY vaccine instead; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ZH7SN, expiry date 31-JAN-2027) for prophylaxis.   On 16-JUL-2024, the patient received Bexsero. On 16-JUL-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the patient was supposed to get the MenACWY vaccine instead). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-JUL-2024 Office Manager stated Bexsero was administered to a 12 year old patient at the wrong time.  HCP stated she was aware that Menveo can be administered as early as 10 years old, but the patient was supposed to get the MenACWY vaccine instead. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A pediatric dose of Havrix was administered to a 2 months old patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received HAV (Havrix pediatric) (batch number BX4EA, expiry date 14-NOV-2025) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: A pediatric dose of Havrix was administered to a 2 months old patient.). The outcome of the inappropriate age at vaccine administration was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2024 The patient received a pediatric dose of Havrix at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Maladministration of an expired dose of Hiberix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old patient who received Hib (Hiberix) (batch number EX777, expiry date 15-JUN-2024) for prophylaxis.   On 17-JUL-2024, the patient received Hiberix. On 17-JUL-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Maladministration of an expired dose of Hiberix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 18-JUL-2024 The healthcare representor reported the maladministration of an expired dose of Hiberix.  She wanted to know if it was needed to administer another dose of this vaccine.  No further detail was provided from the reporter´s end. Consented to follow up.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix dose in 2019 and her 2nd dose "a few months ago" in 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first Shingrix dose in 2019 and her 2nd dose "a few months ago" in 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-JUL-2024 The caller received her first Shingrix dose in 2019 and her 2nd dose was a few months ago in 2024, which led to lengthening of vaccination schedule. Did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic failure
Clinical narrative: LIVER FAILURE; This spontaneous report received from a consumer concerned a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. The batch number was not reported and has been requested. The patient reported when he took the shot, everything went bad. He wasn't going to take it, he saw what it did to people dying, women with blood clots and brain hemorrhaging with the J and J (AE-00119569 (C-INT- 0014620)). It killed a prominent doctor in, he took a shot, 2 weeks later, he exploded, internal hemorrhaging (AE00119573 (C-INT-0014621)). He knew there was issues with the vaccine, but they didn't care, they put it out, he took it, and now his liver was on full liver failure. He was basically just waiting to die, he's waiting for his liver to totally shut down, it was shutting down and it was due to the vaccine. He was informed him again if a new report can be submitted to our Safety Team, and he said oh he left out something, type this in. On an unspecified date, the patient experienced liver failure (Dose in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-.Hepatic failure : Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (a little bit of a sore arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.            It was unknown patient did any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-020911 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patients who were tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patients who were tested positive for Covid) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patients who were tested positive for Covid). At the time of the report, COVID-19 (patients who were tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case contains information about 2nd patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-771701 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2024: Live non-significant follow-up included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771701:Patient 2 of 5
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patients who were tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patients who were tested positive for Covid) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patients who were tested positive for Covid). At the time of the report, COVID-19 (patients who were tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case contains information about 3rd patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-771701 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2024: Live non-significant follow-up included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771701:Patient 3 of 5
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patients who were tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patients who were tested positive for Covid) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patients who were tested positive for Covid). At the time of the report, COVID-19 (patients who were tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case contains information about 4th patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-771701 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2024: Live non-significant follow-up included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771701:Patient 4 of 5
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patients who were tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patients who were tested positive for Covid) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patients who were tested positive for Covid). At the time of the report, COVID-19 (patients who were tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case contains information about 5th patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-771701 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2024: Live non-significant follow-up included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771701:Patient 5 of 5
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patients who were tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patients who were tested positive for Covid) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (patients who were tested positive for Covid). At the time of the report, COVID-19 (patients who were tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case contains information about 1st patient out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-771702, US-MODERNATX, INC.-MOD-2024-771703, US-MODERNATX, INC.-MOD-2024-771704, US-MODERNATX, INC.-MOD-2024-771705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2024: Live non-significant follow-up included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771702:Patient 2 of 5 US-MODERNATX, INC.-MOD-2024-771703:Patient 3 of 5 US-MODERNATX, INC.-MOD-2024-771704:Patient 4 of 5 US-MODERNATX, INC.-MOD-2024-771705:Patient 5 of 5
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Muscle spasms, Musculoskeletal stiffness, Nervous system disorder, Seizure
Clinical narrative: It has caused me to have seizures like three of them a day; Hand cramps out like really bad; Attacking my nervous system; Get stiff, but I can't walk; Get stiff, but I can't walk; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: left arm), for Covid-19 Immunisation. The following information was reported: SEIZURE (medically significant), outcome "recovered with sequelae", described as "It has caused me to have seizures like three of them a day"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Hand cramps out like really bad"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Attacking my nervous system"; MUSCULOSKELETAL STIFFNESS (non-serious), GAIT INABILITY (non-serious), outcome "unknown" and all described as "Get stiff, but I can't walk". Therapeutic measures were taken as a result of muscle spasms. Clinical course: Patient had been doing this all morning. Patient got COVID vaccine of Pfizer, got the 2 shots in the left arm. No other vaccine nothing like that. It was attacking the patient's nervous system. It had caused to have seizures like three of them a day but they didn't last long, the hand cramped out like really bad. Patient's husband had tried to move them in. Patient would get stiff, but can't walk. Yes, it was affecting big time. Patient got done with them. Patient's doctor had recommend. Patient's doctor wanted to know if the Pfizer (Pfizer COVID-19 Vaccine) was causing really bad side effects and were they actually giving out compensation.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient is not having any symptoms or side effects at this time. No additional AE; a health department administered a dose of expired MMR II vaccine to him yesterday/The date of administration was yesterday 7/2/2024.; This spontaneous report was received from a pharmacist and referred to a male patient of unknown age.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 02-JUL-2024, the patient was vaccinated at a health department with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Expired product administered). Then, on an unreported day in July 2024, they called the patient and told him to go to a pharmacy to have a repeat dose (further details were not provided). The reporting pharmacist did not have any information regarding this patient, or any further specific details related to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) product that was administered, it was unknown whether the product was stored at conditions recommended in the PI was unknown. The patient was not having any symptoms or side effects at the reporting time. The pharmacist did not have any additional patient information and stated this was the first time they had seen this patient. No additional adverse events (AE) details were available. No additional adverse event (AE)/product quality complaint (PQC) was reported (No adverse event).
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events; Nurse requested support with an urgent patient issue for VARIVAX. Nurse reported that one of their MAs administered VARIVAX to 2-month-old premature infant today, 19JUL2024 (see AE case 02639686). Nurse reported that patient has not yet experienced a; This spontaneous report was received from nurse and refers to a 2-month-old premature patient of unknown gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 19-JUL-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, administered for prophylaxis (strength, dose, lot #, expiry date, and anatomical route of administration were not provided).  On the same date, the nurse requested support with an urgent patient issue due to inappropriate age of vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) (Product administered to patient of inappropriate age). Nurse reported that patient had not yet experienced any additional adverse events, but wanted to confirm safety of the patient given their age and being premature (no additional adverse events).   Lot number is being requested and will be submitted if received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This is a spontaneous report received from a Consumer or other non HCP from License Party(Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2024-115431 (BRISTOL-MYERS SQUIBB COMPANY).  Information was received from a Consumer or other non health professional concerning a 75 Year(s) old Male patient, who received Suspect product APIXABAN (Tablet) via Oral( 5 milligram(s)2 every 1 Day, from unknown start date ) for Product used for unknown indication, lot number: Unknown;; Suspect product COVID-19 VACCINE from unknown start date ) for Product used for unknown indication, lot number: Unknown;. On an unknown date, the patient had thrombosis (blood clots), which was considered serious due to the following criteria: hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the thrombosis was unknown. Patient wife stated that patient took a covid shot and thinks it's been causing the blood clots that patient had, also stated that patient was in the hospital, no further information reported. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Concomitant medications were not reported. The reporter did not provide a causality assessment for event thrombosis to APIXABAN. The reporter considered event thrombosis related to COVID-19 VACCINE. Tracking of Changes: 18-Jul-2024: Initial information was received.   Bristol-Myers Squibb Comment: This patient who was on apixaban therapy had blood clots. Co suspect reported was covid 19 vaccine. Based on the limited information regarding the suspect therapy details, event onset details, medical history of the patient, it cannot be ascertained with reasonable possibility that suspects contributed to the reported event.  Eliquis is under agreement with Bristol-Myers Squibb.; Sender's Comments: Bristol-Myers Squibb Comment: This patient who was on apixaban therapy had blood clots. Co suspect reported was covid 19 vaccine. Based on the limited information regarding the suspect therapy details, event onset details, medical history of the patient, it cannot be ascertained with reasonable possibility that suspects contributed to the reported event.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: adult dose administered to a 6 months old kid; adult dose administered to a 6 months old kid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-month-old patient who received HBV (Engerix B adult) for prophylaxis.   On 17-JUL-2024, the patient received the 3rd dose of Engerix B adult. On 17-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: adult dose administered to a 6 months old kid) and accidental overdose (Verbatim: adult dose administered to a 6 months old kid). The outcome of the adult product administered to child and accidental overdose were not reported.   Additional Information: GSK Receipt Date: 18-JUL-2024 It was reported that Engerix-B adult dose administered to a 6 months old kid. Lab technician reported to Medical Information Department, after being tranferred from Area, that she administered by error Engerix-B adult third dose to a 6 months old kid which led to accidental overdose and adult product administered to a child.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received an expired first Engerix-B adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HBV (Engerix B adult) (batch number DZ747, expiry date 12-JUL-2024) for prophylaxis.   On 17-JUL-2024, the patient received the 1st dose of Engerix B adult. On 17-JUL-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: patient received an expired first Engerix-B adult dose). The outcome of the expired vaccine used was not reported.   Additional Information: GSK Receipt Date: 17-JUL-2024 Registered nurse reported that a female patient received an expired first Engerix-B adult dose which led to expired vaccine used.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Inappropriate reconstitution technique; Wrong dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) and (batch number AMAA989A, expiry date 30-NOV-2024) for prophylaxis.   On 12-JUL-2024, the patient received Menveo. On 12-JUL-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: Wrong dose). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not reported.   Additional Information: GSK Receipt Date: 18-JUL-2024 Pharmacist explained one of her colleagues used the 1-vial presentation of Menveo to reconstitute the powder of the 2-vial presentation (lot number AMAA989A) and administered a 0.5 ml dose to a 21 year old patient on July 12th 2024 which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. It was unknown by caller if patient received prior Menveo doses.
Age: 39.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: accidentally administered a forth dose subcutaneously instead of intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 39-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Hepatitis B (1st dose received on an unknown date), Hepatitis B (2nd dose received on an unknown date) and Hepatitis B (3rd dose received on an unknown date).   On 12-JUL-2024, the patient received the 4th dose of Engerix B (subcutaneous). On 12-JUL-2024, an unknown time after receiving Engerix B, the patient experienced intramuscular formulation administered by other route (Verbatim: accidentally administered a forth dose subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2024 Nurse stated they accidentally administered a forth dose of Hepatitis B vaccine on July 12th 2024 subcutaneously instead of intramuscularly to a 39 year old patient which led to intramuscular formulation administered by other route. Patient received 3 prior Hepatitis B vaccines but caller did not have brand names, administration dates, lot numbers or expiration dates. Nurse explained they do not have additional information about the patient and declined consent to follow up with Safety.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Myalgia
Clinical narrative: The patient had some muscled soreness right after the shot. She then said the pain subsided and came back two months later.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Basophil count, Bilirubin conjugated, Blood albumin normal
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood bilirubin unconjugated, Blood calcium increased, Blood chloride increased
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood creatinine normal, Blood glucose increased, Blood lactic acid, Blood potassium normal, Blood sodium normal
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood urea normal, Carbon dioxide increased, Condition aggravated, Diet refusal, Eosinophil count
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Jaundice, Lethargy, Lymphocyte count
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Monocyte count, Neutrophil count, Platelet count increased, Platelet count normal, Product administered to patient of inappropriate age
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Protein total normal, White blood cell count normal
Clinical narrative: I am the reporting pediatrician after the event occurred at an outside facility.  Parents informed me of this occurrence and I am reporting.  Patient received above vaccines at Clinic at 3 day old visit due to staff error.  Unfortunately, the facility failed to report the lot numbers/expiration dates/sites given on the immunization record for this patient.  The next day 7/12/24, the patient developed lethargy, increased jaundice, decreased UOP and refused to feed.  Was seen at ER for evaluation.  Labs were reassuring (see below).  Was given bolus of IVF for dehydration.  Feeding and energy level improved and was discharged home early morning 7/13/24.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Gait disturbance, Injection site reaction, Myositis, Pyrexia
Clinical narrative: On evening of 7/16/24, child developed fever of 103 and did not want to bear weight on left leg or walk as prior to vaccinations.  Was seen at clinic on 7/18/24 and felt to have myositis at left thigh and given Keflex antibiotic.  Fever broke on 7/18/24 and child started walking on 7/19/24.   On 7/25/24, child had febrile seizure with temp of 104 when seen at local ER.  Fever felt to be possibly related to MMR vaccine given on 7/16/24.  Mom has history of febrile seizure when she was younger.  Seen at clinic on 7/26/24 and had teething at molars, but no source for high fever.   Patient was back to baseline status and no further febrile seizure with alternating doses of Tylenol and Ibuprofen.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Teething, Weight bearing difficulty
Clinical narrative: On evening of 7/16/24, child developed fever of 103 and did not want to bear weight on left leg or walk as prior to vaccinations.  Was seen at clinic on 7/18/24 and felt to have myositis at left thigh and given Keflex antibiotic.  Fever broke on 7/18/24 and child started walking on 7/19/24.   On 7/25/24, child had febrile seizure with temp of 104 when seen at local ER.  Fever felt to be possibly related to MMR vaccine given on 7/16/24.  Mom has history of febrile seizure when she was younger.  Seen at clinic on 7/26/24 and had teething at molars, but no source for high fever.   Patient was back to baseline status and no further febrile seizure with alternating doses of Tylenol and Ibuprofen.
Age: 0.08
Sex: F
Vaccine: DTAPIPV, PNC20, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is a 6 week infant who received a Kinrix (Dtap and Polio combo) vaccine. This vaccine is for ages 4yrs-6yrs of age. No negative outcome or signs/symptoms while in the clinic.