chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Initial insomnia, Scab, Vaccination failure
Clinical narrative: 2 shots and still got shingles started behind my left ear/suspected vaccination failure; shingles; Still have scabs drying up 3 months now; still hard to get sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: 2 shots and still got shingles started behind my left ear/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), scab (Verbatim: Still have scabs drying up 3 months now) and trouble falling asleep (Verbatim: still hard to get sleep). The outcome of the vaccination failure was unknown and the outcome of the shingles, scab and trouble falling asleep were not resolved.   The reporter considered the vaccination failure, shingles, scab and trouble falling asleep to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure, shingles, scab and trouble falling asleep to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 This case was reported by the patient via interactive digital media. The patient had two shots of Shingrix and got shingles started behind left ear and still had scabs drying up 3 months now, still hard to get sleep. The patient reported that might be without shots could been lot worse. The patient reported that she had friends who had shingles.  The pain they described sounded unbearable. The patient educated herself about the risks and what she could do for prevention. The reporter thought event might not had been related to drug. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: lot of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 67-year-old patient who received Herpes zoster (Shingrix) (batch number Mh67) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number Mh67) for prophylaxis.   The patient's past medical history included shingles (had shingles 9 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced pain (Verbatim: lot of pain). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 02-MAY-2023 The patient asked that, how come you did not let people know they could get shingles after having your vaccine? The patient asked somebody call him/her about your vaccine and the way it did not worked. The reporter thought that it should be made known when you get this vaccine that you will still get shingles, people believed they will never get shingles again this is just not true and also just the two vaccines were not enough if even that. The patient stated that he/she had never seen this information on your commercials everyone he/she know who had gotten the vaccine seems to think they were never going to get shingles and when they give you the vaccine they did not give you this information, so this should be made more well-known. The patient stated that could file a product feedback case with all of this should be made known to okay.  The patient had the both the vaccine 3 years ago and had a lot of pain. The patient stated that he/she could say the vaccine less and the effects of shingles but sadly it did not.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Gait inability, Muscular weakness, Nodule, Wheelchair user
Clinical narrative: Not ambulatory/not able to ambulate and has been using a wheel chair; small nodules on both knees; Patient fell on 03/09/203 causing small nodules; weakness bilateral legs/ both her legs felt weak; This non-serious case was reported by a consumer via call center representative and described the occurrence of lower extremities weakness of in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer and carcinoma brain. Concomitant products included fulvestrant.   On 10-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 10-FEB-2023, less than a day after receiving Shingrix, the patient experienced lower extremities weakness of (Verbatim: weakness bilateral legs/ both her legs felt weak). On 09-MAR-2023, the patient experienced fall (Verbatim: Patient fell on 03/09/203 causing small nodules) and nodule on extremity (Verbatim: small nodules on both knees). On 23-MAR-2023, the patient experienced unable to walk (Verbatim: Not ambulatory/not able to ambulate and has been using a wheel chair). The outcome of the lower extremities weakness of, fall and unable to walk were not resolved and the outcome of the nodule on extremity was resolved.   It was unknown if the reporter considered the lower extremities weakness of, fall, unable to walk and nodule on extremity to be related to Shingrix.     It was unknown if the company considered the lower extremities weakness of, fall, unable to walk and nodule on extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 The patient self-reported this case. The patient received dose of Shingrix and stated that both the legs felt weak the day of the vaccine and it was not resolved. The patient fell causing small nodules on both knees and she was not able to ambulate and had been using a wheel chair. The patient was taking Fluvestrant injections every 28 days which she was receiving prior to getting the Shingrix vaccine.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The representative stated that she met with an NP (Nurse practitioner) yesterday who mentioned that a patient received their first dose of Shingrix at a local unknown pharmacy and developed shingles a couple of weeks to a month later. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix 3 doses administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-DEC-2023) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th December 2022). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 27-MAY-2023, the patient received the 3rd dose of Shingrix. On 27-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix 3 doses administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter reported that the patient received 3 doses of Shingrix which led to extra dose administered.  The reporter asked was there any safety data. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An 11-year-old patient received Infanrix; patient received Infanrix rather than the intended Boostrix; 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 11-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 25-MAY-2023, the patient received Infanrix (intramuscular, unknown arm). On 25-MAY-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: An 11-year-old patient received Infanrix) and wrong vaccine administered (Verbatim: patient received Infanrix rather than the intended Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 30-MAY-2023 The reporter was the Healthcare professional (medical assistant).  The reporter stated that an 11-year-old patient received Infanrix rather than the intended Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Nothing else was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Minor swelling of lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of lip swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received Shingrix. In MAY-2023, 5 days after receiving Shingrix, the patient experienced lip swelling (Verbatim: Minor swelling of lips). The outcome of the lip swelling was not resolved.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.     It was unknown if the company considered the lip swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023 The patient self reported this case. The patient stated that she had a Shingrix vaccine and approximately 5 days later experienced minor swelling of her lips that was unresolved at the time of the reporting.  No further information was reported. The patient stated she did not had time to provide any information.  Minimal information was obtained to file an adverse event.  The consent to follow up was not asked.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong age range, dose of Infanrix was given outside of the recommended range; 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 patient who received DTPa (Infanrix) (batch number 5RM39) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age range, dose of Infanrix was given outside of the recommended range). The outcome of the inappropriate age at vaccine administration 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: 30-MAY-2023 An anonymous healthcare professional called in to request information about the lot number of a vaccine. The reporter declined to give any information and briefly mentioned that a dose of Infanrix was given outside of the recommended range, but they hung up before anything else could be said. The patient received a dose of vaccine than the recommended age, which lead to Inappropriate age at vaccine administration.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Confusional state
Clinical narrative: patient was confused; This non-serious case was reported by a nurse via sales rep and described the occurrence of confusion in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.  On an unknown date, the patient received Shingrix and PNEUMONIA VACCINE. On an unknown date, less than a year after receiving Shingrix, the patient experienced confusion (Verbatim: patient was confused). The outcome of the confusion was unknown.  It was unknown if the reporter considered the confusion to be related to Shingrix.  It was unknown if the company considered the confusion to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-MAY-2023 The reporter was the Nurse Practitioner (NP) who informed GSK Representative during lunch that patient received Shingrix and a Pneumonia vaccine the same day between 8 months and a year ago, in the medical office.  The nurse called the patient that same day and patient was confused, then patient was referred to emergency room (ER), EMS transported patient to ER. A stroke was ruled out at ER. The report back to NP was patient had a reaction to vaccine administered. The reporter consented to follow up. It was unknown if the reporter considered the confusion to be related to PNEUMONIA VACCINE.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache
Clinical narrative: Stomach issues; A red patch about 3-4 inches beneath the injection site; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAY-2023, the patient received the 2nd dose of Shingrix (left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: Stomach issues), skin red (Verbatim: A red patch about 3-4 inches beneath the injection site) and headache (Verbatim: Headache). The outcome of the upset stomach, skin red and headache were resolved.   It was unknown if the reporter considered the upset stomach, skin red and headache to be related to Shingrix.     It was unknown if the company considered the upset stomach, skin red and headache to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 30-MAY-2023 The patient self reported this case. The patient received Shingrix and developed a headache, a red patch about 3-4 inches beneath the injection site and stomach issues.  The symptoms were resolved in May 2023 after the 2nd or 3rd day.  The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix expired dose was administered to a female child 4 days expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 30-MAY-2023, the patient received Kinrix. On 30-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired drug used (Verbatim: Kinrix expired dose was administered to a female child 4 days expired). The outcome of the expired drug 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: 30-May-2023 The reporter consented to follow-up. The patient an expired dose of Kinrix, which led to expired vaccine used.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 30-MAY-2023, the patient received Kinrix. On 30-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix administered). 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: 31-MAY-2023 A nurse reported that a patient was given an expired dose of Kinrix, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal mail.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Caller reported patient received first dose of Shingrix in 2020 and has not yet received the second 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   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: Caller reported patient received first dose of Shingrix in 2020 and has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-May-2023 and 31-May-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expiration date for this lot number was 5/20/2023. The HCP mentioned that this vaccine was administered to a patient on 5/26/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 26-MAY-2023, the patient received Twinrix. On 26-MAY-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expiration date for this lot number was 5/20/2023. The HCP mentioned that this vaccine was administered to a patient on 5/26/2023). 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: 31-May-2023 The health care professional asked that if the dose was considered valid. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: inadvertent administration after above excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 32-year-old female patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 17-MAY-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: inadvertent administration after above excursion). The outcome of the incorrect storage of drug 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: 31-May-2023 No reactions were reported. The reporter consented to follow-up via email. The patient received a dose of Engerix-B after being exposed to 73 Fahrenheit to possibly over 168 hours, which led to incorrect storage of drug
Age: 0.5
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 7 month old patient was inadvertently administered a Bexsero dose on 5/19/2023; 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 6-month-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 19-MAY-2023, the patient received Bexsero (left thigh). On 19-MAY-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a 7 month old patient was inadvertently administered a Bexsero dose on 5/19/2023). The outcome of the inappropriate age at vaccine administration 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: 31-MAY-2023 Medical Assistant called to inquire that, what to look for in the patient? The reporter did not consent to follow-up. The patient was inadvertently administered a Bexsero dose at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Negative (At night of Day 4), and HbA1C average 6.2 A1C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LIFE-CHANGING INJURIES; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced life-changing injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of life-changing injuries was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2023, 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 26-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist states that they had patient dosed with the bivalent vaccine which was administered one and two days beyond the BUD.).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the vial was pulled out of the freezer on 24-Apr-2023 and 4 doses were administered on 25-May-2023 and 2 doses on 26-May-2023. Treatment medications were not provided.  This case was reported for patient 6 out of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-726797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726797:Patient 1
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Myocarditis
Clinical narrative: Recurrent vaccine-associated myocarditis; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Recurrent vaccine-associated myocarditis) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  The patient's past medical history included Myocarditis (vaccine-associated myocarditis).    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Recurrent vaccine-associated myocarditis) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, MYOCARDITIS (Recurrent vaccine-associated myocarditis) and DISEASE RECURRENCE (Disease recurrence) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Recurrent vaccine-associated myocarditis) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  The study was conducted among 431 patients with a prior history of vaccine-associated myocarditis, pericarditis, or myopericarditis. Out of this 171 received COVID-19 vaccine in the year 2021 with median age- 39 years (range 21-67 years).  From the vaccine recipients, 11 patients experienced cardiac-suggestive symptoms (chest pain, palpitations, or dyspnea) within 30 days of COVID-19 vaccination. Four patients met the criteria for recurrent. All 4 COVID-19 recurrent cases fully recovered with minimal supportive care within weeks (myocarditis) to months (pericarditis).  This case describes the patient who developed recurrent myocarditis within 3 days of receiving Moderna vaccine.  Company Comment: This is a Literature non-study case concerning a 49-year-old male patient, with past medical history of vaccine-associated myocarditis, who experienced the expected and serious (due to medically significant) event of Myocarditis, which occurred within 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. As reported, patient fully recovered with minimal supportive care within weeks. No information disclosed about diagnostic tests performed or treatments received. Medical history of vaccine-associated myocarditis could be a confounding factor for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.      This case was linked to US-MODERNATX, INC.-MOD-2023-726875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726875:50 YO male
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Myocarditis
Clinical narrative: Recurrent myocarditis; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Recurrent myocarditis) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  The patient's past medical history included Myocarditis (vaccine-associated myocarditis).    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Recurrent myocarditis) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, MYOCARDITIS (Recurrent myocarditis) and DISEASE RECURRENCE (Disease recurrence) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Recurrent myocarditis) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  The study was conducted among 431 patients with a prior history of vaccine-associated myocarditis,  pericarditis, or myopericarditis. Out of this 171 received COVID-19 vaccine in the year 2021 with median age- 39 years (range 21-67 years).  From the vaccine recipients, 11 patients experienced cardiac-suggestive symptoms (chest pain, palpitations, or dyspnea) within 30 days of COVID-19 vaccination. Four patients met the criteria for recurrent. All 4 COVID-19 recurrent cases fully recovered with minimal supportive care within weeks (myocarditis) to months (pericarditis).  This case describes the patient who developed recurrent myocarditis within 3 days of receiving Moderna vaccine.  Company Comment: This is a literature non-study case concerning a 50-year-old, male patient with a reported medical history of Myocarditis (vaccine-associated myocarditis), who experienced the serious (due to medically significant) expected event of MYOCARDITIS (reported as Recurrent myocarditis) and the non-serious unexpected adverse event of disease recurrence. The clinical presentation was mild. The event occurred within 3 days after receiving the second dose of mRNA-1273 vaccine. The events were reported as recovered. Concomitant and treatment medications were not reported. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-726873 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726873:49 YO male
Sex: U
Vaccine: COVID19-2
Symptoms: Arthralgia, Feeling hot
Clinical narrative: I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.; It felt like every joint in my body hurt (back, Knees, elbows, hips).; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1,  030L20A , left arm) on 25-Jan-2021, Moderna COVID-19 Vaccine (2nd dose ,015M20A, left arm) on 22-Feb-2021, Moderna COVID-19 Vaccine on 22-Feb-2021, Moderna COVID-19 Vaccine (Dose 3, Lot 002F21A, left arm) on 16-Aug-2021 and Moderna COVID-19 Vaccine (felt out of sorts for 24nrs. It was Minor) on 16-Aug-2021. Past adverse reactions to the above products included Headache with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; Joint ache with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine; and No adverse event with Moderna COVID-19 Vaccine.    On 23-May-2023 at 1:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-May-2023 at 10:30 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).). On 24-May-2023 at 8:30 AM, FEELING HOT (I got vaccinated with the Omicron at 1:30p on 23May2023. By 1030p, my skin felt hot. By 11:30p, my skin was on fire.) had resolved and ARTHRALGIA (It felt like every joint in my body hurt (back, Knees, elbows, hips).) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that on 23-May-2023 by 11:30 pm patient skin was on fire. Patient had to get out of bed and thought gonna die .One day while patient was working out in a field across the street from work, patient got stung by yellow jackets. Patient had to go to the hospital. The doctor counted 27 stings. That's how it felt. By 8:30am the next day on 24-May-2023, everything was gone. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, 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 30-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry/Expiration date: 29May2023).    Concomitant medication not reported. Treatment medication not reported.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23).    No concomitant information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-May-2023, 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 30-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    Concomitant product use was not provided by the reporter.  Expiration date was reported as 29-May-2023.  Treatment information was not provided.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any vaccines in the 4 weeks prior to COVID-19 vaccine and did not had any medical condition.    On 23-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 21-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (1st and 2nd doses of the Covid-19 vaccine but they inadvertently gave the one from the vial with the NDC number 80777-283-02 (dark pink cap and label with yellow box)).    Concomitant drugs were not reported. It was reported that patient did not had other vaccinations concomitant to the COVID-19 vaccine. It was reported that vaccine was inadvertently given from the vial with the NDC number 8077728302 dark pink cap and label with yellow box.  Treatment medications were not provided.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergy: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2023) Positive, notes: Had positive test Friday and Monday; (29May2023) Positive, notes: Had positive test Friday and Monday. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 21May2023 to 25May2023.  Clinical course: Patient received vaccine and no other medication in 2 weeks. Finished paxlovid on Thursday. Felt better Friday-Sunday, then started with aches and pain and severe nasal congestion on Monday. Had positive test Friday and Monday.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 17May2023 to 21May2023.  Clinical course: Patient received vaccine and also other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 18May2023 to 22May2023 The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.