chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling cold, Hyperhidrosis, Hypoaesthesia
Clinical narrative: feeling symptoms, body numbed; it still burns me; sudden sweating; it's cold, it's not hot; This case was reported by a consumer via interactive digital media and described the occurrence of body numbness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced body numbness, burning sensation, sweating and feeling cold. On an unknown date, the outcome of the body numbness and burning sensation were not recovered/not resolved and the outcome of the sweating and feeling cold were unknown.   It was unknown if the reporter considered the body numbness, burning sensation, sweating and feeling cold to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-Jan-2023 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient wanted to ask that the patient took treatment but still feeling symptoms, they were not very strong but had a piece of body numbed and still had burns.  The patient also had sudden sweating and feeling cold, it was not hot.  The patient was asking what GSK recommend. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Product administered at inappropriate site
Clinical narrative: Vx administered less than an inch apart; This case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 9-week-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAXHIB) (batch number W021182, expiry date 27th February 2025) for prophylaxis.   On 17th January 2023, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and PEDVAXHIB. On 17th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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: 23 Jan 2023 Reporters comment: Medical assistant reported that the patient received a dose of Infanrix and a dose of Pedvaxhib at the same anatomic site, with less than one inch between each dose.  The reporter consented to follow up. Additional supportive information: As patient received both the vaccine on same application site which led to Vaccine administered at inappropriate site. Note: Pedvaxhib also kept as co-suspect as it was received at same site with Infanrix.
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: 1st dose 22Nov2022,  2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 23-year-old female patient who received HBV (Engerix B) (batch number WO25778, expiry date unknown) for prophylaxis.   On 27th December 2022, the patient received Engerix B. On 27th December 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments: Medical assistant called to report that the patient intended to get a vaccination schedule for Hepatitis B got a first dose of Twinrx and then a second dose of Engerix-B. The reporter consented to follow up via email. Additional Supportive Information: the patient received Engerix B vaccine as a second dose after receiving Twinrix vaccine, which led to wrong vaccine administered.; Sender's Comments:  US-GSK-US2023010233:same reporter
Age: 0.67
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Fluzone and Flulaval on 2022 and another on 2023; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3K75S, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUZONE (SEASONAL INFLUENZA VACCINE)) and INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT VACCINE).   On 20th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, the dose was an unknown dose. On 20th January 2023, the patient started Flulaval Tetra Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FLULAVAL QUADRIVALENT VACCINE, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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: 24-JAN-2023 Reporter's Comments: A medical assistant reported that a male patient 1st received Fluzone on 18th November 2022, then Flulaval on 20th December 2022, and then another dose of Flulaval on 20th January 2023.  No symptoms reported. The reporter consented to follow up via email. Additional Supportive Information: the patient received flulaval vaccine again on 20th January 2023, which led to extra dose administered.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 15YO received Adult doses; 15YO received Adult doses; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 24th January 2023, the patient received Havrix adult and Engerix B adult. On 24th January 2023, unknown after receiving Havrix adult and Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: A Health Care professional called to report that a 15-year-old patient received adult doses of Havrix and Engerix-B.  The reporter asked how to proceed with this patient. The reporter consented to follow up. Additional Supportive Information: The child patient received adult formulation of Havrix and Engerix B, which led to accidental overdose and Adult product administered to child.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: administered a non-approved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA7232, expiry date 9th August 2023) for prophylaxis.   On 9th January 2023, the patient received Menveo. On 9th January 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Nurse Practitioner (NP) called to inquire if how do they proceed. Reporter asked did this person need to be revaccinated. NP reported on 9th January 2023, a patient was inadvertently administered the Lyophilized component of Menveo without approved diluent.  NP assumes it was with a non-approved diluent because they still had the Menveo Liquid component on hand. NP stated unsure what the vaccine was reconstituted with because NP had not spoken to the nurse about further details this morning. The reporter did not consent to follow-up. Additional Supportive Information: the patient was inadvertently administered the Lyophilized component of Menveo without approved diluent, which led to Wrong solution used in drug reconstitution.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This 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 HAV (Havrix adult) (batch number U021561, expiry date 14th January 2023) for prophylaxis.   On 26th January 2023, the patient received Havrix adult. On 26th January 2023, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: The reporter mentioned that one of his/her nurses inadvertently administered an expired Adult Hepatitis A vaccine. The reporter was looking for guidance as to whether they need to re-vaccinate the patient. No other details provided The reporter consented to follow up via web form. No other details provided. Additional Supportive Information: the patient inadvertently received expired dose of Hepatitis A adult vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 3 weeks after his 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Reporter was the HCP (pharmacist) who stated that a patient received his second dose of Shingrix 3 weeks after his first dose which was earlier than the recommended 2 to 6 months.  The reporter consented to follow up. Additional Supportive Information: the patient received 2nd dose 3 weeks after his first dose, earlier than recommended schedule, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given on day 42 after 1st; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: Reporter was a male patient and reports that he received his second shot of Shingrix vaccine on day 42 after his first Shingrix shot.  The patient could not remember where he got the vaccine or which location it was administered in.  He did not have any information about his HCP. The reporter did not consent to follow-up. Additional Supportive Information: the patient received 2nd dose 42 days after his first dose, earlier than recommended schedule, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: History of Shingrix, then had shingles, suspected vaccination failure; Shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for product used for unknown indication.   On an unknown date, the patient received Shingrix and Nucala at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Nucala was discontinued (Dechallenge was unknown). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Nucala.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The sales representative learned the event from the doctor.  The patient involved who was on Nucala for a while doing great and history of being vaccinated with Shingrix.  The patient had a Shingles outbreak but recovered.  The patient was taken off Nucala due to this event.  No other information was provided.  It was unknown if patient received 2 doses of Shingrix or 1.  The reporter was consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19
Symptoms: Blood calcium, Blood creatinine, Blood creatinine increased, Chronic kidney disease, Laboratory test
Clinical narrative: SARCOIDOSIS; CREATININE LEVELS DANGEROUSLY HIGH; CHRONIC KIDNEY DISEASE; SCARRED LIVER; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was hundred percent healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 1 administered on an unspecified date in APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient was admitted to hospital with dangerously high level of creatinine and calcium, and stayed (hospitalized) for 5 days. Laboratory data included: Calcium levels dangerously high, and Creatinine levels dangerously high. On an unspecified date followed by six months tests (Laboratory test), the patient was diagnosed with sarcoidosis. On an unspecified date, the patient also experienced chronic kidney disease, scarred liver and anemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the creatinine levels dangerously high, sarcoidosis, chronic kidney disease and scarred liver was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Sender's Comments: V0: 20230162472-Chronic kidney disease, scarred liver, Sarcoidosis. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0: 20230162472- Creatinine levels dangerously high. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Liver injury, Sarcoidosis
Clinical narrative: SARCOIDOSIS; CREATININE LEVELS DANGEROUSLY HIGH; CHRONIC KIDNEY DISEASE; SCARRED LIVER; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was hundred percent healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 1 administered on an unspecified date in APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient was admitted to hospital with dangerously high level of creatinine and calcium, and stayed (hospitalized) for 5 days. Laboratory data included: Calcium levels dangerously high, and Creatinine levels dangerously high. On an unspecified date followed by six months tests (Laboratory test), the patient was diagnosed with sarcoidosis. On an unspecified date, the patient also experienced chronic kidney disease, scarred liver and anemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the creatinine levels dangerously high, sarcoidosis, chronic kidney disease and scarred liver was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Sender's Comments: V0: 20230162472-Chronic kidney disease, scarred liver, Sarcoidosis. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0: 20230162472- Creatinine levels dangerously high. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Laboratory test, Nervous system disorder, Pain, Tremor
Clinical narrative: TREMORS; BODY ACHES/PAIN; NEUROLOGIC ISSUES; This spontaneous report received from a consumer via other manufacturer (RA) concerned a 5 decade old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic health issues (some chronic health issues so they think it may be something systemic). The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported.  On unspecified date in 2022, the patient started having tremors, irregular cardiac tests, and body aches that lasted for weeks on end, left and came back after 5 months (Dose number in series 2). The patient experienced pain for a couple of months on and off after that and lots of tests to determine why these neurologic issues suddenly came on but the physicians could not determine the reason (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tremors, body aches/pain and neurologic issues was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. 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, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot, and was hospitalized (date unspecified). It was reported that, the patient had blood clot and rushed to the hospital and the surgery was performed. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230201840-blood clot.The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung problems (was born early). 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. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number is series: 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number is series: 1). The patient had previously received second dose of covid-19 vaccine ad26.cov2.s (dose number is series: 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number is series: 2). The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number is series: 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The product was associated with Off label use (off label dosing frequency) (dose number is series: 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient who had been administered with the Moderna vaccine which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient who had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient who had been administered with the Moderna vaccine which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient who had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (patient who had been administered with the Moderna vaccine which were beyond the 30 day beyond use date).    No concomitant medication was reported.  Pharmacist reported that they had more or less 192 patients who had been administered with the Moderna vaccine, which were beyond the 30 day beyond use date.  Beyond use date for lot number 052D22A was reported as 17-Nov-2022.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Upon internal review on 02-Feb-2023, significant corrections performed to update age at vaccination, event onset date, event reported term  and updated narrative. On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated. On 24-Jan-2023: Live Non-significant follow up: Vaccine details updated. On 27-Jan-2023: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, COVID-19, SARS-CoV-2 test, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Covid 19/Covid; Bruises and bleeding after injections; Bruises and bleeding after injections; Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2022, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). In September 2022, the patient experienced VACCINATION SITE BRUISING (Bruises and bleeding after injections) and VACCINATION SITE HEMORRHAGE (Bruises and bleeding after injections). On an unknown date, the patient experienced COVID-19 (Covid 19/Covid). In 2022, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruises and bleeding after injections) and VACCINATION SITE HEMORRHAGE (Bruises and bleeding after injections) was resolving, and COVID-19 (Covid 19/Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant and treatment medications were not reported.  Patient received Moderna covid-19 booster vaccine with number of 4782588.  It was reported that patient had covid, covid-19, had a flare up ankylosing spondylitis, bruises and bleeding after injections and bruises and bleeding after injections with adalimumab solution for injection.  On unknown date, Covid 19 was resolved.  The reporter's causality for the events of bruises, and bleeding after injections, had a flare up ankylosing spondylitis with Adalimumab Solution for Injection was not provided.  The reporter's causality for the events of Covid with Adalimumab Solution for Injection was no reasonable possibility.  Company comment: This spontaneous case concerns a 42-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis an unknown time after a dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling cold, SARS-CoV-2 test
Clinical narrative: Got boosted 2 times and both times it felt like a cold; Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (His first attack was a year ago.). Concurrent medical conditions included Pituitary adenoma. Concomitant products included SOMATROPIN (GENOTROPIN) for Pituitary adenoma, LEVOTHYROXINE and DEXAMETHASONE for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive). At the time of the report, FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         It was reported that patient was used the device about 5 years and will miss doses until new pen arrives. Pen has some numbers and lines for a dead battery. pen showed F9. Cartridge proceeded to put in a cartridge and that came out. it would not move and so patient pushed on the plunger and all of a sudden it just kept going and everything came out.  Patient stated that he was getting over Covid. He was pretty well boosted thanks to us. Patient first attack was a year ago and patient does not know the specifics on each vaccine. Provided Moderna Covid vaccine on 11-Oct-2022 and patient had a booster the year before also.  Patient started taking Genotropin about 10 years ago.  Patient had bloodwork a month ago because it seemed like medication wasn't working so patient doctor determined that patient's Levothyroxine and Dexamethasone doses needed to be adjusted so patient's Genotropin could work better and changed the time of day patient took it.  No treatment medication was reported.   This case was linked to MOD-2023-705975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2023: Follow-up received: PQC number was updated.
Sex: U
Vaccine: COVID19
Symptoms: Disability
Clinical narrative: I have been disabled by your vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DISABILITY (I have been disabled by your vaccine) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISABILITY (I have been disabled by your vaccine) (seriousness criterion medically significant). At the time of the report, DISABILITY (I have been disabled by your vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's neurologist had figured out what was going on. Patient would liked you to send a form to the neurologist. Contact had previously provided AE report and follow-up questions had also been sent to his primary care physician. The reporter requested contact information for his neurologist multiple times however contact declined. Clarified that reporter was unable to guarantee follow-up and contact was frustrated by the statement.  No concomitant medication reported. No treatment medication reported.  Company Comment: This is a spontaneous case reported by a pharmacist, concerns an adult patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Disability (I have been disabled by your vaccine) on an unspecified date after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. It was reported that the Patient's neurologist had figured out what was going on. No information was provided about the details of disability, comorbidities, risk factors, symptoms, clinical course, labs, diagnostics, concomitant medications and treatment. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years; The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years), COVID-19 IMMUNISATION (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech vaccine (Dose 2) and Pfizer-BioNTech vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech vaccine and Pfizer-BioNTech vaccine.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years), COVID-19 IMMUNISATION (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years), COVID-19 IMMUNISATION (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years) 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 assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years) and COVID-19 IMMUNISATION (The patient got the Moderna Bivalent 6 months to 4 years instead of the Pfizer bivalent 6 months to 4 years).    No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) 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. ASKU) for COVID-19 prophylaxis.     It was unknown that patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series) 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 WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series).    No concomitant medications details were reported. It was reported that, a nurse accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent to a patient without receiving the primary series.  No treatment medications details were reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: very mild COVID Disease; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (very mild COVID Disease) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (very mild COVID Disease). In 2022, COVID-19 (very mild COVID Disease) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient received 4 Moderna COVID-19 vaccine so far. The last Moderna COVID-19 shot was administered on 07Apr2022. Patient only had a little cough and patient was fine after a few days. Patient was confused about Monovalent and Bivalent. Patient will go on a cruise on 04FEB2023 and require up to date vaccination records.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706633:Wife case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: wife had very mild COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (wife had very mild COVID Disease) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (wife had very mild COVID Disease). In 2022, COVID-19 (wife had very mild COVID Disease) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient received 4 Moderna COVID-19 vaccine so far. The last Moderna COVID-19 shot was administered on 07Apr2022. Patient only had a little cough and patient was fine after a few days. Patient was confused about Monovalent and Bivalent. Patient will go on a cruise on 04FEB2023 and require up to date vaccination records.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-706625 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-706625:Husband case
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site discomfort
Clinical narrative: He had a side effect/he's having a side effect; discomfort in his arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (He had a side effect/he's having a side effect) and VACCINATION SITE DISCOMFORT (discomfort in his arm) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-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-Jan-2023, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in his arm). On an unknown date, the patient experienced IMMUNISATION REACTION (He had a side effect/he's having a side effect). At the time of the report, IMMUNISATION REACTION (He had a side effect/he's having a side effect) outcome was unknown and VACCINATION SITE DISCOMFORT (discomfort in his arm) had not resolved.        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 medications details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had the Moderna bivalent booster a couple days ago, and he was having a side effect. He woke up with a throbbing discomfort in his arm. He informed he had a hard time putting on his jacket.  No treatment medications details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent vaccine was given 2 days beyond BUD; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event) 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond 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 (Bivalent vaccine was given 2 days beyond BUD).    Concomitant Medication use information was not provided by reporter.  A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.  Treatment Medication use information was not provided by reporter.