chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.) and inappropriate dose of vaccine administered (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.). The outcome of the inappropriate preparation of medication and inappropriate dose of 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: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152368:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient
Sex: U
Vaccine: RV1
Symptoms: Product preparation error, Single component of a two-component product administered, Underdose
Clinical narrative: Administration of the Rotarix Diluent Alone; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of 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: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152363:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient
Sex: U
Vaccine: RV1
Symptoms: Product preparation error, Single component of a two-component product administered, Underdose
Clinical narrative: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of 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: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152371:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in January 2021).   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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated that the patient never received her second dose and asked Should she just get one more or the entire 2-shot series. The VAERS details was reported for 1st dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via postal.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: 4 patients was administered only the diluent of Arexvy; 4 patients was administered only the diluent of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: 4 patients was administered only the diluent of Arexvy) and inappropriate dose of vaccine administered (Verbatim: 4 patients was administered only the diluent of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 Pharmacist reported that patient was administered only the diluent of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Asked to revaccinate. The Hcp mentioned that details will be provided later. The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine (missed the six month window); This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine (missed the six month window)). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The patient self-reported this case. The patient recently got the Shingrix shot 2 and stated that she had received Shingrix shot 1 one to two years ago, which led to lengthening of vaccination schedule. The reporter did not want to share her street address or answer any further questions pertaining to this report.  The reporter did not consent to follow up.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix was administered on 11/02/2023 and expired on 10/27/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 02-NOV-2023, the patient received Boostrix. On 02-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix was administered on 11/02/2023 and expired on 10/27/2023). 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: 02-NOV-2023 The health care professional reported that the Boostrix was administered on 11th February 2023 and expired on 27th October 2023 which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a physician concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to eggs, migraine, headaches, asthma, and obsessive compulsive disorder. 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 MAR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 70 years old. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 40.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP reported patient was given PROQUAD and VARIVAX concomitantly in error to a 40-year-old patient. No additional AE/no PQC.; HCP reported patient was given PROQUAD and VARIVAX concomitantly in error to a 40-year-old patient.; This spontaneous report was received from a medical assistant and refers to a 40-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 25-OCT-2023, the patient was concomitantly vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, lot #W034213, expiration date: 24-APR-2024, (strength, and route of administration were not provided) and  varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, lot #W022605, expiration date: 17-JUL-2024 (strength, and route of administration were not provided), both administered for prophylaxis (Accidental overdose) (Product administered to patient of inappropriate age). No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of PROQUAD after a temperature excursion that occurred on 10/12/2023 and the patient received the dose of PROQUAD on 10/16/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-OCT-2023, a temperature excursion occurred at -12.4 C for 18 minutes. No previous temperature excursion was reported. On 16-OCT-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, lot #X007087, expiration date: 04-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported (No adverse event).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Nervous system disorder
Clinical narrative: CENTRAL NERVOUS SYSTEM DISORDER; This spontaneous report received from a patient via other manufacturer (Novavax) concerned an elderly female. The patient's weight, height, and medical history were not reported. The patient had a polyethyleneglycol allergy (macrogol 4000). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number series 1) (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 01-APR-2021, the patient experienced affected eyes. On an unspecified date, patient experienced felt like it was inducing a pro-inflammatory cytokine response (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin not reported, batch number: 211021A expiry: UNKNOWN) dose was not reported, 1 total administered on 18-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. No concomitant medications were reported. On an unspecified date, the patient experienced central nervous system disorder (Dose number series 2). On an unspecified date in 2022, Laboratory data included: Antibody test 1000 neutralizing antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of central nervous system disorder was not reported. This report was non-serious. This case, involving the same patient is linked to 20211011757 (primary dose case).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: little side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (little side effects) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (little side effects). At the time of the report, IMMUNISATION REACTION (little side effects) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Patient had just finished a documentary about Pfizer - so Patient was not really feeling "close" or good about them as a pharmaceutical brand. Patient had Moderna and had little side effects - much different than patient friends who had Pfizer.  No treatment information was reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Muscle spasms, Pyrexia, Tremor
Clinical narrative: the shakes; fever which was worst on the second dose; headaches; Second dose was the worst; After all the doses of the vaccine her whole body was cramping; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping), TREMOR (the shakes), CONDITION AGGRAVATED (Second dose was the worst), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 002A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE. Past adverse reactions to the above products included No adverse event with PNEUMOCOCCAL VACCINE.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping). In February 2021, the patient experienced CONDITION AGGRAVATED (Second dose was the worst). On an unknown date, the patient experienced TREMOR (the shakes), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 200 milligram. In January 2021, MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping) had resolved. At the time of the report, TREMOR (the shakes), CONDITION AGGRAVATED (Second dose was the worst), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient has received hepatitis vaccines in the past. With the cramps it would prevent her from sewing. That lasted for 08-10 hrs. No concomitant medication was reported.   This case was linked to MOD-2023-748279 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: the syringes where the plunger get stuck midway into injection; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (the syringes where the plunger get stuck midway into injection) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (the syringes where the plunger get stuck midway into injection).    Concomitant product use was not provided by the reporter.  The Device problem code for Spikevax syringe include FDA code 1670, Regulatory code A23 which include Use of Device Problem. The Spikevax syringe device was malfunctioned and the type was CIRM.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, 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 an unknown date, the patient experienced SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up) was resolving.            No concomitant drug was reported.  The patient reported she had no problems until dose 4, which was her only bivalent booster. The patient had the Moderna primary series and first booster with no issues, and it was the first bivalent Moderna shot that caused her to swell up. The patient took over the counter Zyrtec, and reported it was able to help.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: 2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Asthma.  Concurrent medical conditions included Asthma.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant and treatment medications were not reported.  2 weeks after vaccination patient had severe muscle weakness in legs and paresthesia. It was hard to walk and rise up. It seemed like Guillain Barre syndrome. However, everyone at that time refused to believe that the vaccine could cause such adverse effects. The patient was angry for being gas lighted and imagining things.  Company comment- This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI Guillain-Barre syndrome 15 days after a dose of mRNA-1273 vaccine, was administered.  It was reported patient experienced 2 weeks after vaccination severe muscle weakness in his legs and paresthesia. It was hard to walk and rise. It seemed like Guillain-Barre syndrome. However, everyone at that time refused to believe that the vaccine could cause such adverse effects.  No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748336 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748336:Invalid case
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: Itching; Fever; extreme headaches; Chills; very sore at site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection). At the time of the report, PRURITUS (Itching), PYREXIA (Fever), HEADACHE (extreme headaches), CHILLS (Chills) and VACCINATION SITE PAIN (very sore at site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 2nd patient out of 5 patients as described by the reporter.  Concomitant and treatment medications were not reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects. Three of the employees had to call out sick next days with several symptoms ranging from fever, extreme headaches which still haven't subsided, chills, itching, very sore at site of injection.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748404, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received that contains significant information: Batch number and event details were updated. On 06-Nov-2023: Live follow-up received that contains non-significant information: Reporter information and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Patient 1 out of 3 US-MODERNATX, INC.-MOD-2023-748403:same reporter Patient 4 US-MODERNATX, INC.-MOD-2023-748404:same reporter Patient 5 US-MODERNATX, INC.-MOD-2023-748352:same reporter Patient 3 US-MODERNATX, INC.-MOD-2023-748215:Reporters case
Sex: F
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: we have a large  group of long-covid patients and many of us; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us) 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)) for COVID-19 vaccination.     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 POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us). At the time of the report, POST-ACUTE COVID-19 SYNDROME (we have a large  group of long-covid patients and many of us) outcome was unknown. Not Provided          The patient reported we had a large group of long-covid patients and many of us, especially those in the neurological cohort, had experienced severe worsening and some new symptoms with the Moderna bivalent vaccine.  They believed that was due to the spike protein interacting with autoimmunity in their symptoms. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-748314 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748314:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I have five other employees that were given shot same morning all having had adverse side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects). At the time of the report, IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 4th patient out of 5 patients as described by the reporter.  No concomitant medication information was reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748342, US-MODERNATX, INC.-MOD-2023-748404 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow-up received contains non-significant information : secondary reporter added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Master case US-MODERNATX, INC.-MOD-2023-748215:same reporter US-MODERNATX, INC.-MOD-2023-748352:same reporter US-MODERNATX, INC.-MOD-2023-748342:same reporter US-MODERNATX, INC.-MOD-2023-748404:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I have five other employees that were given shot same morning all having had adverse side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031047) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects). At the time of the report, IMMUNISATION REACTION (I have five other employees that were given shot same morning all having had adverse side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 5th patient out of 5 patients as described by the reporter.  No concomitant medication information was reported.  The reporter said that the reporter had five other employees that were given the shot on the same morning of vaccination and all those had adverse side effects.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748333, US-MODERNATX, INC.-MOD-2023-748403, US-MODERNATX, INC.-MOD-2023-748215, US-MODERNATX, INC.-MOD-2023-748352, US-MODERNATX, INC.-MOD-2023-748342 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received that contains non-significant information : secondary reporter added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748333:Master case US-MODERNATX, INC.-MOD-2023-748403:same reporter US-MODERNATX, INC.-MOD-2023-748215:same reporter US-MODERNATX, INC.-MOD-2023-748352:same reporter US-MODERNATX, INC.-MOD-2023-748342:same reporter
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: she had a miscarriage; was pregnant when got the vaccine; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (she had a miscarriage) in a 34-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (1st Dose, Lot number: 012L20A) on 14-Jan-2021, Moderna (2nd Dose, Lot number: 031M20A) on 05-Aug-2021, Moderna (3rd Dose) on 22-Oct-2021, Moderna Bivalent (4th Dose and Lot number:  AS7140C) on 06-Sep-2022; for Product used for unknown indication: Flu Shot (one week ago). Past adverse reactions to the above products included No adverse event with Flu Shot, Moderna, Moderna, Moderna and Moderna Bivalent.    On 29-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine). On 01-Nov-2023, the patient experienced ABORTION SPONTANEOUS (she had a miscarriage) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Sep-2023, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine) had resolved. At the time of the report, ABORTION SPONTANEOUS (she had a miscarriage) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.  Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a 34-years-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Abortion spontaneous, which occurred approximately 1 month after SPIKEVAX 2023-2024, administered as fifth dose within COVID-19 vaccination schedule, at unknown weeks of gestation. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live significant follow-up received contains historical vaccines added, suspect drug information updated, event added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis (She was on maintenance arthritis medications.).    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-May-2023, the patient experienced COVID-19 (covid 19) (seriousness criterion death). The patient died on 25-May-2023. The reported cause of death was covid disease post booster. It is unknown if an autopsy was performed.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   She was fully boosted. She was on maintenance arthritis medications.   No treatment information was reported. Company comment: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history reported, who experienced the unexpected and serious (death) event of COVID-19 and died. The vaccination date with an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine was not reported; hence, latency could not be properly assessed. The reported cause of death was covid disease post booster. It is unknown if an autopsy was performed. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748142, US-MODERNATX, INC.-MOD-2023-748144 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2023: Live follow-up received with no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748142:Patient 3 US-MODERNATX, INC.-MOD-2023-748144:Patient 2; Reported Cause(s) of Death: COVID Disease post booster
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: diarrhea; severe headache; pain in arm; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu.    The patient's past medical history included COVID-19 in June 2022.   On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea) was resolving.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant product use was not provided by the reporter.  The patient received flu and covid shot in same arm.   The patient experienced severe headache, pain in arm, fever-like symptoms, nausea and diarrhea.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Illness
Clinical narrative: covid 19; Sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) and ILLNESS (Sick) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included AFib.    On 22-Sep-2022, 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. In October 2023, the patient experienced COVID-19 (covid 19) and ILLNESS (Sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and ILLNESS (Sick) had resolved.            Patient was not sure whether this was his 3rd or 4th dose.  Patient stayed at home and was sick for about a week. No concomitant medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Influenza like illness, Muscle spasms, Pyrexia
Clinical narrative: flu like symptoms; COVID-19; cramping; fever; the shakes; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes), HEADACHE (headaches) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no existing health problems.  Previously administered products included for Product used for unknown indication: Flu vaccines and pneumonia vaccines. Past adverse reactions to the above products included No adverse event with Flu vaccines and pneumonia vaccines. Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Sep-2022, 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. In September 2022, the patient experienced MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes) and HEADACHE (headaches). On 11-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and COVID-19 (COVID-19). At the time of the report, MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes), HEADACHE (headaches) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and COVID-19 (COVID-19) outcome was unknown.            After the vaccine her whole body was cramping. She had cramps in her whole body. which started 10 hours afterwards. With the cramps it would prevent her from sewing. This lasted 8-10 hours. She also had fever. She had a little of the shakes and also had headaches. No nausea, vomiting, or diarrhea. She took some ibuprofen, maybe 1, 200 mg tablet. Sometimes would also take Tylenol. She was very healthy with no other health conditions at that time.  She had COVID-19 on 11 JUL 2023 with flu like symptoms. She had received pneumonia vaccines, hepatitis vaccines, and flu vaccines in the past. She received a flu vaccine 1 month ago without any problems.   This case was linked to US-MODERNATX, INC.-MOD-2023-748280. This case was linked to MOD-2023-748284.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748280:Different patients
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: flu like symptoms; COVID-19; cramping; fever; the shakes; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes), HEADACHE (headaches) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no existing health problems.  Previously administered products included for Product used for unknown indication: Flu vaccines and pneumonia vaccines. Past adverse reactions to the above products included No adverse event with Flu vaccines and pneumonia vaccines. Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Sep-2022, 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. In September 2022, the patient experienced MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes) and HEADACHE (headaches). On 11-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and COVID-19 (COVID-19). At the time of the report, MUSCLE SPASMS (cramping), PYREXIA (fever), TREMOR (the shakes), HEADACHE (headaches) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and COVID-19 (COVID-19) outcome was unknown.            After the vaccine her whole body was cramping. She had cramps in her whole body. which started 10 hours afterwards. With the cramps it would prevent her from sewing. This lasted 8-10 hours. She also had fever. She had a little of the shakes and also had headaches. No nausea, vomiting, or diarrhea. She took some ibuprofen, maybe 1, 200 mg tablet. Sometimes would also take Tylenol. She was very healthy with no other health conditions at that time.  She had COVID-19 on 11 JUL 2023 with flu like symptoms. She had received pneumonia vaccines, hepatitis vaccines, and flu vaccines in the past. She received a flu vaccine 1 month ago without any problems.   This case was linked to US-MODERNATX, INC.-MOD-2023-748280. This case was linked to MOD-2023-748284.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748280:Different patients