chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: blood and mucus in stool 1x, subsequent stools resolved
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin reaction, Skin warm, Swelling, Urticaria
Clinical narrative: On thursday Jan 9th by daughter was given varicella vaccine. Large, 3 inch diameter, welt appeared the morning after the shot was given. Extremely itchy, deep red, swollen, and incredibly hot to the touch. Got larger 2 hours later, again 6 hours after that, and again the next morning after that. Benedryl cream was administered twice throughout the day with no relief. Took her back to clinic two days later (saturday) so they could report and monitor condition. They said to keep her on some sort of allergy med (zyrtec, etc.)
Age: 16.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: Patient received Tdap vaccine on 01/10/25 and the next day developed a reaction to vaccine on his right arm.  Per physician in office patient developed a possible reaction to Tdap vaccine. Advised to take Ibuprofen 600mg every 8hrs and Benadryl 25mg as needed every 8hrs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: DOSAGE WAS GIVEN TO PT ABOVE APPROVED AGE FOR THIS VACCINE
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Haematoma, Injection site pain, Moaning, Pain
Clinical narrative: 11/4/2024: Employee presented to EHS for influenza vaccination. Given Influenza VIS to review. Risks section of vaccine pointed out. EE agreed to proceed with immunization.  After selecting the site, requested by the employee, II recall, the employee moved away from me after inserting the needle, IM, left deltoid area, using Z-trach technique. At this time, the EE began moaning, moving away from me as the serum was injected, stating, ?It hurts?. I apologized for the pain felt with the injection and placed a Band-Aid over the site after the serum was injected and withdrawing the needle. Vaccination information documented per standard processes including name, lot number, time, location and technique.11/20/2024: Manager initially reported the injury on behalf of the employee, stating, "After receiving the flu shot, her arm was sore, developed a hematoma and swelling. When at work, the area becomes sore, painful with movement, then when off improves, recurring when back to work. 11/19/2024: She spoke with one of the hospitalists while on duty (night shift) who advised she be seen". She has finished her assignment and wishes to return home, clarifying if this is considered a work-related injury and if she should see someone out of network or in network location. It was explained that since this is a WC claim, that in/out of network does not apply. I advised him that the EE needs to complete a incident report. 1235: EE presented to EHS to review injury reporting processes.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: 11/4/2024: Employee presented to EHS for influenza vaccination. Given Influenza VIS to review. Risks section of vaccine pointed out. EE agreed to proceed with immunization.  After selecting the site, requested by the employee, II recall, the employee moved away from me after inserting the needle, IM, left deltoid area, using Z-trach technique. At this time, the EE began moaning, moving away from me as the serum was injected, stating, ?It hurts?. I apologized for the pain felt with the injection and placed a Band-Aid over the site after the serum was injected and withdrawing the needle. Vaccination information documented per standard processes including name, lot number, time, location and technique.11/20/2024: Manager initially reported the injury on behalf of the employee, stating, "After receiving the flu shot, her arm was sore, developed a hematoma and swelling. When at work, the area becomes sore, painful with movement, then when off improves, recurring when back to work. 11/19/2024: She spoke with one of the hospitalists while on duty (night shift) who advised she be seen". She has finished her assignment and wishes to return home, clarifying if this is considered a work-related injury and if she should see someone out of network or in network location. It was explained that since this is a WC claim, that in/out of network does not apply. I advised him that the EE needs to complete a incident report. 1235: EE presented to EHS to review injury reporting processes.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report expired dose of PNEUMOVAX 23 was administered to a patient on 08JAN2025. Product expiration date was 22NOV2024. No temperature excursions reported.  No symptoms reported.  Consent to correspond was granted.  See related case 0273; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 08-JAN-2025, the patient was vaccinated with expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), formulation: injection, lot # X014729, expiration date: 22-NOV-2024, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event (no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Guillain-Barre syndrome, Motor dysfunction
Clinical narrative: hospital for diagnosed as Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a elderly female 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 guillain barre syndrome (Verbatim: hospital for diagnosed as Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was resolving.   The reporter considered the guillain barre syndrome to be related to Arexvy.     The company considered the guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK receipt date: 05-JAN-2025 The reporter reported that they heard this second hand from his/her mother, who was a second cousin to the patient the Arexvy vaccine given approximately three months ago. The dates for diagnosed as guillain barre syndrome after being hospitalized was unknown. The reporter reported that the dates when patient was in hospital for diagnosed as guillain barre syndrome after being hospitalized it was unspecified. The reporter reported that the dose number and expiry date of Arexvy vaccine were unknown. The reporter mentioned that the patient was hospitalized with motor issues and difficulty breathing and had been diagnosed as guillain barre syndrome. The reporter believed this was associated to the RSV vaccination but, it was not clear if this was GlaxoSmithKline RSV vaccine or competitor.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Age: 99.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hives right arm near injection site; This non-serious case was reported by a other health professional and described the occurrence of injection site hives in a 99-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (expiry date 30-JUN-2025) for prophylaxis.   On 12-NOV-2024, the patient received FluLaval Quadrivalent 2024-2025 season (right arm) .5 ml. On 12-NOV-2024, less than a day after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced injection site hives (Verbatim: Hives right arm near injection site). The outcome of the injection site hives was resolved.   It was unknown if the reporter considered the injection site hives to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the injection site hives to be related to FluLaval Quadrivalent 2024-2025 season and Flulaval Tetra Pre-Filled Syringe Device.   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-DEC-2024 The patient experienced hives right arm near injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenitis, Lymphadenopathy, Skin warm
Clinical narrative: Lymphadenitis acute/ Lymphadenitis under the right side armpit; This serious case was reported by a consumer and described the occurrence of acute lymphadenitis in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension (Patient is being treated with Amlodipine). Concomitant products included amlodipine.   On 27-DEC-2024 17:00, the patient received the 1st dose of Shingrix (right arm). On 29-DEC-2024 09:00, 2 days after receiving Shingrix, the patient experienced acute lymphadenitis (Verbatim: Lymphadenitis acute/ Lymphadenitis under the right side armpit) (serious criteria clinically significant/intervention required). The outcome of the acute lymphadenitis was not resolved.   It was unknown if the reporter considered the acute lymphadenitis to be related to Shingrix.     The company considered the acute lymphadenitis to be unrelated to Shingrix.   Additional Information: GSK receipt date: 29-DEC-2024 The patient received first dose of Shingrix vaccine on 27 December 2024. The patient experienced lymphadenitis under the right side armpit, which was the same arm as the site of injection on 29 December 2024.  The affected lymph nodes was enlarged to approximately 1 inch by 2 inch it felt warm and was tender to touch.  On a 1-10 pain scale, the patient described pain at number 2 when physical examination was performed.; Sender's Comments: Lymphadenitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; second time I have had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: second time I have had shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-DEC-2024 The case was received from the patient via interactive digital media. The patient had the shingle shot last year both parts.  The patient reported that this was the second time he/she had shingles the shot does not work.  It cost the patient 120.00. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine(2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine several years ago and now had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given second Hep B vaccine today inadvertently given 8 days sooner than scheduled 1 month; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 16-DEC-2024, the patient received the 2nd dose of Engerix B. On 16-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: given second Hep B vaccine today inadvertently given 8 days sooner than scheduled 1 month). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2024 The reporter reported that patient received second Engerix B vaccine inadvertently 8 days sooner than scheduled 1 month out from the initial dose which led to shortening of vaccine schedule.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: vaccine being used to avoid inflammation; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: inflammation.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for inflammation. The product was associated with off label use. (Dose number in series 1). The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine being used to avoid inflammation. ( Dose number in series 1) The action taken with janssen covid-19 vaccine was not reported.  The outcome of vaccine being used to avoid inflammation was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: UNRELENTING HEADACHES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on 2021, for covid-19 prophylaxis. Additional dosage information included: Dose Series:1. The batch number was not reported and has been requested.    No concomitant medications were reported.   On an unspecified date, the patient experienced unrelenting headaches. HCP was a neurologist called stating that HCP sees a patient for headaches. According to the HCP, the patient has daily, unrelenting headaches (Dose series: 1) after getting the J&J Covid vaccine about 3years ago. HCP stated that HCP has tried many different medications for the patient's headache treatment.  The action taken for  janssen covid-19 vaccine is not applicable. The patient had not recovered from unrelenting headaches.  This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Heart rate, Hypertension
Clinical narrative: fever for "18 hours" on the 7th day after he got the vaccine; hypertension/systolic blood pressure went as high as 198 mmHg andhis diastolic blood pressure went as high as 95mmHg; little sting in the arm; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: hypertension. The patient was previously treated with rsv vaccine for product used for unknown indication and moderna covid-19 vaccine for covid-19 prophylaxis.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Additional dosage information included: dose series 1. Non-company products included: spikevax (form of admin not reported, route of admin not reported, batch number not reported) dose and frequency not reported, administered on 01-Oct-2024 to end date not provided, for covid-19 prophylaxis. Additional dosage information included: dose series 2.  Concomitant medications included: lisinopril for hypertension.  On 01-Oct-2024, the patient experienced hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg and little sting in the arm. On 07-Oct-2024, the patient experienced fever for "18 hours" on the 7th day after he got the vaccine. dose series 2.  On an unspecified date, laboratory data included: systolic blood pressure (NR: not provided) as high as 198 mmHg, diastolic blood pressure (NR: not provided) as high as 95mmHg, blood pressure (NR: not provided) at 130 to 140 mmHg, heart rate (NR: not provided) never exceeded 95bpm, and oxygen saturation (NR: not provided) from 95 to 97.  The action taken with janssen covid-19 vaccine and spikevax was not applicable.  The patient recovered from hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg on Oct-2024. The patient recovered from little sting in the arm and fever for "18 hours" on the 7th day after he got the vaccine on an unspecified date.  This report was serious (other medically important condition).; Sender's Comments: V0:  Hypertension. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Pyrexia, Vaccination site pain
Clinical narrative: fever for "18 hours" on the 7th day after he got the vaccine; hypertension/systolic blood pressure went as high as 198 mmHg andhis diastolic blood pressure went as high as 95mmHg; little sting in the arm; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: hypertension. The patient was previously treated with rsv vaccine for product used for unknown indication and moderna covid-19 vaccine for covid-19 prophylaxis.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Additional dosage information included: dose series 1. Non-company products included: spikevax (form of admin not reported, route of admin not reported, batch number not reported) dose and frequency not reported, administered on 01-Oct-2024 to end date not provided, for covid-19 prophylaxis. Additional dosage information included: dose series 2.  Concomitant medications included: lisinopril for hypertension.  On 01-Oct-2024, the patient experienced hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg and little sting in the arm. On 07-Oct-2024, the patient experienced fever for "18 hours" on the 7th day after he got the vaccine. dose series 2.  On an unspecified date, laboratory data included: systolic blood pressure (NR: not provided) as high as 198 mmHg, diastolic blood pressure (NR: not provided) as high as 95mmHg, blood pressure (NR: not provided) at 130 to 140 mmHg, heart rate (NR: not provided) never exceeded 95bpm, and oxygen saturation (NR: not provided) from 95 to 97.  The action taken with janssen covid-19 vaccine and spikevax was not applicable.  The patient recovered from hypertension/systolic blood pressure went as high as 198 mmhg andhis diastolic blood pressure went as high as 95mmhg on Oct-2024. The patient recovered from little sting in the arm and fever for "18 hours" on the 7th day after he got the vaccine on an unspecified date.  This report was serious (other medically important condition).; Sender's Comments: V0:  Hypertension. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a male patient of unspecified age.(via social media). The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced death. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable.  It was unknown if an autopsy was performed.  Reported cause of death was unknown cause of death.  The patient died on an unspecified date.  This report was serious (death).; Sender's Comments: V0; Death; The event has an 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.; Reported Cause(s) of Death: unknown cause of death
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COvID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COvID-19) in an 82-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.     The patient's past medical history included Head injury. Concurrent medical conditions included Immunocompromised, Chronic kidney disease stage 3, Lung scarring, Scleroderma (bleed internally all the time in stomach and have to keep on getting iron infusions) and Heart disorder (was in really bad physical shape and heart was not good either.).   On 29-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 10-Apr-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) dosage was changed to 1 dosage form. In June 2023, the patient experienced COVID-19 (COvID-19). At the time of the report, COVID-19 (COvID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported post vaccination events.   This case was linked to US-MODERNATX, INC.-MOD-2025-781009, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781010 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781009:SPIKEVAX 2023-2024 US-MODERNATX, INC.-MOD-2025-781011:Spikevax NOS US-MODERNATX, INC.-MOD-2025-781010:SPIKEVAX 2024-2025 PFS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Head injury (she had "5 closed head injuries"), Kidney disorder (she has "stage 3 kidney disease), Lung scarring (scar tissue forming on my lungs), Scleroderma (scleroderma, bleed internally all the time in my stomach from scleroderma and have to keep on getting iron infusions), Heart disorder (heart is "not good either"), COVID-19 (she first contracted with COVID-19 in June 2023) in June 2023 and COVID-19 (she first contracted with COVID-19 in June 2023 and in the "early part of 2024, about March or April) in 2024.   On 25-Jul-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2024, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.       For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include iron infusions. It was reported that the last infection in November was the worst and she experienced hard time breathing and her throat is closing up like she was getting an allergic reaction to it, her chest hurt, and heart rate went high. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-781010, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781010:Same report for different Product US-MODERNATX, INC.-MOD-2025-781011:Same report for different Product (SPIKEVAX NOS) US-MODERNATX, INC.-MOD-2025-781012:Same report for different Product (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blister, Fatigue, Inflammation, Pruritus
Clinical narrative: itching; feeling completely exhausted; She is from head to toe, red with a rash; her hands are blistering and same with her feet; inflammation; she lost about 60% of her hair; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu in September 2024. Past adverse reactions to the above products included No adverse event with Flu.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 06-Oct-2024, the patient experienced BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash). On an unknown date, the patient experienced PRURITUS (itching) and FATIGUE (feeling completely exhausted). At the time of the report, BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching), RASH ERYTHEMATOUS (She is from head to toe, red with a rash) and FATIGUE (feeling completely exhausted) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  They had been to a dermatologist, but They need to go to another step further. patient expressed feeling completely exhausted after 3 months.  It was unknown if the patient experienced any additional symptoms/events. she was using creams for itching. There were no lab data/results available. Specific treatment drugs not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: itching; feeling completely exhausted; She is from head to toe, red with a rash; her hands are blistering and same with her feet; inflammation; she lost about 60% of her hair; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu in September 2024. Past adverse reactions to the above products included No adverse event with Flu.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 06-Oct-2024, the patient experienced BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair) and RASH ERYTHEMATOUS (She is from head to toe, red with a rash). On an unknown date, the patient experienced PRURITUS (itching) and FATIGUE (feeling completely exhausted). At the time of the report, BLISTER (her hands are blistering and same with her feet), INFLAMMATION (inflammation), ALOPECIA (she lost about 60% of her hair), PRURITUS (itching), RASH ERYTHEMATOUS (She is from head to toe, red with a rash) and FATIGUE (feeling completely exhausted) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  They had been to a dermatologist, but They need to go to another step further. patient expressed feeling completely exhausted after 3 months.  It was unknown if the patient experienced any additional symptoms/events. she was using creams for itching. There were no lab data/results available. Specific treatment drugs not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive on PCR for SARS-CoV-2; Tested positive on PCR for SARS-CoV-2; Interchange of vaccine products; This is a literature report for the following literature source: .  A 51-year-old male patient received BNT162b2 (COMIRNATY), in Apr2021 as dose 1, single and in May2021 as dose 2, single for COVID-19 immunisation; elasomeran (SPIKEVAX), in Nov2021 as dose 3 (booster), single) and in Aug2022 as dose 4 (booster), single) for COVID-19 immunisation. The patient's relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. In, a 51-year-old man with a medical history notable only for tinnitus tested positive on PCR for SARS-CoV-2. He had previously received four doses of SARS-CoV-2 vaccines (Comirnaty in Apr2021 and May2021, Spikevax in Nov2021 and Aug2022), most proximally three weeks prior to COVID-19 symptom onset. His acute COVID symptoms included mild cough, fatigue, severe brain fog, heart rate variability, symptoms of paresthesia (skin crawling sensations and tingling in the back), visual snow and mild warping visual distortions, and loss of smell and taste. He began a 5-day course of nirmatrelvir/ritonavir the same day he tested positive (and within 1 day of experiencing COVID-19 symptoms), during which he experienced improvement in some symptoms. After completing the 5-day course, he tested negative on day five, then experienced rebound symptoms, testing positive again 2-3 days after his last nirmatrelvir/ritonavir dose. The likely variant of COVID-19 was Omicron.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded. Consider also the possible contributory effect of interchange of vaccine products in the vaccine efficacy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 infection, confirmed by rapid antigen test; drug ineffective; This is a literature report for the following literature source(s).  A 34-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), in Nov2021 as dose 1, single and in Oct2021 as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19 infection, confirmed by rapid antigen test"; DRUG INEFFECTIVE (medically significant), outcome "unknown". It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: In November 2021, a 34-year-old-woman developed symptoms consistent with a COVID-19 infection, confirmed by rapid antigen test. She had previously received two doses of the Comirnaty SARS-CoV-2 vaccine in October and November 2021.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Covid 19 and Drug ineffective cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 infection/likely variant: omicron; COVID-19 infection/likely variant: omicron; This is a literature report for the following literature source(s).  A 45-year-old female patient received BNT162b2 (COMIRNATY), in May2021 as dose 1, single and in Jul2021 as dose 2, single for covid-19 immunisation; elasomeran (SPIKEVAX), in Jan2022 as dose 3 (booster), single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19 infection/likely variant: omicron". Clinical course: In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis).; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500003572 Same patient, different drug;US-PFIZER INC-PV202500004992 Same Patient / Different Drug;
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Fibrosis, Interchange of vaccine products, Mast cell activation syndrome, Pericarditis
Clinical narrative: chronic pericarditis; Mast Cell Activation Syndrome; cardiac fibrosis; Postural orthostatic tachycardia syndrome; Myalgic encephalomyelitis/chronic fatigue syndrome; Interchange of vaccine products; This is a literature report for the following literature source(s).  A 45-year-old female patient received BNT162b2 (COMIRNATY), in May2021 as dose 1, single and in Jul2021 as dose 2, single for covid-19 immunisation; elasomeran (SPIKEVAX), in Jan2022 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jan2022, outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown", described as "chronic pericarditis"; MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown"; FIBROSIS (non-serious), outcome "unknown", described as "cardiac fibrosis"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown", described as "Myalgic encephalomyelitis/chronic fatigue syndrome". Clinical course: In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis). She received an additional dose of the Spikevax vaccine in September 2022.; Sender's Comments: Although it is difficult to establish temporal association between the reported events PERICARDITIS, MAST CELL ACTIVATION SYNDROME  and suspect drug based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded  as there is no concrete evidence available to eliminate the causal association The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500003569 Same article, different patient;US-PFIZER INC-202500003572 Same patient, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: chronic pericarditis; Mast Cell Activation Syndrome; cardiac fibrosis; Postural orthostatic tachycardia syndrome; Myalgic encephalomyelitis/chronic fatigue syndrome; Interchange of vaccine products; This is a literature report for the following literature source(s).  A 45-year-old female patient received BNT162b2 (COMIRNATY), in May2021 as dose 1, single and in Jul2021 as dose 2, single for covid-19 immunisation; elasomeran (SPIKEVAX), in Jan2022 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jan2022, outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown", described as "chronic pericarditis"; MAST CELL ACTIVATION SYNDROME (medically significant), outcome "unknown"; FIBROSIS (non-serious), outcome "unknown", described as "cardiac fibrosis"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown", described as "Myalgic encephalomyelitis/chronic fatigue syndrome". Clinical course: In January 2022, a 45-year-old woman developed symptoms of a COVID-19 infection. Her Long COVID symptoms included fatigue, breathing difficulties, and severe chest pain diagnosed as costochondritis. Over the first eight weeks of her illness, her Long COVID symptoms worsened and she experienced severe weight loss and migraines. Since that time, clinicians diagnosed her with chronic pericarditis, POTS, cardiac fibrosis, ME/CFS, and possible MCAS. Before her illness, she had received two doses of the Comirnaty vaccine (May and July 2021) and a dose of the Spikevax vaccine in January 2022 (immediately prior to her diagnosis). She received an additional dose of the Spikevax vaccine in September 2022.; Sender's Comments: Although it is difficult to establish temporal association between the reported events PERICARDITIS, MAST CELL ACTIVATION SYNDROME  and suspect drug based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded  as there is no concrete evidence available to eliminate the causal association The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500003569 Same article, different patient;US-PFIZER INC-202500003572 Same patient, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a literature report for the following literature source(s).  A 55-year-old transgender person assigned female at birth developed symptoms of a clinically confirmed COVID-19infection in March 2020 and a reinfection in March 2021 (confirmed by PCR test). Before his illness, he had been diagnosed with Neuromyelitis Optica Spectrum Disorder (2011), ME/CFS (diagnosed in 2017, but began earlier), fibromyalgia, and psoriasis. Following his first COVID-19 infection, he developed tachycardia, brain fog, and mild cognitive symptoms. After his second COVID-19 infection, he developed MCAS symptoms, including frequent, mild-to-moderate sinus congestion, flushing, and throat swelling in relation to many foods. Currently, his Long COVID symptoms include brain fog, difficulty with word finding, MCAS symptoms, sensitivity to histamines, and intermittent PEM. He received one dose of the Spikevax vaccine in February 2021, two doses of the Jcovden vaccine in July and October 2021, a Comirnaty bivalent booster in October 2022, and one primary series dose of the Nuvaxovid vaccine in April 2023. In December 2022, he took a 7.5 day course of nirmatrelvir/ritonavir during a third COVID-19 infection (confirmed by at-home molecular Lucira test and multiple rapid antigen tests). At the time, he was taking cromolyn sodium, ketitofen, low-dose naltrexone, metoprolol succinate XL, rosuvastatin, nortriptyline, modafinil, finasteride, loratadine, valacyclovir, famotidine, and nitrofurantoin daily; testosterone cypionate weekly; leuprolide quarterly; and Zofran and clonazepam as needed. His daily supplements included Deplin (algal oil), cranberry extract, laxin forte, vision optimizer blend, biotin, ubiquinol, alpha-lipoic acid, probiotics, fish oil, flaxseed oil, quercetin, vitamin C, acetyl-l-carnitine, milk thistle, P5P, calcium, skullcap and passionflower tinctures, and DAO and digestive enzymes. He also received twice-weekly injections of glutathione and methylcobalamin. During his acute COVID infection, he also took melatonin and high dose Vitamin C powder. After this course of nirmatrelvir/ritonavir, he experienced several days with no fatigue or notable pain, although his fatigue and pain then returned to his pre-infection baseline within 2-3 weeks. This pattern resembled his experience with his first COVID infection, in which he experienced improvements in his fatigue and chronic pain during the ten days of initial infection, while also experiencing intermittent low-grade fevers. At that time, as his fevers subsided, his fatigue and pain returned.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Covid 19 and Drug ineffective cannot be ruled out.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Headache, Memory impairment
Clinical narrative: Severe headache; memory fog/brain fog; short term memory got real bad; This is a spontaneous report received from an Other HCP.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 2, single (Lot number: EL1283) at the age of 42 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (disability) with onset 11Jan2021, outcome "not recovered", described as "Severe headache"; BRAIN FOG (disability) with onset 11Jan2021, outcome "recovering", described as "memory fog/brain fog"; MEMORY IMPAIRMENT (disability) with onset 11Jan2021, outcome "not recovered", described as "short term memory got real bad". Therapeutic measures were not taken as a result of headache, brain fog, memory impairment.