chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Acute kidney injury, Altered state of consciousness, Asthenia, Atrial fibrillation, Biopsy brain abnormal
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Blood immunoglobulin G increased, CSF protein increased, Cerebral disorder, Depressed level of consciousness, Electroencephalogram normal
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Endotracheal intubation, Fatigue, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Partial seizures
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis, Pneumonia staphylococcal, Positron emission tomogram, Rash erythematous, Respiratory failure
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Spinal cord disorder, Splenomegaly, Unresponsive to stimuli
Clinical narrative: Coma; He first lost his ability to walk, then had 4 strokes; seizure; neurological complications; lost his ability to walk; This serious case was reported by a consumer and described the occurrence of coma in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced coma (Verbatim: Coma) (serious criteria GSK medically significant), stroke (Verbatim: He first lost his ability to walk, then had 4 strokes) (serious criteria GSK medically significant), seizure (Verbatim: seizure) (serious criteria GSK medically significant), neurological disorder nos (Verbatim: neurological complications) and unable to walk (Verbatim: lost his ability to walk). The outcome of the coma, stroke, seizure, neurological disorder nos and unable to walk were not reported.   It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.     It was unknown if the company considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to RSV vaccine.   Additional Information: GSK receipt date: 25-JAN-2024 The reporter reported that their father being in a coma from  neurological complications after receiving the RSV and COVID vaccines the day after holiday. Reporter stated that their dater was lost his ability to walk, had 4 strokes and a seizure. The reporter stated that the patient was previously healthy. The reporter reported that all of the doctors were puzzled. The person wanted to know if GlaxoSmithKline had any data on this type of reaction to vaccines that could help the doctors figure this out, they appreciated any help that could be provided. It was unknown if the reporter considered the coma, stroke, seizure, neurological disorder nos and unable to walk to be related to COVID-19 vaccine. The reporter requested to consented the follow up.
Age: 86.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Pain in extremity, Swelling
Clinical narrative: consistent pain on the vaccination site for one and a half month and I don't think it will go away.
Age: 86.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Injection site pain
Clinical narrative: consistent pain on the vaccination site for one and a half month and I don't think it will go away.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: There are 2 GARDASIL 9 Lot numbers that were involved in the Temperature Excursion and HCP was unable to be sure which was administered to the patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 12-JAN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml once (route was not reported) lot # W028573, expiration date on 06-JAN-2025 or lot # X014788, expiration date on 07-MAR-2025 for prophylaxis (after temperature excursions of -13.21 C, time frame for 6 minutes and 44 seconds, and with previous temperature excursions of 29 minutes at 8.07 C and of 8.08 C for 14 minute and 15 seconds). Furthermore, it was reported that the nurse was unable to be sure which was administered to the patient.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs; Caller reports child received PROQUAD and VARIVAX at same visit.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a licensed nurse practitioner refers to a 1-year-old patient. of unknown gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 19-JAN-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), rHA,  subcutaneous injection, lot # W028566, expiration date :06-MAR-2024 , dose: 0.5 milliliter, subcutaneously  for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection, lot # W039688, expiration date: 13-DEC-2024, dose: 0.5 milliliter, subcutaneously for prophylaxis (overdose).  No additional adverse event was reported.
Age: 1.58
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not report any adverse issues or side effects from the administration. No other AE information was able to be provided during the call.; Improperly stored vaccine was administered to the patient.; This spontaneous report was received from a medical assistant concerning a 19-month-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medications were not provided.   On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# X003664, expiry date: 10-NOV-2025) was stored at 54.3 degree Fahrenheit (F) for 9 hour 32 minutes and 0 seconds; on 05-DEC-2023, at 57.7F for 15 hours 30 minutes 0 seconds; on 06-DEC-2023, at 50.2F for 5 hours 43 minutes 0 seconds; on 07-DEC-2023, at 30.6F for 1 hour 55 minutes 0 seconds and 52.7F for 11 hours 3 minutes 0 seconds; on 11-DEC-2023, at 48.4F for 1 hour 47 minutes 0 seconds. There was no other reported current or previous temperature excursions. On 08-JAN-2024, after temperature excursion, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection 0.5 mL once (route of administration, and anatomical location not provided) as prophylaxis (product storage error). The patient did not report any adverse issues or side effects from the administration. No other adverse event (AE) information was able to be provided (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Product expired 1/7/2024 and was administered 1/29/2024; Product experienced TE on 8/16/2023.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions and previous drug reactions or allergies was not provided. Concomitant product included sterile diluent (MERCK STERILE DILUENT) (Lot# W039700).  On 29-JAN-2024, the patient was administered an expired and improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, at a dose of 0.5 milliliters (ml) as prophylaxis (route of administration and anatomical site of vaccination were not reported; lot# W017557 has been verified to be valid, expiration date reported and established as 07-JAN-2024) (expired product administered, product storage error).   The vaccine was exposed to a temperature excursion of 23.6 degrees Celsius during a time frame of 3 hours and 30 minutes. No adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis A antibody negative
Clinical narrative: Patient had 2 doses of Heplisav-B, and the titer came back Nonreactive; Initial report received on 21-Dec-2023.  A non-significant follow-up report received on 17-Jan-2024 that included the QA investigation results of the mixed product quality complaint: the investigation did not identify a potential lot-related issue, there is no trend.  No potential impact to the lots was identified.     A nurse reported that a 55-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's titer came back "nonreactive."  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 11-Oct-2023, the patient received the first dose of HEPLISAV-B (lot # 943007, expiration date 30-Sep-2025; NDC # not reported) intramuscularly in the left deltoid.  On  08-Nov-2023, the patient received the second dose of HEPLISAV-B (lot #943011, expiration date 31-Oct-2025; NDC # not reported) intramuscularly in the left deltoid.   On 20-Dec-2023, 29 days after having been vaccinated with HEPLISAV-B, the patient had a titer drawn that came back "nonreactive." No other adverse effects were reported. The outcome was not reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure as the serological marker was not reported.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed for vaccine failure as the serological marker was not reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Received 2nd Dose Engerix B; Initial report received on 28-Dec-2023  A pharmacist reported that a 51-year-old male patient (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B as the second dose five months later.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 20-Jun-2023, the patient received a dose of HEPLISAV-B (Lot # 941589, expiration date 31-Aug-2025, NDC #43528-002-01) intramuscularly in the left arm.   On 24-Nov-2023, 158 days after having been vaccinated with HEPLISAV-B, the patient received ENGERIX B as the second dose (Lot # ZX709, expiration date 12-Aug-2024, NDC # not reported) in the left arm. No adverse side effects were reported by the patient.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: SERIOUS MEDICAL ISSUES; This spontaneous report received from a consumer (family member) via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to request the batch number.  No concomitant medications were reported.  On an unspecified date, the patient experienced serious medical issues after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious medical issues was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20240165006 and 20240156462.; Sender's Comments: V0:  Unevaluable event. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: patient had adverse reactions and was down on her fanny for about 4 days after taking those shots, further described as after every covid vaccination the patient's legs hurt, the patient couldn't move them, the patient's legs hurt.; it wasn't doing much for her and she was getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient had adverse reactions and was down on her fanny for about 4 days after taking those shots, further described as after every covid vaccination the patient's legs hurt, the patient couldn't move them, the patient's legs hurt.) and CONDITION AGGRAVATED (it wasn't doing much for her and she was getting worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), BACLOFEN, FLUOXETINE, GABAPENTIN, MAGNESIUM and MODAFINIL for an unknown indication.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (patient had adverse reactions and was down on her fanny for about 4 days after taking those shots, further described as after every covid vaccination the patient's legs hurt, the patient couldn't move them, the patient's legs hurt.) and CONDITION AGGRAVATED (it wasn't doing much for her and she was getting worse). At the time of the report, PAIN IN EXTREMITY (patient had adverse reactions and was down on her fanny for about 4 days after taking those shots, further described as after every covid vaccination the patient's legs hurt, the patient couldn't move them, the patient's legs hurt.) and CONDITION AGGRAVATED (it wasn't doing much for her and she was getting worse) outcome was unknown.            It was reported that patient was down on her fanny for about 4 days after taking those shots, further described as after every covid vaccination the patient's legs hurt, the patient couldn't move them, the patient's legs hurt, the patient had trouble getting up and it was a good thing they had the lift so they could do all of this and it was awful here for 4 days and further was not clarified. Reporter stated that they followed the trend and said they had to stop taking the vaccine and it wasn't doing much for her and she was getting worse, not further clarified. Reporter stated that the patient received the Moderna Covid vaccines and Booster. Reporter stated that the patient's first two shots were given in spring of 2021 and a Moderna booster later in Fall of 2021. Patient received Drofbium Chloride as a concomitant medication. No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Left Eye lid swelling; Red and swollen; Sore injection site for 7 days; This is a spontaneous report received from a Nurse from a sales representative.  A 68-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Jan2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "acute cellulitis" (unspecified if ongoing). Concomitant medication(s) included: KEFLEX [CEFALEXIN], start date: 20Jan2024, stop date: 27Jan2024. The following information was reported: EYE SWELLING (non-serious) with onset 21Jan2024, outcome "recovered" (22Jan2024), described as "Left Eye lid swelling"; OCULAR HYPERAEMIA (non-serious) with onset 21Jan2024, outcome "recovered" (22Jan2024), described as "Red and swollen"; VACCINATION SITE PAIN (non-serious) with onset 21Jan2024, outcome "recovered" (27Jan2024), described as "Sore injection site for 7 days". Therapeutic measures were taken as a result of eye swelling, ocular hyperaemia, vaccination site pain.  Additional information: Patient did not have known allergies. The patient did not receive other vaccine on same date and other vaccine in four weeks. She had left Eye lid swelling for 24 hours. Red and swollen. Sore injection site for 7 days. Adverse event treatment included Benadryl and cool compress.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Did test positive for covid several weeks ago; Did test positive for covid several weeks ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type one diabetic", start date: 1957 (ongoing). Patient went to a diabetic camp in the late 1958 and 1959 to learn to give injections with beef insulin and in 1975 started using pork insulin, which is used by more diabetics in the world. It's been outlawed in my free country. Patient is using generic insulin now. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); SINGLE; Unknown Manufacturer), for Covid-19 immunization; Flu vaccines (DOSE NUMBER UNKNOWN, SINGLE), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Did test positive for covid several weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Clinical course: Patient took RX pills from his/her kidney doctor and am doing good again. Patient is still working at 71-years-old.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400026227 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Jan2024, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset Jan2024, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Jan2024, outcome "unknown", described as "Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)".  Additional information: All events were experienced during the 2 days after COVID-19 vaccination, which occurred 20Jan2024 (Saturday) or 21Jan2024 (Sunday). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20
Symptoms: Arthralgia, Erythema, Nausea, Pain in extremity, Rash
Clinical narrative: rash; nausea; joint pain; painful, red arm; painful, red arm; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 24Jan2024, outcome "recovering", described as "joint pain"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 24Jan2024, outcome "recovering" and all described as "painful, red arm"; NAUSEA (non-serious) with onset 25Jan2024, outcome "recovering"; RASH (non-serious) with onset 25Jan2024, outcome "recovering". Therapeutic measures were taken as a result of arthralgia, pain in extremity, erythema, rash, nausea. Additional information: Patient experience typical side effects within hours of receiving it including a painful, red arm and joint pain. At some point during the night of 25Jan2024, patient developed a rash on the neck. As the day went on, the rash spread from neck to chest and a bit on the back. Patient did have nausea during the day but was otherwise fine. Patient's MD (Doctor of medicine) instructed me to take Benedryl. The antihistamine helped. This note is to report a possible reaction to the vaccine.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: When she tried to mix it, it broke and got everywhere; when she went to push the liquid and it went out instead of into the vial; This is a spontaneous report received from a Pharmacist from product quality group.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9851, Expiration Date: 31Mar2025) for immunisation, Device Lot Number: HG1756, Device Expiration Date: May2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When she tried to mix it, it broke and got everywhere"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "when she went to push the liquid and it went out instead of into the vial". Additional information: When she tried to mix it, it broke and got everywhere. Clarifies further that when she went to screw the diluent syringe onto the vial, the luer lock bit fell off on the diluent syringe, the luer lock, screw part came undone and when she went to push the liquid and it went out instead of into the vial.  The reporter considered "when she tried to mix it, it broke and got everywhere" and "when she went to push the liquid and it went out instead of into the vial" not related to rsv vaccine prot.subunit pref 2v. Causality for "when she tried to mix it, it broke and got everywhere" and "when she went to push the liquid and it went out instead of into the vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V], has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Aplastic anaemia, Biopsy bone marrow, Haemoglobin, Neutrophil count, Platelet count
Clinical narrative: Severe aplastic anemia post covid-19 vaccination in young male; This is a literature report.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no previous or concomitant vaccines or infections. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The patient experienced severe gingival bleeding after dental cleaning, epistaxis and a petechial rash of his extremities (Severe aplastic anemia) 17 days after the suspect product(s) administration. The case of newly diagnosed severe Aplastic anemia (AA), with bone marrow hypo-cellularity and absence of PNH clones reported after bone marrow biopsy, were also revealed after SARS-CoV-2 mRNA vaccine administration, treated accordingly. The case was successfully treated with no follow-up visits referred. The patient underwent the following laboratory tests and procedures: Haemoglobin: 11.2 g/dl; Neutrophil count: 800 /mm3; Platelet count: 2000 /mm3; Biopsy bone marrow: absence of PNH clones. Interestingly, the case required allogeneic stem cell transplantation (ASCT) and was diagnosed with Fanconi anemia after ASCT. Therapeutic approach included ASCT and symptomatic therapy (antifungal therapy).  No follow-up attempts are possible.; Sender's Comments: The event aplastic anaemia is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Age: 37.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given ADACEL instead of the prescribed Flu vaccine, with no reproted adverse event; Initial information received on 24-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 37 years old female patient who was given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of the prescribed flu vaccine (influenza vaccine), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Jan-2024, the patient received a dose 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U7283AA; expiry date: 02-Feb-2024) via intramuscular route in the right deltoid instead of the prescribed flu vaccine, with no reported adverse event (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone QIV given to 9 weeks old patient with no reported adverse event; Initial information was received on 26-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 weeks old male patient who recived INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2024, the 9 weeks old patient received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (lot U8070BA) (strength, and expiry date: unknown) (product administered to patient of inappropriate age, latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Bed sharing, Cyanosis, Diarrhoea, Dyskinesia, Foaming at mouth
Clinical narrative: Had a single episode of diarrhea 2-3 days before the seizure. No fever. Had been having a normal appetite. 1/25 was his normal self. Dad put him to bed; typically goes to sleep in parents' bed and they transfer him to his bed in their room. When mom went to bed he seemed fine. Mom is a light sleeper; in the early morning of 1/26/24 she heard a shout and then a gurgling sound. Called his name and he didn't respond. Turned on the light and saw foam coming out of his mouth. He was seizing; it was his whole body doing a rhythmic jerking, his face was pale. The seizure stopped and he was blue and not breathing. Mom started CPR. By the time EMS arrive he was breathing but not responsive, his temp was a little over 100. Started to wake on the way to the hospital. Vomited twice in the ambulance.  Since then no fever; he felt a little warm the morning they got home from the ED. His appetite has been normal. Yesterday he ate a little less than normal but still ate well. His behavior has been completely normal.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Increased bronchial secretion, Pallor, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Had a single episode of diarrhea 2-3 days before the seizure. No fever. Had been having a normal appetite. 1/25 was his normal self. Dad put him to bed; typically goes to sleep in parents' bed and they transfer him to his bed in their room. When mom went to bed he seemed fine. Mom is a light sleeper; in the early morning of 1/26/24 she heard a shout and then a gurgling sound. Called his name and he didn't respond. Turned on the light and saw foam coming out of his mouth. He was seizing; it was his whole body doing a rhythmic jerking, his face was pale. The seizure stopped and he was blue and not breathing. Mom started CPR. By the time EMS arrive he was breathing but not responsive, his temp was a little over 100. Started to wake on the way to the hospital. Vomited twice in the ambulance.  Since then no fever; he felt a little warm the morning they got home from the ED. His appetite has been normal. Yesterday he ate a little less than normal but still ate well. His behavior has been completely normal.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Skin warm, Unresponsive to stimuli, Vomiting
Clinical narrative: Had a single episode of diarrhea 2-3 days before the seizure. No fever. Had been having a normal appetite. 1/25 was his normal self. Dad put him to bed; typically goes to sleep in parents' bed and they transfer him to his bed in their room. When mom went to bed he seemed fine. Mom is a light sleeper; in the early morning of 1/26/24 she heard a shout and then a gurgling sound. Called his name and he didn't respond. Turned on the light and saw foam coming out of his mouth. He was seizing; it was his whole body doing a rhythmic jerking, his face was pale. The seizure stopped and he was blue and not breathing. Mom started CPR. By the time EMS arrive he was breathing but not responsive, his temp was a little over 100. Started to wake on the way to the hospital. Vomited twice in the ambulance.  Since then no fever; he felt a little warm the morning they got home from the ED. His appetite has been normal. Yesterday he ate a little less than normal but still ate well. His behavior has been completely normal.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Cyanosis, Diarrhoea, Dyskinesia, Foaming at mouth, Pallor
Clinical narrative: Had a single episode of diarrhea 2-3 days before the seizure. No fever. Had been having a normal appetite. 1/25 was his normal self. Dad put him to bed; typically goes to sleep in parents' bed and they transfer him to his bed in their room. When mom went to bed he seemed fine. Mom is a light sleeper; in the early morning of 1/26/24 she heard a shout and then a gurgling sound. Called his name and he didn't respond. Turned on the light and saw foam coming out of his mouth. He was seizing; it was his whole body doing a rhythmic jerking, his face was pale. The seizure stopped and he was blue and not breathing. Mom started CPR. By the time EMS arrive he was breathing but not responsive, his temp was a little over 100. Started to wake on the way to the hospital. Vomited twice in the ambulance.  Since then no fever; he felt a little warm the morning they got home from the ED. His appetite has been normal. Yesterday he ate a little less than normal but still ate well. His behavior has been completely normal.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest, Resuscitation, Seizure, Unresponsive to stimuli, Vomiting
Clinical narrative: Had a single episode of diarrhea 2-3 days before the seizure. No fever. Had been having a normal appetite. 1/25 was his normal self. Dad put him to bed; typically goes to sleep in parents' bed and they transfer him to his bed in their room. When mom went to bed he seemed fine. Mom is a light sleeper; in the early morning of 1/26/24 she heard a shout and then a gurgling sound. Called his name and he didn't respond. Turned on the light and saw foam coming out of his mouth. He was seizing; it was his whole body doing a rhythmic jerking, his face was pale. The seizure stopped and he was blue and not breathing. Mom started CPR. By the time EMS arrive he was breathing but not responsive, his temp was a little over 100. Started to wake on the way to the hospital. Vomited twice in the ambulance.  Since then no fever; he felt a little warm the morning they got home from the ED. His appetite has been normal. Yesterday he ate a little less than normal but still ate well. His behavior has been completely normal.