chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue, Wrong technique in product usage process
Clinical narrative: no adverse event; 2 syringes, 0.5ml in each syringe, and both were administered; inadvertently reconstituted 1 vial of MMR-II with 2 separate vials of the Merck Sterile Diluent. The MMR-II was then drawn up into 2 syringes, 0.5ml in each syringe; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-MAR-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, see description, lot #X011431, expiration date: 19-APR-2025, that was inadvertently reconstituted with 2 separate vials of sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion. The vaccine was then drawn up into 2 syringes (vaccine preparation error, unapproved splitting of product), 0.5ml in each syringe, and both were administered.  No additional adverse event was reported.
Age: 65.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.; This spontaneous report was received from a registered nurse referring to a 65-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) got temperature excursion at 33F for 3 hours 0 minutes 0 seconds; on 13-JUN-2023, at 60F for 4 hours 30 minutes 0 seconds; from 13-JUN-2023 to 23-JUN-2023, at 34.10F for 240 hours 0 minutes.  On 23-OCT-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W036242, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Confirmed no symptomatic adverse events were reported (No adverse event). The temperature excursion also happened on 30-NOV-2023, at 52F for 5 hours 45 minutes and from 01-DEC-2023 at 51.78F for 192 hours.  This is one of several reports received from the same reporter.
Age: 68.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported; This spontaneous report was received from a registered nurse referring to a 68-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) got temperature excursion at 33F for 3 hours 0 minutes 0 seconds; on 13-JUN-2023, at 60F for 4 hours 30 minutes 0 seconds; from 13-JUN-2023 to 23-JUN-2023, at 34.10F for 240 hours 0 minutes.  On 09-NOV-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #W036242, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Confirmed no symptomatic adverse events were reported (No adverse event). The temperature excursion also happened on 30-NOV-2023, at 52F for 5 hours 45 minutes and from 01-DEC-2023 at 51.78F for 192 hours.  This is one of several reports received from the same reporter.
Age: 58.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.; This spontaneous report was received from a registered nurse referring to a 58-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) got temperature excursion at 33F for 3 hours 0 minutes 0 seconds; on 13-JUN-2023, at 60F for 4 hours 30 minutes 0 seconds; from 13-JUN-2023 to 23-JUN-2023, at 34.10F for 240 hours 0 minutes.  On 12-OCT-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter (Product Quantity reported as 1), lot #W036242, expiration date: 01-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Confirmed no symptomatic adverse events were reported (No adverse event). The temperature excursion also happened on 30-NOV-2023, at 52F for 5 hours 45 minutes and from 01-DEC-2023 at 51.78F for 192 hours.  This is one of several reports received from the same reporter.
Age: 65.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.  Confirmed no symptomatic adverse events were reported.  No additiona; This spontaneous report was received from registered nurse and refers to a 65-year-old patient of unknown sex.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-NOV-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) prefilled syringe, lot #W036242, expiration date: 01-OCT-2024, streghth: 0.5 mL administered for prophylaxis (dose, anatomical location and route of administration were not provided). Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023 (Product storage error). On 07-JUN-2023, temperature of 33F for 3 hours 0 minutes 0 seconds, on 13-JUN-2023, 60F for 4 hours 30 minutes 0 seconds, from 13-JUN-2024 to 23-JUN-2023, 34.10F for 240 hours 0 minutes, on 30-NOV-2023, 52F for 5 hours 45 minutes, from 01-DEC-2023, to 09-DEC-2023, 51.78F for 192 hours. There was confirmed no symptomatic adverse events were reported (No adverse event).
Age: 79.0
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023/ was it administered? Yes; This spontaneous report was received from a registered nurse and refers to a 79-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-OCT-2023, the patient was vaccinated with improperly stored dose (product storage error) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection in pre-filled syringe, lot # reported and confirmed as: W036242, expiration date reported and confirmed as: 01-OCT-2024, administered for prophylaxis (exact dose, dose number, site and route of administration was not provided) by a health professional. The vaccine had multiple temperature excursions: 33 degree Fahrenheit for 3 hours (07-JUN-2023); 60 degree Fahrenheit for 4 hours 30 minutes (13-JUN-2023); 34.10 degree Fahrenheit for 240 hours (13-JUN-2023 to 23-JUN-2023). No additional adverse event reported.
Sex: F
Vaccine: PNC20, RV5, UNK
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure; This spontaneous report was received from a physician via a company representative referring to a female infant patient of unknown exact age of the reporter's practice. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On unknown dates, the patient was vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) injection (strength, dose, route of administration, lot#, and expiration date were not reported) as vaccination against Diphtheria, Tetanus, Poliovirus, Haemophilus B, Hepatitis B; rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (strength, dose, lot#, and expiration date were not reported) orally as vaccination against rotavirus, and pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) (formulation, indication, strength, dose, route of administration, lot#, and expiration date were not reported).  On an unknown date, the patient experienced a febrile seizure after the vaccination. The patient made a full recovery at the time of reporting.  The causal relationship between administered diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) and rotavirus vaccine live, pentavalent (ROTATEQ) was unknown.   Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/had three shots and last week developed shingles; Shingles in my eye; had three shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In APR-2024, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure/had three shots and last week developed shingles) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in my eye) (serious criteria GSK medically significant) and extra dose administered (Verbatim: had three shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the ophthalmic herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-APR-2024 The case was received from the patient via interactive digital media.   The patient had three shots of shingles vaccine and last week developed shingles in his/her eye. The patient stated that thank god the medications are working. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; rash; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and rash (Verbatim: Rash). The outcome of the shingles and rash were resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2024. The patient reported that she got her first dose of Shingrix shingles vaccine and a few days later, broke out in shingles rash.  The patient stated it had run its course and was clear now (at the time of reporting).
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the administration of Kinrix in a patient under 4 years of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34mf9) for prophylaxis.   Concomitant products included Pentacel.   On 10-APR-2024, the patient received the 1st dose of Kinrix. On 10-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the administration of Kinrix in a patient under 4 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The physician called and requested information about the administration of Kinrix in a patient under 4 years of age which led to inappropriate age at vaccine administration. During the call, they also mentioned that the patient accidentally received Pentacel but did not requested any data on that topic.  The reporter provided limited data about the vaccine and patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who received SHingrix second dose 2 weeks apart of the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP22N, expiry date 27-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 19-OCT-2023, the patient received the 2nd dose of Shingrix. On 19-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient who received SHingrix second dose 2 weeks apart of the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-APR-2024 The reporter had an immunocompetent female patient who received Shingrix second dose 2 weeks apart of the first dose. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered the Shingrix Adjuvant component only without the Lyophilized component; inadvertently administered the Shingrix Adjuvant component only without the Lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 42P4L, expiry date 13-APR-2026) for prophylaxis.   Previously administered products included Shingrix (on 26th January 2024 received 1st dose).   On 12-APR-2024, the patient received the 2nd dose of Shingrix (right arm). On 12-APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Shingrix Adjuvant component only without the Lyophilized component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Shingrix Adjuvant component only without the Lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 12-APR-2024 Pharmacist called to inquired that how to proceed or when they can readminister or what to look for in the patient. The reporter reported that they inadvertently administered the Shingrix adjuvant component only without the lyophilized component to a patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Oral mucosal blistering, Pain
Clinical narrative: Patient is having Shingles; Blisters like a rash around and inside her mouth/ painfull; Feeling body aches same day/painful; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On 10-APR-2024, the patient received the 1st dose of Shingrix (left arm) and COVID-19 vaccine (left arm). On 10-APR-2024, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: Feeling body aches same day). On 12-APR-2024, the patient experienced shingles (Verbatim: Patient is having Shingles) and oral mucosa blister (Verbatim: Blisters like a rash around and inside her mouth/ painfull). The outcome of the shingles and oral mucosa blister were not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the shingles, general body pain and oral mucosa blister to be related to Shingrix.     It was unknown if the company considered the shingles, general body pain and oral mucosa blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2024 The reporter was a friend of the patient who stated patient received both Shinrgix first dose and Covid-19 vaccine on Wednesday and started feeling body aches same day in the evening.  According to reporter, patient then developed blisters like a rash around and inside her mouth, very sensitive and painful.  The reporter believed the patient was having shingles.  The patient has not seen her doctor yet. The reporter refused to provide her demographics or consent to contact patient's provider. The reporter did not consent to follow-up. It was unknown if the reporter considered the shingles, general body pain and oral mucosa blister to be related to Covid-19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Neoplasm malignant
Clinical narrative: DEATH; CANCER CAME BACK IN A DIFFERENT AREA; stroke; This solicited report received from a consumer via PPSCVM000196: Janssen Social Media Account (via J&J managed social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cancer. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (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 perform follow-up to request batch/lot numbers. No concomitant medications were reported. Patient got the vaccination, first his cancer came back in a different area and right after dealing with that he had a stroke last November (NOV-2023) (Dose number in series 1). On an unspecified date, the patient died due to unknown case (Dose number in series 1). Autopsy performed was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and cancer came back in a different area was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and cancer came back in a different area, stroke, and death was not related.  This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-Death. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration. Neoplasm malignant, Cerebrovascular accident. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY(Cancer), Stroke is likely complication of Cancer as it can lead to hypercoagulable state. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Treatment information was not provide  This case contains information about patient 36th out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: Patient had died
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, COVID-19, Myalgia
Clinical narrative: he caught covid; after he caught covid, 'it seemed like my brain didn't work'; sore muscles were specifically calf muscles and below femur, in the hamstring, and up in the shoulders; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he caught covid), BRAIN FOG (after he caught covid, 'it seemed like my brain didn't work') and MYALGIA (sore muscles were specifically calf muscles and below femur, in the hamstring, and up in the shoulders) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he caught covid), BRAIN FOG (after he caught covid, 'it seemed like my brain didn't work') and MYALGIA (sore muscles were specifically calf muscles and below femur, in the hamstring, and up in the shoulders). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, COVID-19 (he caught covid) and MYALGIA (sore muscles were specifically calf muscles and below femur, in the hamstring, and up in the shoulders) had not resolved and BRAIN FOG (after he caught covid, 'it seemed like my brain didn't work') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had no known allergies. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. He was experienced the same type of pain but worse and had been experiencing it for about 6-8 months now. Patient also reported that he also stated that in August of 2022, he got hurt at work and had to get 17 stitches.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer stage IV
Clinical narrative: DIAGNOSED WITH STAGE 4 BREAST CANCER; This spontaneous report received from a patient concerned a patient via J&J managed social media site concerned a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1, 2)(suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, and dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that patient was part of the company Covid 19 trial, and 5 months after patient's second vaccine, while still in the trial, patient was diagnosed with stage 4 breast cancer (dose series 2). Patient had no history of breast cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diagnosed with stage 4 breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Breast cancer stage IV. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid in 2023; had Covid in 2023; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 1, single (Lot number: EW0180) at the age of 69 years, in left deltoid and on 29Jun2021 as dose 2, single (Lot number: EW0180), in left deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "had Covid in 2023". Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Mar2024 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Addison's Disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Mast Cell Activation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2 , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Positive, notes: test positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid from 03Apr2024 to 08Apr2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: a new Parkinson's like tremor in his left arm and hand that progressed over a few weeks to the left leg and foot; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19", start date: 2020 (unspecified if ongoing), notes: fall 2020, had mild symptoms and recovered. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; unknown manufacturer), for COVID-19 immunization. The following information was reported: TREMOR (disability) with onset May2021, 1 week after the suspect product(s) administration, outcome "not recovered", described as "a new Parkinson's like tremor in his left arm and hand that progressed over a few weeks to the left leg and foot". The events "a new parkinson's like tremor in his left arm and hand that progressed over a few weeks to the left leg and foot" required physician office visit. It was unknown if therapeutic measures were taken as a result of tremor. Clinical course: Patient reports that he was diagnosed with COVID in fall 2020 had mild symptoms and recovered. He reports a second COVID vaccination in May2021. 1 week after vaccination patient developed a new Parkinson's like tremor in his left arm and hand that progressed over a few weeks to the left leg and foot and persists today with left sided tremors that are constant (3 years). Right side of body is not impacted.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Mar2024 at 12:00 as dose 1, single (Lot number: 23-24 nf) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "known allergies: Banana, Kiwi" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Apr2024 and 06Apr2024 with lot number: 311292N.  Clinical course: Approximately 4-5 days after finishing Paxlovid, started with very mild nasal symptoms. This ramped up so that by day 8-9 it felt like a cold and now at day 11 it's worse than when she initially had Covid.
Sex: F
Vaccine: COVID19
Symptoms: Evans syndrome
Clinical narrative: i now have evan's syndrome because of this vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: EVANS SYNDROME (disability, medically significant) with onset Jun2021, outcome "not recovered", described as "i now have evan's syndrome because of this vaccine". The event "i now have evan's syndrome because of this vaccine" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of evans syndrome. Clinical course: The patient had no COVID prior vaccination. It was unknown if the patient was tested for COVID post-vaccination.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3: Vaccine brand other=Moderna, Vaccine dose number=4; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 14:00 as dose 1, single (Lot number: EM6201), in left arm, on 17Mar2021 at 14:30 as dose 2, single (Lot number: EN6207), in left arm and on 13Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jun2022 at 15:30 as dose 4 (booster), single (Lot number: 014822A), in right arm, on 17Nov2022 at 12:00 as dose 5 (booster), single (Lot number: 052D22A), in left arm and on 14Oct2023 at 14:30 as dose 6 (booster), single (Lot number: AU3918E), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Known allergies: iodine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jun2022 at 15:30, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine dose number=3: Vaccine brand other=Moderna, Vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Dec2023 to 02Jan2024.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Infection; COVID 19 Infection; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1 (toppac), single (Lot number: hg4671) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN APOTEX, stop date: 10Apr2024. Vaccination history included: moderna (DOSE 6(BOOSTER), SINGLE, lot number=067h22a,), administration date: 26May2023, when the patient was 72-year-old, for COVID-19 immunization; moderna (DOSE 5 (BOOSTER), SINGLE, Lot number: as7143c,), administration date: 13Sep2022, when the patient was 71-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Lot number: Unknown), administration date: 02Apr2022, when the patient was 71-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, lot number=012f21a,), administration date: 05Nov2021, when the patient was 70-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Lot number: 024m20a,), administration date: 09Feb2021, when the patient was 69-year-old, for COVID-19 immunization; moderna (DOSE 1, SINGLE, Lot number: 027L20A), administration date: 08Jan2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID 19 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid was taken as treatment for COVID-19 from 12Apr2024 to 17Apr2024 and Moderna vaccine was taken as Dose 8 on 27Mar2024
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Mar2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADD" (unspecified if ongoing). Patient had no known allergies.The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE, Anatomical location: Arm Right), for COVID-19 immunisation; Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 03Apr2024 to 08Apr2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure and overweight" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: RAMPRIL, start date: 01Jan2012. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical Location: Arm Left), administration date: 22Apr2023, when the patient was 61-year-old, for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "recovered" (Apr2024) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 05Apr2024 to 10Apr2024. Clinical course: The patient had no known allergies. Patient reported that he got over his fever by day 2 and got over Covid with paxlovid by day 6 he just had a runny nose at night and he tested negative.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1;MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2;MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4(BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  Clinical course: Patient received other vaccination in 2 weeks and did not receive other medication. Paxlovid was taken as treatment for COVID-19 from 07Apr2024 to 11Apr2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Foetal exposure during pregnancy, Medically induced preterm birth
Clinical narrative: An induced pre-term birth/After birth the baby received Beyfortus; An induced pre-term birth/After birth the baby received Beyfortus; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A fetus patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. Concomitant medication(s) included: METFORMIN; PROCARDIA [NIFEDIPINE]. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), PREMATURE BABY (non-serious), outcome "unknown" and all described as "An induced pre-term birth/After birth the baby received Beyfortus".   Additional information: An induced pre-term birth due to doctors concerns for diabetes and high blood pressure. After birth the baby received Beyfortus. Mom had family history with High blood pressure (BP) and diabetes. Mom had relevant history with High BP and diabetes.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Exposure during pregnancy, Gestational hypertension, Pre-eclampsia
Clinical narrative: Gestational hypertension, postpartum preeclampsia; Gestational hypertension, postpartum preeclampsia; RSV SEROEPIDEMIOLOGY AND IMMUNE TRANSFER AMONG PREGNANT INDIVIDUALS AND THEIR PRETERM INFANTS  This is a non-interventional study report (Investigator Sponsor Research/ Clinical Research Collaboration) and received from Other HCPs for protocol.  An adult female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Feb2024 as dose number unknown, 120 ug single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event (gestational hypertension) onset. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] oral taken for factor v leiden mutation; VITAMIN B6 oral taken for nausea; ONDANSETRON oral taken for nausea; DOXYLAMINE SUCCINATE oral taken for nausea. The following information was reported: GESTATIONAL HYPERTENSION (hospitalization) with onset Mar2024, outcome "recovered" (Apr2024), ECLAMPSIA (hospitalization) with onset Apr2024, outcome "recovered" (Apr2024) and all described as "Gestational hypertension, postpartum preeclampsia". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (7-33): (Apr2024) 79 IU/l; Aspartate aminotransferase (9-38): (Apr2024) 80 IU/l. Clinical course: postpartum preeclampsia (diagnosed in Apr2024). History Gestational hypertension, postpartum preeclampsia pertinent details: Gestational hypertension diagnosed during third trimester, preeclampsia developed postpartum.   The investigator considered there was not a reasonable possibility that the event was related to the concomitant drugs.   The investigator's assessment of the causal relationship of "gestational hypertension, postpartum preeclampsia" with the suspect product(s) rsv vaccine prot.subunit pref 2v was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported events postpartum preeclampsia and  Gestational hypertension was related to the suspect product event most likely due to patient underlying contributory factors.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Lack of drug efficacy; Lack of drug efficacy; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Lack of drug efficacy".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 2023, outcome "unknown", described as "POTS". Additional information: Patient was diagnosed by MD with POTS in the spring of 2023. Patient received 3 doses of Pfizer vaccine.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.