chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration, Vaccination failure
Clinical narrative: nerve pain; Suspected vaccination failure; diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 16-APR-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nerve pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she was diagnosed with Shingles on arm today.  It started on vacation and waited to come home to their own doctor.  It was a white swollen line at first and next day had 6 red spots that bled and nerve pain.  The patient had both shingles shots so did not think they could get it, but still can get it (Shingles). The patient reported it as a mild case and did not need the antibiotics and if it spreads they will be put on antibiotics.  The patient reported he/she was not in pain and putting antibiotic cream on it twice a day.  The patient suggested to others get the vaccine shots. The patient stated he/she so glad they did got vaccine or I would be in pain and have a bad case. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I am allergic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: I am allergic). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he /she allergic to the Shingrix vaccination. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never took the second; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never took the second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported and took the first Shingrix shot but never took the second. The reporter asked do the reporter start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles twice, received both vaccine, currently have another shingles outbreak; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles twice, received both vaccine, currently have another shingles outbreak). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles twice. The patient received the vaccine, the both injections, after the first time, that was 2 years ago. The patient currently had another shingles outbreak. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2)..
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: my brother got very sick from the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: my brother got very sick from the shot). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that they had had it was no big deal but, his/her brother had gotten very sick from the shot.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2015, terrible, had them for 8 months.).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick for 3 days). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR049613   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient also had shingles in 2015, terrible, had them for 8 months. The patient eventually got the 1st shot, and like got sick for 3 days. But if it will prevent it, then it was worth it. The patient did not ever want to go thru that again.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2015, terrible, had them for 8 months.). Previously administered products included Shingrix (For tolerance to 1st dose, refer case US2025AMR049326.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick for 3 days). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR049326   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient also had shingles in 2015, terrible, had them for 8 months. Then time for 2nd dose and was leery. The patient got the 2nd shot, and like got sick for 3 days. But if it will prevent it, then it was worth it. The patient did not ever want to go thru that again.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered an intramuscular dose instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered an intramuscular dose instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-APR-2025 Pharmacist called to ask, one of the pharmacist administered an intramuscular dose of Priorix instead of subcutaneously, which led subcutaneous injection formulation administered by other route. The reporter asked did have any guidance on this topic, did need to revaccinate. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient received Priorix intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 68-year-old female patient who received MMR (Priorix) for prophylaxis.   On 08-APR-2025, the patient received Priorix (intramuscular). On 08-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient received Priorix intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-APR-2025 The pharmacist called to report the following that the pharmacist had a question about the Priorix vaccine. The pharmacist had a patient that received it intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administration by other route and the patient was wondering if he needed to be revaccinated.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Potential received 3rd dose of Shingrix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Potential received 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 17-APR-2025 The field representative reported that what was the reports if a patient gets a 3rd dose of shingrix, because they did not remember that they already had two doses when they got the 3rd. The patient received 3rd dose of Shingrix which led to, extra dose administered.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Administration via intramuscular route; Above recommended age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 35-year-old female patient who received MMR (Priorix) (batch number 32YB4, expiry date 01-DEC-2026) for prophylaxis.   On 17-APR-2025, the patient received Priorix (intramuscular). On 17-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Administration via intramuscular route) and inappropriate age at vaccine administration (Verbatim: Above recommended age). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable.   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: 17-APR-2025 The pharmacist contacted to request data and recommendations after a 35 year old female patient which was accidentally administered a dose of Priorix via intramuscular route which led to inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route. They stated the patient had received a series in 1991 and a booster in 2001. The vaccine administration facility was the same as primary reporter.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 16 month-old patient received Boostrix; Dtap vaccine as the 4th dose in the Dtap series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DY3K7, expiry date 14-JUN-2027) for prophylaxis.   On 04-APR-2025, the patient received Boostrix. On 04-APR-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 month-old patient received Boostrix) and inappropriate schedule of vaccine administered (Verbatim: Dtap vaccine as the 4th dose in the Dtap series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   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: 17-APR-2025 Nurse reported that a 16 month old patient received Boostrix instead of Dtap vaccine as the 4th dose in the Dtap series, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The nurse asked for recommendations on this topic.
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: blisters on nose and back; This non-serious case was reported by a other health professional via sales rep and described the occurrence of blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-APR-2025, the patient received the 1st dose of Shingrix. On 03-APR-2025, less than a day after receiving Shingrix, the patient experienced blister (Verbatim: blisters on nose and back). The outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.     It was unknown if the company considered the blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2025 Patient had adverse reaction developed blisters on nose and back same date she received first dose of Shingrix on 03 Apr 2025. They asked if they can administer second dose of Shingrix to patient or not.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an adult dose of Engerix-B was administered to a pediatric patient; an adult dose of Engerix-B was administered to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old female patient who received HBV (Engerix B adult) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   On 14-FEB-2025, the patient received Engerix B adult. On 14-FEB-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient) and overdose (Verbatim: an adult dose of Engerix-B was administered to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable.   Additional Information: GSK Receipt Date : 14-APR-2025 Medical assistant called on April 18, 2025 to reported on February 14, 2025 an adult dose of Engerix-B was administered to a pediatric patient which led to adult product administered to child and overdose.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertent administration of Kinrix under 4 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included Kinrix (patient has 4 Dtaps now), Kinrix (patient has 4 Dtaps now) and Kinrix (patient has 4 Dtaps now).   On 14-MAR-2025, the patient received Kinrix. On 14-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inadvertent administration of Kinrix under 4 years). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 14-APR-2025 Other HCP reported that a 19 months old baby received Kinrix, which led to inappropriate age at vaccine administration. Counting this last Kinrix shot, patient has 4 Dtaps now and asked How to proceed
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7942H, expiry date 02-MAR-2025) for prophylaxis.   On 21-APR-2025, the patient received Arexvy. On 21-APR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 The pharmacist reported that a patient in their facility gave Arexvy that expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 12-month-old female patient who received HAV (Havrix 1440 adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis.   On 22-APR-2025, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable.   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: 22-APR-2025 Medical Assistant called to report a twelve month old female patient that suffered the maladministration of an adult dose of a Havrix Vaccine, which led to adult product administered to child and overdose. Medical Assistant wanted to know if there are any safety (adverse event) and guidance (revaccination advise) on this situation.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number YY22P, expiry date 20-JUL-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 1st November 2024).   On 28-FEB-2025, the patient received the 2nd dose of Shingrix. On 28-FEB-2025, 119 days after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)) and inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 The registered nurse stated that they were not 100 percent sure if the patient had received the full dose or only the diluent.  If the patient had received three doses of Shingrix, what concerns would have needed to be addressed. Patient received maladministration of AS01B Adjuvant of Shingrix, which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blood test, Body temperature, Coma, Constipation
Clinical narrative: tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Hypersensitivity, Illness, Laboratory test, Lymph nodes scan normal
Clinical narrative: tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Restless legs syndrome, Sepsis, Uterine leiomyoma, Viral test
Clinical narrative: tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, West Nile virus test
Clinical narrative: tested positive for Covid 3 months after second Covid injection; tested positive for Covid 3 months after second Covid injection; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955) and on 10Apr2021 as dose 2, single (Lot number: EW0151) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, latency 3 months after the suspect product(s) administration, outcome "unknown" and all described as "tested positive for Covid 3 months after second Covid injection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Hallucination, Headache, Tremor
Clinical narrative: hallucinations; reaction of chills, shakes; reaction of chills, shakes; extreme headache; Initial information received on 16-Apr-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This was a courtesy case received via Pfizer.  This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  The patient's past medical history included Dyspepsia.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Ergocalciferol (Vitamin d); Ethinylestradiol, Levonorgestrel (Simpesse); Omeprazole; Hepatitis b vaccine rHBsAg (yeast) (Heplisav b); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap); and Typhoid vaccine (Typhoid) for Immunisation.  On 08-Apr-2025, the patient received a dose 1 of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot UT8485MA via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination and received a dose 1 of suspect COVID-19 Vaccine (Comirnaty) not produced by Sanofi Pasteur lot LP1776 via unknown route in the left arm (route, strength and expiration date: not provided) for prophylactic vaccination.  On 09-Apr-2025 the patient developed hallucinations (hallucination), reaction of chills, shakes (chills), (tremor) and headache (latency- 1 day).   Reportedly, patient stated that she had her normal reaction of chills, shakes, etc, but after that stopped an extreme headache has settled that has lasted since 4/9. Was having mild hallucinations the first couple days, not being fully aware of where she was.  Action taken- not applicable (for both suspects).  The patient was treated with Butalbital, Caffeine, Paracetamol (Fioricet) for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness criteria- medically significant for hallucination.; Sender's Comments: Sanofi Company Comment dated 23-Apr-2025: This case involves a 45 years old female patient who experienced hallucinations, reaction of chills, shakes, reaction of chills, shakes and extreme headache after receiving Covid-19 Vaccine (Comirnaty) and Influenza usp trival a-b subvirion no preservative vaccine [Fluzone]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not report any adverse issues or side effects from any of the administered doses; A patient who is currently 13 years old received their first dose on 06/19/2023 (lot: W007025 expiration: unknown) and a second dose today, 04/15/2025 (lot: Y005835 e; This spontaneous report was received from a nurse referring to a 13-year-old female patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 19-JUN-2023, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) injection, for prophylaxis (dose, route of administration, strength and anatomical location were not provided; valid lot number W007025, with expiration date not provided but upon internal validations established as 04-DEC-2024).   On 15-APR-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) injection as a dose of 0.5 ml, for prophylaxis (route of administration, strength and anatomical location were not provided; valid lot number Y005835, with expiration date on 06-JUN-2026). (Inappropriate schedule of product administration). There was no adverse effect reported.
Age: 68.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: wrong route of administration; 68 years patient received a priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 68-year-old male patient who received MMR (Priorix) (batch number 2N795, expiry date 13-SEP-2026) for prophylaxis.   On 17-APR-2025, the patient received Priorix (intramuscular). On 17-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: wrong route of administration) and inappropriate age at vaccine administration (Verbatim: 68 years patient received a priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable.   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: 18-APR-2025 The pharmacist reported a patient received a dose of Priorix via intramuscular injection instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. The 68 year old patient received a dose of Priorix vaccine which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2025047931:same reporter
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the third dose 10 days earlier than recommended/early 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 66-year-old female patient who received HAB (Twinrix) (batch number m4b34, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (Patient received second dose on 24-NOV-2024).   On 15-APR-2025, the patient received the 3rd dose of Twinrix. On 15-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: received the third dose 10 days earlier than recommended/early dose). The outcome of the drug dose administration interval too short was not applicable.   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: 18-APR-2025 Reporter asked how to proceed with the schedule of Twinrix when the patient received the third dose 10 days earlier than recommended. The patient received third dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper
Clinical narrative: abdominal stomach pain; This is a spontaneous report received from a Nurse.  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "abdominal stomach pain". The event "abdominal stomach pain" required physician office visit. Additional information: The patient has been sick since the patient received shots from Pfizer, and the patient has been to 8 doctors and a  surgeon and no one could figure out what was wrong with the patient, the patient had abdominal stomach pain that seemed to not be related to anything that they could find and they only thing that changed was the patient had the Pfizer vaccine (Pfizer COVID-19 Vaccine). The patient stated "for four years and I have been treated by 8 doctors." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Blood test normal, Borrelia test negative
Clinical narrative: abdominal stomach pain; This is a spontaneous report received from a Nurse.  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "abdominal stomach pain". The event "abdominal stomach pain" required physician office visit. Additional information: The patient has been sick since the patient received shots from Pfizer, and the patient has been to 8 doctors and a  surgeon and no one could figure out what was wrong with the patient, the patient had abdominal stomach pain that seemed to not be related to anything that they could find and they only thing that changed was the patient had the Pfizer vaccine (Pfizer COVID-19 Vaccine). The patient stated "for four years and I have been treated by 8 doctors." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19, COVID19
Symptoms: Cholecystectomy, Computerised tomogram normal, Dizziness, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: abdominal stomach pain; This is a spontaneous report received from a Nurse.  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "abdominal stomach pain". The event "abdominal stomach pain" required physician office visit. Additional information: The patient has been sick since the patient received shots from Pfizer, and the patient has been to 8 doctors and a  surgeon and no one could figure out what was wrong with the patient, the patient had abdominal stomach pain that seemed to not be related to anything that they could find and they only thing that changed was the patient had the Pfizer vaccine (Pfizer COVID-19 Vaccine). The patient stated "for four years and I have been treated by 8 doctors." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Nausea, Thyroid function test normal
Clinical narrative: abdominal stomach pain; This is a spontaneous report received from a Nurse.  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "abdominal stomach pain". The event "abdominal stomach pain" required physician office visit. Additional information: The patient has been sick since the patient received shots from Pfizer, and the patient has been to 8 doctors and a  surgeon and no one could figure out what was wrong with the patient, the patient had abdominal stomach pain that seemed to not be related to anything that they could find and they only thing that changed was the patient had the Pfizer vaccine (Pfizer COVID-19 Vaccine). The patient stated "for four years and I have been treated by 8 doctors." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea, Pulmonary thrombosis
Clinical narrative: pulmonary thrombosis; nausea; lower back pain; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA301951 (Sanofi).  A 34-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, 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: PULMONARY THROMBOSIS (hospitalization, medically significant), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain". The patient was hospitalized for pulmonary thrombosis (start date: 04Oct2024, discharge date: 06Oct2024, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of pulmonary thrombosis, nausea.  Clinical course:  Patient is taking Apixaban (Eliquis) for pulmonary thrombosis; Prochlorperazine edisylate (Prochlorperazine) and Ondansetron hydrochloride (Zofran) for Nausea and not reported for rest of the events. Hospitalization for 2 days from 04Oct2024 to 06Oct2024 for pulmonary thrombosis.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Injury
Clinical narrative: patient experienced INJURY; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-784929 (ModernaTX, Inc.), MOD-2025-783177 (ModernaTX, Inc.).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single) intramuscular for covid-19 prophylaxis; COVID-19 vaccine nrvv ad (chadox1 ncov-19) (ASTRAZENECA COVID-19 VACCINE), as dose 1, single) for product used for unknown indication; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single) for product used for unknown indication. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INJURY (medically significant), outcome "unknown", described as "patient experienced INJURY". Therapeutic measures were not taken as a result of injury.  Batch/lot number is not provided, and it cannot be obtained.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Broke out in full body hives
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Chest X-ray normal, Influenza virus test negative, Lethargy, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: FEVER, LETHARGY, SHAKING
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: SARS-CoV-2 test negative, Tremor
Clinical narrative: FEVER, LETHARGY, SHAKING
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Pt was given the vaccine IM and not SC
Age: 14.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no reaction. out of age recommendation
Age: 38.0
Sex: F
Vaccine: DT
Symptoms: Injection site paraesthesia, Paraesthesia, Raynaud's phenomenon
Clinical narrative: Tingling in the arm from site to pinky, comes and goes. Also have Raynauds phenomenon in the left pinky after administration
Age: 51.0
Sex: F
Vaccine: HEP, MMR, VARZOS
Symptoms: Hypersensitivity, Influenza like illness
Clinical narrative: Patient reported "allergic reaction" to vaccine administration on Monday 4/21. States starting Monday night, discomfort in arm began. When removing band aid following shower, site of injection swollen, red, reports pain at site, reports "flu like" symptoms. Confirmed with patient and vaccine administration record, arm affected Left side, Shingrix vaccine Advised OTC pain relief, Tylenol and or Ibuprofen, advised antihistamine such as Benadryl for swelling. Cold compress to injection site on/off 15 minute intervals with paper towel between to avoid direct skin contact, avoid lotions/perfumes to site. Offered same day visit with provider for follow up d/t sx not improving in 2-3 days, scheduled for same day of reporting for evening appointment. Advised calling office back for worsening symptoms and or Urgent care. Disclosed to patient vaers report to be filed.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Received the vaccine at a visit on the morning of 4/8/25.  About 8-9 hours, she developed numbness of her lower lip. Felt "like after you go to the dentist and they give you the numbing shot in your mouth."  Numbness was localized to the exterior surface of the lower lip, bilaterally from left commissure to right commissure.  No other numbness elsewhere.  No muscle weakness or asymmetry.  No  facial palsy.  Otherwise felt well.  Was able to talk normally, drink and eat normally.  maybe some mild swelling, per parent.    this sensation lasted unchanged until April 10th,  evening.    At this time she noticed that the  lip numbness was only felt on the left side ( from left commissure to midline).   otherwise felt well.  No cold sores
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash
Clinical narrative: Local rash at immunization.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: 2.5 X 1 CM AREA OF ERYTHEMA AND SWELLING