chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a Physician.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "visually impaired" (unspecified if ongoing); "hearing impaired" (unspecified if ongoing); "one eye infarcted" (unspecified if ongoing); "strokes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "back surgeries" (unspecified if ongoing). The patient's 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". The clinical course was reported as follows: The patient experienced neuropathy or inflammation on the bottoms of his feet several months after the initial infection.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain-Barre was related to the suspect product event most likely due to patient underlying contributory factors.  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.,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different drug dose/event;
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea
Clinical narrative: Fussiness and vesicular rash
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Scab, Skin discolouration, Urine output decreased
Clinical narrative: Fussiness and vesicular rash
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Irritability, Rash vesicular
Clinical narrative: Fussiness and vesicular rash
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Cough, Food refusal, Irritability, Laboratory test, Oral pain
Clinical narrative: Fussiness and vesicular rash
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Rash maculo-papular, Rhinorrhoea
Clinical narrative: Fussiness and vesicular rash
Age: 0.58
Sex: M
Vaccine: RV1, RV1
Symptoms: Extra dose administered
Clinical narrative: Patient given extra dose of Rotavirus oral vaccine. Physician notified. Drug manufacturer contacted for guidance.  No additional care/support advised. Parent notified and guidance provided.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Lethargy, Mobility decreased
Clinical narrative: patient said about 10-12 hours after the vaccine she experienced almost paralytic type symptoms. She needed to use the restroom and could not get up to go to the bathroom.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased
Clinical narrative: patient said about 10-12 hours after the vaccine she experienced almost paralytic type symptoms. She needed to use the restroom and could not get up to go to the bathroom.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Cellulitis, Condition aggravated, Pruritus, Rash
Clinical narrative: arm pain the same arm as the vaccine; that breathing got worse/ worsening breathing; cellulitis flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (Asthma), chronic obstructive pulmonary disease (COPD), tinnitus (Tinnitus), cellulitis (Cellulitis) and thyroid disorder (thyroid condition). Concomitant products included albuterol, fluticasone propionate (Flovent), digoxin (Lanoxin) and triamcinolone acetonide.   On 11-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain the same arm as the vaccine), dyspnea exacerbated (Verbatim: that breathing got worse/ worsening breathing) and cellulitis aggravated (Verbatim: cellulitis flare). The outcome of the pain in arm was not resolved and the outcome of the dyspnea exacerbated and cellulitis aggravated were resolved.   It was unknown if the reporter considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.     It was unknown if the company considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for herself. The reporter was the patient who had received her first dose of Shingrix on 11th April 2025.  She stated that her breathing had worsened, and her cellulitis had flared up.  She also experienced arm pain in the same arm as the vaccine (left arm), which had not resolved after three weeks.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Condition aggravated, Dyspnoea, Pain in extremity
Clinical narrative: arm pain the same arm as the vaccine; that breathing got worse/ worsening breathing; cellulitis flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (Asthma), chronic obstructive pulmonary disease (COPD), tinnitus (Tinnitus), cellulitis (Cellulitis) and thyroid disorder (thyroid condition). Concomitant products included albuterol, fluticasone propionate (Flovent), digoxin (Lanoxin) and triamcinolone acetonide.   On 11-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain the same arm as the vaccine), dyspnea exacerbated (Verbatim: that breathing got worse/ worsening breathing) and cellulitis aggravated (Verbatim: cellulitis flare). The outcome of the pain in arm was not resolved and the outcome of the dyspnea exacerbated and cellulitis aggravated were resolved.   It was unknown if the reporter considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.     It was unknown if the company considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for herself. The reporter was the patient who had received her first dose of Shingrix on 11th April 2025.  She stated that her breathing had worsened, and her cellulitis had flared up.  She also experienced arm pain in the same arm as the vaccine (left arm), which had not resolved after three weeks.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Cellulitis, Chronic obstructive pulmonary disease, Condition aggravated, Discomfort
Clinical narrative: arm pain the same arm as the vaccine; that breathing got worse/ worsening breathing; cellulitis flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (Asthma), chronic obstructive pulmonary disease (COPD), tinnitus (Tinnitus), cellulitis (Cellulitis) and thyroid disorder (thyroid condition). Concomitant products included albuterol, fluticasone propionate (Flovent), digoxin (Lanoxin) and triamcinolone acetonide.   On 11-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain the same arm as the vaccine), dyspnea exacerbated (Verbatim: that breathing got worse/ worsening breathing) and cellulitis aggravated (Verbatim: cellulitis flare). The outcome of the pain in arm was not resolved and the outcome of the dyspnea exacerbated and cellulitis aggravated were resolved.   It was unknown if the reporter considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.     It was unknown if the company considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for herself. The reporter was the patient who had received her first dose of Shingrix on 11th April 2025.  She stated that her breathing had worsened, and her cellulitis had flared up.  She also experienced arm pain in the same arm as the vaccine (left arm), which had not resolved after three weeks.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: arm pain the same arm as the vaccine; that breathing got worse/ worsening breathing; cellulitis flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (Asthma), chronic obstructive pulmonary disease (COPD), tinnitus (Tinnitus), cellulitis (Cellulitis) and thyroid disorder (thyroid condition). Concomitant products included albuterol, fluticasone propionate (Flovent), digoxin (Lanoxin) and triamcinolone acetonide.   On 11-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain the same arm as the vaccine), dyspnea exacerbated (Verbatim: that breathing got worse/ worsening breathing) and cellulitis aggravated (Verbatim: cellulitis flare). The outcome of the pain in arm was not resolved and the outcome of the dyspnea exacerbated and cellulitis aggravated were resolved.   It was unknown if the reporter considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.     It was unknown if the company considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for herself. The reporter was the patient who had received her first dose of Shingrix on 11th April 2025.  She stated that her breathing had worsened, and her cellulitis had flared up.  She also experienced arm pain in the same arm as the vaccine (left arm), which had not resolved after three weeks.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: arm pain the same arm as the vaccine; that breathing got worse/ worsening breathing; cellulitis flare; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (Asthma), chronic obstructive pulmonary disease (COPD), tinnitus (Tinnitus), cellulitis (Cellulitis) and thyroid disorder (thyroid condition). Concomitant products included albuterol, fluticasone propionate (Flovent), digoxin (Lanoxin) and triamcinolone acetonide.   On 11-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain the same arm as the vaccine), dyspnea exacerbated (Verbatim: that breathing got worse/ worsening breathing) and cellulitis aggravated (Verbatim: cellulitis flare). The outcome of the pain in arm was not resolved and the outcome of the dyspnea exacerbated and cellulitis aggravated were resolved.   It was unknown if the reporter considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.     It was unknown if the company considered the pain in arm, dyspnea exacerbated and cellulitis aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for herself. The reporter was the patient who had received her first dose of Shingrix on 11th April 2025.  She stated that her breathing had worsened, and her cellulitis had flared up.  She also experienced arm pain in the same arm as the vaccine (left arm), which had not resolved after three weeks.
Sex: F
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported vaccines administered after temperature excursions; No additional AEs; This invalid spontaneous report was received from a medical assistant and refers to patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y017511, expiration date: 15-Apr-2026) (dose, vaccination site and route of administration were not reported); and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y011019, expiration date: 18-Jun-2026) (dose, vaccination site and route of administration were not reported) administered for prophylaxis.  The vaccines were administered after temperature excursions (temperature: -9.8C; time frame: 2 hours 3 minutes) (product storage error). There was no previous temperature excursion. No other information was provided. No additional adverse events (AEs) or product quality complaint (PQC) was reported.  This case was considered invalid due to lack of patients' identifiers.   Follow up information was received on 25-APR-2025 via complete questionnaire and refers to a 4-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017511, expiration date: 15-Apr-2026), dose number 1, administered by Subcutaneous route in Left Thigh, and with Hepatitis A Vaccine (previously reported as Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX)), Inactivated (lot #Y007585, expiration date: 31-Oct-2025), dose number 1, administered by Intramuscular route in Right Thigh.  This is one of several reports from the same reporter.
Age: 17.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered; This spontaneous report was received from a Nurse and refers to a 17-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015557, expiration date: 16-Sep-2026) diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) for prophylaxis. Temperature excursion occurred at -7.8C for 36 minutes. Previous temperature excursion was at (-14.4 C up to -10.4C) -14.0C for 13 minutes. No additional adverse event was reported.
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Customer calling to report that a dose of VARIVAX was administered after its expiration date.; Information has been received from Business Partner/CRO on 02-May-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #X012281, expiration date: 30-Apr-2025). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for the treatment of Prophylaxis.  The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), for the treatment of Prophylaxis.  On 01-May-2025, the patient experienced Customer calling to report that a dose of VARIVAX was administered after its expiration date.. On an unknown date, the patient experienced No additional AE.   At the reporting time, the outcome of No additional AE and Customer calling to report that a dose of VARIVAX was administered after its expiration date. was unknown.   The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives start on day 2 and I have complete the 4 oral pills every other day and am still experiencing hives.  My husband also took the same oral vaccine and had a more significant hive reaction.
Age: 77.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: severe itching and hives s/p vaccination requiring intervention
Vaccine: TDAP
Symptoms: Device leakage, Underdose
Clinical narrative: While giving Boostrix injection, several drop of vaccine dripped from manufacturer's seal, verified that was not leaking from needle attachment. Most of medication was administered into patient's arm. No harm caused to patient.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Fall, Gait disturbance, Gastrooesophageal reflux disease
Clinical narrative: I received the pfizer COVID-19 vaccine in November of 2022. I started to have symptoms in my feet and hands. Tingling and pins and needles feeling in both hands and feet. It progressively got worse. Then on 4/15/2023, I fell flat on my face and could not feel my legs at all. I had to be carried out of the building I was in and taken to an urgent care/Hospital where they told me to see a neurologist. I saw a neurologist on 5/9/2023. She looked at me, examined me, and sent me straight to the ER at the closest hospital. She knew something was not right. I had always taken Moderna COVID but this one time, I was given the Pfizer and that caused this disease to activate and come out so prominently. After every test possible, a spinal tap, multiple attempts at IVIG, I was diagnosed with CMT type 1A. The doctors at the hospital stated that the Pfizer COVID-19 vaccination brought the genetic disease out so prominently. Since I've had this disease for as long as I've lived, and it had stayed dormant, they had come to the conclusion that this vaccination, brought my disease to surface and now I am highly disabled. I can't feel my feet, have tingling in my hands and can barely walk or pick up every day objects. I'm currently in a clinical trial but there is no cure for my disease since it is genetic. I wish I would have never taken the pfizer vaccine. I probably would have still been living a normal life.
Sex: F
Vaccine: COVID19
Symptoms: Hereditary motor and sensory neuropathy, Hypoaesthesia, Laboratory test, Lumbar puncture normal, Migraine
Clinical narrative: I received the pfizer COVID-19 vaccine in November of 2022. I started to have symptoms in my feet and hands. Tingling and pins and needles feeling in both hands and feet. It progressively got worse. Then on 4/15/2023, I fell flat on my face and could not feel my legs at all. I had to be carried out of the building I was in and taken to an urgent care/Hospital where they told me to see a neurologist. I saw a neurologist on 5/9/2023. She looked at me, examined me, and sent me straight to the ER at the closest hospital. She knew something was not right. I had always taken Moderna COVID but this one time, I was given the Pfizer and that caused this disease to activate and come out so prominently. After every test possible, a spinal tap, multiple attempts at IVIG, I was diagnosed with CMT type 1A. The doctors at the hospital stated that the Pfizer COVID-19 vaccination brought the genetic disease out so prominently. Since I've had this disease for as long as I've lived, and it had stayed dormant, they had come to the conclusion that this vaccination, brought my disease to surface and now I am highly disabled. I can't feel my feet, have tingling in my hands and can barely walk or pick up every day objects. I'm currently in a clinical trial but there is no cure for my disease since it is genetic. I wish I would have never taken the pfizer vaccine. I probably would have still been living a normal life.
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Neuropathy peripheral, Paraesthesia, Reduced facial expression, Tremor
Clinical narrative: I received the pfizer COVID-19 vaccine in November of 2022. I started to have symptoms in my feet and hands. Tingling and pins and needles feeling in both hands and feet. It progressively got worse. Then on 4/15/2023, I fell flat on my face and could not feel my legs at all. I had to be carried out of the building I was in and taken to an urgent care/Hospital where they told me to see a neurologist. I saw a neurologist on 5/9/2023. She looked at me, examined me, and sent me straight to the ER at the closest hospital. She knew something was not right. I had always taken Moderna COVID but this one time, I was given the Pfizer and that caused this disease to activate and come out so prominently. After every test possible, a spinal tap, multiple attempts at IVIG, I was diagnosed with CMT type 1A. The doctors at the hospital stated that the Pfizer COVID-19 vaccination brought the genetic disease out so prominently. Since I've had this disease for as long as I've lived, and it had stayed dormant, they had come to the conclusion that this vaccination, brought my disease to surface and now I am highly disabled. I can't feel my feet, have tingling in my hands and can barely walk or pick up every day objects. I'm currently in a clinical trial but there is no cure for my disease since it is genetic. I wish I would have never taken the pfizer vaccine. I probably would have still been living a normal life.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: About a week after receiving my 2nd shingles shot on April 7th, 2025 a began to have a tingling sensation on the left side of my neck, beginning at the shoulder and creeping up to the base of my scalp. This happens several times per hour (at least 15 and lasts approximately 15 seconds. It feels like "hair standing on end" and is not painful. It continues to this day. I have had no other changes to my diet, medications or lifestyle that would explain this sensation. I am 65, 5 ft 5 in, 125 lbs. No allergies. Medications, which I have been on for over 5 years, include Wellbutrin, amlodipine, losartan.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersensitivity, Oligomenorrhoea
Clinical narrative: I received my first dose of Gardasil 9 on March 5th. After that, I experienced a 14-day delay in my menstrual cycle, which is very unusual for me. I also developed an allergic reaction in my underarm area after the vaccination, which is also strange and has never happened to me before. I believe that the vaccination caused a disruption in my menstrual cycle and may have triggered the allergic reaction.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Albuminocytological dissociation present, Areflexia, Autonomic nervous system imbalance, Axonal neuropathy, CSF white blood cell count negative
Clinical narrative: He developed a clinical picture of Guillain-Bare Syndrome 10 days after flu vaccine. Severe bilateral lower extremity weakness and sensory loss. Absent lower extremity reflexes, axonal neuropathy on EMG (+)  cytoalbuminologic dissociation on CSF. Also had dysautonomia - urinary retention
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Cytology normal, Electromyogram abnormal, Guillain-Barre syndrome, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: He developed a clinical picture of Guillain-Bare Syndrome 10 days after flu vaccine. Severe bilateral lower extremity weakness and sensory loss. Absent lower extremity reflexes, axonal neuropathy on EMG (+)  cytoalbuminologic dissociation on CSF. Also had dysautonomia - urinary retention
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss, Urinary retention
Clinical narrative: He developed a clinical picture of Guillain-Bare Syndrome 10 days after flu vaccine. Severe bilateral lower extremity weakness and sensory loss. Absent lower extremity reflexes, axonal neuropathy on EMG (+)  cytoalbuminologic dissociation on CSF. Also had dysautonomia - urinary retention
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: 4-day history of erythematous circumferential rash to right upper outer extremity that presented 1 day after receiving Prevnar vaccination.  Area is about 3 inches in circumference, with warmth, and mild firmness at center.  No TTP.  No infectious symptoms.  No extension of symptoms beyond the direct site.  She notes it has been reducing in size.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Gait disturbance, Injection site pain
Clinical narrative: PAIN AND LIMPING IN LEFT LEG NO REDNESS OR CELLULITIS
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Discomfort, Dizziness, Headache, Lymphadenopathy
Clinical narrative: Patient started experiencing measles-like rash, left axillary lymph node swelling/discomfort, fever, headache, dizziness, joint pain on Friday, May 2, 2025. Symptoms have now started to improve
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Patient started experiencing measles-like rash, left axillary lymph node swelling/discomfort, fever, headache, dizziness, joint pain on Friday, May 2, 2025. Symptoms have now started to improve
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Ocular discomfort, Pyrexia, Rash
Clinical narrative: Patient reports slight rash on arms on 05/05/2025 with slight fever on 05/05/2025. On 05/06/2025 slight rash om chest and some chills but no fever. Also reports eyeballs feel sore when shifting to look to the sides.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Pt's wife called and said patient is feeling very tired this morning and is feeling lousy. She also mentioned that he felt dizzy when he stood up and had to lay back down.  I suggested the patient take tylenol if they have a fever. I told her he will probably start to feel better later today, but if anything gets worse to call his doctor and also us at the pharmacy
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Multiple blood clots in abdomen.
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Hypoaesthesia, Limb discomfort, Paraesthesia, Peripheral swelling
Clinical narrative: 11/11/24: Prevnar 20 administered, 11/19/24: patient reports, "top of arm is still swollen and red" and "arm feels heavy, tingling and numbness while typing" with a severity of 9/10, patient denies fever or previous reaction. patient prescribed 10-day supply of naproxen 500mg twice a day with meals. 12/3/24 patient calls and says naproxen is not working and she is referred to ortho (cannot see if there was any appointment made or what the results were).3/27/25 patient reports no relief and all the same symptoms continue referred to neurology but patient refuses, offered pain managment referral
Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: X-ray
Clinical narrative: 11/11/24: Prevnar 20 administered, 11/19/24: patient reports, "top of arm is still swollen and red" and "arm feels heavy, tingling and numbness while typing" with a severity of 9/10, patient denies fever or previous reaction. patient prescribed 10-day supply of naproxen 500mg twice a day with meals. 12/3/24 patient calls and says naproxen is not working and she is referred to ortho (cannot see if there was any appointment made or what the results were).3/27/25 patient reports no relief and all the same symptoms continue referred to neurology but patient refuses, offered pain managment referral
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: PATIENT WAS ONLY GIVEN STERILE DILUTENT LYOPHILIZED POWDER WAS NOT ADMINISTERED
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness transient, Erythema, Hypoaesthesia, Mobility decreased, Muscle spasms
Clinical narrative: 10/16/24- Redness, swelling, pain, numbness, muscle spasms, limited mobility. Instances of extreme pain cause temporary blindness.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Swelling, X-ray limb
Clinical narrative: 10/16/24- Redness, swelling, pain, numbness, muscle spasms, limited mobility. Instances of extreme pain cause temporary blindness.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Computerised tomogram abnormal, Computerised tomogram thorax, Dyspnoea, Full blood count
Clinical narrative: Had shortness of breath and intermittent tachycardia for a few months before being transported to ER by ambulance on 2/23/25,  for shortness of breath and tachycardia (150-170). Chest CT with contrast done showing  massive pulmonary embolus.  Taken to cardiac cath lab for pulmonary artery clot evacuation.  Pulmonary artery pressures were elevated to 57/19/35, and returned to normal 24/8/15 post procedure.  IV heparin infusion X 24 hrs,  Eliquis double dose X 7 days then Eliquis 5mg q 12 hrs. indefinitely .
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Prothrombin time, Pulmonary embolism, Tachycardia, Thromboembolectomy
Clinical narrative: Had shortness of breath and intermittent tachycardia for a few months before being transported to ER by ambulance on 2/23/25,  for shortness of breath and tachycardia (150-170). Chest CT with contrast done showing  massive pulmonary embolus.  Taken to cardiac cath lab for pulmonary artery clot evacuation.  Pulmonary artery pressures were elevated to 57/19/35, and returned to normal 24/8/15 post procedure.  IV heparin infusion X 24 hrs,  Eliquis double dose X 7 days then Eliquis 5mg q 12 hrs. indefinitely .
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: PATIENT FELL BACK AFTER RECEIVING VACCINE AND APPEARED TO FAINT/BE UNCONSCIOUS FOR ABOUT 30-45 SECONDS, PER MA IN ROOM. DR DESCRIBED IT TO MOM AS A LIKELY VASOVAGAL SYNCOPE EPISODE.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Blister, Cellulitis, Contusion, Erythema, Muscle twitching
Clinical narrative: The evening of 5/2 the patient started with shaking and muscle twitching. The following day, mom started taking pictures as she noticed left arm redness and swelling that was progressing. Patient was evaluated at Urgent Care where it was determined to be a localized vaccine reaction.   On 5/4 patient was referred to ED for progressing arm redness and swelling with bruising and blistering noted. It was determined to most likely be a vaccine reaction with cellulitis being a less likely cause.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Peripheral swelling, Skin reaction, Tremor
Clinical narrative: The evening of 5/2 the patient started with shaking and muscle twitching. The following day, mom started taking pictures as she noticed left arm redness and swelling that was progressing. Patient was evaluated at Urgent Care where it was determined to be a localized vaccine reaction.   On 5/4 patient was referred to ED for progressing arm redness and swelling with bruising and blistering noted. It was determined to most likely be a vaccine reaction with cellulitis being a less likely cause.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: Palpitations, frequent PVCs that started within 24 hours of vaccination and persisted consistently x 3 days.  Still uncertain if r/t the Shingrix vaccine.  No chest pain, SOB, or lightheadedness.  No other contributing factors identified.  Has not fully resolved, but does feel to be improving on 5/6/25 versus the prior 3 days.
Age: 1.92
Sex: M
Vaccine: DTAP, DTAP, HEP, PNC20, VARCEL
Symptoms: Blood culture, Blood test normal, Computerised tomogram abnormal, Culture urine, Endotracheal intubation
Clinical narrative: Patient presented to emergency room in status epilepticus at 23:25 on 5/5/25 after receiving the above vaccines at PCP earlier in the day. Per documentation, Mother noted tactile fever around 22:00. Around 22:30  saw shaking in his arm and twitching in his face. This lasted around 5 minutes before they called EMS. He was given a dose of IN versed and transported to ED. In the ED, there was concern he was in subclinical status so received 2 doses of Ativan and a Keppra load. He subsequently got intubated for concern for acute respiratory failure and and transferred to the PICU. History only of global developmental delay. Immigrated about 2 months ago.
Age: 1.92
Sex: M
Vaccine: DTAP, DTAP, HEP, PNC20, VARCEL
Symptoms: Intensive care, Muscle twitching, Pyrexia, Respiratory viral panel, Status epilepticus
Clinical narrative: Patient presented to emergency room in status epilepticus at 23:25 on 5/5/25 after receiving the above vaccines at PCP earlier in the day. Per documentation, Mother noted tactile fever around 22:00. Around 22:30  saw shaking in his arm and twitching in his face. This lasted around 5 minutes before they called EMS. He was given a dose of IN versed and transported to ED. In the ED, there was concern he was in subclinical status so received 2 doses of Ativan and a Keppra load. He subsequently got intubated for concern for acute respiratory failure and and transferred to the PICU. History only of global developmental delay. Immigrated about 2 months ago.
Age: 1.92
Sex: M
Vaccine: DTAP, DTAP, HEP, PNC20, VARCEL
Symptoms: Tremor, Urine analysis normal, Viral test negative
Clinical narrative: Patient presented to emergency room in status epilepticus at 23:25 on 5/5/25 after receiving the above vaccines at PCP earlier in the day. Per documentation, Mother noted tactile fever around 22:00. Around 22:30  saw shaking in his arm and twitching in his face. This lasted around 5 minutes before they called EMS. He was given a dose of IN versed and transported to ED. In the ED, there was concern he was in subclinical status so received 2 doses of Ativan and a Keppra load. He subsequently got intubated for concern for acute respiratory failure and and transferred to the PICU. History only of global developmental delay. Immigrated about 2 months ago.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash, Vomiting
Clinical narrative: Patient was in office for apt. at 10:10am and received #1 MMR Live vaccine in office date 04/01/2022 around 11:00am with no symptoms later evening. Patient started with high fever of 105 04/02/2022 early noon 12 and alternated between Tylenol and Motrin Q4hrs PRN with no other symptoms. Mother states patient woke up next morning 04/03/2022 with rash all over body, decreased appetite, not keeping fluids down and continued with high fevers on and off with no redness or warm to touch injection site was not irritated to mothers knowledge.  Mother spoke with an on call provider explaining symptoms she was advised to keep patient hydrated and continue with medications any other symptoms occur seek Medical ER attention. By Tuesday 04/05/2022 patient was much better.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Gait disturbance, Injected limb mobility decreased, Joint swelling
Clinical narrative: pt says she started swelling in the left ankle after the 1st injection. She went to see her PCP    She was told not to worry about it and to have her 2nd injection. After the 2nd injection, both ankles started swelling. She wasn't able to raise her arms over her head.  She could barely walk. She was in a lot of pain from the swelling. She went to back to the doctor and was sent to the hospital to have test. She was told it was not her heart and was referred to Dr. She was told that the swelling was from the covid vaccine and prescribed prednisone. She went to a specialist They did blood work and ran test that were all negative and was told she did not have arthritis.  Her hand Surgeon told her symptoms were from the covid vaccine and that she would have to live with it. She now has problems with the muscles in her arms and her legs and has a follow up appt w/ Dr.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mobility decreased, Muscle disorder, Vaccine positive rechallenge, X-ray
Clinical narrative: pt says she started swelling in the left ankle after the 1st injection. She went to see her PCP    She was told not to worry about it and to have her 2nd injection. After the 2nd injection, both ankles started swelling. She wasn't able to raise her arms over her head.  She could barely walk. She was in a lot of pain from the swelling. She went to back to the doctor and was sent to the hospital to have test. She was told it was not her heart and was referred to Dr. She was told that the swelling was from the covid vaccine and prescribed prednisone. She went to a specialist They did blood work and ran test that were all negative and was told she did not have arthritis.  Her hand Surgeon told her symptoms were from the covid vaccine and that she would have to live with it. She now has problems with the muscles in her arms and her legs and has a follow up appt w/ Dr.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Blood test, Hormone level abnormal, Polycystic ovarian syndrome, Ultrasound scan
Clinical narrative: Nine months after vaccination, my period disappeared for five months, and my hormone levels were imbalanced for who knows how long prior, and I was diagnosed with PCOS. I have never had issues like this before.