chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). 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: 27-APR-2025 This case was reported by a patient via interactive digital media. The 1st shot made patient so sick. He/she did not want to take the 2nd one.
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: mild headache for about five hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: mild headache for about five hours). The outcome of the headache was resolved (duration 5 hrs).   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     It was unknown if the company considered the headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2025 The case was received from the patient via interactive digital media. The reporter got his/her a few years back.  Only side affect he/she had was a very mild headache for about five hours.  Much better than getting shingles's.
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: permanent nerve damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-FEB-2019, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: permanent nerve damage). The outcome of the nerve damage was not resolved.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the nerve damage to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that they had received the round of medication on 04th February 2019 and when the first round did not work, they underwent a second round and unfortunately, this resulted in permanent nerve damage. The re[porter mentioned that by 2025, they were still suffering.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received a dose of Shingrix reconstituted with sterile water; received a dose of Shingrix reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution (Verbatim: received a dose of Shingrix reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: received a dose of Shingrix reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 21-APR-2025 The director of pharmacy called to report that they administered Shingrix reconstituted with sterile water to a patient over 50 years old which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter had a questioned was there any guidance or did the patient needs another dose.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: A 60 years old female patient received only the sterile water portion of Priorix.; A 60 years old female patient received only the sterile water portion of Priorix.; A 60 years old female patient received Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received MMR (Priorix) (batch number 3ER79, expiry date 28-NOV-2028) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: A 60 years old female patient received only the sterile water portion of Priorix.), inappropriate dose of vaccine administered (Verbatim: A 60 years old female patient received only the sterile water portion of Priorix.) and inappropriate age at vaccine administration (Verbatim: A 60 years old female patient received Priorix). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered 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: 22-APR-2025 The nurse manager reported that they administered only the sterile water component of Priorix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Lot number was 2JX7Y and expiration date 01st June 2026 of Priorix that was not administered. The reporter asked was there any potential harm to the patient. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; pregnant patient was administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient was administered Arexvy), drug use in unapproved age group (Verbatim: pregnant patient was administered Arexvy) and inappropriate age at vaccine administration (Verbatim: pregnant patient was administered Arexvy). The outcome of the vaccine exposure during pregnancy, drug use in unapproved age group and inappropriate age at vaccine administration were not applicable.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 23-APR-2025 Other HCP reported that a pregnant patient was administered Arexvy, which led to vaccine exposure during pregnancy and drug use in unapproved population. This was reported to him by the patient's mother.
Age: 0.17
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Accidental overdose
Clinical narrative: accidental overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number m52gg, expiry date 07-SEP-2026) for prophylaxis.   On 21-APR-2025, the patient received the 1st dose of Pediarix and the 1st dose of Infanrix. On 21-APR-2025, an unknown time after receiving Pediarix and Infanrix, the patient experienced accidental overdose (Verbatim: accidental overdose). The outcome of the accidental overdose 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: 25-APR-2025 The reporter stated that a 2 months female baby received Pediarix and Infanrix on the same clinic day, which led to accidental overdose.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix was administered to a 7-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 7-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TC47K, expiry date 29-MAR-2026) for prophylaxis.   On 24-APR-2025, the patient received Pediarix. On 24-APR-2025, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix was administered to a 7-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: 25-APR-2025 The clinical coordinator called to report Pediarix was administered to a 7-years and 5-months old patient, which led to inappropriate age at vaccine administration.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administering the liquid portion only; administering the liquid portion only; 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 62-year-old female patient who received Herpes zoster (Shingrix) (batch number HA5HL, expiry date 13-NOV-2026) for prophylaxis.   On 22-APR-2025, the patient received Shingrix. On 22-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administering the liquid portion only) and inappropriate preparation of medication (Verbatim: administering the liquid portion only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK receipt date: 29-APR-2025 The nurse called to verify when the dose of Shingrix could be repeated after administering the liquid portion only which led to, inappropriate dose of vaccine administered and inappropriate preparation of medication. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temp. excursion of Boostrix and Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number XL223) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PJ3RP) for prophylaxis.   On 23-APR-2025, the patient received Menveo and Boostrix. On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. excursion of Boostrix and Menveo). The outcome of the incorrect storage of drug 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: 29-APR-2025 The reporter called to report a temperature excursion then healthcare professional asked that between the time that the excursion happened until one day before the reporting date, there was 8 vaccines administered, and that's completely fine, correct. The vaccine administration facility was the same as primary reporter. The reporter mentioned that after the temperature excursion, they administered 8 vaccines. This patient received Boostrix and Menveo (1 vial) after temperature excursion, which led to incorrect storage of drug.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Caller had a friend and his wife died from the Covid 19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller had a friend and his wife died from the Covid 19 vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            This case was created for reporter's friend.  No concomitant medications were reported.  It was reported that the reporter had a friend and his wife who died from the Moderna Covid-19 vaccine. The caller was asked if there was an adverse event that happened regarding flu shot, and the reporter asked if Pfizer or manufacturer of the shot be financially liable for the damages incurred from an adverse event or not. The reporter had lots of questions regarding Covid vaccine, he never got it and never got sick but reported that everybody that he knew who got the vaccine always became sick. The reporter did not mention the brand of Covid vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-785520, US-MODERNATX, INC.-MOD-2025-785519 (E2B Linked Report).; Reporter's Comments: Company Comments. The time between vaccination and the patient`s death is unknown. Tozinameran remained co-suspect product. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785520:Invalid case for other patient's US-MODERNATX, INC.-MOD-2025-785519:Wife's case; Reported Cause(s) of Death: Death unexplained
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: Broken upon arrival; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a nurse from product quality group.  A patient (age and gender not provided) received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4927, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LN4927, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 23Apr2025, outcome "unknown", described as "Broken upon arrival".  Causality for "broken upon arrival" was determined associated to device constituent of Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (malfunction).  Additional Information: The reporting laboratory nurse was calling to report issue with Prevnar 20 vaccine (NDC Number: 0005200010). When they received shipment on 23Apr2025, one vial was broken upon arrival. She opened the box and was going to put in Accuvax but one was broken, it is a prefilled syringe that was broken. She was calling to see what the process was and if needed to return the broken Prevnar 20 prefilled syringe to the company. The sample of the product was available to be returned. She is requesting replacement and confirms no patient involvement.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Dizziness while sitting; chest pain; shortness of breath; This is a spontaneous report received from a Physician.  A 17-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 23Apr2025 at 08:00 as dose 2, single (Lot number: FL5302) at the age of 17 years, in left arm for immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL (XR). Vaccination history included: Meningococcal vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Immunization.  The following information was reported: DIZZINESS (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "Dizziness while sitting"; CHEST PAIN (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering"; DYSPNOEA (medically significant) with onset 23Apr2025 at 22:00, outcome "recovering", described as "shortness of breath". Therapeutic measures were taken as a result of dizziness, chest pain, dyspnoea.  Additional information: Vaccine was administered at Doctor's office/urgent care. Patient did not receive any other vaccines on the same date as the suspect vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the suspect vaccine. Patient was taking other medications within 2 weeks of the event starting. Dizziness while sitting, chest pain and shortness of breath 14 hours after having her well visit and Trumenba. Treatment received for the adverse event was IVF (intravenous fluid treatment) in the ER.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events Dizziness, Dyspnoea, Chest pain and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had COVID at least three times; had COVID at least three times; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 61-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID at least three times".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: RSV
Symptoms: Device issue, Discomfort, Needle issue, Pain
Clinical narrative: rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled; causes a little bit more pain and discomfort than it should be; causes a little bit more pain and discomfort than it should be; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEVICE ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "rubber stopper is a little bit more thicker than normal that it causes the needle to be dulled"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "unknown" and all described as "causes a little bit more pain and discomfort than it should be". Therapeutic measures were not taken as a result of device issue, needle issue, vaccination site pain, vaccination site discomfort. Additional information: The vaccine was clarified as Abrysvo Act-O-Vial. It had all in one dose that came in the vial. The pharmacist said, when they used the Act-O-Vial kit that they put the needle into the kit to withdraw the vaccine that they felt like the rubber stopper/plunger was thicker than normal. They felt the stopper/plunger was so thick that it caused the needle as it went through and when they withdraw and stuck it into the patient's arm, it caused the patient a little bit more pain and discomfort than it should be. In pharmacist's opinion the rubber stopper was a little bit more thicker than normal that it caused the needle to be dulled. That was the pharmacist opinion. There was no lab work in past two weeks. The packaging sealed and intact.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 48.0
Sex: M
Vaccine: PNC20
Symptoms: Diabetes mellitus
Clinical narrative: diabetes; This is a spontaneous report received from an Other HCP, Program ID:.  A 48-year-old male patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 23Apr2025 as dose number unknown, 0.5 ml single (Lot number: G5579) at the age of 48 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes".; Sender's Comments: There is not a reasonable possibility that the reported event diabetes 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.
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thrombosis; This is a spontaneous report received from a Physician from a sales representative.  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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown".  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 thrombosis and the suspect drug BNT162B2 OMICRON (KP.2) 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
Symptoms: Immunisation reaction
Clinical narrative: I've had Pfizer boosters which I've had a pretty significant immune responses to; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV25-00240 (Novavax).  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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Novavax covid-19 vaccine (Primary Immunization series complete), for Immunization. The following information was reported: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "I've had Pfizer boosters which I've had a pretty significant immune responses to".  Additional information: Patient was part of the original Novavax trial and following that patient was trying to get a booster. Patient have had Pfizer boosters which patient have had a pretty significant immune response to. Patient wanted to stay away from mRNA. Patient was having a hard time finding anyone that's carrying Novavax.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19; got COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19". The clinical course was reported as follows: The patient got the Pfizer vaccines and then the first time she got COVID-19, and received nirmatrelvir;ritonavir (PAXLOVID) as a treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not have an adverse reaction but did receive an extra dose of flu vaccine.  It was noted in the database after the fact he received a 2024-2025 dose on 10/23/2024.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin discolouration, Urticaria
Clinical narrative: Fever 102, welts and describes arm as being "black and blue"
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Rash, Rash erythematous, Rash macular, Skin warm
Clinical narrative: Red rash with heat on arm and fever then spreading over the next 6 days to include inner arm then chest then blotches on lower half.  Fever was highest at 102.7.  Patient was given Sulfamethoxazole Trimethoprim on 4/10/25 and prednisone on 4/14/25 when the rash spread further.  Took a full 28 days to resolve.    Patient had no problem with Prevnar 23 when given LAST TIME.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a 3rd dose of Shingrix. Patient had gotten two doses already at a different pharmacy.- No adverse reaction
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This vaccine was deemed non-viable as it was stored in a regular freezer and not an ultra-freezer for 77 days prior to administration.
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Expired product administered
Clinical narrative: The hepatitis A vaccines expired 4/24/25 but was given 5/5/25. Patient did not experience any adverse signs or symptoms to my knowledge at the time of the report. Patient's parent was notified of error, and the need to revaccinate, and to let us know if patient needs anything due to error.
Age: 12.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Hypersensitivity, Pruritus, Swelling, Swelling face
Clinical narrative: Yellow fever vaccine was administered to the patient on 4/26/25. It is for a family of 4. The mother came on 5/2/25 to pick up a prescription and upon counseling, I asked how the family was. The mom then told me that patient had an allergic reaction to the YF vaccine 20 minutes later while they were grocery shopping.  Patient felt itching on his body. She then gave him Benadryl to take. Still a few minutes later, he was still complaining and swelling of the face and neck was  observed. He complained of difficulty breathing. They took him to ER. In ER they administered Epi-pen and Solu-medrol. He was in observation for 4 hours. Swelling went down. Released him with an oral Prednisone. Mom was somewhat  okay when I saw her on 5/2/25 and the 3 other family had no reaction whatsoever.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dry mouth, Dysphagia, Myasthenia gravis
Clinical narrative: pt had some dryness in mouth and some difficulty in swallowing, went to dr on 2/13/25 and was diagnosed with myasthenia gravis and given some steroids.  Symptoms improved some, but didn't resolve completely. At end of March pt had worsening symptoms, went back to dr for more steroids, and ended up going to the ER around 3/31/25.  Was released from hospital to rehab, and now back home.   Neither patient or doctor  indicated that they thought his myasthenia gravis was an adverse reaction to the flu shot, but wanted to report it.  Pt  seemed to feel that his previous illness, meds, etc. made his immune system go haywire and may have initiated the the myasthenia gravis episode.
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: HEADACHE, FEVER, DIARRHEA, [PAIN FROM JAW TO WAIST, CANNOT SLEEP ON LEFT SIDE  - PATIENT HAD FEVER, SWELLING, REDNESS - INJECTION SITE REACTION - ADMINISTERED 4/30, STILL RED AND SWOLLEN
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Pain in jaw, Pyrexia, Sleep disorder
Clinical narrative: HEADACHE, FEVER, DIARRHEA, [PAIN FROM JAW TO WAIST, CANNOT SLEEP ON LEFT SIDE  - PATIENT HAD FEVER, SWELLING, REDNESS - INJECTION SITE REACTION - ADMINISTERED 4/30, STILL RED AND SWOLLEN
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Pyrexia
Clinical narrative: Patient reports experiencing fever, joint pain, malaise for days after Covid-19 vaccination
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: pt was inadvertently given MMRV & VARICELLA, reviewed side effects with mother & she verbalized her understanding. as per mother was given Tylenol & will informed us of any other symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Pruritus
Clinical narrative: PATIENT IS REPORTING IMMUNE RESPONSE (SYSTEMIC) REACTIONS (FEVER, MUSCLE ACHES) THAT LASTED OVER 3 DAYS AND AN INJECTION SITE REACTION (REDNESS, SWELLING AROUND THE INJECTION SITE) ALONG WITH SEVERE ITCHING AND RASH. SHE REPORTED THAT THE ITCHING BEGAN THROUGHOUT HER ENTIRE LEFT SIDE, BUT HAS SINCE DECREASED TO ONLY BEING AROUND THE INJECTION SITE NOW. ADVISED PATIENT TO SEEK MEDICAL ATTENTION, AND AS MAY BE SIGNS OF AN ALLERGIC REACTION, TO DISCUSS SECOND DOSE WITH PROVIDER AND OBTAIN ONLY IN A MEDICAL OFFICE WHERE SHE CAN BE CLOSELY MONITORED IF DOCTOR WANTS TO ADMINISTER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: PATIENT IS REPORTING IMMUNE RESPONSE (SYSTEMIC) REACTIONS (FEVER, MUSCLE ACHES) THAT LASTED OVER 3 DAYS AND AN INJECTION SITE REACTION (REDNESS, SWELLING AROUND THE INJECTION SITE) ALONG WITH SEVERE ITCHING AND RASH. SHE REPORTED THAT THE ITCHING BEGAN THROUGHOUT HER ENTIRE LEFT SIDE, BUT HAS SINCE DECREASED TO ONLY BEING AROUND THE INJECTION SITE NOW. ADVISED PATIENT TO SEEK MEDICAL ATTENTION, AND AS MAY BE SIGNS OF AN ALLERGIC REACTION, TO DISCUSS SECOND DOSE WITH PROVIDER AND OBTAIN ONLY IN A MEDICAL OFFICE WHERE SHE CAN BE CLOSELY MONITORED IF DOCTOR WANTS TO ADMINISTER.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red reaction below the injection site, she felt under the weather the couple days after the vaccine, then today on 5/5/25 she reported a red mark underneath the injection site that is painful to touch. I advised her to take benadryl and ice the area and to report back to us if she was not improving
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema
Clinical narrative: Patient's injection site turned red about 3 inches wide, and 6 inches long but was not swollen, and not itching.  It was not getting better but not getting worse after 3 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic disorder, Type 1 diabetes mellitus
Clinical narrative: Attacked pancreas and now doesn?t work and is now a type 1 diabetic that has created other issues
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Erythema, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: 3/31/25 cellulitis type redness up and down arm with swelling. Started the day following vaccination.  Patient sought follow-up with a provider on 3/31/25 and was prescribed ciprofloxacin.  Due to her history of arrythmias, her husband (another provider) prescribed bactrim ds.  She started with bactrim ds and then ciprofloxacin. On 4/2/25 more swelling occurred and her primary provider gave prednisone taper. Patient did not seek any more followup and never responded to requests for more information.  Following vaccination also patient said she had chills, fever, and feeling of illness for around 3 days following.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Asthenia, Chronic lymphocytic leukaemia, Confusional state, Dysmenorrhoea
Clinical narrative: Within minutes I felt fatigued, exhausted, confused, sluggish, felt a drop in my heart rate. Once I got home I fell asleep on the floor for several hours. I experienced flu like symptoms for months. Within a week of getting the initial vaccine, my menstrual cycle came again that same month and was horrible! Blood clotting and cramping, but much more strange and worse than ever. I even brought it to the attention of my gynecologist around March of 2022, I believe.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate decreased, Influenza like illness, Menstruation irregular, Sluggishness
Clinical narrative: Within minutes I felt fatigued, exhausted, confused, sluggish, felt a drop in my heart rate. Once I got home I fell asleep on the floor for several hours. I experienced flu like symptoms for months. Within a week of getting the initial vaccine, my menstrual cycle came again that same month and was horrible! Blood clotting and cramping, but much more strange and worse than ever. I even brought it to the attention of my gynecologist around March of 2022, I believe.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Within minutes I felt fatigued, exhausted, confused, sluggish, felt a drop in my heart rate. Once I got home I fell asleep on the floor for several hours. I experienced flu like symptoms for months. Within a week of getting the initial vaccine, my menstrual cycle came again that same month and was horrible! Blood clotting and cramping, but much more strange and worse than ever. I even brought it to the attention of my gynecologist around March of 2022, I believe.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood culture negative, Blood test, Hip arthroplasty
Clinical narrative: Jan. 2021 Sudden onset of joint  pain in all of joints starting with both shoulders, both hips, and right knee. Joint pain in ankles and hands. Started in shoulders within 2 weeks in injection. Severe pain in Right knee, milder pain on both hips. Treated with steroid injections in both shoulders, both hips and right knee throughout 2021. Knee pain progressed rapidly that lead to Total Knee replacement in Nov. 2021 and Hip Replacement in 2024. 2021-2025 Multiple visits to doctors that were unable to diagnose an autoimmune disease or a cause for rapid onset of Osteoarthritis other than adverse effect of COVID vaccine  which is only documented by rheumatology, no other physician would document this finding.. Sudden onset of all over body aches and pain lead to ER visitOct . 31 2021. WBC count over 18, blood cultures were negative, one night in hospital,  with treatment for pain. No diagnosis.  Rheumatology every 6 months. Currently take Diclofenac and anti steroidal pain relievers. Anticipating left hip replacement this year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Knee arthroplasty, Magnetic resonance imaging, Osteoarthritis, Pain, Red blood cell sedimentation rate
Clinical narrative: Jan. 2021 Sudden onset of joint  pain in all of joints starting with both shoulders, both hips, and right knee. Joint pain in ankles and hands. Started in shoulders within 2 weeks in injection. Severe pain in Right knee, milder pain on both hips. Treated with steroid injections in both shoulders, both hips and right knee throughout 2021. Knee pain progressed rapidly that lead to Total Knee replacement in Nov. 2021 and Hip Replacement in 2024. 2021-2025 Multiple visits to doctors that were unable to diagnose an autoimmune disease or a cause for rapid onset of Osteoarthritis other than adverse effect of COVID vaccine  which is only documented by rheumatology, no other physician would document this finding.. Sudden onset of all over body aches and pain lead to ER visitOct . 31 2021. WBC count over 18, blood cultures were negative, one night in hospital,  with treatment for pain. No diagnosis.  Rheumatology every 6 months. Currently take Diclofenac and anti steroidal pain relievers. Anticipating left hip replacement this year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased, X-ray
Clinical narrative: Jan. 2021 Sudden onset of joint  pain in all of joints starting with both shoulders, both hips, and right knee. Joint pain in ankles and hands. Started in shoulders within 2 weeks in injection. Severe pain in Right knee, milder pain on both hips. Treated with steroid injections in both shoulders, both hips and right knee throughout 2021. Knee pain progressed rapidly that lead to Total Knee replacement in Nov. 2021 and Hip Replacement in 2024. 2021-2025 Multiple visits to doctors that were unable to diagnose an autoimmune disease or a cause for rapid onset of Osteoarthritis other than adverse effect of COVID vaccine  which is only documented by rheumatology, no other physician would document this finding.. Sudden onset of all over body aches and pain lead to ER visitOct . 31 2021. WBC count over 18, blood cultures were negative, one night in hospital,  with treatment for pain. No diagnosis.  Rheumatology every 6 months. Currently take Diclofenac and anti steroidal pain relievers. Anticipating left hip replacement this year.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cardiac failure congestive, Coronary arterial stent insertion, Death, Myocardial infarction
Clinical narrative: Thier are so many see intire Packet sent along with form will list. First. EMS. Call Emergency to Hospital. Legs swelling temp 105 Blood Press 217/110 unberable pain #2 Hospital Bleeding from Rectum. #3 Hospital Leg swelling. Had Heart attack in Emergency room #4 Hospital Put in a shunt on Heart Blood vessel. Diag swollen legs Remove massive blood clots from both legs. The clots stated by Doc Surgeon. Never have seen these kinds of Blood clots. Never seen by mankind. #5 Hospital congestive Heart failure fluid leak from skin #6 Hospital Congestive Heart Failure Fluid lek from skin
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Rectal haemorrhage, Skin weeping, Thrombectomy
Clinical narrative: Thier are so many see intire Packet sent along with form will list. First. EMS. Call Emergency to Hospital. Legs swelling temp 105 Blood Press 217/110 unberable pain #2 Hospital Bleeding from Rectum. #3 Hospital Leg swelling. Had Heart attack in Emergency room #4 Hospital Put in a shunt on Heart Blood vessel. Diag swollen legs Remove massive blood clots from both legs. The clots stated by Doc Surgeon. Never have seen these kinds of Blood clots. Never seen by mankind. #5 Hospital congestive Heart failure fluid leak from skin #6 Hospital Congestive Heart Failure Fluid lek from skin
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thier are so many see intire Packet sent along with form will list. First. EMS. Call Emergency to Hospital. Legs swelling temp 105 Blood Press 217/110 unberable pain #2 Hospital Bleeding from Rectum. #3 Hospital Leg swelling. Had Heart attack in Emergency room #4 Hospital Put in a shunt on Heart Blood vessel. Diag swollen legs Remove massive blood clots from both legs. The clots stated by Doc Surgeon. Never have seen these kinds of Blood clots. Never seen by mankind. #5 Hospital congestive Heart failure fluid leak from skin #6 Hospital Congestive Heart Failure Fluid lek from skin
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Pt came in to health department for second dose of Shingrix. Nurse on clinic has never given this particular vaccine before and was unaware that the dilutent was included in the box with single does vials. Nurse reconstituted dose with sterile water. Vaccine was administered. Approx 1.5 weeks later during inventory the dilutent was was discovered left in the fridge. It was then discovered vaccine was reconstituted incorrect agent. Nurse that administered vaccine was made aware at this time. CDC was contacted for further advice at this time. Administering nurse reviewed Education material sent by CDC.    Below is the answer from the CDC:   Question:  A  dose of Shingrix was given with the sterile MMR/varicella diluent instead of the diluent provided in the box, does this dose of vaccine count or does it need to be repeated? If it does need repeated does there need to be an interval between the doses?   CDC Response:  Yes, the dose needs to be repeated. Diluents are not interchangeable unless specified by the manufacturer, and vaccine doses prepared using the wrong diluent are invalid.   The diluent required to reconstitute the lyophilized component of Shingrix contains an AS01B adjuvant, which helps create a stronger immune response in people receiving the vaccine. The MMR/varicella diluent is unadjuvanted sterile water. The two diluents are not interchangeable; therefore, this was a vaccination error. Because the vaccination was invalid, the dose must be repeated. Since the vaccine is non-live and administered without the approved diluent, the repeated dose can be administered at any interval after the invalid dose (no minimum interval recommended).   For all vaccine administration error: Inform the recipient of the vaccine administration error. Consult with the state immunization program and / or immunization information system (IIS) to determine how the dose should be entered into the ISS. Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in the "Vaccine Administration" chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on the CDC's vaccine administration web page, including a job aid for preventing errors.   In addition, if not already done, we encourage you to report this error to the Vaccine Adverse Event Reporting System (VAERS) event if the patient has not symptoms. Reports to VAERS are important because they can help CDC and Food and Drug Administration (FDA) detect new or unusual adverse events or patterns that could indicate a problems with vaccines. To file an electronic report, see the VAERS website.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Laboratory test, Myelopathy, Nerve injury, Pain
Clinical narrative: Nerve damage Pain Pneumonia brain blood clot Spinal cord degenation
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Nerve damage Pain Pneumonia brain blood clot Spinal cord degenation
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Balance disorder, Chills, Diplopia, Fatigue
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: Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep
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;