chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Swelling of left forearm down to wrist, similar to a bee sting patient had gotten previously so he thought he should report as an ADR.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, MMRV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None noted at this time
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient recieved a 2nd Arexvy vaccine on 01/06/2025 when he previously recieved an Arexvy vaccine on 10/20/2023. The CDC and manufacturer only currently recommends 1 dose of Arexvy per lifetime.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Itchy rash all over, starting on legs near injection site
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: patient felt dizzy and fainted to the floor however was attended to and was conscious promptly
Age: 0.5
Sex: M
Vaccine: DTAPIPV, PNC15
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered instead of Pediarix. Patient waited for 15 minutes and tolerated well
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAXNEUVANCE (y002643   10/4/2026) Temperature:  4; This spontaneous report was received from an Other Health Professional and refers to a 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 31-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #y002643, expiration date: 04-OCT-2026, administered for prophylaxis (strength, dose, units, and route of administration were not provided). It was reported that the patient received improperly stored vaccine after a temperature excursion of 46.6 F for a timeframe of 1h55min (Product storage error). There was no adverse event reported.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Hyporesponsive to stimuli, Lethargy, Pyrexia
Clinical narrative: Child developed fever 30 mins after receiving the vaccine. Fever started at 101.5F and then developed into 103F, lasted for 4 days. He was lethargic and disengaged. No other symptoms - no coughing or runny nose.
Age: 0.75
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was mistakenly given vaccine despite being 9 months old, and had not had any prior vaccines.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No ADE. Patient underage at time of vaccination for Flublok
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm.  Next to injection site toward the patient's back.  Discomfort since vaccine given ( over 75 days) 3 on pain scale per patient.  No redness, no injury spot seen.  Middle of the upper arm.  Movement of the arm does not help nor hurt the arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Gait inability, Tremor
Clinical narrative: Violent shaking, inability to walk, shortness of breath, about 12 hours after receiving shot. At midnight I was able to  hold onto the wall to get to my 650 mg Tylenol. The Tylenol eased the symptoms. I repeated in 4 hours. I was fine the next day.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Spikevax Vaccine. Expires 60 days from date taken out of freezer. Took vaccine out of freezer on 10/22/22. Was given to patient on 12/24/24. Vaccine had expired on 12/21/24. Noticed this error today when completing storage and handling duties of vaccines and chart reviews. Attempted to call parent today to inform them of error and discuss any concerns. Unable to reach parent today.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient given a Moderna Spikevax pediatric dose (6m-11year) by mistake. Lot # 3044186.  Realized mistake before they left the clinic and vaccinated with another dose of Pediatric Moderna Spikevax to equal the adult dose. (same lot #).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: After reconciling number of vaccines in our storage, our clinic noticed this vaccine was expired when administered to this patient. The vaccine was taken out of the freezer and placed in the refrigerator on 10/22/24. Per manufacturer, vaccine expires 60 days after being taken out of the refrigerator. The vaccine, therefore, expired on 12/21/24. It was administered on 12/24/24. This nurse spoke to mother of patient today. She reported the child felt fine after receiving the vaccine and she had no concerns.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: Dr called the pharmacy and asked if the patient received two Fluzone HD injection this 2024 Flu Season. After checking the pharmacy systems, the patient did indeed receive 2 immunizations - 10/25/24 and 1/3/25 from two different pharmacist
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-DEC-2024, the patient received Shingrix (left arm). On 09-DEC-2024, 2 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). On 10-DEC-2024, the outcome of the fatigue and headache were resolved (duration 1 day).   The reporter considered the fatigue and headache to be related to Shingrix.     The company considered the fatigue and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2024 Consumer reported that he took Shingrix vaccine and experienced fatigue and headache.
Sex: U
Vaccine: RVX
Symptoms: Erythema, Feeling abnormal, Feeling hot, Pain in extremity
Clinical narrative: My arm is red; sore arm; arm is feels feverishly hot; felt badly; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced erythema of extremities (Verbatim: My arm is red), pain in arm (Verbatim: sore arm), extremities hot feeling of (Verbatim: arm is feels feverishly hot) and feeling abnormal (Verbatim: felt badly). The outcome of the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal were not reported.   It was unknown if the reporter considered the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal to be related to RSV vaccine.     It was unknown if the company considered the erythema of extremities, pain in arm, extremities hot feeling of and feeling abnormal to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 08-DEC-2024 This case was reported by a patient via interactive digital media. The reporter reported that patient received Respiratory syncytial virus vaccine on Thursday and have felt badly. Patient arm was red and feels feverishly hot and sore.  Also reporter hope it does not bother much longer.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This non-serious case was reported by a pharmacist via market research programs and described the occurrence of pain in arm in an unspecified number of  patients 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 pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was resolved.   The reporter considered the pain in arm to be related to Shingles vaccine.     The company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2024  Pharmacist asked that if they already had soreness from another vaccine. This one caused a lot of soreness and it was liked being punched in arm 1000 times. It was implied in conversation that the reporter had personally seen individuals experience this side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles within 30 days of receiving their first dose of Shingrix; This non-serious case was reported by a consumer and described the occurrence of shingles in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patients experienced shingles (Verbatim: developed shingles within 30 days of receiving their first dose of Shingrix). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-DEC-2024 The reporter knew five patients who developed shingles within 30 days of receiving their first dose of Shingrix. The case is linked with case US2024AMR165920, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR165920:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: for about 30 years Boostrix has been administered to patients under 10 years; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: for about 30 years Boostrix has been administered to patients under 10 years). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-DEC-2024 The registered nurse called stating she has been working at her facility for 11.5 years and she stated that for about 30 years Boostrix had been administered to patients under 10 years which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183475:SAME REPORTER
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: A patient received a dose of Boostrix and Menveo today (12/9/2024), and also the patient received Boostrix and Menveo 3 months ago (less than recommended interval); This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475, expiry date 08-MAY-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis.   Previously administered products included Boostrix (received 1st dose 3 months ago) and Menveo (received 1st dose 3 months ago).   On 09-DEC-2024, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 09-DEC-2024, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: A patient received a dose of Boostrix and Menveo today (12/9/2024), and also the patient received Boostrix and Menveo 3 months ago (less than recommended interval)). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-DEC-2024 The medical assistant called to report that on the day of reporting she administered a dose of Boostrix and Menveo to a patient, she mentioned that 3 months ago the patient had received also a dose of Boostrix and Menveo which led to extra dose administered. The reporter asked were there any safety recommendations.
Age: 70.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Blood pressure increased, Fatigue, Headache, Injection site pruritus
Clinical narrative: her left arm deltoid where the SHINGRIX was administered was having itchiness; she was more tired than normal; checked her BP and stated it was elevated at 126/104; 24 hours later started having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-DEC-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) and the 1st dose of Arexvy (intramuscular, right deltoid). On 10-DEC-2024, 1 days after receiving Shingrix and Arexvy and not applicable after receiving Arexvy, the patient experienced injection site itching (Verbatim: her left arm deltoid where the SHINGRIX was administered was having itchiness), tiredness (Verbatim: she was more tired than normal), increased blood pressure (Verbatim: checked her BP and stated it was elevated at 126/104) and headache (Verbatim: 24 hours later started having a headache). The outcome of the injection site itching, tiredness, increased blood pressure and headache were not resolved.   It was unknown if the reporter considered the injection site itching, tiredness, increased blood pressure and headache to be related to Shingrix. It was unknown if the reporter considered the tiredness, increased blood pressure and headache to be related to Arexvy.     It was unknown if the company considered the injection site itching, tiredness, increased blood pressure and headache to be related to Shingrix. It was unknown if the company considered the tiredness, increased blood pressure and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-DEC-2024 The reporter was the patient who stated she received the 2nd dose of Shingrix along with, Arexvy vaccine. The patient stated she was fine after receiving both injections, then, 24 hours later started having a headache and checked her blood pressure and stated it was elevated at 126/104. The patient did state this was quite unusual for her. The patient also stated she was more tired than normal and her left arm deltoid where the Shingrix was administered was having itchiness.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: it is been 10 years and he never received the Second Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose 10 years ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: it is been 10 years and he never received the Second Dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:11-DEC-2024 Pharmacist called to report about Twinrix and asked What if a Patient had the first dose and then, it had been 10 years, and he never received the Second Dose. First dose of Twinrix was administered 10 years ago and Patient did not receive the second the dose which led to incomplete course of vaccination.
Age: 73.0
Sex: M
Vaccine: FLUX, RSV
Symptoms: Dyspnoea, Lethargy
Clinical narrative: Shortness of breath; Lethargic; This non-serious case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine (Flu vaccine VII) for prophylaxis.   On 12-DEC-2024, the patient received the 1st dose of Arexvy (intramuscular, left deltoid) and Flu vaccine VII. On 13-DEC-2024, 1 days after receiving Arexvy, the patient experienced shortness of breath (Verbatim: Shortness of breath) and lethargy (Verbatim: Lethargic ). The outcome of the shortness of breath and lethargy were not resolved.   It was unknown if the reporter considered the shortness of breath and lethargy to be related to Arexvy.     It was unknown if the company considered the shortness of breath and lethargy to be related to Arexvy.   Additional Information: GSK Receipt Date:11-DEC-2024 Reporter was the patient who received the Arexvy vaccine on 12-DEC-2024 in the left deltoid. Reporter also stated that he received the Arexvy vaccine and a flu vaccination at the same time 12-DEC-2024 in different arms.  12 Hours after the Arexvy and flu vaccine was given the reporter stated lethargic and shortness of breath that was ongoing.  The reporter was unaware of the name of the Flu vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose; administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2024, the patient received the 2nd dose of Shingrix. On 03-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid (adjuvant) part of the vaccine alone to a patient for a Second dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the nurse administered only the liquid (adjuvant) part of the vaccine alone to a patient for a second dose of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked was there any advise on when to give another valid dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with sterile water; Shingrix reconstituted with sterile water; This non-serious case was reported by a nurse 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: Shingrix reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Shingrix reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-DEC-2024 The nurse supervisor reported that they had a Shingrix reconstituted with sterile water instead of the included diluent and they were currently running reports to find out who was the patient involved, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked does the effect the efficacy of the vaccine and stated that they found the error during vaccine counts. The patient's information was not available at the moment.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given a second dose of HAVRIX less than six months apart; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) (batch number LM99N, expiry date 04-MAR-2026) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 25-JUN-2024, lot number 423NL, expiry date 16-MAR-2025).   On 14-NOV-2024, the patient received the 2nd dose of Havrix. On 14-NOV-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: given a second dose of HAVRIX less than six months apart). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2024 The registered nurse reported that a pediatric patient that was given a second dose of Havrix less than six months apart.  The reporter asked about further guidance on that topic.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Consumer states in 2024 she has had several small outbreaks of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2018, the patient received the 2nd dose of Shingrix. On 30-JUL-2018, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Consumer states in 2024 she has had several small outbreaks of shingles). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-DEC-2024 The case was self reported by patient. The patient received both doses on Shingrix vaccine and in 2024 she had several small outbreaks of shingles (lack of effect). The outbreaks are on the middle part of the front of her body and her legs.   Consumer states that she does take Acyclovir.   This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Neurological examination
Clinical narrative: feeling dizzy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (feeling dizzy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced DIZZINESS (feeling dizzy). At the time of the report, DIZZINESS (feeling dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neurological examination: Negative.         No concomitant medication was reported. She received a Moderna covid-19 shot back in Sep-2022 with no issues. She was feeling dizzy for the past two months since OCT-2024. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix first dose in 2024. Past adverse reactions to the above products included No adverse effect with Shingrix first dose.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that, 7 days after receiving the vaccine the recipient developed shingles. Patient attended the ER and was diagnosed and began treatment. Patient was treated with antivirals and returned to work 3 weeks after initial diagnosis. It was unknown if the patient experienced any additional symptoms/events.   This case was linked to US-MODERNATX, INC.-MOD-2025-780516 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-780516:invalid case for multiple patients
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Widespread skin hives within 14 days of 2024-2025 Comirnaty; This is a spontaneous report received from a Company Representative.  An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Widespread skin hives within 14 days of 2024-2025 Comirnaty". It was unknown if therapeutic measures were taken as a result of urticaria.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Loss of personal independence in daily activities, Myelitis transverse
Clinical narrative: Transverse Myelitis; Guillain Barre; general weakness and loss of strength; he is now a couch potato/now he has become a weakling; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 58-year-old male patient 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: MYELITIS TRANSVERSE (medically significant), outcome "not recovered", described as "Transverse Myelitis"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "not recovered", described as "Guillain Barre"; ASTHENIA (non-serious), outcome "not recovered", described as "general weakness and loss of strength"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "he is now a couch potato/now he has become a weakling". Therapeutic measures were taken as a result of myelitis transverse, guillain-barre syndrome. Clinical course: Patient experienced general weakness and loss of strength, he want to know how to get better. At first they thought it was Guillain Barre then neurology diagnosed Transverse Myelitis, the doctor sent report to Pfizer and CDC. He has basically been on prednisone 2 and a half years and has not gotten better or healed. He mentioned there might be other people with this problem. He said he was a big promoter of the vaccine but unfortunately, he got this adverse reaction. He is reaching out for help as the doctors have not been able to treat his AE or deal with it or they have not been able to get him better and nothing has changed. He described he is now a couch potato per his words and that he is 58 years old and that he was outgoing and physically strong 3 years ago and now he has become a weakling. He wants to know or find out any direction. He has not been able to work for all 3 years, he has lost 3 years of income and on top the thousand of dollars he has invested on getting better. He want to know how to best deal with this cases as the Pfizer vaccine has caused him harm. He has stopped prednisone and was transferred to another specialist doctor but he could not help him. He also let me know that this was not helpful and that he is tired of hearing sorry. That Pfizer is his last resort. Talked with the No Info SRD for his specific question and provided that according to the PI there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Comirnaty. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning mouth syndrome, Hypoaesthesia, Oral pain, Pain, Pharyngeal hypoaesthesia
Clinical narrative: vomited for 45-60 min; Numbness on left side of face; Numbness on left side of face, continued to throat; Constant pain, 7-10 daily; Severe pain in the mouth; Diagnosed with Burning Mouth Syndrome; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LYRICA; LAMICTAL. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EW0191), administration date: 16Jun2021, for COVID-19 immunisation; comirnaty (DOSE 2, SINGLE, Lot number: EW0176), administration date: 06Jul2021, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Constant pain, 7-10 daily"; BURNING MOUTH SYNDROME (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Diagnosed with Burning Mouth Syndrome"; HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face"; PHARYNGEAL HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face, continued to throat"; ORAL PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Severe pain in the mouth"; VOMITING (non-serious) with onset 19Jan2022, outcome "not recovered", described as "vomited for 45-60 min". Therapeutic measures were taken as a result of vomiting, hypoaesthesia, pharyngeal hypoaesthesia, pain, oral pain, burning mouth syndrome.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Clonazepam BID was given as treatment for the event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited for 45-60 min; Numbness on left side of face; Numbness on left side of face, continued to throat; Constant pain, 7-10 daily; Severe pain in the mouth; Diagnosed with Burning Mouth Syndrome; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LYRICA; LAMICTAL. Vaccination history included: comirnaty (DOSE 1, SINGLE, Lot number: EW0191), administration date: 16Jun2021, for COVID-19 immunisation; comirnaty (DOSE 2, SINGLE, Lot number: EW0176), administration date: 06Jul2021, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Constant pain, 7-10 daily"; BURNING MOUTH SYNDROME (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Diagnosed with Burning Mouth Syndrome"; HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face"; PHARYNGEAL HYPOAESTHESIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Numbness on left side of face, continued to throat"; ORAL PAIN (non-serious) with onset 19Jan2022, outcome "not recovered", described as "Severe pain in the mouth"; VOMITING (non-serious) with onset 19Jan2022, outcome "not recovered", described as "vomited for 45-60 min". Therapeutic measures were taken as a result of vomiting, hypoaesthesia, pharyngeal hypoaesthesia, pain, oral pain, burning mouth syndrome.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. Clonazepam BID was given as treatment for the event.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine; I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had covid before and take Pfizer vaccines 6 times in the past. And patient had took Paxlovid in 10Jul2023 and had helped. Patient is concerns that cannot afford for this prescription.  During the call, patient states, "I have covid. I've had six Pfizer vaccines, and this is my second time with covid and the last time I had it I got Paxlovid, and it helped and this time I went to the emergency room, and they gave me a script for Paxlovid". Later in the call, the representative asks if the patient would like to be transferred to "our medical line" because the patient has taken Paxlovid before and the patient declines to be transferred. Later in the call, the patient states, "I got put on Paxlovid 10Jul2023 and that was after my fifth vaccine so now I've had six vaccines and I've had it twice but I get so sick so I'm assuming the vaccine is keeping me alive."; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400083171 same patient, same event, different dose of vaccine;
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: sick; a high fever; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "a high fever". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Cellulitis, Pain, Pruritus, Rash
Clinical narrative: patient came to pharmacy on 1/6/25 to pickup prescription for antibiotic, ICD- 10 L03114, cellulitis of left upper limb per MD. She stated this was a reaction from her prevnar-20 vaccine that was given on 12/31/24. Per patient, she developed pain, swelling, rash and itchiness, hot burning sensation 24hrs after vaccination,  she took benadryl for 2 days, and  on 1/5 she took tylenol since it was painful.  She went to see provider on 1/6/25.  Doctor prescribed an antibiotic for cellulitis, she came to pharmacy on 1/6 to pickup antibiotic and reported the adverse reaction from the vaccine to pharmacist.
Age: 15.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient reports that after returning home from receiving vaccines he had a fever.  After waking up the morning after receiving vaccines he had a rash purple in color that covered his entire body from his face down to his feet that lasted for three days.  He also reported that he had shortness of breath and difficulty breathing that lasted for three days.  Patient's mother reports that she did not take him to a medical provider because the family does not have insurance coverage.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Patient received vaccine, stood up and passed out. Patient came to within seconds. States his head had felt "fuzzy". Patient was given ice pack to his head and a Pedialyte popsicle and lay down for 10 minutes before leaving with his mom. No trauma found on head where he had hit a corner of the rounded baby scale on his way to his knees before he was caught by mom and LVN present.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: After vaccine was administered by tech, pt lost consciousness for a few moments, gasp, then regained consciousness.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient was administered a vaccination for COVID-19 Comirnaty vaccination booster on 12/03/2023 but the information was processed under a different patient's profile that had the same name but different date of birth and address. The patient realized this on there paperwork on January 7th, 2024 and made the pharmacy aware.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: No abnormal symptoms at this time reported by parent
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received 2 rsv shots around a year apart. Pt did not realize he had an rsv shot before. He has no adverse effects.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event
Clinical narrative: NO ADVERSE SYMPTOMS AT THIS TIME REPORTED BY PARENT
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Not Available
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of RSV vaccine on 09/11/2023 and 12/30/2024
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Alpha 2 globulin, Alpha-1 anti-trypsin, Balance disorder, Blood 25-hydroxycholecalciferol, Blood albumin
Clinical narrative: bi lateral drop foot, numbness in calf,  poor balance, poor gait, numbness in both legs - below and above knee
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Blood homocysteine, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood thyroid stimulating hormone
Clinical narrative: bi lateral drop foot, numbness in calf,  poor balance, poor gait, numbness in both legs - below and above knee
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Cryoglobulins, Electromyogram, Electrophoresis protein, Gait disturbance, Hypoaesthesia
Clinical narrative: bi lateral drop foot, numbness in calf,  poor balance, poor gait, numbness in both legs - below and above knee
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Immunoelectrophoresis, Immunoglobulins, Magnetic resonance imaging spinal, Peroneal nerve palsy, Protein total
Clinical narrative: bi lateral drop foot, numbness in calf,  poor balance, poor gait, numbness in both legs - below and above knee
Age: 67.0
Sex: F
Vaccine: FLU3, PNC20, RSV
Symptoms: Scan with contrast, Vitamin B1, Vitamin B6
Clinical narrative: bi lateral drop foot, numbness in calf,  poor balance, poor gait, numbness in both legs - below and above knee
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVE AREXVY VACCINE ON FEBRUARY 10TH, 2024 AND RECEIVED ANOTHER ONE 10 JANUARY  04, 2025. THI VACCINE IS ONLY GIVING 1 DOSE FOR LIFE
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Prevnar 20 on 1/6/25, received first dose on 5/25/24. Outside of CDC guidelines,
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives (urticaria)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Immediate post-injection reaction, Pain in extremity
Clinical narrative: My entire left side of my body from my head to my toe has been tingling and my left arm and in my left chest area is aching.  I was fine after my first Shingrix injection but immediately after the second one I have been having these problems.  These symptoms do not come and go they are constant when I go to bed and when I wake up.  I did go to the doctor for chest pain and left arm pain he did a chest X-ray and ekg which were negative.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: My entire left side of my body from my head to my toe has been tingling and my left arm and in my left chest area is aching.  I was fine after my first Shingrix injection but immediately after the second one I have been having these problems.  These symptoms do not come and go they are constant when I go to bed and when I wake up.  I did go to the doctor for chest pain and left arm pain he did a chest X-ray and ekg which were negative.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid infection, on-going
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Cardiovascular disorder, Chronic fatigue syndrome, Echocardiogram, Erythema
Clinical narrative: Severe rash the whole body that lasted 2 weeks, dysregulation of the circulation( redness of feet and hand), POTS symptoms, dysautonomia, photophobia, small fiber neuropathy, chronic fatigue syndrome. Chronic acid reflux
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Photophobia, Postural orthostatic tachycardia syndrome, Rash, Small fibre neuropathy
Clinical narrative: Severe rash the whole body that lasted 2 weeks, dysregulation of the circulation( redness of feet and hand), POTS symptoms, dysautonomia, photophobia, small fiber neuropathy, chronic fatigue syndrome. Chronic acid reflux
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Erythematous raised confluent blanching rash to trunk extremities and cheeks starting 1/2/2025. One day of fever on 12/30/2024.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Erythematous raised confluent blanching rash to trunk extremities and cheeks starting 1/2/2025. One day of fever on 12/30/2024.
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: received Arexvy during pregnancy; received Arexvy during pregnancy; Erroneous administration of Arexvy, rather than Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-DEC-2024, the patient received the 1st dose of Arexvy (unknown deltoid). On 07-DEC-2024, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: received Arexvy during pregnancy) and wrong vaccine administered (Verbatim: Erroneous administration of Arexvy, rather than Abrysvo). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: received Arexvy during pregnancy). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-DEC-2024 The pharmacist reported that a pregnant patient received Arexvy vaccine which led to vaccine exposure during pregnancy and drug use in unapproved population. Erroneous administration of Arexvy, rather than Abrysvo, to expectant mother, which led to wrong vaccine administered.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given immunization that was not storred appropriately, no adverse reaction reported by patient
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was given immunization that was not storred appropriately, no adverse reaction reported by patient.