chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4628) at the age of 93 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Acute pain of left shoulder", start date: 22Dec2016 (unspecified if ongoing), notes: Acute pain of left shoulder; "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Benign prostatic hypertrophy" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes mellitus (CMS-HCC); "Diverticulosis" (unspecified if ongoing); "GERD" (unspecified if ongoing), notes: GERD (gastroesophageal reflux disease); "HL (hearing loss)" (unspecified if ongoing), notes: HL (hearing loss). Concomitant medication(s) included: LOSARTAN, start date: 19Sep2023; GABAPENTIN, start date: 12Jun2023; RIVAROXABAN, start date: 25May2023; OMEPRAZOLE, start date: 24May2023; METOPROLOL SUCCINATE, start date: 16Jan2023; LORATADINE, start date: 12Dec2022; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE], start date: 07Mar2016. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; lot number: GH9702, vaccine location: Left arm), administration date: 01Oct2022, when the patient was 92-year-old, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE; lot number: FJ9943, vaccine location: Left arm), administration date: 02Apr2022, when the patient was 91-year-old, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE; lot number: FD8448, vaccine location: Left arm), administration date: 28Sep2021, when the patient was 91-year-old, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE; lot number: EM9809, vaccine location: Left arm), administration date: 11Feb2021, when the patient was 90-year-old, for Covid-19 immunization; bnt162b2 (DOSE 1, SINGLE; lot number: EL9261, vaccine location: Left arm), administration date: 21Jan2021, when the patient was 90-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Treatment of COVID 19 with Paxlovid, treatment start date was 24Nov2023 and treatment stop date was 28Nov2023. Other medication in 2weeks product also reported as, fluticasone furoate-vilanteroL 200-25 mcg/dose blister with device, start date: 31Oct2023; sulfamethoxazole-trimethoprim 800-160 mg per tablet, start date was 16Oct2023; and atorvastatin 10mg tablet start date was 23Oct2023.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 28Nov2023 to 02Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "A fib" (unspecified if ongoing), notes: Other medical history: A fib; "CAD" (unspecified if ongoing), notes: Other medical history: CAD. Concomitant medication(s) included: ASPIRIN 81 oral, start date: 23Oct2023. Past drug history included: Dofetilide, reaction(s): "Known allergies: Dofetilide", notes: Known allergies: Dofetilide. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2023) Positive, notes: Previous; (30Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Orally administered Paxlovid from 24Nov2023 to 28Nov2023 for the treatment of COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: For the treatment of COVID 19, patient administered Paxlovid from 21Nov2023 to 26Nov2023. No known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin", notes: Known allergies: Neomycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Paxlovid started on 16Nov2023 and stopped on 21Nov2023 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Known allergies: Sulphate drugs" (unspecified if ongoing), notes: Known allergies: Sulphate drugs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BBOSTER), SINGLE; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Treatment of COVID 19 with Paxlovid Treatment start date was 24Nov2023 and Treatment stop date was 29Nov2023. Patient received Paxlovid and symptoms started to improve within 2 days. Patient Other medication in 2weeks was Mucinex start date: 24Nov2023 and stop date: 04Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Musculoskeletal disorder
Clinical narrative: Vaccine administered to patient was Spikevax ( moderna) NDC #80777-0102-96. Lot #208F23A. Patient states his left arm feels numb after the vaccine from the shoulder down to the elbow. He also states he cannot make his thumb and pointer finger come together.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Erythema
Clinical narrative: has a very red arm from her shoulder to her elbow and the redness wraps around to the back of her arm and is spreading.  she did go to urgent care for an antibiotic.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Breast mass, Cancer surgery, Chemotherapy, Pancreatic carcinoma
Clinical narrative: Self palpation left breast mass, dx with breast cancer, went through chemo, rad, surgery. Then in '22 developed pancreatic cancer
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Radiotherapy
Clinical narrative: Self palpation left breast mass, dx with breast cancer, went through chemo, rad, surgery. Then in '22 developed pancreatic cancer
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Herpes zoster
Clinical narrative: Shingles Outbreak (initiated Sept 30)
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Nasopharyngitis, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: He developed a cold, runny nose, and a cough, 5 days back to back with a fever of 100. He also developed a rash on his face.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: He developed a cold, runny nose, and a cough, 5 days back to back with a fever of 100. He also developed a rash on his face.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave the incorrect vaccine. Gave MMRV instead or MMR. Pt mother was informed and stayed in clinic with vaccinated child for 45 minutes as caution.  No adverse events occurred.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Dysphonia
Clinical narrative: Patient states that soon after her vaccine, she started becoming hoarse and has been hoarse ever since, although it has started to improve now.  She saw her PCP and they gave her prednisone, which helped some.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Hypertension, Laboratory test abnormal, Systemic lupus erythematosus, Vasculitis
Clinical narrative: Developed lupus, blood pressure high, vasculitis and arthritis things I never had before, I have an evolution of more than a year and a half, started specifically after the third vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Malaise, Myalgia
Clinical narrative: Extremely severe muscle aches, fever, headache, fatigue. Felt worse than any flu I've ever had, and worse than when I had covid - basically the sickest I've ever felt in my life.  The only thing I could do was sleep, for about 20 hours straight. Felt fine by the 2nd day after (12/6). I'm fine with the reaction - it's preferable to having shingles - but do want to report it for the record.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extremely severe muscle aches, fever, headache, fatigue. Felt worse than any flu I've ever had, and worse than when I had covid - basically the sickest I've ever felt in my life.  The only thing I could do was sleep, for about 20 hours straight. Felt fine by the 2nd day after (12/6). I'm fine with the reaction - it's preferable to having shingles - but do want to report it for the record.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Gait inability, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt called the pharmacy couple of days after receiving Arexvy vaccine complaining of radiating shooting pain from the site of administration to the leg on the same side. She couldn't walk for the next 3-4 days and slowly the pain went away. Coincidentally, pt didn't tolerate Shingles vaccine well (had a flare up of colitis).
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Bruising, redness, soreness around injection site started on day of injection.  Looks like a bruise or rash at the injection site and surrounding area 3 days later.  Patient states it hasn?t spread and it getting better.  No fever
Age: 12.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was at clinic for Meningococcal vaccine and was given PSV23 instead.  She has no high risk indicators for PSV23 at this time.  12/7/2023 Mom notified and denies any reaction after vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The patient received cominarty vaccine on 10/11/2023. Received another comirnaty vaccine dose today 12/7/23.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death, Myocarditis
Clinical narrative: Pt died due to suspected myocarditis 2 months after vaccine
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sudden death
Clinical narrative: Pt died due to suspected myocarditis 2 months after vaccine
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: The morning after the injection was given, noted a painful, swollen, red, raised (bumpy), itchy area surrounding the site of the injection.  The size of the rash grew every day.  Yesterday, it measured 8 x 4.5 cm.  Today, it is not as red but still is very itchy and painful.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Heart rate increased, Loss of personal independence in daily activities, Urinary tract infection
Clinical narrative: patient has high heart rate,  is very weak unable to take care of self, and now having chronic UTI
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: swelling, discoloration and aching and iching. Swelling for 2 weeks Discoloration  in area of injection appeared formed a red square in the swelled up area.   Aching - area was quite painful Iched for 3 1/2 weeks after the vaccination Currently no more swelling nor iching but the muscle in that area continues hurt.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Herpes simplex
Clinical narrative: genital HSV recurrence 6 weeks after receiving 2nd Shingrix vaccination
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Muscle spasms
Clinical narrative: Patient called the pharmacy and stated that she received the vaccine on a Thursday. She experienced no side effects until Sunday mentioning that she was having spasms in the arm where she received the vaccine. After speaking with the patient today, she said she still has spasms, but they are not as frequent and has gotten better since she reported the effects to the pharmacy.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PT WAS ADMINISTERED COMIRNATY VACCINE ON 12/4/23 BY PHARMACIST. ON 12/5/23, PSCP CALLED TO CHECK VACCINE INVENTORY AND IT WAS DISCOVERED AT THAT TIME THAT THE VACCINE ON-HAND HAD EXPIRED ON 12/1/23.  THIS DATE WAS ASSIGNED BY WHOLESALER MCKESSON AND REFLECTED THE 10-WEEK EXPIRATION DATE ONCE REMOVED FROM ULTRA COLD FREEZER.  PHARMACIST CHECKED MANUFACTURER WEBSITE, USING LOT #HG4680 AND FOUND EXPIRATION DATE TO BE 12/31/23 (AS ASSIGNED BY MANUFACTURER). PT HAS NOT CALLED TO REPORT ANY ADVERSE EFFECTS, AND PT ALSO RECEIVED 2 OTHER VACCINES AT SAME VISIT (FLUZONE HIGH DOSE AND AREXVY).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ON 12/2/23, PATIENT RECEIVED THE COVID-19 VACCINE, COMIRNATY, WHICH WAS ADMINISTERED BY PHARMACIST AT 11:29AM.  ON 12/5/23, PCSP CALLED TO CHECK INVENTORY ON VACCINE, AND IT WAS DISCOVERED AT THAT POINT THAT THE VACCINE HAD EXPIRED ON 12/1/23.  THIS EXPIRATION DATE WAS ASSIGNED BY THE WHOLESALER, AND IS 10 WEEKS AFTER VACCINE IS REMOVED FROM THE ULTRA COLD FREEZER.  PHARMACIST ALSO CHECKED THE EXPIRATION DATE ON THE MANUFACTURER WEBSITE, USING LOT # HG4680, AND WAS GIVEN AN EXPIRATION DATE OF 12/31/23.  PHARMACIST SPOKE WITH PFIZER'S MEDICAL INFORMATION SAFETY TEAM ON 12/7/23, AND WAS ADVISED TO FILL OUT NECESSARY DOCUMENTATION REGARDING EVENT.  PT HAS NOT REPORTED ANY ADVERSE EFFECTS FROM VACCINE.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Chest X-ray, Computerised tomogram head, Confusional state, Delirium
Clinical narrative: pt became delirious  hours after covid 19 update; confusion, agitated
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: pt became delirious  hours after covid 19 update; confusion, agitated
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Urinary tract infection
Clinical narrative: dizziness lightheaded and frequent UTI
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient received.vaccine on 12/7/23 that had a bud of 12/06/2023
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Atrial fibrillation, Heart rate increased
Clinical narrative: Patient came into the pharmacy today to pick up some prescriptions and she told us that she was told that she could not have any vaccinations ever again as she had to go to the emergency room as she was having atrial fibrillation and high pulse. She didn't specify the length of time, but it took them a while to "calm her down"
Age: 66.0
Sex: U
Vaccine: RSV
Symptoms: Blister, Papule, Pruritus, Xerosis
Clinical narrative: Puritic papules over left shin followed by vesicles and xerosis resloving
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Choking, Dyspnoea, Electroencephalogram, Full blood count normal, Gaze palsy
Clinical narrative: According to gma seizure like activity 3 hrs after a flu shot hands were trembling and head and eyes were deviated to the left.  she was choking and had trouble breathing afterwards
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test normal, Seizure like phenomena, Tremor
Clinical narrative: According to gma seizure like activity 3 hrs after a flu shot hands were trembling and head and eyes were deviated to the left.  she was choking and had trouble breathing afterwards
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Paralysis, Paraplegia, Product use in unapproved indication
Clinical narrative: now I'm a paraplegic; paraplegic.; Shingrix indication for Transverse Myelitis; This serious case was reported by a consumer and described the occurrence of paralysis in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 5kk99, expiry date 29-OCT-2021) for prophylaxis and myelitis transverse.   Concurrent medical conditions included myelitis transverse.   On 22-OCT-2019, the patient received Shingrix. On 22-OCT-2019, an unknown time after receiving Shingrix, the patient experienced product use in unapproved indication (Verbatim: Shingrix indication for Transverse Myelitis). On an unknown date, the patient experienced paralysis (Verbatim: now I'm a paraplegic) (serious criteria hospitalization and GSK medically significant) and paraplegia (Verbatim: paraplegic.) (serious criteria GSK medically significant). The outcome of the paralysis and paraplegia were not resolved and the outcome of the product use in unapproved indication was unknown.   It was unknown if the reporter considered the paralysis and paraplegia to be related to Shingrix.     It was unknown if the company considered the paralysis and paraplegia to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-DEC-2023 The patient went to the physician for a routine physical and was stupid enough to say yes when she suggested a shingle vaccine.  The patient was a competitive swimmer in excellent physical condition, and now (at the time of reporting) was paraplegic.  The patient attorney had been held off for years by yours.  The reporter just wanted to say, shingles did not care, neither did GSK.  Thank you for screwing up the patient life. The patient received Shingrix for myelitis transverse, which led to product used for unapproved indication. The reporter did not consent to follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Gait disturbance, General physical health deterioration, Homeless, Impaired work ability
Clinical narrative: After vaccination I started to have severe reaction numerologically and physically. I developed Fibromyalgia and can no longer walk unassisted. I'm still not able to to this day. Many more symptoms.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Walking aid user
Clinical narrative: After vaccination I started to have severe reaction numerologically and physically. I developed Fibromyalgia and can no longer walk unassisted. I'm still not able to to this day. Many more symptoms.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Admit date: 12/1/2023  Discharge date: 12/4/2023    Admitting Physician:  Attending Physician at the Time of Discharge:  Primary Care Physician:  Reason for Admission: COVID-19   Brief Summary of Hospital Stay: Patient presented to our ED for their complaint of shortness of breath. On initial workup in the ED, patient was evaluated for his shortness of breath and was found to be COVID-19 positive. Patient was subsequently transferred to the inpatient unit for appropriate medical care and treatment.  With shared decision making, the optimal location for this patient to be discharged to was back to his home. Patient was discharged to home via personal transport with appropriate follow ups scheduled
Age: 77.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: had adverse reaction after her COVID vaccine in September which caused diffuse arthralgias/myalgias for a month and resolved by the end of October.
Age: 77.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Arthralgia, Immunisation reaction, Myalgia
Clinical narrative: had adverse reaction after her COVID vaccine in September which caused diffuse arthralgias/myalgias for a month and resolved by the end of October.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: guillain-barre syndrome (gbs) after receiving fluzone qiv np; Initial information received on 15-Nov-2023 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to case 2023SA360402.  This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); varicella zoster vaccine (Varicella Vaccine); and Hepatitis B Vaccine all for Prophylactic vaccination.  On 03-Nov-2023, the patient received a dose 0.5 ml of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8219LA) (strength; expiry date unknown) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine (guillain-barre syndrome) (unknown latency).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This event was assessed as medically significant. The patient was hospitalized for this event and was hospitalized on 12-Nov-2023.  Additional information was received on 01-Dec-2023. case validity was upgraded to valid case and an event was added (missed to be assessed by previous user). Clinical course updated and text amended accordingly.; Sender's Comments: Sanofi Company Comment dated 01-Dec-2023: This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent]. Further information on allergy history, patient's medical history, family history, past or concomitant medication, laboratory investigation, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain-barre syndrome (gbs) after receiving fluzone qiv np; Initial information received on 15-Nov-2023 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to case 2023SA360402.  This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR); varicella zoster vaccine (Varicella Vaccine); and Hepatitis B Vaccine all for Prophylactic vaccination.  On 03-Nov-2023, the patient received a dose 0.5 ml of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8219LA) (strength; expiry date unknown) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine (guillain-barre syndrome) (unknown latency).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This event was assessed as medically significant. The patient was hospitalized for this event and was hospitalized on 12-Nov-2023.  Additional information was received on 01-Dec-2023. case validity was upgraded to valid case and an event was added (missed to be assessed by previous user). Clinical course updated and text amended accordingly.; Sender's Comments: Sanofi Company Comment dated 01-Dec-2023: This case involves a 45 years old male patient who experienced guillain-barre syndrome (gbs) after receiving influenza quadrival A-B vaccine [Fluzone Quadrivalent]. Further information on allergy history, patient's medical history, family history, past or concomitant medication, laboratory investigation, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Epstein-Barr virus infection, Laboratory test, Scan
Clinical narrative: Pain, fever, foggy brain, bilateral leg twitching, falls, heart palpitations, fainting with low blood pressure.  Loss of job (Trauma ICU Nurse of 20 years.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Antinuclear antibody positive, Brain fog, Cytomegalovirus test, Epstein-Barr virus test positive, Fall
Clinical narrative: Pain, fever, foggy brain, bilateral leg twitching, falls, heart palpitations, fainting with low blood pressure.  Loss of job (Trauma ICU Nurse of 20 years.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hypotension, Loss of employment, Muscle twitching, Pain, Palpitations
Clinical narrative: Pain, fever, foggy brain, bilateral leg twitching, falls, heart palpitations, fainting with low blood pressure.  Loss of job (Trauma ICU Nurse of 20 years.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia, Syncope
Clinical narrative: Pain, fever, foggy brain, bilateral leg twitching, falls, heart palpitations, fainting with low blood pressure.  Loss of job (Trauma ICU Nurse of 20 years.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Paranoia
Clinical narrative: lost her appetite; she got paranoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing); "She has lost inches" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, in Sep2023 as dose number unknown, single; ALPRAZOLAM taken for anxiety (ongoing). Vaccination history included: Covid-19 vaccine moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "blah feeling"; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DECREASED APPETITE (medically significant) with onset Nov2023, outcome "recovered" (2023), described as "lost her appetite"; PARANOIA (medically significant) with onset Nov2023, outcome "unknown", described as "she got paranoid". Therapeutic measures were not taken as a result of decreased appetite. Clinical course: Patient's weight was about 117 pounds. She had been on Alprazolam for a couple of years. Caller had the booster shot three weeks ago. She made appointment and went there. It was fine no pain in arm. The next day she lost her appetite for three days. She was really scared. She thought she was dying. It was mainly she got paranoid because she didn't had an appetite. After the third day, she started eating again. She realized every time, she usually got Moderna, the next day she would get blah feeling. Caller clarified she started out with Moderna shot. She got reaction from that too, but it wasn't like this one. She was thin and ate healthy. She was skeptical. Caller clarified booster shot as Pfizer COVID booster shot. Caller clarified she got Moderna COVID shot to start with way back when. That was what happened. She was five foot five inches and now she was five foot three inches. Caller confirmed loss of inches were prior to getting Pfizer COVID booster shot. Loss of appetite started the day after getting the booster shot and then continued on. It was 3 days that she didn't have her appetite. Outcome of Event: she had recovered completely. After 3 days she started to have the feeling she wanted to start eating. She would have been very scared if it didn't come back. Concomitant Medications: Alprazolam: Took it every day when she was anxious. She usually cuts in half. They did help her sleep so she took a whole one to sleep. It was 1mg. Caller was kind of freaked out and had crazy thoughts. Height: she had lost inches. That what happened. She was five foot five inches and now she was five foot three inches. Caller confirmed loss of inches were prior to getting Pfizer COVID booster shot.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac failure, Myocardial infarction
Clinical narrative: cardiac failure; myocardial infarction; arrhythmia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division.  A male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (death, medically significant), outcome "fatal"; MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal"; ARRHYTHMIA (death, medically significant), outcome "fatal". The patient date of death was 16Jan2022. Reported cause of death: "cardiac failure", "myocardial infarction", "arrhythmia". It was not reported if an autopsy was performed.  Clinical course: Reporter was filed a lawsuit against Pfizer, Inc., based on a 500 page report of clinical data released by the company and displaying willful misconduct as related to their COVID-19 mRNA shots resulting in a shocking number of adverse cardiac events, including cardiac failure, myocardial infarction, and arrhythmia, of which reporter's father unexpectantly died on 16Jan2022 in withheld. Reporter was suing for the funeral expenses of father, who was the victim of false claims and blatant deception by Pfizer, as he was assured by the company that he would be protected from COVID-19 If he took Pfizer's series of mRNA shots. He instead died as a result of these injections  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: cardiac failure; myocardial infarction; arrhythmia
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), SUSPECTED COVID-19 (medically significant) all with onset 05Oct2023, outcome "unknown" and all described as "covid". Clinical course: The reporter stated that she had COVID back on 05Oct and was diagnosed with COVID. She had all of her shots and was getting ready to get her boosters, but she contracted COVID. She wanted to knew when she could get her booster shot, and it had been two months.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive on Wednesday morning; positive on Wednesday morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization; influenza vaccine (INFLUENZA), on 09Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunization. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Had symptoms worse than, had 2 yrs ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovering" and all described as "positive on Wednesday morning". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: positive on Wednesday morning.  Clinical information: The patient had a Pfizer vaccine with the influenza one 09Nov23. The patient believe was not yet immune when catching it 25Nov2023 (as reported). The patient symptoms started Tuesday evening, positive on Wednesday morning. Had symptoms worse than the patient had 2 yrs ago. The patient still recovering, but wondering how's every other newly vaccinated person doing .  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: My son received the latest in your series of Covid vaccine and a week later came down with Covid; My son received the latest in your series of Covid vaccine and a week later came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "My son received the latest in your series of Covid vaccine and a week later came down with Covid".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid after around 10-20days of phizer Covid vaccine; got Covid after around 10-20days of phizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after around 10-20days of phizer Covid vaccine".  Clinical information: Reporter stated that "Two of my friend got Covid after around 10-20days of phizer Covid vaccine."  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300197607 Same reporter and product, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: caught COVID 19 and had severe symptoms; caught COVID 19 and had severe symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 12Feb2021 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), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "caught COVID 19 and had severe symptoms". Clinical Course: On 26May2021 patient attended a wedding reception and caught COVID 19, had severe symptoms by 01Apr2021. He was bedridden. On 06Apr2021 he felt better and went for a one-mile walk.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome
Clinical narrative: multisystem inflammatory syndrome (MIS); This is a spontaneous report received from non-contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (death) with onset 08Feb2021, outcome "fatal", described as "multisystem inflammatory syndrome (MIS)". The patient date of death was 08Feb2021. Reported cause of death: "multisystem inflammatory syndrome (MIS)". Clinical course: (Name withheld) recounted the case of a young orthopedic surgeon (name withheld) who died on 08Feb2021 from multisystem inflammatory syndrome (MIS) after receiving his second dose of Pfizer's vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Multisystem Inflammatory Syndrome and the suspect drug cannot be completely excluded. 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.; Reported Cause(s) of Death: multisystem inflammatory syndrome (MIS)
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID back on 05Oct and was diagnosed with COVID; had COVID back on 05Oct and was diagnosed with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID back on 05Oct and was diagnosed with COVID". Clinical course: A caller had COVID back on 05Oct and was diagnosed with COVID. She had all of her shots and was getting ready to get her boosters, but she contracted COVID. She wants to know when could she get her booster shot, and it had been two months now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: just got Paxlovid; Also got Covid Vaccines Shots and Boosters; just got Paxlovid; Also got Covid Vaccines Shots and Boosters; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "just got Paxlovid; Also got Covid Vaccines Shots and Boosters". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Caller called in, just got Paxlovid, but she was feeling better, she wants to know if she still needs to take it. Also got Covid Vaccines Shots and Boosters. Patient got the vaccines and boosters already but still got mild symptoms after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Parkinson's disease
Clinical narrative: I now have Parkinson's from it; I can no longer work and cannot do all my daily activities doing yoga and Pilates and 4 mile walks each day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 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: PARKINSON'S DISEASE (disability, medically significant), outcome "unknown", described as "I now have Parkinson's from it"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "unknown", described as "I can no longer work and cannot do all my daily activities doing yoga and Pilates and 4 mile walks each day". Therapeutic measures were taken as a result of parkinson's disease.  Clinical course: Patient had Covid injection two years ago and now have Parkinson's from it and patient is upset about it since patient have to live with it and is very debilitating. patient using a walker as if patient did not use it patient would be falling. Patient is on permanent disability since patient can no longer work and cannot do all the daily activities doing yoga and Pilates and 4 mile walks each day all because of the vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.