chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a 69 year old female of an unspecified ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: penicillin allergy (neomycin), allergy to cold temperature, and mold allergy. The patient had lot of allergies. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) dose was not reported, therapy start date was not reported, 1 total administered for covid-19 prophylaxis. No adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: unknown) dose was not reported, 1 total administered to the left arm on 16-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported. It was reported that on 16-NOV-2021, a few minutes after getting the booster the patient started feeling tingling in tongue. It was also mentioned that they kept her for past 15 minutes, but as the patient did not have any breathing problems, they let her went. The tingling in tongue stayed for a few hours then it went away and patient mentioned that it was been like this since and it was on and off. It was more frequent the first week then it became less frequent. The patient went to the dentist and got an anesthetic injection and she said it came back worse after the injection wore off. It was again worse and more frequent and affected her lips and palate, the first week then less frequent. It was mentioned that it seems somewhat related to stress. The patient said she thought it was over a couple of time but it came back a month later so she was never really sure if it was gone for good. The patient also said that she consulted with her allergist at first and the allergist told it was not an allergy. She was recommended to see a neurologist and the neurologist told her it was paresthesia (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia. This report was non-serious.
Patient received extra dose, 3rd dose, of Varicella. Had previously received doses on 11/26/03 and 4/5/07.
While administering vaccine had patient with bleeding "more than usual"; This is a spontaneous report from a contactable primary reporter. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. While administering vaccine had patient with bleeding "more than usual". Patient wanted to know if it effects the vaccine effectiveness. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 19 year old male patient. In January 2018, the patient was vaccinated with a first dose of GARDASIL 9 for prophylaxis. On 13-JUN-2018, the patient was vaccinated with a second dose of GARDASIL 9 lot # N023828, expiration date 25-JUN-2020. No adverse effects were reported.
Came down with COVID while staying, on vacation. Symptoms started approx 4 days after travelling by air across country. Arrived at airport. Stayed one night in hotel before driving to ultimate destination.  COVID diagnosed here.   Received rx for Paxlovid via telephone visit with MD.  Did not see provider in person.   Symptoms: slight sore throat, sinus congestion, cough, headache.  No fever/chills.  Reminiscent of a bad cold.  No worse.
VS- SaO2 98%  HR 86 R 18 BP 124/88 Dizzy, mild light headed.  Stated similar to blood draw/ possible anxiety?  Feels better- Home
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Sjogren's syndrome" (unspecified if ongoing). Concomitant medication(s) included: TURMERIC [CURCUMA LONGA RHIZOME]; QUERCETIN; ESTROGEN; MAGNESIUM; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has taken Pfizer antiviral drug for the treatment of COVID-19 from 13Sep2022 to 17Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10 mins after the patient received his dose, he states he feels nauseous, I gave him the garbage bin to throw up into it, after that I offered him Gatorade sat there for another 10 mins, was feeling better after that and went home.
Information has been received from a physician concerning a 5 year old male child who, at 12 months, on 8/15/2000, was vaccinated with a first 0.5 ml subcutaneous dose of varicella virus vaccine live (lot 635980/0446K). It was reported that the patient had breakthrough chickenpox of about 31 lesions. Subsequently, the patient recovered without any additional problems. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Developed light fever and migraine (sensitivity to light and sound, and nausea). Started by the evening of the shot. Took two acetaminophen the next day, which reduced symptoms. Migraine lasted from evening of shot, through next day, and every other day for about a week.
Pain; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took glatiramer acetate injection and experienced pain. The patient reported that he has pain with his glatiramer acetate injections at times. He reported that it hurts more than the vaccine he got today, 26Mar2021 did. The outcome of the event was unknown. The event was assessed as serious, medically significant.  No follow-up attempts are needed. No further information is expected.
Headache, 102 Fever, nausea, chills, body aches, extreme fatigue Started 3-13-2021 at 7 pm until 03/14/2021 @ noon Nausea/upset stomach and extreme fatigue until 3/15/2021 Continue to have mild upset stomach and body fatigue with irritated airway
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with Gardasil vaccine (yeast). Subsequently the patient experienced dizziness and blurry vision "a short time after her vaccination". Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. No further details were provided. Additional information has been requested.
No additional AE reported; received first dose at another facility when they were 15 years old in September 2018/now 18 years old and did not complete the series; This spontaneous report has been received from a registered nurse referring to a 15 years old male patient and his twin brother. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On an unknown date in September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. The reporter stated that at the reporting time, the boyis 18 years old, had not complete the series and missed the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). No additional adverse events were reported.       This is one of two reports from the same reporter (MARRS#2103USA005674 twin brother case).; Sender's Comments:  US-009507513-2103USA005674:
VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a 13 month old female. The patient's weight, height, and medical history were not reported.The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for an unspecified indication. No concomitant medications were reported. On 24-MAR-2021, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
rt thigh red, swollen, dark red colored in center, a few streaks coming from inject site;
Pt hospital immunization clinic. Approx 30 min after receiving DTaP #4, Comvax #2. Child present with patchy red, itchy rash on nose, ears, neck, upper back. No respiratory distress. Skin warm and dry. Sent to hospital ER.
19 days after initial vaccination, arm pain and weakness returned at the point of vaccination. The previous two weeks after the initial 2-3 days post injection pain wore off had been pain and symptom free. The pain returned with no obvious reasons for the increased soreness and tenderness.
Discharge Provider: DO Primary Care Provider at Discharge: None Physician, DO None Admission Date: 8/7/2022 Discharge Date: 08/9/2022  PRESENTING PROBLEM: Hypokalemia [E87.6] Hypomagnesemia [E83.42] Hypoxia [R09.02] Alcoholic intoxication without complication  [F10.920] COVID [U07.1] Suspected COVID-19 virus infection [Z20.822]   HOSPITAL COURSE: Patient is a 41-year-old male who presented to the emergency department with alcohol intoxication and was incidentally found to be hypoxemic with COVID-19 infection.  In the emergency department, vital signs were stable except for hypoxia on room air.  He was placed on supplemental oxygen.  Chest x-ray was unremarkable.  Lab work revealed a potassium 2.9, magnesium 1.5, AST 188, ALT 37, bilirubin 1.1.  COVID-19 was positive.  Patient was started on Decadron and admitted to the Internal Medicine Service.  Patient was able to be quickly weaned from supplemental oxygen.  Given patient's significant use of alcohol psychiatry was consulted.  He was placed on psych protocol for withdrawal treatment.  PT/OT evaluated the patient and recommended subacute rehab.  This was being arranged when the patient eloped.
Caller states that her Booster shot was Pfizer; she tested positive for covid; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FJ4489) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 04Feb2021 as dose 1, single (Lot number: 007M20A), on 04Mar2021 as dose 2, single (Lot number: 036A21A) and on 24Oct2021 as dose 3 (booster),single (Lot number: 014F21A) for covid-19 immunisation. The patient's relevant medical history included: "Allergy NOS" (unspecified if ongoing), notes: She is allergic to so many things. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 31Jul2022, outcome "unknown", described as "Caller states that her Booster shot was Pfizer"; COVID-19 (medically significant) with onset 31Jul2022, outcome "unknown", described as "she tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2022) Positive, notes: tested positive for covid on Sunday 31JUL2022. Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products. Clinical Course: Reporter stated that she was taking the Paxlovid. She had a question about it, she tested positive for covid on Sunday 31Jul2022. She started taking Paxlovid on Tuesday and has been taking it for 3 days. She had also had the covid vaccines, all 4 of them. The doctor suggested that since she would had mild case of covid that she might want to try the Paxlovid. reporter stated that she had been taking it, and she was not known, she  she was getting better, she was no congested, she had a little cough and nose running, but with the Paxlovid she was noticing that she feels agitated. reporter asks is it okay to stop taking the paxlovid. Reporter clarified that she had 4 doses in total, the first 3 were from Moderna, the last shot she got was from Pfizer.
Pt received a dose of vaccine that was discovered to be undiluted Pfizer 5-11 (Orange Top.)  The vaccine was drawn up by RN who said she had diluted it, however, was unable to get more than 3-4 doses from the vial.  Pt and siblings had observation period and no abnormal signs were observed or mentioned, and then left with parent.  Parent was contacted regarding the event and mentioned that her three children were experiencing sore arms, severe nausea, and headaches.
Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger; Plaque Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) and PSORIASIS (Plaque Psoriasis flare-up) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis flare-up.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) and PSORIASIS (Plaque Psoriasis flare-up). The patient was treated with BETAMETHASONE for Peeling, at an unspecified dose and frequency. At the time of the report, SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) had resolved and PSORIASIS (Plaque Psoriasis flare-up) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient indicated that he thought the COVID vaccinations may had caused this flare up to appear. It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger and plaque psoriasis flare up was not provided.
Pt recvd vax & exp immed burning which lasted about 5 mins; also had msucle aches, general malaise, h/a lasting bout 36 hrs;
elevated temp 102.4 & higher, very irritable, not wanting to be touched, some diff using rt arm;no local rxn noted;sx from the evening of the inj 25MAR & the following day 26MAR;was better on 27MAR suggestive of hypotonic episode;
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 29 years and 09 months. No concomitant medications were reported.  It was reported that the vaccines were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine.  No treatment medications were reported.
States after TDAP redness, swelling left arm, states still sore left thumb area. No signs or symptoms noted on 12/7/09, vaccine given 11/18/09. No swelling or redness noted. Client moves left thumb with full motion. No visual symptoms c/o pain. Stated several time needed pain medication and should go away.
Pt recvd 1st dose of vax on 3AUG92 & on 8AUG92 devel a macular papular pruritic rash primarily on trunk; No further details were provided;
Case number PHEH2015US024219, is an initial spontaneous report from a pharmacist received on 17 Nov 2015. This report refers to a 3 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN PFS (batch number: 158201) intramuscularly on 13 Nov 2015. No adverse event was reported.
blighted ovum seen on ultrasound followed by miscarriage. post 5 weeks of 1st injection. eventual follow up ultrasounds and D&C.
22 hrs p/1st doses felt weird, lightheaded, nauseated, dizzy; 22APR93 went to school;
Tenderness at injection site (expected). Blotchy red welts (hives?) and extremely tender underarm later that evening. Took 2 Aleve tablets at 2:00am. Reported reaction to doctors office on Wednesday. They advised to continue with Aleve and also take Benadryl for redness. Pain subsiding and redness going away by Wednesday (7-11-12)pm. Doctors office called to check with me on Thursday, very concerned. All ok by Friday am (7-13-12).
dizziness, vomiting immed p/inject 5APR93; Pallor began clearing throat; minimal response to verbal stimuli; gazing w/minimal response in 1-2 min p/inject 1JUN93; Epi given;
DID NOT STORE CAPSULES IN FRIDGE ONCE SOLD, CONTINUED TO TAKE THAT DOSAGE SCHEDULE; This spontaneous case report (PVX2019-2730) was received on 29-Oct-2019. It described a 61-years-old adult female consumer who "did not store capsules in fridge once sold, continued to take that dosage schedule" (PT: Product storage error), while being on Vivotif capsule for unknown indication.  Case report: The consumer did not store Vivotif in fridge and continued to take it. Then, she got another prescription and took dose schedule again.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not store capsules in fridge once sold, continued to take that dosage schedule" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "did not store capsules in fridge once sold, continued to take that dosage schedule" was considered as not applicable.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: This case was reported by an administrator. The age at vaccination was not reported. The healthcare professional reported that the patient had reaction to SHINGRIX. When asked the reporter also stated that, she did not believe that the patient was in imminent danger. She then stated that she had no further information and would have to call back.
NECK PAIN; FLU; THUMB PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number: 1169051 expiry: UNKNOWN) 15 mg, 1 time every 1 day, from 2022 for rheumatoid arthritis. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc, ergocalciferol, famotidine, gabapentin, methotrexate, omeprazole, prednisone, retinol, sertraline hydrochloride, and tizanidine hydrochloride. On 2022, the patient experienced thumb pain. On FEB-2022, the patient experienced flu. On an unspecified date, the patient experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The patient had not recovered from thumb pain, and neck pain, and the outcome of flu was not reported. This report was non-serious.
24 hours after inj. started with swelling measuring 4x5 " on arm- then yellow blisters, hot to touch. Quite painful. Now resolving- 4 days later
developed headache and malaise after, symptoms have persisted up through visit on 05/14/2021.    At that point, headaches or varying from bad to mild, continue to be drowsy, continued to feel best when lying down
Within 4 hours experienced dizziness, nausea, weakness, headache, fever and chills, coughing. Symptoms lasted for approx. 16 hours.