chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nose bleeds; Fainted; Insomnia; headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: ER8737), via an unspecified route of administration, administered in left arm on 05Apr2021 18:45 (at the age of 49-years) as single dose for COVID-19 immunization. Medical history included migraine and known allergies to sunflower oil, chamomile, mold, and dogs. The patient is not pregnant at the time of the vaccination. Concomitant medications included atenolol and rizatriptan benzoate (MAXALT). The patient has no other vaccine in four weeks. The patient previously had allergies to hydroxyethyl methacrylate, sodium pentothal, and erythromycin. The patient was not tested for covid post vaccination. The patient experienced insomnia and headache for three days, and chills on and off for over a week on 05Apr2021 at 21:00. The patient also experienced fainted on 06Apr2021 and nose bleeds lasting 15-45 minutes on 07Apr2021, 14Apr2021, 20Apr2021, and 23Apr2021 (patient never get nose bleeds previously). The patient received pain and antibiotics medications as treatments. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
On January 21, 2023 I started having a sore throat that stayed persistent throughout the day. On January 22, 2023, I took a home COVID-19 test that came back positive, I went to a urgent care to have a PCR COVID-19 test. It came back positive on January 23, 2023. I was prescribed the Paxlovid that I started that day. I started feeling better that day and was feeling good. Within two days of finishing my regimen of Paxlovid I was testing positive and for COVID-19 and this time it was much worse.
The pt experienced a fever of 103 and above, and a brief febrile seizure beginning approximately 26 hours post vax.
Pt c/o new onset itchy throat and trouble breathing. Pt diaphoretic. BP 154/95. Per MD, patient had throat swelling. Pt treated with epinephrine 0.3mg IM @ 1206 and 1226, Benadryl 25mg IV @ 1210, racemic epi 0.5mL @ 1223, prednisone 60mg po @ 1415.
This spontaneous report as received from a health care worker refers to a 11 year old female patient. Her pertinent medical history included attention deficit disorder and she did not have any drug reactions or allergies. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose not reported), lot # L043214 and expiry date: 30-AUG-2017, intramuscularly. Concomitant therapies included CONCERTA, acyclovir (manufacturer unknown) and MEDROL DOSEPAK (dosage, frequency and indication were not reported). On 13-AUG-2016, the patient woke up with low fever and vomited 'once or twice'. It was reported that these events resolved as quickly as they came on the same day (13-AUG-2016). On 16-AUG-2016, the patient woke up with facial drooping (side was unspecified), which, the reporter described as 'symptoms of Bell's palsy' (facial paralysis). No treatment was given for the event. The patient sought medical attention and the patient mother called the physician. The outcome of pyrexia and vomiting was reported as recovered. The outcome of facial paralysis was reported as not recovered. The causal relationship between the suspect therapy and the events was not reported. There was no product quality complaint (PQC) involved. Upon internal review, the event facial paralysis was determined to be medically significant. Additional information has been requested.
Had a Pneumococcal vax left arm   Now has 4x7inch ( her measurement) induration w/ redness, swelling and pain at injection site Able to move and function w/ left arm and shoulder  No fever,
Slept around the clock after the First Vaccine; Confusion; Shivering; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Hypertension, Seizure and Dyslipidemia. Concomitant products included SIMVASTATIN for Dyslipidemia, METOPROLOL for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever). On 04-Mar-2021, HYPERSOMNIA (Slept around the clock after the First Vaccine), CONFUSIONAL STATE (Confusion), CHILLS (Shivering) and PYREXIA (High Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 104 (High) 103-104 F. On an unknown date, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-228389 (E2B Linked Report). This case was linked to MOD-2021-226399 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-228389:Same reporter
This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 04-SEP-2015 at 14:46 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
sore throat like the onset of a cold; sore throat like the onset of a cold; Some minor chills; minor fatigue/Moderate fatigue; Day of injection sore arm/Day 2 very sore arm/ Minor arm soreness; This is a spontaneous report received from a contactable consumer (patient, self-reporting). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6199 and expiration date was not reported), (patient was 71-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 03Mar2021 at 12:45 as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809 and expiration date was not reported), via an unspecified route of administration in left arm on 08Feb2021 at 12:30 PM for COVID-19 immunisation. On 05Mar2021 at 12: 00 pm, the patient experienced day of injection sore arm/day 2 very sore arm/ minor arm soreness, on 06Mar2021, the patient experienced minor fatigue/moderate fatigue and on 07Mar2021, the patient experienced sore throat like the onset of a cold, some minor chills. Reported that patient had not received other vaccine in four weeks. Reported that Day of injection sore arm. Day 2 very sore arm, minor fatigue and Day 3 Very sore throat like the onset of a cold, some minor chills, no fever, moderate fatigue, minor arm soreness. Day 4 Back to normal. The sore throat was surprising more so because of the day. Adverse event on 05Mar2021 at 12:00 PM, no treatment received for AE. Patient had no COVID prior vaccination and not tested COVID post vaccination. The outcome of events was recovered on 08Mar2021.  No follow-up attempts are possible; no further information is expected.
Patient was administered with an expired Menactra/no adverse event; Initial information regarding an unsolicited valid serious case was received from an other health professional via Global Medical Information (GMI) (Reference number- 00329737) and transmitted to Sanofi on 23-Oct-2020.  This case involves patient with an unknown demographics who was given 0.5 mL once dose of expired suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot u6346aa and expiration date: 03-Aug-2020) on an unknown date via unknown route at an unknown administration site for prophylactic vaccination. (expired product administered)  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was admitted to hospital on May 22, 2021, for a complex combination of neurological symptoms including double vision, abnormal eye movement called nystagmus, leg weakness, and numbness.
No adverse effect reported; The patient got out of their restraint and movement caused the needle to be dislodged; This spontaneous report was received from a medical assistant regarding a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. ]  On 09-AUG-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S004091, expiration date 11-FEB-2021 for prophylaxis (strength, dose, frequency, and route of administration was not reported), the vaccine was reconstituted with sterile diluent lot number S008567, expiration date 23-SEP-2021. On the same date, the patient got out of their restraint and the movement caused the needle to be dislodged from the site losing the vaccine on the table. It was not sure how much of the dose the patient actually received (incorrect dose administered). No adverse effect reported.
Fever, severe sore throat, headache, muscle pain, joint aches, nausea
With Injection1, loss of taste with sweet stuff only for 7 days, pain at injection site for 3 days. With injections 2, taste metal for 1 day, collarbone lymph node swollen ~1.5cm with intense pain, pain at injections site for 2 days.
pt recv vax & devel swelling of injected arm which extended down to the tips of the fingers & up to the neck & face;pt hosp & reported to be improving @ date of this report;this is one of 3 children from this site to have an exp p/vax
Had febrile seizure on 3/15/19 - EMS called but pt. was not transported. Sz. lasted approximately 5 min.
I received two doses of Moderna COVID-19 Vaccine EUA in April and May. After the first dose my Menstrual period was late for 10 days. After the 2nd dose, my Menstrual period was late for 15 days. The volume was larger than usual with bad cramping pain. My back hurts a lot during the Menstrual period, which was rare before. I also feel pain on my left breast. My blood pressure was 15-20% higher than two years ago (I did not consistently monitor my blood pressure.  so I am not sure if it is related to vaccine)
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-FEB-2018 the patient was inadvertently vaccinated with one expired dose of M-M-R II (lot # M002418, expiry date: 12-JAN-2018) for prophylaxis (expired product administered). No adverse effects were reported.
BP dropped to 65/45; joint swelling ;fainted twice and twisted/bruised my leg in the process of falling; emesis; diarrhea; general myalgia.
Lump on the right hand inch an half long half inch wide. and I have one on the left hand smaller.. Have photos It hard to type please call me
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered.   Information on lot/batch number has been requested.
Patient reported a small local reaction after the vaccine which she expected, the patient reported using hydrocortisone cream topically to alleviate the redness and itching. The local reaction resolved after a few days as reported by the patient. The patient also reported tactile pain that resulted when something "brushed" across the portion of the arm surrounding the injection site.  Touching the area didn't cause pain, just when something softly brushed over the area like clothing or a sheet.
Pregnant and received Vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine) in a 31-year-old female patient who received mRNA-1273 (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was date. On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine). The patient received mRNA-1273 during pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  The patient was 27 weeks pregnant at the time of vaccination.
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 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid (Lot number: 3006903455307) for COVID 19 treatment from 22Jan2023 to 26Jan2023. Patient had no known allergies. Patient did not receive other medication in 2 weeks.  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.
About two months after receiving vaccination I noticed a swollen lymph node in my left groin. I noted no pain or tenderness. Spoke with PCP who referred me to a surgeon who ordered the lymph node ultra sound, then a biopsy, and then I was referred to an oncologist and diagnosed with Non Hodgkins Lymphoma.  Began treatment for lymphoma on 09/20.
Parent reports on 10/21/2019 that child has "warm to touch, swollen thigh for 48 hours."  "No fever or any other symptoms."   RN referred mother to VIS where it states that this is not an unusual side effect.   Also  advised her to take child to PCP if she does not show signs of improvement.  Mother states she already contacted PCP who told her to wait another day for swelling and heat to subside.
Pt returned to clinic 8/3/17. She rec'd TDaP on 7/26/17 office visit. She states that her bicep area has been sore ever since. Today she developed a water filled blister below the bicep near site where injection was given and bruising. Pt was given amoxicillin and pain med NORCO.
Patient developed 6.5 x 8 cm erythematous  induration with indistinct border, left lateral deltoid
Pt began with temp 100.1-100.2 8 hours after HPV9 and TRUMENBA was administered. Pt also reports bad back pain. Left arm had swelling and was warm to touch.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JAN-2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
very bad hives/itchy welts on skin; red resin spot comes and gets irritated; itchy welts on skin; she scratches it, there is a red resin spot that comes and gets very irritated; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SPIRONOLACTONE for an unknown indication.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated) had not resolved.            It was reported that the treatment drug prednisone did not help much in resolving the adverse events.