chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed liver and vesicular lesions that erupted eleven days after Varicella (Varivax) injection Fever lasted x 5 days and vesicles cleared by 6th day
Acute low back pain that could have had no other cause. Visited Urgent Care on Sunday October 9, 2022.  Was given Flexeril; no relief.  Obtained prescription for physical therapy from my family doctor and started therapy on Friday October 14, 2022. I am still in physical therapy to date.  Exercises and other modalities are helping.
Pancreatitis. hospitalized   They removed my gallbladder on 3/3/21
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 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe body aches, headache, nausea, chills, sweating, passed out.
MENQUADFI vaccination was given along with Menevo vaccine by mistake, with no adverse event.; Initial information was received on 12-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.   This case involves a 16 years old male patient who experienced menquadfi vaccination was given along with menevo vaccine by mistake, with no adverse event while receiving vaccines MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO] and meningococcal A-C-Y-W135 (T CONJ) vaccine [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 12-Jul-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U6823AA) (dose, formulation, strength and expiry date: unknown) via intramuscular route in the left deltoid for immunization.    On 12-Jul-2022, the patient received a  dose of suspect MENVEO not produced by Sanofi Pasteur lot number (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for immunization.    On 12-JUL-2022 the patient developed a non-serious menquadfi vaccination was given along with menevo vaccine by mistake, with no adverse event (extra dose administered) (latency same day) following the administration of menveo and menquadfi.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi vaccination was given along with menevo vaccine by mistake, with no adverse event. .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Employee upper arm red, swollen, firm and hot to touch. Also had hives break out on face and neck.
Beginning 03/28/21, experienced severe body aches and pains, nausea, extreme fatigue, loss of appetite, bad headache/migraine and irritability. These symptoms lasted for about five days. From the sixth day to present (05/07/21), I have had brain fog, extreme fatigue, compromised ability to concentrate, uncharacteristic irritability, mood swings, some loss of appetite, malaise, headache (not migraine) and inability to sleep well.
Information has been received from a physician concerning  17 month old Caucasian female with a history of partial onycholysis of some distal fingernails and no other past medical history and no allergies who on 09/26/96 in the AM was vaccinated with the first dose of varicella virus vaccine live (lot 0389D-invalid for this product), which had expired. There was no concomitant medication. There were no adverse events noted at that time. Follow-up reported that "late addendum: pt did develop rash at vaccine stie and on face at 2-3 weeks."
Tightness in upper arm where injection was administered.  Also sharp shooting pain with movement of arm which continues till todate.  Cold and hot compress.
Headache, Myalgia,  Hot flashes and chills Narrative:  Other Relevant History:
Generalized body aches, cough, shortness of breath since receiving booster 5 days prior.
Had a severe cough; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. Medical history included immunocompromised (she was immunocompromised) and severe arthritis. Concomitant medication included etanercept (ENBREL INJECTION). The patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunisation and experienced no reaction for 1st dose. The patient stated that she was immunocompromised because she had severe arthritis and was aware that the vaccine can be less effective to her. She was taking Enbrel injection and wanted to know information on the timing of the vaccine vs the timing of injectables. The patient added that her doctor had px taking multiple drugs that compromised her immune system. On an unspecified, patient had a severe cough and tested negative for COVID. They tested her antibodies with both doses of the Pfizer COVID-19 vaccine and got a result of zero antibodies. The patient underwent lab tests and procedures which included antibody test: zero antibodies and sars- cov-2 test: negative on an unspecified date. The outcome of the event was unknown.    Information about batch/lot number has been requested.
Tachacardic response.  Normal resting heartrate is 53.  Resting heartrate jumped to 141.  Awoken from sleep with racing heart rate.  Slowly resolved over the next 8-12 hours.   Blood pressure at 6am was 82/51 with a RHR of 123.   I have since returned to baseline.
Fever >100.0, nauseaus, dizziness, chest pain, fast hart rate. Eventually lost consciousness while driving and got into a car accident.
Patient had an onset of 103 fever just a couple of hours after the vaccine.  His fever lasted 5 days an arm swelling up with soreness for over 2 weeks.  His speech became slurred and lasted over 30 days.  He is still having problems concentrating/body aches. MD will not have patient vaccine again.
Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted, No AE; Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted, No AE; Initial information received on 23-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 73 year old male patient who was vaccinated with a 0.5 mL dose DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6603AA and expiry date: 03-May-2022) via an unknown route and administration site for prophylactic vaccination (PT: product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  It was a case of an actual medication error due to incorrect product storage.   It was also the case of product shipment delay.  It was reported that Tenivac was administered to a patient which was sent to outline clinic on Wednesday 15th by mail but it arrived on 20th and upon arrival the product was warm and the ice packs had melted.  At the time of report, 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 holder's 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.
Flu like symptoms; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Head ache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Head ache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and HEADACHE (Head ache) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
felt like a cramp in face on one side of her cheek and it felt like her face was not working right; arm and legs were tired; tingling in her forehead and in nose/tingling in arms and in legs and her feet felt the worst; numbness; Muscle weakness; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient reported that she had some things happened just after receiving the COVID-19 vaccine on Tuesday morning (12Jan2021). The patient later on experienced tingling in her forehead and in nose on 13Jan2021. The next day (14Jan2021), it started like tingling in arms and in legs and her feet felt the worst.  On 14Jan2021, two days after (Thursday), she felt like her arm and legs were tired. On Friday (15Jan2021), she woke up and felt like a cramp in face on one side of her cheek and it felt like her face was not working right. Three days later (Friday), she still feels that it is better than it was. The patient also experienced numbness and muscle weakness (both in Jan2021). She don't know what she should do or if she should get the next shot, she almost felt like it was the worst and need to go to the hospital but her body was not so fatigued, she felt her muscle worked hard, described as weak. The patient haven't seen by her doctor or visited in emergency room. The patient did not receive treatment for the events. Outcome of the events was unknown. The events were assessed as non-serious.
Redness at site, warm w/cellulitis. MD visit w/prescrip of BACTRIM 2xday for 14 days.
Information has been received from a health professional concerning a male who on an unspecified date was vaccinated with a dose of MMR. Subsequently for five days after vaccination, the patient experienced a stiff neck and headache. No further information was provided. There was no product quality complaint involved. Additional information is expected.
Narrative: 75 y/o M with PMH of PTSD, HTN, HLD, and CVA. Received 1st COVID-19 vaccine (Pfizer) on 2/26/21, 2nd dose COVID-19 vaccine (Pfizer) on 3/19/21 with no reported adverse reactions. Received booster COVID-19 vaccine (Pfizer on 12/1/21, also received influenza vaccine same day. Within 1 day of receiving both vaccines, developed rash "all over body" that started on neck and spread. Used hydrocortisone cream OTC for some relief. Has had rash for 2 months, also with hives and some hives rupture skin and result in bleeding. No new meds or OTC, NKDA, no food allergies, no new cosmetics, clothes, pets.
Information has been received from a healthcare worker referring to an unspecified number of patient s with unknown age and gender. On unknown date in 2015 ("after 17-NOV-2015"), the patients were vaccinated with dose of improper stored M-M-R II (lot # K024035, expiration date 26-NOV-2016; lot # L005291, expiration date 17-FEB-2017; lot # K011188 expiration date 12-AUG-2016; lot # L012481, expiration date 10-APR-2017)(dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
felt sick; fever; body aches; chills; numbness of bilateral distal arms and legs (forearms/hands & shins/feet); This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: Patient has prior Hx of possible Multiple Sclerosis; "abnormal imaging" (unspecified if ongoing), notes: Brain MRI showing some abnormal imaging 5 yrs ago; "abnormal EEG" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 20Mar2023, outcome "recovering", described as "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received his first COVID-19 vaccine 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He then only had very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet but plans to see his Neurologist in follow up. Optional Information patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  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-202300145275 same patient/SD, different AE/dose;
Headache and sick to stomach for 1 day after recieving, swollen at site of injection 1 day later, quarter size redness and warm to touch 2 days later at site of injection, painful when touch site of injection.
Within 18 minutes of getting flu vaccine, patient experienced moderate-> severe itching on (L) side of neck - redness noted - no rashes - BENADRYL 3/4 tsp given at 1057 am with immediate relief of symptoms. Lump clear bilaterally to auscultation.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of RECOMBIVAX HB, 0.5 nl, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a second Moderna Bivalent booster 1 month and 12 days after his first bivalent booster. This was a clerical oversight, staff has been retrained. Patient was monitored and shows no adverse reaction.
Had the vaccines listed below on 10/10/06 also had for the first time pediatric Ibuprofen and rice cereal.
Patient recieved 2 flu vaccines by mistake. The Medical Assistant mistakenly administered the flu vaccine that was meant for the mother instead of the Hep A that was intended. The patient had already been administered her flu vaccine.
Patient developed a pretty bad rash all over his right arm (vaccinated arm) after 48 hours of receiving vaccine. He also developed a slight headache and body chills, although no fever was reported.
Patient had received her HPV vaccine and sat with the nurse for a 5 minutes and then her mother decided to get her the COVID vaccine and while she was getting the paper work she stood up and stood off to the side of the room in the corner.  After standing for a few minutes patient passed out, falling to the floor. Nurses responded the moment they saw her falling and she immediately regained consciousness and became alert and oriented x3. She did complain of some dizziness that lasted about 5 minutes she remained on the floor with her feet elevated above her head until the dizziness subsided.  She then was able to move to the chair and was observed for another 15 min.  She had no further complaints and was taken home by her mother.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. On an unknown date, the patient developed shingles. The patient received unspecified antiviral medication and gabapentin as a treatment of the adverse event (also reported as "(1) patient was given antiviral treatment only and the 2nd patient received the antiviral medication and gabapentin"). The patient sought medical attention, she visited the physician's office. The outcome of shingles was reported as recovering/resolving. The relatedness between the event and the ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
fever  fatigue Acute kidney injury (CMS/HCC) Sepsis due to urinary tract infection (CMS/HCC) Severe sepsis (CMS/HCC) Hydronephrosis Endometrial cancer (CMS/ Urinary tract infection
Confirmed wtih caller no other AE occurred.; The caller reported a patient received both PROQUAD and VARIVAX on 09-MAR-2022; This spontaneous report was received from a nurse and refers to a 19-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot # u009261, expiration date: 19-SEP-2022 (formulation, dose, strength, site and route of administration were not provided) for prophylaxis; and varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # t040418, expiration date: 01-DEC-2022 (formulation, dose, strength, site and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). No other adverse event occurred (No adverse event).
Soreness in arm, warm to touch and redness at injection site for a day after vaccine. Fatigue also. Felt like a bad cold. Then, red, swollen, itchy rash at injection site 8 days later. Ongoing issue.
Moderna Covid - 19 Vaccine  Chills time 2 days, same day of vaccine the taste of metallic stayed in my mouth times 2 days. Low grade fever  of99.5. times 2 days. Exhausted!
Red, swollen, painful, itchy. I recommended ice and BENADRYL. Pt went to walk in and saw Dr and she recommended the same, if not better they want her to go to hospital.
This spontaneous report as received from a pharmacist refers to a 20-year-old female patient. The patient's medical history included anxiety issues, nausea and fainting. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. During the administration of the vaccine, the patient flinched and received a partial dose of GARDASIL 9. After receiving the vaccine, the patient became instantly ill and vomited. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not provided.
Patient has history of COPD. Vaccinated with Pfizer. Diagnosed with symptomatic COVID19 on 7/24/21.
Patient got the H1N1 shot Wednesday 12-2-09.. by 10ish that night she had huge welts on the bottom of her back, had to take deep breaths to breathe and still felt like she wasn't getting enough air, had a "fluttering" in her upper side along with the chills... went to the ER... had an allergic reaction - now she is on an inhaler for awhile, steroids, and Benadryl.  She is a school teach and the shot was given at school.