chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acquired Covid/Her symptoms were mild; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Acquired Covid/Her symptoms were mild) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Acquired Covid/Her symptoms were mild). At the time of the report, COVID-19 (Acquired Covid/Her symptoms were mild) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided by the reporter.
In the evening it felt like a strep throat infection. Sore, scratchy throat. Went to urgent care, where they ran strep and COVID-19 tests, rapid and PCR. Rapid COVID-19 test was negative, but PCR was positive. Fatigue, malaise, body aches, lasted about a week. Emotional dysregulation lasting about 3 weeks. Very short temper and unable to manage emotions. Things returned to normal except for bouts of breathlessness when speaking.
This spontaneous report was received from a registered nurse and refers to a 5 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
3/30/21 after 2nd vax, got rash torso/back, itchy.  several wks of itching went to Urgent Care.  prescribed oral prednisone 5 days.Cleared up. 6/2021 started getting bumps/itchy areas, dermatologist diagnosed as SUN ALLERGIES. Prescribed HYDROXYZINE 25mg. sort of helped. 10/2021 started getting dry areas.  Dermatologist diagnosed eczema-spot treat with prednisone ointment&Aveeno. sort of subsided.  then early 2022 got purpura arms/lower legs. Awful, constant red areas, sensitive skin.  more details when asked. Purpura has been the worse.
Information has been received from a physician concerning a 18 year old female with no relevant medical history of illness at the time of vaccination who on 22-FEB-2007 was vaccinated with a first dose of Gardasil in the left deltoid (lot # 655503/0012U). On 24-FEB-2007, the patient complained of myalgias. On 25-Feb 2007, the patient developed diarrhea. On 26-Feb-2007, the patient developed fever of 101F that lasted for several days. On 28-FEB-2007, the patient developed a red, itchy maculopapular rash on the upper body from the waist up. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. The patient was seen by the physician on 01-Mar-2007. The patient's fever resolved on 02-Mar-2007. The patient's rash resolved on 02-Mar-2007. The pateint's rash resolved on 09-Mar-2007. The patient was considered recovered on 10-Mar-2007. No additional information is expected.
headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a contactable Other HCP. A 27-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EJ1686), ), intramuscularly on Left arm on 20Jan2021 13:30 at single dose for covid-19 immunization. Other medical history includes Eczema, hypoglycemic, anemic. Known allergies includes Rondec. I had a baby. I had been weening from breastfeeding in January. As a result I start my menstrual cycle around the same day as I got my first shot. I sort of had a headache before the shot and definitely had one later that day and the next after the shot. I also felt a little nauseous the next day after receiving the shot. I also started my menstrual cycle again 2 weeks later (around February 8) which would be 2 weeks early. I've been on a birth control pill for 6 months and before having a child, would never had irregular periods. My left arm itches at the injection site for maybe 3 or 4 days. Adverse events was start date on 21Jan2021. And did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered".  Information on the batch number has been requested.
Lt thigh swollen, warm to touch, splotchy red areas inject site, ecchymotic, limited ROM, painful mobility; Pt won't bear weight; Seen by Md not tx;
Facial and lip edema, mild dysphagia diffuse macular rash to legs, trunk, face with intense pruritus.
Varivax given 7/18/01, mother reported varicella exposure 12/18/02. Low grade fever, cold symptoms 12/28, on 12/31 varicella lesions - few (6-10) arm, nose ribs. Not ill.
Thursday: Felt chills, difficult to concentrate/foggy brain, night sweats, couldn't sleep.
No true adverse event product was sent short dated from the manufacturer.  Expiration date of the LOT was 09/30/22 but Pfizer determined that the stability data supported immunization with this lot through 10/19/22 and we n/awere instructed that re immunization was not recommended or needed.
Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Ten days after I received my vaccine, I went to care for my daughter who had had an accident. She cut her face and broke her hand which required surgery. I was there one week. Two days later she was diagnosed with shingles. She is 41.
Exactly two hours after vaccination, I started to lose my voice and then within 15 minutes of that my throat started to tighten/swell.  I took another Allegra and the swelling stopped and subsided within an hour.    I still am suffering from loss of voice.
possible positive Covid-19 test; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (possible positive Covid-19 test) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced SUSPECTED COVID-19 (possible positive Covid-19 test). At the time of the report, SUSPECTED COVID-19 (possible positive Covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: assume as a negative result.         Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Chronic spontaneous hives, was given antihistamines and Prednisone  which only helps relieve the problem not solve it. I now experience angioedema in my hands and feet. The chronic spontaneous hives get worse with my menstrual cycle. The immunologist told me this may be due to the vaccine.
Muscle spasms on and off since vaccine. Severe premenstrual side effects.. much heavier period than ever before the last three periods, much more severe mood changes prior to period and much more pain during and bf period.
Patient had low grade fever and headache for 2 days following injections. Patients symptoms cleared on the third day.
Bandlike headache and anxiety.  Headache is persistent since then. Blood pressure is on normal parameters.
Developed fever after MMR vaccination given.  Tylenol was given for fever, no rash!
received 4 vaccines, Not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (received 4 vaccines, Not immunocompromised) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
My left ear became clogged like I was under water and I had resulting pressure heads behind my ear.  When I went to see the doctor he gave me antibiotics saying that it may be an inner ear infection, I took the full course and still have minor symptoms.
12 x 14 red rash (Lt) deltoid - treatment ATARAX 10/5ml 10 ml PO Q6hrs. Warm compresses.
Received DTAP in left deltoid on 01/16/04. Developed redness, swelling, discomfort and hot to touch.  Mom not sure of onset because they were with the father.  Redness measures approximately 5x6cm.  Mom reported reaction today 01/19/04 when she came for TB test reading.
Flu-like Illness started Day 2 at waking up.  2 nights of Weird , confusing dreams,  chills, Nausea, fatigue - tiredness, some quick headaches, NO fever, lasted through day 5
No signs or symptoms reported; a temperature excursion on VAQTA that was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies. On 22-APR-2021, the patient received one improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), lot # T023913 and expiration date 31-MAR-2022 for prophylaxis (dose was reported as 1 time dose; anatomical location and route of administration were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of above 47 degrees Fahrenheit (48.2 degrees Fahrenheit) for 2 hours. No data logger was involved. There were no previous excursions reported. No signs or symptoms were reported. This is one of several reports received from the same reporter. Combination product report: Yes; Brand Name: VAQTA SYRINGE (DEVICE); Common Device Name: Hepatitis A Vaccine, Inactivated; Product Code: FMF; Device Type: SYRINGE, PISTON (FMF); Device lot number: T023913; Expiration date: 31-MAR-2022; Device age and unit: 0 ; Malfunction: Unknown; Device usage: Initial; Reason for non eval: 81 Other; Labeled single use device: No; mdc pre-portability: No; mdc pre-rationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007215.
Fever 102.1; lymph node swelling with pain on left side under arm, breast, neck.  Fever lasted for 2 days, swelling for at least 5 days.  Still note a 'lump' in left arm pit / side breast area.  Called provider's office next day after shot but no one returned call.
Information rec'd from HCP. Post vaccine pt experienced headache, fatigue, nausea, diarrhea and lightheadedness.
8-20-09--Pt. came to medical center presenting with a rash on his face, torso, back, and legs.  Raised, red, itchy rash noted.  Preceded by 2 days of fever as reported by his mother.  No fever today.  To date pt. had previously recieved 4 Dtap's with the last one on 1-12-06.  He also received 3 IPV's with the last one on 11-5-04.  PHN suggested seeing an MD. Per RN
Two days after vaccination patient presented with red skin reaction about 2 inches below the site of injection. It appeared to almost be a band that went across the skin. He did report some tenderness at the injection site but described no pain and was able to use his arm alright.
102(F) fever/Having real bad reactions has temperature over 102.6; face swelling/Facial swelling; chills; headache; muscle pain; This is a spontaneous report from a contactable consumer. A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in right arm, on 19Mar2021 08:00 (at the age of 58-years-old), at dose 1, single for covid-19 immunization. Medical history included covid-19 from Nov2020. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced real bad reactions of temperature over 102.6 /102(f) fever, face swelling/facial swelling, chills, headache, muscle pain on 19Mar2021 18:00. No treatment was received for the events. The patient underwent lab tests and procedures which included body temperature: over 102.6 Fahrenheit and 102 Fahrenheit on 19Mar2021 18:00. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
the vaccine has helped get rid of my headaches; This is a spontaneous report from a Contactable consumer (patient) via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), dose 1 via unspecified route of administration on an unspecified date as a 1st dose, single and dose 2 via unspecified route of administration on an unspecified date as a 2nd dose, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient was working in healthcare and had both doses. For some reason the vaccine had helped patient to get rid of headaches that patient had every single day. Patient stated that even with all the stress of everything in the world today, patient have not had a headache since the first vaccine. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Moderna Vaccine administered to Patient who is still a minor.  Pt monitored for 15 minutes, Pt reports no symptoms, no adverse reactions and is asymptomatic at the time of event.
The reaction happens fever 102.6, lymph notes swelled up and flu like symptoms. Did not work for 2 days. Just called doctor and penicillin. Thursday went to the doctor and noting had got worst, the medicine helped.
PATIENT REPORTED HAVING MINOR ALLERGIC REACTION (RED RASH) ON LEFT ARM TO FLUCELVAX IMMUNIZATION 2 DAYS AFTER SHOT.  PATIENT TOOK BENADRYL AND THE RASH RESOLVED, THEN TWO DAYS LATER SHE STARTED HAVING RASH ON RIGHT LEG AND PROGRESSED TO BOTH LEGS THE DAY AFTER AND INCREASED IN SEVERITY. ADVERSE EFFECT ON LEGS WAS REPORTED TO BE SEVERLY INFLAMED AND HOT TO THE TOUCH. PATIENT ALSO COMPLAINED OF SEVERE ITCHING.
This spontaneous report as received from a 60 year old male patient regarding himself. No concomitant conditions was reported. The patient's medical history included genital herpes. On 22-JAN-2016 the patient was vaccinated with ZOSTAVAX, (dose, lot #, strength expiry date were not reported) one shot/once subcutaneously. Concomitant therapies included VALTREX. Patient will remain off the VALTREX for 14 days per his physician's instructions. On an unknown date in January 2016 the patient experienced an injection site reaction consisting of a "red small firm lump about 2 inches in diameter". The lump was "tender". The patient sought medical attention which included an office visit. No lab diagnostics studies were performed. The patient did not receive any treatment. The outcome of the event was reported as not recovered/not resolved. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved.  Additional information has been requested.
20DEC91 pc to MD pt had fever about 101, chills, cyanotic lips, & a red, irritated pharynx; MD suspect child abuse, rather than a rxn to DTP;
Patient states that she experienced pain in her left arm within hours of the injection; she went to bed that evening with increased arm pain and generalized body aches; patient denies taking any pain meds or any type of treatment for the pain.  Patient states she slept well but 'knew her arm was in pain.  The morning of 02/23/2021 patient awoke as usual but said she was still in extreme pain and felt her vertigo beginning.  She did not take any of her vertigo medication.  The last memory she has at home that morning was walking into the bathroom.  her next memory was being in a helicopter.  Patient reports that when she lost consciousness in the bathroom, she fell and sustained a head trauma.  her husband called an ambulance that transported her to Medical Center; she was then air lifted to Hospital.  Patient states she spent 10 days in ICU to treat an intracranial bleed.  She is now in a rehab facility and expects to be there for 2 weeks before being discharged to home.
Client was wearing a mask due to covid.  Client was asking questions in the lobby for example how big is the needle and does the whole thing go in my arm.  Client appeared nervous due to questions she was asking.  PHN had client seated in a chair.  PHN gave the Tdap first in the right deltoid then HPV in right deltoid at 10:40am.  Then as PHN was giving the MCV4 in the left deltoid client asked am I supposed to feel dizzy.  PHN stayed knelt down by client and watched clients face turn white.  PHN placed both hands on clients arms incase she were to faint.  Client's upper body started convulsing and then her head fainted forward and then back in the chair.  Client then awoke.  Foster mom asked her what her date of birth was and client was confused and could not tell her.  Client then began to throw up.  She reported that she was hot so an icepack and water was given.   Client did not remember what happened to her.  This all happened in a matter of two minutes.  Client and foster mom hung around for about 10 more minutes and when client felt ok they left.  PHN called client about an hour later to see how she was doing.  No other signs/symptoms reported.  Client states that she has never had a seisure or fainted prior to this.  PHN reported incident to PCP.
No adverse reactions yet. Just accidently gave a high dose shot to someone who won't be 65 until ~2 months from now. Will be more diligent about checking ages in the future. Also our third party doesn't have a hard stop for this age restriction anymore
pt had an episode of twitching lt arm, shaking, then progressing to rt arm; legs stiff, glassy star, blah a short time afterward; no fever; OK afterward; no other episodes; neurology consult indicated not likely from vax; no rx;
12 hours after shot: chills, headache, queasiness, muscle pain, joint pain  started at 4 AM and continued for 16 hours, moderate to severe in nature Tylenol mildly helpful  2X 48 hours later symptoms dissipated but fatigued, 72 hours later fatigued
daptacel administered a week past the expiration date with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 19 months old male patient who experienced daptacel(diphtheria-15/tetanus/5 ac pertussis vaccine) administered a week past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine; and HIB VACCINE CONJ (TET TOX) (Acthib).  On 28-Jun-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5893AA) (strength, expiry date unknown) via intramuscular route in unknown administration site for Immunization and daptacel administered a week past the expiration date with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event daptacel administered a week past the expiration date with no reported 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.; Sender's Comments:  US-SA-2023SA199359:01671773 2023SA199793:01671983
severe headache, chest pain, nausea, vomiting, stomach spasms, weakness leading to ER visit approximately 18 hours after the vaccine injection