chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an 80-year-old female patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient had no known drug reactions or allergies. On 02-JUL-2007, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiry date were not reported). On 20-OCT-2015, the patient was vaccinated with a dose of PREVNAR 13 (formulation, dose, route of administration, lot# and expiry date were not reported). On 27-SEP-2016, she received another dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiry date were not reported), along with a dose of an unspecified flu vaccine (formulation, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 27-SEP-2016, reported as since receiving her second dose of PNEUMOVAX 23 concomitantly with the flu vaccine, the patient experienced extreme fatigue and malaise. No treatment was given for the events and no diagnostic lab studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the suspect vaccines was not provided. Additional information has been requested.
Insomnia, Fever, Severe chills, sharp shooting body pains all over, fatigue, muscle aches, vomiting Treated with Tylenol, Advil, not much helped- 24 hours later still lingering symptoms with random sharp shooting body pains,
Eight days after vaccine, noticed irritation on face - in p.m. Next morning face and eyes swollen, stinging-continued till 10/01/09 when went to ER. Put on PREDNISONE for 20 20 days- no difficulty breathing.
Woke up the next morning achy. By lunch I was very achy and running a temp of 99.7.  The injection site is sore..  I slept for a few hours and feel tired
After first shot, my arm hurt for three days and one day after the vaccination event I was extremely tired the next day. After the second shot my arm was very painful and swollen and red. By the next night I was exhausted. I woke up in the middle of the night with hot flashes and experience hot flashes in the morning as well as a low-grade headache
unable to work the day following both vaccinations; Fever; chills; Body aches; Fatigues; Headache; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right (as reported Upper right arm) on 27Jan2021 09:30 (Batch/Lot Number: EL8982) as single dose (at age of 39-years old) for covid-19 immunization. Medical history included hypertension from Aug2012 to an unknown date. Family medical history relevant to AE(s): Hypertension. The patient's concomitant medications were not reported. There were no adverse events prior to vaccinations. The patient previously took first dose of BNT162B2, Solution for injection via unspecified route of administration on 09Jan2021 as single dose for covid-19 immunization and experienced Fever, Chills, Body aches, and Fatigue. The patient experienced fever, chills, body aches, fatigues, and headache on 27Jan2021 19:45. On unknown date, the patient was unable to work the day following both vaccinations. Side effects began 6-8 hours after the vaccine administration. Therapeutic measures were taken as a result of fever, and headache: treatment included Tylenol for fever/Headache. The patient was not admitted to hospital. It was reported that, were any of the events above considered serious due to being Life-threatening, or due to persistent or significant disability/incapacity or any other reason? IF yes, note the below which event/s and seriousness criteria: Unable to work the day following both vaccinations (unspecified information). Adverse events did not require Emergency room or Physician office visit. The patient was not deceased. A reasonable possibility that the event was related to suspect product/s reported as yes. The outcome of the events Fever, Chills, Body aches, and Fatigue was recovering while the outcome of the event unable to work the day following both vaccinations was unknown.  Follow-up attempts completed. No further information expected.
Headache, Myalgia, Fever, fatigue Narrative:  Called Occ Health to report flu like s/s, fever, fatigue, full body myalgias, headache onset approx. 30 hours post injection. improved some this AM, but not completely resolved.
Achy on 1/12/21 1/13/2020: bilateral eyes painful, cloudy vision
severe headache, worsening irregular menstrual bleed. admitted to hospital for blood transfusion
"nausea during 20 minutes''; small fatigue; pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in shoulder), NAUSEA ("nausea during 20 minutes'') and FATIGUE (small fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History were Reported.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ARTHRALGIA (pain in shoulder). On 18-Mar-2021, the patient experienced NAUSEA ("nausea during 20 minutes'') and FATIGUE (small fatigue). On 18-Mar-2021, ARTHRALGIA (pain in shoulder), NAUSEA ("nausea during 20 minutes'') and FATIGUE (small fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines were not provided by reporter
Fever to 104 deg, pain, swelling, redness R arm with development of localized severe sterile abscess R deltoid.
NOT REPORTING ANY ADVERSE EFFECT JUST REPORTING THAT PATIENT GOT 3RD 0.25 ML  DOSE BEFOR THE 6 MONTH THAT IS RECOMMENDED CALLED PATIENT TODAY DAUGHTER SAID THERE IS NO REACTION WHAT SO EVER DAUGHTER SAID HE IS DOING WELL NO REACTION AT ALL
Mild Fever after first shot; Mild Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Leg cramps (Patient had a medical history of mild leg cramps that flared up every once in a blue moon).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot). On 09-Mar-2021, PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-410071, MOD-2021-410072 (Patient Link).
Patients received vaccine after allowed expiry at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after allowed expiry at room temperature) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after allowed expiry at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after allowed expiry at room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received on 27-Jul-2021 and contains no new information.
I was sitting at lunch on 04/09/21, when I became unresponsive for ~2 minutes, but did not collapse. My wife called EMS, by the time of whose arrival I was fully conscious, with short-term some memory loss that cleared over an hour.  Taken to ED, where physical exam, ECG, BP, labs were normal.  Discharge  ~4pm.  Subsequent evaluation at Hospital neurology showed normal EEG and normal contrast MRI.  Diagnosed by history  as possible absence seizure. No repetition since (through Nov 2021).  About the same time following the fist dose, there may have be a similar unobserved episode as I was sitting in a chair.  I came upstairs telling my wife that I felt odd and disoriented, and lay down.  Resolved in an hour.
an expired Infanrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Infanrix. On 11-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: an expired Infanrix was administered to a patient).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2023 It was reported that an expired Infanrix was administered to a patient which led to expired vaccine used. The reporter gives consent to follow up with Healthcare Professional
Pt fully vaccinated.  COVID positive on 11/14/2021.  Admitting dx: COVID-19 pneumonia, hypoxia, ileus, acute renal failure.  The patient came because of severe diarrhea and cough with chest tightness, sharp in nature.  The patient has been sick for the past 5 days.  She was tested positive for COVID.  She was having profuse diarrhea with generalized fatigue and weakness.  Her potassium was very low that has been under a replacement.  Denying any fever.  No chills.  No blood in the stool or the urine. Treatment:  oxygen, steroids, Lovenox, hypokalemia correction, hydration. Discharged to home.
body ache; Chills; fever; This is a spontaneous report from a contactable other hcp. A 40-year-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular route, administered in right arm on 22Feb2021 10:30 (age at vaccination 40-year-old, Batch/Lot Number: EN5318) as single dose for COVID-19 immunisation. The patient had no medical history. The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular route administered in right arm on 01Feb2021 09:00 AM (Batch/Lot Number: EL3248) as single dose for COVID-19 immunisation. The patient experienced body ache, chills and, fever on 23Feb2021 12:00. Patient not received treatment. The No other vaccine in four weeks. Patient had no known drug allergies. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
This case described the occurrence of seizures in a 4 year old female pt who received DTAP for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional.  On an unspecified date in January 2002 the pt received the 5th dose of Infanrix. On the same day, she also received injections of IPV and MMRII. Later that day, the pt experienced four seizures within a 24 hour period.  The pt was seen by a physician, who prescribed an unspecified anticonvulsant. The mother reported that the pt had no further seizures; however, she continued to take the anticonvulsant as of 07/14/03.  Seizures are considered manufacturer medically serious (OMIC).
Passed out for <1 minute after 3rd injection. Tdap first, Menveo second, and HPV given third.
04/01/2021 I went to the Emergency Room and was diagnose with pneumonia, I then went back 2 more weeks in a row with symptoms not getting better. My chest stills hurt, headaches getting worse, body aches getting worse, rash, vision is blurry. My doctor has no clue why I'm still having these symptoms. I a 43 YO female that suffer from hEDS,
Two weeks after receiving the vaccine I went to the ER with excruciating pain in my chest.  Was diagnosed with a pulmonary embolism.  My son who is 33 yes old had the same result after his first Pfizer vaccine in the exact same time frame - yesterday.
Joint pain.  Have preexisting nagging right hip that lit up latter that day.  Within a couple of days I was having lots of joint pain, including both shoulders which also had preexisting issues (torn cuff in left, bone spurs and arthritis in right).  But not intense pain. It sputtered off an on for awhile.  In mid May the joint pain got worse and was interfering with sleep.  Saw primary care doc May 24.  She prescribed Celebrex and referred me to hip specialist.  Within a couple days of starting the celebrex, the joint pain greatly subsided.  I am doing PT for the hip and had a steroid injection 6/21.  The hip is improving but pain does flair with activity.  Continue to have intermittent periods of joint/muscle pain - like maybe one every week or so which will last for a day or so.  Nothing as bad as before I started the celebrex.
Patient reported blurry vision in left eye and headache a few minutes after receiving shot. Nurse at clinic monitored her and blurriness became worse and spread to right eye. She said felt like she had her contacts out. Transported to ED by WC. Seen by doc 35min later. Given diphenhydramine 50mg iv x1, famotidine 20mg iv x1, ondansetron 4mg iv x1 and methylprednisolone succinate 125mg x1. Symptoms improved but not resolved. Offered head CT which she declined.. Pt discharged w/short course of oral prednisone and instructed to see pcp in 2-3 days and report back to ED for any acute symptoms. Our corporate health will follow up with her today as well.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 31-AUG-2012. Lot # was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hours). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8/3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes. This is one of several reports received from the same source. 1209USA007525, 1290USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
At approximately 1338 Patient had finished 30 minutes observation following the 1st dose of Moderna COVID vaccine. Patient stood up and immediately became dizzy, stumbled twice, and started to fall. Two nurse assisted Patient to the ground, protecting patient's head. Patient was not coherent or answering questions appropriately. At 1339 Rapid response Team was called. Staff attempted to get vitals and blood glucose. Patient was not cooperating and disoriented. Patient was attempting to sit up and stand despites staffs effort to encourage to stay laying down. Rapid Response Team arrived and took over. Patient was assisted to gurney and taken to ED.  Dizziness & Seizure like activity
fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100  lasting all day and fatigue.
My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, 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), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Information: He was a patient, and he was calling to ask if there was a correlation between Paxlovid and all of the vaccination they received. He mentioned that he was fully vaccinated with Pfizer however they were positive with Covid19, he and his wife. The Correlation between Paxlovid and all the other vaccination that he received that was his exact question. All the vaccination he had received, he mentioned that he was fully vaccinated with Pfizer (Later clarified as COVID-19 Vaccine hence captured as suspect and manufacturer checked Yes for Pfizer) and they still got positive with Covid. Consumer Stated, what is the correlation between Pfizer vaccinations and boosters My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered. What is the correlation between Paxlovid and all the vaccinations we had from Pfizer. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200836728 Same reporter/drug/AE, different patient;
Shingles, started with rash in the chest, with pain, burning and itching. I went to the ER on Sunday April the 25, because the pain was too intense. The Dr. told me that it was shingles, gave me treatment, and I called my primary Dr. and she told that it was not necessarily caused by the vaccine but to make a report
Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.; Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), 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 (Dose 1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4, Unknown manufacturer), for Covid-19 immunization; Flu shot (I have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which is my problem.), for Immunization, reaction(s): "Muscle pain"; Flu shot (I have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which is my problem), for Immunization, reaction(s): "same pain". The following information was reported: MYALGIA (non-serious), VACCINATION SITE REACTION (non-serious), outcome "not recovered" and all described as "Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it.".  Additional information: Patient did Inquiry that what was in the bivalent shot that was not in the first Covid shots. Had a reaction to the bivalent shot of persistent muscle pain but not to the four Covid shots before it. Patient have been told not to take a flu shot because of the same pain that had persisted for years. Suspect that it has a stabilizer (or something else) which may be a problem. Patient further asked "regarding a booster that does not have the new extra ingredient.  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.
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. In 2006, the patient was inoculated with the ZOSTAVAX vaccine 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 31-MAY-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as a herpes zoster, 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.
Within 15-minutes of vaccination, the patient became lightheaded. EMS treated the patient on-site.