chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient who was reported to be "14-16" year old who on an unspecified date was vaccinated with the first dose of GARDASIL. It was reported that the patient developed syncope with tonic clonic movements after receiving her dose of GARDASIL. The reaction happened within minutes of receiving the vaccine, while the patient was in the office. The patient sought medical attention while at the physician's office. There were no laboratory diagnostic test performed. It was reported that on an unspecified date the patient recovered. Upon internal review tonic clonic movements was determined to be an other important medical event. Additional information has been requested.
Localized (R) arm reaction from MENACTRA administered 2/1/17. Mom, patient's mother, states pt. had welt the size of half dollar that was red, raised and warm to touch, itchy. Came to the office 2/3/17 and seen by provider. Skin marking pen used to mark area. Mom states area a little bigger 2/4/17 half diameter of golf ball. Today 2/6/17 Mom states area has decreased in size and is not as red or welted.
I have had a high fever, my left arm has been extremely sore and painful to move and my hand was numb for 38 hours.  My body was hurting so badly for the first 48 hours that the pressure of my clothes was unbearable.
Upon receiving the vaccine I felt light headed immediately. I was observed for 30 minutes, I was given some juice. Within a few hours after arriving home I had terrible flu symptoms. These lasted 5 days and  included severs body aches, fever and chills, terrible headache, coughing , just not feeling well at all. I received no medical treatment After 5 days I was fine
At 3AM with fever (101 degrees) and chills. 81 mg. aspirin and used cool washcloth to bring fever down. 5AM still had fever and palpatations. Took 2 more low dose aspirins. Nitro lingual spray for palp. also cool cloth. Symptoms seemed to go away. By 8:30AM normal.
This spontaneous report was received from a physician referring to an 2-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with M-M-R II (lot # M035388) albumin status unknown (dose, route of administration, anatomical location and expiration date were not reported) for prophylaxis. It was reported that, in the period from 01-MAR-2017 to 23-MAR-2017, the M-M-R II was stored in a freezer that was not monitored twice daily for temperature variability. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004: US-009507513-1703USA014463: US-009507513-1705USA007311: US-009507513-1705USA007310.
This spontaneous report was received from a physician and from a support services director via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 23-FEB-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL (lot # K023435 with an expiration date on 05-NOV-2016; dose and route of administration were not reported). The dose of the vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.556 degrees Celsius) and the second one lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient was administered covid vaccine past expiration time on medication. patient reported no adverse effects and will continue with second dose as scheduled.
12/6 Temp 101.2, moist lungs, non- productive cough, Temp remains elevated in evening. Tylenol Suppository. 12/8 remains in critical condition with renal and respiratory failure.
As per patient - " About 6 hours after the vaccination, I noticed my lower back was achy and then during the night, had chills.  The chills and aches continued for about 48 hours.  I have also had a loss of appetite and diarrhea."
patient fainted approximately 2 minutes after receiving vaccine. came too after about 10-20 seconds. she had a cut on chin and in mouth. emt's were on seen in 5 minutes. patient's father was taking her for follow-up treatment.
Td given IM 3/16/06. Pt c/o soreness 3/17/06. Red, hot to touch and 14cm x 17.5cm whelp noted 3/21/06 to right deltoid area. Pt reports fever 3/18-3/19/06. Pt took Tylenol for fever 3/18-3/19/06. Pt instructed to take Benedryl for swelling. 3/23/06 order for Rocephin IM 1gm and Zithromax 500mg PO q d x 4 days.
fainted; At 3am I woke up feeling very sore; came to drenched in sweat; felt very heavy; having trouble moving my limbs and holding my head up; experienced palpitations band an elevated heart rate; experienced palpitations band an elevated heart rate; threw up; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 18May2021 14:15 at age of 27 years old as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 27Apr2021 14:15 as a single dose for COVID-19 immunisation.  The patient experienced 'fainted, at 3am I woke up feeling very sore, came to drenched in sweat, felt very heavy, having trouble moving her limbs and holding her head up, experienced palpitations band an elevated heart rate, threw up, diarrhea', all on 19May2021 03:00.  At 3am she woke up feeling very sore so she got up and walked to the bathroom to take some Tylenol. Before she could take any she fainted. After it passed she tried to sit up with her back against the wall and fainted again. She came to drenched in sweat and felt very heavy. She was having trouble moving her limbs and holding her head up because they felt too heavy. She also experienced palpitations band an elevated heart rate during this. Then she threw up and had diarrhea. No treatment received. The outcome of the events was recovering. The report was reported as non-serious. The patient was not pregnancy at time of vaccination. The patient had no known allergies. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination included oral birth control. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event faint cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
injection site is warm, red and spreading / Reporter stated outcome as between persisting and worsening; injection site is warm, red and spreading; injection site is warm, red and spreading; This is a spontaneous report from a contactable Pharmacist. A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot#: X39675, NDC number: 0005197102, Expiry Date: Jul2020), via an unspecified route of administration on 18Jul2019 at single dose for routine vaccination. Medical history included allergic to adhesive. There were no concomitant medications. The patient experienced injection site is warm, red and spreading on 20Jul2019 with outcome of not recovered, reporter stated outcome as between persisting and worsening on an unspecified date with outcome of unknown.
10-3-13, the next morning after receiving HIB and PREVNAR, child had red, bumpy rash on face, neck, arms torso and legs. No difficulty breathing. Had ran low grade temp of 99 degrees during night. Lungs auscultated by this nurse, they were clear with no wheezes, no rales, no rhonchi. Advised to see MD, pt, MOC declined at this time. Recommended hydrocortisone cream on rash and if not less red by end of day to notify MD and this nurse. MOC conveyed understanding.
p/vax broke out in hives w/a sl fever (about 100) the evening of 6/10/99;called the MD & said was having an allergic rxn to vax;took DPH & hives went away p/3 days;
Information has been received from an office manager at a physician's office, via a company representative, concerning an approximately 18 week old ("4 months) female infant, who on 11-DEC-2007 was vaccinated with a dose, 0.5 ml, of PEDVAXHIB (OMPC) (lot # not reported, but specified as from recalled lot).  Concomitant therapy included PREVNAR and ROTATEQ (MSD) (lot # not reported).  On 11-DEC-2007, following the vaccination, the patient developed increasing redness and irritation at the injection site.  At the time of this report, the patient had not recovered.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/2008. Initial and follow up information has been received from an office manger at a physician's office, concerning an approximately 18 week old female infant with no pertinent medical history and no known allergies, who on 25-SEP-2007 was vaccinated with the first dose (lot #657385/0820U) with no symptoms reported, and on 11-DEC-2007 was vaccinated wit the second dose, 0.5 ml PEDVAXHIB (OMPC) (lot # not reported, but specified as from recalled lot). Concomitant therapy with the second dose on 11-DEC-2007 included PREVNAR and ROTATEQ (MSD) (lot # not reported). There was no illness at the time of vaccination. On 14-DEC-2007 (previously reported as 11-DEC-2007), following at the injection site. The infant's twin sibling was vaccinated with the second dose of PEDVAXHIB (OMPO) on the same date, and experienced no adverse event. At the time of this report, the patient had recovered (date and duration not specified). The infant did not require a visit to the physician. Additional information has been requested.
Sudden severe  polyhydramnios at 38 weeks pregnant leading to urgent c-section.
Headache, Myalgia, Fever, NauseaVomiting, FATIGUE Narrative:
Pt stated feeling hot, sweaty, fast heart rate, flushed arms and chest, and weak.
pt recv vax; on 2feb96 pt was covered w/ varicella, had swelling at the back of head, an inc R post cervical lymph node & devel over 300 pox; tx w/ erythromycin;
shingles; Rash/ pain in rash; burning in the rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd April 2019, 12 days after receiving Shingrix, the patient experienced shingles, painful rash and burning sensation. On an unknown date, the outcome of the shingles, painful rash and burning sensation were unknown.   It was unknown if the reporter considered the shingles, painful rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: On 2nd April 2019, the patient developed a rash and saw the physician on 8th April 2019 complaining of pain and burning in the rash. The rash was described by the physician as one dermatome, right sided T10-11 and diagnosed as shingles. The patient had not followed up with the reporter, so she does not know if the rash has resolved. Emergency room visit was required.
Myocarditis; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s):   An elderly male patient received BNT162b2 (BNT162B2), as dose 2, 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, single, unknown manufacturer), for Covid-19 immunization. The following information was reported: MYOCARDITIS (death, medically significant, life threatening), outcome "fatal". The patient date of death was unknown. Reported cause of death: "Myocarditis". It was not reported if an autopsy was performed.  Additional information: The caller reports that he is aware of a patient over the age of 80 and passed away. The caller did not know if the vaccine was Moderna or Pfizer. Agent decided to go ahead and report the adverse event. Elderly Patient in country withheld received A Covid-19 vaccine and developed Myocarditis and subsequently died. The caller did not have any other information on this patient at this time besides what is reported above.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the available information, possible temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event "Myocarditis". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: Myocarditis.
The day after my injection on 1/13/2021 I started getting body aches and a headaches. I also had a fever of 100. I called off of work that night . The next morning I woke up and felt normal and called they told me to fill this form out since it was a reaction and I was free to return to work.
I received the Pfizer Covid-19 vaccines and developed myocarditis 7 days after the 2nd dose. The first dose was injected on 3/19/2021 at hospital. Lot number pfizer EN6205, second injection was administered on 4/9/2021 at hospital Lot# EW0162. I am a 58 Y/O male with the chest pain occurring each night for 5 days in a row waking me up. The pain was similar to having a tooth ache over my left enter mediastina and seem to resolve after 5 days. I went for a cardiac workup including cardiac echo, exercise stress test w/o nuclear then with nuclear imaging. All test results came back normal.
patient passed away with in 90 minutes of getting vaccine; This is a spontaneous report from three non-contactable consumer reporting on behalf of the patient via a Pfizer sponsored program, Corporate (Pfizer) Social Media Platforms. A 90 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), via an unspecified route of administration in right arm (reported as AR) on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nursing home patient and received the first dose of COVID vaccine on 30Dec2020. The patient was monitored for 15 minutes after getting shot. Staff reported that the patient was 15 days post COVID. The patient passed away with in 90 minutes of getting vaccine on 30Dec2020.  The patient did not require office/ ER visit.  An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient passed away with in 90 minutes of getting vaccine
At injection sight a  round, feverish,  itchy red mark with painful lump appeared a couple hours after injection.  This lasted 5 days and then disappeared.  On day 7 the round itchy red mark and painful lump reappeared around the sight of injection.  The itch and lump disappeared approximately 3 days later.  After 3 weeks since injection, there is still a noticeable red area around injection sight, although painful lump and itch are gone.
Increased knee pain after vaccines--pain was a 7 on a scale of 10 after vaccine. Pain now approximately 8.5. Spring 2002 - pain in both elbows; doctor recommended brace. Pain in both hips and back requiring epidural and PT. Sometime numbness/tingling in hands and can't close completely. Fall 2000 4 day period of major flare up of joint pain in ankles, knees, elbows, fingers, shoulders, hands and wrist.
This spontaneous report as received from a physician concerning a patient of unknown gender and age who on an unknown date in 2011 was vaccinated with dose 1 GARDASIL and on 16-AUG-2012 received dose 2 of GARDASIL. No adverse event reported. This is one of several reports received from the same source (other case number 1208USA011006). Additional information is not expected.
Fatigued Light-headed Confusion Trouble focusing on tasks These symptoms have been sporadic since receiving the Pfizer booster shot on 1/3/22. I have had to call off of work twice because they were so bad. My original vaccine was the J&J version administered on 3/11/21
vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vertigo, dizziness and hypotension.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after the first dose of vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, vertigo, dizziness and kind of low blood pressure sensation now and then for about three weeks after the first dose of vaccine was unknown.
A report was received by a health care professional on 27 October 2003, concerning a vaccinee of unknown demography who experienced hives and total body itching on the same day as receiving Fluvirin on 16 October 2003. on 16 October 2003 the vaccinee experienced hives and total body itching. the symptoms had not resolved at the time of the report, so the vaccinee's physician planned to treat the symptoms with unspecified corticosteroid therapy. Update 1, 09 Feb 2004. A follow-up report was received from a health care professional concerning a 68 year old female vaccinee who developed a rash and intense itching on an unreported area the same evening as she received Fluvirin in her left deltoid on 15 October 2004. The rash appeared the following day on the left deltoid. A biopsy from this site was reported as probable urticarial reaction. The reporter reported this as possibly related to drug reaction. At the time of the follow-up report the vaccinee's itching had resolved, but the rash had not resolved. The vaccinee was treated with oral prednisone. The reporter assessed the causality of the rash as probably related to Fluvirin, and the causality of the itching also probably related to Fluvirin. Update 2, 15 March 2004: Further information received from a health care professional indicated that the vaccinee's rash and itching have now become a chronic problem. The vaccinee is now under the care of an allergist who reports that the vaccinee's symptoms were probably not from the flu injection. The vaccinee has commenced treatment with allergy medication and continues to use topical steroids. Update 3, 19 April 2004: A follow-up report was received from a health care professional indicating that the vaccinee continues to have rashes and itching which was diagnosed as allergies and eczema. The vaccinee continues to have treatment and is currently on unspecified oral antihistamines and unspecified topical steroids. The vaccinee was reported to have a history of eczema and an unspecified allergy. Follow up pending.
Sore throat, ears ringing, light headed, muffled hearing, runny nose, tired
04/02/2023 I started having sinus pressure, sore throat, coughing, fever and fatigue. I tested positive for COVID-19 on 04/04/2023. I contacted my Physician and was prescribed a 5 day course of Paxlovid. Symptoms lasted 6 days. I tested negative on 04/09/2023. I am feeling well but continue to have a lingering cough and chest congestion.
very sick; did not get 2 dose; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) and PYREXIA (fever). At the time of the report, ILLNESS (very sick) and PYREXIA (fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 99 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Developed hematoma at site of vaccination and 1 day later developed erythema below the site. Erythema is spreading over 48 hours. Follow up info received 10/2/02: the pt had fully recovered from her symptosm of erythema and swelling. The pt was seen by the doctor on 9/11/02 and was put on Keflex for 10 days. They marked the swollen, red area with marker. After approximately 48 hrs, on Friday 9/13/02, the pt's swelling, redness and heat at the injection site were gone, but the site was stil a little tender. The pt was seen on Monday 9/16/02, and her arm was normal.
Extreme diarrhea and vomiting w/i 8 hours extreme body pain & shortness of breath. Shingles breakout 3 days later Dr. prescribed valacyclovir 10 mg. Continued abdominal stress-pain!!! Dr. prescribed Bella Donna Alkaloids w/PB. Pain-pain-pain.