chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was vaccinated on 1-9-03.  Mother states that he cried for 36 hours, starting that day, most of which was unconsolable.  Stated had a fever which began that nite. The next day mother had bundled him up to take him for a drive to console him.  Upon returning home and removing his clothing, noted a rash, mostly on his chest.  Had then taken him to the emergency room to be evaluated.  ER physician recommends DT for remainder of vaccines.  Mom did then follow up with the baby's physician on 1-13-03.  He also concurs.  Patient has since received a dose of DT on 3-6-03.  NO report from mother on any further problems.
outbreak of shingles 4 days after the 2nd dose of Moderna.  I have received both shingrix vaccines.  This shingles outbreak is the 2nd time I have had shingles since being fully vaccinated against shingles
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 5-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 06-FEB-2014 at 2:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event was also reported as 27-FEB-2014 at 10:00 AM). A revaccination dose was declined. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Aching muscles; headache; Light red rash on both facial cheeks; This is a Spontaneous report from a Contactable Consumer (Patient). An 89-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported), via unknown route in the Arm left on 11Feb2021 at 13:30 (at the age of 89-year-old non-pregnant) as UNKNOWN, SINGLE DOSE, for COVID-19 immunization. The patient medical history included rheumatoid arthritis (Diagnosed one year ago), high blood pressure, historical vaccination included shingrix (Lot_number: NDC58160-082311, in left arm). Past drug included hyzaar for hives in mouth. Allergic to methotrexate, Sulpha, hyzaar. The patient's concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL [AMLODIPINE BESILATE; BENAZEPRIL HYDROCHLORIDE]); Omeprazole ; levothyroxine sodium (THYROXIN) daily for unspecified indications, Prednisone 10 mg per daily for unspecified indications. On 13Feb2021, the patient experienced light red rash on both facial cheeks. Did not itch nor painful, it had brighter red center almost looked like an insect bite. On an unspecified date the patient experienced aching muscles and headache. The patient did not receive any treatment for the event, 'light red rash on both facial cheeks'. All the events were non-serious. The outcome of the event light red rash on both facial cheeks was not recovered. The outcome of the events aching muscles and head-ache was unknown.
Immediately stated, "I don't feel well." Requested back brace be removed due to tightness of Velcro strap around abdomen. Reported nausea, began shaking which continually progressed into full body shaking/shivering, denied chills. Had pallor, upon asked stated throat may have felt like it was swelling, no dyspnea witnessed. Was tachycardic. Within 10 minutes, mother transported patient to Urgent Care Clinic next door to Health Department while RN called ahead to advise patient was coming. Clinic then had patient transported to local ER for further treatment.
Hypersensitivity reaction at vaccine site, red rash, swelling, warm to touch, itchy
My initial reaction was within a couple of hours after receiving the vaccine. I felt queasy and had some headaches that were strong going into the evening. I went to bed but couldn't sleep. I tried to take Tylenol, but I had trouble breathing. I was having shortness of breath; my heart was beating fast. I had a tingling sensation on my lips and toes. I had a dry mouth. I called the nurse hotline. The nurse wasn't able to rule out if it was an allergic reaction, so she advised me to go to the ER. I went to the ER on March 27th at midnight. The ran test that came back normal. I wasn't diagnosed with anything or prescribed any medications. They just provided counseling on how to manage my breathing. They advised me if it continued or worsened to come back. The next 3 days after vising the ER I had experienced strong headaches to the point that I couldn't really function.
Information has been received from a health professional concerning a female dialysis patient who was vaccinated with a 3rd 40mg dose of Hepatitis B virus vaccine rHBsAg (yeast) and developed a white coating on her tongue the next day. It was reported that the patient gargled with eucalyptus oil(+) methyl salicylate (+) thy mol (Listerine) and the coating disappeared. The next day she had hives on her neck. A swollen tongue, and lips, and swelling of the face. She started taking diphenhydramine hydrochloride (Benadryl) and at the time of the report the swelling is subsiding, but not completely gone as yet. Unspecific medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information from a health professional indicated that on 10-DEC-2004 at 6:00 PM the patient developed a white coating on her tongue that went away with a LISTERINE rinse. On 11-DEC-2004 the patient developed a red mark on her neck and experienced increased tongue and facial swelling. She self medicated with BENADRYL. The swelling decreased by 13-DEC-2004 but did not go away completely until 15-DEC-2004. The patient was reported as recovered on 15-DEC-2004. Additional information is not expected.
This case was reported by a physician via sales rep and described the occurrence of fainting in a female patient who received BEXSERO for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, unknown after receiving BEXSERO and HPV vaccine, the patient experienced fainting. On an unknown date, the outcome of the fainting was unknown. It was unknown if the reporter considered the fainting to be related to BEXSERO and HPV vaccine. Additional details were provided as follows: The age at vaccination was not reported. The physician did not agree for follow up.
Pt states (L) arm hurt immediately after receiving injection. States arm is stiff and hurts to lift.
Patient began to have chest pain 12-24 hours after administration of vaccine. Chest pain worsened over 48 hours. Pain described as constant pressing sternal chest pain. He also had associated fatigue.  Initial work up consistent with peri/ myocarditis.  Chest pain has no longer been persistent during admission.  No chest pain at rest any longer. Patient describing some ?throbbing? heart pressure with walking.
On 6/14/00, the pt received his 3rd dose of Lymerix and 5 days later, on 6/19/00, he developed a headache and fatigue. On 6/20/00, he developed a low-grade fever, sweating, sinus congestion and nasal stuffiness which, the vaccinee stated, made it "harder for him to breathe". The most recent information received on 6/20/00, reports the outcome of the event as unresolved.
Shaking chills, fever up to 101F, blood shot eyes, arm capillaries seemed to be raised on bilteral arms only.  Took benadryl 50 mg at 5:30, Symptoms reduced by 11:30 pm, resolved by 11/22 AM.
Rash on the chest, arms, back, and hands. Rash appeared the day after the first shot was received on the forearms. Rash cleared up after about a week. Then it came back on the back, arms, and chest. Rash seems to rotate from all those locations. Second shot was received on February the 21st, the rash once again presented on the arms chest and back and has not cleared up. Has been treating with antihistamine and cortisone cream. Rash is not painful but does itch. He did not report the rash after the first or second shot to his primary doc.
Dry heaves, fever 100.3, low grade temp following day (10/4/20), malaise, unable to lift Left arm x 3 days.
Patient got ZOSTAVAX injection 11/16/2016 and 11/17/2016.
This is a spontaneous report from a contactable consumer. A 4-year-old male patient received the second catch-up dose of PREVNAR13 on 28DEC2011. Past vaccine history included 4 doses of PREVNAR7 as an infant and a dose of PREVNAR13 in 2010 (therapy regimen changed). Relevant medical history and concomitant medications were not provided. The patient was administered a second catch-up dose of PREVNAR13 on 28DEC2011. The patient appears to be tired which was reported to be normal for him after being administered vaccines. The outcome was unknown. Follow-up (02MAR2012): Follow-up attempts completed. No further information expected.
I had a headache and got a metallic taste in my mouth around 5-10 minutes after my injection. I still have the metallic taste 11 hours later.
COVID-19; elevated heartbeat; Dizziness; Fever; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 11-Apr-2021, the patient experienced HEART RATE INCREASED (elevated heartbeat). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, DIZZINESS (Dizziness), HEART RATE INCREASED (elevated heartbeat), COVID-19 (COVID-19), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Pyrexia: other (High) 102.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication information were provided.
Pt states the evening of receiving the vaccine she had left arm swelling, area red and hot to touch, also states fever of 101.0.
Pt is c/o a flu shot- Fluvax 09/24/20 at her place of employment. Pt works and was well at the time of her vaccine, not pregnant. Services were provided by an outside company hired. Pt received in her left shoulder at 10:45 am. The next day pt had body aches, fatigues, chills for 3-4 days. She felt like she was getting the flu. That completely resolved.  About 2 weeks later pt began with tingling in both arms in the backs of them. The muscles in her posterior arm ache constantly. She is able to sleep. Pt does not have sx's in the front of her arms or shoulder area. Pt denied this sensation in forearms or hands.  Pt has right hand pain since yesterday. Pt noticed her handwriting was different today. She erased her signature 3 times, then rewrote it. Pt is right handed, no dropping of items. Pt denied weakness in arms or legs.  Nothing makes it worse or better. Pt has tried self massage with no improvement. Pt denied strange sensation in her feet/ falls/ near falls.
Patient stated that he was not fond of needles prior to injection.  After Td injection IM in L deltoid, patient stood up to walk out of door and stated " I better sit down for a minute".  Patient sat and immediately  lost consciousness for about 15-20 seconds total.  His body stiffened; jaw clenched and hands clenched to chest.  This nurse held him upright in the chair until he started sliding to the floor.  Allowed with assistance.  No injuries resulted.  Upon "coming to" patient was sweaty and pale.  Applied cool compress to forehead.  Patient arose and walked across room to a couch and lied down.  Gave water and a protein bar.  Patient stated his teeth hurt, top and bottom, from clenching.  BP 130/78.  Laid there resting for several minutes.  Discussed his fear of needles and the fact that he is not surprised  at his reaction to getting the injection.  Stated he felt better and was ready to return to work.  Advised to report any further changes and to lower to ground if he feels lightheaded again.  Verbalized understanding.
Myalgia PNEUMONIA The patient reports that she had a reaction to the flu shot and acquired pneumonia.
EMDPLOYEE WOKE UP FEELING WEAK AND DIZZY AND HEADACHE AND COUGHING.  EMPLOYEE'S TEMPERATURE WAS 100.2 AT WORK 2/9/2023.
Low grade fever (99...typical is 96-97 for me), intense lower back pain and headache. Also, lethargy and a heaviness to my breathing when exercising.
PT COMPLAIN OF DIZZINESS STATED THAT HE DID NOT EAT, CAR SEAT WAS PULL BACK ,PT WAS RELAX AND TAKE DEEP BRE  ATH, V/S CHECKED BP 132/86 HR 64 O2SAT 98%. STABLE,PT WAS HYDRATED. OBSERVED. V/S STILL THE SAME 132/82 HR68. PT STATES THAT HE IS MUCH BETTER AND WAS SENT HOME
I had a headache, diarrhea, sore throat and congestion. The congestion lasted for about a week .My water broke on 1/20/2021 and gave birth on 1/21/2021 I was 34 1/2 weeks. It depends on how you look at it I think Covid caused the premature labor.
I had a hip arthroscopy on the left hip on 10/27/21 and was recovering well. The surgery was to repair a torn labrum and shave down ball/socket so it would better fit together. Also shaved off CAM lesions. One week prior to the vaccine I was recovering so well that I was able to walk 1-2 miles normally. Two days after my booster (third shot) (12/22/21), I was in so much pain in left hip that I was unable to walk. I had to go back on crutches and was in pain intermittently until seeing my surgeon on 1/10/21 who prescribed MethylPRESDNISolone because he believed that the pain was being caused by increased inflammation in the joint as a result of the COVID-19 vaccine. He reported other orthopedic surgery patients reporting similar symptoms following vaccination. I have been taking the prescription (4mg) for two days now and am already feeling better, not perfect - so I do think this had to do with inflammation that was not causing any issues prior to COVID19 booster.
Nov 24, 2021 hive rash breakout on both forearms and chest. took Benadryl and went to sleep. rash continued.  unable to come up with anything new in regiment (soap, lotion, detergents etc.) Went to PCP Nov 29 advised to try Pepcid 2x a day and Zyrtec at night Benadryl prn.  with no relief called PCP back Dec 1 prescribed prednisone took 6 day burst and continued Pepcid, Zyrtec and Benadryl.  no relief - went to dermatologist Dec 8 given hydroxyzine and CeraVe w/ triamcinolone. blood labs and urine sample proved negative for UTI, Strep, thyroid etc. all within normal limits. Went to Allergist Dec 10 and advised it its probably due to the booster and to continue the medication. Today is day 16 of rash
2 days after the vaccine, developed flu like symptoms including vomiting.  Vomiting / symptoms lasted for 36 hours.  Fever, chills, dizziness, etc lasted for 5 more days.  Persistent cough lasted for a month.
Patient was hospitalized on 2/18/21 and 3/4/21; within 6 weeks of receiving COVID vaccination.
itchy left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy left injection site arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy left injection site arm). At the time of the report, VACCINATION SITE PRURITUS (itchy left injection site arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-303323 (Patient Link).
Reaction to GARDASIL 9 vaccine, dose #1; 2:50 PM HPV #1 vaccine administered to LD. C/O of feeling tired and nausea. Dad instructed to call staff for assistance. 2:52 patient fainted and unresponsive, body shaking for a few seconds while sitting on chair. No harm done. 2:53 Staff and Dad present, B/P 102/65 pulse 66 resp 20 patient felt better and was placed laying position and felt better. Good skin color, warm to touch, clinic assessed patient. 3:00 PM 93/64 RA P- 89 3:28 PM 97/64 RA P- 96 warm to touch and feeling better without dizziness and responding well. Good skin color.
Sore arm, redness at the injection site - since day after injection body aches, low-grade fever - 2 days after injection
Pt. received an Afluria 2014-2015 vaccine instead of a Tdap vaccine. Patient then received the Tdap vaccine in the other arm as well. The patient had received a flu vaccine in late August and this was a second dose of the flu vaccine for 2014-2015 this year. The manufacturer was contacted and they had no information about receiving 2 flu shots. They think the patient may experience more of the injection side effect. Talked to the Patient the next day and she was fine just felt tired and was sore at the injection site.
No adverse events at time of reporting or complaints. Pt was given a vaccination that was outside both standing  order protocol and guidelines ( indicated for pts 65 and over, pt that received this vaccination was only 61 yo.  Higher dose may put pt at higher risk of adverse reactions and at risk for more severe adverse effects (fever, more intense pain and body aches, Chills)
Achy on day of injection then noted tingling burning from lateral aspect of scapula thru shoulder down (L) arm thru lateral aspect of elbow joint continuing down arm thru to pulmar side of hand- numbness and tingling- tried hot/cold compresses, Tylenol, aleu, Ibuprofen Repostan no relief.
Received jab at 1:00pm ...at about 1:15 pm , exhibited extreme rapid pulse for 4-8 minutes. Pulse gradually declined to a more normal range.  Monitored by onsite nurse. Waited onsite for about 1/2 hour afterwards. Pulse normal.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 04Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19: the patient received treatment with Paxlovid from 17Nov2022 to 21Nov2022.  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.
I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 045A21A and 029A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow). At the time of the report, VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow) had not resolved.      No concomitant medications were reported. Patient reported that the area was larger than the previous one on 26-Sep-2022. No treatment medications were reported.   This case was linked to MOD-2022-650770 (Patient Link).
on 03Sep2021, tested positive for Covid, was hospitalized; on 03Sep2021, tested positive for Covid, was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as DOSE 2, SINGLE and (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 03Sep2021, outcome "unknown" and all described as "on 03Sep2021, tested positive for Covid, was hospitalized". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Sep2021) positive. Therapeutic measure immunoglobulin was 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.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events  Drug ineffective , Covid -19 and the suspect drug BNT162B2 cannot be excluded
Approx 8 hrs after immunization began to cry for two hours. Became more and more sharp Then vomited 10-15 times. Then had shakes and was gasping for air and howling. Went to ER-parents told them he stopped breathing at home. Tx IV fluids, CBC, CMP, UA, blood culture, CXR. Overnight observation for PO fluids and seizures. Dx: acute gastritis, MOD, dehydration, reaction to immunization.
Asthma, fevers, high blood pressure, lymphnodes in armpits and nipples ruptured resulting in discharge at nipples