chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 24 year old female with allergy to penicillin and without a pertinent medical history who 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). On 20-JUN-2009, the patient was vaccinated with the second dose of GARDASIL. The patient did not experience any AE after first or second dose. On 09-NOV-2009, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml (lot number was not provided). There was no concomitant medication. The reporter mentioned that on 09-NOV-2009 she experienced headache, dizziness, lost of appetite, nausea and she felt very tired after getting the third dose of GARDASIL. No laboratory or test diagnostics were performed. The patient sought a physician for medical attention. At the time of reporting the patient had not recovered. No further information is available.
Extremely swollen arm, too painful to sleep, pain in my neck and chest seemed tight, rapid heartbeat, stomach felt bloated, couldn't think clearly, this went on for 24 hrs. All symptoms finally subsided 48 hrs after vaccination. No fever at all. I was told my color was not good.
Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other player called 911.  One fire truck followed shortly by one ambulance both with two very cute EMTs. All vital signs normal.  Very similar to dehydration attacks but worse and that always followed rising and walking. This attack worse and was not set off ambulating.  Worried about a worse effect after second vaccine.
Appendicitis; This is a spontaneous report from a contactable other health care professional.  A 63-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL8982), dose 2 intramuscular, administered in left upper arm on 14Jan2021 at 16:00 (at the age 63-years-old) as dose 2, single for COVID-19 immunization. Medical history included Meniere from 2019 and its ongoing. Patient had no family medical history relevant to adverse event. Historical vaccine included 1st of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284) as 1st single dose intramuscular, administered in left upper arm on 23Dec2021 at 15.00 (at the age 63-years-old) as dose 1, single for COVID-19 immunization. Patient had no prior vaccination. It was reported that, patient not had COVID-19 itself. No concomitant medication was reported. Vaccination facility type at Hospital not at other facility. The patient experienced an appendicitis and patient had no illnesses until appendicitis. Seriousness criteria include Hospitalization/ Prolongation of Hospitalization, Important medical event. Adverse event required Emergency room visit. The outcome of the event was recovering. The patient underwent lab tests and procedures which included computerized tomogram: positive, CT showed appendicitis and Full blood count: wbc 15 increased on 25May2021. Treatment include appendectomy performed on 25May2021. The outcome of the event was recovered on 25May2021.  Information about lot/batch number has been requested.  Follow-up(25Jun2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Patient age at time of vaccination, dose 1 and 2 lot number, administration site were update. Family medical history and other medical history added. Lab data was update. Outcome of the event reported.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Appendicitis. 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.
Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (dose and frequency were unknown, lot # M019707 with expiration date 25-OCT-2017) orally for prophylaxis.  No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003275: US-009507513-1612USA003276.
Extreme arm weakness, numbness in all 5 fingers.  Tingling in arm.  Pain in shoulder area.  Went to ER on 10/4/12.  Weakness improved, but pain in shoulder region has only gotten worse.  Soreness in rotator cuff area.  Examined by Physician Asst. in November.  Examined by primary care physician on 12/12/2012.  Physician recommends NSAIDS and soft tissue scan and refer to orthopedic specialist.  Possible nerve/rotator cuff injury.  Bursitis type symptoms are constant.  Shoulder "pops" and "snaps" loud enough to hear close to 100 times per day.
Received vaccine about 10:00am. Reported vomiting, nausea, and fatigue by 1:00pm. Checked in at about 8:00pm and reported continuing symptoms and fever and chills. Checked in next day; feeling better no more nausea, vomiting, fever, or chills. Still fatigued.
Extreme joint pain and exhaustion. Four days later still having joint pain. Could not even use a can opener on Saturday.  Lost all of Saturday to exhaustion and joint pain, moderated some on Sunday, and Monday.  Returned to work on Tuesday but still have pain and am tired.
Patient was administered Hep B on 2/23/23 with pediatric vaccine instead of adult vaccine. no adverse events were observed.
tiredness; This is a spontaneous report from a contactable consumer (patient himself). A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via an unspecified route of administration in right arm, on 09Mar2021 11:30, at a single dose, for covid-19 immunization. Medical history included diagnosed with recurring MDD (major depressive disorder), general anxiety disorder, and high cholesterol. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; duloxetine taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for MDD (major depressive disorder) from an unspecified start date and ongoing; and clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he returned home, ate lunch and slept for approx. 3-hours. He mentioned that he was diagnosed w/ recurring MDD and without his Adderall he will sleep most of the day. He stated he didn't take Adderall till after waking up. He stated that it was hard to tell if tiredness on 09Mar2021 13:30 was due to vaccine or MDD. No treatment was received for tiredness. The outcome of the event tiredness was unknown. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Every time I have taken one I have gotten sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 14-Dec-2020.  This case involves an unknown age patient who reported every time had taken one patient gotten sick (Illness), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported every time had taken one patient gotten sick (Illness), following the administration of INFLUENZA VACCINE. Patient reported So if it was not the flu what was it, patient will never take another since they were only 35% effective in patient age group. Also had the flu in 10 years without the flu shot.  Relevant laboratory test was not reported.  Final diagnosis was Illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.   There would be no information available on batch number for this case.
Patient fainted immediately following vaccine. She was seated and did not fall. She was unconscious for only a few seconds. The technician administering asked the pharmacist for help. The patient was given water to drink. She became nauseous and was given a trashcan to vomit into. She was vomiting on and off for about 20-25 minutes. The technician remained next to the patient to observe her in case she fainted again, but she did not faint again. The technician confirmed that patient's friend was driving her home and the pharmacist cleared her to leave after she spent a total of 30 minutes in the pharmacy.
CDC reports: 15 mo child developed fever to 103 & hypotonia within 2 hrs p/receiving DTP/OPV/MMR immun. Duration of illness 1 day.
Patient fell on floor at 3:45pm. Patient states that "felt room starting to spin. A little lightheadedness. I do not remember falling on the floor." Patient states "every time I've gotten a shot I have almost always passed out." Patient is afraid of needles. Patient came to and was laying on stomach. EMTs got patient up slowly to cot. B/P 147/89, pulse 67, O2 97%. Patient once moved to cot was alert and oriented.
Flat red rash on back, then fever of 103, cold symptoms then the rash spread to stomach and face. The fever went away and the rash then got worse more brighter red, raised like hives all over his body, face, head everywhere then it went to his feet. The whole thing lasted 2 almost 3 weeks.
Patient who received their first dose of GARDASIL 9 a couple of years ago. The patient did not receive any additional doses after first dose; No other Adverse Events; This spontaneous report was received from a customer concerning a patient of currently 35-year-old. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.       On an unknown date (couple of years ago/unable to specify date of administration), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot#, and the expiration date were not reported) for prophylaxis.       The patient did not receive any additional doses after the 1st dose. Confirmed with customer no other AE occurred (inappropriate schedule of product administration and no adverse event).
Dry heaving, hands and feet went numb while driving (16 hours after). Fever of 102 (while taking max dose Tylenol ATC), myoclonic jerking, hypersensitive skin- it was painful to touch sheets/blankets, muscle aches, DTRs +3: I was concerned I was going to have a seizure.  Signs and symptoms resolved at around 0100 on 03/30/2021.
The moderna dose that was administered on 11/21 was from a lot that had expired on 11/17. There have been no known adverse reactions. The manufacturer has been contacted for viability. The patient will continue the primary series as recommended, so he will receive his second dose in at least one month from 11/21.
Patient reports getting smallpox vaccination 9 days ago.  He complains of an area on his chest that came up at about the same time period as the vaccination site.  He complains that the site on his chest is itchy and that it seems like it might be the vaccine spreading.  He complains of the typical symptoms of fatigue and feeling like he has a viral infection.  He wears a long sleeve shirt but complains that he has trouble not picking at sores.  He also notices three more spots.  One on his right chin, upper abdomen, and one on his back.
pt brought to ED via EMS; pt hypoxic; was previously diagnosed positive for COVID in nursing home (unable to locate name of nursing home on medical records); was on O2 supplementation; renal failure; given dexamethasone and breathing treatments; O2 needs increased; pt's condition worsened; DNR; family decided on comfort care; pt passed away in the hospital
The spontaneous report has been received from a nurse referring to a 42 year old male patient with hypertension. The patient had completed a three-dose series of an unspecified hepatitis B vaccine (manufacturer unknown) on an unspecified date many years ago. On 31-MAY-2016 the patient was inadvertently vaccinated with a 40 mcg dose of RECOMBIVAX HB 40 mcg (dialysis formulation) for prevention of hepatitis B instead of an intended dose RECOMBIVAX HB 10 mcg (adult formulation). No product confusion occurred. The nurse stated that the error occurred because her facility only carries ROCOMBIVAX HB 40 mcg and she was unaware that there was another formulation for which the patient was actually indicated. Additional information has been requested.
So the event was, I fainted and could not stay lucid, passed out in my bathroom while getting ready for work. Pain in shoulder and called an ambulance. Tests were ran and I did not have a cardiac event. It was concluded I had low magnesium and dehydration. Recovered within a day or two, no medications were prescribed.
Information has been received from a registered nurse concerning a 16 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 24-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot # J002616, expiration date 01-MAR-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # K014191, expiration date: 10-MAY-2017 (dose and route of administration were not reported). No adverse symptoms were reported. Additional information has been requested.
Bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (Bruise at injection site). At the time of the report, INJECTION SITE BRUISING (Bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. Treatment information was not provided.
Arm was red; Itchy arm; Swollen arm; Pain on injection site; Rash on injection site; Skin reaction around the injection site; A spontaneous report was received from a consumer concerning a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin reaction around injection site/vaccination site reaction, rash on injection site/vaccination site rash, pain on injection site/vaccination site pain, arm was red/erythema, itchy/pruritus and swollen/peripheral swelling.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, seven days after injection, the patient experienced skin reactions around the injection site.  On 19 Jan 2021, the patient started having rash, pain on injection site. Her arm was red, itchy and swollen.   Treatment for the events were not reported. She went to the urgent care.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, skin reactions around the injection site, rash, pain on injection site, arm was red, itchy and swollen were unknown.
Besides normal headache, body aches, fever, general malaise. Received inj Tuesday.  Thursday night, got hives about 3? below injunction site. Friday, arm became swollen, hard, hot, burning pain, and hive just turned into one big red area, going around my arm. Saturday, red area much worse and raised and had burning pain. Very hot. Pictures available.  Went to clinic. Was seen by physician assistant.  She advised me was a reaction to shot, not cellulitis, which I was worried about. Said I had a robust immune system.  Today is Monday. Redness has diminished, still swollen, burning, itchy. The red area was larger than the size of my hand.
Patient called about 1 month after vaccine to state she had developed back pain and/or a flair up of arthritis due to ZOSTAVAX. Dr was running tests.
Throat swelling after COVID vaccine; Tongue swelling after COVID vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced throat swelling and tongue swelling after Covid vaccine on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Received shot about 1:00 PM and by 3:00 PM started hurting all over and later started having fever and freezing. I was in horrible pain all over all night. Was better about 9:00 AM or so.
allergic reaction to the vaccine; This case was reported by a consumer via Shingrix GSK and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The reporter's wife had an allergic reaction to the vaccine, it had gone on for ten days. No contact details were available.
Donor began to experience dizziness, blurred vision, weakness and numbness in her ears. Was pale and diaphoretic BP 84/41 pulse 56 15 min after vaccine. Also, had completed a plasma donation of 825 ml. 15 min prior to vaccination.
After the first dose had a headache, after second dose started having heart palpitations. Anxiety has gotten worse.
Information has been received from a registered nurse concerning a patient who on 20-MAY-1999 was vaccinated with a dose of Varivax. Subsequently, on 18-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Redness x 2 days (resolving), itching x 2 days (has not resolved)
Immediate burning when shot administered, then left arm sore and hard to lift, then headache, muscle aches, dizziness, room felt like it was spinning both when eyes open and eyes closed, could barely stand. All first day. Sore throat 2nd day as well as all other symptoms continuing. Lasted 5 days. Around November my hair started shedding in very large amounts until around early February.  Very noticeable hair loss.
immediately collapsed; she couldn't feel her feet and her feet felt numb; immediately collapsed; she couldn't feel her feet and her feet felt numb; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb), FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb) and INJECTION SITE PAIN (injection site pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (injection site pain). On 15-Apr-2021, the patient experienced HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb) and FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb). On 14-Apr-2021, INJECTION SITE PAIN (injection site pain) had resolved. At the time of the report, HYPOAESTHESIA (immediately collapsed; she couldn't feel her feet and her feet felt numb) and FALL (immediately collapsed; she couldn't feel her feet and her feet felt numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-080418 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080418:Crosslinked
pt received double the dose 0.5ml  parent took child to hospital due to having high fever 41 C, vomiting , diarrhea and real fussy.  at this time they are doing Tylenol and keeping a eye on her,
Patient developed acute onset of hives ~9 hours after receiving below vaccines along with fever of 101.  He was seen in urgent care ~1900 on 8/5 and given BENADRYL and MOTRIN with hives nearly resolved prior to discharge.  Hives recurred a few hours later, and were present on office visit to my office at 1100 on 8/6/08.  He had no associated cough/wheeze, eye/tongue or lip swelling.
2-3 cm erythema about 1-2 min. after vaccine given. Ice placed to area. BENADRYL ordered but pt wanted to wait to see if ice was helpful.
pt recv vax 11JUN96 & pt exp high temp & sl rash on face & arms; dx pharyngitis, then tonsillitis; fever persisted, dx otitis med, subsequently recovered;
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 17-FEB-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (lot number and expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent. The pharmacist stated that, PNEUMOVAX 23 had been inadvertently mixed with sterile water and administered to the patient (product preparation error). Furthermore no adverse event was reported and no product quality issue was involved. Additional information is not expected as consent to contact the reporter was not provided.
mom noticed half dollar size redness & swelling on right leg on 7/20/99; right leg completely red to right above pt knee & very swollen