chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and pain at the injection site, chills, severe headache, shortness of breath, vertigo started within approximately 15-20 of injection.  These symptoms continued to get worse as the evening went on till I black out and fell trying to go the bathroom.  I doesed myself with 50mg of benadryl and 600mg of ibuprofen and tried to sleep despite the danger because I wasn't think clear and felt feverish.  I check my temp once home it was 102.8 then 2 hours later it was 97.1 and continued to bounce up and down for the first 12 hours or so. When I got up the next I realized more than my arm had swelled. My neck and face on the right side had swelled. I called off work the next because the headache and vertigo were horrible.  Day 2 I was off and did a little bit of activity but still very weak, vertigo, headache, and short of breath.  I went home early from work day 3 and went to be seen because I wasn't getting better. Md ruled out covid and ear problems, but couldn't rule out vaccine lasting affect or other viral possibility. I'm still having issues and can't work as of today day 4.
Until 10PM only slight ache at injection site.  All of a sudden tremendous headache, muscle pain, shivering, nausea.  Could not get warm until approx 4am.  Took 2 advil-no relief of the headache. 6am 1/28 99.9 temp-still with headache, dizziness and very sore arm-feels like its in the bone.
suspected Vaccination failure; Eye irritation that was diagnosed as shingles in the eye; Eye irritation; Irritation underneath the right armpit; Right armpit with little red dots / from her back to the breast; Bad sensation upon touch and a reaction (like it has a life of its own); This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 11 and 12 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), eye irritation, skin irritation, red rash and tenderness. The patient was treated with topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)) and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, eye irritation, skin irritation, red rash and tenderness to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of the Shingrix vaccine back in last March and the 2nd dose last June.  The patient stated that in the beginning of this month she had an eye irritation that was diagnosed as shingles in the eye by her doctor. The patient reported that there were no pimples or pustules on the face. She was prescribed an antibiotic ointment and an antiviral that cleared it up.  A week later, she had another irritation underneath the right armpit with little red dots that stretched from her back to the breast. The patient was given the same antiviral to take. The patient stated that the irritation did not show anything on the body, except there was a bad sensation upon touch and a reaction (like it has a life of its own). The reporter did not consent to follow-up. Not all information was available. This case was reported as suspected vaccination failure since the details regarding laboratory confirmation was not given.
After 15 minute observation period, patient got up to walk to the front of the clinic and felt dizziness. She was unable to stand up due to dizziness. Vitals were taken, patient was hypertensive, HR in the 80s, pulse Ox was over 96%.  Ambulance was called and patient taken to ER for evaluation.
This spontaneous report as received from a nurse refers to a 61 year old patient. Medical history and concurrent conditions were not reported. On 13-APR-2015, the patient was vaccinated inadvertently with VARIVAX (Merck) instead of ZOSTAVAX (Merck) 0.5 ml subcutaneous (lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
the patient could not move his neck; This spontaneous report as received from a pharmacist via a company representative refers to a male patient in his 70s. The patient ho no concomitant medication. The patient had never had an issue with vaccines in the past. No information regarding the patient's pertinent medical history, drug reactions and allergies was provided.   On an unknown date in September 2019 (reported as sometime last week), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient received a dose of influenza virus vaccine (unspecified) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unknown date in September 2019 (reported as the day after receiving vaccines, sometime last week), the patient could not move his neck. The outcome of movement disorder was reported as recovered on an unknown date in 2019.  The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
It was reported that a 14 year old female patient received an unknown form of BCG (either vaccination or for bladder cancer) deep intramuscularly, as a result of medication error, approximately one year ago. The original order was for "tetanus TD". About one month after the injection, she developed fever and a deep muscle abscess in her right anterior thigh (the injection site). The abscess was surgically drained and has subsequently healed with no long-term sequelae. It is unknown if Tice BCG was the drug administered. For additional correspondence received on 03/05/01, it was reported, "Reviewed, no additional info at this time."
Nausea,  chills, sweats, dizziness, headaches, sensitivity  to light and sound
Fever 102.1 chills severe joint pain congestion weakness 3 days and continues but improving
Dose 3: Pfizer-BioNTech 10/29/202102/24/ 2022. Delay on-site of new condition of Chest pains around 02/24/2022, contact my physician and went to scheduled doctor's appointment on Doctor 03/03/2022. Did some blood work, glucose level was elevated and A1C test was with normal range. Chest pains new diagnosis and doctor want me to see a Cardiologist. Notice why doing normal exercise routine in the gym doing cardio and chest began to get tight. Currently or periodical I would experience chest pain without any activity. Cardiologist was recommended and on the schedule 05/11/2021.
Localized injection site irritation. Skin is red and hot at injection location. Symptoms increased on Sunday -- injection was Friday.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a certified physician assistant for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
The RN who was/is working  in our store failed to adequately screen the date of birth for the patient. There are no symptoms, signs or other information to report.
Patient reports mild loss of hearing on day of vaccination, continues to persist x 6 days. Rec. PSE in case of sinus congestion.
Chest pain; under armpain; dizziness; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN]; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D 3. Vaccination history included: BNT162b2 (Dose 2, Single, Route of administration: Intramuscular, Anatomical location: Right arm), administration date: 20Dec2021, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "Dose Number 1 21Dec2020 / Dose Number 2 20Dec2021"; BNT162b2 (Dose 1, Single, Route of administration: Intramuscular, Anatomical location: Left arm), administration date: 21Dec2020, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 19Sep2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 19Sep2022, outcome "not recovered"; AXILLARY PAIN (non-serious) with onset 19Sep2022, outcome "not recovered", described as "under armpain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, axillary pain, dizziness.  Additional information: Known allergies were none. Facility type vaccine was pharmacy or drug store. If other vaccine in four weeks was no. If covid prior vaccination was no. If covid tested post vaccination was yes.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024142 same product, patient, different AEs, different dose;
Information has been received from a physician concerning a male patient who in April 2010 was vaccinated subcutaneously, with a dose of 0.65 ml ZOSTAVAX (Merck) (Lot # not reported). The physician reported that on approximately 25-MAR-2011, the patient was seen at his office with a case of shingles. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) had resolved.            No Treatment medications were reported.
Was called in to have take a Covid Booster shoot, by 1am in the 3 day after the shot, ability to breath decreased dramatically, by the time we made it to the ER , he could not walk very low oxygen level and immediate Ventilator
Vertigo that was fleeing first 2 days.  Continued getting  worse every day and was constant after 3rd day. Lasted for 3 weeks. Still having occasional feelings of vertigo.
8 hours after receiving vaccine, experienced a sore arm, then headache , chills, muscle/joint aches followed.  PCP ordered a COVID and Flu test on 1/15/21 and results same day- negative. On 1./16 attempted to work, but unable to.  Off work due to headaches from 1/17 through 1/23/21. Recovered & returned to work on 1/24/21.
splitting headache; sore muscles; ran a temperature of 99.9 F for half a day or better; tenderness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced TENDERNESS (tenderness in the arm). Not Provided    No concomitant details were provided Treatment details include Tylenol  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     (E2B Linked Report).; Sender's Comments:  :2nd dose :wife case for dose 1 :wife case for dose 1
A pharmacist reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed an injection site reaction characterized by redness and swelling "the size of a golf ball". No further information was available at the date of this report.
This spontaneous report as received from a consumer who saw a segment of a broadcast refers to an unspecified number of female patients. The patient's medical history was not reported. On an unknown dates, the patients were vaccinated with the doses of GARDASIL. On an unknown dates, the patients were losing their lives because of those. The reporter considered deaths to be related to GARDASIL. Additional information is not expected. This is one of several reports from the same reporter.
Patient was admitted on 7-9-22 with dyspnea, weakness, dehydration and covid 19.
About 30min after injections were administered patient started shaking and vomiting. Patient was very pale, so mom immediately called the check-in employees for help. A medical assistant was nearby when the incident occurred and took the patient back to a room where they check all vitals. Pulse Ox 97, BP 100/72 L arm, Pulse 75, and Temp. 97.6 Patient was treated by our CPNP, whom strongly agrees that this reaction was caused by the Dtap. Provider ordered a Strep Test which came back positive. Patient stayed in observation for approximately 1hr 30min and was able to be discharged once he felt better.
patient received a Fluzone Quadrivalent instead of the Fluzone High-Dose Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00362060) and transmitted to Sanofi on 17-Nov-2020.  This case involves a 65 years old female received 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot no and expiry date were not reported) via intramuscular route in unknown administration site for prophylactic vaccination instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on an unknown date (wrong product administered)  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was a case of an actual medication error due to wrong vaccine administered (latency same day).  The physician now wants to give her a booster to increase her immune response because they feel she should have received the High-Dose. Health care professional does not know when the immunization was given or other information about the events as it occurred at a different facility.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Her arm hurts at the injection site; During this time it is painful to pick up small objects.; In the morning it hurts to raise her arm and lift it from her body for about an hour.; This spontaneous report was received from a a  72 year old female patient, reporting on herself. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On 05-NOV-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23))(strength, dose, frequency, lot # and expiration date were not provided) in the right arm for prophylaxis. The patient began experiencing symptoms the evening of the shot. Her arm hurt at the injection site when she went to sleep, it was so painful that it woke her up. In the morning it hurt to raise her arm and lift it from her body for about an hour. During this time it was painful to pick up small objects.    At the reporting time, the outcome of the  events was unknown.        Causality was not provided.
Moderna COVID-19 Vaccine   Woke up with a headache and chills around 2:30am. Tried to sleep it off. Woke up at 5:00am with 103.1 fever, nausea, headache, body aches, chills. Drank fluids and took ibuprofen,  fever under control, aches subsiding. Headache lingering. Chills gone.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant product use was reported. Patient received half dose. The vial was initially stored in the refrigerator on 4Jun2022. Vial did not undergone any temperature excursions.  No treatment information was provided.
fever; chills; malaise; This is a spontaneous report from a contactable physician (Patient)  via Pfizer-sponsored program.   A 27 year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever and chills on 18Dec2020 (in the night); the patient also experienced malaise throughout the weekend (in Dec2020). Patient had vaccine on 18Dec2020 and was still having symptoms 3 days later. As of 20Dec2020, patient stated he was feeling better but wanted to know if he should get tested or did the vaccine cause these symptoms. Final outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
Patient received vaccine for flu and MENACTRA, one in each deltoid muscle, walked to waiting room unattended, sat in waiting room chair. Per mom's report, patient demonstrated seizure activity and fainting spell. Emergency team responded with PCP, patient response, vitals and color returned to her norm, PCP advised to go to local ER for evaluation. ER notified.
The patient (let's call him me/I) had previously existing mild tinnitus for many years. (Too many punk-rock shows when I was a teenager,  I think.) It presented as an annoying high-pitched sound, though generally I would only notice it if I was in a very quiet room. On occasions where I had an illness like a cold or fever, the tinnitus would become noticeably worse and recede again when I returned to feeling well.  In the weeks after my first covid vaccine I noted the tinnitus became significantly worse -- now it is moderate/severe and I can hear it at all times. More or less it became the same level all the time as when I had a fever before.  In addition to the high-pitched ringing it is now accompanied by occasional light popping sounds and occasional mild dizziness.  I had not heard that tinnitus was a symptom of covid or the vaccines. It took me some time to put together that the more severe tinnitus had begun around the time I got the first covid vaccine. At that point I searched whether tinnitus was a symptom of the vaccine and that is when I discovered that it does seem to happen, though rarely.  The second vaccine dose did not make the tinnitus noticeably worse.  The condition has not improved or changed from it's moderate/severe form in the eight months since I got the first vaccine dose.
PATEINT EXPERIENCED ACHYNESS IN THE BODY , HAD A FEVER AND EXPERIENCING BLISTERS/ RASH, BLISTERS/RASH WERE IN BETWEE N HANDS, TOP OF NECK AND HANDS
DOSE 3 (BOOSTER), SINGLE; His O2 levels tanked on day 24 and he's back in the ICU.; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: My dad, withheld is inpatient at withheld on day 25 of COVID. The patient's concomitant medications were not reported. Past drug history included: Rituxan for a recurrence of ANKA. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; OXYGEN SATURATION INCREASED (hospitalization, medically significant), outcome "unknown", described as "His O2 levels tanked on day 24 and he's back in the ICU.". The events "dose 3 (booster), single" and "his o2 levels tanked on day 24 and he's back in the icu." were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: increased, notes: His O2 levels tanked on day 24. The lot number for bnt162b2 was not provided and will be requested during follow up.
BURNING SENSATION DEVELOPED ON R CHEST AND BACK ON 2/7/15, THEN ERYTHEMATOUS PAPULES AND VESICLES DEVELOPED ON 2/9/15 (HERPES ZOSTER-LIKE RASH).