chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a the patient's sister-in-low and refers to a female patient of an unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, after receiving the dose of ZOSTAVAX the patient developed shingles. The outcome of the event and causality between development of shingles and ZOSTAVAX were not reported. Additional information is not expected, as there was no consent for further contact.
Baseball size rash at the site of injection that is slightly raised. It does not itch and is not hot when touching it.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were received.   This case was linked to MOD-2021-395985 (Patient Link).
Quarter size reaction on right arm at injection site.  Was told to use cool compresses and Benadryl every 6 hours as needed.
7 Feb about noon started to feel nauseous, 9 Feb right knee pain started to increase. 10-14 Feb nausea continues, knee pain increasing. 15 Feb nausea continues, knee pain increasing, muscle, and joint pain. 16 Feb continued nausea, and knee pain increasing, full body muscle, and joint pain. 17 Feb Pain level 8/9+. 18 Feb Went to Dr. X-ray and ultra sound. Rx NARCO. 19 Feb Pain level 8/9+. 20 Feb Went to Hospital drained Rt knee and cortisone shot. 22 Feb Released from Hosp. 22Feb- 2 Mar pain level 4/5.
Drenching night sweats; This is a spontaneous report from a contactable physician (patient).   An 80-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3249) intramuscular at single dose at left arm on 04Feb2021 08:30 for COVID-19 immunisation.  Medical history included hypertension, gout, no known allergies. The patient had not experienced COVID -19 prior vaccination. Concomitant medication in two weeks included metoprolol (manufacturer unknown), irbesartan (manufacturer unknown), allopurinol (manufacturer unknown), ASA (manufacturer unknown). The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EK9231) intramuscular at single dose at left arm on 15Jan2021 09:00 for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced drenching night sweats on 06Feb2021 01:30. Course events was as follows. drenching night sweats 2nd and 3rd nights. This report written morning after 3rd night, so the reporter did not know if sweats will continue. No treatment received. COVID was not tested post vaccination. The outcome of event was recovered in Feb2021 at time of reporting.
After patient was injected with influenza into (Rt) deltoid, IM patients arm, site of injection, immediately started to swell up into about a 40mm circle around injection site. Dr. came in and advised to place an ice pack. Ice pack was placed and monitored for 15 min. Patient denied prior reactions to flu injection. Also denied any SOB, itching or chest pain.
left axillary lymph neck lymph nodes swollen.; hive on neck; Huge hive on arm lower than injection site; Hives on neck and face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on neck and face), LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.), VACCINATION SITE URTICARIA (hive on neck) and VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced URTICARIA (Hives on neck and face). On 16-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site). On 19-Jan-2021, the patient experienced LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.) and VACCINATION SITE URTICARIA (hive on neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on neck and face), LYMPHADENOPATHY (left axillary lymph neck lymph nodes swollen.), VACCINATION SITE URTICARIA (hive on neck) and VACCINATION SITE URTICARIA (Huge hive on arm lower than injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details was not provided.
Vaccinator prepped deltoid and child was sitting in moms lap and not resisting in any way. when needle was inserted the patient pulled away and no dose was administered.
For 2 days achy arm and slight swelling. Now had a red area up by shoulder and down by elbow. No warmth to area, pain or temp. No itching. Pt seen 7/19/13. Localized reaction. No systemic symptoms. Continue with Benadryl, consider Zyrtec f/u as needed.
Patient was evaluated 4/14/21 during Doctors computer visit.  I did not give her the vaccine and history is all as per her report and am not sure where exactly she received the vaccine. She noted having the Johnson and Johnson COVID-19 vaccine 3/13/21 in left shoulder.  She noted having immediate lightheadedness and arm soreness at vaccine site by provider and was given water and stayed at vaccine site for an hour before going home.  She noted nausea, diarrhea, and headache.  She noted fever, chills, diaphoresis, abdominal pain, bodily shaking and progressive headache 3/13/21 and felt she has ?visual hallucinations and trouble speaking? transiently when at home later with husband.   The headache pain did radiate down back and to all extremities but worse on right.   She stated she did follow up with a chiropractor who Manipulated neck.   She noted her right foot feeling more ?cold? than left and that since 3/13/21 she had dizziness with sensation she was ?falling to the right? since day of vaccine.  She stated she did see a dentist on 3/17/21 and prescribed Amoxicillin x 10 days for suspected odontogenic infection for jaw pain that improved.   She noted seeing her primary care doctor at  an outpatient and was diagnosed with anxiety and had labs done (I did not have copy of results during visit over computer visit) and was prescribed alprazolam but did not take any.   Severe headaches were persisting over this time since vaccine and unlike prior headaches and sense of imbalance was unusual for her and persistent from 3/13/21-4/14/21.  Overall following the computer visit it was unclear what the cause of her symptoms was and was advised to go to the ER but declined and opted to attempt to follow up with her established neurologist the same day.  Calls to this neurologist on that day were unsuccessful.
Broke out with strange bumps with designs and similar to chicken pox. She went to emergency room and they said they never seen anything like it. Dr gave her prescription for (PACK) and she went to dermatologist and he gave her some cream. Nothing has helped. She is still breaking out. She itches.
Anxiety and depression symptoms formerly in remission since 2019 have reoccurred. Sudden irritability, loss of focus, fatigue, sweating, headache, unable to sleep.  No medical treatment has been sought yet. Attempting to control through methods such as meditation and removing triggers from environment. Should symptoms worsen, I will seek medical treatment.
SWOLLEN ANKLES/BOTH THE LEGS; PAIN IN ANKLES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding after first baby, blood transfusion, dnc after a month for second baby, and heart surgery to get water out of heart, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. medical history include hormone pill ,thyroid pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride, loxapine, and quetiapine fumarate. On 15-MAY-2021, the subject experienced swollen ankles/both the legs. On 15-MAY-2021, the subject experienced pain in ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankles/both the legs, and pain in ankles. This report was non-serious.
back pain; legs, calves, feet extreme pain; cramping; extreme fatigue for 6 days and nights better 7th day; headache; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 75-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3246; Expiration Date: unknown), via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:15 as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, cardiac failure, atrial fibrillation, renal failure, rheumatoid arthritis, gastroesophageal reflux disease, irritable bowel syndrome, hypertension from an unknown date. Concomitant medications included apixaban (ELIQUIS), metoprolol, pravastatin sodium, indapamide for an unspecified indication. The patient previously took morphine and experienced drug hypersensitivity. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On Jan2021 at 7:00PM, the patient experienced back pain, legs, calves, feet extreme pain, cramping, extreme fatigue for 6 days and nights better 7th day, headache. The clinical outcome of the events was recovering.  No follow-up attempts are possible, no information is required.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 05-NOV-2015 the patient was vaccinated with improperly stored M-M-R II therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L001336 with expiration date: 13-JAN-2017). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, itching, swelling (seen day after vaccination - 11/30; some edema near lower portion of swollen red site. Site size approximately 5" by 3-4"...patient used BENADRYL. Was counseled regarding use of hydrocortisone topically as well as 24  hour ALLEGRA.
This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. This physician reported "could hardly move are for one week". The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
This spontaneous report was received from a physician concerning an unknown number of patients (demographics unknown). On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and Lot# not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Extreme irritation and itch, pain when pressure applied (ex. sleeping on area), 2in diameter original bump/rash in injection site, after benedryl ointment (reccommended by doctor's office who administered vaccine) applied for temporary treatment the area grew to nearly twice the size.
throat slightly swelling, Lips tingle, mouth outside tingle, itching. Area next to injection Red itching for days after. had to use Benadryl & throat felt better.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 1:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 1:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.29 years  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 20 AM, the temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  Vial was stored on cooler 1, on 29-Apr-2021, Excursion duration at 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM : 44, 3 PM: 45 and 4 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Small red, raised and warm welt at injection site noted 24 hours ago. The are remains redden, but reduced tenderness and edema. No changes in strength or range of motion left upper arm. No numbness or tingling or any other radiating symptoms from indurated injection site.
Was feeling some fatigue, some chills.  On day 9 after a shower noticed redness on the injection area, all around it.  She looked it  up and noticed it was called Covid arm.  She called her derm, and told her to put Cortisone cream on it.  She left it alone and did not do anything for it.  It is day 17 and is a little concerned about the 2nd vaccine.  It has lightened up a little but she does still see it.
This was the patients first dose in the primary series. Patient was suppose to receive the monovalent pfizer vaccine but received the bivalent instead.
Broke out in hives 2 days after being vaccinated. Was given BENADRYL which didn't work then was given Prednisone.
1st vac, only sore arm for 2 days.(3;18/2021)  2nd vac  4/15/2021 both vacs around 1:45 pm., itching began after 2nd vac about 8 pm, - next day itching increased, heat and rash.  Self treated with ice and topical benedryl.
4 days after receiving vaccination heart rate began to elevate, severe migraines, was diagnosed with POTS (Postural Orthostatic Tachycardia Syndrome).
About an hour after I received the vaccination, my left leg fell asleep. That never has happened before.  on 4/7/2021, at approximately 1:00 pm, I stood up, got light headed and blacked out for a few seconds.  I took my blood pressure and it was in the normal range.    I didn't think much of this until the recent reports on the Johnson and Johnson vaccine started circulating. I've had no other issues.
On 8/20 I woke up with a red, oval rash directly around my injection site on my left arm. It increased in size the following day and became uncomfortable to the touch. I tried treating with OTC allergy medicine (Benadryl and Zyrtex) but it didn't go away. It was mildly painful to the touch for several days. The rash finally went away 8/22. On 8/21 my left armpit's lymph node because enlarged and uncomfortable to the touch. It is still there today as I report. Also on 8/21 I was unusually dizzy and fatigued.
I got left hand shake after receiving the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 29Nov2022, outcome "recovered with sequelae" (Nov2022), described as "I got left hand shake after receiving the first dose". The event "i got left hand shake after receiving the first dose" required physician office visit. Therapeutic measures were not taken as a result of tremor.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain on right side of stomach above navel. Broke out in rash on stomach area near pain.  Went to Doctor on October 31, 2011. Diagnosed with shingles.  Doctor has prescribed Acyclovir and Prednisone.
patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case is linked to case 2021SA056035. (same reporter)  This case involves a male patient (reporter's father in-law) (age unspecified) who died (death), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient died from a flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events before death.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was reported as, the patient died from a flu shot.  At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot
Fever of 100.6 for 48 hrs , aching for 3 days, lymph nodes under left arm swollen to size of golf ball on same  arm that injection was given. Lymph node still swollen.
Pt received their Janssen vaccine and patient started to complain of throat tightness and a funny feeling. Pt had no swelling of the tongue or obvious facial or throat swelling; pt as well refused all medications other than Cetirizine. 30 minutes after Cetirizine, patient stated the symptoms had totally resolved.
Began vomiting and having diarrhea an hour after vaccine. Became dehydrated, did not know who I was or where I was. Fell down repeatedly, just laid there trying to figure out what was wrong! Finally fell so hard I broke my spine in two! Repeated trips to ER and admitted each time!
I was having pain in my arm after the shot, mostly when I move my arm I would get sharp pains. My primary care doctor sent me to get an ultrasound. After that I got referred to my orthopedic surgeon, he gave me two shots of cortisone which had no effect on the pain. I also had 8 weeks of physically therapy which made it worse. Now just my arm hanging I have pain. On May 2nd, I have an appointment with my orthopedic surgeon to get an MRI to discuss surgery. I also have a follow up on May 6th.
pt recvd vax;exp rash & ran T 103 p/ vax;advised mom to call MD;MD felt unusual rxn but not related to vax;mom to take pt for a throat culture & ear check;
Patient experienced a rash around neck and chest within 30 minutes of first vaccine that persisted for several days.
SEVERE SCHIVERRING FOR MORE THAN 14 HOURS.  EXTREME WEAKNESS
She reports pain and fever that started the day after her 3rd injection.  The pain was all over.  She had a really bad headache which required imitrex.  She was requiring ice and a heating pad to help with the pain.  She prepared a lukewarm bath and it felt like it was burning her hand.  She reports that the sensitivity to water is ongoing, she feels like her skin is burning when she bathes or washes her hair, she feels like she is sitting in acid.  She reports that her hair is falling out.  She feels that her skin and her joints are in pain (knees, elbows, and shoulders.)
Patient said she had shakiness,tingly in her hands,arms, and around her eyes later on in the evening after her shot. She had swelling on the left sides of her face which was swelled out to her jaw line, neck and shoulder. Her swelling went away in 48 hours. Sharp nerve pain in big right toe. Her left pointer finger she had sharp pain and also her back.