chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 11 May 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; received on 10 October 2008, 10 December 2008, 06 February 2009 and 11 December 2009 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 22 March 2012, approximately 25 months after the last dose. On 23 March 2012, the subject developed a paroxysmal cough with a whoop sound. Laboratory testing included positive PCR on 26 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
EIGHT ADVERSE EVENTS RELATED TO THE  ACTUALLY MORE LIKE TEN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced eight adverse events related to the actually more like ten. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eight adverse events related to the actually more like ten was not reported. This report was non-serious.
numbness and tingling of hands and fingers last 12 months now. nightly for 10 months and still 5/7 nights.  also, pain in the right shoulder developed about 2 months after the vaccination and progressed to a neuritis.  Symptoms consistent with small fiber neuropathy and brachial plexus neuritis
Initial unsolicited case received from a physician via other company (Pfizer) under the Manufacturer report number: 2017467169 on 16 Nov 2017. This case involves 66-year-old female patient who was vaccinated with dose one of FLUZONE HIGH DOSE (Batch number: UI877AB, expiry date: 17 May 2018) intramuscularly in left deltoid and 0.5 ml dose of PREVENAR 13 (Manufacturer: Pfizer) (Batch number: T08483 or TO8483, expiry date: 30 Sep 2019, dose in series not reported) intramuscularly in right deltoid on 17 Oct 2017. Patient medical history was reported as history of iron deficiency (it was also reported as due to this patient probably had a B12 deficiency), cervical cancer and patient was in the process of treatment for cancer and bariatric surgery on Nov 2014. The patient had no adverse events following previous vaccinations. Patient concomitant medication was reported as 75 mg Ranitidine twice daily for reflux. The patient was not taking any vaccines within four weeks prior to the suspect vaccine. On 18 Oct 2017, one day following the vaccinations, the patient experienced pain to the right arm from shoulder down, numbness and weakness to third fourth and fifth fingers of right hand. On 26 Oct 2017, nine days after the vaccinations, patient developed Pain across right upper back and shoulder blade area. It was reported as the patient required a visit to physician office. No relevant lab tests were performed. (It was reported as the reporter had ordered some tests, but the tests have not been completed) Patient corrective treatment was not reported. The outcome of the events numbness and weakness to third, fourth and fifth fingers of right hand and pain to right arm from shoulder down was not recovered (it was reported as both events were persisting). The outcome of events Pain across right upper back and shoulder blade area was unknown. The case was considered as serious by the reporter due to medically significant events. The other company assed the causal relationship between the suspect vaccines and with all the events as related. List of documents held by sender: none.; Sender's Comments: Patient experienced pain in right arm, numbness of fingers, upper back pain and shoulder blade pain after vaccination. Time to onset is compatible with the role of vaccine. Additional information regarding patient medical history, infectious history, vaccination technique, immune status at the time of vaccination, concomitant medication and investigation results to rule out the alternative causes are needed for complete assessment of the case. Moreover, as two vaccines were administered, the role of each component cannot be assessed separately.
Fever, chills, headache, neck ache, injection site pain; diarrhea
how do you know this is the vaccine and not I didn't catch the virus; how do you know this is the vaccine and not I didn't catch the virus; husband exposed to her; Fever; Aching; Chills; Headache; Lung pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21Dec2021, outcome unknown; EXPOSURE TO SARS-COV-2 (non-serious) with onset 21Dec2021, outcome unknown; PYREXIA (non-serious) with onset 21Dec2021, outcome unknown; PAIN (non-serious) with onset 21Dec2021, outcome unknown; CHILLS (non-serious) with onset 21Dec2021, outcome unknown; HEADACHE (non-serious) with onset 21Dec2021, outcome unknown; PULMONARY PAIN (non-serious) with onset 21Dec2021, outcome unknown.  The patient reported I have all this side effect I took the vaccine. Yesterday I have fever, aching, chills, headache, lung pain, all that ho do you know this is the vaccine and not I didn't catch the virus? My husband is work he expose to me, he expose to his coworkers, they working at home how can we assume all this symptoms are from the vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
tastebuds have been different; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (tastebuds have been different) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A and 041L20A) for COVID-19 vaccination.     No past medical history was reported.   Concomitant product reported included LOSARTAN and HYDROCHLOROTHIAZIDE.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced TASTE DISORDER (tastebuds have been different). At the time of the report, TASTE DISORDER (tastebuds have been different) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   No treatment information was reported.
did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (did not receive the full (0.5ml) dose of the Moderna COVID-19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  The patient claims that he was not administered a full Moderna COVID-19 vaccine dose and wants to start over (receive 3 doses) or start Pfizer COVID-19 vaccine instead.
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.On 06-MAR-2020, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter, intramuscular in the left thigh for prophylaxis(lot # reported as 747P5 with expiration date not provided).No adverse event was provided.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2003USA002275:
- Rash all over entire body - not sleeping well - fussy Perscribed - Atarax on 6-5-19
Rash appeared above top on lip, lip then became numb (top lip and inside on mouth) this lasted roughly 30-40 minutes. Took Benadryl/antihistamine and reaction subsided.
I got a 3rd shingrix vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 2 doses, 3 years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received 3rd dose of Shingrix, because he/she forgot that he/she had the vaccine 3 years ago, which led to extra dose administered. The patient asked if this was dangerous.
Patient seen in the ED on 11/21/22 with abdominal pain for the past two weeks and cough that began the night prior. She recently received her second booster on 11/17/22. In the ED, her O2 sats were at 89-90%, so she was placed on 1L O2 by nasal cannula. COVID-19 PCR test was done in the ED which resulted positive. Ultimately, she was admitted 11/21 for acute hypoxic respiratory failure likely due to a combination of COVID-19 and CHF, acute exacerbation of chronic diastolic heart failure, and bradycardia. Patient discharged 11/24/22.
Experienced heart pain (tightness) for about 2 hours, which occurred 26 hours after second vaccine dose, and immediately after 30 minutes of high-intensity interval exercise (which I regularly complete 3 times per week and without any heart pain prior to this day).
So after I get the vaccine, the day after I feel hotness and feverish but when I took temperature it was only 99. I feel tiredness and pain where the vaccine was. The next day was less symptoms, just tired and exhausted. The arm where I got the vaccine was pain and swelling for about a week. I took some Tylenol on the first day and that is about it.
Patient presented to the ER with right sided extremity weakness.  Initial CT showed no hemorrhagic stroke so patient was admitted for treatment of ischemic stroke.  Was started on IV Heparin drip and condition improved greatly.  Subsequent CT showed small ischemic stroke on left.  Patient recovered and was sent home on Plavix, Aspirin and Atorvastatin.
Pt vaccinated with Influenza developed keratoacanthoma at the site of injection four wks after receiving influenza vaccine. Hospitalized and the lesion was surgically removed.
Immediately after vaccination (30 min) headache and feverish feeling last couple days 1 day of significant emesis. Hourly!
Next morning had overwhelming nausea and headache. I then  went outside on our deck for fresh air and passed out.  When I awoke my husband had found me on the ground and I had hit my head. A similar symptom occurred later in the day but my husband was able to get me to the bed before falling.
Received Varicella 7/1/09, 7/6/09 noted develop few rash on face / trunk / neck 2 mm--> 6 mm diameter of papule vesicle lesions.
Discharge Provider: DO Primary Care Provider : MD    Admission Date: 9/26/2022 Discharge Date: 10/07/2022 Admitting Diagnoses: Active Problems:   Goals of care, counseling/discussion   Multiple comorbid conditions   PRESENTING PROBLEM: Septic shock    HOSPITAL COURSE: 87 y.o. man who has a past medical history significant for hypothyroidism, prostate cancer, hypertension, depression, and GERD who was brought to the emergency department with altered mental status and was found to be hypotensive.  Patient was also noticed to have some degree of ST changes involving the inferior leads.  Initial workup was significant for elevated lactic acid at 4.6, hyperkalemia with K of 6.2, AKI with creatinine of 2.73, mild transaminitis with AST of 144, ALT of 95, initial elevated troponin but with flat delta, and positive COVID swab.  He received IV fluids along with antibiotics.  Cardiology evaluated the patient and given his AKI, decision was made not to proceed with a left heart catheterization.  TTE was performed and showed LVEF of 60-65% with normal RV function and size.  No pericardial effusion.  Given his persistent hypotension, patient was started on norepinephrine infusion.  MICU team was consulted for hypertension and decision was made to transfer the patient to MICU service for evaluation and management of shock.  CT head was unremarkable.   Patient's shock it did improve and he was weaned off pressor therapy.  Patient renal failure also did improve.  Patient was continued to seen by Cardiology recommendation was to continue with medical therapy.  Patient was started on aspirin and Eliquis however unfortunately patient developed a persistent nosebleed which required ENT evaluation and rhino rocket placement.  Recommendation from ENT is to use hold the Eliquis and aspirin for a total of 5 days.  On discharge patient will be continued on aspirin daily.  Will continue to hold Eliquis due to his risk of bleeding and limited benefit on hospice services.  Patient was discharged under hospice care on 10/07/2022
This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of M-M-R II (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses GARDASIL (dose and route were not reported, lot # K011325, expiration date 08-APR-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Within a couple of hours of receiving the vaccine shot 1 of 2 I became very nauseous and I vomited about 4-5 times. I also felt tired and generally under the weather.  Later in the evening I felt better after several hours.  The next morning I felt much improved.  Arm pain followed.
Pt recv vax on 11/13/97; post vax pt cried inconsolably more than 4 hr
Sudden onset of rapid heart rate, dizziness, and near syncope.  Heart rate 230 on arrival to hospital.  Patient was administered Adenosine x2 to convert heart to normal rhythm.  Heart rate remained elevated for several hours after admission to the hospital.  Patient hospitalized x 24 hours. 11/9/09 Medical records received for date 10/31/09. vaccine info received. Pt received H1N1 vaccine on 10/29/09. DX: Paroxysmal supreventicular tachycardia. SX: 10/30/09 c/o palpitations, near syncope, cough this AM. Assessment: tachycardia.
pt recv vax 3MAR95 exp single lesion on lt forearm;no tx given;
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 55 year old female. Initial information was processed along with the additional information received on 20-JUL-2022. The patient's height, weight, no past medical history or concurrent conditions were reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, 1 total, administered on 11-MAR-2021 at right arm for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported.  The patient additionally received two doses of Moderna (spikevax) vaccine (elasomeran) (first dose) (dose number in series 2) (form of admin and route of admin was not reported, batch number: 017F21A, expiry: unknown) dose was not reported, administered on 26-OCT-2021 at left arm and second dose (form of admin and route of admin was not reported, batch number: 057M21A, expiry: unknown) dose not reported, administered on 29-APR-2022 at left arm for covid-19 prophylaxis. On an unspecified date in JUN-2022 patient had COVID-19 for the first time and patient received non company suspect Paxlovid (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 27-JUN-2022 till 01-JUL-2022 for covid-19 treatment. The patient felt better for about 5 days and tested negative, and on an unspecified date in JUL-2022, patient had started worse symptoms (confirmed covid 19 infection) (dose number in series 2) than original and tested positive again (confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with Paxlovid was drug discontinued. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000242947.; Sender's Comments: V0-20220737071 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related
On 4/18/2021 ~0800, pt's husband reported that pt described feeling like "felt like bones are broken". Today (4/19/2021), pt's husband reports that this morning pt was sweating to the point where she was dripping wet and her temp was slightly elevated Temp 99.6, and feeling fatigue. Pt's husband reported that pt took 2 tablets of 500 mg Tylenol ~1430 today (4/19/2021). Recommend that pt keep hydrated and rest. Counseled on the importance of making sure pt does not take more than 4,000 mg of Tylenol per day to avoid liver injury. 4/20-Completed up call on 4/20/2021 at 11:47am: Pt reports she feels much better today, only have a little achiness and fatigue. Recommend to take Tylenol PRN and to stay hydrated
Arm of injection site swollen from  shoulder to wrist , red and warm  to  the touch as  well  as  painful  per  patient.
Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient has had 3 episodes of shingles before getting her Shingrix vaccine; the severity of the shingles episodes decreased with every episode.).   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient.  The patient had 3 episodes of shingles before getting her Shingrix vaccine and with every episode, the severity of the shingles episodes had decreased. The patient had the vaccine month ago from reporting date on the left arm and had a sore arm for almost a week. Lot and expiration dates were unknown. The reporter consented to follow-up and also gave consent to follow-up with health care professional.
Day 1 - Shot (Second Shot) I went to bed feeling weak, but not feeling badly.  Needle site was tender. Day 2  I awoke at 2:00 am with shaking & severe chills.   Also my old injury joints hurt >   Right knee, Right should, Left thumb, and I had a fever (forehead scan) of 101.4. Despite many quilts it took a while for that set of chills to subside. I had several more chill/shaking episodes occasioned when I got up from the bed. I took Tylenol as suggested when I got the 2nd shot.  Day 3  The chills/shaking were gone , but I was weak and my joints hurt. I continued fluids (gatorade) and Tylenol.  My face was flushed , but the fever was gone. Day 4 Feeling much better.  Felt weak, but joint pain was gone. My face was flushed from time to time today... reduced Tylenol.  Day 5 Feeling better. Occasional face flushed. Tylenol only once in morning and at bedtime Day 6  Feeling much better.  Eating normally and no pain. I plan to go for a short walk. No Tylenol -- seem recovered. END
had sore glands; it got worst; coughing; aching; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of 68 an unspecified unit received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included coughing and aching. Concomitant medications were not reported. Patient got her second covid vaccine shot this Saturday. The morning and night before that she is already experiencing coughing and aching and 2-3 days after her second covid vaccine shot it got worst and she had sore glands which she is unsure is this is normal. The patient wanted to ask what specific test she should be taking to test for covid. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
devel encephalitis approx 1mo post vax MMR involving primarily white matter;child left w/severe sequelae w/some slow recovery;