chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 6-8 hrs p/immun, infant experienced an aseptic meningitis. Infant was febrile 103 & irritable for several days. Hospitalized for 2 days. All cultures negative. Antibiotics discontinued on day 3. Infant is currently asymptomatic.
Dizziness, seizure, spill saliva & urine --> gave EPIPEN 0.3 mg injection.
pt recv vax 21MAR99 & w/in 4-5hr pt devel redness on ears, face & back which turned into small pin-head sized spots, some sl raised;became fuzzy & vomited x3;no fever;resolved in 24hr w/o further complications;
Multiple neuroinflammatory symptoms that led to a diagnosis of multiple sclerosis in may, 2021 symptoms eventually treated with steroids in may, 2021, and multiple times since to current time. Responded minimally/moderately. symptoms are ongoing.   double vision, dizziness, nerve pain in right hand, balance issues, slowed speech
This spontaneous report was received from a pharmacist and refers to an adult male patient in his fifties. The pertinent medical history and concurrent conditions were unknown by reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # M001746, dose unknown, via subcutaneous route. On approximately 19-AUG-2016 (3 weeks ago) the patient developed a huge rash which spread and was hot to touch. The outcome of the events was reported as recovered on an unknown date in 2016. No further information available. No product quality complaint reported. The reporter did not assess the causality of the events with ZOSTAVAX. Additional information has been requested.
pt inadvertently recv HIBTITER & Tetramune on same day;that evening pt fussy & irritable;mom stated that pt behaved as though was exp pain @ inj site; tx w/APAP & recovered;
Fever, severe vertigo, nausea/vomiting, extreme weakness/fatigue from  3:00 a.m. February 3, 2021 through 10:00 a.m. February 5, 2021.
DIARRHEA; This spontaneous report received from a patient 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 not reported, batch number: Unknown, and batch number: JJ1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
No adverse events reported by the patient. The error in dosing was recognized, and patient was informed that a second monovalent dose would be required per CDC guidance.
sore arm/ Mild body aches; mild headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired). At the time of the report, MYALGIA (sore arm/ Mild body aches), HEADACHE (mild headache) and FATIGUE (Tired) outcome was unknown. Not Provided          No relevant concomitant medications were reported.   Treatment information was not provided.  The patient was tired and experienced sore arm, mild headache and mild body aches after both the Moderna shots.    This case was linked to MOD-2021-213478 (Patient Link).
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An elderly (Age: 65+) patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and swelling both on an unspecified date with outcome of unknown. The reporting pharmacist saw higher frequency and severity of redness and swelling with patients receiving pneumococcal 13-val conj vac (dipht crm197 protein) compared to other vaccines administered at this pharmacy.
Heart palpitations/ racing heart post vaccination. I received the second dose 02/16/2021 Moderna 015M20A, HNVHD- HANOVERCOHD.. I experienced heart palpitations as well. I was concerned and contacted my PCP who referred me to a Cardiologist for some time. Went and told him about palpitations post COVID vaccination who said his wife had the same thing happen to her.  Physician confirmed a long standing heart murmur. Note, I don?t think of the heart murmur as a chronic problem.
SPONDYLITIS ANKYLOSING FLARE; DIABETES; This spontaneous report received from a patient concerned a 42-year-old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On SEP-2021, the patient experienced diabetes (diabetes mellitus). On NOV-2021, the patient experienced spondylitis ankylosing flare (aggravated). It was unknown if patient was enrolled in a Covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from diabetes mellitus, and spondylitis ankylosing aggravated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215456-COVID-19 VACCINE AD26.COV2.S-diabetes mellitus. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211215456-COVID-19 VACCINE AD26.COV2.S-spondylitis ankylosing aggravated. This event(s) is considered not related. 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: MEDICAL HISTORY
Large knot/lump in armpit of my left arm. Where my lymph node is located.  Severe fever, chills and Migraine
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 06-JUL-2016 the patient was inadvertently vaccinated with M-M-R II (lot # J006139 with expiration date 17-APR-2015, subcutaneous; therapy type and dose not reported) which was expired. Concomitant therapy was not provided. No adverse effect reported. Additional information has been requested.
Body aches, low-grade fever, chills, tremors, fatigue, migraines.
Patient was given the ZOSTAVAX on 9/19/11. On 10/10/11 his wife was diagnosed with shingles (10/8/11 onset). She is on immune-suppressing medicine for RA. She is worried that her husbands vaccine gave her the shingles. I advised her that there no evidence of this in the literature.
From initial info received on 03/20/2003 from a medical assistant regarding an adverse event occurring in the USA, it was reported that a 57-year-old female pt received an injection of Tetanus Toxoid, lot #U0737AA, administered in her right deltoid on 03/04/2003. That same day the pt experienced "pain and redness at injection site, extreme flushing of skin, face and lips swelling". The pt reportedly did recover from these events. A similar event was also reported for another female pt who received an injection of Tetanus Toxoid from the same lot (U0737AA) [see case 2003-00468 for details] on 03/05/2003. The reporter of this case is the same reporter of case 2003-00468.
This initial spontaneous case, was received from other health care professional (pharmacist) on 06-Nov-2017, concerns a 57-year-old adult male patient. On 05-Nov-2017, the patient was administered with FLUAD (route of administration: intramuscular, anatomical location: left deltoid, dose, batch number, expiry date: not reported). On the same day, 57-year-old patient received FLUAD instead of FLUCELVAX (explicitly coded as inappropriate age at vaccination. It was reported that, the patient did not experience any adverse event (uneventful). The outcome of the events was not reported. The reporter assessed this case as non-serious.
anaphylactic reaction to an influenza vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (Reference number- 00416355) and transmitted to Sanofi on 05-Jan-2021.  This case involves female patient of an unknown age who experienced anaphylactic reaction, while she received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination 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 and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Reporter was told that the reaction was due to the egg content and informed about components of Flublok.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns female patient of an unknown age who had anaphylactic reaction, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patent has a history of egg allergy. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
pt recv vax 31JAN97 & 21NOV97 pt devel chickenpox approx 60 lesions;
Had headache for 3 weeks with nausea. Throbbing headache top of head.
Dizziness- Heavy dizziness for three days and continued dizziness since vaccine. Rapid Heart Beat- Rapid Heart Beat came in waves for 1 day.  I didn't time the rapid heart beat events. Lower back pain- still experiencing Muscle aches come is waves
Swelling around the injection site, redness, seizures, pneumonia, and rash all over the body
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.            She was given several cortisone treatments but that did not help the problem. The doctor was talking about another medication switch but was undecided.  The flare ups might had gotten worse since getting Covid-19 vaccination but she was not sure. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a registered nurse via company representative refers to a 53 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date of 2018 (also reported as this week), the patient experienced titre negative. The outcome and causality assessment were not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA002393: US-009507513-1811USA002393.
MOTHER CALLED TO REPORT FEVER, KNOT ON LEFT THIGH, WARM TO TOUCH AND CONSTANT CRYING.
Developed cellulitis in left arm; Knots in arm where there was pain; Knots in arm where there was pain/ Large golf ball size nodule on collar bone (lymph gland?); Fever 101 for 3 days; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number: FN6198 or EN6198 and Expiration date were not provided) on 02Mar2021 15:15 via unspecified route of administration in left arm at SINGLE DOSE for COVID-19 immunization. The patient's medical history included stage 4 metastatic breast cancer, allergies to Penicillin and Cephalexin. The patient's concomitant medications included palbociclib (IBRANCE), letrozole and cetirizine hydrochloride (ZYRTEC). On 07Mar2021, the patient experienced cellulitis in left arm, painful spots in arm as if a bruise but not bruised but knots in arm where there was pain, bright red in left arm and felt hot from elbow to hand, severe swelling of left arm from elbow to hand, peeling of skin on left forearm, large golf ball size nodule on collar bone (lymph gland), fever 101 for 3 days and headache. The patient visited doctor or other healthcare professional office due to events and treated with antibiotics. The patient did not take other vaccine in four weeks. The patient did not have Covid prior to vaccination and not tested post vaccination. At time of report, the patient was recovering from all the events.   Information on the lot/batch number has been requested.
Injection was given subcutaneously in the fatty part of the tricep area of my left arm. on Wednesday, Nov. 15, 2023. On Thursday at 1 p.m., I noticed an 8 inch long by 2 inch wide red rectangular shaped "rash". I marked the perimeter of the rash in black pen, then called the  medical office where the injection was administered, spoke to employee who said it was common to have a rash after an influenza injection. On Friday, Nov. 17, I had a televisit with my primary care doctor because the rash did not start to disappear. She prescribed cephalexin 500 mg.  On Saturday, Nov. 18th at 1 p.m. the red rash was increased significantly in length down to my inner elbow. I made an appointment with urgent care. I had a temperature of 99.20, (my normal temperature is 97.6). She diagnosed it as Cellulitis, stating it was red and warm.
flu; She feels sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset Dec2021, outcome "unknown", described as "flu"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "She feels sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hearing loss; This is a spontaneous report from a contactable Nurse Anesthetist (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0140) on 18Dec2020 at single dose in the left deltoid for COVID-19 immunization.Medical history included ongoing anaemia. There were no concomitant medications. On 06Jan2021 at 16:00 the patient experienced hearing loss, serious as medically significant. Patient had no problems with her ears before hand. On 06Jan2021 around 4 PM, she was just walking in the store, with no loud music or anything, and all of a sudden her hearing in her left ear went lost and muffled. On 07Jan2021 she went to the Otolaryngologist (ENT doctor) to get her ears checked. They said no it looked perfectly fine. They did an audiogram and hearing test on 07Jan2021 and there was a 20% hearing loss. She had no idea what it was from. She took no other medications. She had anemia but that was it. She was wondering if hearing loss has been reported with the vaccine either in the studies or recently. She researched it, and with the COVID virus itself, back in Jul2020 and Oct2020, people reported hearing loss. So she went and had a COVID test in Jan2021 and it was negative. Patient stated it was very scary and weird. Event treatment included high dose oral steroids to see if it can be treated and the ENT doctor was also giving her steroid shots in the ear. She was due to see him again in Jan2021. The outcome of the event Hearing loss was not recovered.  Patient also clarified that she did continue with her second dose of the vaccine on 08Jan2021. She had asked the ENT doctor his opinions on still getting the second dose, and he recommended it. The second dose of the vaccine was given on 08Jan2021 (lot EL3302, EXP: May2021) at single dose in the left deltoid for COVID-19 immunization.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss cannot be excluded.  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.
Severe muscle aches/severe joint pain/dizziness/tingling/numbness in extremities. Temp-103.8 on and off for 3.5 days.
24 hours after getting second dose of Moderna Covid-19 vaccine the patient was walking in house from closet to another room and her husband saw her have near syncopal reaction, she was lethargic and unable to stand up for several hours: history of heart disorder PAF s/p PM, f/u by cardiology and stable history of diabetes.
Mild redness, 2 1/2 inches across, pain. MD speaks to mom over phone and intsructs to use hot packs.
Body aches. Headache. Low grade fever. Congestion. Coughing. Fatigue. Exhaustion.
Itchy rash, weight loss, nausea, panic attack, anxiety.   Began in earnest 22 days after 4th vax..
activate autoimmune system ? effect on skin (dry , itchy on scalp/face) and  organ (spleen?) -- > body fluid function: 1) tear gland ( dry eye, posterior capsular opacification)--YAG capsolotomy  2) salivary gland (extreme dry mouth -- > tooth decay --extraction of 3 teeth ; removal of gum abscess  3) reabsorption of fluid in GI (colon?) -- > 16 diarrah/day
3-24-21 3:54PM PT FEELS LIGHTHEADED, WARM, DIAPHORETIC, PALE'.  REMOVED FLANNEL OVER SHIRT, WATER GIVEN. PT SITTING IN CHAIR. A/O, NO RESP DISTRESS. 4PM 'FEELS BETTER NOW'  PINK, W/D. RESP REG WITH EASE.  4:15PM AMBULATORY TO EXIT, GAIT BRISK AND STEADY. NO DISTRESS NOTED.
Information has been received from a physician concerning a male who was vaccinated with a dose of ZOSTAVAX.  On approximately 01-DEC-2007 "4-6 weeks after vaccination", the patient developed a mild case of shingles.  Unspecified medical attention was sought.  No additional information was provided.  There was no product quality complaint.  Additional information is expected.
Within 12 hours post vax, pt developed an injection site reaction characterized by an area of redness, warmth and induration measuring 3 inches in diameter and extending in length from the shoulder to the elbow.  Pt also developed a rash on the extremities described as a red, rough, bumpy, itchy rash with pustules. As of 06/03/1999 the rash was resolving.
Admission Date: 12/25/2022 COVID positive Date: 12/25/2022 Admitting Diagnoses:  COVID-19 Discharge Date: 1/5/2023  PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia (HCC)   HOSPITAL COURSE: With patient is a 88 year old female presented with complaints of hypoxia and hypercapnia. She was found positive for covid. She was placed on bipap. She was started on decadron and remdesevir. Her oxygenation improved and she returned to her baseline oxygenation.  She completed her 10 day course of Decadron.     She developed right leg pain with numbness. Stroke code was called. She was evaluated by neurology. She had CT spine , CT head, CT angio and MRI brain. IT did not show stroke. Her pain got better next day.  An incidental cavernoma was identified and the patient should follow up with with Neurosurgery in the outpatient setting.  Otherwise her symptoms are likely explained by sciatica exacerbated by position the in bed.   In the midst of the stroke workup it was identified that the patient had high cholesterol in the OB started on Lipitor at time of discharge.  The patient should follow-up with her PCP for post hospitalization evaluation.   PT and OT evaluated the patient and recommended home with assist.  The patient will return to her home.