chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 year old received a dose of the Janssen SARS-COV 2 shot.  Within the first 24 hours of receiving the shot had a fever of 102, chills, sweats, malaise:  but then resolved completely by 48 hours after receiving the shot.  Has not had any further symptoms as of day 4 post vaccine.
Spouse awoke 20Dec and found spouse dead; This is a spontaneous report from a Pfizer sponsored report. A non-contactable consumer (patient's husband) reported that a female patient of an unspecified age (Age: 89, Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899, Expiry date: unknown), intramuscular on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that spouse awoke  and found spouse dead on 20Dec2020. Patient was not transferred to hospital. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Spouse awoke 20Dec and found spouse dead
Chills, low grade fever, achy, nausea, some fatigue. Took TYLENOL for relief and it helped.
March 14, 2021,  17 days after my 2nd Covid vaccine,  I experienced a very sudden attack of "vertigo". I experienced 3 severe attack during a 8 hour period which my legs felt paralyzed, I had a very sharp pain in my left eye and the sensation of falling as well as room spinning. I went to my GP who thought it was vertigo and I was sent to an ENT. During that visit 2 days later I was advised to go to the ER during the exam to rule out a TIA. I had a drooping left eye, dropped left foot and trouble forming words and concentrating. After a CT scan, brain MRI and carotid US they could not explain what what wrong. I was sent to several different doctors (opthomologist -who thought I had MG) and Neurologist who could not figure out what was wrong with me. I was sent to see an Eye Specialist who said I had Blephospasm (which now moved to my left eye), but could not say why I was having these issues. I spent 8 weeks,twice a week, in Vestibular therapy just so I could walk and move my my head at the same time. I spent thousands of dollars out of pocket and countless doctors all the tell me "they could find nothing to cause these issues".  I was out of work for 4 months and finally went back as I did not want to  lose a year towards my pension. I used a cane till July and finally was able to start to drive in August. I continued to have vertigo and eye  issues. Fast forward 8 months later, I still have Vertigo and perception issues.  After months of 24/7 eyelid spasms and trouble focusing my eyes, it has finally seemed to resolve itself. I am now regaining my balance and not having constant tintinus. Again, this started 17 days after my 2nd covid shot. I was a healthy, active woman who worked out almost everyday and did not have any real health issues that could not be helped by medication. No one can tell me why any of this happened since after all the tests, blood work, CT, MRI's..nothing showed up.
Similar to the reaction to his first dose, patient experienced extreme fatigue and increased seizure frequency, and more generalized seizures that worsened, and then resolved by day 26. Rescue medication (ativan) was used at home on 5 occasions. On April 7, 2021, (day 14) Pt had an in-person with neurologist to follow up on the seizures that occurred after the first dose. Later that day, Pt went into status epilepticus and had to go to the emergency room, which resulted in his being admitted to the neuroscience ICU for observation. He was discharged to home on April 8. Symptoms improved gradually and resolved by April 19 (day 26). Video foolow-up visit with neuro on 4/22.
6-8 hrs after injection. Aches, pains, fever (102), chills, sweating, headache, dizziness, elevated heart rate (110), swelling at site (goose egg size). Redness at site.
pt seen by MD 5AUG93 w/elevated temp of 103 & on 6AUG93 w/temp rt arm swollen & under armpit;
pt recv vax 30DEC96 & pt was found to have elevated liver enzymes on 28JAN97;pt was retested again on 24MAR97 & the results came back nl;pt MD is going to check enzymes once more before & p/booster shot in MAY;
swollen and painful lymph nodes in collarbone area and under armpit, both on the side of the injection
Patient was immunized wilh GARDASIL 9 at 37 weeks, 1 day gestation; no adverse reactions; received Gardasil instead of influenza vaccine; Preparation for Adiministration: medication selection/verification error of medical assistant administering vaccine; This spontaneous report was received from a nurse and a clinical manager referring to a 35 years old (also reported as 30 (units not reported)) pregnant female patient. The patient's concurrent condition included diabetes. There was no information about the patient's drug reactions, allergies, medical history, and concomitant therapies provided.   On 02-OCT-2020, the patient at 37 weeks and 1 day gestation, who was erroneously vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)) (0.5 ml, intramuscularly in the left deltoid, lot # S023475 with expiration date 26-MAR-2022) for prophylaxis (reported as routine immunization) instead of influenza virus vaccine (unspecified) during pregnancy. It was due to a medication selection/verification error of medical assistant administering vaccine (product preparation error). It was not ordered by provider. The last menstrual period (LMP) was calculated to 16-JAN-2020. The estimated date of delivery (EDD) was calculated to 22-OCT-2020. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse reactions noted. The vaccine was not available for return/evaluation due to it was disposed after administration. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient is reporting muscle pain and soreness that has gotten a little better but he states he still feels the pain especially when moving his arm. To date he has only tried APAP (which he has used nightly for approximately 2 years) and recently heat applications.
redness initially the next day around area on Saturday 10/09/10 multiple blisters formed around area with drainage noted- very itchy
Onset of slight fever the evening of the shot.  Patient was also jet lagged after returning from home 1630 the night of 5 JUN 07.  Patient reported to Hospital 16 JUN 07 with fever of 105 degrees Fahrenheit and sore throat and fatigue and released 21 JUN 07.  Patient given Augmentin 125mg daily for 7 days, starting Monday 18 JUN 07.  Patient describes feeling good today.
Dizzy/ lightheadedness; Resting heart rate of 105; Body aches; Fever of 100.1 F; Headache; Itchy throat; Really tired; Injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), DIZZINESS (Dizzy/ lightheadedness), PALPITATIONS (Resting heart rate of 105), FATIGUE (Really tired) and VACCINATION SITE PAIN (Injection arm is sore) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE and MELOXICAM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced THROAT IRRITATION (Itchy throat), FATIGUE (Really tired) and VACCINATION SITE PAIN (Injection arm is sore). On 13-Apr-2021, the patient experienced DIZZINESS (Dizzy/ lightheadedness), PALPITATIONS (Resting heart rate of 105), MYALGIA (Body aches), PYREXIA (Fever of 100.1 F) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Itchy throat), DIZZINESS (Dizzy/ lightheadedness), PALPITATIONS (Resting heart rate of 105), FATIGUE (Really tired), VACCINATION SITE PAIN (Injection arm is sore), MYALGIA (Body aches), PYREXIA (Fever of 100.1 F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 100.1 (High) 100.1F. On 13-Apr-2021, Heart rate: 105 (High) 105.         This case was linked to MOD-2021-075592 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2012, the patient was inadvertently administered, due to human error, a dose of VAQTA lot # H012642 for prophylaxis (dose, rote and expiration date were not reported). The reporting nurse stated that the patient was to have received an unspecified hepatitis B vaccine (manufacturer unknown) not the VAQTA on that date. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
This case was reported by a nurse via sales rep and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported, but the patient's age was in the range of 50 to 60. The patient received the dose of SHINGRIX without diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not agree to be followed up. Follow up information was received from nurse on 28th August 2018: The patient's demographic details were updated. On an unknown date, less than a year after vaccination, the patient experienced hurt like hell for 3 days.
Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; vertigo; dysautonomia; POTS; MCAS; menstrual cycle changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 15:00 (Lot number: EW0169) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER; GABAPENTIN; VENLAFAXINE XR; LAMICTAL. Past drug history included: Septra, reaction(s): "Known allergies:Septra". The following information was reported: CHRONIC FATIGUE SYNDROME (disability), POST VIRAL FATIGUE SYNDROME (disability), DISEASE RECURRENCE (disability) all with onset 13Apr2021 18:00, outcome "not recovered" and all described as "Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline."; VERTIGO (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "vertigo"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "POTS"; MAST CELL ACTIVATION SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "MCAS"; MENSTRUAL DISORDER (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "menstrual cycle changes". The events "worst relapse of me/cfs i''ve ever had in 18 years. have been bed bound since, never returned to baseline.", "vertigo", "dysautonomia", "pots", "mcas" and "menstrual cycle changes" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) negative, notes: Blood test; (10Dec2021) negative, notes: Nasal Swab. Therapeutic measures (MCAS labs, Valtrex, Claritin, Pepcid AC, Benadryl) were taken as a result of chronic fatigue syndrome, post viral fatigue syndrome, disease recurrence, vertigo, autonomic nervous system imbalance, postural orthostatic tachycardia syndrome, mast cell activation syndrome, menstrual disorder.  No follow-up attempts are possible. No further information is expected.
missed her  second dose; got Covid-19 infection after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknwon) 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) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her  second dose) and COVID-19 (got Covid-19 infection after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Medical History information was reported. No treatment and   concomitant drugs are not provided.   Reporter did not allow further contact
Received FLUZONE on Friday 11/10, right arm and forearm swollen, warm to touch, little redness, moderately painful when touched - mom first noticed the swelling Saturday morning and decided to monitor, but swelling has not decreased, also with small cluster of blisters on right arm above elbow - patient seen in office and doctor noted: right arm with swelling compared to the left - angioedema noted around the injection site below to the elbow - no streaking noted on the skin but overall mildly erythematous and pruritic - 2 small blisters noted right above the elbow where she was "itching a lot" per mom - diagnosed with allergic reaction - prescribed BENADRYL and to monitor for now.
Painful upper arm; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful upper arm) and INJECTION SITE PAIN (Injection site soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful upper arm) and INJECTION SITE PAIN (Injection site soreness). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Mar-2021, INJECTION SITE PAIN (Injection site soreness) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (Painful upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.
covid vaccine breakthrough case  dose 1 2/27/21 EN6202 dose 2 3/20/21 EN6207 dose 3 8/17/21 FC3180
Mother of pt. calls 1030 am 3-20-05 , on 3-21-05 pt. was tx with amoxicillin for an ear infection at ER.  On 3-23-05 pt. developed 3 red bumps on his LT, on 3-25-05 pt. developed one red bump on his L jaw, neg. fever, ADL's are WNL.  Currently bumbs on LT are dry and flat, bump on L jaw is very red, 8 yr old sister did "squeeze" the bump on the L jaw.  Placed bluestar oint and 1% cortisone on the L jaw - "kind of looks like a ringworm" and has no oozing.  Sister has no bumps, sister has a hx of eczema.  Referred to another clinic to further eval infected varicella rash -vs- amox. allergy - vs- ringworm - vs - eczema -vs differential dx.
This spontaneous report was received from a pharmacist referring to a 71 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to office today with complaint of rash all over body, papular, fine erythema. Was last in office 1/28/08; Received 1 yr vaccines at that time. Rash started yesterday 2/6/08
Pt experienced sudden onset of blurry vision both eyes about 20 minutes after receiving first dose of Pfizer vaccine.  No other deficits noted, feeling well otherwise.  No breathing difficulty, rash, dizziness.  Vital signs stable.  Neuro and eye exam normal.  Visual acuity 20/70 both eyes and 20/50 together.  Blood sugar 124. We monitored patient in the health center for one hour, gave juice and crackers, and blurry vision persisted.  The health center is located 5 blocks from Hospital Emergency Room.  Pt felt well enough to walk to ER for further evaluation.
I do not have the information for the vaccine lot, it was given at the pharmacy.  Patient states she was given the vaccination "slightly higher" on the deltoid than she is used to, by the evening after she received her vaccination, her left shoulder joint ached. It has not stopped aching since she had her vaccination.  If she reaches too fast with that arm, she will get a sharp pain, otherwise it is a bit better in the am and worse as the day goes on, becoming more achy and painful by the end of the day.
This report of SIDS is being submitted in an expedited time frame was requested by the FDA. Follow up information received from the investigator provided the autopsy results and coroner's report. Information regarding Prevnar was received from an investigator regarding a 9 month old male participant in a Prevnar Post-Marketing Safety Surveillance Trial. At 6 months of age, the participant received the second dose of Prevnar on 7/27/00. The patient's concurrent illness includes drug hypersensitivity. The infant had not been eating and was sluggish for a few days prior to his death. Indication for Prevnar was immunization. Product was administered on 7/27/00. Dose regimen was 1 dose. Concomitant therapy included Hib-TITER, Infanrix, and Recombivax-HB. On 11/6/00, the infant was found unresponsive by his mother about twenty minutes after he was put down for a nap. He was blue, and not breathing. The coroner's report stated that there was foam coming out of his nose and mouth. Emergency services were called and resuscitation was attempted. He was seen an emergency room where resuscitation efforts continued unsuccessfully. The infant was pronounced dead on 11/6/00 at 4:10 PM. The autopsy report indicated the infant had pulmonary edema and congestion, visceral organ congestion, and cerebral flattening. The infant had no congenital anomalies. The autopsy report stated that the cause of death was unexpected sudden death in a 9 month old infant. The coroner's report indicated that the pathologist reported the cause of death as sudden infant death. Toxicology test (results: negative blood toxicology screen) was done on 11/7/00. The investigator and medical monitor considered sudden infant death syndrome (expected as per US package insert) was not related to study vaccine administration.