chrisvoncsefalvay/vaers-outcomes huggingface dataset:
professional cyclist accuse heart problems after Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "professional cyclist accuse heart problems after Pfizer vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My menstrual flow was interrupted and still has not come. I have taken many tests and I am not pregnant according to them.
patient received both vaccines in same arm, a few hours later she said she developed fever of 101, aches, diarrhea, soreness at inj site, extreme fatigue.
Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the  exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed  analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day.  He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour  and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced
Felt like she was hit by a truck; Fever; Weird fatigue; Pain in lymph nodes under arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, 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 FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms). At the time of the report, FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms) outcome was unknown.             3rd dose on 16-AUG-2021 with lot number 002F21A. As she was cancer patient doctor advised to take 3rd dose. No concomitant medications reported. No treatment information was reported by reporter.   This case was linked to MOD-2021-293269 (Patient Link).
red spot; Itchy rash; Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine), RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M204) for COVID-19 vaccination.     The patient's past medical history included Ulcerative colitis in 1984. Concurrent medical conditions included Drug allergy (Sulfa drugs), Allergy (Adhesives), Diabetes (Diabetes Type 1) since 12-Feb-1978, Hashimoto's disease in 1995, Hypertension in 2010 and Osteoporosis in 2019. Concomitant products included MESALAZINE (ASACOL) for Colitis ulcerative, INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, LISINOPRIL for Hypertension, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, ATORVASTATIN CALCIUM (LIPITOR), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash). At the time of the report, PRURITUS (Patient started itching and got a big red spot in front of the arm(not on injection site) 5 days after receiving 1st dose of vaccine), RASH ERYTHEMATOUS (red spot) and RASH PRURITIC (Itchy rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medicine      Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient demographics is updated.Patient medical history is updated.Concomitant product information is updated. Outcome of the event is updated.
Patient presented to ED with worsening SOA and increased O2 requirements. States that she had a loss of taste and sense of smell starting early this week and was tested a couple days after her daughter tested positive for Covid and tested positive herself. States that she received casirivimab and imderimab infusions on 12/29. Patient states that this am her SOA and chest pain/tightness became worse, prompting her to come to the ED. Patient states that her family was going to initially get together for the holidays, however when her brother tested Covid positive, they cancelled all plans; then her daughter and husband became sick and she is now sick. Patient received both Covid vaccines and the booster. Hospital medicine consulted for admission.    Acute hypoxic respiratory failure sec to COVID 19 pneumonia 63yo F w/ CML s/p BMT c/b CGVH, previous hx of bilateral DVT ( completed treated ), HTN, neuropathy, GERD presenting with worsening respiratory failure due to COVID19 requiring oxygen.   -COVID positive on 12/31. -CT PE - negative for PE. Multifocal GGO.  procalcitonin elevated to 0.22 on admission and trended down to 0.09 without any treatment -12/30: started remdesivir and dexamethasone. Finished 5 days of remdesivir. Discharged with dexamethasone to finish until 1/9/22 dexa for total 10 days. Resume home prednisone 30 mg daily after that.  -required up to 5 L NC . Improved to 2 L NC at rest and on exertion.  -she was discharged with home oxygen 2 L NC at rest and exertion. Recommended to check oxygen twice a day.   Discharge Disposition/Condition Disposition: Home with Home Health Condition: Stable (s/sx potential problems absent or manageable)
inflamed red hot lt triceps area rxn around site of inj + itch @ time of rxn but more several hr later;
she has gotten the Moderna shot each time even though she got a horrible rash each time; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time). At the time of the report, RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment dug information was provided.  Reporter did not know the name of the patient.
This spontaneous report was received from an approximately 75 year old female patient regarding herself. Current condition of the patient included thyroid disorder (unspecified), high cholesterol, penicillin allergy, sulfa allergy, LIBRIUM allergy, CEPRO allergy, large doses of aspirin allergy and allergy to bone density medication (1 month, 70 milligrams, name unspecified). On an unknown date in June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included CRESTOR (5 milligrams, 1x) and unspecified thyroid medicine (dose unknown). On an unknown date in May 2012, the patient experienced 2nd outbreak of shingles in her head. No treatment was given. No lab tests were performed. The outcome of 2nd outbreak of shingles in her head was reported as not resolved as the patient still had the symptoms at the time of reporting. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Right thigh swollen and red, Child was seen in the ER and was placed on ABX however seen in the office 1 day after the ER and told to DC ABX.
Client came in with Mother for EED and Immunization.  EED preformed and entered in computer. MMR Immunizations enter into computer and given.  Upon checking vaccines in system, The lot # was wrong on clients chart. The vaccine given has expired.   Mother was called and made aware that the MMR vaccine was expired. The mother said she will bring him back in in 30 days to repeat vaccine
3/31/06 night vax given left deltoid, developed red/warm swollen tender area. On 4/1 exam in clinic 13cm area erythema, induration, warmth rx'd with Keflex for possible cellulitis. Resolved 4/3 following.
I received the Pfizer vaccine on 05/11/21.  On 05/12/21 I heard a thumping in my right ear and had difficulty hearing. This hearing loss in my right ear continues to today. I have since been diagnosed with sensorineural hearing loss.
Patient received Hep B peds instead of adult dose. Pt is diabetic and was getting 3rd dose of series.
Friday 3/19 7:30-8:00 pm feeling hot 8:00 pm-8:15 pm extreme nausea 8:00pm - 10:00 am extreme chills 12 pm-10 am night sweats  Saturday 3/20 12 pm-10 am chills 12 pm-10 am night sweats  Sunday 3/21 12 pm-10 am night sweats
Overnight vomiting several hours after taking oral Typhoid better by AM and went to school. Father has similar episode several days prior.
under left axilla area sore & difficult to raise arm, no redness or streaking on site or under arm;
Pt recvd DTP/HIB/OPV on 25SEP91; both thighs somewhat red & edematous, seen by MD 27SEP91 & thought to be okay; On night of 27SEP91, pt devel red, edematous "welts" all over both thighs, was quite restless; Advise by MD to given DPH;
COVID19 PNA sob, cough, fever. pt now admitted requiring HFNC
Fever of 102 and LOC. Seen in ER, 12 hours, post vax.
Sore arm within 3 hours of injection, light headed, dizzy, slight nausea, headache by the morning (8am) symptoms lessened by 3PM on 05/14/2021
Post inoculation, pt felt SOB that subsided in "a few minutes." Also noted with elevated BP, 172/93, pulse 80 bpm with a repeat BP of 156/106.  H/o HTN controlled with medication.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, since 01-MAR-2015, the patients were vaccinated with improperly stored doses of M-M-R II, (dosing details and lot# not reported). No adverse effects were reported. The vaccine was exposed to high temperature of 10.3 degree Celsius for a cumulative time frame of 731 hours from 24-NOV-2015 through 26-OCT-2016. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # M010485, expiration date 01-MAR-2018 and lot # M012990 expiration date 14-MAR-2018) dose and route of administration were not reported for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 74 hours. A previous temperature excursion of 6 to 14 degrees Fahrenheit for 11 hours was reported. No data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010593:
Pneumonia, Kidney failure, Sepsis Vent for 2.5 days Steroids, heavy dose of antibiotics - 7 days
I developed Shingles and now have to be treated for shingles with accompanying symtoms.   In addition, I had pressure on my chest and a metalic taste in my mount for the first day or so.
As a result of the Moderna coronavirus vaccine, I had redness, itchiness, and swelling on 2/12/21 for a few days. At its peak, it resembled a bee sting 2" in diameter, and was accompanied by muscle swelling near the injection site and soreness.
Heavy menstrual bleeding with large clots for 1st dosage after 2nd dosage it got heavier and more severe.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 72.93 years. No concomitant medications were reported. The vial underwent temperature excursion on 17-Feb-2021 with temperature 22 degrees Fahrenheit and the vial was initially moved to the fridge on 11-Feb-2021 and proposed beyond use date was 13-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Information has been received from a pharmacist concerning a 90 year old female patient who was vaccinated with a dose of ZOSTAVAX (lot# not provided). On 25-DEC-2008 the patient developed diarrhea and was admitted to the hospital for the diarrhea. At the time of the report the patient may still have been hospitalized. Follow up information received from the pharmacist who reported that the doctors determined that diarrhea resulted from bacterial infection and not from administration of ZOSTAVAX (Merck), given on 16-DEC-2008 subcutaneously. Patient was treated with antibiotics and then released approximately 3 days later. The pharmacists talked to the care giver to see how the patient was feeling and the care giver told him that the diarrhea could have also come from long term use of ulcer medicine, which in turn destroyed the "good" bacteria needed for digestion. She was "doing as good as expected" and it was determined that there were no ill effects from vaccination with ZOSTAVAX. On an unspecified date, the patient recovered. No further information is available.
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches .  symptoms began 9am on 1/9/21 and lasted 24 hours.  utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
Small red rash on inside of arms, back of neck, entire torso, back, stomach, chest. Itchy. Progressively more prominent between Weds and Saturday. - now
Feb '22 new evaluation for rapid cognitive decline. Very independent until spring-summer '21 where family began to note to cognitive changes. Impairment in executive function, short and long term memory recall, word finding trouble and regression of language production, and loss of awareness. Deficits are profound for her normal. No behavioral component. No hallucinations. Movements have slowed down. Gait is not shuffling but just very slow for her normal. No tremors. No myoclonus. No sleep disturbance. Routine labs found mild B12 deficiency now on parenteral treatment with normalization of values but no clinical improvement. Brain MRI shows mild global volume and hippocampal loss. Mild-moderate small vessel disease. SLUMS performed in PCP office Jan '22 consistent with severe dementia: 7/30.        INTERIM: My initial visit raised concern for CJD, a rapidly progressive fatal dementia syndrome. Confirmation testing performed through CSF analysis. This was sent off and took longer than normal for results to return. Results as follows:        Prion protein specific RT-QuIC was negative (90% sensitivity and 98% specificity) but the 14-3-3 was very elevated while the T-tau was normal. While this doesn't indicate CJD is the cause of her rapid cognitive decline, she still has objective and subjective evidence of a rapidly progressive neurodegenerative dementing disease.
Patient stated her period started at the same time (on the 18th), but it was heavier than normal after her first dose of COVID-19 vaccine. (She also reported feeling feverish around 2 p.m. on either Monday or Tuesday, but she didn't check to see if she had a fever, and it subsided 1/2 hr later.)
After 1st vaccine: very fatigue by next morning lasting 3 days.  Arm was sore for ~5 days, then became very itchy.   After 2nd vaccine: Very fatigued and slightly nauseous for 2 days.  Ate nothing on first day and slept for 2 days.  Arm sore for ~4 days, and also itchy starting 3rd day.  Today, is the 4th day and it is still itchy, tho not as bad as from the first vaccine.
Moderna details: Spikevax 50/0.  Mode 5 ML. PFS In the past when I have gotten Moderna shots, I do feel sick for about 24 hours then symptoms subside. This time I awoke in the middle of the night, went to the bathroom, then passed out in the bathroom. I fractured my ankle.
Pt recv vax on 8/24/98; on 8/25/98 pt exp red, raised, blotchy rash over entire body; fever (99.7); tx=Benadryl
Trouble breathing; Lung pain; Coughing; Extreme exhaustion; Muscle pain; Jaw pain; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 2), for COVID-19 Immunization, reaction(s): "only sick for 24 hours"; Moderna (Dose: 3), for COVID-19 immunization, reaction(s): "only sick for 24 hours". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Trouble breathing"; PULMONARY PAIN (non-serious), outcome "unknown", described as "Lung pain"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown", described as "Extreme exhaustion"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain"; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Call in regards to Covid-19 booster. Got it on Friday and she has been very sick since then. Its the fourth day since getting it. Last night, she had trouble breathing. Tested herself with an at home Covid test and she was negative, but she's sick. Wants to report this. Should she go to the doctor? Right now, she has lung pain, coughing, and extreme exhaustion, muscle pain, and jaw pain in particular. Was searching and looking into how long symptoms should last. Had Moderna vaccines for the last three vaccines and was only sick for 24 hours. This was her first Pfizer vaccine. This was the fourth day and she was getting worse. Should it last this long?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shortly after administration of HPV vac. pt. collapsed from a sitting to supine position. She was motionless, non responsive but breathing on own with no change in HR O2 sat, BP of 80/42/ M49/nl BS. Taken to ED after ox 45 in/IVF given in office.
4/2/21 She experienced headache, body ache watery eyes, 4/8/21 face and neck rash, mouth shifted to the left hand side, headache (allergy was gone). then 4/10/21 went to urgent care md prescribed prednisone 20mg 2 tab daily for 3 days  then 1 tablet daily for 4 days pt did not mention to md of covid vaccine
Breakthrough case admission after 2 vaccines Moderna 4/9/21 Lot# 040B21A;  Moderna 5/14/21 Lot# 033C21A