chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe pain in the center of my chest; severe heart burn borderline of blocking my air way; severe heart burn borderline of blocking my air way; I have g.e.r.d.s so I know what a flair up feels like. This was 1000 times worse than anything I've ever experienced; continuous belching; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old Non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182 and Expiry date was not reported), via an un-specified route of administration on 21Aug2021 16:00 (at the age of 57-years-old) in Arm left as dose 2, single for covid-19 immunization. The Patient Medical history included ongoing gas-trooesophageal reflux disease G.E.R.D.S , hypertension from an unknown date and unknown if ongoing , osteoporosis from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing  known allergies: Sulfa and directives , hypersen-sitivity from an unknown date and unknown if ongoing  known allergies: Sulfa and directives. Concomitant medication(s) included tramadol (TRAMADOL); methocarbamol (ROBAXIN); omeprazole (OMEPRAZOLE); colecalciferol (VITAMIN D [COLECALCIFEROL]) all taken for an un-specified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, compazine [prochlorperazine maleate] and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Batch/Lot Number: FA7485 and Expiry date was not re-ported), via an unspecified route of administration on 31Jul2021 16:00 (at the age of 57-years-old) in Arm left as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. The Patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient had not tested for COVID-19. On 21Aug2021 16:00, the patient experi-enced severe pain in the center of her chest and severe heart burn borderline of blocking her air way, she have g.e.r.d.s so she know what a flair up feels like. This was 1000 times worse than any-thing she ever experienced. It was over an hour of continuous belching and chest pain before even the slightest relief was felt. The pain finally eased up, but came back full force that evening, and into the next day. Then it completely went away. Very scary. The pain was indescribable. The Patient did not received treatment for the adverse events. The outcome for the event severe pain in the center of her chest was recovered in August 2021 and for the events severe heart burn borderline of blocking her air way, she have g.e.r.d.s so she know what a flair up feels like. This was 1000 times worse than anything she ever experienced and over an hour of continuous belch-ing was unknown.  Follow-up attempts are completed. No further information is expected.
This solicited report was received from a physician referring to a 60 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2016, the patient was vaccinated with 1 dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in 2016, the patient went down with a "self contained" injection site reaction that lasted approximately 3 days (shingles) after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles in 2016. Causality assessment was not provided. Additional information is not expected, as there was no consent for follow up.
sore arm; she was tired for a week; scaling on her face; droopy eyes; droopy eyes and itchy; She said it looked like facial psoriasis; felt weird; it hurt going into my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes) and EYE PRURITUS (droopy eyes and itchy) in a 71-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 information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm). On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy) and PSORIASIS (She said it looked like facial psoriasis). The patient was treated with PIMECROLIMUS (ELIDEL) (topical) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy), PSORIASIS (She said it looked like facial psoriasis), FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm) outcome was unknown.
Massive headache and blurry vision.  Slight body aches and mild tiredness.     I stayed in bed, drank water for 2 days starting at onset.  No food until nearly 24 hours had passed.  Headache remained but I had a slice of bread with peanut butter. I did not take Tylenol because I had read mixed messages that it would reduce the efficacy of the vaccine.  Some messages said do not take Tylenol before vaccine and other messages said not to take Tylenol after vaccine.  After 2 days, headache was more tolerable but it was not fully gone until after 4 days.
Blurry vision, Confusion, Dizziness, Cognitive issues, Brain fog, Watery eyes, memory issues, Sleep issues. Symptoms worsened over the next week - Visited Doctor,
she had developed swollen lymph node near her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "she developed swollen lymph nodes in her arm". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she had developed swollen lymph node near her throat". Additional information: The patient received the second dose a week ago (date cannot be confirmed). The reporter wanted to know if the adverse event could be from BNT162B2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a Nurse Practitioner concerning an approximately 39 year old white female who on 24Nov03 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On an unspecified date in 2003, the pt experienced diffuse abdominal pain in upper left and right quadrant of abdomen, a temperature of 99.4F, she had a metallic taste in her mouth and had increased salivation. On 01Dec03, the pt was in the office with diffuse abdominal pain in upper left and right quadrant of abdomen, a temperature of 99.4F, a metallic taste in her mouth and increased salivation. The nurse practitioner instructed the pt to go to the ER if the pain increased in the abdomen. The outcome of the upper abdominal pain, metallic taste, and increased salivation was unknown. Additional information has been requested.
Wrist and thumb pain and swelling, began 1 day after vaccine administered in ipsilateral extremity.
Tinnitus @4 times existing volume in right ear: hasn't returned to normal volume to this date; 102.6 temp Aching all over Very fatigued  Head hurt and felt very heavy, especially with the loud volume of ringing in right ear
About 12 hours after second Moderna shot, experienced 3 hours of debilitating teeth chattering, full body tension, dizziness, hot/cold, feverishness, nausea, disorientation. Then evolved into another day of dizziness. Also sore shoulder at injection site throughout. Side effects ended after third day.
Patient received Fluzone HD, 65yrs+, 0.7ml, IM, Once with expiration date of 6/30/2022.  Patient was contacted and made aware she incorrectly received an expired vaccine. Dr. advised no adverse effects to the patient.
Rapid Heart Rate the evening after the vaccination. I have since been diagnosed with Supraventricular Tachycardia (SVT) and have continuing problems with heart rate and occasional arrhythmia.
IV had thick covered throat covered throat/locked up Jaw, Locked up joints/Fingers/Toes/Legs/arms. Many high temperatures, part brain damage as well. Through the last 35 years.  04/17/2007 Spoke to reporter/patient who reports that the current AE was rash.  Pt. states he was hospitalized for "gall bladder surgery" where the rash was noted.  Box 8 data does not relate to current AE per pt.  Box 8 data was related to past reactions, as was info in Box 7.   04/17/2007 MR received. Pre-op H&P dated 3/05/2007 for upcoming cholecystectomy. Tetanus booster given. Operative and path reports report done 3/7/07 included. 04/27/2007 MR received for post op visit (03/21/07)with Assessment: Satisfactory post-op course.  No c/o other than diarrhea.   No other records available per pt./reporter.
Patient was not vaccinated at our site, so I do not have information regarding lot number, etc. Vaccinated with dose #2 of Moderna vaccine 10 days prior to admission.  Patient began feeling poorly, with fatigue and weakness the day following his vaccination.  10 days post vaccination, mother found him with right arm weakness, facial droop, and tongue deviation.  Patient was severely encephalopathic with moaning, eyes deviated, unable to follow commands, diaphoretic.  No focal deficits noted.  CT head negative for acute finding.  Platelet count low at 24,000. LDH elevated at 2856.  UDS negative.  Patient suspected to have aTTP and treated appropriately with high dose steroids, plasmapheresis, and rituximab.
Gradual increase of ringing in the ears while at the same time experiencing hearing loss. Within a few weeks the ringing increased to almost permanent, especially in one ear. The tinnitus is as a high pitched noise and occasionally sounding like crickets. There has also been an adverse reaction to caffeine that causes the tinnitus to increase.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 18th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and skin tightness. On an unknown date, the outcome of the injection site erythema, injection  site warmth and skin tightness were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and skin tightness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced tightness at injection site. The events were slowly spreading downwards towards the elbow. The patient was still experiencing these reactions at the time of reporting. No additional information was provided.
Information has been received from a registered nurse concerning a 65 year old patient who on 27-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot number 662125/0379Y) instead of ZOSTAVAX (Merck) due to a nursing error. No adverse reactions reported. The registered nurse stated that the label on the vial was intact and legible. It was unspecified if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. No further information is available.
it's still red and puffy; it's still red and puffy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy). At the time of the report, INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Further details could not be probed as consumer hung up the call abruptly. Hence, further probing could not be done and limited information available over the call. Reason of delay: Daily spike of incoming calls due to COVID-19 vaccine   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant follow up appended
Injection site swollen, indurated, red, tender, edge not well defined size approximately 5 x 10cm a few blister, no treatment given.
Trouble swallowing cramps severe nausea dizziness confusion choking on food (whole) severe migraines weakness pain & numbness.
Pain, tenderness left arm, twenty four hours after vaccines (Hep A & b),Parent used Tylenol and hot compresses. Parent called 08/21 Advised: Tylenol and cool compresses and actively with arm, To see health care provider if symptoms worsen, No swelling and redness reported.
This spontaneous report as received from a healthcare worker refers to a 25 years old female medical assistant. The patient was vaccinated with her first dose of GARDASIL (lot number not provided) subcutaneously instead of intramuscularly on 07-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient reported pain, redness and swelling at injection site. No treatment was given for adverse events. The outcome of adverse events was unknown. The patient did not seek medical attention. Additional information is not expected.
EE was given 2nd Pfizer vaccine 2 days ago today she presents with reddness and her at the site
faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Patient did not have any adverse reactions. Vaccine was administered to 14 years old (minimum age is 16 years old for pfizer covid 19 vaccine on date of vaccination 04/10/2021). Patient's mother put in DOB of 04/19/2004 on the website to register the patient. Correct DOB was entered on the vaccination consent form.
Patient received covid-19 booster but was too early.  Second shot was administered on 09/01/2021
red splotchy rash, nausea/vomiting, headache, dizziness, fever.  OTC Benadryl, topical hydrocortisone cream for rash; continue to follow closely.
This is a 67y.o. male with a past medical history of ESRD on hemodialysis, afib, asthma, and adrenal insufficiency who presents with shortness of breath and a fall. He reports that he fell last night and was on the ground all night, and because of the fall he is now having shortness of breath. He was diagnosed with covid 7 days ago, and he is vaccinated fully with Pfizer  since March. He has a minor cough that is productive of brown sputum. His SOB is worsened by exertion and was helped by breo and albuterol. He reports that he didn't hit his head and nothing hurts. He does reports he has fatigue and weakness which is abnormal for him.  He denies use of alcohol, tobacco, or other drugs.    In the ED his potassium was 7.2 and had a creatinine of 17.7. His GFR is 3, and an ABG showed metabolic acidosis with a pH of 7.27. To treat his high potassium the ED gave him sodium bicarb, calcium gluconate, and albuterol to bridge him until he could receive hemodialysis. According to EMS he was satting in the 70s so they gave him duonebs and started him on CPAP, which brought him into the 90s. He also had a temperature of 101.4, and was given a dose of tylenol which brought it down to 100.3.   67y.o. year old male who presents to Hospital due to increasing SOB/hypoxia. Patient reports his wife was having symptoms of possible Covid last week and went to be tested for covid and was found to be positive. He therefore went to be tested and also was positive about 8/20/21. He has become progressively more short of breath and subsequently came to ER where he was found to be acutely hypoxic and is requiring High flow O2 40% BIPAP. CXR 8/24: Patchy bilateral airspace disease suggestive of atypical pneumonia Procalcitonin not reliable in dialysis patient. Leukocytosis noted. Patient is fully vaccinated for COVID, Pfizer 2/11-3/4/  2021 I do not have confirmation of COVID testing.
flu shot recvd on 26OCT; 28OCT lt arm became achy-shoulder to wrist & up into neck; c/o some tingling also; no redness or swelling reported; no fever;
Skin: ABNORMAL inspection: RIGHT THIGH 4.5 x 5.5 superficial non tender erythematousarea of erythema- warm to touch. Rash - likely inflammatory reaction to vaccine. Reaction first observed at daycare the day after vaccines administered. Temp: 99.7 F PLAN: cont close monitoring - trial benadryl and ice packs and or hctz cream 1% bid prn itching.   Likely pentacel since this is first time getting, but possible to PCV
pt recv vax 22JUL98 between PM that noc had a fever of 102, inc lethargy;24JUL97 AM started vomiting;not taking liquids well;
On July 7th 2021 at 4:30 PM, I had two strokes which caused confusion in speech and difficulty in finding words.  I was taken to the local ER and then to Neurological Intensive Care Unit at Hospital for three days.  I was started on Pradaxa, an increased dosage of Atorvastin, lisinopril.  I was discharged on July 9th, but rehospitalized on July 10th with blood clots in my spleen and kidney.
TDAP 9/9/10 then next day fever, body ache. Lt arm swelling, redness, blotchy shoulder to elbow - warm to touch.
Microvascular changes and paresthesia in distal fingers bilaterally. Blanching of skin and delayed capillary refill at 4-5 seconds. Numbness and tingling that lasted for 4-5 hours.
she feels her mind is leaving for a few seconds; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (she feels her mind is leaving for a few seconds) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.    Co-suspect product included non-company product AMLODIPINE for an unknown indication.    No medical history was reported by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced DISORIENTATION (she feels her mind is leaving for a few seconds). At the time of the report, DISORIENTATION (she feels her mind is leaving for a few seconds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Pt to ED 8/18 for syncopal episode. Pt COVID+ 8/18. 8/19 pt not qualified for remdesivir due to acute renal failure, rx decadron. 8/20 pt VSS, no signs of distress, denies pain, no dizziness or SOB. 8/22 pt denies pain, not in any distress and vital signs are stable. 8/24 Pt alert, orient x4, no distress noted and denies pain. Pt discharged 8/25.
No AE; A dose of MMR-II expired on 12-JAN-2022 and was administered on 18-JAN-2022; This spontaneous report was received from a pharmacist referring to a patient of unreported age and gender. The patient's relevant medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 18-JAN-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (expired product administered) (lot number T001213, expiration date 12-JAN-2022; dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), had no previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Parent reported increased swelling at injection site and increased redness "size of football". She stated that patient's father felt it might be "infected", so he started him on Amoxicillin. She reported that after three days the redness and swelling went away. Reaction was in left leg.