chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Little fatigue; Not as much body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (She was a survivor of three open heart surgeries and has artificial heart valve). Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN) and LIOTHYRONINE for an unknown indication.    On 10-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 HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache). At the time of the report, HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache) outcome was unknown.        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.   No Treatment informations were reported.   This case was linked to MOD-2021-395918, MOD-2021-395919 (Patient Link).
Patient was given a Moderna bivalent booster instead of a Moderna monovalent primary dose for the first dose.
Large, red welt on tricep - itchy, sore. Started 3/12/2021 at 12:00pm. Lasted 24+ hours.
Pulmonary embolism; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on sometime in April 2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome 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 information was not provided.  This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Sender's Comments: This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.
About a week after 2nd shot I noticed an increased volume of tinnitus. Very loud. It continues to be very loud to this day.
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting,  diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
Sudden onset of Heavy Nosebleed with chunks . Occured 3 to 5 times in last 1 week.  Visited emergency and they treated by clipping it.  Visited urgent care and they stopped it with the Silver nitrate.  Has history of spotting in the nose in the past - comes during winter / dry air.  No other allergies known.  Pending PCP and ENT visit. Not sure if it's related. Wanted to report even if I am unsure if it's related yet.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 13-NOV-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009875 (Same reporter link). Additional information has been requested.
This is in follow-up to report(s) previously submitted on 1/7/2008; 4/7/2008. Information has been received through the Merck pregnancy registry through a health professional concerning an 18 year old female with a history of Herpes simplex, a positive Human Papillomavirus test and sports induced asthma, who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (Lot # 657736/0389U). On 21-MAY-2007, the patient developed a bump on her left arm at the injection site.  The bump on her arm resolved without treatment.  On 12-JUL-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of Gardasil (Lot # 658100/0525U).  On an unspecified date the patient found out she was pregnant (LMP approximately 01-MAR-2007).  On 16-AUG-2007, the patient reported the pregnancy at an office visit. On 17-AUG-2007, the patient had a serum alpha-fetoprotein test which was negative. On 30-NOV-2007, the patient had an ultrasound for screening. Prenatal screening tests (not specified) were normal.  Concomitant medications include VALTREX to prevent a Herpes simplex outbreak at the time of delivery.  Additional information has been requested. Follow up information indicated that on 02-Jan-2008, the patient delivered a normal female baby at 39 weeks from the LMP. The baby weighed 2267 grams and had an apgar score of 8/9. It was also reported that the baby "size was less than dates." No further information is available.
After vaccine arm was a bit sore but nothing major.  Patient had a  TIA on 8/25; face drooped on one side, speech slurred and weakness. TIA occurred within similar window to first dose.    Patient went to ER.   Patient kept over night for observation.  Patient followed up with PCP. He is doing well.
Headache Cold chills  Hot chills  Tired  Neck stiffness  Unable to lift shot arm
12 hours after receiving injection, I began to feel aches and chills.  Went to bed. After sleeping, woke up (about 24 hours after receiving the vaccine) feeling nausea and my head was aching.    After several hours of feeling nausea, I began to vomit.  I had only drank liquids since dinner the night before. Several days after the vaccine, I had a headache for 24 hours, with pain focused above my right eye.
Shingles/painful rash on left side of the chest area; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 25-NOV-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered a painful rash on the left side of the chest area and was diagnosed with shinlgles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
0/06/2022: Event occurred after 2nd vaccine. presenting for an episode of vomiting yesterday which she believes contained blood.  She states she felt fine and went to make some soup after eating a few bites she got fall and then vomited. recently in the emergency department 2 days ago for nonspecific abdominal pain with subsequent discharge. patient denies: Diarrhea, fever, dysuria/discharge, Headache, blurred vision/vision change, focal deficits, abdominal pain, back pain, palpitations, chest pain, lightheadedness/dizziness, shortness of breath/cough, rash.  01/11/2022: for discharge home today
injection site pain; general sense of malaise; This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were unknown.   It was unknown if the reporter considered the injection site pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient reported that he had seen higher frequency of pain at the injection site for the second dose of Shingrix in his overall population. The patients had also stated a general sense of malaise after vaccination. The reporter did not agree to follow-up from GlaxoSmithKline.
aching; chills; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) 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 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PAIN (aching), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.            No treatment information was provided
Information has been received from a 33-year-old licensed practical nurse concerning with mild asthma, sulfa allergy, and intrauterine contraceptive device insertion who in 1993 was vaccinated with RECOMBIVAX HB. There was no concomitant medication. In 2003, her titer level was 11. On 17-JAN-2007, the patient had a low titer of less than 3. Unspecified medical attention was sought. No symptoms were noted. No additional information to report. There was no product quality complaint. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, weakness, nausea and vomiting. On an unknown date, the outcome of the fever, chills, muscle pain, weakness, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the fever, chills, muscle pain, weakness, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and experienced fever, chills, achy muscles, weakness, nausea and vomiting. The events resolved after 3 days. Consent to follow up was provided.
Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away; Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Fk9893) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Cr8730, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Mar2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0162, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 14Apr2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: 320308d, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 25Oct2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), TASTE DISORDER (non-serious) all with onset 07Apr2022 at 13:00, outcome "not recovered" and all described as "Texture and taste of food changed - can barely taste and texture is like chewing on a wet sponge - terrible - has not gone away". Therapeutic measures were not taken as a result of dysgeusia, taste disorder.
body aches; feeling pretty miserable; Fever; worn out; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date was not reported), via an unspecified route of administration in right arm on 30Mar2021 11:30 (at the age of 80-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date was not reported), via an unspecified route of administration in arm right on 09Mar2021 11:30 (at the age of 80-years-old) at dose 1, single for covid-19 immunization. The patient experienced body aches, felt pretty miserable, fever and worn out on 30Mar2021. Patient was taking Tylenol for the events. The outcome of the event fever was recovered, outcome of the event worn out was unknown outcome of rest of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366575 same reporter/drug/similar events, different patient.
BELLS PALSY SWOLLEN LIP AND EYE-MEDROL 25MG 2X-3X A DAY FOR 5 DAYS-SWELLING STARTING GOING DOWN AFTER 2 DAYS NUMB ON ALL OF FACE HEADACHES-ADVIL-WORKED SOME FATIGUE DRY EYE-PATCH ON EYE AT BEDTIME-WORKED AFTER A MONTH AND A HALF I STARTED TO FEEL MYSELF AGAIN.  IN 4 MTHS AFTER 1ST REACTION I WOKE TO SIMILIAR SYMPTOMS BUT NOT AS SEVERE-TOOK MEDROL PACK 4 MG  FOR 10  DAYS *UP UNTIL THIS POINT I HAD NEVER HAD A REACTION TO A VACCINE. THIS IS THE ONLY ONE I HAVE EVER HAD ONE TO.
Sickness; Difficulty breathing; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness) and DYSPNOEA (Difficulty breathing) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness) and DYSPNOEA (Difficulty breathing). At the time of the report, ILLNESS (Sickness) had not resolved and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had all her shots for COVID was of Moderna. Patient was sick and can hardly breathe.  Treatment information was not reported.   Reporter did not allow further contact
I woke up yesterday morning and I was fine. Then I went back to sleep and when I woke up I had chills and I was super cold. I got nauseous all of a sudden. I went to sleep again and when I woke up and it was 2 times worse. I went to urgent care and they did a Covid test but I do not have the results yet. They did not prescribe any medications.
He mentions that he recently got covid (4th day of being infected); He mentions that he recently got covid (4th day of being infected); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, 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: COVID-19 (medically significant) with onset Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "He mentions that he recently got covid (4th day of being infected)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: He mentions that he recently got covid.  clinical information: Caller stated that last year after he received his second dose of Pfizer covid vaccine, he was hospitalized due to myocarditis. The myocarditis was not present now but he does have few concerns regarding the Pfizer BioNtech covid vaccine. He mentioned that he recently got covid (4th day of being infected) and would like to know if the myocarditis reaction from the vaccine would have any effect on his situation now. Was he more prone to myocarditis from Covid just because he had the myocarditis from the Covid vaccine. Caller would like to know which component of the vaccine is associated with myocarditis. Caller would like to know if Paxlovid can be started 3-5 days within testing positive for covid. Caller stated it would be helpful if Pfizer would send reports to people with myocarditis and follows up with them to see if they got the booster dose or if they were infected with Covid and to come up with some statistics of this occurrences. It would be helpful if pfizer conducted more research about myocarditis. Caller would like to know if he could still receive the Pfizer BioNtech covid vaccine Booster dose despite his history of myocarditis and his current covid infection. He wanted to know what criteria would make him eligible for "Subjects at High Risk of Progressing to Severe COVID-19 Illness" given that he had myocarditis but the myocarditis occured last year after his second dose and he does not have it now. He also asked if he could take the Paxlovid to prevent infection from Covid given his history of myocarditis.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
100.6 fever, headache; better that afternoon. Had run a mile in morning of 10/20/04.
pt came in and asked for 1 st dose of covid. after hours when billing admin fee found out pt had janssen shot in march.
one of her contact lenses started to be blurry; burning eyes; watery eyes; soreness in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning eyes), LACRIMATION INCREASED (watery eyes), VISION BLURRED (one of her contact lenses started to be blurry) and INJECTION SITE PAIN (soreness in the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness in the site of injection). On 15-Feb-2021, the patient experienced EYE IRRITATION (burning eyes) and LACRIMATION INCREASED (watery eyes). On 16-Feb-2021, the patient experienced VISION BLURRED (one of her contact lenses started to be blurry). At the time of the report, EYE IRRITATION (burning eyes), LACRIMATION INCREASED (watery eyes), VISION BLURRED (one of her contact lenses started to be blurry) and INJECTION SITE PAIN (soreness in the site of injection) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
He has been sick for a week; Bad cold; lost his sense of smell; lost his sense of taste; had trouble breathing one night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night) 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 03-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night). At the time of the report, VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. Concomitant product use was not provided.
Received Td vaccine in right arm on friday, increased pain and increased travel of pain down arm and up to neck on right side by sunday.  Pain to great and decreased mobility.  So went to ER for evaluation.  Taking vicodin and alleve for pain.  Mobility increased, pain decreased.