chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy; pukey; deaf in her left ear; water sounds in her ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (deaf in her left ear) in a 55-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.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DEAFNESS (deaf in her left ear) (seriousness criterion medically significant) and TINNITUS (water sounds in her ear). On an unknown date, the patient experienced DIZZINESS (dizzy) and NAUSEA (pukey). At the time of the report, DEAFNESS (deaf in her left ear), TINNITUS (water sounds in her ear), DIZZINESS (dizzy) and NAUSEA (pukey) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: not provided (Inconclusive) Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-062183 (E2B Linked Report). This case was linked to MOD-2021-062183 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-062183:
Grandmother states since child was given varicella vaccine on 9/10/02 child has been breaking out with vesicular, crusty looking lesions. Note time 2+months.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 55-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 14 in the literature article. On an unknown date, 6 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included wheezing, shortness of breath, eye red and eye pruritus. The subject was treated with antihistamine, steroids nos, bronchodilator (nos) and medication unknown (fluids). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included wheezing (recovered/resolved), shortness of breath (recovered/resolved), eye red (recovered/resolved) and eye pruritus (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, wheezing, shortness of breath, eye red and eye pruritus may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 55-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 6 hours after the vaccination, the patient developed wheeze, shortness of breath and red and itchy eyes. This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine, oral steroids, bronchodilators, fluids and rest. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Around 2 AM on 1/15/21 (about exactly 12 hours after receiving the 2nd COVID vaccine injection) I woke up with severe chills and had a fever of 102 degrees F. Also had joint pain in knees/ankles and thigh muscle pain, as well as injection site pain. Around 9 am, fever had increased to 104.4 degrees F. After taking 1000 mg of Tylenol, fever decreased to between 100 and 101 degrees F. Around 3 pm, fever was still above 100 degrees F so took 400 mg of ibuprofen. By 5 pm, fever was finally below 100 degrees F.  By 1/16/21, all side effects had resolved except lymph node in injection arm was significantly swollen, hot, and tender. By 1/17/21, side effects still resolved besides swollen and tender lymph node.
48 hours s/p shot; rash noted & then with spread throughout body in next 2-3 days; classic varicella on exam with pruritus & tactile temp at home; supportive care & isolation at home.
At first, I had joint pain, nausea, diarrhea and fatigue. Each day got a little bit better, lasting a few days. The headache started on the second day and that kept getting worse. Headache, every time I went to swallow anything, the headache would be excruciating hurting at these times. It was unbearable and I had to go ER. They checked to see if I had a blood clot. I didn't. They gave me a pain injection, Dilaudid, which made me feel disgusting and didn't help. No medications to take home. Had a phone visit with my doctor. The headache continued, and it lasted me a full two weeks. It has eased up now.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA177770, 2018SA177766 and 2018SA177771. This case involves a patient (age reported as 16-20 years, gender not reported) who experienced redness, swelling and lump at injection site, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient did not receive any other vaccine on the date of administration. On 18-Jun-2018, the patient received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5541AA, expiry date: 13-Nov-2020) via intramuscular route in the deltoid NOS. On an unknown date, the patient developed a non-serious redness, swelling and lump at injection site, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant tests were not reported. Final diagnosis was lump at injection site and redness, swelling at injection site. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.
Day 1  (day of shot) - within 90 minutes, started experiencing eye strain/sensitivity to light and chills (without fever) Day 2 - Intense chills, fever (high 101.7 but my baseline is only 97.5), body aches, fatigue, brain fog Day 3, - fatigue. blurred vision, nausea (as a result of trying to read with blurred vision), random pains in body (sciatica-like pain in both legs, kidney pain, liver pain, chest pain), brain fog, lack of stamina. Day 4 (today) - leg pain, brain fog, blurred vision (particularly in left eye), eye strain, sensitivity to light, lack of stamina, sensation of swaying when standing up/standing still
Information has been requested from a health care student concerning a 13 year old female sulfa allergy and latex allergy and no pertinent medical history who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. There was no concomitant medication. On the morning of 27-OCT-2010 the patient returned to the office and complained of vomiting and diarrhea that had started at approximately 1:00 AM on 27-OCT-2010. It was further reported that the patient was receiving intravenous fluids and seemed to be improving. The patient was still in the office during the call. Complete blood count (CBC), serum lipase and amylase, serum calcium, thyroid levels, serum insulin and glucose levels were drawn during the office visit on 27-OCT-2010 and results were pending. Follow-up information has been received concerning the 13 year old female with sulfonamide allergy, latex allergy and gastrooesophageal reflux disease and no illness at time of vaccination, who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 665607/1332Y) intramuscularly into her left deltoid. Concomitant therapy included FLUZONE on the same day. It was reported that the patient present for evaluation of nausea and vomiting. Onset of symptoms was today on 27-OCT-2010. The patient described nausea as severe. Vomiting had occurred 9 times over the past hours. Vomitus was described as bilious, brown. Symptoms had been associated with abdominal pain of moderate severity, diarrhea, occurring 5 times over past 12 hours, inability to keep down fluids, fever to 101.5 and suspicious food/drink: fish. Patient denied hematemesis, melena, possibility of pregnancy, alcohol overuse. Course to date had been gradually worsening. Evaluation to date had been none. Treatment to date had been none. History was reviewed. The patient had no pertinent past medical history. The patient was here yesterday on 26-OCT-2010 and was not sick but got GARDASIL and FLUZONE. Vomiting, nausea and abdominal pain started at 1:00 AM on 27-OCT-2010. At the time of reporting, the patient had recovered from the events. Additional information is not expected.
When exercising at a moderate pace, I experienced chest pain and intense shortness of breath. The chest pain lasted several hours after the event. This occured 3 days after my second dose and again, when I tried to exercise again, 7 days later. On day 8, I went to the Emergency Department at my local hospital.
Patient experienced tremors or convulsions less than 24 hours after series of 4 month old vaccines. Tremors involved head and arms and were stopped when I aroused child by yelling his name. They were the most frequent the first week after the shot (several times a day) and stopped 3 weeks later. Most of the time they were while he was drinking a bottle or falling asleep and yelling his name would stop them. Duration of shaking was 10-30 seconds.
presented to ED June 9 complaining of numbness in hand 2 days prior to admission  He walked his dog for 1 mile day prior to admission, without difficulty On day of admission developed numbness in the feet and trouble walking .  His coordination was off, cut himself shaving.  Patient denies any headaches any vision changes.  No facial asymmetry no slurred speech.  On May 31, had returned from a  1-week fishing trip. He reported finding a tick on his right arm while on the trip.  He was feeling tired when he returned, no fever reported, no rash.  On June 6, had a Moderna COVID booster, 1 day prior to onset of symptoms.   Additional history obtained after discharge, was bitten by a garden snake, had taken a picture and confirmed the species. Admitted 6/9, LP done IVIG started on 6/10 Transferred to ICU overnight 6/10, dyspnea, decreased vital capacity, placed on bipap, and intubated on 6/11 On 6/14, no neurologic improvement noted, intubated and sedated, not moving extremities, was started on pheresis.No neurologic improvement with IVIG and PLEX for GBS Was made comfort measures and expired on 6/21
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) (date and dose was not reported).  Subsequently the patient experienced shingles and was hospitalized.  The outcome of the shingles was not reported.  Additional information has been requested.
Initial and follow up information has been received from a physician's assistant (PA), concerning a 19 year old female, patient, with no known drug allergies and a fear of needles, who was vaccinated (date unspecified) with the first dose of Gardasil without any complications, and on 09-JUL-2007, at 10:00am, was vaccinated IM in the right deltoid, with the second dose of Gardasil (Lot # 0469U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). There was no illness at the time of vaccination. On 09-JUL-2007, immediately after receiving the second dose, she did not respond, described as, the patient couldn't see, couldn't hear, and couldn't talk. When she regained her ability to speak, she told the physician she felt "spaced out," and then went into a blank stare; she was also sweating and shaking. The patient's blood pressure was reported as 80/40mmHg, and then also reported to be "normal" (value not provided) during the events; blood glucose was 115 (units not specified). The physician applied cold compress to the patient's head, and her symptoms subsided "within one minute". She was then asked to lie on the exam table for a few minutes; after 10-15 minutes she felt better and left the office. The PA reported it was not determined if the patient will receive the third dose of Gardasil. Follow up information from the PA indicated that the patient's boyfriend accompanied her to the vaccination, and stated that the patient became nervous and "worked up" and had previous similar reactions when she received a vaccination, or had to give blood. The PA felt that the events were not related to therapy with Gardasil, and were considered to be non-serious. Additional information is not expected.
Pt admitted with acute appendicitis that was treated non-operatively due to COVID positive status.
CHRONIC HYPOTENSION 10/14/2021 HYPOTENSION  HYPOTENSION 7/7/2021 HYPOTENSION  CHRONIC HYPOTENSION 10/14/2021 HYPOGLYCEMIA  HYPOTENSION 7/7/2021 HYPOGLYCEMIA
Swollen, bruised left arm that is painful and hot touch. Adverse event was first noticed by patient on 12/29/2018 (the day after the immunization). She went in and saw her PCP and was prescribed keflex antibiotic (SIG: 1qid x5d) which she filled and picked up on 12/30/2018.
This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown gender and age. Concurrent conditions and medical history were not reported. On unknown dates the patients received an extra dose of hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot# and expiration date were not reported) of hepatitis A vaccine series. This is one of the two reports from the same reporter. Additional information has been requested.
Patient has not had any adverse effects or symptoms from this dose.; a dose of expired MMRII was given to a patient today; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical condition and current condition were not reported. The patient's concomitant medication included sterile diluent (lot number: T022572 with expiration date: 12-FEB-2023).   On 29-APR-2022 (reported as today), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (0.5ml/once, lot number: T013727 with expiration date: 21-APR-2022, strength and route were unknown) for prophylaxis (expired product administered). The patient did not  have any adverse effects or symptoms from the dose. Vaccine had no temperature excursions and was supported per protocol.
Within 24 hours, i was stuffed up to the point of not being able to breath at all through my nose.  This lasted for over 1 week.  Into the second week after the shot, my sinuses cleared and i was able to breathe once again through my nose.  That has remained satisfactory.  Into the third week, i started to develop hives all over my body whenever i would eat anything that i normally ate.  I went to an allergist who suggested i take Zyrtec twice a day rather than once.  That did not help.  This persisted for 3 months before i researched Mast Cell Activation Syndrome, and began following dietary protocols for this condition.  That seemed to help.  It is now 9 months later, and it would seem as though the hives are finally subsiding.  I've added a number of supplements to control the hives and have eliminated a lot of things from my daily diet, i.e. gluten, sugar, chocolate, alcohol, caffeine, red meat, legumes, etc.  As the effects of the shot wear off, the hives seem to be disappearing as well.
No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022J21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First Booster dose) on 01-Sep-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related.    Caller has had two Booster doses, one on 01-Sep-2022 which was Pfizer and then on 02-Dec-2022 which was Moderna. Caller said they had Moderna for the original COVID-19 boosters but then got the Pfizer's new modified version. Then they got the Bivalent booster of Moderna. Caller said they were told they can get the Moderna bivalent booster done after 2 months repeatedly. Caller said after 3 months it starts wearing off. The information they got said the vaccines starts tapering off. Dates for previous doses and monovalent boosters were not gathered to ensure given within authorized vaccine schedule. Caller declined contact information and declined consent for follow up.  No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
chest tightness; redness on my left arm BCG childhood vaccination spot about 5 days after the vaccination; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration on 13Apr2021 at 12:30 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included dietary supplements, vitamin B, and gummy bear vitamins from unknown dates for unknown indications. The patient previously received Bacillus Calmette-Guerin (BCG)  vaccine on an unknown date. On 18Apr2021 at 08:00, about 5 days after receiving BNT162B2 the patient experienced redness on her left arm  BCG childhood vaccination spot. The patient also experienced chest tightness for about 5 minutes "at breading" and that occurred about 10 days after the first shot (23Apr2021). The patient did not receive any treatment for the events. The outcomes of redness and chest tightness were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.
administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 3rd March 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. On an unknown date, the patient received Boostrix. On 3rd March 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Medical office support reporting vaccines administered after temperature excursion of 26 Fahrenheit for an undetermined length of time for Bexsero, Menveo, Boostrix, Infanrix, Kinrix, Engerix-B, which led to incorrect storage of drug. Health care professional (HCP) did not had pertinent adverse event information available at time of call but gave permission for safety team to follow up. Possible multiple patients were involved. The reporter consented to follow up.
No additional AE reported; an expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.       On 05-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133 with expiration date 15-SEP-2020; strength, dose and route were not reported) for prophylaxis (expired product administered). the product did not have any previous temperature excursion. Not supported disclaimer was provided. No additional adverse event (AE) reported. No product quality complaint (PQC).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Left sided numbness, tingling of face, arm and leg.  Loss of hearing in left ear.  Called 911.  Air rescue to Hospital.  Workup labs, CT, MRI and carotid ultrasound.  Symptoms resolved 5 hours.
Began the day after, including arm soreness, "swelling" above the clavicle, and headache.  Symptoms lasted 3-4 days.  Presented to Dr office 2/2/2023 with vaccine reaction concern