chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of smell and taste; COVID-19 virus test positive; Loss of smell and taste; dizziness; Nauseated for 2-3 days after second dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 12-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste), DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 015M2O8) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nauseated for 2-3 days after second dose). On 24-Mar-2021, the patient experienced AGEUSIA (Loss of smell and taste). 24-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and ANOSMIA (Loss of smell and taste). On 20-Mar-2021, NAUSEA (Nauseated for 2-3 days after second dose) had resolved. At the time of the report, AGEUSIA (Loss of smell and taste), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive), ANOSMIA (Loss of smell and taste) and DIZZINESS (dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were taken. Treatment medication included IV infusion.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated events from unknown to recovered. On 22-Jul-2021: Follow-up Information Received contains No New Information
Noted mild redness and swelling to left upper deltoid area, warm to touch. Patient taking Tylenol for pain able to use arm. No serious injury noted. Healed
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On an unknown date RECOMBIVAX HB (dose, route and site of administration were not reported) vaccines have been administered to multiple patients post supported excursions. No adverse effects reported by any patients. This is one of several reports from the same source. Additional information has been requested.
Body ache; Chills; This is a spontaneous report received from a contactable other Health Care Professional (patient, self-reported). A 56-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date was not provided), via an unspecified route of administration, on 24Mar2021 10:15, as single dose for COVID-19 immunization, at Workplace Clinic. Patient's medical history was not reported. The patient had no allergies. Concomitant medications included escitalopram oxalate (LEXAPRO, 10 mg) at 10 mg and multivitamin (received within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247, Anatomical location of vaccine: Left arm), on 03Mar2021 at 02:30 PM for COVID-19 immunization. On 25Mar2021 at 06:30, the patient experienced Body ache and had chills on same day (25Mar2021, time not specified). The patient was received treatment for the adverse events with Ibuprofen. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Outcome of the events was reported as recovering.  Information on the lot/batch number already available. Other information has been requested.
03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns according to staff.  Her appetite was her usual described as fair.  She received her 2nd Moderna vaccination on 03/08/21.  Within hour she because very ill according to facility staff. She began to vomit up to 5 times.  Her stools because loose.  She became more lethargic. She was started on compazine for the vomiting. Her oral intake was minimal. Her symptoms did not resolve and she was visited by the nurse again on 03/11/2021 where she was not very responsive.  Her vitals included an irregular pulse and apnea noted in her breathing up to 15 seconds.  She died on 03/12/21
I received the Moderna COVID-19 Vaccine EUA on 01/27/2021 in my left arm. Within thirty minutes of the vaccine, I experienced tingling and slight numbing  on the left side of my face, specifically my cheek. After a few hours I experienced severe arm pain for 48 hours accompanied by body aches and joint pain.
12/23/2019 at noon, I (the patient) received Shingrix on my left arm At 2PM, I developed a severe pain on my arm, and that I could not move my arm At 4PM, my arm was paralyzed.  At 6PM, the pain was radiating to my chest, neck, back, under my right breast.  At 6PM, I had a severe chest pain. My feet and hands turned very cold. At 8PM, I had a very severe headache, nausea, and vomiting then the chill then fever.   I had a flu like symptoms including muscle aching for the next two days. Then, I have developed a big sore from inside to outside my lower lip.  All the skin on the lips is also broken and peeled.  I had not ever had a flu or a cold sore before the shot.
Tingling sensation on inner part of the arm; Crampy; Difficulty in sleeping; Fever; Chills over night; Vomited one time; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on inner part of the arm), MUSCLE SPASMS (Crampy), INSOMNIA (Difficulty in sleeping), PYREXIA (Fever) and CHILLS (Chills over night) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced MUSCLE SPASMS (Crampy), INSOMNIA (Difficulty in sleeping), PYREXIA (Fever), CHILLS (Chills over night) and VOMITING (Vomited one time). On 18-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation on inner part of the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Apr-2021, MUSCLE SPASMS (Crampy), INSOMNIA (Difficulty in sleeping), PYREXIA (Fever), CHILLS (Chills over night) and VOMITING (Vomited one time) had resolved. On 27-Apr-2021, PARAESTHESIA (Tingling sensation on inner part of the arm) had resolved.      No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: First dose details, vaccination facility details and event outcome changed from unknown to recovered.
Lymphocytic colitis; This literature-non-study case was reported in a literature article and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.         No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered COLITIS MICROSCOPIC (Lymphocytic colitis) to be related.    No concomitant and treatment medications were reported.  Lymphocytic colitis occurred in a healthy middle-aged man post 1st and 2nd dose of Moderna SARS-CoV-2 mRNA vaccination. This revealed an unexpected complication of a mRNA vaccine that presented as worsening diarrhea after vaccination in a dose dependent pattern.  Author stated caregivers should be aware of lymphocytic colitis as a possible complication of the Moderna vaccine and monitor those patients closely for symptom resolution.  Company comment:  This  literature-non-study case report concerns a 71-year-old male patient, with no relevant medical history, who experienced serious (medically significant) unexpected event of Colitis microscopic which occurred after the patient had received the first dose of the mRNA-1273 vaccine, as well as after he received the second dose of the mRNA-1273 vaccine, therefore rechallenge is considered positive. Reportedly, the patient developed worsening diarrhoea. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the event, as well as treatment information were available. The patient's age is considered as a risk factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This  literature-non-study case report concerns a 71-year-old male patient, with no relevant medical history, who experienced serious (medically significant) unexpected event of Colitis microscopic which occurred after the patient had received the first dose of the mRNA-1273 vaccine, as well as after he received the second dose of the mRNA-1273 vaccine, therefore rechallenge is considered positive. Reportedly, the patient developed worsening diarrhoea. At the time of this report, the outcome of the event remained unknown and no additional details regarding clinical course of the event, as well as treatment information were available. The patient's age is considered as a risk factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
FEVER; FATIGUE; SORENESS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever, fatigue, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and soreness was not reported. This report was non-serious.
Child presented to our clinic today (04/30/2015) Pediatrician's office was out of Prevnar.  Gathering history from Mom, through interpreter, Mom reported patient had abdominal surgery for twisted bowel 2 weeks ago.  Noted had Rotateq 4-11-15 prior to illness.
High Blood Pressure, high heart rate, vomiting, diarrhea, burning in chest, tired, tremors, hives all over, dizzy, shortness of breath
Pt rec'd H1N1 FluMist y/d and developed nasal itching, congestion and swelling that night. No difficulty breathing. Bloody emesis x 1 later that night.
client describes red rash @ injection site with 2 days after vaccination then indentation (muscle atrophy) noted to left deltoid
Headache started at 10 PM on the date of the injection and chills. Sore arm started following day in the AM. Tiredness, dizziness, headaches, stuffy nose, sleepiness and overall not feeling well started Saturday evening. Took Tylenol. Sunday I felt tired and sleepy all day in addition to rest of symptoms. My body ache was like I had the flu. Took more Tylenol and ate citrus to help boost vitamin c. Monday the headache still has not subsided the tiredness/sleepiness was there and so are the body aches. Monday I had two small bumps protruding from my neck?Lymph nodes. Rested most of Monday. More Tylenol.  Had a harder time breathing just like I would during any normal asthma issues. If I went up and down the stairs I would have to take deeper breaths in my chest felt tight.  Tuesday a little bit of energy returned. The headache subsided. Tiredness is still there. The deep breathing is still hard. The lymph nodes still swollen. Neck/collarbone.  Today is Wednesday 08/18/21, some of my energy has returned the headaches bodyaches seem to have subsided completely however my lymph nodes are still swollen and painful
Moderna COVID-19 Vaccine EUA  Within 2 hours: Injection site pain, fatigue with headache increased to a migraine throughout day.  Chills and nausea, increased throughout day with loss of appetite. Around 6pm, vomited after smelling food. Unable to consume anything but water. Around 9pm, vomited after swallowing 2 acetaminophen pills and a couple of sips of Gatorade. On the next day (01/30/2021) light migraine, muscle aches, nausea, and injection site pain. On 01/31/2021, mild migraine, injection site pain, and shortness of breath. Used albuterol inhaler.
soreness at the injection site; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EH9899) on 18Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient used to receive unspecified vaccines and experienced pain at the injection site. After 8 hours of taking bnt162b2 and into the next day patient reported soreness at the injection site on 19Dec2020. She described it as "normal" and like pain felt after other vaccines she has received. The outcome of the event was unknown.
Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a non-health professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported. Patient had booster dose of Pfizer on 02 Nov 2021 with Lot- F63527. It was stated by the health department that for both the Moderna and Pfizer shots the primary care physician did not keep a log of the storage temperature of the vaccine and was not documented as per CDC requirements and that it is unknown if the vaccines were stored properly for the storage temperature requirements and that these vaccines could be compromised or not as effective. The clinic assured patient that the vaccines were stored properly, but they have no records at all. No treatment medication reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
20 min following vaccine pt reported dizziness and difficulty swallowing.  Pt reported that this sometimes occurs following thyroid removal in 2019.  Pt also reported that his eyes felt tired and that they "hurt".   Pt advised to go to ER by ambulance, but the patient refused.  Facility transferred care of to EMS at 18:19.    Pt's daughter reported that she was taking pt to the hospital for further evaluation at 18:30.
first dose after vaccine was open in refrigerator over 12 hour expiration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (first dose after vaccine was open in refrigerator over 12 hour expiration time) had resolved.      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 concomitant medications were mentioned. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-138570, US-MODERNATX, INC.-MOD-2021-138601, MOD21-091233 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138570:Crosslinked: Same Reporter US-MODERNATX, INC.-MOD-2021-138601:Crosslinked: Same Reporter MOD21-091233:Crosslinked: Same Reporter
Pfizer-BioNtech COVID 19 Vaccine  Left arm pain, mild to moderate from the time of receiving the shot until the next morning at which time left arm pain began to improve.  The following morning, woke up with a fever of 102F, intermittent fever all day ranging from 99.9 - 102F. Dulled sense of smell and taste since the injection. Decreased appetite.
This case was reported by a consumer (also the health professional) and described the occurrence of itchy eyes in a 55-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. The subject has a history of latex allergy. No additional medical history was provided. The subject was not receiving and concurrent medications. On 19 October 2006 the subject, also the nurse, administered 50 Fluarix injections to subjects. The nurse has a medical history of latex allergy, so someone else removed the tip caps from each dose of Fluarix. After administering the injections, the nurse developed itchy eyes, a red face and cold symptoms, even though she did not touch the latex containing parts of the Fluarix. She had some improvement in symptoms by the following day. On follow-up the reporter stated that she also experienced stuffy nose and chest tightness.
Sensation of pressure in eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Sensation of pressure in eye) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free,Solution for injection in pre filled pen. On an unknown date, the patient experienced OCULAR DISCOMFORT (Sensation of pressure in eye). At the time of the report, OCULAR DISCOMFORT (Sensation of pressure in eye) was resolving.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine trail.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N021315, expiration date 07-AUG-2019) and M-M-R II (lot # M049212, expiration date 16-DEC-2018) (strength, dose and route were not provided for the vaccines) for prophylaxis. The reporter also stated that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccines did not undergo a temperature excursion. The vaccines were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (6F) for 7 minutes which was detected by the data logger. Prior temperature excursion from 6°F to 14°F for 38 minutes was also reported. No adverse effects were reported.
5cm area of erythema around the injection site with 2 cm area of induration beneath the injection site.
Pt presented 5 wks later complaining of pain at injection site. rec MOTRIN +/- x ray
improperly stored vaccine administered to patient; This spontaneous report was received from a licensed practical nurse and refers to a 23-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  20-AUG-2020, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 milliliter (strength, route of administration, anatomical location were not reported; lot number S008151 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 48.39 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
onset of facial edema, urticaria, lower extremity joint pain; also some lower extremity edema; pt seen 1JUN93, treated w/12 day tapering course; pt is leaving town 4JUN93 will f/u w/own MD;
Very sore arm (more than 1st dose) 2-3 days. Cold chills, began 14 hrs after receiving vaccine, lasted 5-6 hrs (woke in the night, couldn't get warm). Insomnia the night of the vaccine, from midnight till about 5 am (when I was so cold) Extreme fatigue after getting up about 7 am; slept most of the time from 7 am through 3 pm. Slight nausea, no appetite, 24 hrs.
A 4 month old was given the flu vaccine.  No harm to infant as of now, but was too young to receive the vaccine.