chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest flushing; Racing heart rate; This is a spontaneous report from a contactable nurse (patient). A 51-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in the left arm on 24Dec2020 11:30 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lysine hydrochloride, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acid succinate, zinc oxide (ONE A DAY MULTI VITAMIN & MINERALS). The patient did not receive other vaccine in four weeks. The patient previously took ephedrine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The patient experienced chest flushing and racing heart rate on 24Dec2020 11:45. Outcome of the events was recovered in Dec2020; no treatment was needed for the events. The events was assessed as non-serious.
No additional AE reported; ROT ATEQ that experienced a temperature excursion; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 18-OCT-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # T040207 was confirmed to be valid with expiration date 18-JUL-2022, 2 milliliter, orally (dose number were not provided) for prophylaxis. The temperature excursions were 33 degrees Fahrenheit for 15 minutes and 10 minutes. There were no previous excursions reported. No adverse effects were reported.
Received both flu and pneumococcal shot in same arm. About one hour after receiving shots, arm began to hurt, turned red and hot. Required medical attention by doctor the next day. Arm was red, hot and swollen.
First dose on 09Dec2020 and 4 weeks later contracted Zoster; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2020, the patient received the 1st dose of Shingrix. On 30th December 2020, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called for information regarding the second dose of the Shingrix vaccine. The patient received first dose and 4 weeks later contracted zoster. No other information was reported.
Chronic urticaria; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prevention.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Jul-2021, the patient experienced URTICARIA CHRONIC (Chronic urticaria). The patient was treated with PREDNISONE for Chronic urticaria, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Chronic urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medication included antihistamines.
This case was reported by a consumer via call center representative and described the occurrence of asthmatic attack in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included asthma. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, several minutes after receiving Flu trivalent vaccine, the patient experienced asthmatic attack, wheezing and documented hypersensitivity to administered product. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the asthmatic attack and wheezing were recovered/resolved and the outcome of the documented hypersensitivity to administered product was unknown. The reporter considered the asthmatic attack and wheezing to be related to Flu trivalent vaccine. Additional details were provided as follows: The patient received flu vaccine in an unknown arm. The patient stated that approximately 15 years ago she received a flu vaccine (unknown manufacturer) and a few minutes after receiving the injection, she experienced wheezing and had an asthma attack. The patient stated that she was allergic to eggs and believed that it was the egg component of the vaccine that caused the asthma attack. The patient stated that prior to this incident, she did not have an asthma attack for 30 years. The patient stated that she no longer gets the flu shot. The patient had denied permission to contact their physician. The patient had limited information regarding the event. The patient did not want to provide age or date of birth.
Temperature 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature 101.5) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PYREXIA (Temperature 101.5). At the time of the report, PYREXIA (Temperature 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.5 (abnormal) 101.5.         No concomitant medications were provided. No treatment medications were provided.  Patient had taken 2 Tylenol . The second night he experienced temperature 101.5.   This case was linked to MOD-2021-375351 (Patient Link).
Immediate auto immune disorder flareup. Nausea, vomiting, weakness leading to dehydration and 20 pound weight loss. Three hospital stays. Dehydration lead to kidney infection   Congestive heart failure
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of post viral acute disseminated encephalomyelitis" (unspecified if ongoing); "chronic residual neurological symptoms" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies:  nitrofurantoin". Vaccination history included: Covid vaccine (Dose number unknown, single), for Covid-19 Immunization, reaction(s): "Known allergies: COVID vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (08Aug2023) positive, notes: by antigen. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Jul2023 to 03Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
When pt received 2 st she developed cellulitis and treated w KEFLEX. She informed and still wanted to get 2nd dose. Explained the possible side effects with this vaccine which are severe redness/pain/swelling at the injection site. The next day she noticed the swelling/pain and told us that the symptoms are exactly same as what happened w 1st dose. She went to urgent care on 12/12 and is treating with KEFLEX. Dr. told her that it is cellulitis. The swelling got bigger from 12/11 to 12/12 but once she started antibiotic the symptoms are getting better.
I started having migraine issues (no prior history) intense pain in the head, sensitive to light, blurred vision, and not able to concentrate (December). I have numbness, pins and needle sensations from the elbow to the fingers, extreme temperature differences between fingers, loss of strength in arms, extreme sharp pain in both elbows (Bi-lateral ulnar nerve entrapment symptoms).
Dermatographia/urticaria. Itching my body causes linear wheals/hives to appear, and redness/swelling occurs along the area I scratch. The symptoms are worse at night. The dermographia/urticaria can occur anywhere on the body/face and can migrate around the body due to physical contact like scratching, wearing a watch, bumping into something, or clothing rubbing against me.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: BV6J2527) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: STATIN EZ, start date: 01Nov2021, stop date: 08Oct2022. Past drug history included: Tetracycline, reaction(s): "Known allergies Tetracycline", notes: Known allergies Tetracycline; Doxycycline, reaction(s): "Known allergies Doxycycline", notes: Known allergies Doxycycline.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Shingles; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 The representative stated that she met with an NP (Nurse practitioner) yesterday who mentioned that a patient received their first dose of Shingrix at a local unknown pharmacy and developed shingles a couple of weeks to a month later. The reporter consented to follow up.
Patient reported he felt dizzy/lightheadedness few minutes after getting the covid-19 vaccine. He admits feelings of anxiousness in getting the vaccine, as he was scared to get the vaccine but he got the vaccine (Janssen) due to it being required for his job. His physical exam was normal except he was pale and diaphoretic. Blood pressure was 106/72 heart rate 62, oxygen saturation 99%.He was monitored for 35 minutes and reported feeling well. Blood pressure rose to 112/78. He left facility in stable condition with his wife.  Charge nurse followed up with wife the next day 11/9 and patient was said to only be experiencing a sore arm. Stable condition.
Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect product storage in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number P7K5P, expiry date 10th March 2023) for prophylaxis.   On 14th November 2022, the patient received Shingrix (intramuscular). On 14th November 2022, unknown after receiving Shingrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Linked case(s) involving the same patient:  US2022170353   Additional Information: GSK Receipt Date: 16-Nov-2022 Reporter's Comments:  The reporter was pharmacist (HCP). The patient was administered Shingrix vaccine, on 14th November 2022, after it was stored at room temperature for two weeks. The employee pharmacy within a medical center dispensed vaccine to patient or employee who was then directed to go to Human Resources (HR) for administration.  The patient or employee mistakenly took the vaccine home, stored it unrefrigerated for two weeks, then returned with it to HR for administration. Nothing else was reported.  The reporter consented to follow up at employee pharmacy or via email.  No other details were available at the moment of the call. Additional Supportive Information: the patient received dose of vaccine, which was stored at room temperature for 2 weeks, which led to incorrect storage of Vaccine.; Sender's Comments:  US-GSK-US2022170353:Same reporter
Platelets too low; Fever, 101.8F; Covid arm, rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (Platelets too low) and PYREXIA (Fever, 101.8F) in a 34-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 Bone marrow transplant (Patient had undergone bone marrow transplant 16 months ago.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelets too low) (seriousness criterion hospitalization), PYREXIA (Fever, 101.8F) (seriousness criterion hospitalization) and RASH (Covid arm, rash at injection site). At the time of the report, PLATELET COUNT DECREASED (Platelets too low), PYREXIA (Fever, 101.8F) and RASH (Covid arm, rash at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 degree fahrenheit. On an unknown date, Platelet count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is hospitalized for further treatment. The case number is given to reporter and he is going to call back for those details. Gave consent for safety team to follow up.  Company comment: 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.
heart palpitation, sweating, nausea, sore arm, collapsed on floor, throwing up
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 17-AUG-2010. The patient received the second dose of GARDASIL on 02-SEP-2010. Another dose of GARDASIL was given on 26-OCT-2010. The office would administer a dose of GARDASIL on today 16-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
I got very dizzy, like room spinning dizzy. Arm swollen up like grapefruit size and lymph nodes swollen up around my neck between my chin a shoulder blade.  In June I went to the ER I couldn't move my right arm, been having headaches. A couple weeks later had to go to the ER because I couldn't move my legs. I went to physical therapy.
Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately three days after vaccine administration patient developed itching and redness of face and body. Went to urgent care and prescribed hydroxyzine which patient took and immediately relieved symptoms. No other medications administered and no other symptoms reported.
Arm swelling X 48 hours after MENACTRA & GARDASIL given in same arm. Symptomatic treatment with BENADRYL, cool compresses.
Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Five minutes after receiving injection, pt c/o dizziness, shortness of breath and heart palpitations. Pt placed in triage room at 3:10 PM and given epinephrine and Benadryl by attending physician. At 3:14 PM, pt taken to ER by EMS where he was later released. Pt has since recovered without further adverse reactions.
Chills no fever. Felt like legs were made out of lead and walking was like walking in quick sand. Then chills stopped and started sweating but again no fever. Symptoms started about 6hours after vaccination and continued for 12 hours. Following 2 days felt very fatigued.
Patient received first dose of Pfizer vaccine but had already been vaccinated with Moderna's vaccine on 3/21/21 at "HS", assumed to be the high school where the patient lives. The patient did not have any immediate adverse events due to the pfizer vaccination. This record is to report vaccine administration error in which the patient received Pfizer 4/16/2021 instead of Moderna. A root cause analysis will be performed for this medication error.
PITYRIASIS ROSEA; RASH; .This spontaneous report received from a parent concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, and fragile x gene mutation, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18005022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced rash. On an unspecified date, the subject experienced pityriasis rosea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, and the outcome of pityriasis rosea was not reported. This report was non-serious.
1st dose 19/Sep/2022, no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose on 19 September 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 19/Sep/2022, no 2nd dose yet). The outcome of the incomplete course of vaccination 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 Information: GSK receipt date: 19-Apr-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
This spontaneous report as received form a pharmacist refers to a 68 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) in left arm and a dose of INFLUENZA (manufacturer unknown) (Lot # not reported) in her right arm on 22-SEP-2012. Concomitant medications included: Warfarin. The pharmacist reported that on 23-SEP-2012, the patient experienced left arm hard was swollen, painful and kind of hard to move and tender down to the elbow. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Information has been received from the healthcare worker who reported that on 05-MAY-2014, the a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0,5 (units not provided) of MMR II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter. Additional information has been requested.
After being fully vaccinated I contracted the COVID virus (05/14/2021). I had an bamlanizimab IV infusion.