chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lesions over body month after vaccine series; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BLISTER (Lesions over body month after vaccine series) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 0111J20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 1998. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for Migraine.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BLISTER (Lesions over body month after vaccine series). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and Manual therapy (high dose Prednisone x 7 days, 20mg daily.) for Blister. In March 2021, BLISTER (Lesions over body month after vaccine series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-111413 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: NNI On 06-May-2021: Patient demographics, medical history and concomitant medications were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-111413:Same reporter
some soreness in her arm; didn't know if there was some kind of sleep medicine in the COVID-19 Vaccine because she hasn't slept that good in years; didn't know if there was some kind of sleep medicine in the COVID-19 Vaccine because she hasn't slept that good in years; This is a spontaneous report from a contactable consumer (daughter) reported for her mother. A 95-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some soreness in her arm and didn't know if there was some kind of sleep medicine in the covid-19 vaccine because she hadn't slept that good in years on an unspecified date. No further details provided. Clinical outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
About 3 minutes after the vaccination was administered patient fell off their chair and began seizing. The seizure lasted about 20 seconds. Patient was on the floor in the fetal position, eyes rolled back and seizing. After the patient was alert and oriented. No history of seizures or diabetes.  Paramedics arrived and took patient from there.
This case was reported by a healthcare professional and described the occurrence of viremia in a female subject aged between 30 and 39 years old who was vaccinated with Twinrix for needlestick prophylaxis. In June 2007 the subject received the first dose of Twinrix (1 ml, unknown). At an unspecified time after vaccination with Twinrix, the subject experienced viremia and fever of 103 degrees Fahrenheit. The events persisted for 48 hours. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Twinrix.
Pt complained of golf sized bump on site with intense itch, burn, and pain. Also complaint of shortness of breath.
Pt called started vomiting 4 hours after vaccination and had to go to er, where they gave her lots of anti nausea meds. she is doing well the day after.
Allergic reaction to flu shot given 9/25/09. I broke out in hives. Treatment was 14 days of ZYRTEC 10 mg taken 1 x day. Dr (dermatologist) diagnosed and prescribed ZYRTEC. Still under treatment until 10/11/09.
Git weak, into a daze after HBV 32 given; felt weak no treatment given.
R arm swollen. Hot to touch pain-17cm top of shoulder to right above elbow.
See attached. 11/30/2009 PCP records from 10/30-11/23/2009, also ED record for visit 10/31/2009. Patient with c/o's upper and lower extremity weakness and numbness and blurred vision.
Low-grade intermittent fever from the day after the vaccination (11/19/2021) through 11/23/2021. Patient suffered two major seizures and a minor seizure on 11/22/2021. He had no prior history of seizure.
Pt. has increased swelling on L arm from top of shoulder to mid-humerus, rednessover same area with itching. Pt. also complains of pain upon movement. A small circular briuse is noted around injection site approx. 1cm in diameter, with redness around at injection site. Slight swelling was noted one day after vaccine was given, increasing to above discription two days after injection.
Pt states, "hard knot developed at site of injection, size of large lemon. Site was red and fevered. Could barely move arm. Knot had decreased in size by time of Dr visit." Reaction occurred approx 6 hours after injection. Tx'd with med for soreness.
Client received his vaccination successfully without incident. However, as he stood by to observe his friend  receive his injection, client became dizzy and nauseous. Client walked over to trash can and threw up. Dr.  present for assessment client. Client appeared pale and confirmed SOB, denied dizziness and nausea. VS: #1 BP: 83/45, P: 58, O2: 98%; #2 BP: 103/59; #3 BP: 122/86, P: 96. Dr.  encouraged client to drink a bottle of water and a bottle of Gatorade. Client was compliant. After-which, client denied SOB, dizziness and nausea. Color returned to his face. Dr.  released client to be observed for 15 more minutes under the observation tent. Client denied discomfort, dizziness and nausea at time of departure.   Client was stable when he exited the premises.
Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included rash all over chest and back 2 years ago and lupus. The patient's concomitant medications were not provided. The patient experienced rash on an unspecified date. The patient rheumatologist wants to put her on steroids-6 day pack then 5mg thereafter to quiet everything down but said to wait a week before starting to take it, however the pharmacist said it would not interfere. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fatigue; Muscle aches; Fever; This is a spontaneous report from a contactable consumer, reporting on behalf of their co-worker. This female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient experienced fatigue, muscle aches and fever. It was unknown if treatment was received. The clinical outcomes of the events fatigue, muscle aches and fever were unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
I couldn't even move tired; she was "ringing wet" that night; fever; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired). On 03-Mar-2021, MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired) had resolved.            No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-364859 (Patient Link).
Over one week after injection I am having itching, redness, a swollen lump at the injection site. This occurred when I got the injection but returned 8 days after the injection.
has been in bed x16 days; his breathing is worse; he had the weird prickly headache again; he is really having a hard time breathing; tired; has no appetite; the patient said he feels like he has been hit by a big truck.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 16Mar2021 at 12:45 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 23Feb2021 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization and experienced having a hard time breathing; in bed for 8 days and couldn't get out of bed; couldn't hardly eat, and had no appetite; really bad headache, a prickly headache; sweating but wasn't running a fever; really tired; and he was in bed for 8 days and couldn't get out of bed. The patient's medical history included COPD, diagnosed at least 10 years ago; and High Blood Pressure, Diagnosed maybe 15 years ago. The patient's concomitant medications included Felodipine for High Blood Pressure, 5mg once a day; Pro-Air for COPD, 90mcg PRN, Rescue Inhaler as needed, been on for at least 5 years; Spiriva for COPD, 2.5mcg 2 puffs a day, been on for at least 5 years; Breo for COPD, 200mcg one puff a day; and Albuterol for COPD, 0.083% use 1 vial, up to 4 times a day as needed. On 16Mar2021, the patient experienced he had the weird prickly headache again; he is really having a hard time breathing; has been in bed x16 days; tired; has no appetite; the patient said he feels like he has been hit by a big truck; and on an unspecified date his breathing is worse. The treatment received by the patient was started taking Advil a couple of days ago and it is dulling it. States she read that he should not be taking anything right away because the body needs to react to vaccine. States he is using his normal medications and increasing the frequency of his nebulizer. The outcome of event his breathing is worse was unknown and for all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client was diagnosed with COVID-19 at facility he lived at. Death was reported on 11/1/2022 by facility Administrator
Patient felt light headed, dizzy, slight SOB, nauseous, tingling on both hands, and sweating. Vital was taken by nurse on site. BP: 160/90. HR: 50. Oxygen: 99%.  Nurse and EMS cleared patient.  Patient left in stable condition.
Chest discomfort Windedness  Pain in arms Braydicardia Headaches
After getting vaccine patient felt lightheaded while sitting on chair in waiting room.  Pharmacy team member called 911 and they arrived and took his vitals.  Patient left with EMS.
pt recv vax OCT95 & devel an inj site rxn;this is one of four patients from this site who exp above rxn;
Body aches, prolonged headache, minor chills starting a few hours after the vaccine was given and lasting through the next day. No treatment was given or recommended, symptoms went away with rest and time.
Lost consciousness (passed out) for several seconds; Went pale; Started seeing stars; Remained weak for several hours; Nauseous; Chills; Fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lost consciousness (passed out) for several seconds, fever, chills, nauseous, went pale, started seeing stars and remained weak for several hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 05 Feb 2021, approximately few hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On 05 Feb 2021 Friday night, the patient had chills and fever. On 06 Feb 2021, patient gradually became nauseous, went pale, started seeing stars and then lost consciousness (passed out) for several seconds (medically significant event). The patient remained weak for several hours but gradually recovered and was back to normal at the time of this report.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, chills, fever, lost consciousness (passed out) for several seconds, nauseous, went pale, started seeing stars and remained weak for several hour was recovered on an unspecified date.; Reporter'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.
Extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness). At the time of the report, DIZZINESS (Extreme dizziness) was resolving.        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 reported. No treatment was given for the event.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: No specific follow-up information recorded.
10:20 received H1N1 flu shot in left arm. At 10:30 am, c/o lightheadedness, chest heaviness, shakiness, and anxious. Positioned her on lying on floor, elevated knees; gave water after vital taken. VSS taken at 1030, 1045, 1100, and 1115 am. RR 18-20 bpm, BP 130/98. Progressively felt better over 45 minutes of monitoring. At 11:20 AM felt completely better and teacher returned to work (classroom). Case manager called back 2 hrs later and reported she is feeling fine.
3 to 5 minutes after vaccination patient had nausea and then had a seizure that lasted about 30 seconds.  Patient was transported to ER via EMS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "bronchiecstasis" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: 01Nov2021, stop date: 04Dec2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date was 05Dec2022, and treatment stop date was 09Dec2022, patient had no allergies.  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 the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # J007354 and expiration date: 20-FEB-2016. On 01-MAR-2016, the patient received an expired dose of GARDASIL 0.5 ml, intramuscularly, lot # J007354 and expiration date: 20-FEB-2016 as the second dose of the vaccination series. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
pt recv vax 16JAN97 pt exp failure to seroconvert based on lab values;
Patient received Varicella vaccine (sub-cut) left thigh along with PCV-RT. Approx. 15 min later, mom noticed redness at Varicella inj. site. 16mm induration at site resolved after 1 hour.
pt recvd vax;numbness of hands & feet then progressed to lips & mouth;28oct,cough,fatigue,muscle weakness;to MD & given cortisone inject & ATB,sxs became worse in eve of 28oct;29oct was adm to hosp; PE=absent reflexes in arms & legs; tx wp;
Redness, swelling, warm to touch to left deltoid area with itching. Treatment: Motrin, Benadryl, Keflex.
Sore arm, malaise, fever, chills lasting 36 hours.  Refractory to tylenol.  Mild response to ibuprofen.
No adverse reaction. Moderna 1st dose was given on 3/9/2021 and 2nd dose was given on 3/29/2021 too soon.
Moderna bivalent booster dose was given 4 days after products expiration date. Lot# 044h22a.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, medical histories, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ taken orally, lot # M025565, expiration date 06-NOV-2017 (dose was not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Administered doses of vaccines were exposed to the temperature of 46.8 degrees Fahrenheit for 2 hours (date unspecified). A digital data logger was not involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011634.
UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI".  Additional information: Caller was calling on an employee who has a question, the employee had the vaccine on 24MAR2021. The second vaccine was next Wednesday, 14APR2021. Caller wants to know if the employee can take cipro or cipra for UTI while receiving vaccine. They haven't taken it, just wanted to know first. Caller adds that online it just says people can take antibiotics, and there was no interaction. Caller adds that the employee was waiting for approval to take the cipro. Caller adds she does not know the name of the medication - but confirms it was spelled cipro. Caller adds that online does not say Pfizer, it just says that covid19 vaccine has no interaction with antibiotics, so she was calling for guidance. caller does not have any information on the product the employee received. Caller adds that she was good, but not that good. Caller confirms it was the Pfizer Covid19 vaccine that she was calling about.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extremely tender, swollen, reddened  upper arm;dx arthus rxn;pt feeling much better today;
Patient reported blurry vision, feeling weak, tingles in hands immediately after administration.  We had patient sit for an extended period of time.  She feels better, but reporting slight headache.  After 30 minute observation, she returned to work.
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, 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. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and 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. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    No concomitant information was reported. Suspect product dosage text was reported as unknown. Doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023 No treatment information was provided.
Initial unsolicited report received from a consumer on 23 March 2016. This case involves a female patient (age unknown) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, route and site of administration were not reported) on an unspecified date of 1980. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications was not reported. On an unspecified date in 1980, three days following the vaccination patient was extremely ill and was staying in bed. The patient's lab data and corrective treatment were not reported. The patient had not recovered from the event. List of documents held by sender: none.
Difficulty swallowing sore throat. Within 15 min of shots given. Given prednisone 10mg-4 tabs, Diphenhydramine HCl elixir-2 tsp. Wheezing-albuterol 2.5mg. Was examined by NP and monitored in the office for over an hour.