chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for COVID; Positive for COVID; Second dose would be administered more than 42 days; Second dose would be administered more than 42 days; This is a spontaneous report received from Medical Information from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration on 05Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient received his first dose of the vaccine on 05Mar2021. He tested positive for COVID-19 and received the monoclonal antibodies/ passive antibody therapy on 21Mar2021. The pharmacist inquired if the patient will need to wait 90 days before receiving the second dose of the vaccine. The pharmacist inquired if the patient will need to restart the vaccination over with the second vaccine being about four months out. The second dose would be administered more than 42 days, longer than recommended intervals for mRNA vaccines. The outcome of the events drug ineffective and COVID-19 was unknown.  The lot/batch number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
starting Sunday he was achy with fever (for 3 days). arm swollen and red to the touch and also a cough.
After patient's second set of toddler shots he began to have staring spells, he lost words and had problems walking his head also swoll up. He developed.
Pt reports receiving vaccine afternoon 8/19/14. Went to work that night, noted slight arm pain. At work second night, started running fever, noted swelling, increased pain left arm. Unable to break fever w/ antipyretics. To emergency dept 8/22, admitted to hosp for IV antibiotics. Discharged 6PM 8/23 on po HTB. Details obtained per phone w/ patient.
Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Oct2021 at 11:00, outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No Other medications in two weeks. Patient received Treatment with Paxlovid from 06Apr2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Nausea; Running fever; Woke up shaking really bad; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Woke up shaking really bad), NAUSEA (Nausea) and PYREXIA (Running fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Woke up shaking really bad). On an unknown date, the patient experienced NAUSEA (Nausea) and PYREXIA (Running fever). At the time of the report, CHILLS (Woke up shaking really bad), NAUSEA (Nausea) and PYREXIA (Running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient treatment information was not provided.
A third dose of monovalent MODERNA 6 months to 5 years was administered instead of a bivalent dose.
coronary artery disease (three blockages); Three blockages; has also not received the second dose of Shingrix due to the COVID-19 outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of coronary artery disease in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronary artery disease (serious criteria clinically significant/intervention required), heart block and social problem. The patient was treated with total blood transfusion. On an unknown date, the outcome of the coronary artery disease, heart block and social problem were unknown.   It was unknown if the reporter considered the coronary artery disease and heart block to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced coronary artery disease with three blockages and had to have a triple bypass and blood transfusions.  This patient had also not received the 2nd dose of Shingrix due to the COVID-19 outbreak. The reporter consented to follow up.
This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck), lot number L031602, expiration date 18-FEB-2017 (dose and route not reported). Concomitant therapies were not mentioned. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 4/9/01 about 17:00, redness noted to RLT. Mom put child in warm water to soak and bathe child. Motrin was given for fever. On 4/10/01, mom took pt to ER due to fever of 103F with mom having given Tylenol and Motrin. Redness had worsened. ER evaluated and counseled mom to continue warm soaks and Tylenol and Motrin. On 4/12/01, mom brought pt in to be re-evaluated. RLT reddened with lower border skin taught and measures 6.5cm at widest point. Skin is not broken but warm to touch. Mom states fever continues but using Motrin and Tylenol to reduce. Fever today only around 101F-102F. Re=evaluation on 4/12/01 done at health dept.
Presented to clinic on 8/4/06 with c/o HA, fever, and chills. Diagnosed as Smallpox viremia. Toradol 30mg given IM. To push fluids. Discharged with Motrin order and return to clinic prn.
Felt flushed in face and noticed hives (without itching) on face, chest, arms, legs, and back. Experienced no difficulty breathing or speaking but felt a bit "lethargic". On his own, took Benadryl 50 mg without relief. Then went to Emergency Center for evaluation.
9 days after vaccine administration (5/15/19), developed fairly acute onset of headache, chills and malaise.  Over the subsequent 4 days she developed  worsening arthralgias, starting in distal medium joints that progressed to generalized arthralgias to the point that she had difficulty ambulating.  On 5/20/19 admitted to hospital for 24 hr observation and started on a 6 week course of steroids.  She had to cancel her planned overseas trip for which she received the vaccinations in the first place. She went on to a complete recovery of her symptoms over the subsequent weeks of treatment with steroids and has no permanent sequelae or persistent symptoms.
got the 2 shots and broke out again/suspected vaccination failure; got the 2 shots and broke out again/when they broke out, it was worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the 2 shots and broke out again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the 2 shots and broke out again/when they broke out, it was worse). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient v                                                                                                                                                                                                                                                                                                                                                                                                              interactive digital media. The patient received two shots of shingles vaccine and it only lasted for 8 months before he/she broke out again with shingles. The patient reported that it was supposed to be lasted at least 3 to 5 years and when they broke out, it was worse than without the shots. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Case previously recorded as MA2009-3971. Initial case report received from a nurse via Novartis on 06 NOV 2009. A child under the age of 4 was vaccinated with an off label use of S-OIV FLUVIRIN (batch no. 102044P1) 0.5 mL i.m once on 06 NOV 2009. No adverse effect was reported. Company reference no.: NA09-007775.
Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart.  Rate measured at 100 bpm.  Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.
Hospitalization 8/15/22-8/18/22 weakness, cough, SOB, lightheadedness, fever, pleural effusion, hypoxia, UTI, thrombocytopenia,
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history and current conditions were not provided. On unknown day in 2008 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route were not reported). On 09-APR-2015, the patient was vaccinated with a second dose of GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse event was reported. Additional information has been requested.
Wasn't breathing the next morning.  Kept turning white when he would sleep.  He has been having staring spells and sleeping much more than normal. He has also been less responsive than he was prior to the shots.  He was put on an event monitor and admitted to the hospital the evening after his shots to be checked for sleep apnea.  He has been given an EEG and will have a CT scan today to check for seizures. I do not know the manufactures of the shots or where they were administered exactly... only that they were given in his legs.
A couple of days after I got a rash on my arm.  Looked it up and I believe they are calling it "Covid Arm"  started two days after vaccine and lasted about 4 days.  It was hot and red and was raised.  Did not itch until the last day and did not hurt but was uncomfortable.  It went from the top of my arm by the injections site down to about 2 inches above the elbow, so about 7 inches long and went about 3/4 of they way round my arm.
No adverse event; Dose administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 20-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after published expiration date).    It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient received 4 doses of Moderna vaccine previous on an unspecified date.  Treatment information was not provided.
1 hour after vaccine administration, patient had burning sensation upon raising vaccinated arm and opposite arm soreness from shoulder to elbow.
Swelling of lymph nodes under jaw line on my right side only, tenderness and minor swelling of cheek just above.
Information has been received from a registered nurse female who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The nurse developed a zoster-like rash on both sides of her mid-line after administrations of ZOSTAVAX (Merck), on 02-DEC-2010. It was also reported that the rash had resolved (date unspecified). The patient sought unspecified medical attention. Follow-up information has been received from the registered nurse who reported that the rash that she had experienced did not happen until about 18 months after receiving ZOSTAVAX (Merck). She also reported that she did not report this event to her physician and had been thinking to find a description if breakthrough a case of shingles. She mentioned that she was not even sure if the rash was shingles. The query was rule out curiosity. She did not want to take this any further. Additional information is not expected.
pain/soreness at injection spot from covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in. In August 2021, the patient experienced VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination). At the time of the report, VACCINATION SITE PAIN (pain/soreness at injection spot from covid-19 vaccination) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken of co-suspect ADALIMUMAB (HUMIRA) was reported as unknown with respect to the event.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  It was reported Primary reporter contact for lot number information was unsuccessful.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Live follow-up received additional no new information was reported.
5AUG91 c/o itching on chin, forehead & ears & between eyes; 6AUG91 hives on face, swollen nose, o.s. swollen shut ears swollen & reddened; Redened raised area 1.5" diameter on waistline; 7AUG91 instructed to see MD or go to ER; t99;
Local skin reaction - red, approx 4 cm, round, mildly indurated, itchy. Tx - compress, TYLENOL, steroid lotion for itch. Return if worsening.
After the vaccine he came home, felt a little less sore than a flu shot.  The next day when he took a shower, and when he went to wash under his armpit was very swollen, and very tender.   He put some ice on it which did not help the swelling.  It bothers him when his T-shirt touches the area, so he tried to wear a regular shirt.  He also had achy pain in his back, weakness in his arms, sore throat and a little cough, no fever.  The armpit still hurts and is still swollen.  Other than the ice he did not take anything else as he takes a lot of medications as it is.  He has not called his doctor because it happened over the weekend, but is going to call her today.   He did have a COVID test yesterday drive through facility at the community hospital as he has a surgery coming up, and they were going to call him if it was positive.  He is scheduled for surgery on his right knee on Thursday.
hives, various places on body, started around midnight on the day of vaccination.   Hives have been recurring on a daily basis, tends to be worse at night.  I've been taking antihistamine, 125mg, daily, averaging between 2 to 3 per day.  Hives don't seem to be progressively subsiding.
Couldn't breath, dizziness, pain in heart, couldn't talk. Pharmacist administered epipen. I was taken to the emergency room where tests were ran. I was discharged by 10:00pm.
Headache, chills, dizziness, nausea, muscle soreness. I didn't seek out treatment beyond taking over the counter medications for the symptoms. Unsure of outcome as symptoms are still present as of this reporting about 24 hours after shot.
ADULT PT GIVEN A TETANUS TOXOID INJECT AND EXPER CHILLS AND REDNESS AT SOI
Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left arm where shot was received.
This spontaneous report was received from a registered nurse (R.N.) via telephone call on 20-OCT-2015, concerning a 5 year old patient of unknown gender. No concurrent conditions or medical history were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024825 Expiration date: not reported) and with an improperly stored dose of VARIVAX (Merck) (Lot No. L005299 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Pt is experiencing swollen lymph nodes. Can't raise arm or make a fist. Started day of vaccine administration a few hours later
YF incident. Faulty syringe. As soon as the plunger was pushed, the syringe started leaking and the syringe was immediately pulled out by pharmacist #1. Spoke to manufacturer and confirmed most likely patient did not get the vaccine. Confirmed patient and family to proceed ahead with a full dose (2nd shot) from pharmacist #2. Informed family of all the risks of not repeating a dose or getting shot #2 even if there was a slight chance of getting a bit of the vaccine from shot 1.
Pregnant while receiving the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant while receiving the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
G51.0 LEFT FACIAL PALSY 3/1/2023 BELLS PALSY
Patient presented to the ED and was subsequently hospitalized for acute on chronic respiratory failure, COPD exacerbation within 6 weeks of receiving covid vaccination.
Headache jaw pain Narrative:  employee states: she has an increase in pain going from the injection site up to her jaw and behind the ear. Additionally she is experiencing a headache.
MUCOUS SINCE PROBABLY AFTER TWO WEEKS GETTING THE SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced mucous since probably after two weeks getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mucous since probably after two weeks getting the shot. This report was non-serious.
Two days after vaccination patient has a 30-40 min episode of upper and lower extremities rhythmic jerking movements without LOC; No fever;recovered with IV valium.