chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash started on arm, by Tuesday morning had spread to right side of abdomen. Rash kept moving over parts of body, eventually reaching neck and face. By Wednesday night throat was tight, went to hospital for steroid treatment. Currently taking prednisone, and Zyrtec, still have rash, waiting for results.
Patients eyes closed and felt weak after vaccination called paramedics and patient was checked out and released and went home. Patient remained conscious throughout and resolved on own
Sore ribs on right side beginning day 5 to 6 after vaccination. No rash or other outward visible signs.  No other explanation for soreness.   Soreness lessened over the following week but had not disappeared as of day 21 after vaccination.  Soreness is no longer interfering with daily activities  but does disturb sleep slightly.
On 09/19/2022 I received my Covid-19 vaccine. On 11/01/2022 I had an Atrial fibrillation and 11/03/2022 it was reported that I had a sinus rhythm. On 11/15/2022 it was reported that I had Bradycardia. I was prescribed XARELTO.
7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense heart beat, intense body shaking. I was taken to emergency hospital right away  for next 6 hours and then released home. Following day after vaccination: pain in the kidneys' area started, light pressure in the heart area Second day after vaccination: pain in the kidneys' area, lower and upper back pain, low blood pressure part of the day (94.5 F) Kidney area still in pain.
Pt c/o facial itching, tingling of face almost immediately p/vax; pt became diaphoretic, nauseous, BP 120/100; Given DPH; Also began shaking & feeling lightheaded; Went to pvt MD who recommended DPH;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease, Penicillin allergy, Sulfonamide allergy (Allergic to Sulfa drugs), Food allergy (Allergic to corn products and Mt Dew.), Drug allergy (Allergic to Ilosone), Drug allergy (Allergic to Cipro), Drug allergy (Allergic to Avelox), Drug allergy (Allergic to Valtrex), Drug allergy (Allergic to Flagyl) and Drug allergy (Allergic to Dacyclomins). Concomitant products included DIAZEPAM from 1977 to an unknown date and IMIPRAMINE HCL from 1977 to an unknown date for Agoraphobia, MESALAZINE (PENTASA) for Crohn's disease, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CITRATE;COLECALCIFEROL]) and ASCORBIC ACID (ESTER C [ASCORBIC ACID]) for an unknown indication.    On 20-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer stated that she has been using pentasa drug, 3 or 2 times per day, for Crohn's disease, since 2 or 3 years.  Treatment information was not provided.   This case was linked to MOD-2021-114492 (Patient Link).
Red, itchy raised area below injection site; pain in joints and muscles all over body (arms, legs, back, knee joints, elbows, wrists, ankles, calves), short of breath, weakness.  Severest late Saturday and through night of March 27th and March 28th.  Still feeling restrictions in back, lung area on Monday, March 29th.
This spontaneous report was received from a 79 year old female patient via a company representative referring to herself. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, in 2011 (reported as "5 years ago") the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route, lot # and expiration date were not reported) to treat shingles. On 12-DEC-2016,  the patient reported that her physician, confirmed she had developed shingles and the patient was given therapy to treat the rash that had, "developed quite well on the side of her torso".  The outcome of the patient's shingles was reported as recovering. The relationship between the aforementioned event and ZOSTAVAX was not reported. No product quality complaint (PQC) was involved in this report. Additional information has been requested.
This spontaneous report was received from a medical assistant (who is also the patient's parent) via a company representative, and refers to her daughter, an 11 year old female patient. The patient had no medical history, concurrent condition or drug reactions/allergies. On 04-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscular in the left deltoid, (lot # N004799 with an expiration date in 15-NOV-2019), (dose and frequency were not provided). Concomitant therapies included MENACTRA and BOOSTRIX. On an unspecified date in August 2017 (reported as "within 6 hours of receiving the dose"), the patient developed nausea and vomiting. Moreover, on an unspecified date in August 2017, the patient experienced arm pain for 24 hours and malaise for 48 hours. Additionally, it was reported that the patient did not seek for medical attention, no treatment was prescribed for the events and no laboratories studies were performed, as after 48 hours the symptoms were self-resolving. At the time of reporting, the outcome of pain in extremity, vomiting, nausea and malaise was reported as recovered after 48 hours on an unspecified date in August 2017. The causal relationship between the events and GARDASIL 9 was not provided.
Within 15 minutes of receiving Moderna second dose vaccine patient began experiencing facial flushing, hives, difficulty swallowing, sensation of throat closing, and chest tightness. Blood pressure: 138/88. SpO2 on room air: 97%. Heart rate: 104. NP administered Benadryl 50 mg via intramuscular to right deltoid. EMS arrived and assumed care of patient.
Pt recvd vax on 13JAN93 & 14JAN93 pt devel a mild petechial, not wildly itchy but warm to the touch dry rash that started below the inject site to wrist on lt arm, as well as on rt arm; rt arm was redder & warmer to touch;
I awoke this morning with irritation, pain and slightly blurred vision in both eyes.  The irritation is slightly worse in my right eye, but the blurred vision is mostly in the left.  At this point I have not sought medical attention for the event, but will continue to monitor. In addition to the eye symptoms I have more commonly known side effects, the injection site is sore and mildly swollen and general body aches.
This spontaneous report as received from a licensed practical nurse refers to patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB injection 10 (dose, therapy and lot number were not reported). Other suspect therapies included LIQUID PEDVAX HIB and COMVAX. Concomitant medications was not reported. On an unknown date, RECOMBIVAX HB; LIQUID PEDVAX HIB and COMVAX might have been administered to unspecified number of patients after being exposed to 30F for 6 hours. No adverse effects reported. Additional information has been requested.
Sore muscles, headache, fever, swollen supraclavicular gland or swollen scalene muscle (in that area hard to tell which)
Headache, fever (to 101.6), body ache, vomiting beginning < 24 hours after influenza vaccine received.
Pt had covid vaccines through Walgreens coming to her ILF. She had the vaccines 1/18/21 and 2/15/21. Pt presented with new edema on 2/17/21 and venous doppler confirmed. left peroneal DVT. Pt required oral anticoagulation. Pt is very self ambulatory and now previous hx of DVT. She has no dx of obesity.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Mango" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (lot number: 1910752A) taken orally from 04Aug2022 to 05Aug2022. Clinical course: Vaccine was received and within two weeks other medications were also taken.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and WRONG PRODUCT ADMINISTERED (Patient received the 611-year-old Moderna COVID-19 vaccine instead of the 12 plus Moderna COVID-19 vaccine).    No concomitant product was reported.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day. Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml. The vials were returned to the freezer and were still frozen.  No treatment information was reported.
ON 9/27/07 1145 RECEIVED VACCINE WHILE AT DAILYSIS CENTER AT 1730 WIFE NOTICED WHELPS DEVELOPED ON PATIENT FACE THAT WORSEN AND THEN GEGAN TO RESOLVE NEAR 2000, RESOLVED ON SKILL NURSE VISIT 9/28/07
Severe body aches, chills, fever, and nausea started one day after vaccination and have continued for past 24 hours.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the dose the patient received was unspecified. On an unspecified date, the patient developed genital warts after receiving the vaccine. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Almost two months later found out had COVID-19 I felt very congestion, coughing still going on today. After a shot got a bright red mark after vaccination and stung. I got also another green bruise a few days later.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional Information: The reporter stated that; he had been having symptoms for 3 months, ever since his first dose of the Pfizer BioNTech Covid-19 vaccine. He did not receive a second dose, stating that if he gets any worse, he will be dead. Has seen a neurologist as well. He reports that he was healthy before this and took no medications, and that he now takes a lot just to get a couple of hours of sleep. He said that you can get a vaccine on any street corner. He got the vaccine, and was severely sick; he lost weight, can't sleep, has ringing in his ears, and has severe pain. He says there were nowhere to get help, and that Pfizer needs to get together with the CDC and FDA to help patients and maybe fix the vaccine. States the doctors need advice; they don't know what to do. Has seen a neurologist as well. He reports that he was healthy before this and took no medications, and that he now takes a lot just to get a couple of hours of sleep. People are getting seriously ill. He says that if you get Covid, they'll give you top notch care. States it was mentally draining, and that this has almost killed him. He talks about a 17 year old football player that was bed-ridden, had heart problems, and was pulled out of school since getting the vaccine. He said the coach took a group of players to get the vaccine, and 3 of them got sick, including the aforementioned player. Caller himself went to the ER twice, and was given morphine the second time with no effect. He just wants Pfizer to take this concern seriously, and asks that it be moved up the ladder and not tossed in the trash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash started  12-09-04. Office visit stated diffuse maculo-papular erythematous rash on face chest and abdomen.  Benadryl allergy susp 12.5/5ml  3/4 tsp every 6 hours and prn for itching  Aveeno baths
There were no adverse events, the Hepatitis B was just given 2 weeks too early. Client will need to get the vaccine again. No adverse reactions noted.
cause of death of unknown aetiology (her spelling) coronary artery disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CORONARY ARTERY DISEASE (cause of death of unknown aetiology (her spelling) coronary artery disease) (seriousness criterion death). The patient died on 30-Jan-2021. The reported cause of death was unknown aetiology (her spelling) coronary artery disease. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant and treatment medications were reported.  Company comment- This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, male patient with no known medical history, who experienced the unexpected event of CORONARY ARTERY DISEASE. The event occurred approximately 11 days after the first dose of Spikevax and had a fatal outcome, with death occurring in this day. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown aetiology (her spelling) coronary artery disease
Fever, shaking, twitches, lost ability to focus, outburst, extreme adhd
right hand sore, hot to touch, beginning to tingle, progressed to left hand, hands aching
Migraine began at 01:00pm following hot flashes, diarrhea, vomiting and nausea at about 2:30pm. Migraine became more pronounce when under light. Sweating began at 8:30pm when I notified charge nurse of side effects and requested to leave. I?ve taken 500mg of Tylenol at 1:00pm which helped until 3:00pm when I took 500mg again which lasted until 11:00pm when effects of medicine started to wear off.
Treatment of COVID-19/positive COVID-19 infection; Treatment of COVID-19/positive COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8732) and on 23Apr2021 as dose 2, single (Lot number: EW0170) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23Apr2022 as dose 4 (booster), single (Lot number: 001M21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) in two weeks included: LEVALBUTEROL HCL; SINGULAIR; SYMBICORT; XYZAL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19/positive COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Rebound - return of positive COVID-19 infection; (Jul2022) negative, notes: repeat negative testing following completion of paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details for COVID-19 Treatment included Brand-PAXLOVID, with treatment start date on 07Jul2022 and treatment stop date on 12Jul2022. Rebound-return of positive COVID-19 infection after repeat negative testing following completion of paxlovid course. Adverse event start date was reported as 16Jul2022.
missed the second dose of Twinrix at appropriate time; This case was reported by a pharmacist  and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on an unknown date in February 2020).   On 16th November 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient received 1st dose and missed second dose of Twinrix at appropriate time. The patient received the dose but later than recommended interval, which led to lengthening of vaccine schedule. The reporter did not consent to follow up.
headache, sore throat, body aches, runny nose, dry cough, scratchy throat, chills starting 12/21/21
Presented with slightly swollen and reddened area starting from shoulder socket down - Lowest part of swollen circle area appears to be just above where vaccination would have been given. It is not itchy or irritated and does not hurt, it is slightly swollen and warm to the touch per patient Started am of  3/13/21 --Recommended cold (ice) compresses this evening and tomorrow and Gave patient my cell phone number to check in if needed