chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced localized swelling and erythema that spread predominantly from the right thigh injection site. Patient had increased work of breathing, developed wheezing, and  began having a productive cough, runny nose, and red/itchy eyes. Hives appeared on the left side of the neck, left shoulder, and left arm. Lips were swollen. This began within seconds of receiving the vaccine. Patient was given EpiPen Jr (0.15mg) x 1 immediately, 2 puffs of albuterol and 22.25 mg of Benadryl at 1510. Respiratory symptoms, runny nose, and cough improved following EpiPen administration. Patient was transferred to ED for further monitoring. Patient did not receive additional medication while admitted to the ED.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-9 and patient will consider getting revaccinated.
pt recvd Tetanus shot 29JUN92 in ER; 2AUGu92 site became red, hard 23AUG92 site erupted w/purulent drainage; no c/o nausea; pt states that exact event occurred  in 1983 p/tetanus;
Patient is a 96-year-old female activated as a stroke in Urgent Care and transferred here and saw our Neurologist on arrival.  Not candidate for tPA based on INR of 2. CT head and CT angio head and neck were obtained prior to arrival.  Neurologist recommended inpatient MRI of brain.  Urinalysis is normal.  CBC unremarkable, digoxin 1, basic metabolic panel unremarkable, troponin 63, alcohol negative, ALT 11, magnesium 2, calcium 9.6 and quad nasal screen was negative.  EKG obtained.  No chest pain.  Patient admitted to Medical service for further workup and care.
Left arm soreness, numbness, and decreased range of motion for 3 months following vaccine.
This is a spontaneous report from a contactable consumer (patient)   A 30-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 02:30 (Batch/Lot Number: EL3247) (at the age of 30) as single dose for covid-19 immunisation. The first dose was received on 23Feb2021 03:15 PM in Arm left, Batch/Lot number: EL3247 (at the age of 30). Medical history included anxiety, Raynaud's phenomenon. Concomitant medication included nifedipine taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain on 17Mar2021 09:00, headache on 17Mar2021 09:00, chills on 17Mar2021 09:00, fatigue on 17Mar2021 09:00. No treatment received. The events recovered in Mar2021.    No follow-up attempts are possible. No further information is expected
Shingrix 50 MCG  - cold chills, fever, extremely hot, sweating, cold, body aches, nausea, muscle aches, bone aches, slight headache
Patient developed headache, body aches and occasional pox 2 days after injection. His 4yr daughter developed chicken pox (dx by pedi) 1 week after his symptom began. She had been vaccinated so had a very mild case
Red, swelling, hot, (R) deltoid. Woke with s/s. Tx CLARITIN.
Hives starting on 8/19/19 on leg  (took Benadryl to address them) then progressed over day of travel to full body hives, precipitating in an ER visit in Hospital (work related  trip) that evening (7pm ET) - hives reached from feet to tops of ears. Treated with Prednisone and  released with a 5 day prescription for prednisone and counseled to continue with antihistamines.  Did not receive epinephrine due to potential for irregular heartbeat (I have a history of PVCs).
vaccine created significant pain at time of injection.  2/1/20 patient felt uncomfortable, no appetite, tired and fever.  2/2/20 patient felt better. 2/3/20 arm was red and hot.  2/4/20  At 10am, arm was red and burning so made PCP appointment.  At 2pm appointment 1st noticed 5"x6" red raised area with 2"x3/4" blister.  Was diagnosed as cellulitis and treated with antibiotic, ibuprofen and undetermined cream per patient.  On 2/20/20 patient filled Medrol dosepack and silvadene cream to treat and reported treatment area was much improved
HAVENT BEEN ABLE TO STOP SHAKING; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced havent been able to stop shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from havent been able to stop shaking. This report was non-serious.
Bilat. lateral deltoid erythematous and edematous. BENADRYL given as tx.
Shingles the 2nd time; So painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had experienced shingles twice. The patient got the shingles vaccine and shortly after experienced shingles second time and was so painful. Additional Supportive Information: The follow up would not possible, as no contact, details were available. From the narrative it seems that the patient had shingles twice and shortly after vaccination the patient experienced shingles 2nd time, hence the case was not considered as suspected vaccination failure.
he felt tired the day of but continued doing his daily activities, on april 6 morning  a friend couldn't reach him by phone and went to his home and found him on the floor, the hospital said he had a brain bleed, acute hypoxia, the bleed was on the left side of his brain,   the doctor stated it was a cerebral bleeding  that cause him to fall.
Felt like "flu".....slight headache, upset stomach, scratchy throat ----fatigue .  Resulted in long afternoon nap, no appetite for most of the day.  Worst LONG TERM effect is FEVER BLISTERS !!...still in effect, 3 days later.  Recovered from fatigue and flu like feeling by 2nd day afternoon.....
My body felt like it was dipped in lead and that I was drugged; Felt very nauseous; blood sugars rocketed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 16:15 (Lot number: EW0175) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IDDM - type I" (unspecified if ongoing), notes: Other medical history: IDDM - type I. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=1, Lot number: ER8737, Administration date= 02Apr2021, Administration time: 11:00 , Vaccine location= Right arm), administration date: 02Apr2021, when the patient was 61 years old, for Covid-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 24Apr2021 06:00, outcome "recovered" (2021), described as "My body felt like it was dipped in lead and that I was drugged"; NAUSEA (non-serious) with onset 24Apr2021 06:00, outcome "recovered" (2021), described as "Felt very nauseous"; BLOOD GLUCOSE INCREASED (non-serious) with onset 24Apr2021 06:00, outcome "recovered" (2021), described as "blood sugars rocketed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, nausea, blood glucose increased.   Additional information: The patient had no known allergies. The patient was not tested with Covid prior vaccination and post vaccination. The patient did not receive any other vaccine in four weeks and received other medications in two weeks. The patient drank about a gallon and a half of water those hours.   No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients (no demographic details were provided). No medical history was provided. The pharmacist mentioned that sometimes, ZOSTAVAX stings for a moment when administered to a patient. ZOSTAVAX was administered subcutaneous. No further dosing information and no administration dates were provided. Furthermore, no co-suspected or concomitant medications were reported. It was reported that medical attention was sought in the pharmacy, due to the adverse event. The onset date of the adverse event stings for a moment was not specified. The outcome of stings for a moment was reported as recovered/resolved. The reporter did not provide a causality assessment for ZOSTAVAX and the adverse event. Additional information has been requested.
Developed what they are calling covid arm. Large red, inflamed rash on left arm over the injection site. It burns and is raised. Received prescription for Hydroxyzine as I am allergic to benadryl.
The day after I received the injection I had body aches, chills, and fatigue. I spent the day resting. By the following day I was 100% better.
Patient signed up to get Moderna booster #2 at her senior housing center. Patient came to appointment without her vaccine card. She went back to her apartment to get it, but was unable to find it. I did not have access at that time. Patient stated she received her first booster in November when we gave boosters to others in her building. She had received the initial vaccines with the health department in spring 2021. I learned today when putting the vaccines into the system, that patient had received booster #1 on 2/3/22.  Spoke to patient today (24 hours later) who stated she is feeling well
Patient received 0.2ml of the  COVID 19 Pfiizer/BioNTech which wasn't mixed with the diluent. Patient did wait 15 minutes in the office.  Provider will be calling the parents and let them know.
Headache, Myalgia, NauseaVomiting, SWEATS AND FATIGUE Narrative:
Narrative:  Pt has 1st dose Pfizer vaccine on 8/27/21. Reports headache for 5 days, ocular pain, and body aches with fatigue and weakness. Also reports join pain. Reports a fever for 2 days, diarrhea for 6 days after vaccination. Took APAP but did not provide relief. Reports 10 lb. weight loss because could not eat. Did not see MD or go to ED. Symptoms self-resolved.
Patient was administered ROTARIX after recommended age of 8 months 0 day per manufacturers guidelines. Incident was reported to GSK safety department and per correspondence and recommendations of WHO, vaccine is recommended to be administered prior to 24 months of age. Patient's mom was notified of error and recommended monitor patient's stools. No adverse event or reaction thus far, just error in administration.
Several hours after vaccine administration patient reported shortness of breath that has lasted several days. This effect has not been accompanied by any other signs or symptoms pe r the patient's report.
The initial reaction started as an injection site reaction about three weeks post-vaccine. It was painful and itchy. About two months after , on or around May 13, the initial injection, the rash from the arm spread to my chest, which then spread to my stomach. Near the end of June the rash from my stomach and chest spread to my back. At the beginning of July, it spread to my left arm. As of July 15, it spread to my nose and up my neck.
Slight pain in groin area, primarily on left side,  left testicle swollen to 3 times normal size
Erythema-surround site and up leg vaccine given at clinic 2 days ago (10/14/02) placed on Cephalexin and Benadryl.
Fever/chills/body aches six hours after the second dose which lasted for three days. The site of injection used to become sore every couple of days for almost two months. On July 20, had to rush to ER due to severe chest pain which could not be controlled for many hours. However, all tests related to heart came out negative. GFR (kidney function) has come down from 90 to 70. Lipid profile test showed high cholesterol which was normal until a few months back.
This spontaneous report as received from a physician via company representative refers to a 85 year old female patient. On 06-NOV-2006 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml/once. Concomitant therapies included gabapentin (it was reported that the patient was taking gabapentin (unspecified dose/frequency and manufacturer) at the time of the report, but it was unknown if she was using the medication at the time of administration ZOSTAVAX). On 03-SEP-2013, the patient developed shingles after administration of ZOSTAVAX. The outcome of shingles was not reported. The patient sought medical attention by an office visit on an unspecified date. The causal relationship between ZOSTAVAX and shingles was not reported. Additional information has been requested.
Day 1. Arm sore, neck ache, headache. Day 2-5 Slight redness at injection site. Day 6 Very bright red from injection site to elbow. Called Doctor. Advised to use warm, moist compress. No tenderness or fever, so just monitor.
within 24 hours circular brown spots about the size of a quarter and the color of a dark bruise appeared on both arms and at top of one leg;  spots were not painful and did not itch.  they are ongoing
tired and tipsy around 8:30-9 pm, bed early, then sweats/chills, 101.9 fever during night, terrible headache. Woke up tired and bit sore/achey but ok.
Swelling from elbow upwards, mild pain, red, itchy & puffy arm. Reaction happened the next day after the shot. Pt. was itchy & itched hard with her fingers. Reaction subsided on 9/3/09.
Moderna COVID-19 Vaccine EUA I'm not sure if this is an adverse side effect or not, but wondering if it might be.  Received vaccine on 3/12/2021 at approximate 11:00am.  At approximately 8:30am on 3/14/2021 I began itching.  Not much if any rash, feels more like under the skin.  Took Benedryl, which did absolutely nothing to take away the itching.  Continues yet today - 3/15/2021.  Neck, head, face and at times chest and legs.
Pt reports malaise beginning the morning following the shot, followed by a fever of around 101 for approximately 1 day. The malaise continued for 2-3 days after the shot.
At 8:45pm Pt started sounding like she was trying to vomit, turned grey and went limp. We rushed her to the ER at the medical center. When we got there, she was still unresponsive and she started to come to while we were being triaged. She had a fever of 100.3 at the time. We were sent to the waiting room; after an hour or two, she was fully alert and back to her normal color. We decided to go home and monitor her because there was a very long wait time at the ER and a lot of sick people and we were uncomfortable keeping her around that many sick people.  Saturday morning, she had a fever of 103, we gave her Tylenol and it came down. She didn?t have a fever the rest of the day. That afternoon, I went to change her diaper and noticed the bottoms of her feet were red, swollen and hot to the touch. She was then inconsolable for 4-5 hours and I spoke to the after hours nurse and the on call provider at pediatrics clinic and they said we needed to go back to the ER. We packed up and went to the hospital and they did a chest X-ray, labs, and EKG and all came back normal. They called it a brief resolved unexplained event.
Mild case of Covid after 3 doses of Moderna Covid; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) and COVID-19 (Mild case of Covid after 3 doses of Moderna Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 vaccination.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth). On an unknown date, the patient experienced COVID-19 (Mild case of Covid after 3 doses of Moderna Covid). At the time of the report, DYSGEUSIA (Metallic taste in mouth) had not resolved and COVID-19 (Mild case of Covid after 3 doses of Moderna Covid) outcome was unknown.            No other medications, medical conditions, labs, testing was reported.  On 13 MAY 2022, after taking Paxlovid immediately within 15 minutes of taking it, patient got a metallic taste in his mouth. Also reported that he had been double vaccinated and had one booster. The metallic taste in his mouth started spontaneously after the first dose of Paxlovid and it was still ongoing.  No treatment medications were provided by the reporter. COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old male patient with  medical history of 3 doses of Moderna COVID-19 Vaccine in January, February and August 2021 who experienced the unexpected events   of COVID-19 (AESI) and DYSGEUSIA unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. On May, 13, 2022 the patient started with NIRMATRELVIR, RITONAVIR at an unspecified dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old male patient with  medical history of 3 doses of Moderna COVID-19 Vaccine in January, February and August 2021 who experienced the unexpected events   of COVID-19 (AESI) and DYSGEUSIA unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. On May, 13, 2022 the patient started with NIRMATRELVIR, RITONAVIR at an unspecified dose The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received first dose Pfizer on 7/14/21 with signed consent form indicating no previous COVID-19 vaccinations and/or treatment. Upon documentation of Pfizer dose, report of Janssen vaccine on 4/5/21 was found in the ImmTrac Reporting System. Patient was called and did not admit to receiving Janssen vaccine. Called Pfizer medical line (interaction #00336730) and no guidance given to administer second dose Pfizer.
Vaccine Puevax -23 given at 5 pm (L) deltoid. At 7pm, pain, reden, swelling at site. Progressed today swelling at site and redes; 3 x 7 inches; Hot to touch, painful;
Pt recv vax on 1/13/99; on 1/16/99 pt exp red papular/raised/ itchy rash on breasts & hips, chilled feeling, swollen glands, fever (99.6); dx=scabies, contact dermatitis; tx=Ellmite w/ no change, Elocon cream,Alegra,cortisone cream,Benadryl
dizzy; fast heart rate; almost passed out; hot flashes AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HEART RATE INCREASED (fast heart rate), PRESYNCOPE (almost passed out) and VACCINATION SITE WARMTH (hot flashes AT INJECTION SITE) 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), HEART RATE INCREASED (fast heart rate), PRESYNCOPE (almost passed out) and VACCINATION SITE WARMTH (hot flashes AT INJECTION SITE). At the time of the report, DIZZINESS (dizzy), HEART RATE INCREASED (fast heart rate) and PRESYNCOPE (almost passed out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No treatment information was reported.
redness to throat and complaint of itchy throat; redness to throat and complaint of itchy throat; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 intramuscular at arm right on 29Mar2021 12:45 (age at 51 years old, Batch/Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included Cardio myopathy, multiple sclerosis (MS) and anaphylaxis to multiple meds. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine or received any other medications within 2 weeks of vaccination. It was also unknown if the patient was diagnosed with COVID-19 prior to vaccination or the patient been tested for COVID-19 since the vaccination. The patient presented with redness to throat and complaint of itchy throat on 29Mar2021 12:45. The patient was speaking in full sentences. The patient blood pressure was 110/70, pulse rate was 94, respiratory rate was 20, oxygen saturation was sat 97 %. Diphenhydramine hydrochloride (BENADRYL) oral at 25 mg given as treatment for the event and the patient was transported to ED for further evaluation. The outcome of the events was unknown.
Tired flu symptoms then the rash started-just a few each day and only on one side of the body, went to doctors, said it was shingles.