chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; BREATHING ISSUES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: asthma. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. On an unspecified date, the patient had breathing issues within 20 min of vaccination and used Albuterol inhailer (Dose number in series 1). The outcome of the breathing issues was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had breathing issues (used Albuterol inhailer) within 20 min of vaccination and the patient was ok. The patient got covid (suspected covid-19 infection) and was sick for 5 weeks (Dose number in series 2). It was reported that "I took 2 shots and had breathing issues within 20 min. Each time I took a Covid shot. I had to use my Albuterol inhailer and I was ok. was afraid to take the third one. My doctor wanted me to take the third one and said I would still have the breathing issues with it too. I didn't take it. I got Covid and I was so sick for 5 weeks. Wasn't sure I was going to make it. I have asthma too ".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and breathing issues was not reported. This report was non-serious. This case, involving the same patient is linked. This report was associated with a product quality complaint:
A report has been received from a health professional concerning a (herself) female patient. No information was provided regarding relevant history, concurrent diseases and concomitant medications of the patient. The patient has been received FLUMIST (intranasal), unknown frequency, started on an unknown date for an unknown indication. A female patient received FLUMIST, and a few days after she got very sick with Flu symptoms. The outcome of the event of got very sick with Flu symptoms was unkonwn. The report was considered to be non-serious by reporter. The reporter considered the event of got very sick with Flu symptoms with the suspect drug of FLUMIST to be related.
Shrill high pitched cry approx 2 hrs p/receiving immun & screamed for 2.5 hrs constantly;
I had redness and soreness at the injection site which redness spread to approx a 2-inch blob. In the next 24 hours I started to feel lethargic and ran a fever of 101 and laid in bed for a day.  This happened both times I had the shots. The redness and soreness went away in 3-4 days and the fever after 24 hours.
pt stated that her left arm got very sore and she was very fatigued.   A couple of days later she had bad body aches, lightheaded with chills.  Pt had a virtual appt w/ her PCP and for her to be tested for Covid since she had been exposed.  She tested negative.  Doctor told her take Tylenol and meloxicam.  She kept these symptoms about 6 days before they subsided.
ACHY; SLIGHT HEADACHE; SHOULDER PAIN AT INJECTION SITE; WEAK; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced shoulder pain at injection site. On 11-MAR-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, slight headache, shoulder pain at injection site, and weak. This report was non-serious.
c/o itching localized to skin rash or sore Anthrax reaction shot in right arm 2 days ago " per health record".
my arm's a little bit sore, but otherwise I feel fine; This is a spontaneous report received from a contactable physician. This male physician of unspecified age reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number: unknown) via an unspecified route of administration on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported on social media that his arms were a little bit sore but otherwise he felt fine after receiving the vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient experienced severe pain on left arm about 2.5 hours after getting the vaccine. Patient couldn't lift the arm on top of his head. Patient took 2 tabs of Aspirin 325 mg and put cold compress on Oct 13 and 2 tabs Acetaminophen 500 mg on the morning of Oct 14. I advised the patient to take Ibuprofen (if not allergic) to help with the swelling and inflammation.
feel dizzy and faint; feel dizzy; felt so bad; couldn't breath; sick; irregular heart rhythm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EVEL64) at the age of 51 years 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: ARRHYTHMIA (medically significant) with onset Aug2021, outcome "unknown", described as "irregular heart rhythm"; SYNCOPE (medically significant) with onset 03Aug2021, outcome "unknown", described as "feel dizzy and faint"; ILLNESS (non-serious) with onset Aug2021, outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "unknown", described as "feel dizzy"; FEELING ABNORMAL (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt so bad"; DYSPNOEA (non-serious) with onset 03Aug2021, outcome "unknown", described as "couldn't breath". The events "feel dizzy and faint", "feel dizzy", "felt so bad" and "couldn't breath" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) kept going up and down; electrocardiogram: (2021) abnormal; heart rate: (2021) was up. Clinical course: Caller stated that 5 min after his first dose of the Pfizer Covid Vaccine he began to feel dizzy and faint. He was kept at his Dr. office until they closed. Caller said when he left he had to try and drive slowly home but had to pull over because he felt so bad. Caller said he felt dizzy and like he couldn't breath for almost an hour sitting in his car. He said a police office stopped and drove him home. Caller said he later went to the hospital and his blood pressure kept going up and down his heart rate was up and he had an abnormal EKG. Caller said he previously went online and made report to Pfizer. Reported everything through the app. Ended up having to go to the hospital. Now has an irregular heart rhythm. Caller was sick for so long, he doesn't want to die. Clarified caller was referring to the COVID-19 Vaccine. Had the reaction after the first dose. Did not get second dose.   Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of palpitation in a 32-year-old male patient who received RABAVERT (batch number 587011A, expiry date 30th April 2019). Concomitant products included Tetanus vaccine and immunoglobulin. On 20th September 2016, the patient received the 2nd dose of RABAVERT (intramuscular). On 20th September 2016, less than a day after receiving RABAVERT, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was not recovered/not resolved. The reporter considered the palpitation to be almost certainly related to RABAVERT. Additional details were provided as follows: On 16th September 2016, the patient received Tetanus vaccine on an unknown arm. The patient received 2nd dose of RABAVERT in his left arm and experienced heart palpitations in the same night. The patient reported that he had been to the emergency room twice since 20th September 2016. The patient planned to continue follow-up with his physician on an unknown date. The vaccination date was wrongly reported as 16th September 2016 for suspect vaccine, however corrected to 20th September 2016 as per narrative description.
Right deltoid erythema 6 cm x 6 cm area hot to touch. Tx. with Augmentin 200 mg bid and Benadryl
No adverse effects were reported; The patient received her fist dose of the vaccine on 01-JUL-2015 and she was in the office "today" for her second dose; This spontaneous report has been received from a nurse prescriber concerning to a 23-year-old female patient.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 01-JUL-2015, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified day in June 2019 (also reported as today), the patient was in the nurse's office for her second dose (inappropriate schedule of product administration). No adverse events were reported.
we have had 3 doses total; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patients received 3 doses of Shingrix, which led to extra dose administered. The reporter stated that, after getting shingrix vaccine, they found paperwork which showed that patients had already received 2 doses. This case has been linked with US2021AMR101266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101266:same reporter
Breakthrough seizure; This is a spontaneous report from a contactable consumer. This consumer reported for a 16-year-old male patient (reporter's son) who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW0183 and expiration date was not reported), dose 1 via intramuscular route, administered in arm right on 08May2021 at 09:00 as dose 1, single and dose 2 via intramuscular route, administered in arm right on 29May2021 at 09:00 (lot number was EW0191 and expiration date was not reported) as dose 2, single for COVID-19 immunisation. Medical history included epilepsy. The additional information reported as: he had not a seizure in over an year until he got the vaccine. He was on medication and he has just got his level checked, a month before and they were fine, they were in range. The patient did not receive any other vaccination within 4 weeks prior to the first administration of the suspect vaccine. Concomitant medications included levetiracetam (KEPPRA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in May2021, the patient experienced breakthrough seizure. The clinical course of the event was reported as: The reporter was calling just to let know that, a week after each of the vaccine shot the reporter's son got, a week after each of those shots he had a bad seizure, a breakthrough seizure which was he was on his medication. His end level range and had seizure that whether it was the side effect from Pfizer or not the reporter just wanted to make aware it happened both times the first time was coincidence but happened twice, just wanted to make aware. 09 days after the first shot he got a seizure and then after his second shot, 12 days later he had a seizure. The reporter inquired if someone aware of it, in case someone else had the same thing. The outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
The day after the 3rd dose, I started experiencing a dry cough and mild pressure in the chest, along with other known side effects of the vaccine (fatigue, joint pain, sore arm, low fever 100.3).
Immunization given on 2/25/14, c/o pain in right thigh 2/26/14, warm and indurated on 2/27/14. Was seen in the office on 2/28/14. Rt thigh with 7x7 cm area of erythema and induration around the injection site. Antibiotics were used for pain.
Information has been received from a physician concerning a 9 year old female with penicillin allergy and Rocephin hypersensitivity and a history of gastroesophageal reflux and stomach ache who on 19-JUN-2008 was vaccinated intramuscularly with first dose of GARDASIL (lot # 659655/14486U) 0.5 mL, on 20-AUG-2008 was vaccinated with a second dose of GARDASIL (lot # 660389/1968U) and on 20-NOV-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). There was no concomitant medication. On 20-NOV-2008 the patient developed a swollen and red area about the size of a golf ball at the site of injection after the third dose of complained of pain when pressure was applied to the area and during movement of her arm. The patient visited the office. Ice was applied to the area and improvement occurred within 20 to 30 minutes. At the time of reporting, the patient was recovering. Additional information has been requested.
Patient reported muscle stiffness, tightness of chest, swelling and redness of injected arm.
* see 2nd page written by the patient discussing this in detail. The reaction involved the pneuno vaccine (left arm) fever 102.6, arm swollen, red, cellulitis, AB tx
After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse  and had a phone consult with Dr.  I had a blood test the following morning and recieved a call the next morning at 5:40 a.m. directing me to my local Emergency Department as my platelets measured only 16.  I checked in 3/30/21 and following a new blood test showing my platelet count was down to 2, a Gastroenterologist diagnosed me with severe ITP.  I then was treated with prednisoone, plasma transfusion and IGG (i think) infusion.  An additional blood test showed my platelet count rose to 50.  A CT scan showed no abnormalities.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported vaccines were reconstituted with less than the recommended amount of diluent. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA007501, 1407USA008557 and 1407USA008559 via same reporter link. Additional information has been requested.
Shingrix vaccine soreness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The pateint asked for recommendation of pain killer for Shingrix vaccine soreness.
At 12:30pm, approximately 5 minutes after administration, patient reported itching and hives on the neck and back.  She did not report difficulty breathing or swelling on the neck and face.  The patient did not report any adverse event with the previous doses in the series.  The patient purchased diphenhydramine 25mg tablets and took one.  She remained to be observed.  At 12:50 pm the patient reported feeling much better and left the pharmacy.  We advised to follow up with her primary care physician and to advise us of any changes in her condition.
Information has been received from a healthcare worker concerning a 13 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 28-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, unit and route not reported, lot # L046506 and Exp. date 17-MAY-2017) (inappropriate schedule of drug administration). No adverse effect was reported. This report is linked with 1603USA013691 (sibling and same reporter). Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 45 years old female patient. The patient was inadvertently vaccinated with PROQUAD (lot number, dose, route not reported) instead of MMR II on 22-OCT-2012. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 21Aug2022 at 14:00 as dose 5 (booster), single (Lot number: FP7138) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Generalized Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "chronic moderate Asthma" (unspecified if ongoing); "Known allergies: Lavender" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 01Mar2022, stop date: 13Sep2022; BUSPIRONE, start date: 01Apr2022, stop date: 12Sep2022; ESCITALOPRAM, start date: 01Jun2022, stop date: 20Sep2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2022, stop date: 20Sep2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient was mistakenly given Moderna Covid19 Vaccine meant for 18 years and up. Per CDC recommendation It's ok but we still need to report it. Patient has not reported any allergic reaction. Patient was also observed for at least 15 minutes before allowed to leave the facility.
My tongue started to tingle and became itchy, I started to get slight shortness of breath, I had benadryl 25mg po . called 911 because I was on the highway when this started to occur. EMS and police came, by the time the EMS arrived the symptoms had stopped. I went to a friends house to sleep off the benadryl, came home, called my primary physician I have an appointment with her in the am.
(L) arm pain s/p tetanus vaccine (Tdap) that triggered migraines.
w/in 5 minutes p/DTP/OPV, pt exp generalized hives lasting 1 hr & local rxn described as red & warm to the touch; tx DPH & APAP for 24 hrs; local rxn still present @ time of this report;
experiencing itchiness; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than 2 weeks after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix two weeks prior to the report, and at the time of report the patient experienced itchiness. The patient wanted to ask if this was side effect of Shingrix. The follow up is not possible.
Client called Clinic on 11/16/2010, informed me that her L arm was expectedly sore for a couple of days after injection, the ache continues without improvement.  She also c/o loss of L arm push and pull strength.  She informed me that the shot never hurt, that she thought it was a good shot, and she never had any problems with her arms before the shot.
Sore arm; Intense headache; Chills; Sweating; Throwing up; Diarrhea; Rumbling stomach; A lot of tension; Tightness from the middle of my head; Lightheaded; Tightness from the middle of my head down to my upper back and shoulder area.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 19:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Sep2021 at 07:00, the patient experienced sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach, also and still had a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded often. Reactions lasted for 3.5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, intense headache, chills, sweating, throwing up, diarrhea, rumbling stomach was resolved on 27Sep2021; while that of a lot of tension, tightness from the middle of the head down to her upper back and shoulder area and lightheaded were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.