chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Feeling Achy; Feeling supper exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Feeling Achy) and FATIGUE (Feeling supper exhausted) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Feeling Achy) and FATIGUE (Feeling supper exhausted). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Feeling Achy) had resolved. At the time of the report, FATIGUE (Feeling supper exhausted) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The symptoms started 3 to 4 hours after receiving the vaccine and it got worse 6hours after receiving the vaccine. The symptoms lasted for about a week, but he still feels exhausted.
Information has been received from a licensed practical nurse concerning a patient who in July 2007, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The nurse stated this was an error by a staff member and not product confusion. No adverse experience is related to this event. No further information was provided. There was no product quality complaint involved. Follow up information from the registered nurse indicated this was truly a human error by a new employee (nurse) who had been trained on vaccinations for 1 month. The nurse was not paying attention and the office believes that the nurse may have dyslexia as other issues have arisen in their office which indicate this (none were provided). The patient did not experience any adverse events from the vaccination. Additional information is not expected.
Potential revaccination with Bivalent vaccine as the first dose in the primary series; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Bone marrow transplant.    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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series) 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 OFF LABEL USE (Potential revaccination with Bivalent vaccine as the first dose in the primary series).    The concomitant medication was not reported by reporter. It was reported that patient need of revaccination of primary series, potential revaccination with Bivalent vaccine as the first dose in the primary series. Patient who had a Bone Marrow Transplant and needed to restart the COVID vaccine series. Patient had not been able to find the monovalent vaccine locally and patient's doctor said she could repeat the series using the bivalent booster vaccine. The treatment medication was not reported by reporter.
2 3/4 in. by 1 3/4 in. area of redness with some swelling and slight itchiness.
pt recv vax 19OCT98 & pt devel an inj site rxn characterized by redness, swelling, warmth, itching, pain & a huge knot;tx w/cortisone cream 7 recovered p/1wk;
Chills, body Aches, headache diarrhea, Very Tired symptoms started about 22 hours after Vacine
No adverse effects reported; one unspecified patient received third dose in vaccination series of GARDASIL 9 "four months late" on 04/29/2019; This spontaneous report as received from a Pharmacy Technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-APR-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # R001262 and expiration date 10-NOV-2020 per intramuscular route for prophylaxis four months late of the appropiate scheduele. Pharmacy Technician reported that patient received first dose and second dose in vaccination series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as per the prescribing information. No adverse effects were reported.       This is a non-valid case due to no patient identifier.
A spontaneous report  was received from a consumer concerning fea 51-year-old, female patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced Injection site pain. The patient's medical history, was not provided by the reporter. Concomitant medical conditions were reported included  Liver enzymes elevated, pancreatitis - doesn't feel symptoms,in menopause - has hot flashes. Concomitant Product Code were reported amlodipine 10 mg atenolol Bayer aspirin, vitamin supplements. The patient received their first of two planned dose of mRNA-1273 on 22 Jan 2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) in the left, non-dominant upper arm at a Walmart Pharmacy for prophylaxis of COVID-19 infection. Experienced injection site pain.  On the morning of 23 Jan 2021, after receiving mRNA-1273, the patient felt "pain" in the arm. Treatment for the pain included with ice and cold packs and took one hydrocodone. No relevant lab data was reported by the reporter. Action taken with mRNA-1273 in response to the events was not reported. The outcome of Injection site pain was unknown. The reporter did not provide an assessment for the Injection site pain. Patient gave consent for Safety to follow-up with them if necessary. Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, the patient's healthcare provider at an outpatient clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Information has been received from a pharmacist concerning multiple unspecified patients of unknown age and gender. On unspecified dates, the patients received doses of ZOSTAVAX (dosage and route not reported, lot # K016318 with expire date of 24-DEC-2015) that was improperly stored. The conditions storage was "-10 Centigrade" for 1464 hours. There was previous intermittent temperature excursion over a few months. No adverse effects were reported. Additional information has been requested.
diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced COVID-19 (diagnosed with covid). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, COVID-19 (diagnosed with covid) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The doctor asked patient to take Tylenol and Sudafed if needed and get quarantined until symptoms go away. Patient's quarantine got finished on 14-Apr-2021. Patient's second dose of Moderna was scheduled on 22Apr2021.  No other relevant concomitant medication were reported. Tylenol and Sudafed were taken as treatment.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up contains nonsignificant information. Patient declined further follow up.
Several weeks after my first vaccine I developed a rash that was very itchy on my right forearm and on my scalp. once the tops were off they remained itchy for 2 days they took over a week to heal almost 12 days.  Had other itchy areas on my body but no bump or pimple like described above formed. Once healed have had no further issues or itching
legs were painful, cardiac arrest, nauseated, dizziness, heart rate dropped to 24, had to get pacemaker
Triggered asthma reaction-wheezing and mild throat swelling-had swelling and redness at injection site of R deltoid area
I?m having a more severe allergic reaction this time.  I had no side effects with the first one.  My arm is swollen, blotchy red, and very itchy.  I did have fever and chills, no appetite on Thursday and Friday.  The itching in the arm started Saturday afternoon and continues today. (Monday 4/12/2021)
Information has been received from a consumer concerning her 15 year old daughter who on 11/1/99 was vaccinated with a third dose of Hep B vaccine. The following day, the pt experienced aching in her left arm, back and shoulder and numbness in her fingertips. The pt sought unspecified medical attention. Additional information has been requested.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 22Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: testing negative (3 times); Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 12/21/2008 with atrial fibrillation. Vaccination took place on 9/22/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 6/19/08 Received SAE for hospitalization of 12/21-12/24/2008. FINAL DX: atrial fibrillation Records reveal patient experienced sudden atrial fib w/rapid ventricular response & associated anginal pain.  Tx w/meds, no recurrence & d/c to home. ICD9 Codes: 427.31.
7 x 7.5 cm whelp in area that vaccine was given. Patient reported on 3/2/15.
Back pain and bilateral side pain. No numbeness, loss of continence, weakness. Complains of limited range of motion..difficulty performing activities of daily living without assistance.
3inch diameter red, hot raised area of lt deltoid; aches; used ice for 3 to 4 days; observed 3NOV92; area 2 inch pink area, no lump or induration @ pt what pt states was inject site;
This spontaneous report as received from a nurse refers to a 22 year old patient. The patients pertinent medical history included dialysis, hypertension, end stage renal disease. No known allergies were reported to drugs. Concomitant therapies included amlodipine, ferric sulfate, LISINOPRIL (manufacturer unknown), OMEPRAZOLE (manufacturer unknown), albuterol and TYLENOL. On 19-MAY-2014 the patient was vaccinated with PNEUMOVAX23 lot # J013555 expiration date 02-MAY-2015, dose 0.5 ml, route intramuscular in the deltoid of right arm. Approximately on an unknown date in MAY 2014 (reported as with in 24 hours) the patient developed redness, warm to touch, swelling at the injection site of right arm. The nurse stated comfort measures of warm compress was recommended to patient and follow up with his health care provider. The outcome of redness, warm to touch, swelling at the injection site or right arm was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
had allergies before the shot and now they are getting worse; chills; they are getting worse; felt dizzy; This is a spontaneous report from a contactable consumer. A 71-year-old female patient reported for herself that received (pfizer-biontech covid-19 vaccine, Formulation: Solution for injection, Batch/Lot Number was EW0168, Expiration Date: Unknown), dose 2 Single on Friday, via an unspecified route of administration, on 14May2021(age at vaccination 71 years old) for covid-19 immunisation. Historical vaccine included dose1 (pfizer-biontech covid-19 vaccine, formulation: Solution for injection, Batch/Lot Number: EW0164 ; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on 07Apr2021 for covid-19 immunisation.Medical history included asthma which was going on, sore throat , swelling under her glands in her throat, her ear hurt, itchy eyes from her allergies. Concomitant medication included Singulair every day and Prednisone.On an unknow date, it was reported that  first dose was given 07Apr2021, with lot number EW0164, and the second dose was given 14May2021, with lot number EW0168. The first vaccine she didn't have allergy issues yet. Her allergies weren't acting up. The second shot gave her the same symptoms as the first. They did tell her not to take allergy medicine like Claritin or anything before the vaccine.On 14May2021, she received her second dose of the vaccine last Friday.She said that she had allergies before the shot, and now they are getting worse.She has asthma and she takes Singulair every day.She mentioned that she felt dizzy for a couple of days after the second shot, and she had chills.The caller clarified the details provided by the transferring agent.She had chills dizziness after the first shot too.The second shot did the same, but now she has allergies going on.She started to have allergies before the second shot.She just has her normal allergies going on.She called to ask if she could take prednisone. The previous agent said it would be up to her doctor.The pharmacy said not to that it might affect her immune system.She had the same symptoms after the first and second vaccine.She reported the first she thinks because she called to ask if dizziness was a part of it. She would get up and things would spin.That lasted a couple of days both times. She just had her normal allergies going on. Patient knows the allergies are not from the vaccine. She has allergies every year at this time, and she relates that to her asthma. She told the pharmacy before her second shot that her allergies were acting up.She was told not to take prednisone until 2 weeks out from the vaccine so it doesn't affect her immune system. The  outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Before I administered the vaccine, the mother stated that she sometimes has an issue with fainting, but mainly at the doctor's office out of fear.  She assumed that since this was a different environment, she would be okay.  After giving  her the shot , she fainted.  The mom called 911.  I waved  an ammonia inhalant under her nose, and she was revived.  Her twin brother informed me that she has been in an ambulance 4 times prior after getting shots.  Had I known she had a history of fainting, I would have suggested that she receive the vaccine at the pediatrician's  office once it becomes available. The mom refused to go to the hospital once paramedics arrived. She sat for 15 minutes, I applied a cool cloth, she  drank water and was able to walk out on her own.
LEFT HAND FEELING LIKE HAMMER HIT IT; NASTY TASTE IN MOUTH; THROAT PAIN; 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 not reported, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  On 30-APR-2021, the subject experienced left hand feeling like hammer hit it, nasty taste in mouth and throat pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left hand feeling like hammer hit it, nasty taste in mouth and throat pain was not reported. This report was non-serious.
Patient was incorrectly given 5-11yo vaccine as a booster (LOT# FL8094) instead of 12+ vaccine. Patient was redosed immediately with Pfizer 12+ vaccine as booster (LOT# FJ5682)
This case was reported by a physician and described the occurrence of headache in a 39-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), influenza. Concurrent medical conditions included high blood pressure and seasonal allergy. Concurrent vaccination included hepatitis B vaccine recombinant;GlaxoSmithKline;unknown;unknown given on an unspecified date. Concurrent medications included Vitamins, VONTROL and clonidine. On 3 May 2013 at 16:00 the subject received 2nd dose of ENGERIX B (1 cc, unknown route, left deltoid). On an unspecified date the subject received a dose of influenza vaccine (unspecified) (unknown details). On 3 May 2013, 7 hours after vaccination with ENGERIX B (also described as 21:00 and "that evening", the subject experienced headache, nausea, vomiting, and diarrhea. At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced headache, nausea, vomiting, diarrhea and fever. At the time of reporting the outcome of the events were unspecified.
Pt recv vax on 8/25/98; on 9/3/98 pt exp "febrile" seizures; pt hosp for 1 hr.
Altered mental status, delusions, hallucinations, not making sense of things, feelings of confusion/disorientation. Symptoms and odd behaviors started on 3/13/2021 and started to clear by the afternoon of 3/17/2021.
Sore arm right away - that evening I could hardly move my arm. When I woke up the next morning, I had all of the symptoms that I had when I had the virus and I had 100.5 fever - headache; tired; achy. And those lasted not even a whole day and then they went away. Then the next night after that I couldn't sleep on the arm it hurt so bad. And the next day I noticed a rash - in the area around the shot on the top part of the left  arm and it was burning and hot  and it itched real bad. I took Benadryl. I went to the doctor (on the 18th or 19th - went for other reasons and I also showed her my arm) and she gave me some prednisone but I didn't take all of it because it started going away. I only took a day of the prednisone and day 6 it seemed to be going away.  I have photos of it. My symptoms had resolved by second dose. 2/12/2021 - I had a headache for a day after the second dose but that was it.
Zoster related vision loss; Bell's Palsy; Zoster related vision loss; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On or about 30-SEP-3026, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions, at the pharmacy. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for Bell's Palsy (facial paralysis) and for zoster related vision loss (herpes zoster and blindness). As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of facial paralysis and blindness were considered medically significant.