chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dr. prescribed Arexvy to 56 yp patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 56-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included asthma, rheumatoid arthritis, sjoegren's syndrome, fibromyalgia and hypothyroidism.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: dr. prescribed Arexvy to 56 yp patient). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK receipt date 20 Oct 2023: The pharmacist reported that physician prescribed Arexvy to 56 year patient with severe asthma, rheumatoid arthritis, Sjogren syndrome, fibromyalgia, and hypothyroidism.  The pharmacist stated that she was not going to administer, which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Muscle pain; fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration in the left arm, on 17Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included tree pollen allergy. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), on 29Jan2021 09:45 AM in the left arm for covid-19 immunization. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient was not pregnant. The patient did not have covid prior vaccination. The patient experienced muscle pain and fever on 18Feb2021 11:00 with no treatment received. The outcome of the events was unknown. The patient was not covid-tested post-vaccination.
LETHARGIC & UNRESPONSIVE ON POST-VACCINATION DAY 2 REQUIRING LOCAL HOSPITALIZATION
Soreness at the injection site,; Circular redness of two and half inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site). On 22-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Hydrocortisone 1%cream. No relevant concomitant medications were reported.
Patient admitted to the hospital with shortness of breath and      cough after being diagnosed with pneumonia in the clinic.  He was found to have Covid pneumonia and      was treated with maximal support but unfortunately became profoundly delirious and developed      worsening hypoxia associated with Covid pneumonia.  Family was called to the bedside due to      progression in his illness and concerns for cardiac dysrhythmias occurring in the setting of      worsening hypoxia on maximal support.  Decision was made to transition to comfort care and      aggressive life-prolonging interventions were discontinued for primary focus on comfort.  Patient     subsequently expired at 1810 on 04/18/2021.           Patient was vaccinated against COVID 19.   Death Certificate Information:  Part 1: Cause of Death: A. COVID B. SARS COVID 19  Part 2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia
Pt vacc. /w DTP/OPV began /w fever shortly /p shot treated w/Tylenol q4h. generalized tonic/clonic seizure last about l hr child taken to hosp & admitted temp of 102.6 discharges after 2 days.
October 16, 2018 received 2 shots. Arms became very sore could hardly raise them. Next day left arm (pneumonia) side large red patch and very sore. Oct 18 developed serious rash all over front and back torso. Oct 19 and 20, terrible itching.
Chest pain, tightness in chest, shortness of breathe, all-over travel pains (muscle, joints), extreme fatigue, brain fog, and hair loss.
Patient experienced a vasovagal event within one minute of vaccination, became lightheaded and nauseated. Patient was placed in trendellenberg position and given gatorade. Patient was returned to upright seated over 10 minutes, given crackers to eat, able to stand and walk without problems, and waited an additional 5 minutes in the waiting room. Discharged without further even.
Reported as Unrelated to vaccine in survey.  The survey asked about other health conditions so I reported that I  was diagnosed with a pituitary macroadenoma in April 2021 and had surgical removal August 11, 2021.
pt recvd 2 doses of vax on 28JAN92 & 4MAR91 & the evening of 4MAR91 pt exp dizziness, muscle pain, joint pain, swelling, including throat; swollen joints, fatigue, hoarse voice;
Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LEVOTHYROXINE, IRBESARTAN and LANSOPRAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: pneumonia pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to hospital on an unspecified date and x-ray exam showed that he had pneumonia. The patient was prescribed with antibiotics and cough medicine. The patient was to check if doxycycline and promethazine medicine will effect on his second dose schedules on 21-APR-2012. The reporter did not provide an assessment for the event , pneumonia.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe non- stop coughing about half hour after vaccine.  Very scary. Almost couldn?t breathe.
Painful at injection site since the administration of the vaccine. Itching noticed 6/17/2014. Noticed painful, red, swollen area that continues to itch on 06/18/2014.
2 weeks after vaccine given left arm started to itch when checked are was red at injection sight with no noted swelling or fever.
STILL GOT BIZARRE BODY ACHES; SLEPT ALOT FOR 3 DAYS; HEADACHES; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included COVID19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced still got bizarre body aches, slept alot for 3 days, headaches, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still got bizarre body aches, headaches, mild fever and slept alot for 3 days was not reported. This report was non-serious.
(L) deltoid developed scattered risen red pustule, no drainage, rash 2" wide by 4 1/2 " long. Appeared to be area skin was cleaned with alcohol pad before getting flu shot. Started 24 hrs after flu shot. C/o itching only in this area. No other signs. "Not sick". Client reported had blood drawn 2 weeks ago broke out.
Muscle spasms/twitching in right arm evening of first dose. Muscle twitching/spasm in left arm evening of second dose. Narcolepsy symptom of daytime sleepiness exasperated since vaccination ?worse since receiving second dose, but somewhat worse after first dose. Has persisted and is worse than prior to receiving vaccine.
pt had hives on her neck and shortness of breath. pt is now on prednisone
Tinnitus left ear, recommended white/brown noise by PCP,  ongoing ringing/buzzing
Vaccine received 10/4/17. PM of 10/4/17-Hive-like bumps, itching around the injection site, about 2 inches. 10/6/17 Bumps still there but itching is gone. 10/10/17 injection site reactions gone.
On day 10 after child had varicella vaccine child had red welt on the upper left tricep that was swollen and tender to the touch. Child had a fever of 101.1 for 2 days. On day 12 after vaccination child presented with a mild varicella/chickenpox type rash.
89yr old female presents from own home with complaints of general weakness, right index finger pain, left hip pain and frequent falls at home. Patient reports she has fallen multiple times at home over last two months. Last night she fell walking in dining room- patient denies injury.  Patient complaints of left hip pain that has been getting worse for couple of weeks. Noted swelling, redness and drainage to right index finger. Patient reports she first noticed right index finger hurting yesterday.    Cellulitis of finger of right hand  Fall, initial encounter  Open wound of finger, initial encounter  Urinary tract infection without hematuria, site unspecified
Significant chest pain. Much difficulty breathing. Most intense for about 4 hours. Soreness when breathing is still persisting, but not as intensely.
At 9:43 am client states she has tingling sensation in back of her throat. Client advised to drink water. 9:45 am an MD onsite at the clinic is requested to assess. Client did not complain of any flushing, or difficulty breathing. She states she has her own Benadryl was advised not to take it because she was going to drive home.  Client was reassessed at 10:08 and 10:14 am states feels better and can drive.  Client was on observation for 30 minutes before released to go to home.
TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female 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 not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 10-APR-2021, and had not recovered from tiredness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Patient received ZOSTAVAX, after 5 min reported complaints of nauseous and woozy. Kept patient under close observation for about 90 min. In that time patient complained of slight headache/throat discomfort. Upon conversation the patient noted she had not eaten anything for about 16 hours. After 45 min. patient given granola bar and felt better. Left pharmacy on her own accord 90 min after vaccine administration.
After receiving Td vaccination on 8/20/04 patient came back with a complain of arm reaction (red, swollen, hard area 3x3"), low grade fever, muscle aches (whole body) and feeling faint.  Advised Pt to take Advil and recommended warm soaks. Pt told to watch the reaction for a while. Pt previously received Td in 1993 with no adverse effects.
Within 3-4 hours was having mild side effects such as fatigue, soreness. The next 2 days his symptoms became more severe with nausea, chills, diarrhea. The 2nd day he developed a blood clot in his stomach and died as a result.
Red, raised warm area on left arm at site of vaccine administration starting several hours after vaccine; fever (Tm 100.4) and left cheek red one day after vaccine.
Patient received 1st dose of Moderna vaccine.  She had facial swelling on her lips and tongue.  She had the sensation of her throat swelling and closing.  Patient was brought to the observation area, VSS, Epi was given, and patient was transported to the ED via gurney.  The doctor was notified and she ordered Tryptase to be drawn in the ED.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 02-NOV-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (incorrect product storage) (lot # M005971, expiry date: 02-FEB-2018) (dosing regimen and route of administration unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 48.2 Fahrenheit (F) for 21 hours 57 minutes. Previous temperature excursion was reported on an unknown date, at a temperature of 57.6 F, for a duration of 20 hours 27 minutes. This case was reported because of a data logger. No product quality complaint (PQC) was reported. Additional information has been requested.
the next day, dizzy , 2 days later sore throat pain, chest pain short lived ( not like when he has had heart attacks in past ) , fever 99.2, coughing  Advised may want to talk to PMD about breathing treatments, if chest pain seek medical attention.  Placed follow up call on 4/16/2021 at 11:17: Pt reported that he is feeling much better today. Pt reported that the ADEs he had occurred within couple of days of rcvding his 1st Moderna vaccine, by the 3rd day all the symptoms had cleared up, and on day 4 he reported still had some running nose (which he contribute to his allergies). Pt reported for his symptoms he did not try anything to help alleviate his symptoms, he stated he is already taking Tylenol daily.
pain started out as aching 1 hour after vaccination.  Client states pain (Left Arm) was at it's worst 1 week after vaccine (04-03-09) when she experienced burning pain from her thumb up to her neck with the strongest pain between her elbow and shoulder.  Client denies redness or swelling at site, states had quarter-sized bruise where vaccine given.  Denies fever. States has been difficult to use arm because of the pain. States pain has improved with use of OTC pain reliever and "Icy-Hot" topical rub.  Client has not seen physician at this time, encouraged to see her family physician for further follow-up at time of report.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a non-Health care professional (Office staff). This case involves a 22 months old male patient received vaccine FLUZONE via intramuscular route in left thigh on 27 Sep 2018. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to overdose. It was reported that FLUZONE QUADRIVALENT vaccine was administered 0.5mL to a 22-month old patient yesterday. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On 18-JUN-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing, regimen, route were unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality issue reported. Follow up information was received on 10-JUL-2015. It was reported that lot number L005295 with an expiry date of 17-AUG-2016 is a valid lot number for PROQUAD (Merck). On 03-AUG-2015, a phone call was made to the certified medical assistant. The phone call went directly to voice mail. A voice mail message was left requesting that the certified medical assistant return the phone call. Additionally, a request was made for patient identifiers, lot number, expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from the reporting Certified Medical Assistant (C.M.A.) during a phone call on 05-AUG-2015. The C.M.A. reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 4-year-old patient of unknown gender. On 11-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L005295. This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event information and narrative were updated.
L arm slightly swollen, red, slightly warm to touch.  Pain at site.  Grandmother had applied ice & given motrin at 3 pm.  She said arm looked better.  Pt. stated arm hurts when he does any jerky movement; otherwise no pain.  Will continue to follow up with telephone call on Sunday.
Vaginal bleeding started 24hrs after vaccine. Menstruation bleeding started prematurely by at least 2 weeks, my period was not due and yet it started the next day of the vaccine.  I was not having anymore stress than usual, the only factor was the covid shot. This has never happened to me before, my periods are regular.   I had bleeding from the abnormal menstruation for 5 days and the amount was a little less to about the same I usually have of bleeding. Did have craming. The period ended in its own. No other un8sual symptoms. I did have fever, aches,  headache as expected and told to watch for the next day of vaccine.  **the side effect of early bleeding and menstruation  was not told to me as possible side effect and I was taken by surprise.
Around 1;00 a.m. patient started coughing and was unable to sleep; which continued for over a month. For the next month his eczema got worse and worse. Rough patches appeared all around his face. His asthma and coughing  also got worse and worse; resulting in hospitalization. Currently he is still struggling with his asthma, sleeping and eczema.
Tuesday night 5/17 I had a sore arm from the injection and I just felt a little off. I assumed it was just a minor reaction to the booster. The next day 5/18, I was informed that a person who was at the same funeral that I attended 5 days earlier had tested positive for Covid. Later that day I took an at home Covid test which came out invalid. I still felt off that day, so I went to my local pharmacy the next morning to get a Covid test done. I did not receive my results right away and called the pharmacy on 5/20 at which point they asked me to come back for another test due to invalid results of the previous test. I ended up testing positive on 5/20. I had been experiencing a sore back and a headache and a low grade fever. I called my doctor after receiving my positive test results to inquire about a Paxlovid prescription which he did prescribe. I began taking it that night on 5/20. Through the weekend, my fatigue, headache, and low grade fever persisted. Today, on 5/23, I'm beginning to feel better but am still experiencing some mild symptoms.
Pt developed redness, swelling and warmth to left thigh and knee. He began limping due to leg pain. He was seen in MD's office 2 days post vax. Mother states leg had hurt since injections on 8/21/01, and pt started limping on 8/22/01. The swelling, redness and warmth occurred 8/22/01-8/23/01.
Tested positive for COVID-19 on 5/24/2022 after experiencing flu like systems with fever previous two day.. Personal physician prescribed Paxlovid.
got the shingles; chest pain; back pain; Lips were swollen; This case was reported by a nurse via patient support programs and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles, chest pain, back pain and lip swelling. On an unknown date, the outcome of the shingles, chest pain and back pain were unknown and the outcome of the lip swelling was recovered/resolved.   The reporter considered the shingles, chest pain, back pain and lip swelling to be related to Shingrix.  Additional details were provided as follows: The called and stated that she had reactions due to the Shingrix vaccine. The patient had chest and back pain.  The patient's lips were swollen for a week plus got the shingles even after the vaccine. The patient consented to follow up and agreed to follow up with her health care provider.
I had a fever, cough, drainage, fatigue, and I was also prescribed PAXLOVID for my symptoms and I started to feel better after taking the medication.
Vaccine reaction on site of injection. Left Deltoid, swollen, red, hot to the touch.
Tinnitus.  I had my first dose on 04/27/2021 of the COVID-19 Pfizer shot.  Tinnitus began with this vaccination.  The ringing was in both ears and loud enough to be heard during normal conversation.  Similar to the ringing after attending a loud concert without ear protection.  No loss of hearing occurred.  The ringing did not improve with my second dose on 05/25/2021.  I visited a health care provider who examined my ears and confirmed that there were no other causes (structural, ear infection, etc.).  I worked with HCP and was able to finally begin to reduce the volume of the ringing using ketotifen and cromolyn.  It had improved to no ringing in left ear and a ring that could only be heard in the quiet in the right ear.  However, with my booster shot, the ringing returned within the day to full strength again.  We are very confident the tinnitus is due to the COVID vaccination.  While not life threatening, it does substantively impact my quality of life, such as hearing my young children's voices clearly.
Lack of energy, headache, body aches, increased pain in lower back, slight nasal congestion, mild shortness of breath on exertion.
h/a x 3 days;extreme fatigue x 3 days;chills, sweats, felt achy, sick;