chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT WAS NEVER STARTED ON THE ROTAVIRUS SERIES AND DURING HER 6 MONTHS PHYSICAL SCHEDULED ON 12/7/2022, SHE WAS GIVEN THE ROTAVIRUS(ROTATEQ) VACCINE FOR THE FIRST TIME IN ERROR. ROTAVIRUS IS NOT RECOMMENED AFTER THE AGE OF  15 WEEKS.
Chills, muscles aches, fever of 103.8, crushing headache, pounding heart beat, red swollen arm, hives
Date of Admission: 5/29/2023  Discharge Date:  June 7, 2023 Discharge Disposition: Inpatient Rehab Facility or Unit  Presented to the hospital after a fall.   5/30 COVID+ Does not have any respiratory symptoms.  Afebrile, no leukocytosis, no respiratory distress or hypoxia. No need for respiratory medications, antivirals or steroids. EN5318 2/3/2021 EN6201 2/25/2021 33030BD 12/6/2021 GJ2524 9/23/2022
16MAY96 pt recv vax & 18MAY96 lt deltoid swollen, red & tender more than normally seen;
In Pentacel it contains DTap, Polio and HIB. The diluent is DTap and Polio and the powder mix is HIB. I gave the Diluent only. I then Gave HIB on its own after I figured out that I made a mistake. There was no treatment needed, and the outcome was ok.
Pt states that she started with pain in her arm the day after vaccine and has continued for 12 days, pt has a dr's appointment for something else, but will discuss with them.
This case was reported by a healthcare professional and described the occurrence of eye fluttering in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 16 July 2010 the subject received unspecified dose of HAVRIX (.5 ml, unknown route). On an unspecified date in July 2010, less than one week after vaccination with HAVRIX, the subject experienced eye fluttering and body temperature elevated. Relevant test results included temperature of 103 degrees Fahrenheit on 20 July 2010. At the time of reporting the outcome of the events was unspecified. On 20 July 2010 at 17:00, the subject's mother informed the healthcare professional that the subject had a temperature of 103 degrees F and eye fluttering.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Oct2022, outcome "unknown", COVID-19 (medically significant) with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: after 2 negative tests; (23Oct2022) Positive, notes: I took a positive test Sunday 23Oct and Tuesday 25Oct; (25Oct2022) Positive, notes: I took a positive test Sunday 23Oct and Tuesday 25Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: patient did not take other medications in 2 weeks. No known allergies and no medical history. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was vaccinated on 8/19/2022. He  reported to the MPX clinic on 8/31/22 to inform the staff that he had been diagnosed with Cellulitis by his PCP. The patient reports he developed a hard knot with bruising on his right arm, that eventually spread through out the entire arm. The patient further reports he was prescribed antibiotics for treatment.
itchy spots on skin / chest, breast, back, arms, back and front / what looked like measles or chicken pox on various parts of her body; sensitive to one of the components in Shingrix; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult female patient who received Herpes zoster (Shingles vaccine) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Zostavax (had infection with live shingle shot(zostavax) about 5 to 7 years ago). Concomitant products included medication unknown (Other Medications).   On 30th August 2019, the patient received the 1st dose of Shingles vaccine (intramuscular). On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced itchy rash and drug hypersensitivity. On an unknown date, the outcome of the itchy rash and drug hypersensitivity were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and drug hypersensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The reporter stated that, prior to vaccination had no skin issue. After vaccination with dose of Shingles vaccine, had spot looks like measles or chicken pox on various parts of the body. The patient had scraping done by a dermatologist and stated that, was highly sensitive to one of the components in Shingrix shot. The reporter stated that, the doctor advised to not to get the second shot in the series. The reporter stated that, had spot on chest, breast, back, arms, back and front of legs and couple spots on face and currently on back. The patient reported that the spot came and went and location varies and were very itchy. The patient did not changed soap or detergent or medications. The patient stated that nothing has changed in the past 3 months and did not have this skin condition prior to vaccination. The reporter consented to follow up.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot # M013639, expiry date: 15-SEP-2017; lot # I042846, expiry date: 15-SEP-2017 and lot # I010595, expiry date: 12-NOV-2016). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
pt wife reported 2 mos after booster vaccine for covid the patient had an uptick in his Multiple Myeloma
His wife had an allergic reaction after second shot that lasted 3-4 days.; This is a spontaneous report from a non-contactable consumer or other non hcp (reporter's wife). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced his wife had an allergic reaction after second shot that lasted 3-4 days. on an unspecified date. Description of Event: (Withheld) put in a message that his wife had an allergic reaction after second shot that lasted 3-4 days. He did not specify which vaccine she received. Name of Product: Covid vaccine. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Second dose received 8:55am, symptoms began that evening around 10 pm lasting 3 days. Fever, chills, body aches, nausea, headache, sore arm . Day after slept all day long which is very unusual for me.  Felt like I'd been run over by a truck...
A sensorineural hearing loss happens when there is damage in my inner ear.  3 steroid medicine injection in my left inner ear.
upper body hives Narrative:  Patient reported having hives on upper body 24 hours after receiving the 1st dose of the COVID vaccine. Discussed this with provider and pharmacy who recommended not giving second dose in clinical setting. Recommended that patient receive 2nd Vaccine in hospital setting where he could be more closely monitored as the chances of him having a more sever reaction to the second vaccine were high.
Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129941, 2014SA129934, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) having expiry date 30 June 2015 on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. It was unknown that the patient received any other vaccinations within 4 week of vaccination. On 15 September 2014, on the same day after vaccination, the patient experienced nausea, vomiting, diarrhea, headache and fatigue. The patient's corrective treatment and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
DRY HEAVING; VOMITING; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced dry heaving. On 24-AUG-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and dry heaving. This report was non-serious.
Had constant intense pain rolling throughout my body for the first  3 to 4 days. I felt like crap. Couldn?t think, didn?t want to eat. I looked very swollen?face & body. Slightly short of breath. Felt like I had the flu. Not a temp. And DIZZY. After the first week, I was much dizzier. I can?t get anything done because I?m exhausted & in pain. I?ve been taking Benedryl and sea sickness pills which help. Sinus meds for the stuffy head and nose running. I?m at the end of week two and can?t believe I?m not better. I don?t go out and my fiancée doesn?t have covid. I?m not coughing.
Flu like symptoms which included chills, body ache, Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for RA, Plaque psoriasis and Ulcerative colitis.    No Medical History information was reported.   On 25-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms which included chills, body ache, Fatigue) had not resolved.            No concomitant medications were reported. Patient experienced flu-like symptoms which included chills, body aches and  fatigue. The reporter's causality for the event of flu like symptoms with Rinvoq (upadacitinib) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Patient visited hospital and received urgent care and medication. No treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (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: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient took Paxlovid (lot number: Fw4118) from 16Jun2022 to 21Jun2022 as COVID 19 Treatment. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Reported events were Covid rebound after paxlovid completion, increased symptoms of fatigue, coughing. Rapid test + on day 10. Adverse event started on 23Jun2022. Patient not recovered for the reported adverse events and no treatment were received. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 24 hours after my Moderna shot, my left arm became itchy, red, & painful from my shoulder to my elbow.  I had pain running from my shoulder down to my fingers. I saw my doctor on Friday & she prescribed ibuprophen, twice a day.  After 3 doses, the issue was pretty much resolved.
Arm got red, itchy, sensitive and sore, slightly discolored. Lasted about 3-4 days and has since resolved
03/12/2021 at 4:00 AM I woke up and my head was spinning like crazy, I just laid in bed since I felt like I was going to throw up. I called the doctor's office and they said go to the ER. 7 weeks it has been ongoing. I have begun PT for the vertigo. After the second dose I went thru the same experience.
Fatigue; mild muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 16 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 Immunization; Covid-19 vaccine (Dose 2), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, manufacturer Unknown), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Sep2022, outcome "recovered"; MYALGIA (non-serious) with onset 11Sep2022, outcome "recovered", described as "mild muscle aches". Therapeutic measures were not taken as a result of fatigue, myalgia. Additional information: Patient had no other vaccine in four weeks and no other medications in two weeks. Patient had no COVID prior vaccination and not COVID tested post vaccination.
On 01/19/2021, 4 days after receiving the first dose of the Moderna COVID-19 vaccine, a small, splotchy red patch appeared on my left arm beneath where I received the vaccine. Over the next few days, the rash became increasingly red and square-shaped. By the time I received my second dose of the Moderna COVID-19 vaccine on 02/12/2021, the rash had mostly subsided with some general redness remaining. Then on 02/13/2021, the rash reappeared as a milder and smaller version of the original rash. No treatment has been used, and I have not seen a medical professional about the rash. As of 02/15/2021, the rash is still present.
Patient developed shingles of the forehead and eyelid about 11 days later with subsequent herpes zoster iritis.
VERY SORE BACK/HOT PATCHES; SEVERE CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination.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 subject experienced very sore back/hot patches, and severe chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the severe chills and very sore back/hot patches was not reported. This report was non-serious.
Pt immunized for a needle stick on 15APR91 & on & off x 10 days pt exp that arms & legs would go to sleep; Also c/o tingling in the hands & toes; On 25APR pt was better; pt to see MD on 1MAY; neurology work-up showed neg;
Vaccination site is swollen and very itchy.   Patient is taking Benadryl to treat the symptoms.
NO ADVERSE event OTHER than the fact this Vaccine was given in stead of the TDaP.
Each vaccine I had a fever and exhaustion for 3 days, when I got COVID I started sneezing then it started feeling like I had a bad head cold, body aches, fatigue and then a week after I ended up with a nasty sinus infection. I treated it with Mucinex, and Ibuprofen. I have residual lung stuff. My exhaustion and headaches have eased.
Localized reaction to the L arm. Had both shingles and Pfizer booster.  Shot on Morning Friday. Rash noticed on Sunday, could have been there longer. Red and warm but atypical for cellulitis.
Patient was given the vaccine and complained of being light-headed/dizzy following the injection. She answered questions and told us she hadn't ate all morning. After sitting for 1 minute, we brought her husband over to sit with her. She went in and out of consciousness for the next 3 minutes before having a four-minute seizure.
8th Jan@1430-Tired 9th Saturday-tired, nauseated, aches, chills 10th Jan Sunday-nauseated, tired, chills, aches-body 11th Jan Monday-aches-body, tired, nauseated, Headache-Treatment-none, When she can she eats a little & drinks when not nauseated
This report was received from a health professional on 09 May 2008.  This patient is one of three patients reported as part of a cluster.  A child (exact age not reported) experienced itching and redness at the injection site after receiving an intramuscular injection of DAPTACEL (lot number C2935AA).  No other information was provided.  The other two patients in this cluster are captured in case numbers 2008-01490 and 2008-01489.  Additionally, this health professional reported fever and inconsolable crying following DAPTACEL and ActHIB administration; that event is captured in 2008-01488.
vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator).    No concomitant medication were reported.   Number of doses/vials: 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
Injection site of the Bexsero was warm to touch; Injection site of the Bexsero was red; Blister just below where the band aid was covering the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine).   On 8th January 2020, the patient received the 2nd dose of Bexsero (intramuscular). In January 2020, 2 days after receiving Bexsero and not applicable after receiving Flu vaccine, the patient experienced injection site warmth, injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site blisters to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and a flu shot unknown brand to have tuberculin skin test red and it was noted that the injection site of the Bexsero was warm to touch, red and the presence of a blister just below where the band aid was covering the injection site