chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 57 year old female patient with no pertinent medical history and with no drug reaction or allergies. On unknown dates the patient received an unknown number doses of (Merck) VARIVAX (Lot#, dose and route not reported). Concomitant therapies included phentermine, LOVAZA, metformin and SYNTHROID. The patient came back with "low level titers" for varicella IgG on 16-MAR-2013. No treatment was given. At the time of this report the patient had not recovered from "low level titers" for varicella. The reporter did not assess the drug relationship. Additional information has been requested.
patient received 2 dose of shingrix on 6/12/19.  patient's wife called and reported her husband had been out biking earlier today (6/13/19) and 3 hours later was feeling light headed, had an elevated heart rate in the 140s, and had low blood pressure (80s/50s) measured via an at-home wrist blood pressure monitor.   Patient's wife stated that he had irregular heart rates in the past.   Advised to re-check blood pressure again and if measures do not improve or patient is symptomatic to call their doctor or go the the ER.
Information has been received from a health professional concerning a 4 year old male with eczema who on 5/16/2002 was vaccinated with a dose of varicella virus vaccine live (lot 638361/0564L). There was no concomitant medication. It was reported that the patient used topical triamcinolone when needed for his eczema. In the evening, on 7/13/2005, the patient developed a rash. It was reported that on 7/13/2005 the school notified the patients mother regarding cases of chickenpox in the school. On 7/14/2005 the patient was seen by the physician who confirmed the rash as atypical varicella. No treatment was ordered. At the time of the report the patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
The left arm was swollen and inflammed later on in the evening the same day of the immunization. The patient came to the pharmacy the day after the vaccine and was observed by associate who recommended ice and BENADRYL. I called her later on that evening and the next day and they said that the swelling was going down but still lingering.
SHINGRIX given to a 47 yr old male at office visit. No treatment needed. No adverse effect thus far.
Patient has history of anxiety and panic attacks. He was very nervous to get the vaccine and debated for about 15 minutes in clinic whether to get it that day or not. He agreed to get it, he felt fine prior to and during the vaccination process. He walked from the clinic room to the waiting room after the immunization was given and within a minute he came back into the clinic and said his chest felt tight/burning, his throat was burning, felt light headed, dry heaving. We did his vitals which were stable and within normal limits except BP was 160s/80s, his O2 was within normal limits. Provider asked if he wanted to be evaluated by EMS and he said yes, called 911. EMS did EKG that was negative. After about 30-45 minutes patient felt better. EMS did a driving test on patient to make sure he was safe to drive home. Patient independently walked out of clinic. No medications were given.
She wasn't sick. She just said that she was tired and needed to go home to get some rest and she died that afternoon.
After 10mins as patient waiting in waiting room for observation after received vaccine  pt heart had a heart rate of 99 and No SOB No sweating No Nausea. Patient request ambulance. EMT asked me to give 4 tablet of ASA 81  chewable
swollen, red, and painful toes; swollen, red, and painful toes; swollen, red, and painful toes; having a hard time sleeping; ankle swelling; the toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened; This is a spontaneous case received from a contactable consumer (patient).  A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8736), via an unspecified route administered in right arm on 27Apr2021 (age at vaccination 79-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ongoing COPD (Chronic obstructive pulmonary disease) from 2006, ongoing atrial fibrillation from 2006 and pollen allergy. Concomitant medications included guaifenesin (MUCINEX). The patient reported that the toe right next to her big toe, on the right foot, is beet red and swollen and painful, on May2021 her ankles are also swollen, and she had redness on the outside of her foot on both feet, they have worsened because it started on her right foot, now it was both feet and now the sides of her feet in the morning are red as well, and she was having a hard time sleeping because of the pain from her feet. The outcome of the event ankle swelling and he toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened was not recovered, and outcome of other events was unknown.  No follow-up attempts are needed. No further information was expected.
Got very tired yesterday afterwork and ran a slight fever.; dehydrated; Got very tired yesterday afterwork and ran a slight fever.; This is a spontaneous report from a non-contactable consumer. A adult female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On 17Mar2021 consumer stated I took second shot yesterday and I have had nothing extreme in way of symptoms. Got very tired yesterday after work and ran a slight fever. This morning felt like I got hit by a man truck. I did feel dehydrated but will follow their advice to take lots of fuel. I will try and rest up today. The patient was not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. Information about Lot/Batch number cannot be requested. No further information is expected
dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional information: The patient mentioned she had the Pfizer vaccine yesterday and mentioned that she was feeling dizzy today. She was asking if it was normal to feel a "little dizzy" after getting the Pfizer Covid-19 vaccine. She hardly had anything last night so it might be that that caused her dizziness. She's very relieved to hear that dizziness was a common side effect of Comirnaty then asked for how long could it last. Caller mentioned she usually had Moderna and had no reactions with it so this was a very unusual thing to happen to her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was evaluated in urgent care two days after vaccines received and started on antibiotics for red, swollen, hot left leg. Initially couldn't walk on leg, was evaluated in clinic 5 days later, swelling better, still with redness.
This case was reported by a physician, via a GSK representative, that described the occurrence of high fever in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline).  Concurrent vaccinations given on the same date (unspecified) as PEDIARIX included ACTHIB (Sanofi Pasteur); unknown; ROTATEQ (Merck); oral; and PREVNAR (Wyeth); unknown.  On an unspecified date, the subject received the 2nd dose of PEDIARIX (.5 ml, unknown).  At an unspecified time after vaccination with PEDIARIX, the subject experienced a high fever, reported to be in the 103 degree Fahrenheit range.  At an unspecified time after vaccination with PEDIARIX, blood was drawn from the subject and the test results showed a white blood count "shift to the left", but no bacteria was detected.  The subject was hospitalized (dates and duration unspecified).  The subject was treated with at least one dose of ROCEPHIN.  The fever was reported to be resolved within 24 hours, but the outcome of the abnormal white blood cell count was not reported.
Developed rash on trunks, neck, forearms and feet on evening of 2/21/07. Went to physician 2/22/07. Doctor states that she wasn't sure if the reaction was from the Hep B vaccine or something else. Patient was given Methylprednisone and Hydroxyzine HCl, which helped improve the rash recommended as stated by the patient.
Extreme nausea, followed by violent vomiting. Continue to vomit every hour. Consuming water when I could to ease the bile. I got an email off to my MD asking him to prescribe a anti nausea suppository to help me. Dr. phoned in Promethegan. I started the medication on 1/11/2013 @ 2 pm. It worked. I took the medication every 4 hours, for a total of 4 doses. I phoned the pharmacy on 1/11/13, sharing my story. The Pharmacist was off that day. I left my name and number and asked they share what I experienced. Also, I noticed I had a rash on my chest and abdomen, prior to starting the suppository.
symptoms, signs, time course, etc.) 78 yo female patient with PMHx of paroxysmal atrial fib / COPD / smoking / anxiety-depression / obesity / arthritis and prior bil PE in 2018 after knee surgery (anticoagulated with Xarelto) who presented to FH on 03/30/2021 with SOB x2 weeks. Of note she received her 2nd COVID vaccine dose on 03/05/2021 and since she has worsening SOB. Pt reported cough w/ yellow sputum prior to her admission. At urgent care, she was hypoxic with Sat 82%, therefore she was transferred to ED for further w/u. Lab w/u showed BNP of 1,074 and trop of 32. She was found to have a negative POC COVID-19 and PCR is pending. Bil venous Dopplers show acute occlusive DVT in the R popliteal vein above and below the knee w/ slow flow in the R fem vein and no DV IN the LLE. TTE on 03/31/2021 showed EF 65-70% w/ G2DD, mod-severe RV failure and severe pulmonary HTN, mod TR, and dilated IVC. Decision was made to CT chest w/ contrast despite renal function given high suspicion for PE. CT chest w/ contrast showed large clot burden PE w/ findings c/w R heart strain, a 12x9 mm lobulated nodule in the RUL concerning for neoplasm, increasing patchy infiltrates, and increasing R pleural effusion and new trace L pleural effusion. Patient required 12L O2 via NC. IR was contacted at but felt that patient was not a candidate for CDT or for IVC filter. Patient was transferred to ICU for further care. Patient received IV heparin per the PE Protocol from, Alteplase 40mg on 4/1, and was started on treatment dose of Eliquis.
This spontaneous case, initially received on 05-Oct-2016, was reported by a health professional and concerns a 60-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 26-SEP-2016 to 26-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 26-Sep-2016, the patient experienced local red raise warm reaction, hives on chest back and abdomen, reaction did subside (outcome: recovered / resolved). Reporter comments: The healthcare professional considered all events as non-serious.
try to attach the needle, the cap keeps on spinning on the vial; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "try to attach the needle, the cap keeps on spinning on the vial".  Additional information: The clinical course was reported as the reporter mentioned due to a malfunction 2 vials of the prevnar 13 could not be used. The reporter also mentioned the top cap does not let you tighten the needle. When they try to attach the needle, the cap keeps on spinning on the vial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered after 11 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 11 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were provided. No treatment medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a male patient who received BOOSTRIX (batch number 54MX9, expiry date 21st October 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage o drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: One dose of BOOSTRIX and one dose of PEDIARIX were given to different pts. after the vaccine was exposed to 31F, HCP had info on the BOOSTRIX dose, but did not have the info. available for the PEDIARIX dose.
Flu symptoms, muscle and joints pain, headache, eye pressure, insomnia, fogginess, dizziness.
Information has been received from a Nurse Practitioner via a field employee concerning a 19 year old female patient with no pertinent medical history or drug reactions. The patient was vaccinated with three doses of GARDASIL (dose, lot number and expired date not reported, intramuscular) on 12-AUG-2011, 12-OCT-2011 and 15-MAR-2012 respectively. On unknown dates in 2011 the patient experienced muscle and joint pain, bloating, hair loss and anxiety. The patient sought medical attention by office visit. On an unknown date, unspecified lab diagnostic studies were performed. The patient had not recovered from the events. No treatment was given to the patient. Additional information has been requested.
Patient stopped by the pharmacy stating that she will have to have surgery to correct her issue from Shingrix. Patient reports swelling, numbness, pain radiating down arm, decreased range of motion, worsening symptoms as time progresses since date of administration. Patient also stated taste disturbances and changes.
Flu-like symptoms; Feeling weak; Whole body is aching; Pain in right arm; Dizziness; No energy; Some negative reactions; Muscle pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm) and DIZZINESS (Dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 01-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (Feeling weak), PAIN (Whole body is aching), PAIN IN EXTREMITY (Pain in right arm), DIZZINESS (Dizziness), ASTHENIA (No energy), VACCINATION COMPLICATION (Some negative reactions) and MYALGIA (Muscle pain in right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Giant hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported; lot number and expiration date were not reported) as a 1st dose, single, with route of administration unspecified, for immunization. Medical history included primary progressive multiple sclerosis; multiple drug intolerance syndrome (with a very long list of allergies) (allergy to anticonvulsants); chronic obstructive pulmonary disease (COPD); optic neuritis; epilepsy; seizures; and pain. Concomitant medications included ibuprofen for pain; and diazepam for seizure. The patient previously took tetanus toxoid for immunization, and had anaphylaxis. On an unspecified date, the patient had giant hives. The outcome of the events was unknown.
Fever, fatigue, headache, nasal congestion, nausea, anorexia
Information has been received from a health professional concerning a 21 year old female who on 14-FEB-2008 was vaccinated with her second dose of Gardasil (lot # 659962/1740U). Concomitant therapy included KLONOPIN. On 14-FEB-2008 the patient experienced shortness of breath and almost passed out. The patient was treated with oxygen and is feeling better. Subsequently the patient experienced pain at injection site after receiving the first dose at an unspecified date. No other information was provided. Additional information has been requested. This in follow-up to report(s) previously on 1/14/2008. Initial and follow up information has been received from a medical assistant and a licensed practical nurse, concerning a 21 year old caucasian female patient with no known allergies and no illness at the time vaccination, who on an unknown date was vaccinated with the first dose of GARDASIL. Concomitant therapy included KLONOPIN. With the first dose, she experienced pain at the injection site: the physician's note indicated that the patient had an episode of "screaming and swearing with first shot." On 14-FEB-2008 she was vaccinated with the second dose, IM in the left deltoid, of GARDASIL (lot # 659962/1740U). Following the second vaccination, the patient "became short of breath and faint," and a physician was called emergently to examine her. The physician's note described the patient as "tachypnoic" and with "acute panic with GARDASIL vaccine."She was noted as being fully conscious and oriented at the examination. Vital signs were "normal". Oxygen was administered, her breathing slowed down with coaching, and she recovered within 20-30 minutes. No diagnostics were ordered. The patient was advised to not receive the third dose in the series. Additional information has been requested. All available medical records will be provided upon request.
Information has been received from a physician concerning a male who was vaccinated "a couple of months ago" in 2007, with Zostavax (Oka/Merck).  A few days after injection, (dates not reported), he sought medical attention from an urgent care physician (not his primary physician) after he developed a welt or blister like reaction at the injection site.  It was reported that it did not look like a zoster rash or injection site like reaction.  The physician thought it could be a reaction to the vaccine itself.  The physician did not follow up with the patient.  Subsequently, current patient status was not reported.  A product quality complaint was not reported.  No further information was reported.  Additional information has been requested. 03/26/2008 Follow up information from the reporting physician reported that the patient was not his patient, was seen in urgent care, and the vaccine was given at another unspecified clinic. Additional information is not expected.
I felt like I had the flu the first day after the vaccine, with achey muscles, head ache, very low energy.  The 2nd day I felt better but still had extreme fatigue, and the injection site was pink and warm. The 3rd day (today) I feel pretty well, but the injection site is still pink and warm.
Follow up on 12/10/03: "Pt given flu and pneumonia combination by mistake; advised by director to re-vaccinate with flualone." No adverse events.
16 years old - Moderna vaccine.  Off label.  Not 18 years old yet.  Client's mom, reports client immediatly "just felt off."  When asked if she could describe further this feeling she states, "she just generally didn't feel good."  States this lasted 2 days, starting on the day of vaccination and was gone by the end of the day, the day after vaccination.
Experiencing body aches and extreme fatigue for 24 hours, headache occurred at 36 hours.  Body aches ,fatigue, and headache ongoing at this time. Self treating with bed rest and ibuprofen.