chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a 14-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have a swollen gland under my arm, on the side of the injection and its sore as well; fever; headache; tiredness; Chills; pain at injection site; slept all day; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08May2021 as Dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration as Dose 1, single for COVID-19 immunization. On 10May2021 the patient experienced a swollen gland under his arm, on the side of the injection and it was sore as well, added on 09May2021 he had chills, headache, fever and tiredness. He slept all day on 09May2021". Also had pain at injection site. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10 min. after vaccination, pt felt lightheaded, dizzy, and queasy. Intense fatigue & blurred vision 20 min later.
Information has been received from a physician concerning an 84 year old female with sulfonamide allergy, penicillin allergy and allergy to MACROBID and a history of getting hives every year who on 14-NOV-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included atenolol, LIPITOR and ACTONEL.  On 15-NOV-2007, The consumer reported that her arm got red and itchy at the injection site.  She also had a high fever and diarrhea.  On 01-DEC-2007 the patient broke out with herpes on her buttocks but " " this happens about once a year when I am under stress"  It was reported that the patient recovered about three days after it started."  The patient sought unspecified medical attention.  Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, nausea, muscle weakness, joint pain and headache. On an unknown date, the outcome of the pain, nausea, muscle weakness, joint pain and headache were recovered/resolved. It was unknown if the reporter considered the pain, nausea, muscle weakness, joint pain and headache to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a reaction after receiving 1st and 2nd dose of SHINGRIX. The patient experienced joint pain, a headache, soreness, nausea, and muscle weakness which resolved after about a day. It was reported that she felt like she got hit by a mac truck. This case has been linked with case US2018GSK039262, same patient 2nd dose and US2018GSK040393, reported by the same reporter for other patient.
This is a spontaneous report from a contactable Other Health Professional (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 09:45 AM (at the age of 56-year-old), as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included lyme disease from an unknown date and unknown if ongoing. The patient had allergies to clams and Sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other concomitant medications within two weeks. The patient had not received any other vaccine within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264), via an unspecified route of administration, administered in Right arm on 09Feb2021 at 09:45 AM (at the age of 56-year-old) for covid-19 immunisation and had Pronounced joint pain with 1st injections, had an exaggeration of L lateral epicondylitis that was present at the time. From there, within 2 days wrist pain became pronounced bilaterally. Joint pain has become far worse in areas of her body that had older injuries and were not in pain at the time of the 1st injection. On an unspecified date in 2021, the patient experienced very pronounced left knee pain and left ankle pain/Currently suffering from right wrist pain. It was reported that after her second Covid 19 vaccination, developed very pronounced left knee pain and left ankle pain. Currently suffering from right wrist pain, exquisitely painful. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Voltaren gel for ankle were taken as a result of very pronounced left knee pain and left ankle pain. The events did not result into death, Life threatening, Caused/prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect. The case was reported as non-serious. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of pronounced left knee pain and left ankle pain/Currently suffering from right wrist pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Feb2021 as dose 2, single (Lot number: En6201), in left arm, on 17Oct2021 at 12:30 as dose 3 (booster), single (Lot number: Te3590), in left arm and on 26Apr2022 at 14:00 as dose 4 (booster), single (Lot number: Fk9720) at the age of 78 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: Patient did not receive any other medication with in 2 weeks. The patient received Anti-viral of Pfizer for the treatment of COVID-19 from 03May2022 to 10May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fully vaccinated with J&J.   Boosted on 1/17/22.  COVID infection breakthrough with inpatient stay
This spontaneous report was received from a physician via a company representative and refers to a 12-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-NOV-2018, the patient was vaccinated with PROQUAD (lot # R020676, expiration date: 15-JAN-2020, dose and route of administration were not provided) for prevention. On 17-NOV-2018, the patient experienced fever between 102 to 104 Fahrenheit degrees after receiving PROQUAD. The patient was seen in emergency room on 24-NOV-2018. The patient received an unspecified treatment for the event. An unknown test for influenza and strep and chest x-ray were performed on an unknown date in 2018. The outcome of the fever was reported as recovered on an unknown date in 2018. The relatedness between the event and PROQUAD was not reported.
Patient received the Moderna vaccine 0.25ml instead of the bivalent.  We will contact the patient to schedule to come in for the bivalent in 2 months from 9/9/22.
Dizziness,  vertigo, ear fullness, ear pain, face numbness for more than 2 weeks.  Treatment 1: Antibiotics + decongestant Treatment 2: Steroids (10 days) + nasal spray.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored M-M-R II. Dose, route, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient became extremely disoriented and confused. Described visual hallucinations when he closed his eyes - swirling fragments of colored maps. Did not recognize our street when we were driving on it. Mild sweating. Headache. Nausea. Three bouts of diarrhea in a 4 hour period. Symptoms began to clear up at noon, and he seems himself again now (3:00 PM, same day).
Within 15 seconds I got a sore throat.  Within 5 minutes I had muscular pain all over body.  Chills.  Felt very tired.  Headache.  Nurse checked oxygen level within 10 minutes and it was well above normal.  Nurse put me in recliner and I slowly calmed down and felt sleepy.  Left in one hour walking to car and driving home.  These symptoms lasted 7 days.  Very irritated for 7 days.  Very uncomfortable.
Extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 11:00 (Lot number: 3248) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EL3248, Vaccine location: Right arm, Administration time: 03:30 PM), administration date: 03Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021 12:00, outcome "recovered" (2021), described as "Extremely tired". Therapeutic measures were not taken as a result of fatigue.  Additional information: Patient had not other vaccine in four weeks. Patient had received Gabapentin, Lexapro medications in two weeks. Patient had not covid prior vaccination. Patient had not covid tested post vaccination. Extremely tired the day after the shot; took a short nap in the middle of the day, but otherwise still able to function normally, was just very tired. The Pfizer US Drug safety unit recently received the attached report submitted by you via (website withheld). Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse considering a 23 year old female with no known drug allergies and no previous medical history who on 28-JAN-2008 was vaccinated IM in the deltoid with her first dose of GARDASIL vaccine (yeast) (lot#659657/1487U) 0.5 ml. There was no concomitant medication. The patient received her second dose of GARDASIL vaccine (yeast) (lot# 659182/1757U, site not reported) on 28-MAR-2008. Subsequently she "passed out" and felt nauseous after the second dose. The patient did not seek treatment for her symptoms and recovered on an unspecified date. No further information was available Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medication and drug allergies were not reported. On 22-MAR-2019, the patient was vaccinated with a dose of M-M-R II "therapy type: rHA" (lot # N032427/expiration date: 16-NOV-2019) (dose, unit, frequency, anatomical location were not reported) that had not been completely reconstituted with sterile diluent (lot # N028090/expiration date: 13-FEB-2020) (dose, unit, frequency date were not reported) for prophylaxis. It was reported that the patient had no adverse effects. The outcome of the events was reported as unknown. The product quality complaint was filed.
Headache; Chills; Runny nose; Burining eyes; Dizziness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), RHINORRHOEA (Runny nose), EYE IRRITATION (Burining eyes) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), DICLOFENAC POTASSIUM (VOLTAREN ACTI), ESCITALOPRAM OXALATE (LEXAPRO), CARBAMAZEPINE (TEGRETOL), BISOPROLOL FUMARATE (BISOPROLOL FUMERATE) and CLONAZEPAM (CLONAPIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), RHINORRHOEA (Runny nose), EYE IRRITATION (Burining eyes) and DIZZINESS (Dizziness). At the time of the report, HEADACHE (Headache), CHILLS (Chills), RHINORRHOEA (Runny nose), EYE IRRITATION (Burining eyes) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's physician instructed them to take meclizine for the treatment of the events and it has been helping.
Petechiae rash on palms only.  Onset 08/23/2003.  Immunization on 08/20/2003.  Initially with itching-non resolved-and rash is improving.
pt recv vax & 12hr later eyes swelled shut;gen itch;edema of face;aching;peeling of facial skin;hives on inj arm;
Patient took a home COVID test on 12/6/22 which resulted positive. On 12/12/22, she was seen in urgent care, where she was found to have abnormal labs (sodium level was 114). Patient was told to be evaluated in the ED due to her abnormal labs. Ultimately, she was admitted 12/12/22 - 12/18/22 for severe hyponatremia; intractable nausea, suspect due to COVID infection; and severe body aches, suspect due to COVID infection. Per discharge summary, provider notes "Sodium was 114 on presentation, likely due to SIADH related to COVID-related symptoms of severe nausea and body aches...as the patient's body aches and nausea has further improved, the patient has not required additional salt tablets or hypertonic saline." She has received the primary COVID vaccine series and one booster.
Moderna COVID-19 Vaccine EUA RECEIVED 2 PFIZER SHOTS  2/25/21, 3/18/21 AND MODERNA BOOSTER 11/22/21
Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting; This is a spontaneous report from a contactable Nurse reporting for herself. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration at right arm on 23Dec2020 15:00 at single dose, then received the second dose of BNT162B2 (lot number: E10140), via an unspecified route of administration at left arm on 11Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension, and depression, and allergy to latex. Concomitant medication included desvenlafaxine succinate (PRISTIQ), hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT). Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense indigestion followed but intense vomiting on 25Dec2020 11:00. Occurred 48hours after 1st injection and 56 hours after 2nd. Was much more intense after 2nd injection. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
comes with sodium chloride diluent and it was reconstituted with sterile water instead with no reported adverse event; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and non-healthcare professional via the [Medical information under reference number- 00794785].   This case involves a patient of (unknown demographics) who was vaccinated with YELLOW FEVER VACCINE - US [YF-VAX] that was reconstituted with sterile water instead sodium chloride diluent (Product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   It was reported "she had Yellow Fever (YF) vaccine which comes with sodium chloride diluent and it was reconstituted with sterile water instead. Caller stated the vaccine was administered to a patient. Caller said she read research that says the vaccine is not going to work and has to be redone. Caller wants to know what should be done. Caller requested call back because she was busy and could not wait to be warm transferred."  At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.  There will be no information available on batch number for this case.
severe chills, body pain, likely fever and fatigue at 7:30pm that lasted until 7am 2/6/21. i was not able to stand up or move during the period fr 7:30pm 2/5 to 7am 2/6. i was able to stand up and walk for 5 minutes (to care for my dog) and returned to bed w chills, fatigue and body pain through 2/6/21. fever and chills ended around 8pm 2/6/21. headache lasted 3 more days. fatigue lasted an additional 5 days. hives and skin rash on chest, arms and back started 8 days after dose 2 and have been recurring since then and progressively getting worse. dr prescribed 10 mg zyrtec and 20 mg pepcid ac (both meds bid for 14 days) for vaccine reaction. i started meds 4/10/21 and hives are starting to resolve but too soon to tell if will effectively calm immune response.
Swollen lymph nodes around armpit and breast on left side where shot was administered. Began 48 hours after vaccine
Left deltoid greater than 24 hours: red, swollen, warm and tender to touch, 8 x 8cm.  Tylenol and Benadryl.
Information has been received from a nurse practitioner and a licensed practical nurse concerning a 15 year old, female, student with no illness at time of vaccination with Bactrim allergy, rash who on 09-APR-2007 at 2:00 p.m. was vaccinated intramuscularly with the first dose of Gardasil, (Lot #656049/0187U). It was reported that at 8:00 a.m. on 10-APR-2007, the patient had 'a tickly feeling in her throat - which caused her to clear her throat, constantly. It was reported that the patient's "tickly feeling in her throat" which caused to clear her throat, constantly, went away after twenty four hours. It was reported that there was no soreness to the injection site noted. The patient sought unspecified medical attention. Additional information has been requested.
About 2 hours after injection my stool began to be more liquid than usual and continued that way for about 36 hours
Hospitalized on 9/22/01 with a dx of meningitis. Results pending. (Pt is a twin). Follow up report received 12/10/02, "Child was diagnosed with brain abcess- (Comatose X 1 mo, Hospitalized X 2 mo) not vaccine related. She gets check - up @ UMC. Is on phenobarbital for seizures. She continued immunization and is current for her age,
On the Friday after I got the vaccine I started having tachycardia when standing. I would feel very tired and jittery while standing. I went to the ER on 8/14/23 for high heart rate (180's) and high blood pressure.  I have never recovered and now have to take medication everyday.
Approximately 20 minutes after vaccination patient stood up and stated "I feel weird". Assisted client to chair and part of his buttocks missed the seat. He fell onto the floor and landed on his bottom. Provided first aid, cool compress to forehead, back and chest. Gave him soda & crackers. Monitored pt for additional 10-15 mins. Patient left with family w/o any complaints.
Measles vax given 1032am, @ 1035am pt c/o SOB, "funny feeling" in throat & dizziness.Adrenalin given.B/P-154/100;P-104;R-20. O2 via mask admin. 1048 am B/P-160/100;P-92. 1057am c/o dyspnea,A.R. 166. 1055am:ice to inject site....see WORM
This case was reported by a nurse via call center representative and described the occurrence of injection site bruising in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional additionally reported that the patient experienced bruising below the injection site after intramuscular administration of the vaccine. The patient and product details were unavailable.
Approximately 3 hours post vax, the pt developed bilateral arm weakness, numbness and facial weakness, which lasted 3 hours then, resolved. the pt reportedly was seen in the ER.