chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physicians assistant concerning a 9 year old female who was vaccinated with Gardasil. Subsequently 6 hours after the vaccination the patient experienced vomiting. Unspecified medical attention was sought. Additional information has been requested.
Large local erythematous reaction that appeared within 5 minutes of giving the vaccine and spread rapidly to an area of about 6cm x 4 cm. It responded well to Benadryl and cool compress.
chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 16-Jun-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicabl
Burning pain and sore to touch all along deltoid muscle that is progressively getting worse 2 weeks following injection. Bruise apparent 2 weeks after, as well. Bruise appeared 6/17/18.
Arexvy vaccine administered during pregnancy; HCP states that MD sent 36 week (3rd trimester) female to pharmacy with a prescription for Arexvy and it was administered; Inappropriate age-off label use; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age-off label use). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy vaccine administered during pregnancy) and drug prescribing error (Verbatim: HCP states that MD sent 36 week (3rd trimester) female to pharmacy with a prescription for Arexvy and it was administered). The outcome of the vaccine exposure during pregnancy, drug prescribing error and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 01-NOV-2023 The pharmacist requested data on use of Arexvy in pregnancy.  The HCP (health care professional) stated that MD (Doctor of Medicine) sent 36-week (3rd trimester) patient to pharmacy with a prescription for Arexvy and it was administered in September 2023 (exact date unknown), which led to vaccine exposure during pregnancy and drug prescribing error. The patient received vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Nurse calling for TE evaluation on frozen products states products have been administered.; No additional AE details.; This spontaneous report has been received from a nurse, concerning an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On an unknown date, the patient was administered vaccine measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) subcutaneous injection (valid lot number W004029 [expiration date 02-AUG-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, and sterile diluent (dose, vaccination scheme, frequency, lot number, expiration date were not provided), after a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees F (8F) for 0 hours (h), 18 minutes (min) and 0 seconds (sec), 14 F up to 46 F (18.40F) for 0 h, 45 min, 0 sec (product storage error). No previous temperature excursion was reported.   No additional adverse event (AE) details.  Thisis one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA002184: US-009507513-2206USA002208: US-009507513-2206USA002249: US-009507513-2206USA002264: US-009507513-2206USA002383:
Her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow; Fatigue; A slight cough; Her left arm began to ache and shake/left arm pain; Her left arm began to ache and shake/left arm shaking; She had arm pain when woke up the next day, and the 28th she had slight swelling; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated on Sunday morning while taking a phone call her left arm began to ache and shake and she had to end the call. Caller states her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow. Caller states she can't use her left hand too much because it starts to ache and shake, says she was holding the phone talking to someone and after about 50 minutes her arm hurt, then 5 minutes later it started to shake and she had to stop using her hand to hold the phone. She says she had the same problem driving to work last night, she works night, she couldn't use her left arm driving for the trip because it was shaking. then she couldn't do as much of her usual work because it starts to shake and she needs two hands to do her job. She says today she also has a little bit of a cough and fatigue. The patient reported that since it was after her first dose that she had these problems she would like to know if it is safe for her to have her second dose that is scheduled for 24Apr2021. She could use her left arm now and was currently holding the phone in that hand to see if the event reoccurs. She says her arm aches above her injection site to two inches below her elbow, and when it shakes it was like her arm was having a seizure. She was used to having 4 hour phone calls to stay in touch with people and holding a phone for long periods of time was not unusual for her, but her arm could not hold it after that 50 minute call. She had arm pain when woke up the next day, and the 28th she had slight swelling by Saturday afternoon or evening, then she woke up more swelling the next day. She said this was at a mass vaccination site she got her first dose. She had a constant ache, and she hasn't taken any Ibuprofen for it. Since she has been holding the phone this call, it has begun aching more, she has been holding the phone 15 minutes, and it started to ache, but there was no shaking yet. States she is scheduled for the second dose on 24Apr2021. She would like to know if her side effects are normal and if she should receive the second dose. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Large bump/swelling on left deltoid. Bump & bruise inside. ice, OTC Tylenol and Benadryl given. Dr checked pt's lungs -no wheeze. Immediate redness, swelling within 5 minutes of shots. did well with po 25 mg Benadryl local reaction, no cardiorespiratory.
Induration of 3.0cm asked her and remain for observation - 15 minutes - left without recheck. Called and mailed patient parent letter. Advised patient will not give 2nd Varicella per MD.
Information has been received from a pharmacist referring to several patients of unknown age and gender (pregnant: no). Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced soreness, pain and agitation after having been vaccinated. The outcome of the events was unknown. The causality assessment was not provided.
Redness and induration right and left arms. Fever for 48 hours, then fever resolved.
erythema 3" x 3" & large lump devel-noticed first on 22OCT97;soreness @ site began 22OCT97;
Swollen ankles; All over body rash; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0178), via an unspecified route of administration on arm right on 23May2021 12:00 PM (Age at Vaccination: 49 years) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included Known allergies to Codeine, Morphine, Laytex, Tree pollen (seasonal allery). Prior to the vaccination, the patient was not diagnosed with COVID-19. device timestamp was reported as 08Aug2021. Since the vaccination, the patient has been tested for COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient Concomitant medications received within 2 weeks of vaccination included Chlorthalidone, Colestipol taken for unspecified indication, start and stop dates was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731), via an unspecified route of administration on arm right on 29Apr2021 01:00 PM (at the age of 48 years) as dose 1, single for COVID-19 immunization. On an unspecified date in Jun2021, the patient experienced All over body rash and swollen ankles that appeared week 2 after dose 2 of vaccine given, symptoms lasted one week. The lab tests included SARS-CoV-2 test (Nasal Swab): negative on 09Jun2021. Treatment received for the adverse event was reported as no. The outcome of events was resolved on Jun2021.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2022 19:00 (Lot number: FK9895) at the age of 37 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Stomach pain", stop date: Mar2011, notes: Appendectomy; "Flu like symptoms", start date: 03Jan2022, stop date: 10Jan2022, notes: Did multiple Covid tests, they were all negative. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0181, Date/time, Date: 19Jun2021, Route of administration: intramuscular [checked], Batch/lot number: EW0181), administration date: 19Jun2021, when the patient was 37 years old, for Covid-19 immunization, reaction(s): "TSH/ abnormal", "free thyroxine/ abnormal"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk9895, Dose: 1st, Date/time, Date: 29May2021, Route of administration: intramuscular [checked], Batch/lot number: PEW0178), administration date: 29May2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: TACHYCARDIA (medically significant) with onset 12Feb2022, outcome "unknown", described as "Tachycardia"; THYROID DISORDER (medically significant) with onset 12Feb2022, outcome "unknown", described as "Thyroid problem"; HEART RATE INCREASED (medically significant) with onset 12Feb2022 14:00, outcome "recovering", described as "Rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm". The events "tachycardia", "thyroid problem" and "rapid heart rate the next day of the vaccination with resting rate of 100+ bpm and standing rate of 120+ bpm" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (12Feb2022) thyroid results, notes: showed that my thyroid results only on 16Feb2022; blood thyroid stimulating hormone (0.35-5.5): (02Feb2022) 0.020 MiU/mL, notes: Abnormal; electrocardiogram: (12Feb2022) tachycardia; free thyroxine index (0.61-1.30): (02Feb2022) 1.44 ng/dL, notes: Abnormal; heart rate: (unspecified date) 100+ bpm; (unspecified date) 120+bpm, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; (12Feb2022) mostly high, notes: while I was sitting and watching TV, the next day around 02:00PM eastern time. Since 02:00 PM-08:00 PM on 12Feb2022 (next day) my heart rate was mostly high at which point; sars-cov-2 test: (unspecified date) negative, notes: Did multiple Covid tests, they were all negative; thyroid function test: (Nov2021) normal. Therapeutic measures were taken as a result of tachycardia, heart rate increased. It was unknown if therapeutic measures were taken as a result of thyroid disorder.
Injection site reactions: pain, tenderness, swelling (hardness), and redness General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and diarrhea, and fever
Mother states child developed a large red area on right leg where PCV13 shot was given.  And that is spread down his leg and up toward his back.  She states he has never had a reaction to a vaccine in the past.
Information has been received from a nurse concerning a male child with a history of laryngomalcia who on 27 Sep 2006 was vaccinated with his first dose of Rotateq (Lot# 655050/0778F) and his second dose of Rotateq (Lot# 654489/0941F) (date unspecified). "About a week after the second dose", the patient developed vomiting and diarrhea. On 26 Feb 2007, the patient had a positive lab screen for rotavirus. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Follow-up information has been received from a physician concerning a 21 week old male who was vaccinated with first dose of ROTATEQ on 27-NOV-2006 (previously reported as 27-SEP-2006), second dose on 12-FEB-2007, and third dose on 02-APR-2007.  Concomitant vaccines included Hib conj vaccine (unspecified carrier), PREVNAR, and PEDIARIX.  The patient was also vaccinated on 29-SEP-2006 with hepatitis B vaccine (unspecified).  On 27-FEB-2007 the patient experienced positive lab screen for rotavirus, vomiting and diarrhea which lasted approximately 4 days, the patient's required a doctor visit.  The patient's outcome was reported as recovered.  Additional information is not expected.
Noticed 3 Red dots on stomach a week after first dose ; after second dose ; felt feverish and had skin irritation on right side of stomach and right side back. Went to doctor on April 26 and they diagnosed it as shingles.  It is a mild case but I believe it is associated directly with getting the vaccine.
rash near injection site (left arm).  Hives on top of both hands, top and bottom of wrists, elbows, tips of fingers of both hands very sensitive to pressure (but no hives on those)
Fever for  a few days immediately following shot. Then a low grade fever for months, then got sick and after months of drs diagnosed with POTS. Bed ridden continues. Low grade fever daily for 5 months.
Patient was seen at clinic for 2nd covid vaccine. Patient was scheduled for 2nd pediatric covid vaccine. Patient was given COVID-19 vaccine mRNA(PF) (Pfizer/BioNTech)5-11yrs (IMM611) 0.2 dosage.
This is reported by the nurse who gave him the vaccine, he got his vaccine and his only complaint was dizziness.  The patient was transferred to the ER for FU.  He is just being monitored.   His VS were really good, the only complaint was dizziness.  He was doing fine while being transported to the ER.  Mother reports he has never had a reaction to vaccines in the past.
Pt is a/o x 4, Pt received her booster shot and stated that she is severely allergic to eggs. Pt stated that she noticed redness developing on her neck and asked for Benadryl. When pt was informed the Benadryl was IM route pt refused stating that she would take some when she got home. Pt ambulated independently to the front door where she stated she began to feel worse. Pt became visibly agitated, diaphoretic and stated that her throat felt funny. Pt was determined to be having a moderate allergic response and was administered 50mg Benadryl IM @1608. Pt condition immediately improved stating that she felt much better. Pt was advised to follow up with her provider and further evaluation with EMS. Pt refused EMS evaluation signing a refusal stating such.
After COVID booster patient developed fatigue and fever.  Received booster on 10/04/2021.  Reports friday after getting covid booster she developed vision changes in left eye.  Reports she went to see Dr. optometrist who performed eye scans and diagnosed her with Multi-evanescence white dot syndrome.  Reports she was referred to retina specialist.  Patient reports she continues to have vision changes and difficulty seeing out of right eye.  Reports vision changes are restricting vision.  Patient states she called and also report adverse reactions to Pfizer.
atient presented to COVID vaccine clinic today and developed an allergic reaction after receiving the Moderna COVID-19 vaccine. Pt reports hx of allergies to sulfa and cat dander. Denies any allergies to PEG or vaccines. Denies any hx of anaphylaxis. Ten minutes after vaccine administration pt reported chest tightness, mild SOB, mild dizziness and a sensation of a ?cotton ball? in her throat. Pt reported throat sensation similar to her cat dander allergy. Pt developed slight swelling and tingline of the lower lip. Denied difficulty swallowing or nausea. HR 78. Pt placed on 2 L of O2 for SOB. Epi pen and albuterol inhaler present. Code Blue called & ED code team arrived and transported patient to ED for further workup.
Pt was administer Moderna vaccine at an off site event. Pt was adamant that she had not had this vaccine in the past and that this was her first dose. When paper work was brought back to Health Department to be scanned and entered into VHN/ GRITS it was found that patient had received her first vaccine on 02/01/2021, eight days prior. Pt sat in waiting area x 15 min and was feeling fine when patient left to go back to her room, no side effects noted. Daughter (POA) was notified of this event and that her mother (pt who was vaccinated) does not need any more vaccination as the time.
Within 5 mins of vaccination the patient reported tingling tongue and mouth. Headache beginning about 11:16 am
Information has been received from a pharmacist concerning her daughter, a 22 year old female with asthma, food, insect, and environmental allergies including anaphylaxis to bee stings and to dairy consumption, who on 30-AUG-2010 was vaccinated with the first dose of PNEUMOVAX 23 (LOT# 665402/1339Y, expiration 22-MAY-2011). Concomitant therapy included ASMANEX, albuterol and hormonal contraceptives (unspecified). On 31-AUG-2010, the onset of symptoms approximately 24 hours after vaccination, the patient experienced fever, body ache, and a local injection site reaction described as red, hot, swollen, and approximately six inches in diameter. There was no lab diagnostics studies performed. The patient sought medical attention by contacting pharmacist. At this time of reporting, the patient's symptoms persisted. Additional information has been requested.
It started on 12/24/2021, severe muscle and joint pain, along with severe fatigue and brain fog. Dizziness, vertigo, and difficulty standing and walking. Dyscognition, haven't been able to think straight.
Received Wednesday 9/28/22, woke up Thursday morning at 4 AM feverish, body aches, headache just overall feeing bad, was able to get thru work.  Woke up Friday, 9/30/22 feeling much better, applied my deodorant and noticed my underarm (Rt) was swollen and sore.  Did go back to Employee Health to have them look- they recommended I notify PCP as well as CDC.  No other issues with Rt arm.
Heart palpitations, felt difficult to swallow, sweating, flushed face, intense headache, difficult to catch breath a few hours after the first dose administration. All above besides headache lasted briefly, 10-15 minutes before subsiding.
Vaccinated for Shingles ~ 10 days before outbreak of shingles on lower right side of neck below hair line (2 locations), and upper right shoulder (3 locations).
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated IM with a second dose of GARDASIL (lot # not provided) for prevention of cervical cancer. "A couple of weeks ago" the patient became faint after receiving the second GARDASIL. Subsequently the patient recovered in the office. No lab diagnostics studies performed. Patient sought unspecified medical attention. Additional information has been requested.
Woke up with rash and double vision.  Generalized rash all over body.  Went to Urgent care  4/23 and then primary for further dx next week.  Saw doctor for double vision on 5/5 for further help with double vision.  Rash resulted in skin peeling and resolved in 10 days.
Large erythematous area around site of vaccine.  5x5 inch area tender resolved in 4-5 days.
Severe migraines now taking migraine medicine . Migraine come with vision issues and light sensitivity
My allergies were bothering me when my wife and I were in other places. Once we got back my wife and I both were experiencing the same symptoms but once my wife developed a sore throat we felt we should test for COVID 19. We used our home COVID 19 Test that came back positive. We then went to the county testing facility bus and they confirmed with a PCR COVID 19 Test that we were positive. We were prescribed Paxlovid that we picked up from our pharmacy and started taking it. During the time I was taking the Paxlovid my blood pressure was very high but has come back down to normal. My symptoms were mild and felt more like an allergy attack nothing like having the flu.
I had a Mammogram at the end of December 2022 and they called back in January 2023 for another and Mammogram and Ultrasound. The Ultrasound was negative but the Mammogram was positive for Breast cancer again. I went for a biopsy on 11JAN2023 which was positive for Ductal Carcinoma In Situ stage zero. I met with a surgeon who asked for an additional biopsy which was completed on 17JAN2023. Surgery was scheduled for 21FEB2023 and a removal two calcifications was done. A biopsy post surgery of five extractions one of which was suspect, twenty radiology treatments are forthcoming  and .5 tamoxifen for three years.
This spontaneous report as received from a physician via a company representative, refers to a 65 year old male patient. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) for prophylaxis. On unknown dates, the patient experienced chronic inflammatory demyelinating polyneuropathy and severe pain. The patient sought medical attention, he spoke with the physician. At the time of reporting, the patient was in severe pain. The outcome of chronic inflammatory demyelinating polyneuropathy was unknown. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.