chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up on 12/31 to full-body itchy hives, centered around lower torso but radiating out everywhere else, with some swelling (including of the eyes)- no known cause, no known recent other exposure or allergens. Started to have heartburn on the evening of 1/1 with a wave of pain up and down the center of my chest, that kept me up all night. On 1/2, went to the Emergency Department for this chest pain as well as the hives (this was now the 3rd day they persisted and seem to be spreading). ED provided IV benadryl, pepcid, and fluids. Itching and swelling and heartburn seemed to be managed by that IV. Discharged after a few hours, told to treat with OTC drugs like allegra/zytrec and benedryl. Hives still persist- woke up with swelling of wrists, thighs, eyelids on 1/2.
Presents to hospital on 05/04/21 for leg swelling and shortness o breath; PMHx most significant for HTN, colon cancer, CKD, CVA with residual left sided deficits, DM; discharged to hospital on 05/13/21 .
Pain at injection site 2 weeks post immunization. Indicates "hurt" for 2 days, did not hurt for 1 day & then started hurting again. Reports no pain to touch but when lifting arm.
#2 dose of varicella given 7-8-19 and Employee presents with redness, swelling and warmth to touch at the injection site.
Fever 100.1.  Nausea.  Joint pain. Fatigue. Chills. Pain redness rash swelling at injection site.  Rash still on 2/14/2021.
7x10 cm red erythemic mark on right leg where HepA and Proquad vaccine was administered.
Patient came to pharmacy and stated after flu shot her arm started to hurt. Redness and swelling is also present. She is using ice and TYLENOL.
Yesterday, around 3:30 left arm little itchy. 8:45pm, left arm had soreness with a lump. This morning, left arm soreness, headache, back pain, chills, nausea, body aches , headaches radiates to ears and low grade temperature, 99.3-99.4, tireness  and low energy.
High temp 104 day of immun had a sz; Seen in ER given APAP temp down next day;
Have had a small Lymph Node since 11/2020, after dose 5 COVID-19 vaccine it became enlarged. Started off with feeling a raw sore throat, and noticed that my right Tonsil was larger that normal. Went to Urgent Care and had a throat culture. Later saw an ENT and was tested for COVID-19 and had a thorough exam. My previous Primary doctor had retired and I had to choose another doctor. When I saw this doctor, I had a blood panel drawn and wanted me to have a CT Scan that confirmed it was a Lymph Node. Saw an ENT again and was examined further and was scheduled for an Ultrasound to find the exact size of it. Doctor also wanted to determine if a biopsy was needed.  I was sent a message in the portal and was told that the node was in the normal parameters. I contacted my ENT because I wasn't satisfied with just brushing it off. Went back in for an exam and asked a list of questions and was told to come back in 3 to 4 months to have further testing if needed.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB injection, lot # M006708, expiration date: 02-JUN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 63.25 hours. There was no previous temperature excursion. "Digital data logger" was involved. No adverse effects were reported.
Information has been received from a medical assistant and a registered nurse concerning a 15 month old patient who vaccinated with a dose of GARDASIL due to nursing error. No adverse effect reported. Follow up information was received on 27-Jan-2009: The healthcare worker reported that the patient was supposed to received  Enders-Edmonston + Jeryl-Lynn + Wistar RA 27/3 but the nurse grabbed GARDASIL instead. It was reported that the patient experienced a rash on his trunk and neck. It was reported that the patient was given Benadryl and the symptoms improved. It was reported that the patient has not received Enders-Edmonston + Jeryl-Lynn + Wistar RA 27/3 MSD. Follow-up information received from a registered nurse on 30-Jan-2009 who reported that the rash that the patient developed faded the next day and was gone by 2 days. No further information is available.
she looked at her arm with a band aid on it, then it hurt; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program .A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine and had no side effects and didn't even feel the vaccine until she looked at her arm with a band aid on it, then it hurt. She was wondering if the first and second dose of the vaccine were the same. The outcome of the event was unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
While completing paperwork in immunization room, patient's mother stated she thought her daughter was starting to react to the vaccine. It appeared patient was starting to pass out so pharmacist and mother lowered her down from the chair to the floor to prevent injury. Patient's pulse was very faint to the touch and patient was difficult to arouse. Pharmacist delegated pharmacy technician to obtain AED. Patient's mother stated patient was beginning to shake and was becoming very hot and sweaty. 911 was dialed. No health conditions or medications were noted that would cause this reaction. Pharmacist was beginning to take BP when EMS arrived. EMS continued taking vitals. BP 100/65, HR 84, SPO2 96%. Patient started to become alert again as vitals were being taken.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 02Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FX9883) at the age of 76 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "Osteo arthritis" (unspecified if ongoing). There were no known Allergies. Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride]; Fluticasone; Buspirone; Nabumetone; Losartan; Myrbetriq; Rosuvastatin; Celebrex. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (26Jun2022) positive, notes: eight days after last Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, Covid-19.
Cellulitis diagnosed at the site of injection 3 day post vaccination. Area of induration & erythema 7 x 7 mm treated with AUGMENTIN.
Chills, fever 101, headache, earache, nausea, insomnia- all lasting for 24 hours.
Pt reports that on 2/28/2021 pt woke up at 7 am and was unable to move. Pt reports that she was paralyzed for about 3 hours. Pt was vaccinated on 2/27/2021 at a vaccine site. Location was High school and was administered by hospital. This was given in the left arm.
headache; injection site was hot; injection site was itchy; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE ERYTHEMA (injection site was red) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE ERYTHEMA (injection site was red) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included ibuprofen, aspirin, acetaminophen, caffeine, diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1) After the first shot, my blood pressure went up, and I felt dizzy and light-headed with a pressure behind my left ear at the base of the skull. They kept me for a while until it went down, and I was ok. 2) I didn't notice any effects initially after the second shot, which I was expecting. In fact, I felt so good that I went on a 12-mile bicycle ride. However, I began to experience diarrhea around 6:30 that evening. The next day I had headache, stiff neck, body aches, and a general malaise. The next day I had a rash all over my torso.  Those effects ceased, but on Saturday evening I broke out in hives on several areas of my legs, buttocks, and elbow. The hives were gone by the next day. The only thing that remains is a slight stiff neck. I never had fever, chills or any breathing problems. I spoke to my doctor the next day, and she was satisfied that I did not have any lingering symptoms or problems.
Bivalent vaccine was given 2 days beyond BUD; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD).    Concomitant Medication use information was not provided by reporter.  A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.  Treatment Medication use information was not provided by reporter.
swelling,  itching, rash, warm to the touch, 8 days after injection
A non-serious report of medication error has been received from a physician concerning a nine-month-old infant. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No medical history nor concomitant medications were provided. The patient received Flumist on an unknown date. The physician realized that FluMist had been inadvertently administered to a nine-month-old infant. No other events were reported. No outcome for the event was provided by the reporter. No dechallenge or rechallenge occurred. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
HLH; chronic lyme disease; an active EVB infection; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a female patient of unspecified age (reporter's wife) that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration at single dose for COVID-19 immunization, first dose on an unspecified date and second dose on 19Mar2021. Medical history was not reported. Concomitant medications were not reported. The patient was currently in the ICU with a diagnosis of HLH. They noticed something going in in her bloodwork in Apr2021. She had chronic lyme disease which was an active EVB infection. There is a study in the public library for NIH, about HLH occurring in people with an active EVB infection. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Staff was called out to lobby. When this RN went out to lobby patient was found unconscious on the floor. Her son was present and stated she did not hit her head. It took approximately one minute to regain consciousness. VS 110//62, 98%, HR 68, RR 16. EMT called for further evaluation. EMT tried to sit her up and she immediately started vomiting. She states "I just need to lay back down." When they attempted to sit her up again several minutes later she started vomiting again and wanted to lay back down. At this time (15:43) EMT transported her to healthcare facility for further eval.
pt c/o severe h/a 24hrs p/vax;saw MD on 4OCT95 c/o achiness, weakness, h/a, earache & fluid in chest;gave Kenalog, Fiorinal, Maxaire & Duravent;returned 12OCT95 w/severe h/a & was given Imitrex;13OCT95 c/o lt sided body weakness & neck pain
Patient given first Covid 19 immunization.   Came back to clinic with in the hour and had head to toe intense itching.  Saw provider and diagnosed with urticaria.   Gave zertec  and took Benadryl.  Symptoms resolved when seen for a follow up the next week.  Per provider, recommended to get the second Covid immunization as planned.   Patient notified
1st noticed retention of fluids in lower abdomen on 01/15/2022 with extreme shortness of breath.
Pt recvd 2 doses of Engerix-B & 1-2 days following exp severe reaction, itching sensation @ inject site, joint pain, extreme fatigue, hot flushes, sweating & mental attitude alteration;
my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
31 yo healthy female presented to HC for evaluation of a vaccine reaction to her (R) upper arm. She received MMR (MFX TSR lot # not recorded) to her Right Arm on 26 January at 14:30 and Varicella to her left arm. She states she had no initial reaction: no urticarial lesions, no oral or throat swelling, chest pain, increased HR, dizziness or nausea or emesis. The next evening she noted severe pruritus and burning starting to her upper arm. Her boyfriend noted redness and swelling on her upper arm and gave her a topical steroid (type unknown) and BENADRYL, which provided relief and she continued to dose. The next morning she noted a raised area at the injection site, and the affected area has continued to enlarge to include her shoulder and chest wall, and burning radiating distal to her wrist and hand. Her (R) earlobe itches and external (R) neck. There is no shortness of breath, oral itching, burning or swelling. There was no numbness or tingling. She had tenderness at the injection site, affected pruritic areas and axilla. She did not have joint pain including shoulder and elbow. She felt otherwise well, without fever or chills or malaise. She had normal strength and function, and only mild discomfort. Physical exam demonstrated 2x2 inch area of edema and erythema at posterior upper arm injection site surrounded by less severe very large patch 13 x 12 inches to right upper posterior arm and extending posterior and lateral across scapula, (R) chest wall, palpable lymphadenopathy to (R) axilla with tenderness and tenderness only to supraclavicular area. Increased warmth, tenderness, darker skin tone and edema to involved area. Edema noted to posterior axilla. She was treated with oral prednisone 60 mg daily and topical LIDEX and oral cetirizine three times a day. She was much improved in 24 hours per telephone follow-up. She was seen in clinic at 48 hours with symptoms nearly resolved in the medications were stopped.
Headache, fever, fatigue, body aches, joint pain, swelling and tenderness in axillary of injection site arm.
The pt's mom states the pt developed hives, itching, fever of 103 and nausea. No appetite. Resolving post Benadryl and Motrin by 12/12/00. Onset the evening of the shot.
Arm became swollen from the deltoid down into the wrist. Patient presented to the same-day clinic and the provider suggested the needle from the vaccine hit a nerve causing the swelling. The provider recommended taking Benadryl OTC three times a day for the swelling as well as ice and rest.
reported blurry vision, intermittent x 1 month starting day of vaccination. Currently monitoring, awaiting further workup
Redness and swelling at injection sites on both thighs; 2-3 isolated hives on chest / back. Tylenol and cold packs to immunization sites and observation.
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient has been contacted and informed of the vaccine administration error.  Reports no adverse reactions.
Patient presented to the ER with complaint of swelling in right lower extremity for 3 weeks.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient developed symptoms of SOB and a cough on 08/06/2021. Presented to the ER on 08/13/2021 for these symptoms and tested positive for COVID-19 on 08/13/2021.
Starting on evening of 4/7, patient started experiencing side-effects from Shingrix vaccination: Fatigue, soreness in arm, swelling/redness.  Patient took Benadryl and Motrin, as well as applying cold compresses to arm.  On 4/11 patient returned to pharmacy for additional medical advice.  I told her to contact her prescriber for seeking additional medical attention.
Swelling of the left eye, with rash/skin eruption on face. Received IV of Solumedrol 125mg and Pepcid 20 mg at a facility. Was prescribed Prednisone for 5 days.
pt recv vax 11OCT95 & devel an inj site rxn characterized by pain,warmth,swelling & redness;this is one of nine patients from this site who exp above rxn p/vax
left ear being plugged; hearing muffled; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2022, the patient received the 1st dose of Shingrix. On 28th March 2022, less than a day after receiving Shingrix, the patient experienced headache and fever. On 13th April 2022, the patient experienced ear feels clogged and muffled hearing in both ears. On 31st March 2022, the outcome of the headache and fever were recovered/resolved. On an unknown date, the outcome of the ear feels clogged and muffled hearing in both ears were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, ear feels clogged and muffled hearing in both ears to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and on the same day she noted she had a headache and fever post vaccination which lasted about 3 days and was now resolved.   A week ago the patient also noticed a sensation of her left ear being plugged or blocked.  The patient also noted her hearing was not decreased but muffled. Symptom had not resolved.  The patient called in to inquired on possible side effects of Shingrix. Provided information per PI (Package insert) on side effects with Shingrix.  Provided medical advise disclaimer and referred to HCP (Health Care Professional). The patient refused to provide full demographics or DOB. She stated her age was above 50. The reporter did not consent to follow-up.
She was so cold; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2nd reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's friend had the Pfizer vaccine yesterday and she was complaining that she was so cold. She has to turn on thermostat in her house. Event outcome was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021103039 same reporter/drug/event, different patient