chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; >35 days interval of doses; hives on 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on 2nd dose), PRURITUS (itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days interval of doses) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteopenia and Osteoarthritis. Concomitant products included ATORVASTATIN for Cholesterol, METRONIDAZOLE for Rosacea, GABAPENTIN, COLECALCIFEROL (VITAMIN D3), MAGNESIUM, ZINC and ACETYLCYSTEINE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (hives on 2nd dose). On 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days interval of doses). On an unknown date, the patient experienced PRURITUS (itchy). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency; CORTISONE for Adverse event, at a dose of 20 milligram; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of 40 milligram twice a day and HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency. On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days interval of doses) had resolved. At the time of the report, URTICARIA (hives on 2nd dose) and PRURITUS (itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her Dermatologist performed a punch biopsy and She underwent multiple blood tests and diagnostic procedures (MRI, Xray), all were not indicative of a certain diagnosis  Patient also took the concomitant medication oestrogen patch 0.25 mg.   This case was linked to MOD-2021-321014 (Patient Link).
Pt states "Chills, diaphoresis, nausea and almost passed out."  Pt states he has not eaten yet today. P:  111/57, HR 61, O2 100% RA
Rash that started on her wrist 3 days after immunization - spread all over her body treated with MEDROL dose pak.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Full Body Hives-Medium, Additional Details: Patient reported onset of full body hives about 10 days after booster dose of Moderna covid vaccination.  Patient reports consulting with physician to confirm delayed onset allergy.  Patient has been taking famotidine, benadryl, cetirizine, and steroid to treat hives.  As of date of this report, patient is still experiencing hives, with slow recovery after antihistamine and steroid treatment.
4/6/21 woke with headache, by 2pm serious headache, chill, body aches and tired.; 4/6/21 woke with headache, by 2pm serious headache, chill, body aches and tired.; 4/6/21 woke with headache, by 2pm serious headache, chill, body aches and tired.; 4/6/21 woke with headache, by 2pm serious headache, chill, body aches and tired.; 4/6/21 woke with headache, by 2pm serious headache, chill, body aches and tired.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8729) via an unspecified route of administration in the left arm on 05Apr2021 at 13:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and other medication received within two weeks of vaccination was not reported. The patient had no known allergies to food, medicine or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021, the patient woke with headache, by 14:00, she experienced serious headache, chill, body aches and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events woke with headache, by 14:00 serious headache, chill, body aches and tired was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Right shoulder soreness; Right axillary lymph node swelling; This case was reported by a nurse via call center representative and described the occurrence of shoulder soreness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, 1 days after receiving Shingrix, the patient experienced shoulder soreness and enlargement of lymph nodes. On an unknown date, the outcome of the shoulder soreness and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the shoulder soreness and enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The nurse reported that she was the patient and experienced right shoulder soreness and right axillary lymph node swelling. The healthcare professional described sore shoulder as sore arm.  The healthcare professional noted that the soreness and swelling began the day after she received dose one of Shingrix.  The reporter was unable to query healthcare professional for lot number, expiration date, consent to follow up, and physician contact details due to healthcare professional's abrupt end to conversation.  The healthcare professional did not provide phone number and address when queried.
Erythema multiforme minor. Started with what thought to be hives on 7/28 seen in urgent care and told to start Benadryl. Continued with full body EM rash with target lesions. Placed on steroids and Benadryl.
Pt recvd 3 doses of Engerix-B on 16APR90, 18MAY90, & 19OCT90 was found to be a non-responder;
migratory arthralgias and joint swelling ( wrist, knees) , headache, chills
severe eye aches; dripping sweat; every joint was shaking; "Juice tasted like oil"; No taste at all; no appetite; felt like he had Covid again; intense fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil") and AGEUSIA (No taste at all) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 in November 2020.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills). At the time of the report, EYE PAIN (severe eye aches), HYPERHIDROSIS (dripping sweat), TREMOR (every joint was shaking), TASTE DISORDER ("Juice tasted like oil"), AGEUSIA (No taste at all), DECREASED APPETITE (no appetite), SUSPECTED COVID-19 (felt like he had Covid again), PYREXIA (intense fever) and CHILLS (chills) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and No Treatment medications were reported.   This case was linked to MOD-2021-067425 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non significant follow-up contains primary reporter Email address.
VOMITING; FEVER; NAUSEA; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a child of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced vomiting. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting and product administered to patient of inappropriate age was not reported. This report was non-serious. Version created to amend previously reported information on 20-MAR-2021. Upon review the following information was amended: The event as Product administered to patient of inappropriate age was added and relevant fields were updated.
It started right away with the injection site pain and swelling. Aches and a headache started early evening and a fever lasted most of the night into the next. I called out from work because of the fever, the aches, and the fatigue. I slept most of the and all night. During the early morning hours, I started having bad pain under my left arm. By mid-morning, l found a lump, swollen lymph node. By mid-afternoons rash down my left side across my ribs and up to my right under arm. Today the rash is also across my back and around my neck. I don't feel achy or fatigue, but the rash is starting to itch. The second shot I had slight flu like symptoms. The first booster the flu like symptoms were more severe. And now this...
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient showed up and checked in for both flu and c19 booter shots.  As patient received the c19 booster shot he immediately started sliding of the chair. i help him in place and called 911 immidiately. patient never lost conscious and was very alert however, he was sweating heavily. the patient reached out to his grand father who outside and he rushed in. shortly 911 arrived and took over.   after he was cleared by 911 team patient his flu short but i ask him to come in another day.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old patient who experienced leg was hot to touch and was very sore and could not walk. The patient received a dose in Jul-2010. The patient experienced leg was hot to touch and very sore and could not walk in Jul-2010. The outcome of the events was unknown. No additional information was available at the time of this report.
17OCT97 had physical-no problems;PSA down to 48;21OCT97 h/a, felt funny;22OCT97 felt worse to MD for lab work;23OCT97 to hosp in kidney failure;blood not coagulating;kidney dialysis 3x wk x 1wk;7NOV97 w/hypertens & n;MD states toxic rxn
Shortness of breath during / after exercise, first started next day and continued for about 10 days. I didn't report it originally because I just sort of assumed it was unrelated - I don't know why I would think I had suddenly gotten much less fit but I guess I did assume that . Anyway after it stopped I realized that it only happened after the vaccine. There is a hill in my neighborhood that I walk up every day; for those ten days I had to stop twice to catch my breath and again at the top. For comparison today I walked up that hill without stopping and at the top I was not out of breath. I am very active; walk a lot, probably 5 miles or more a day and during the 10 days to 2 weeks after the first vaccine I had quite a lot of trouble breathing while walking, particularly on hills or going fast.
she got very sick; Nausea; Fever 101 F; Vomiting; Has not received the second dose; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she got very sick), NAUSEA (Nausea), PYREXIA (Fever 101 F), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A2119) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had COVID-19 disease in 2020) in 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ILLNESS (she got very sick), NAUSEA (Nausea), PYREXIA (Fever 101 F), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose). On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) had resolved. At the time of the report, ILLNESS (she got very sick), NAUSEA (Nausea), PYREXIA (Fever 101 F) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, SARS-CoV-2 test: negative (Negative) She finally got a negative COVID-19 test. On 02-Mar-2021, Body temperature: 101 f (High) Fever 101 Fahrenheit. On 16-Mar-2021, Antibody test: positive (Positive) She did three antibody tests three times. The first had antibodies and positive (Positive) The Second had antibodies. In September 2021, Antibody test: zero (Negative) 3rd time zero antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment details were reported. Patient's doctor told her not to get the second vaccine.
Sat after injections pt felt fine. Pt states that the only time his arm hurt when he opened his pop bottle. Sunday AM when woke up both arms were hurting, both arms were swollen at this time. Monday morning his rt. arm was swelling even more and the injection site was bigger. Left arm was starting to swell and under his arm was swollen. Then Monday morning pt woke up with fever, cough and a lot of pain.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016M20A and 026L20A) for COVID-19  immunization. No medical history reported. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 11, 2021, patient experienced pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot). Patient treated with Plavix (clopidogrel bisulfate) for adverse event, at an unspecified dose and frequency and Crestor (rosuvastatin calcium) for adverse event, at an unspecified dose and frequency. On Feb 13, 2021, pyrexia (fever after 2nd shot) and headache (mild headache after 2nd shot): resolved. The reporter did not provide any causality assessments or concomitant medication. This case linked to MOD-2021-386996 (patient link).
Itching on the night; Hot to the touch; Swollen; It get red; Arm was sore for one day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for one day), PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for one day). On 13-Jan-2021, the patient experienced PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red). On 06-Jan-2021, PAIN IN EXTREMITY (Arm was sore for one day) had resolved. At the time of the report, PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  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.; 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.
This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown), and experienced not responding to therapy. At an unknown time after completing the vaccination series with TWINRIX, the subject was tested for hepatitis A antibody and the physician reported that the subject was "not immune" (not responding to therapy).
Pt had a 2.5 inch in diameter localized area of redness on left deltoid and c/o itching. UrticariaPruritus. Diphenhydramine 25 mg once.
On 1/4/21 the event follows: 11:37am I got the vaccine  11:50am I got symptoms of tingling with numbness in lips and fiery hot in injection site  12:00pm tingling in left arm below injection site to finger tips 12:20pm felt like my arm was asleep  12:54pm I was given diphenhydramine (Benadryl), fatotidine (Pepcid), and prednisone (deltasone) 1:25pm my left shoulder moving up my neck behind left ear started having pain  1:40pm I was given ibuprofen (Motrin) 2:28pm I was told the symptoms left were known/normal and I am to watch symptoms and take Motrin and Tylenol as needed.  Around 4pm made it home and went to sleep.  9:20pm I woke up pain was minimal and went back to sleep. On 1/5/21 I woke up @6:35am and pain was minimal in injection site no other symptoms. Throughout the day I started feeling more pain but was bearable. @6pm my arm was in pain and hurt to touch @7pm I decided to look at my arm and noticed a red ring around injection site
First day- lump in breast and redness in breast left side, pain in arm left side and headache and fatigue  Second day-same Third day- chest pain and pain in left arm  Fourth and fifth day- chest tightness pain, left side neck and shoulder frozen, back pain and headache, heart beat fluttering. I?m scared :/
No additional AE; 1st PROQUAD dose via intramuscular route instead of and not by subcutaneous route; This spontaneous report was received from a nurse and refers to a 11-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-JUN-2021, the patient was improperly vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), via an intramuscular route instead of subcutaneous route (lot# T013602 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date: 15-MAR-2022) (formulation, strength, frequency, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported. The reporter requested measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) medical information.
Pt recvd 1st dose of Hep B vax on 5JUN91 & the next day devel a h/a, backache, systemic weakness, & a fever of 103 which persisted x 4 days; tx ASA & later recovered;
Tingling and numbness down the fronts/shins of my lower legs down to the tops of my feet, very noticeable when sitting but not when walking,  and tingling and numbness in forearms and hands noticeable when sitting and lying down.  Symptoms appeared after first shot. Symptoms greatly intensified right after second shot, then dropped down again to same level as after first shot.
Pt was administered 2 doses of Covid19 vaccination, 03/16/21 and 04/06/21. Pt tested (+) for COVID19 on 05/08/21.  Had contact with a suspected COVID + patient on 5/3/21.  Presenting for testing with no symptoms.
LATE 2ND DOSE; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: LATE 2ND DOSE). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 The health care professional reported that patient received 1st dose of Shingrix on 01/24/2022 and is in the office to receive dose 2, now which led to lengthening of vaccination schedule. The vaccine administration facility is the same as primary reporter. The health care professional did not have the exact date of vaccination or lot number or expiration details.  The reporter consented to follow up via email.
Vaccine given 9/24/09. Diarrhea started at 01:00, 9-25-09. Patient was nauseated, no vomiting. Felt weak and dizzy. Mouth and mucous membranes appear dry. Slight headache, SOB, hoarseness and wheezing. Pulse at 104. Also c/o fatigue. Refused treatment.
11/03/2017 tonic straightening of both lower extremities, failure to respond to stimulation and left upward gaze.
Fever to 105 degrees with dizziness, some congestion. Treated with ibuprofen & cool baths. Improved to 102 degrees, lasted at 48 hrs.
congestion that has not gone away; little light headiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little light headiness) and NASAL CONGESTION (congestion that has not gone away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (little light headiness). On 25-Apr-2021, the patient experienced NASAL CONGESTION (congestion that has not gone away). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, DIZZINESS (little light headiness) outcome was unknown and NASAL CONGESTION (congestion that has not gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.