chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Pharmacist via Company Representative refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of GARDASIL (dose and route not reported) Lot # H020901 with expiry date: 05-JUL-02015 or J006236 with expiry date: 25-FEB-2016. It was unable to be determined which lot number the patient was administered. It was unknown if that was patient's first dose of GARDASIL. On an unknown date the patient experienced allergic reaction in his eyes. The patient sought medical attention by visiting physician and the reaction was treated with unspecified medication. There was no intervention to prevent serious criteria. The outcome of allergic reaction in his eyes was unknown. Relatedness between the event and GARDASIL was not specified. Additional information has been requested.
64 year old received Fluzone HD which is intended for 65+ age group - no side effects.
Initially with pain at site, the swelling continued over 1.5 weeks then slowly decreased.
Fatigue, headache  8 days later. Gone day 9. Nausea day 9.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included LIPITOR (used LIPITOR in the past) and Shingles vaccine (past administration of live Shingles vaccine in 2017). 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 fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine and does not remember when the injection was given but thought it was either in December 2017 or on 26th April 2018. The patient was scheduled for his 2nd shot of SHINGRIX on 30th July 2018. It was administered at his Medical doctor office. The patient experienced a painful arm and a fever. With respect to the painful arm the patient said he had to hold his arm to avoid using it. The events resolved after 2 to 3 days. No further information was provided.
Received IM vaccine 11/09.  Had latent side effect on 11/13 - noted hard redden area surrounding injection site, the size of a  quarter, swollen and raised.  Referred to MD. MD ordered oral antibiotics and administered 2 Rocephin IM's. Diagnosis of cellulitis. 11/14 noted increased swelling, redden rash radiated down the biceps.  Admitted patient for IV antibotic therapy vancomyacin.  Hospitalized 2 days.  Taken off vancomyacin as of 11/21/07.  Will continue on oral antibotics.  The right deltoid is still visabily slightly redden and swollen; the muscle feels somewhat harder than right deltoid muscle and has one minute areas of serous leakage which is covered with a bandaid.   No tunneling.  Pain has alleviated and is only noted in right upper deltoid.  ROM normal today.  Will continue monitoring of site and stay on oral antibotics12/3/07-records received  for DOS 11/14-11/16/07-DC DX: Right upper arm cellulitis. Increasing redness and swelling and pain.
No further AE; HCP called to report that a dose of VARIVAX was given less then 4 weeks apart from a dose of MMR II. HCP became aware of this today. No symptoms reported. HCP gave permission to contact. No further AE details/No PQC; This spontaneous report was received from a nurse referring to a 2-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      In May- 2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (route of administration, lot number and expiration date not reported) for prophylaxis, and less than 4 weeks, on 07-JUN-2023, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number W031811, expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.  Both vaccines were diluted with sterile diluent.
Within a half hour of receiving the vaccine, I had a headache. Within 1 hour of receiving the vaccine I also began feeling body aches, fatigue, and joint pain. On day 3, I developed severe diarrhea,  which lasted for about 24 hours. On day 4 after the vaccine, I had some lymph nodes on the left side of my neck inflame.  They were tender and it would hurt to turn my head.   Also on day 4, I forced myself to go to work, exhausted.  On day after the receiving the vaccine, I started my period 10 days early. My cycle had always been predictable and regular. The headache continued for more than 6 days, the body aches and joint pain continued for 6 days. The lymph nodes in my neck have decreased but are still a little bit inflamed still today (4.25.2021) Also, still experience fatigue on a daily basis since the vaccine.
Breakthrough case admission after three vaccines Moderna 3/18/21 Lot# 002B21A; Moderna 4/15/21 Lot# 040B21A;  Moderna 3/1/22 Lot# 027L21A
Dark urine; Congested throat; Dizziness; Body aches; Fever; Fatigue; Redness on face; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face) and PAIN (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness on face). On 17-Feb-2021, the patient experienced CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Treatment details included None.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Vomiting-Mild
RASH ON RIGHT CHEEK PER PHONE CALL FROM MOTHER AT 3:30 PM, VACCINE ADMINISTERED AT APPROXIMATELY 2:20 PM. NO PREVIOUS PROBLEMS WITH VACCINATIONS REPORTED FROM HISTORY GIVEN BY FATHER.
scratchiness in throat; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (scratchiness in throat) and INJECTION SITE PRURITUS (Itchiness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (scratchiness in throat) and INJECTION SITE PRURITUS (Itchiness at injection site). On 29-Jan-2021, OROPHARYNGEAL DISCOMFORT (scratchiness in throat) and INJECTION SITE PRURITUS (Itchiness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not reported. Treatment information was not provided.
Patient was to receive second dose on 5/28/21 and received second dose on 5/19/21
Felt itching on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received Shingrix. On 30th August 2020, 5 days after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. About five days later on 30th August 2020, the patient stated she felt itching on the injection site. The itching was ongoing till the time of reporting. There was nothing visible on the skin, but the patient continued to itch. The reporter consented to follow up.
Pt developed a fever and an injection sire reaction characterized by warmth, redness and swelling described as cellulitis.  One day post vax, the pt was seen at the ER.  No treatment was given.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    The case was reported for 47th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient had tightness of the throat with shortness of breath which started 5 to 10 minutes after receiving vaccination. This was followed by labored breathing for which an EpiPen was administered. Patient had also consumed Benadryl (unknown dose) and Pepcid AC approximately 5 minutes after receiving vaccination.
20 mins in pain from deltoid to deltoid and up neck into head. At 5 hour mark I had a rash/hives and swelling on whole arm that had the injection and it was creeping up my neck to my ear, temp of 99.4, headache, fatigue, and nasal congestion. I took 25mg benadryl and used ice on my arm for 1.5 hrs before I got relief and then went to bed. When I woke at 5am I still had redness where the hives were but no hives and the site still hurt but I've been fighting swelling in my face. I've been taking chloratab allergy medicine q4-6 hours and ibuprofen to keep it at bay. Awoke this am (8/20) with swelling of my eyelids. Allergy meds are helping.
She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there; She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21); This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning ((unable to recall more precise date)) in 2021. Previously administered products included for an unreported indication: FLU in 2020. Concurrent medical conditions included Hashimoto's disease, Penicillin allergy and Allergy to animals. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and SPIRONOLACTONE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)). At the time of the report, LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)) had resolved.            Treatment information was not provided.
Dull pain at injection site, feeling of 'puffiness' and periodic tingling on Left side of face, left arm, and left hand. Itchiness left hand. Sore throat (mostly left side). Tiredness. Neck ache. General Malaise. Extreme thirst. Difficulty sleeping.
This literature marketed information has been received from a published literature article title as stated above and refers to a 55 years old women, with known preexisting alpha-gal allergy. The patient developed on an unspecified date in 2017, disseminated urticaria and peripheral edema within 30 min of M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. The patient was treated at home with BENADRYL. At the time of reporting, the outcome of the events was not reported. The reporter considered the events to be related to M-M-R II. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066).; Sender's Comments: US-009507513-1809USA011156:Original Case: 1809USA011156.
had pains throughout her body; Funny feeling in chest; abdominal pain; elevated blood pressure; not take a deep breath; felt dizziness; a bitter taste in mouth; weakness; could hardly walk; felt unbalanced; nausea; blurred vision; chills; blisters on her tongue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FC3181), Dose 1 via an unspecified route of administration, administered in the right arm on 15Sep2021 at 09:18 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 from 2020 to an unknown date (she had covid last Oct/Nov2020), nervous system disorder from an unknown date and unknown if ongoing , respiratory distress from Nov1999 to Nov1999 , multiple sclerosis from Nov1999 and ongoing , blister from an unknown date and unknown if ongoing This is what happened when she had covid last Oct/Nov2020. The patient's concomitant medications were not reported. On 15Sep2021, the patient experienced elevated blood pressure (medically significant), not take a deep breath, felt dizziness, a bitter taste in mouth, weakness, could hardly walk, felt unbalanced, nausea, blurred vision, chills, blisters on her tongue, funny feeling in chest, and abdominal pain. On an unknown date, the patient had pains throughout her body. The patient underwent lab tests and procedures which included blood pressure measurement: 186/86 on 15Sep2021. The patient recovered from the events, a bitter taste in mouth and chills. The patient had not recovered from the events, elevated blood pressure, not take a deep breath, felt dizziness, felt dizziness, weakness, could hardly walk, felt unbalanced, nausea, blurred vision, had pains throughout her body, blisters on her tongue, funny feeling in chest, and abdominal pain.   Follow-up attempts are completed. No further information is expected.
C/O of tenderness with obvious 2-3 inch long raised, pink "welt" over L triceps where vaccine given SQ.
covid vaccine breakthrough   booster on 12/20/2021 Pfizer FE3594
received shot in a.m. on Monday 4/29, symptoms started in the late afternoon: fatigue, pain in arm, sudden nausea, dizziness, fever of 102 degrees, body aches, body chills, loss of appetite, headaches, could not do any normal activities, bed ridden, itchy throat.  Symptoms lasted for two days, headaches and fatigue lasted for 5 days.
Janssen COVID-19 Vaccine EUA she had vaccine at 2:50pm, that nigh she woke up at 4am, nauseated, felt like were going to pass out, then vomited multiple times, she went back to bed and had a fever the next morning and very tired. Sore arm but fever broke by the afternoon.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a rash on his face that gradually spread to the entire body. The pt was mildly sick and was treated with Benadryl and cocoa butter. The symptoms lasted for 5 days.
It felt like my heart was fluttering/racing and I was so lightheaded that I had trouble driving my car. I was on my way out of town to meet some friends but instead drove to the emergency room.  They performed an EKG and some blood tests.  All were normal. As I sat there waiting for the test results, I started to feel better. I never passed out and they released me. I drove home without incident and the following day I drove 3 hours to meet my friends. I have been experiencing the fluttering sensation every day since, but not as intense and as debilitating as the first day (which was Tuesday, Oct. 4). I am following up with my cardiologist but have not yet been able to schedule an appointment with him.
Big bout of diarrhea; Stool was black; fatigue; tiny bit of chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), PYREXIA (low grade fever), FATIGUE (fatigue) and CHILLS (tiny bit of chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (low grade fever). On 03-Feb-2021, the patient experienced DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), FATIGUE (fatigue) and CHILLS (tiny bit of chills). At the time of the report, DIARRHOEA (Big bout of diarrhea), FAECES DISCOLOURED (Stool was black), PYREXIA (low grade fever), FATIGUE (fatigue) and CHILLS (tiny bit of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetes medicines. Treatment information was not reported.; 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.
got super nauseous when standing; body chills; Five minutes after getting the shot her hand started hurting; sluggish; dizzy; felt like she had COVID again; really felt sick; whole body hurt she was in tears; slight temperature change of 99F; felt like she was hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills) and ILLNESS (really felt sick) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck) and MALAISE (felt like she had COVID again). On 18-Mar-2021, the patient experienced NAUSEA (got super nauseous when standing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck), NAUSEA (got super nauseous when standing) and MALAISE (felt like she had COVID again) had resolved. At the time of the report, VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was given 3rd rota past 8 months, they were 8 months and 8 days.
61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient  took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.
Sometime post vax, pt developed red area at site that was warm to touch. From additional correspondence received on 07/06/2000, it was reported that the pt recovered from this experience. Additional pt, vaccine and responsible physician info was also provided.
Soreness in arm where vaccinated, lasted for several days then dissipated. Symptoms returned then abated several times. Extreme fatigue, chills. Symptoms appear to be lessening, but still come and go as of today 10/17/15.  No treatment.