chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After flu administration and PPD, staff felt dizzy, lightheaded, immediately after. After 2-3 min. walked back to classroom but passed out. Chang in LOC lowered to mat, 911 called, O2 at 2L/,min, VS taken. Pale, diaphoretic noted. BP 114/73, HR-71, O2 Sat=97%.
Immediately, I noticed that he gave it to me really close to my armpit, so my doctor thinks that my be the issue. I was tingling over my body and my heart was beating fast. From that day, I've had pain in my arm that doesn't stop. It even hurts to the touch. I had an appt two weeks later and my doctor told me to keep taking Tylenol, icing it and alternate hot/cold treatment. It's improved, but it has not gone away.
generalized body aches "sore" today; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 38-year-old female patient.  A 38-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 09Aug2021 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. and concomitant medications include Paracetamol (TYLENOL) and Ibuprofen. On 10Aug2021, after the vaccination, the patient experienced generalized body aches "sore". The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101041000
At about 6:30 am, today, I began to experience extreme nausea, upset stomach.  Began sweating profusely with "pins and needles, numbness" from head to toe, including inside of mouth and throat.  Hands, fingers, feet began to draw up and inward to the point I couldn't use them and could not stand.  Thumbs, fingers were completely stiff and rigid and drawn completely into palms.  Feet were stiff and rigid and curved inward.  Also had severe pain in these areas.  The episode began to subside within 10 - 15 minutes and was totally over within 20 minutes.
can hardly stand up; arm really hurts; when took band aid off it was kind of bloody; Aches and pains in knees; light headache; higher fever, for 26-27 hours the patient has been having 100.8 F; First shot on 08Aug2021/Second shot on 15Sep2021; Patient had to grab onto things, and patient was staggering/could hardly get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Patient had to grab onto things, and patient was staggering/could hardly get out of bed), DYSSTASIA (can hardly stand up), PAIN IN EXTREMITY (arm really hurts), VACCINATION SITE HAEMORRHAGE (when took band aid off it was kind of bloody) and ARTHRALGIA (Aches and pains in knees) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2021. Concomitant products included QUINAPRIL, PRAVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced GAIT DISTURBANCE (Patient had to grab onto things, and patient was staggering/could hardly get out of bed). 15-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 08Aug2021/Second shot on 15Sep2021). On an unknown date, the patient experienced DYSSTASIA (can hardly stand up), PAIN IN EXTREMITY (arm really hurts), VACCINATION SITE HAEMORRHAGE (when took band aid off it was kind of bloody), ARTHRALGIA (Aches and pains in knees), HEADACHE (light headache) and PYREXIA (higher fever, for 26-27 hours the patient has been having 100.8 F). The patient was treated with PARACETAMOL (TYLENOL) on 15-Sep-2021 at a dose of 500 mg twice a day and ACETYLSALICYLIC ACID (ASPIRIN LOW) for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 08Aug2021/Second shot on 15Sep2021) had resolved. At the time of the report, GAIT DISTURBANCE (Patient had to grab onto things, and patient was staggering/could hardly get out of bed), DYSSTASIA (can hardly stand up), PAIN IN EXTREMITY (arm really hurts), VACCINATION SITE HAEMORRHAGE (when took band aid off it was kind of bloody), ARTHRALGIA (Aches and pains in knees), HEADACHE (light headache) and PYREXIA (higher fever, for 26-27 hours the patient has been having 100.8 F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 degree fahrenheit (High) For 26-27 hours the patient had been having 100.8 degree Fahrenheit.         This case was linked to MOD-2021-321134 (Patient Link).
30 minutes after administration, patient reported itching all over her body and presented with red rash on chest and legs. Vaccination site was not red or swollen. Patient reported feeling hot, but temperature was 97.7 degrees F. Blood pressure was taken and was 133/95 mmHg (patient does have hypertension). Patient self administered Benadryl 25 mg and 20 minutes later reported feeling much better with itching resolved. No other symptoms were exhibited other than the itching. Patient called her primary care provider and was instructed to take a second Benadryl, but the patient said she did not need one as she was no longer itchy. Patient was observed for an additional hour after reporting symptoms. Then, 2 hours after the incident the patient was called and she reported feeling fine.
19 days following the vaccine, patient started losing hair from the head at an alarming rate. Continues to lose hair daily with 90% or more missing from both scalp and eyebrows.
RASH INNER L EAR AND CHEEK. LOCAL REACTION TO INJECTION SITE- REDNESS AND SWELLLING. TO TAKE 5CC OF BENDADRYL Q 6 HRS AND F/U TOMMOROW.  IF WORSE SWELLING ER, CONSIDER STEROID
knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 01Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient needs to take Tylenol for knee pain on 01Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day after receiving 2nd dose, she started with noise in her head,still bothering her; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Next day after receiving 2nd dose, she started with noise in her head,still bothering her) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL and PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Next day after receiving 2nd dose, she started with noise in her head,still bothering her).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-238917 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, Fatigue, Injection site pain Narrative:  Other Relevant History:
The same day I got the vaccine my only symptom was soreness in my arm. The next day when I woke up my arm was not sore anymore but I was feeling fatigued, dizzy and nauseous. My head and the rest of my body have felt extremely heavy since. It is hard to get out of bed and perform daily activities. When I eat I often feel nauseous afterwards or have diarrhea, even if the food is light.  I have taken Advil and Tylenol occasionally as treatment, but they did not help much so I haven't taken anything since. There are certain times where I am feeling a bit better, like yesterday on 4/30 and on 4/24, but the symptoms keep coming back even though I am staying hydrated and eating and getting plenty of rest and sleep.
25AUG pt had no rash no local reaction or fever; mom c/o lethargy & behavior change; 26AUG to MD no temp, sore throat, pharyngitis & rhinopharyngitis;
Regarding Moderna COVID 19-Vaccine, symptoms included fever 100, chills, body aches, headache, weakness, fatigue, these lasted approx 12-24 hours  and a dry cough has lasted since approx 12 hours after the vaccination and I am still coughing.
Headache, Myalgia, Fever, injection site itching, redness, swelling. Fatigue, chills  Narrative:  Other Relevant History:
Pain at injection site immediately post vaccination.  Continued to worsen.  5 hours post, unable to raise arm, fever (101.8), whole body muscle ache, severe back pain below rib cage.  Muscle aches and back pain continued for seven days.
Have been experiencing a strong coldness in my feet,hands, head and penis since receiving the second vaccine
This spontaneous report was received from medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L035510 with expiry date: 13-MAY-2017, (dosing details not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 0.50 mg of vaccine per prescribed dose in left deltoid. She walked out of exam room, talked with her father and turned to me stating, Mommy I am going to throw up, she became very pale, diaphoretic and fainted. 5cc of Benadryl given PO and she recovered completely about 30 mins later.
Hives develop rapidly on right arm. Patient was given 50mg diphenhydramine. After 30 minutes hives disappeared.
I smell smoke. Anywhere, anytime. if I hold something close to my nose I can smell what it actually is but when I am just smelling ambient air, it smells as though there is cigarette smoke going right in my nose. sometimes to the point where it may cause me to tear up.
husband had a extreme sore arm with the first injection; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: This case was reported by the patient's wife. The patient received dose of Shingrix vaccine and experienced an extreme sore arm. The reporter did not consent to follow-up.
After 15 minutes: Tingling lips, flushed face and neck, elevated heart rate, swollen fingers  After 30 minutes: jaw tightness on left side.   Administered dramamine after 20 minutes. Symptoms mostly subsided after 45 minutes. Released from observation after 2 hours.
he got COVID; he got COVID; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he got Covid on an unspecified date in 2021 with unknown outcome. He was asking if he was supposed to get his 2nd dose.  Information on the lot/batch number has been requested.
Next day arm sore at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Penicillin allergy (Severe itching on back) since 1957 and Sulfonamide allergy (Itching) since 2003.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (Next day arm sore at injection site) and HEADACHE (slight headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient partial date of birth was reported as the year 1942.  No concomitant medications were provided. No treatment information was provided by the reporter.   This case was linked to MOD-2021-016765 (Patient Link).
Over 42 days, 1st dose 06/10/21, 2nd dose 08/12/21
Temperature excursion on vaccine fridge on 11/12, dose considered invalid by DPH
Little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (Little fatigue). At the time of the report, FATIGUE (Little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included acetaminophen. No concomitant medications reported.   This case was linked to MOD-2021-100450 (E2B Linked Report).; Sender's Comments:  MOD-2021-100450:Second Dose
1 pt c/o very sore arm following 1st dose of Engrix-B & many c/o about inject site soreness p/2nd dose of Engerix-B;
whole head felt like it was on fire; Groggy; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (whole head felt like it was on fire), SOMNOLENCE (Groggy) and DIZZINESS (Dizzy) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEADACHE (whole head felt like it was on fire), SOMNOLENCE (Groggy) and DIZZINESS (Dizzy). At the time of the report, HEADACHE (whole head felt like it was on fire), SOMNOLENCE (Groggy) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022). At the time of the report, COVID-19 (Patient caught Covid a week and a half ago after first dose of Moderna/ not contagious/ tested positive on 18 Aug 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.  Patient still tested positive at the time of the report.  Treatment details was not reported by the reporter.  Company Comment:  This is a spontaneous case, reported by a patient family member, concerning 2-year-old male patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 22 days after receiving the first dose of mRNA-1273 vaccine. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637089, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637095 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case, reported by a patient family member, concerning 2-year-old male patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 22 days after receiving the first dose of mRNA-1273 vaccine. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637089:Reporter case US-MODERNATX, INC.-MOD-2022-637094:Child 2 US-MODERNATX, INC.-MOD-2022-637095:Child 3
Information has been received from a consumer concerning her 12 year old granddaughter with a history of rash from head to toe when she was child and received some vaccines (unspecified), who on unspecified date was vaccinated with 0.5 ml dose intramuscularly of GARDASIL (lot # unknown). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (Lot # unknown) (route and dose not reported). The consumer reported that after receiving the second dose, her granddaughter's arm went numb for a couple of days and it came back to itself. It was unknown if the patient sought medical attention. No further information is available.
Information has been received from a cardiologist and a receptionist concerning a 17 year old female with no pertinent medical history or drug reactions/ allergies who on 20-NOV-2009 was vaccinated with a dose of GARDASIL. Concomitant therapy included SEASONALE. The patient was nasally vaccinated on 19-NOV-2009 with H1N1. The reporter mentioned that on 20-NOV-2009 the patient received GARDASIL and within minutes could not walk out of the office. It was stated that the patient had premature ventricular contractions. The physician felt a significant disability was the patient "can not drill team". The receptionist stated that the patient was a new patient of the cardiologist and was first seen on 24-NOV-2009. The patient sought a physician in office for medical attention. The patient had the following lab/diagnostics tests: CBC, telemetry, PSH and troponin all of which were normal. At the time of reporting the patient had not recovered. The physician considered the patient unable to walk out of the office, premature ventricular contractions and can't drill team" as disabling. Additional information has been requested. 12/3/2009 Cardio Consult records for 11/24/2009, patient seen for c/o's palpitations and lightheadedness. EKG done at PCP office was abnormal noting PVC's, Tx Holter monitor, recommended addition of fish oil and magnesium
noticed a warm, hard, painless, itchy area at injection site several days after the pain from the injection had resolved. it is not painful, but it is tender to touch,  it is about 2.5 cm across, and circular in shape
On 01/29/01, a phone call from patient's mother; the child had a seizure at 5 PM on 01/28/01. Also had a fever of 103, the mother was giving Motrin. Called the EMS. The patient was evaluated by EMT, he was not taken to the hospital. No other seizures.
Weird ear thing; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Weird ear thing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (Weird ear thing). At the time of the report, EAR DISORDER (Weird ear thing) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  The patient reported that Group of people who had hives after the COVID booster.   This case was linked to MOD22-000532 (Patient Link).
via subcutaneous instead of Intramuscular; Hot to touch  R Tricep; Redness; Swollen; This case was reported by a pharmacist via call center representative and described the occurrence of feeling hot in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KM49, expiry date 26th November 2021) for prophylaxis.   On 12th June 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 12th June 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2020, the patient experienced feeling hot, erythema and swelling. On an unknown date, the outcome of the feeling hot, erythema and swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the feeling hot, erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated they inadvertently administered Shingrix via subcutaneous instead of Intramuscular to a patient, which led to intramuscular formulation administered by other route. The patient experienced swollen, redness and hot to touch at right tricep and it was spreading. The reporter did not consent to follow up.
Urticaria/hives. First time in her life getting this reaction. Took her to the allergist and she came back not allergic to any foods she was eating. I can't afford to continue with further testing (Igg panel, etc).