chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable health care professional. A 43-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an intramuscular route of administration in the left arm on 15Mar2021 at 15:45 (at the age of 43-years-old), as a second single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), BIOTIN, Vitamin D (MANUFACTURER UNKNOWN), Vitamin B (MANUFACTURER UNKNOWN), LEXAPRO, BUSPAR, RESTASIS, FLEXERILL for an unknown indication from an unspecified date and unknown if ongoing. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not pregnant. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318), via an unspecified route of administration in the left arm on 22Feb2021 at 15:45 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. On 17Mar2021 at 00:00, the patient experienced left lower bicep with redness, swelling, pain. This was approximately 1-2 inches below the injection site. Patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, vaccination site redness and vaccination site redness were not recovered. No follow-up attempts are needed. No further information is expected
body feels like I have flu; arm was sore; Fatigue; muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; CYCLOBENZAPRINE at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-106468 (Patient Link).
pt recvd vax & wife reports that devel partial loss of use of both arms; pt is to be evaluated by a neurologist;
Injection arm extremely painful, can?t lift it. Pain is in the upper muscle.  Mild nausea
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL, (dose, frequency and lot # unknown) intramuscularly for prophylaxis on 15-APR-2010 and 24-JUL-2014. No adverse effects reported. Additional information has been requested.
Fever up to 101.1,  2 days after vaccine administration, chills, headaches, moderate to severe body aches and pains, especially to elbow and knee joints. I am now in day 3 and still having low grade fever with continued headache, body aches and pains.
My wife and I drove back from a vacation on 05/23. We both felt a bit tired and out of it. By Tuesday on 5/24, we were still not feeling well so I took an at home Covid test and mine was negative. We went that day to the local county health department and took a PCR test. We received positive results the next day 5/25. I called my doctor's office who advised that I just keep an eye on my respiratory symptoms. By the weekend, I was beginning to feel normal again. I'm still experiencing a bit of cough and fatigue but am feeling mostly better.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old male patient who received KINRIX. On 10th August 2016, the patient received KINRIX. On 10th August 2016, less than a week after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth to be related to KINRIX. Additional details were provided as follows: The patient had no prior allergy to vaccine. Initially it was reported that, the patient's left arm was swollen, hot when touch and very, very red after vaccination. Later it was reported that, immediately after vaccination with KINRIX the patient experienced injection site pain. Few hours later the patient experienced injection site redness. Less than a week after vaccination the patient experienced swelling, redness and warm to touch in the left arm (10 into 5 cm). The patient had pain at injection site with movement. The patient was treated with ice. The patient did not have fever.  The patient's father was cardiologist.
Resident received vaccine 10/9/14. On 10/10/14 localized edema and red at injection site. On 10/11/14 - systemic raised, non-pruritic, red areas noted to entire body (trunk, arms, BUE). Red is BKA.
Cellulitis of right thigh, give Keflex. Vaccination site was red, no fever.
chills; dizziness; spinning; nauseous; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (BNT162B2 Batch/Lot Number not provided) dose 1 on an unspecified date via an unspecified route of administration as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. O an unspecified date the patient experienced chills, dizziness, spinning, nauseous. Patient also wanted to know if she was going to get a medical certificate once she was done with the second dose of the vaccine since she had to travel to different country. outcome of the events was unknown.  Information on the lot/batch number has been requested.
I felt like I had  a cold for the first 3 days after shot. I was fine for 3 days. On the morning of the 6th day, 1/21/21, I had very intense deep muscle pain in my lower back, left arm, hands and headache. About two hours after this started I started to have the very intense chills, my headache got worse and for the first time a low fever of 99 degrees. I felt like this for 2 days, couldn't sleep for 2 days because of the pain. On the third day 1/24/21, it was much better and almost all gone by the fourth day, 1/25/21. Thank you
pt had prolonged high pitched scream starting 1 hr p/shot & cont until 10PM was very difficult or impossible to quite;
Patient had a low grade fever for 1 day and started to fell ill 2 days ago. Pt broke out in measles rash this afternoon.
04/22/2022 began feeling sore throat, congestion, and flu like that evening. Went into ER on Saturday 04/23/2022. Received an IV infusion for COVID-19 vaccine. I was held over for about an hour after infusion and then released. Within 24 of infusion I began feeling better. About 95% recovered.
Very sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 14 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerance" (unspecified if ongoing). Concomitant medication(s) included: HPV VACCINE taken for immunisation, on 05Dec2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose 1, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster), Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Dec2022, outcome "recovering", described as "Very sore arm at injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient had not received any other medications in two weeks. Patient had no covid prior vaccination and had not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE ERYTHEMA (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE SWELLING (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE PRURITUS (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.) and VACCINATION SITE RASH (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE REACTION (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE ERYTHEMA (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE SWELLING (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE PRURITUS (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.) and VACCINATION SITE RASH (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE ERYTHEMA (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE SWELLING (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.), VACCINATION SITE PRURITUS (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.) and VACCINATION SITE RASH (With first dose, had COVID arm, red swollen, itchy and splotchy area on upper left arm.) had not resolved.    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication was not provided.This case was linked to MOD-2021-404961 (Patient Link).
Janssen COVID-19 Vaccine EUA. One day after vaccine, patient reports onset right sided weakness (face, upper and lower extremities). Found to have stroke on brain imaging: L inferior M2 branch occlusion.
About 2 hours after shot - went for a run and noticed she had difficulty breathing which continue through the night. About 3 hours later pt had swelling in eyes and lips with discharge in eyes. Pt had headache runny nose, chills through night. Next day lips and eyes slightly swollen and the headache continues. Pt just took some Benadryl and Ibuprofen. No longer having difficulty breathing. This was patients first flu vaccine.
Case number PHEH2013US014898 is an initial spontaneous report from the medical assistant on 11 Jul 2013, with a follow up received from the medical assistant on 05 Aug 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M10133) at a dose of 0.5 ml in the left arm on 09 May 2013 at 11:00 AM. On the same date, he underwent TB test in the right arm. next day morning (10 May 2013, after vaccination his left deltoid was very swollen, about 3 cm long at the injection site. It was reported that when the patient came back for follow up of the TB test, he had a very swollen deltoid. His physician (MD) advised to apply compresses on the arm. The outcome, seriousness and causality of the event were not reported. Follow up received from the  medical assistant on 05 Aug 2013: Updated patient demographics, MENVEO batch number, dose and vaccination date and time.
pt recv vax 30APR97 & awoke the next morning had nasal congestion & swollen eyes;dx by MD as allerg rxn & was typical of the sx pt devel p/eating foods to which is allergic;
1. Itchy rash-hives and blisters on one buttock x 4 d. 2. "Softball" size area at injection site (deltoid), severe redness and swelling with hives x 4-5 d, treated with BENADRYL. Both areas started with rash approx 8-10 hrs. after shot.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the patient experienced injection site itching, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site itching, pain in arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site itching, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of his patients received the SHINGRIX and complained that it was red at the injection site, swollen at the injection site, hard at the injection site. A week later patient experienced severe itchiness at the site of the injection. The patient reported that the same arm where she received the injection, she experienced pain from the shoulder down to her elbow. The patient also experienced difficulty using the arm where she received the injection.
From initial information received on 09/Jun/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a five year old male patient received his fifth dose of DAPTACEL, lot number C2221AA, administered in the left deltoid as well as a dose of MMR/Measle, Mumps and Rubella vaccine, lot number 0029R, administered in the right deltoid, on 25/May/2005. The routes of administration were not reported. The following day, the patient developed pain, swelling, redness, and warmth at the site of injection of the left arm. Reportedly, the swelling spread from the shoulder to the elbow. The reporter did not know the exact duration of the events. Reportedly, the patient recovered from the events. The reporter of this case is the same reporter as case 2005-01112. Follow-up information received on 22/Sep/2005. Per reporter there is no additional information at this time. Follow-up information received on 02/Dec/2005. As per reporter the patient is doing well at this time. Other than symptomatic care, nothing else was required.
Patient received both doses of Pfizer/BioNtech vaccine in February 2021 and now tested positive for COVID 19; Patient received both doses of Pfizer/BioNtech vaccine in February 2021 and now tested positive for COVID 19; This is a spontaneous report from a contactable consumer.   A 73-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation (Age at vaccination 73 years) .  Medical history included diabetes mellitus.  Concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The  patient received both doses of pfizer/biontech vaccine in February 2021 and now tested positive for covid 19  (medically significant) on 07Sep2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 07Sep2021  .  Therapeutic measures were taken as a result of the reported events including Monoclonal Antibody Infusion. The patient visited a Physician office as a result of the events.  Information about Lot number has been requested.
Raised his sugar and dropped quickly, made his blood pressure spike  A week after first vax smell and taste has become a  problem and after 2nd vax it became more pronounce. Pt is becoming very down and despondent and is in need of help with problems.
Pt had TWINRIX, Td, yellow fever vaccine 5/29/08.  On 5/30/08 developed fever 100-101 degrees, hives feet and lower extremities, torso, chills, aches.  Denies SOB, or CP, no N/V/D.  Hx anaphylactic reaction to pertussis as child.
Immediately after receiving shot experienced right arm numbness, tingling, pins/needles from neck to finger tips. Started to develop hot, itchy, blotching rash at injection site approximately 4 inches in diameter.
Narrative: Patient hospitalized due to COVID infection with hypoxia on 6/9/22.
Headache,  tiredness, body aches, cough, pain at injection site. redness, swelling, hot to touch rash like at injection site started 3 days after injection.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N003703, expiration date 29-OCT-2019 (dose, route and site of administration were not reported) from a box of GARDASIL 9 that was on the counter and intended to be shipped to Merck. There was no adverse effect reported. It was unknown what kind of temperature excursion administered dose of vaccine experienced and for how long it was stored improperly. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Two days after receiving the Johnson & Johnson vaccine in my right arm, I woke up the next morning with a raised bump on my chest and a feeling that something was in my left eye (that could have been my allergies). However, I do still have a raised bump that is slowly going away.
This report describes the occurrence of arm swelling in a 7-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  This report was received from the subject's mother and has not been verified by a physician or other healthcare professional.  The subject's medical history, concurrent conditions, and concurrent medications were not specified.  Approximately one year ago, in 2002, the subject received an injection of Infanrix, which is not recommended for immunizing individuals 7 years of age or older.  At an unspecified time post-immunization, the subject experienced "swelling in his arm."
Herpes outbreak 4 days after injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 06Apr2021 at 13:30 (at the age of 47-years) and dose 1 via an unspecified route of administration on 16Mar2021 at 10:30 (at the age of 47-years), both as single dose in left arm for COVID-19 immunization. The patient's medical history included Herpes, systemic scleroderma, hypothyroidism and allergic to seafood, mango, other various intolerances (start date and ongoing status was unknown). The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 20Mar2021 at 16:00, four days after first injection, the patient experienced herpes outbreak. The patient has not had an outbreak in over 5 years. It was unknown if patient received any treatment for herpes and outcome reported as not resolved. On 12Apr2021 at 18:00, six days after second injection, she again had a herpes outbreak and received treatment with Valacyclovir. Since the vaccination the patient had not been tested for COVID-19. The outcome of event was resolving.  No follow-up attempts were Possible. Information on lot/batch could not be obtained.
Symptoms were flu like, with Sub normal temps, chills, nausea, itchy generalized rash,