chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful menstrualcramping; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in right arm on 29Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotos thyroiditis and hypothyroidism. The patient was allergic to dairy, tramadol and gluten. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID) and liothyronine sodium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 08Mar2021 at 10:00(at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00, the patient experienced increased painful menstrual cramping which was abnormal and patient usually had menstrual cramping on second day in past, but instead it got extreme after 8 hours of the shot. Unspecified NSAIDs only took the edge off. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the event painful menstrual cramping were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, SkinRash, Localized pain; chills, fatigue Narrative:
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-MAR-2015, patient received improperly stored VARIVAX dose 2, from batch/lot # K007982 (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
I developed tinnitus shortly after the vaccine. It started out mildly ringing then gradually build up to the ringing being very loud and more frequently. Sometimes it is very loud then can be a humming noise. I went to my doctor and got a referral to go to and ENT. I had a hearing test and was prescribed hearing aids. I have not received my hearing aids as of yet. I have had other issues with the vaccine and those has been reported to VAERS as well.
Pt received vaccine at 1030. At 1055 reported feeling hot, anxious and a little dizzy. Patient removed mask to reveal swelling of lips and face. First responder called and Epi pen administered.
Red, sore, itchy spot about 1 inches big at vaccination injection site. Feels a little painful
Hospital 1/8-01/21/2021. Hospital for pneumonia and sickle cell crisis.
RN x 2 resonded to vehicle.  Pt c/o feeling dizzy.  Is wretching.  Vomited small amoung of clear emesis.  Epinephrine given @ 1055;  Refused transport by ambulance.  Dirver advised to take to ER for further observations.  States they will o to ER.   Nurse called facility and told that patiet is is still in ED and will be ofbserved for six hours.   Someone attempted to reach.    4/12 @ 12 10.   States they will give her the message.    Called back and left message for Nurse @ facility.  Nurse did not return call
immed intense pain @ inject site, rt deltoid pain, weakness & paresthesia since that time;
This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0170/Batch number was not reported), dose 2 via an unspecified route of administration on 17Jun2021 at 11:00 (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, The Lot is either ER8737 or FR8737/Batch number was not reported), dose 1 on an unspecified date and via unspecified route of administration (at the age of 73-years-old) as dose 1, single for covid-19 immunization and no reaction exposure to vaccine. On 17Jun2021 at 20:00, the reporter stated that he felt something coming on and reports a fever of 100.6 Fahrenheit and feeling achy and sore. The reporter had paperwork that said he could take acetaminophen, but all he had in his house was aspirin and ibuprofen and enquired if that was ok to take aspirin. It was advised that reporter was unable to provide treatment recommendations. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 17Jun2021. The outcome of the events was unknown.
103.6 temp,bodyaches, headache, nausous, lethargic, no appetite & vomiting.
This spontaneous report was received from a medical assistant and refers to 12 months old male patient. No information was provided regarding medical history, concurrent conditions or concomitant medications of the patients. On 20-NOV-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N014945, expiry date 31-AUG-2018) for prophylaxis (dose and route of administration were not reported). The VAQTA was stored in temperature of 32 degree Fahrenheit (°F) to 35 °F for 4 hours. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
No adverse event per say just that FLUAD is meant for ages 65 and older but was mistakenly given to 29 year old male.
"felt like has cold"; increase in daily allergies; fatigue; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (fatigue), HEADACHE (Headache) and MYALGIA (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Allergy. Concomitant products included IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC) and BENZONATATE (TESSALON) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (sore arm). On an unknown date, the patient experienced NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (fatigue) and HEADACHE (Headache). On 15-May-2021, MYALGIA (sore arm) had resolved. At the time of the report, NASOPHARYNGITIS ("felt like has cold"), HYPERSENSITIVITY (increase in daily allergies), FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included high blood pressure pills. Treatment medication was not reported.   This case was linked to MOD-2021-229486 (Patient Link).
My husband started feel bad on the 29, so we tested him and this was at 1600. I started feeling sick, headache, fatigue, body aches, sore throat, congestion, diarrhea, and nausea. I was very sick on the 30th, so on the 31, I called my doctor. I couldn't because couldn't get my heart rate under 115 beats per min laying down. Once I was tacky, I went into the doctor that day and started Paxlovid to keep me from getting admitted -5 days -. I started feeling moderately better on Sunday (April 3) I was bedridden before that and I was out of work. I am still recovering I went to the doctor I am still having chest tightening, dizziness, nausea and migraine.
Approximately 5 minutes after Varicella vaccine administered patient developed sneezing, coughing, hives, facial flushing - received IM Benadryl in office and transported to ER for further management / observation, received PO steroid in ER.
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
106 F fever; Swollen right armpit with size just under an egg; A spontaneous report was received from a consumer concerning a 52-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 106F and swollen right armpit with size just under an egg.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07 Jan 2021, approximately two days prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) on intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient had 106 F fever and swollen right armpit with size just under an egg. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events 106 F fever and swollen right armpit with size just under an egg was not reported.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Fever and axillary lymphadenopathy is consistent with the known safety profile of the vaccine.
Pt. states that after receiving the 1st dose of Phizer 09/11/2021, started experiencing symptoms of weakness, headaches, and hot flashes. Still continuing to experience symptoms.
Information has been received from a physician concerning a 37 month old male with a history of coarctation of the aorta and ultrasonic dopplerography who on 19-JUN-2007 was vaccinated with a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 654686/1003F) in the left thigh. On 19-JUN-2007, the patient developed bronchospasm, tachycardia and pallor which required a doctor's visit. Subsequently, the patient recovered on the same day, 19-JUN-2007. Additional information has been requested.
From phone contact received at manufacturer on 4/29/02, it was reported that a female PT received Infanrix and Ipol on 4/23/02 in the right thigh. MMR and Hep A were administered in the left thigh at the same time. Later that evening, the child was taken to the hospital ER because of swelling, redness and heat of the entire right thigh. The ER administered steroids and the child was sent home.
pt recv 2 doses of vax & lab values indicated that pt had undetectable antibody levels;
Around 04/30/2021 I ended up getting some facial paralysis, a pretty quick onset on the left side of my face. I started to notice I had some difficulty shutting my eye. I wasn't having any slurred speech. I recognized it as a possible Bells Palsy because I have coworkers that have it. My eye sight started to become more affected. I went to the ER that same day to rule out stroke. They ran blood tests and CT scan to rule out any signs of stroke. Everything came back negative and they found no cause for paralysis and assumed it was bells palsy. . I was put on prednisone and an anti-viral drug Baclamir (something that started with B ) . I was on about a weeks worth of the anti viral and about 10 days of the prednisone, and the first 8 days I was showing signs of improvement .  I couldn't shut my left eye, raise my eyebrow, my whole face was numb on L side and I lost taste on L side of tongue. They did test me for Covid when I went to ER. I had a metallic taste in my mouth. I took medicine and recovered quickly but within 3-7 days, I ended up getting a rash on my back but it wasn't a regular rash because it didn't itch. It was the worst back acne possible, around 200 bumps on back that erupted overnight. The ER did r/o shingles but this rash was on several different nerve paths, it looked more like a reaction to the prednisone. I am an Archeologist and they ran a test to see if I had lyme disease because I come across ticks regularly but they came back negative for current and past infection.  When I take Amoxicillin I do get heart palpitations and that's why I was on the doxycycline. I do take testosterone 1 shot a month in the hip. On the 8th day around 05/08/2021  it started to improve and every day after that was a 5% improvement.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HCM" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive; (unspecified date) Unknown result; (unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any other medication within 2 weeks. Paxlovid was given for Covid-19 treatment from 14Jun2022 to 18Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling of arm; Lump at injection site; Hot to the touch at injection site; Sore arm; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of arm), VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE WARMTH (Hot to the touch at injection site), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling of arm), VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE WARMTH (Hot to the touch at injection site), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PERIPHERAL SWELLING (Swelling of arm), VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE WARMTH (Hot to the touch at injection site), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Redness at injection site) 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.   No concomitant product reported by the reporter  No treatment medication reported by the reporter
A few hours after the second dose of Moderna vaccine I began to feel achy. This was the beginning of a 24 hour period of systems. Fever, chills, sweats, body aches, could barely move my left arm, pain in my bones and joints, pain in my pelvis, couldn't sleep because my body hurt so badly.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer, and other pre-existing medical conditions included patient takes oral, targeted medicine (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was non-serious.
pt recvd vax 12NOV92 & on 13NOV92 c/o pain in legs; 16NOV92 devel congestion & cough; denies fever; did not consult MD;
This currently 71 year old female patient received a pneumonia vaccine "some time in the last week" in 2015. On 16Sep2015, the patient came to pharmacy to get a flu vaccine. The arm the pneumonia vaccine was administered to was red and hot. The patient was referred to her primary care provider and did not receive the flu vaccine. As of 16Sep2015 the patient left the pharmacy for her primary care providers office and the outcome of the event is unknown.
It started on the 9th - a burning sore throat and sinus congestion; On the 10th - body aches, chills, headache, fever, nausea and still sinus congestion and sore throat. Monday - 11th  - body aches, chills,  fever, nausea - the sore throat had resolved. The nausea resolved by Wednesday.  Wednesday I was feeling better - fever was lower and body aches not as severe  - but I wasn't able to go to work until the 15th. I still felt pretty crummy. I didn't feel 100% until about the 18th. Seen at Clinic - Sunday, the 10th. And I had a really bad cough starting Monday, 11th,  and didn't resolved until the 29th. I got the second dose on January 26th.
Diffuse swelling, redness, and itching of left shoulder and upper arm progressed from onset to 2nd day of reaction when evaluated by MD. Prescribed diphenhydramine, cool packs, elevate arm. Allergist referral. No enhanced redness, tenderness, or swelling at injection site.
Patient's arms both turned red on the skin with some bruising. Left arm showed more redness from injection site down to elbow. Right arm only showed little bruising and some redness/irritation.  Patient went to the hospital for evaluation by Physcian Assistant who diagnosed cellulitis or possible blood clot. Patient was put on Cephalexin and topical hydrocortisone cream.
Presented to ER for acute onset shortness of breath and tachycardia 5 hrs. Post injection.
Pt fainting during vaccination. Pallor at vaccination area. Vitals wnl.
devel cluster of 5-6 papular/vesicular lesions w/sl erythema surrounding @ site of inj 17 days p/vax;presented to office day 18 & parents noted 6 more papules scattered on trunk, neck, scalp, sl runny nose;no fever or other c/o;
A physician reported that a nurse administered vax to 10 pts on Oct 22, 1999. On Oct 23, 1999, the nurse developed myalgia, cramping  and nausea. She recovered, the physician stated. Do not believe this pt sx were related to the flu vax.
itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; itching on the skin of my ears, spread to her scalp and face, itching spread to her arms and legs, along with a rash; swelling of lymph nodes in her neck; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 2 via an unspecified route of administration in right arm on 20Jan2021 (at the age of 44-year-old) as dose 2 single for covid-19 immunization at Workplace clinic. Medical history included Type 1 diabetes, hypothyroid. No known allergies. No Covid prior vaccination. Not tested for covid post vaccination. Concomitant medications included insulin, levothyroxine, amitriptyline hydrochloride (AMITRIPTYLIN), escitalopram, all received in two weeks. No other vaccine received in four weeks. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration in left arm on 30Dec2020 at 04:00 PM (at the age of 44-year-old) as dose 1 single for covid-19 immunization. After first injection she experienced brain fog and confusion, which resolved after 4 weeks. On 11Feb2021 07:00 AM, three weeks after the 2nd injection, she developed itching on the skin of ears. A week later this spread to her scalp and face. She had swelling of lymph nodes in her neck, and 10 days after the itching started, her face swelled, especially around her eyes. That same day, the itching spread to her arms and legs, along with a rash. These symptoms have persisted. Events resulted in visit to Emergency room/department or urgent care. Received treatment with Cetirizine, hydroxyzine. The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.