chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness on the left arm; lump between breast and armpit left arm; tiredness; redness of the injection site; Wasn't feeling great; Knot or ball between armpit and breast, on the same side as injection, left; Knot or ball between armpit and breast, on the same side as injection, left; Soreness on arm, can't lift it; Injection site pain; Feeling hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:15 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "soreness on the left arm"; MASS (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "lump between breast and armpit left arm"; FATIGUE (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "tiredness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "redness of the injection site"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Wasn't feeling great"; BREAST MASS (non-serious), AXILLARY MASS (non-serious) all with onset 07Apr2021 17:00, outcome "not recovered" and all described as "Knot or ball between armpit and breast, on the same side as injection, left"; MOBILITY DECREASED (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Soreness on arm, can't lift it"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Injection site pain"; FEELING HOT (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Feeling hot".  No follow-up attempts are possible. No further information is expected.
About 10 minutes after receiving the vaccine, patient began feeling nauseous and started dry heaving.  She then complained of feeling dizzy and weak.  She repeatedly stated that she "just didn't feel right".  She then started with tremors in her arms and legs.  She laid down and grabbed the exam table stating she "just needed to hold on to something".  She complained of mild chest tightness.  She denied any difficulty breathing.  No rash.  She was unable to support her own body weight or walk.  Her pulse, resp rate and pulse ox remained stable.  Her blood pressure became mildly elevated.  EMS was called and she was transported to the ER.
HYPOTENSION 4/2/2023 TRAUMATIC SUBARACHNOID HEMORRHAGE, INIT
Within a minute...Hot/cold flashes... Room fuzzy..felt light headed...heart started racing...trembling. About 1 hr later chest felt like someone was sitting on it...hard to breathe.  Was down for two weeks.
Headache, fatigue, chills, slight breathing issue/cough, aches, slight burning/rash all over. Resting and Tylenol.
On 14 Apr 2012 patient received one expired Anthrax shot. Anthrax lot # FAV 294 had expired on 02 Apr 2012. This was patient's 7th Anthrax dose. Patient stated to me on 07/15/12 that he had no adverse reaction to this Anthrax vaccine. A entry of this event was placed in patient's medical record as well as copy of this form.
Occipital neuralgia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of migraines" (unspecified if ongoing), notes: History of migraines. The patient's concomitant medications were not reported. The following information was reported: OCCIPITAL NEURALGIA (non-serious), outcome "unknown".  Additional information: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided.    Reporter did not allow further contact
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.
Post vax the patient reported a large bruised, reddened area with a large knot at the site of injection.
pt stated that she had body aches, upset stomach, uncontrollable shaking, fever, headache
- high fever (102.3) - sore throat - dizziness/lightheadedness - fatigue
Information has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2006 was vaccinated with the first dose of Gardasil, injection, 0.5 ml. Concomitant therapy included Ortho Tri-Cyclen. On approximately 27-OCT-2006 one week after receiving the first dose of Gardasil, the patient developed vomiting. On 19-DEC-2006, the patient received the second dose of Gardasil. On approximately 26-DEC-2006 one week after received the second dose of Gardasil, the patient developed vomiting. The patient sought unspecified medical attention. Subsequently on unspecified dates, the patient recovered from the events of vomiting. Additional information is not expected.
Burning sensation and swollen red raised skin at eyelids, and under eyes. Grey half moon circles under eyes. Sore to touch
Developed generalized rash on the night after Hep B #1 was given. No respiratory problem was seen in ER, was given Benadryl and anti-inflammatory med.
Injection occurred at 1:30pm Friday Severe stabbing muscle pain around ribs starting in the back intercostal muscles around 8pm Friday.  Muscle spasms and pain increased and spread to back and front intercostals as well as upper back muscles making it painful lay down or walk most of the day Saturday.  Muscle pain made sleeping difficult Friday and Saturday nights.  By Saturday morning the pain started to subside and spasms were only affecting lower intercostal muscles.  By the time I woke up at 6am Sunday all pain was gone.
depression 1st day post vax, fatigue; lt chest pain radiating entire lt cavity aching, large erythema reaction @ site of 2nd inject reddness radiating to elbow; painful, fever, serum like sickness;
Case number PHEH2017US002881, is an initial spontaneous report received from a nurse on 25 Jan 2017. This report refers to a 03 years and 1 month old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866) intramuscularly at a dose of 0.5 ml on 21 Nov 2016, when she was 03 years and 01 month old (less than 04 years of age). No adverse reaction was reported following this administration error. The seriousness of the event was reported as non serious.
Moderna COVID-19 Vaccine EUA Nausea going on 4 days,, vomiting, migraine for 2 days, sweating through clothes, joint pain, and fatigue. Plus the  syringe  Broke in my arm.
On 11/18/00, post vax, arm was sore. On 11/19/00 AM, pain in chest, also "pressure" for last 2 days PM, had "excruciating" pain in left side of face and head. On 11/20/00, pain in sinuses with "yellow" nasal discharge. On 11/21/00, sinus discomfort continued. Started on OTC "cold capsules". Stated she is somewhat "better". All this, as reported by pt on 11/27/00. Pt continued with daily activities on 11/18/00 through 11/21/00. Pt refused to seek medical treatments.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 29-MAR-2016, the patient was vaccinated with VAQTA intramuscularly, (lot number, expiry date, dose and anatomical site of injection were not reported); and then, he/she received another dose on 01-MAY-2016. Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
On 7/22/22 after second booster, I developed a sore throat and within the next couple of days turned into a moist cough, heavy congestion, running nose, body aches that continued to this day (9/26/22).  Had annual physical on 8/31/22 and dicussed with doctor and perscribed Benzonatate 100 MG which has helped a little.  Started to feel a little better after holiday (9/5/22) and then it ALL started over gain with the sore throat, etc, etc, etc, including today 9/26/22
Excruciating pain to  entire right arm, inability to raise arm, and overall severe discomfort.
Coughing up phlegm, constipation, gas, sour arm. As of 5/22/16 symptoms still remain. I went online and read bacteria degrades protein by process called ribosylation. That large doses of nicotinamide can stop the process. I tried it symptoms stopped. After a month I stopped taking nicotinamide symtoms returned. I started taking it again symptom remain.
Information has been received from a pharmacist regarding two patients of unknown age. The patients medical history, drug reactions or allergies were not provided. On an unknown date, both patients were vaccinated with a improperly stored dose of ZOSTAVAX (dose, route and lot number were not provided). No adverse effect reported. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with three doses of ROTATEQ. Subsequently the patient developed rotavirus. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Follow-up information has been received from a registered nurse concerning the 20 months old male patient who was vaccinated with all 3 doses of ROTATEQ on 20-AUG-2007, 19-OCT-2007 and 27-DEC-2007 respectively. Lot numbers reported as 657514/0667U and 657520/0670U (dose numbers unspecified). On 25-FEB-2009 the patient developed diarrhea rotavirus. On 27-FEB-2009, the patient tested positive for rotavirus. On 03-MAR-2009, the patient was positive for rotavirus. The physician spoke with the patient's mother and it was reported that the patient was doing well and the diarrhea had improved. The patient had good oral intake. On an unspecified date, the patient recovered. Additional information is not expected.
edematous, sore upper arm dx'd w/cellulitis lt arm; treated w/Duricef ATB
This spontaneous report as received on 28-OCT-2015 from a registered nurse refers to a 14 year old male patient. On 05-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L011846), dose 1. The patient immediately experienced pain at the injection site following the administration. On 28-OCT-2015, the patient was seen at her office still experiencing the pain. The nurse reported the pain is not in the joint but in the muscle at the injection site. The patient rated the pain as 4 out of 10 on the pain scale. The nurse reported the patient has full range of motion but cannot sleep on the affected arm. The patient's mother was intermittently administering ibuprofen. On 28-OCT-2015, the physician initiated a scheduled dose of ibuprofen to the patient (unspecified dose and frequency). The outcome of injection site pain was reported as not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the vaccine I was very dizzy on and off throughout the day for about 2 weeks
24 after injection onset right lip swelling, tongue swelling and cheek swelling. First time angioedema in life.  Required ER and Decadron, Benadryl ranitidine. Symptoms recurred 4/28/2021 requiring 2nd ER visit but no new intervention. Had 2 similar episodes between the ER visits.
originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; headache; originally received the J&J vaccine in June went to get the Pfizer booster 10/30/2021; chills; This is a spontaneous report from a Non contactable Pharmacist (Healthcare Professional). This Pharmacist reported for a 33-Years-Old male patient received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: 32030BD and expiration date not reported), via an Intramuscular route of administration in arm Left anatomical location on 30Oct2021 at 05:30 AM (at the age 33-year-old) as a DOSE 3, (BOOSTER DOSE) SINGLE for covid-19 immunisation. Patient historical vaccine included received the first dose and second of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date not reported), via an unspecified route of administration on an unspecified anatomical location on unspecified date as a dose 1 single and dose 2 single for covid-19 immunisation. The patient medical history included asthma start from unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had Off label use, Interchange of vaccine products, Booster. Patient who originally received the J&J (COVID-19 VACCINE JANSSEN) vaccine in June went to get the Pfizer booster at the local pharmacy The next evening, on 31Oct2021 developed chills and a headache adverse event start time was 08:00 PM. Patient took treatment of Excedrin. The outcome of the event chills and a headache was recovering.  No follow-up attempts are possible. No further information is expected.
the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On 05-FEB-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R013564, expiration date: 13-MAY-2020 (dose and route of administration were not reported). The vaccine was reconstitued with a sterile diluent (DILUENT MRK) that was properly stored.  On an unknown date pior to administration, the vaccine underwent a temperature excursion and was stored for 3 hours and 6 minutes in the temperature between 15 and 46 degrees Fahrenheit. There was no previous temperature excursion. Digital Data Logger was involved.
Heart palpitations and major anxiety. I thought my thyroid medicine had suddenly become too strong because the symptoms were similar BUT, I had my thyroid checked just the week before and it was over 8 because I had been off my thyroid meds for about a week. I also thought maybe prescription for the Levothyroxine that I picked up on the same day as my first vaccine was somehow tainted.  I checked with the pharmacist and he said there were no reports of problems with the medicine. I was experienced strong anxiety due to the constant palpitations.   The anxiety was even waking me up in the middle of the night and giving me insomnia. When I went in for my second vaccine, I told the check in person that I was experiencing anxiety and palpitations.  The person wrote down only anxiety and laughed saying that everyone was a little nervous...I told her that was not it, like at all. I eventually stopped my thyroid medicine because I didn't know what else to do to stop the almost constant palpitations.  I started noticing that they palpitations became less and less over a few weeks.  I made an appointment with my cardiologist but by the time I got in the palpitations were almost gone and no significant problems were found other than the congenital anomalous right coronary artery which I already knew I had. My doctor's office put me on the lowest dose of brand Synthroid 25mcg and I go back in next week for a thyroid check.  A previous check from last month showed that my TSH was 6 but my T4 was normal.
Administered only the liquid portion of Menveo to a patient; Administered only the liquid portion of Menveo to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administered only the liquid portion of Menveo to a patient) and inappropriate dose of vaccine administered (Verbatim: Administered only the liquid portion of Menveo to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt Date: 09-AUG-2023 The reporter reported that she administered only liquid portion of Menveo vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal.
Pins And needles feeling all over body (still have), 104.3 fever & chills  for 3 days feel dizzy and headache(still have) heart .  worst part of all is hard to breath still walking upstairs getting winded ... trying to catch my breath since shot...
mom states pt c/o pain in rt leg;had trouble walking;some lethargy in PM;mom gave children APAP;did not note temp;mom contacted MD
Lump was size of tennis ball in axilla area with pain; Rash-welts; Dizziness; Axilla Lump; axils swelling; red welts streaking arm and breast; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).   A 47-year-old non-pregnant female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FF8841; Expiration Date: 31Mar2022), via intramuscular route, administered in right deltoid on 07Oct2021 at 15:30 (at the age of 47-year-old) as dose 2, single for covid-19 immunization. Medical history included , ongoing Subclinical hyperthyroid from 04Feb2013, ongoing anxiety from 07Oct2019, ongoing prediabetes from 30May2019, ongoing gastro oesophageal reflux disease from 21May2020, ongoing DUB from 16Mar2020. Family medical history relevant to AE was none. Relevant past drug history reported for an unknown drug and reaction experienced was allergy. Concomitant medications received within 2 weeks of vaccination included metformin, clarithromycin (CLARITIN [CLARITHROMYCIN]), famotidine (PEPCID [FAMOTIDINE]), oral contraceptives taken for an unspecified indication, start and stop date were not reported. The historical vaccine included, received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch No. Not available/Lot Number: FC3183; Expiration date: 31Oct2021) via intramuscular route, administered in right deltoid on 16Sep2021 at 15:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Prior vaccinations was none. On 08Oct2021 at 21:00, the patient experienced axils swelling and red welts streaking arm and breast. On 09Oct2021, patient experienced axilla lump. On 10Oct2021, patient experienced rash-welts, dizziness. On an unspecified date, patient experienced, lump was size of tennis ball in axilla area with pain. Patient was not received treatment for events. No hospitalization prolonged. The seriousness was reported as non serious. No therapeutic measures were taken for the events. The outcome of the events axils swelling and red welts streaking arm and breast, rash-welts, dizziness was not recovered and rash was still present as of 15Oct2021, event axilla lump was recovered on an unknown date in 2021, outcome of event Lump was size of tennis ball in axilla area with pain was unknown.  Follow-up attempts are completed. No further information is expected.
CHILLS; MUSCLE ACHE IN THE BACK AND BILATERAL ARM; FEVER; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced muscle ache in the back and bilateral arm. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle ache in the back and bilateral arm, and the outcome of fever was not reported. This report was non-serious.
High fever eyeballs felt hot, rash from shoulder to elbow on arm, chills, couldn't sleep for 36 hours after shot, tired, headache,  aches and pain over body,