chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; Each time I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and back after a few days; redness; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 22Aug2022, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: ER8729) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (ongoing), notes: Onset date- since childhood, stop date- ongoing, no meds taken for many years.; "Osteoporosis", start date: 2012 (ongoing), notes: stop date- ongoing, Diagnosed in 2012 during screening test. No fractures no medication yet.; "Prior post fever rashes after some illness", start date: 1990 (ongoing), notes: Onset date- 1990's, stop date- ongoing, intermittent may be once every few years. Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE] oral taken for osteoporosis (ongoing); VIT D [VITAMIN D NOS] oral taken for osteoporosis (ongoing). Past drug history included: Thimerosal, start date: 1980, reaction(s): "Thimerosal allergy", notes: Onset date- since early 1980's, stop date- ongoing, Diagnosed by eye doctor due to thimerosal in contact lens solution. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 16:30 hrs., Anatomical site: Left Arm, Route of administration- Intramuscular, Batch/lot no: ER8732), administration date: 24Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "itching", "Rash", "redness". The following information was reported: RASH (non-serious) with onset 17Apr2021, outcome "recovered", described as "Each time I got a Covid vaccine (2 initial doses and 2 boosters), I got a 'torso' rash over my whole front and back after a few days"; PRURITUS (non-serious) with onset 17Apr2021, outcome "recovered", described as "itching"; ERYTHEMA (non-serious) with onset 17Apr2021, outcome "recovered", described as "redness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, rash, erythema. Additional information: Patient did not have any prior vaccination within 4 weeks. Family medical history relevant to AEs: No known family history for adverse events related to vaccines. Patient had no history of reaction to any other vaccine including flu and shingles. Specific Relevant tests for thromboembolic events with thrombocytopenia was reported as none. Facility type for vaccine was reported as Primary care clinic. This report was not related to a study or program.
feeling abnormal; Arm started to hurt at injection site; injection site is hard; injection site is swollen; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (feeling abnormal), VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.      Medical history was not provided.     On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced DIZZINESS (dizzy). On 21-Jul-2021, the patient experienced VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen). On an unknown date, the patient experienced FEELING ABNORMAL (feeling abnormal). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (feeling abnormal), VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
On the second day after receiving Moderna vaccine, patient developed uncontrolled Blood Pressure and admitted to the ED at the Medical Center in area. His systolic BP was >240, shortness of breath, respiratory distress, and acute kidney injury
Right arm and right breast  swelled for tow days and redness occured for two days.  Could move arm but it was painful all the time.
Fainted shortly after receiving one dose of GARDASIL-9; Pain from the injection; This spontaneous report was received from a pharmacist via company representative concerning to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug reactions / allergies and concomitant medications were unknown by reporter.     On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular, as prophylaxis (reported as "vaccination") (strength, dose, and formulation were not provided; lot # and expiration date were unknown by reporter).         On an unknown date, the patient fainted (syncope) shortly after receiving one dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to pain from injection (pain). It was unknown by reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if the patient received any treatment for the events.     The outcome of the events was unknown,  and the causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.  Upon internal review the event syncope was determined to be a medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003485:
right arm red and swollen and vomiting / 4th time this lot # has been reported
Arm became itchy; Rash on the back and upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the back and upper arm) and PRURITUS (Arm became itchy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (Rash on the back and upper arm). On 06-Feb-2021, the patient experienced PRURITUS (Arm became itchy). In February 2021, RASH (Rash on the back and upper arm) had resolved. At the time of the report, PRURITUS (Arm became itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. Treatment included Triamcinolone 1% on her skin for her symptom.
Raised, red, itchy area at injection side, about 7 cm, began on day 8 and slowly improved overnight with redness last thing to resolve
Chills; Low grade fever; Fatigue; Body aches; This is a spontaneous report received from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: GN6208), via unspecified route of administration in the left arm on 10Mar2021 at 13:30 (at the age of 32-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19 infection as it was reported that prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient was not allergic to medications, food, or other products. Concomitant medication included birth control medication (unspecified), which the patient received within 2 weeks of vaccination. On 11Mar2021 at 10:00, the patient experienced chills, low grade fever, fatigue and body aches. The patient did not receive any treatment for these events. The clinical outcome of the events chills, low grade fever, fatigue and body aches were recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sharp pains in calfs , jumping around in different areas. Sharp pains in forearms, random body pains all over, Fatigue, twitching.
Numb tongue in center. Itchy throat with cough. Ringing ears. Irritable skin sensation on face.
Patient was given the second dose of the Pfizer vaccine nine days early on 8/4/21.  On 8/5/21, he developed a fever of 103.6  He was given tylenol 650mg po and sent to Medical Emergency room.  He has been cleared by the MER and he is to be sent back to Hospital and he will continue to be monitored.  He returned to hospital and he continues to do well.
Normal reaction at first: sore arm, mild fever, fatigue, flu-like symptoms beginning within 24 hours. Resolved within 36 hours. Then hives (itchy red bumps) began appearing on right side of torso and neck after 48 hours. Still not resolved. Continuing to develop. Is not life-threatening, just uncomfortable.
all types of things started happening to him; chills; fever; got into bed and slept for 24 hours straight/woke up and slept for another 48 hours; he woke up he felt very weird; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), VACCINATION COMPLICATION (all types of things started happening to him), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. In March 2021, the patient experienced SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (all types of things started happening to him). At the time of the report, SOMNOLENCE (got into bed and slept for 24 hours straight/woke up and slept for another 48 hours), FEELING ABNORMAL (he woke up he felt very weird), VACCINATION COMPLICATION (all types of things started happening to him), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Treatment, Lab data and other concomitant medications were not reported.   This case was linked to MOD-2021-138784 (Patient Link).   Reporter did not allow further contact
FELT REALLY SICK; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 10-MAR-2021 12:00 a.m. for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 10-MAR-2021 15:30, the subject experienced felt really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt really sick was not reported. This report was non-serious.
high blood pressure was down; This is a spontaneous report from a contactable other health care professional via Medical information team. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 23Jan2021 at dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 3 to 4 days after the 1st dose in Jan2021, patient noticed his high blood pressure was down around normal: 120/80. Everything was back to normal. He visited the cardiologist who has no other patient who have taken the vaccine with reports similar to his but advised him to call Pfizer. Caller has also reported to VAERS. He logs his blood pressure daily for his doctor. He was a former surgical technologist and nursing assistant. Currently retired. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 hours after immunization started feeling ill having low grade temperature 100 degrees and vomiting. Mother called 04/13/04 at 11:30am and I advised her to call her PMD and have her daughter checked. 04/17/04 I spoke with her mother again and her daughter has greatly improved. 04/13/04: not going to her PMD.
Pt states that night arm very very sore with chills and weakness. Upper arm on 01/29/05 was very sore bruised color from elbow to shoulder. On interior side back part of arm had a large patch of redness that was warm and swollen. Pictures were taken.
body ache; head ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head ache), CHILLS (chills) and MYALGIA (body ache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, COLECALCIFEROL (VITAMIN D 3), TIMOLOL and LATANOPROST for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (head ache) and CHILLS (chills). On 16-Feb-2021, the patient experienced MYALGIA (body ache). At the time of the report, HEADACHE (head ache), CHILLS (chills) and MYALGIA (body ache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Afternoon of receiving vaccine, pt broke out with systemic hives and mouth and lips became swollen.  Took benadryl and symptoms subsided.  Did not see MD
Severe sore throat  Cough Severe nasal and chest congestion  Extreme fatigue  Shortness of breath  Loss of taste and smell that has not completely resolved to date
Extreme heavy menstrual period. So far lasting more than 4 weeks. Previous periods have been normal. Blood tests normal. No fibroids/polyps. Doctors cannot figure out cause. Birth control not working to stop period.
This is a spontaneous report received from contactable consumer or other non-HCP. A 50-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed herpes zoster/shingles, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Linked report(s): US-PFIZER INC-202101738950 same reporter/drug/event, different patient.
pt recvd vax; 22dec94 while mom bathing pt,turned limp,face pale,hands bluish then coughing up white plegm;saw MD;fever & URI dx'd;high fever again 31dec;to er;sent home w/ recomm of apap;T varied from 102.5-105;
Patient presented to the ED and was subsequently hospitalized on 4/13/21 with Stroke of right basal ganglia. She was discharged to rehab on 4/17/21 and is currently admitted there.
neuropathy got worse; flare ups of her Pott's disease; faint; severe jaw pain; tailbone burning really bad; felt really off; ear pain; ear pressure; heart palpitations; migraine; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease) and SYNCOPE (faint) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX), VITAMINS NOS and GABAPENTIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, 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 NEUROPATHY PERIPHERAL (neuropathy got worse) (seriousness criterion medically significant), BONE TUBERCULOSIS (flare ups of her Pott's disease) (seriousness criterion medically significant), SYNCOPE (faint) (seriousness criterion medically significant), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease), SYNCOPE (faint), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-201988 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Neck stiffness/pain, extremity weakness, muscle spasm, fatigue, headache beginning in the afternoon of 10/25/14 and has continued to worsen over the past days. Contacted physician office over concern 10/27/14.  Told to treat symptoms ie pain medication, rest if no improvement call for follow-up appt. As of 10/28/14, no improvement will call physician again.
This spontaneous report as received from a nurse professional refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (Lot#unspecified) on 02-SEP-2009, dose 2 on 08-NOV-2011 and dose 3 on 24-JAN-2012. No other co-suspects and concomitant medications were reported. No treatment information was reported. No adverse effects were reported. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
Got shot 3-19-21 at 4:20pm. Felt fine all evening. Woke up next morning with fever. 102 degrees. Took Tylenol. Slept all that day. Next morning woke, fever 101.6. Took Tylenol. Slept until noon,  woke up drenched in sweat,  fever broke.  Later that day lips started puffing up with little bubbles ,, which turned into big blisters,.  All the way around lips, almost solid in blisters. Blisters lasted  a few days, then  they broke, and it took 2 weeks for "scabs" to heal as they kept cracking and bleeding.   Other than fever and blisters, all was fine.
Vaccinated on 02/08/2002. Primary response on 02/15/2002. On 02/17, the pt developed redness, swelling with red streaking to left axilla, fever of 102 deg. F., lymphaderopathy. Prescribed with Augmentin. On 02/19/2002, resolving cellulitis.
Fever and chills 3/6 and 3/7 Rash/hives entire body 3/10 treated with benedryl
Irregular menstrual cycle - more painful cramping, more bloating, more frequent bowel movements
injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th May 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced injection site soreness that lasted for one day. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019144925.
pt recv vax 4PM @ 415PM began itching, coughing & chest feeling tight;face flushed;BP 110/70, 88, R16;pulse ox 98%, P106, peak flow 450 NMT started finished 430PM;BP 100/72, 95, pulse ox 98;450PM BP 104/72, p88, peak flow 430 feeling fine;
First vaccine chills and feverish but did not have a fever. Headache, nausea, joint pain, Body aches , runny nose, brain fog, fatigue and swollen lymph nodes . 2 days after the first vaccine. Second  vaccine chills, feverish, runny nose, head ache and body aches, fatigue and feels like she is going to have swelling in the lymph nodes again.
Headache, chills, subjective fever, n/v/d, and redness/swelling around injection site.
Red & painful & itchy lump noted at site of influenza vaccine site 2 days after vaccination.
WAKING UP AT NIGHT; EXTREME PAIN IN EVERY JOINT ON THE BODY; FATIGUE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced waking up at night. On APR-2021, the subject experienced extreme pain in every joint on the body. On APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme pain in every joint on the body, fatigue, and waking up at night. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Symptoms started with sore throat 11/6/99. Mouth covered with white superficial painful peeling surface.Injection of both eyes.Progressed into ulcers of oral mucosa of throat and lips. Dehydration, weight loss, rash. Stephens Johnson synd.
Patient had an appointment for Pfizer Covid vaccine booster dose, pt was processed for the correct vaccine and filled out correct form, however at time of vaccination pharmacy technician gave a flu shot of afluria inadvertently to the patient, Pt was informed she received the flu shot and was given the correct Pfizer covid vaccine. So patient received both the flu shot and the covid vaccine although she did not originally make an appt for a flu shot after consultation with the pharmacist she was informed that the flu vaccine and covid vaccine can be administered together per the CDC. Pt was then processed for the flu vaccine so records can reflect that she did also receive the flu shot. Pt was asked to wait 30 minutes after receiving both shots and did not report any adverse events. pt was informed of the expected side effects: sore arm, tiredness, drowsiness, etc .