chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported fever, arm pain and chills, and also a red spot at injection site. She took ibuprofen (400 mg) to relieve symptoms. On 3/30/2018 when given a follow up call she reported pain better but injection site red, warm and itching. She had taken CLARITIN and ibuprofen earlier in the day and was advised to continue to take ibuprofen and possibly a cold compress topically and diphenhydramine 25 mg by mouth at bedtime.
second dose outside of 42 days; diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer COVID vaccine on 15Mar2021 and then diagnosed with COVID-19 on 29Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Mar2021. The reporter was calling on 10May2021 and wanted to find out when could the patient receive the second dose of the Pfizer COVID vaccine. The outcome of the events was unknown.  Information on the  lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and COVID-19 and the suspect drug.
arm pain/ soreness in his arm; feeling it and wanted to know if the booster would have aggravated it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single and administration date 25Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose 1, single; Lot number: EN6199), administration date: 04Mar2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "arm pain/ soreness in his arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "feeling it and wanted to know if the booster would have aggravated it". Therapeutic measures were taken as a result of pain in extremity. Additional information: He took his first Pfizer Covid vaccine was on 04Mar2021 with lot EN6199, the second dose was 25Mar2021 with ER8730 and states he does not know the exact date of his booster dose and does not know the lot number but states it was on 15Oct2021 and they gave him two receipts and on his wife's receipt it has lot FE3590; he was unable to provide lot number for his own booster dose despite further attempts at clarification. Patient had the Pfizer Booster dose administered about 2 weeks ago in his left arm and he can feel it in his right arm and the soreness began but he may be wrong on when it happened and he may have felt it before and was trying to find out if he felt it before he got the booster and now knows he was feeling it and wanted to know if the booster would have aggravated it. He can't really say if he felt it before the booster dose and has been taking Tylenol 3 and the soreness was still there and that was why he was inquiring about this and stated that he has no lot, expiry date or NDC or dosage to provide for the Tylenol as it was not with him at this time but states it was over the counter Tylenol 3. Reporter questioned that "If his arm was sore before you got the booster dose can it aggravate the other arm and stated that he was taking Tylenol 3 previously and he didn't know if that was related or not but because the form they give us with the listed side effects, it said arm pain, does that mean where he got the shot or anywhere. He got clarified with the representative that he was asking if he gets the injection in one arm can he have the side effect of arm pain in the other. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the vaccine and at 11:02am  felt light headed and at 11:03am patient fainted. Patient regained concience at 11:04am and was fine after that. I applied an ice pack to patient and he was fine.
Presented to ER on 11/25/21: 46F h/o severe persistent asthma, HTN here with wheezing and SOB that started  this morning. pt reports she was in a substance use treatment program  until 8 days ago. she came back and she thinks the cold weather  prompted her asthma to act up. she ran out of her albuterol 2 days ago. has  been coughing. no fever/chills. hoarse voice and nasal congestion. denies CP,  leg swelling. denies any substance use since leaving treatment program.  noted to be 81% on RA when EMS arrived. pt given 1 duoneb and was 93% on RA on  arrival.  ER COURSE:  duoneb decadron 12mg mag 2g  ___________________________________________________________ CLINICAL IMPRESSION/PLAN: 46F h/o severe persistent asthma here with wheezing, SOB and cough x2 days  after running out of her meds. reported to be hypoxic to 81% on RA at home. sig improvement with duoneb and  was 93% here on RA. mildly tachy, AF. still with sig wheezing but moving air well, no accessory mm use, speaking in  full sentences. second duoneb, decadron, mag labs, CXR, covid swab reassess after second duoneb  1226pm reassessment after second neb- pt breathing comfortably. still with diffuse  bilateral wheezes. SaO2 97% on RA but drops to low 90s at times and when  sleeping to 88-89%. CXR clear will start 1hr cont albuterol neb given ongoing diffuse wheezes  1311 covid test positive patient well appearing, moving air well covid explains hypoxia despite good air movement and no accessory mm use start remdesivir will require admission to Hospital.
Pt experienced a pre-syncopal/vasovagal episode.  She was laid supine and observed for 25-30 minutes.  She began to feel better and was able to sit and then stand with no symptoms.  She felt able to leave the clinic on her own and was advised to seek medical attention should symptoms return or worsen.
After 7 hours from vaccine i felt sharp pain on right arm where vaccune was administred and i could not sleep. I had chills, fever and body aches. On the second day i only had body aches amd felt weak. Today the third day after vaccines feel tired but starting to feel normal again. I did not take meds to feel better. The first shot 4 months i did not have any adverse effects.
4 minutes, post injection, became dizzy, was laid on cot - vitals stable, remained dizzy - was given orange juice (had not eaten this day) & her mom gave granola bar, was closely monitored x15 minutes, then was assisted to sit up and closely monitored x15 more minutes. Felt her usual and left site with her mother.
Shingles; Condition aggravated; rash appear across his chest, down his arms and onto his stomach; little red whelps, splotches; Itchy splotches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 20th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd June 2019, 3 days after receiving Shingrix, the patient experienced shingles (serious criteria clinically significant/intervention required), condition aggravated (serious criteria clinically significant/intervention required), erythromacular rash (serious criteria clinically significant/intervention required), welts (serious criteria clinically significant/intervention required) and itchy rash (serious criteria clinically significant/intervention required). The patient was treated with prednisone, antihistamine (Antihistamines) and dexamethasone. On an unknown date, the outcome of the shingles, condition aggravated, erythromacular rash, welts and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, condition aggravated, erythromacular rash, welts and itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix while he still had active shingles. The patient experienced shingles outbreak.  Rash appeared across his chest, spread down to his arms and onto his stomach. He noted it was also down his left leg at the time of reporting. He described the rash as little red whelps, splotches that are slightly itchy that started where his shingles were on her right side of chest, spread to left chest, down both arms and down onto stomach. The patient stated his shingles began on his back and came around his right side. The patient saw his primary care physician on 1st July 2019, who recommended to see a dermatologist. He saw the dermatologist on 18th July 2019. The patient was given a Prednisone shot and that did calm the itch and rash but didn't resolve.  The patient was also given a Prednisone dose pack and told to take an antihistamine, but noted the antihistamine didn't help.  The patient was using dexamethasone cream at the time of reporting, which did help but the rash was still not resolved.  The patient stated the dermatologist stated she did not think this rash was related to dose 1 of Shingrix. The reporter consented for follow up.
We received via Vaccine Information Service the following information: A 24-year-old female patient, born on 9 JUL 1982, had a bat in her house that did not bite her, however it did hit her on the right shoulder. Therefore she received her first dose of RabAvert with one dose of HRIG on 17 JUN 2007. On 20 JUN 2007 at 1 a.m. the patient was presented to hospital with pressure behind her eyes and ears. A CBC was done which showed 8000 WBC and 50% lymphocytes. A dose of Solumedrol was administered. We are awaiting further information. Preliminary company assessment. Seriousness criterion: hospitalisation. Causality: pending. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measure necessary. VIS no. NA07-002157
Patient has been treated on two separate occasions for Parsonage-Turner Syndrome (brachial plexus neuritis) following influenza administration in 2003 and again in 2007.  He has been treated my neurology Dr. for the condition.
This is a spontaneous report from a contactable physician communicated to a sales representative. A male patient (age unknown) received a dose of PREVNAR13 intramuscularly in DEC2011. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date following administration of PREVNAR13, the patient developed an unspecified reaction in the eye. Subsequently, the patient was taken to the emergency room for evaluation (not further specified). The outcome of the event at the time of the report was unknown.
gave 2 booster 0.25 instead of second 0.3ml Pfizer dose -
At local hospital COVID-19 & Flu Vaccine Outreach Event on 1/25/22. Client received his first Moderna vaccine. RN administered the vaccine around 5:15pm with no incident, and pt. reported no HX of problems with vaccines and no allergies. Pt. went to observation area. At 5:25pm, client came up to nurses at site, and reported that he had numbness in his tongue and that he felt like "he had icy hot on his upper back". Client denied trouble breathing and denied throat itchiness, swelling. Client reported that he last ate at 2:30pm and he ate lasagna. Client denied dizziness. Had client sit back down. At 5:25pm BP: 157/107, HR: 78, R: 14. Client denied HX of high blood pressure. Client denied having previous reactions to vaccines, reported that he typically does not get vaccines, and estimated his last vaccine was upon going to high school. Client reported that he frequently gave plasma without issue, last time being around 2 months ago. Client felt warm on upper back and clammy. 5:30PM: BP: 158/96, HR: 77. Continued to have client rest. Client continued to verbally respond and continued to deny breathing issue. At 5:34pm client reported he felt nauseous and slightly dizzy. Provided client with paper bag, and cooling rag for neck. Advised client to take slow deep breaths. At 5:37pm EMS was contacted by RN on site. 5:40PM: BP: 168/103, HR: 103. Client reported that he was anxious. At 5:43PM: BP: 156/103, HR: 100. Client's hands appeared shaky. At 5:44PM client reported that both of his arms, and right shoulder were tingly and starting to feel numb. Client reported that his tongue was still numb and his back still felt like "icy hot". Client continued to deny difficulty breathing. 5:47PM EMS arrived. 5:53PM: BP: 158/100, 02: 100%. Client continued to report numbness and tingling in tongue and back, and denied breathing difficulty. Client reported hesitancy towards getting his vaccination. EMS advised client to take slow deep breaths. At 5:56pm client reported decreased numbness. Client ambulated around the room without issue, he denied dizziness but reported he felt "cloudy". Client sat back down. EMS reported client was stable and appeared to be having anxiety. EMS asked client if he wished to go to the hospital. Client wished to go to the hospital. Transportation arrived around 6:09pm and client left walking with EMS without issue.
6-1/Received vaccine. 6-2/tenderness at site. 6-3/Bilateral underarm edema & pain. 6-4 & 6-5/increased edema, increased pain. 6-6/Employee Health MD visit  - prescribed prednisone & hot soaks for 5 days for lymphadenopathy. 6-21/call to MD prescribed Ibuprofen for 1 week. Mild edema/pain still remains numbness upper arm area at times, better but not well yet.
Narrative: COVID infection following COVID vaccine series 08/12 Janssen, dose #1 08/12 COVID swab, result: detected 08/13 pt cc: cough, diarrhea, loss of taste or smell exposure: unknown
Mom stated child had been running t 104 within a few hrs then p/2 days t spiked to 105. Mom gave child sponge bath & Tylenol & fever came down to 102. on 8FEb91 temp still 102 & 103 to report to MD this AM.
Headache, Myalgia, Fever, HA, MYALGIA, PAIN AT SITE WHOLE ARM, Narrative:
pt recvd vax 27JAN92 & next evening started vomiting, had high fever of 103 & vomiting persisted; 30JAN devel maculo-papular rash over entire body (groin, legs, chest) w/blisters & itchy & puffy eyes; tx included calamine lotion;
Approx 10 hours after receiving vaccine began feeling nauseous with headache that worsened. Followed by high fever of 102 came down to 100 with use of ibprofuen. Fever was on and off for another 12 hours fever and headache/body aches resolved by 3 pm on 12/25/20
Fever 101.2F lasting 8-10 hours.  Mild body aches.  Mild head ache.  Pain at injection site.
Full body rash on palms of hands and soles of feet (same issue happened w/ 2nd dose), severe vomiting (10-12 times) for 24 hours and fever or 36hrs.
pain, swelling, warmth, redness, low grade temp;+lab results 10cm area of swelling
5 days after receiving  vaccine, hives appeared from shoulders, down to legs.  Hands were itchy and warm.  These symptoms continued off and on for 5 days.  Symptoms mostly appeared in the late evening.
Left arm sore and tender to the touch for five days; three days of mild headache, body aches, fatigue and nausea.
Redness in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in arm) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR) and PANTOPRAZOLE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 ERYTHEMA (Redness in arm) and HEADACHE (Headache). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness in arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065351:Dose 2
Patient was given the Pfizer 5-11 yr formulation instead of the Pfizer 12yrs+ formulation
Since the Vaccine I have loss of concentration, focus, fatigue,  memory loss and forgetfulness.  I also have troubles remembering words that I can see in my head but cant get it out.  This does not happen all the time but is happening more and more.  Light sensitivity and noise startle me that never use to.
First vaccine - fever and aches, then a large lump on the clavicle at the base of the neck on the right side only - tender and enlarged for a week or more - getting smaller and less tender consistently.  On 3/21/21 I felt like I had canker sores in the roof of my mouth and lips.  I used some Abreva on my lips and nothing developed.  Second vaccine taken April 15, 2021 and again with fever and body aches - followed by lump at right jaw line and considerable tooth ache- throbbing -Dentist could not locate a problem and slowly the swelling and pain  subsided.
Severe chills, fever (101.3 degrees) from 9pm -4 am. Took 1advil at 1:45am. Diarrhea. Headache. Sinus Congestion. Took another Advil at 3:45am.  Fever broke around 5am.  At 9:00am, feel fine-/just extremely exhausted with slight lingering headache.   I haven?t had a headache in years.
On evening that vaccine was given pt noted pruritic area on upper extremities which when scratched resulted in erythematous raised linear lesions. Sensation and confluent lesions progression on abdomen.
Nausea,  chills, fever, headache,  body fatigue sore throat and diarrhea.  Conditions lasted 2 days and resolved by day 3.  I tested positive for covid in December but the vaccine side effects were much worse than Covid.
Afib came roaring back; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib came roaring back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Cardiac ablation in June 2020. Concurrent medical conditions included Atrial fibrillation.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ATRIAL FIBRILLATION (Afib came roaring back) (seriousness criterion medically significant). The patient was treated with Surgery (Cardiac ablation) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (Afib came roaring back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided. Patient had to unfergo cardiac ablation again 3 Jun 2021.  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. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected.   Reporter did not allow further contact; 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. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected.
This spontaneous report received from a nurse refers to a patient of unknown age. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with VARIVAX lot # M005971 for prophylaxis. The Nurse reported that the vaccine administered was improperly stored. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. Lot M005971 was stored at 12°C for 63 hours, and in the range of -14°C to-10°C for 487.5 hours. No previous temperature excursion. The call was not because of a "data logger". This is one of the several reports reported from same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA010910: US-009507513-1707USA010911: US-009507513-1707USA010912: US-009507513-1707USA010913: US-009507513-1707USA010914: US-009507513-1707USA010915: US-009507513-1707USA010916: US-009507513-1707USA010917: US-009507513-1707USA010918: US-009507513-1707USA010919: US-009507513-1707USA010920: US-009507513-1707USA010921: US-009507513-1707USA010922: US-009507513-1707USA010923.
Pt returned to our office 2 days post vax with complaint of chest and back pain, temp of 103.4, redness and swelling at injection site. Pt was treated with Prednisone.
This case was reported by a nurse via call center representative and described the occurrence of injection site discomfort in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a retired nurse and mentioned that her friend had the SHINGRIX injection and then experienced arm discomfort (at the injection site). No further information was collected.
The first thing I started to feel was pain under my arm. Swollen lymph nodes under left arm. Flu like symptoms that night and gone the next morning. Swollen and pain under my arm lasted for 10 days.
Chest was feeling wierd; Coughing; Arm was sore; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), DIZZINESS (Dizzy), CHEST DISCOMFORT (Chest was feeling wierd) and COUGH (Coughing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and DIZZINESS (Dizzy). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest was feeling wierd) and COUGH (Coughing). At the time of the report, PAIN IN EXTREMITY (Arm was sore), DIZZINESS (Dizzy) and CHEST DISCOMFORT (Chest was feeling wierd) outcome was unknown and COUGH (Coughing) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: 102 (High) Heart Rate up to 102. On 11-Apr-2021, Heart rate: 40 (Low) Heart rate was down to 40. On an unknown date, Heart rate: 50 (normal) Normally was in 50's.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095612 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095612: