chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1132:  After 30 min observation patient notified the observer in the waiting room that she was experiencing lightheadedness and dizziness. She also described a burning sensation down her right arm , which is the arm that the vaccine was administered in. Patient was brought to room 1 , vitals B/P 180/74 SPO2 97% , heart rate 70 11:00 am Patient was given orange juice 4 oz and did report an improvement in symptoms.  APN and doctor called to the vaccine clinic to observe the patient. Vitals as follows: 11:02 am B/P 160/94, heart rate 69 11:03 am B/P 165/77 11:07 am B/P 174/72 11:10 am B/P 175/80 SPO2 98% , heart rate 70 Doctor did manually take the patients B/P at 11:13 am 154/82, Doctor cleared the patient for release to home  with orders to take her blood pressure and that we would call to check on her in 2 hours (1330 pm) . Final vitals before release from the clinic are as follows: 11: 30 B/P 170/66 Heart Rate 68 SPO2 97% Patient escorted to her vehicle registered nurse and nursing student 1751 provider noted: I called the patient and checked on her just a few moments ago.   She reports that she has been feeling well, her blood pressure has come down in the 120s over 60s.   She denies any concerns.   She was advised to contact office for any questions or concerns.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with small cell lung cancer. Vaccination took place 12.11.2008. According to the physician the relationship is Unlikely. We would be happy to fax you the Studys SAE report.
Information has been received from a medical assistant concerning a female patient who on 02-JUL-2007 was vaccinated with the first dose of GARDASIL. The second and third dose of GARDASIL were administered on 26-JUN-2008 and 19-JAN-2009. On 28-JUL-2009, the patient received the fourth dose of GARDASIL. Concomitant therapy included ADACEL, which was administered on the same day but different site. The site of injection for ADACEL was warm to touch and red. The patient had visited the office. At the time of the reporting, the patient had not recovered from injection site warm and red. Follow up information has been received from a physician who reported that the 26 year old female who on 28-JUL-2009 was vaccinated IM with a fourth dose of GARDASIL in the right deltoid at 11:52 a.m. (lot number: 662404/0312Y). Concomitant vaccination included a dose of ADACEL (lot number: UF484BA) IM into the left deltoid and a second dose of hepatitis A virus vaccine (unspecified) (lot number: AHAVB285AB) IM into the left deltoid on the same day (28-JUL-2009) at 11:52 a.m. There was no illness at the time of vaccination. On 29-JUL-2009 (also reported as 2 days after vaccination), the patient developed warmth, redness and swelling at the injection site. The physician reported that by day 3 it started to resolve and the events had not caused further problems. The patient's vaccination history included a dose of ADACEL in 2008. Additional information is not expected.
I started feeling sick 7 hrs after the vaccine I developed chills, fevers, fatigue. My fever went up to 102.9, my eyes started to swell, I felt congestion. I went to the ER on 1/11/201 at around 11pm they gave me medications. The next day I also had diarrhea. The fevers resolved by the following day the body aches & the chills lasted for 1 week & the diarrhea lasted for 1 day.  Fatigue is still going on & off it has not completely resolved.
Large area of erythema and warmth at site of Dtap injection 7cmx9cm over L deltoid
Pityriasis rosea that started about a week or two before his first COVID vaccine in Nov 2021, flared with first and second doses in Nov 2021, improved, flared with booster May 2022, improved, then flared with bivalent booster October 2022.  He has has this rash for a full year now, which is very unusual for pityriasis rosea.
Covid positive after the first dose in Mar2021; Covid positive after the first dose in Mar2021; This is a spontaneous report from a contactable consumer (patient) Medical information team. A female patient of an unspecified age received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single and bnt162b2 (Comirnaty, Solution for injection) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was covid positive, after the first dose. Patient wanted to know if there was a certain time frame that she needs to wait to get a 3rd dose of the Comirnaty vaccine. Response received that 3rd dose was recommended for those with certain types of immune compromise and referred her to speak with her HCP. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on an unspecified date in 2021. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swollen lymph nodes in collar bone & armpit on side of injection Headache  Body aches Dizziness
The subject, I,  experienced sudden loss of consciousness --with no warning--for a few minutes a day following her first dose.  Although she is now well, it could had been poentially life threatening to self and others if the incident occured while behind the wheels as there were no physical warning signs prior to the incident.
patient with history allergies and asthma, DM and increased lipid, HTN immunized with Moderna vaccine at blitz event at TCHS.  15min post vaccination felt suddenly "light headed" and dizzy.  history vertigo in past.  was totally normal in AM prior to vaccination but had not eaten.  BP 102/70 x 2 HR 85 RA sat normal . Was with 10yo son, no one to watch her at home so requested spouse to come and get her and take her to ED for obs. no signs of allergic reaction. ED not allergy dx vertigo.
Unusually red and swollen 3 days out. 10 inches in diameter. Given course of antibiotic by dr.
Red rash bilateral arms & shoulders. Hot to touch. Pt. reports edema in (L) arm on 1/15/13 & resolving 1/16/13. Pt. referred to her PCP - being seen today.
he tested positive for the Coronavirus; he tested positive for the Coronavirus; This is a spontaneous report from a contactable consumer reported for his father. An 89-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient received his first vaccine 3 weeks ago in Jan2021. Yesterday 09Feb2021 he tested positive for the Coronavirus. The reporter was trying to figure out how much protection does the patient had after receiving the first dose. He had probably been infected two or three days. He was trying to find out is the patient 50% protected, 65% protected, or 70% protected. Maybe he was not going to be as sick as a lot of people would be. The reporter asked how much was he protected from the first vaccine? He was wondering if he was protected some and it may increase his chance of surviving the virus. He stated that (domain name) stated that after 14 days the first dose of the vaccine was 52% effective and wanted to know if this is true and how much he is protected against the virus now that he has it. The reporter stated he was asking something very simple (about whether one dose of the vaccine would increase the chance of survival if getting Covid) and had the right to this information and should not have to check with a healthcare provider to get this information. The report was reported as non-serious. The outcome of the events was unknown.  information on the lot/batch number has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2007, the patient was inoculated with ZOSTAVAX at the county health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 28-AUG-2015, the patient was treated at an urgent care for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient called reporting "red blotches" on face - 10/27/11 AM.  Recommended patient take BENADRYL and call in pm if not resolved. Patient called again on 10/29 reporting unresolved facial swelling & blotches. Was recommended to seek treatment. Pt had NP prescribe steroids & antihistamines.
4 cm area of fluctuant subcutaneous fluid at (L) lateral thigh, slightly raised, very tender, with multiple small (L) inguinal L nodes enlarged and tender to touch. OMNICEF Day 7.
Pt recv vax on 9/2/98; on same day pt exp vax site swelling from shoulder to elbow; tx=warm compresses & Tylenol
Lump  under the armpit (possible enlarged lymph node)  for about 5 days. Intense heartburn or chest tightness 3 days after the  vaccination - unsure if it's related to vaccine. Resolved overnight.
Hives onset 6.3.07. Hives on arms, chest, back, thighs, itchy
Very Bad Pain in arm hand Upper back. Unable to move are at time. having lots of pressure in all places. headaches nausea unable to sleep. sever pain!!!!!!
Patient reports left arm pain days after receiving shot. Patient denies having previous history of left arm pain. Pain persists now greater than 7 mos. later.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning an 80-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804102 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Blisters & rashes on hands & foot the night after getting the SHINGRIX vaccine. Which got worse after one week.
Chills, fever, headache, nausea, weak and fatigue 8 hours after the 2nd dose
0.5 -1.5 hour after  2nd  dose/shot in the left arm, numbness on the top of left hand, numbness in the face around mouth, numbness in the top of head, slight difficulty speaking. These symptoms disappeared within 1.5 h after shot. Chills, weakness cold sweats , near passing out at 1 am that night, feeling like about to throw out but unable, pressure in the top of head and left temple region. Shooting pain in the left side of scalp/brain, temple region.  Blurred vision in the left eye. The majority of symptoms are gone by now except for the ones associated with the head. ( shooting pain and pressure in the top of head).Yesterday extremely hot top of the head with a huge pressure building up. Planning to see a doctor on Monday.
Sinus infection; Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Mar2021, she started with a sinus infection that she gets every year. She tested positive for COVID 19 on an unknown date in Mar2021. The patient was due to get her second dose in March 31, asked if that was okay. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Had a temperature; Her arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore) and PYREXIA (Had a temperature) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 024M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Her arm was sore). On 26-Oct-2021, the patient experienced PYREXIA (Had a temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm was sore) and PYREXIA (Had a temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Body temperature: 99 (High) Wife had a temperature of 99°F. On 27-Oct-2021, Body temperature: 101 (High) Wife has a temperature of 101°F.         Concomitant medication list was not provided.
Initial information has been received from a pharmacist concerning his son, a 2 months old male patient, with no pertinent medical history or drug reaction / allergies. On 27-NOV-2012, the patient was vaccinated with ROTATEQ. No other co-suspects were reported. Concomitant medications included: VITAMIN D3. On 05-DEC-2012, the patient developed hematochezia after receiving a first dose of ROTATEQ. The patient had loose stools that contain a varying amount of blood. The reporter stated that the patient had been having bloody stools for one and one half weeks post vaccination with ROTATEQ. The patient had a complete blood cell count that showed an elevated white blood cell count, a stool culture that was negative and an occult blood test that was positive. No treatment information was reported. At the time of report, the patient had not recovered. It was reported that the patient sought medical attention. Additional information has been requested.
pt recvd vax May94 & 2mon p/vax pt hospitalized 5 days w/neuropathy, trouble walking, lt sided weakness, swelling in extremity & hypersensitivity in extremity;sxs affected T4 down;dx acute transverse myelitis & GBS
09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; 09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; 09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; This is a spontaneous report from a contactable consumer or other non hcp. A 76 years female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.The patient's Medical history included drug hypersensitivity, Hives  The patient's concomitant medications were not reported. Caller stated that her My back was itching before she got the vaccine. So that was nerves, that had nothing to do with the vaccine. But her stomach got that little spots on it, not like little, tiny rash, nothing raised or anything. she got the Pfizer covid vaccine first dose on 09Feb2021 and couple days later she got a slight rash on my stomach and back and it was itching and a little redness. It was a little red, faint which spread on my stomach and it was itchy. I was told to use Eucerin cream. Then went to see my Primary Care Physician to make sure and she called Pfizer and advised me not to get the 2nd vaccination. With this rash, some people have effects with the 2nd one. The consumer enquired about the ingredients, dose and virus of the second dose. She narrated that her son got the Moderna one and he got chills, fever, felt like he got the flu. Therapeutic measures were taken as a result of 09feb2021. The outcome of the events was unknown
This non-valid spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions and allergies was provided. On an unknown date, the patient received an unspecified dose of improperly stored ROTATEQ (lot # R003534, expiration date 31-AUG-2019), orally for prophylaxis. It was reported that the vaccine was stored in temperature of 35.29 Fahrenheit degrees for 26 minutes (date unspecified). There were no previous temperature excursions recorded. A Digital Data Logger was involved. No adverse effects were reported.
Patinet received Td vaccine on 04/08/05 at approximately 2:30 PM. She states her arm was extremely achy and tender to touch. Upon waking the next morning, she states her vaccine site was swollen and red. She started taking 800mg Motrin Q 4H. She presented to clinic on 04/11/05 at 10:00 AM. Vaccine site was still red and swollen with palpable induration of approximately 40mm in diameter. Patient states she feels like she is improving and was advised to continue taking Motrin/ Tylenol and to return if condition worsens.
passed out on the highway while driving; A spontaneous report was received from a consumer concerning himself, a 73 years old male patient, who received Moderna's COVID-19 vaccine and he passed out on the high way while driving/loss of consciousness.  The patient's medical history was not provided. Concomitant product was not provided by the reporter.  On 2-Mar-2021, prior to the onset of event, the patient received their first dose of mRNA-1273(batch number unknown) intramuscularly on his left arm for prophylaxis of COVID-19 infection.  On2-Mar-2021, after vaccination he passed out on the high way while driving. The event passed out on the high way while driving was considered to be medically significant.  Relevant laboratory investigation included blood pressure test which revealed as normal.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event which he passed out on the high was while driving was resolved.; Reporter's Comments: This case concerns a 65-year-old female with a serious unexpected event of loss of consciousness. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Trouble swallowing followed by gradual muscle weakness in upper body and mild rash on skin of fingers dermatomyositis diagnosed by my dermatologist and by a rheumatologist.
Patient recieved Moderna vaccine in her left deltoid and five minutes later started to feel flushed in her face  which continued and became full body . She stated" I feel like I'm on fire ".Patient was assisted to the cot  to lie down   . Cool compresses given and vitals taken at this time . Patients VS stable and remained stable .  This reaction lasted thirty minutes and then she stated she felt better . Patient 's  supervisor notified and she was instructed to go home and follow up with her PCP.
Information has been received from a registered nurse referring to an unknown number of patients (names and other demographics unknown). On unknown date, the patients received an unknown number of doses of ROTATEQ (Lot M032643 expiration (Exp.) date 04-MAR-2018; dose and route not reported) following temperature excursions of 54.12 degree Fahrenheit (F) for 33 minutes and 55.25 F for 37 minutes. Data logger was involved. There was no previous temperature excursion. No adverse events were reported in any patients. This is one of both reports received from the same reporter. Sender's Comments: US-009507513-1708USA010856.
Blisters, itching. Tx Benadryl, Calomine lotion. Still breaking out 11/3/03.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. on 19-SEP-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J004174, expiration date 08-OCT-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Burnt sensation and itchiness to tongue, rash to face, neck and ears, shortness of breath
Pt reports redness and swelling in right arm 24 hours after vaccination administration. States that swelling and redness has spread significantly each day. Advised patient to seek medical care. Patient was reluctant to give info and claims she would be calling a lawyer.
No adverse effect; One patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager (also reported as healthcare business professional) referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and drug reactions/allergies and concomitant therapies were not reported.  On 08-JUL-2019, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713 and expiration date 20-JUN-2020 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). The temperature excursion was reported as total time and lowest temperature below 36 degree Fahrenheit (F) (33.9 F) for 40 minutes. No additional doses were administered. No adverse effects and no product quality complaint (PQC) were reported. The call was because of data logger.  The previous excursions were reported as total time and lowest temperature below 36 degree F (30.3 F) for 90 hours and 7 minutes, total time and lowest temperature below 36 degree F (30.5 F) for 1 hour 45 minutes and total time and lowest temperature below 36 degree F (35.2 F) for 2 hours 5 minutes.
Patient not eligible for the booster shot. It had not been 6 months. There was a miscommunication between nursing staff and pharmacy vaccinators.
50 - 100 scattered erythematous papules many are crusted and many have vesicle, distributed over entire body.  Diagnosis:  Varicella.
Client fell to floor 10 minutes after receiving flu vaccine, appeared to have passed out. Client hit back of head but no injuries found. Client cried immediately after falling and was neurologically intact. Client ambulated independently with family after event.