chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient's pertinent medical history included vertigo, acid reflux, allergy to penicillin and allergy to latex. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot # K008880, expiration date: 20-SEP-2015) subcutaneous. The patient did not take any concomitant medications. On an unspecified date in October 2014, the patient experienced a reaction at the injection site. The pharmacist reported that it began as a hard little lump at the injection site which has grown into an extremely red and inflamed area covering half of back of the arm. The reporter stated that there was no rash present, only redness and swelling. On an unspecified date in October 2014, the patient also experienced headache and vomiting. There was none treatment given for adverse events and none lab diagnostics studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. The patient sought medical attention by calling to pharmacy. Additional information has been requested.
I developed severe vertigo with nausea and vomiting, unable to stand or move around effectively.  Cold and clammy. Symptoms lasted about 2 hours.  No difficulty breathing and no headache. No fever or focal neurologic signs.  Pulse was regular and blood sugar was 95.
extremely stiff; pain in neck, shoulders, traveling to arms back and hips; pain in neck, shoulders, traveling to arms back and hips; pain in neck, shoulders, traveling to arms back and hips; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 65-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 16:00 (Batch/Lot Number: ER8731) as DOSE 2, SINGLE (at the age of 65-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history reported as none and had no Known allergies. The patient did not have covid prior vaccination. Concomitant medications (other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN) and calcium, colecalciferol (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 26Mar2021 at 16.00 (Batch/lot number: ER8733, Left arm) (at the age of 65-year-old) for covid-19 immunisation and experienced thin line of numbness on the tip of tongue. The patient not received other vaccine in four weeks. The patient experienced started getting extremely stiff and pain in neck, shoulders, traveling to arms back and hips on 18Apr2021 at 07.00. The event caused Physician Office Visit. The patient not tested for covid post vaccination. The patient received unspecified anti-inflammatory and muscle relaxer. Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
fever of 101 degrees; nausea; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Enbrel).   On 24th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 25th August 2019, 1 days after receiving Shingrix, the patient experienced fever, nausea and vomiting. On 26th August 2019, the outcome of the fever, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the fever, nausea and vomiting to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient experienced fever of 101 degrees and nausea and vomiting all day the day following their second dose of Shingrix. As of in morning of day of reporting, all symptoms were resolved. The reporter consented to follow up.
Pt was here for 2nd dose of hep B. Hib given instead of hep B.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 02Oct2023 to 06Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329595 same patient, different drug/AE;
HAD THE VACCINE IN MARCH AND NOW IN DECEMBER IS HOSPITALIZED WITH COVID-19 INFECTION.  HOSPITALIZED ON 12-6-21 AND STILL IN HOSPITAL TODAY
Four to five hours post vax, this pt developed numbness and tingling in the deltoid, thumb and first finger. Reportedly these symptoms are still occurring.
pt stated she had a rash growing from the injection site since 5/15/21 when she received her 1st moderna shot. she went to urgent care today 5/20/21 and came to pharmacy to pick up rxs that md prescribed and informed pharmacy (at another pharmacy location) just today. urgent care treating for possible cellulitis. no other adverse reactions to report aside from the growing rash.
Headache, Sore Throat, Muscle Ache, Lethargic, Dizziness
Within hours, a raised red circle 2.5 inches in diameter appeared at the injection sight.  The site was also hot to the touch.  Muscle sore.  Two days later, swollen area still swollen but warm but an itch surrounded the raised area.
Pt. states that after receiving the 1st dose of Phizer 03/17/2021, started experiencing symptoms 03/20/2021 of shortness of breath, pain with breathing, and fatigue. Tele-Health appt. with Primary, "Wasn't too concerned with the side effects." Little bit of dizziness, continuing.
Two days after vaccine, I went and got my regular allergy shot. An hour later I became flushed and started wheezing. A half hour later I developed hives that were only from my knees to my neck. I went to Urgent Care and was having a severe allergic reaction. They immediately gave me ice packs to cool down, then was given a steroid shot of Solumedrol. Was prescribed Prednisone, Atarax, Hydrocortisone cream. Felt back to normal 2 days later.
Sharp searing (like lightening) neuropathy pain in my legs; caused me to buckle and sometimes fall
Patient received her Arexvy vaccine on 9/5/23 and reported to pharmacy on 9/18/23 that her lymph nodes were swollen on 9/15/23 due to Arexvy vaccine. She saw her pcp and radiologist on 9/15/23.  Patient said she had her mammogram and ultrasound scan done.  Per her radiologist,  the results showed that her lymph nodes were swollen.  She said her radiologist  told her that it's caused by Arexvy vaccine and it will take at least 6 months for her lymph nodes to return to normal.
Nonproductive cough.  Anterior nasal discharge, clear. Sensation of postnasal drip.        She has felt warm intermittently, temp not taken   Generalized myalgias. starting 1/12/2022
Difficulty breathing; Flushing; Prickling/Tingling sensation; vomiting; Strong Smell; Uncomfortable in the back of her Throat, and it moved to her chest; Bad Taste in her mouth/Unusual taste; Jaw was Shaking; Uncomfortable in the chest; Nausea; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation), PAROSMIA (Strong Smell) and THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ARMODAFINIL (NUVIGIL) for Narcolepsy, TRAMADOL and BACLOFEN (BACLOPHEN) for Pain, ESTRADIOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore Injection Site). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation) and VOMITING (vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 1 dosage form. On 03-Mar-2021, PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest) and NAUSEA (Nausea) had resolved. On 17-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), FLUSHING (Flushing) and PARAESTHESIA (Prickling/Tingling sensation) outcome was unknown and VOMITING (vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Thyroid replacement for Low thyroid.   Treatment included Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information was received from initial reporter: Patient details updated, concomitant medications and new events were updated.
02/19/2023 I had a ticklish throat and no other symptoms. 02/20/2023 I had the symptoms of a heavy cold, extreme fatigue, coughing,sneezing, heavy nasal output I also felt feverish but my temp was normal. I took a home COVID-19 and tested positive. I had fatigue for about 2-3 weeks after onset.
slight fever 99.8 F; soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site) and PYREXIA (slight fever 99.8 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on the injection site). On an unknown date, the patient experienced PYREXIA (slight fever 99.8 F). On 13-Jan-2021, VACCINATION SITE PAIN (soreness on the injection site) outcome was unknown. At the time of the report, PYREXIA (slight fever 99.8 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician assistant concerning a female patient (age not reported) who on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (Lot # 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question ahs been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Rebound of symptoms and confirmed with antigen testing. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
The patient described a severe headache that started 2 days after the injection on 1/15/2021. Headache was associated with nausea and vomiting. Pt took Tylenol 325mg once and then repeated it 4 times in the next 24 hours before the symptoms resolved.
Swollen at site of injection.  post 15 days and still swollen it started at about 2 inches and has gone down to a quarter size.  Itchy/ blotchy spots on chest, neck, belly. it happens randomly though out the day. very itchy. (daytime) when i''m asleep i'm not itchy.  using benedryl/allegra. its helping a little.
Patient is a 65 y.o. female patient of a DO with history of CHF, DM 2, hyperlipidemia, hypertension, CVA, GERD presented to a local Hospital with generalized weakness..   Severe Sepsis Bacteremia UTI Present on admission: yes Etiology: COVID, UTI VSS, AF, feeling slightly better. Initial lactic acid: 4.4. Repeat lactic acid: 1.3 Current antibiotic regimen: vanc and cefepime Culture data: Blood CX 2/2 with GPC and 1/2 with GNB. Urine Cx with Pseudomonas.  Recheck blood CX 3/26, negative so  far ID following, await final recs UA done today. Appears clear Discharged on Doxycycline   Covid-19 Virus Infection Acute respiratory failure with hypoixa Can come off isolation Date of onset of symptoms: 3/17/22 Date of covid positive test: 3/22/23 Vaccination status: vaccinated Oxygen requirements on admission: 1-2L Current oxygen requirements: None, on RA. . Medical therapy: remdesivir and steroids Anticipated special isolation end date: 3/28   Acute metabolic encephalopathy Resolved, pt is AAOX3
o  Hot sensation over my entire body o  Dizzy- nauseous  stomach pain o  Extreme headache immediately (beyond my common migraines) o  Felt as though someone was setting off a blowtorch in all openings of my body (i.e. nostrils, ears, anus, vaginal, mouth, eyes) o  Went immediately to the floor o  Fever of 101  immediately following onset of hot sensation(see hospital records for stats/labs/test results) o  Felt like someone ripped my entire skeletal structure out of my body, crushed it and threw it back in my body o  My head felt as though there was a 3-inch metal band circled around the circumference of my head and had a notch on it  tightening on the second  I could feel something in my head snapping, popping  I thought something was going to burst in my head o  My fingernails/fingertips, toenails/toes felt like they were being crushed o  My muscular system felt like one entire Charlie horse  it felt as though my body was one entire muscle and it was being twisted AND twisted and would not release itself o  I began moaning and humming to somewhat ease the intensity of what I was going through o  I couldn't focus  o  I kept rocking, rolling side to side to somehow ease the pain of the complete body muscle spasm, skeletal-nerve pain o  The pain became so intense I started vomiting                                          this all occured all at once, after I started vomiting, my husband drove me to the Emergency room
pt recv vax 28SEP95 & 8AUg96 pt devel a large, blistered rash w/pustules on lt buttock & thigh;no fever was noted;dermatologist confirmed that pt had developed herpes zoster;
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L044258 with expiration date of 09-FEB-2017, dose and route unknown. No adverse effect was reported. Additional information has been requested.
collapse w/shock-like state; no sz, no fever was fine p/20-30mins; no rx;
no adverse event; on 24-FEB-2020, patient received a dose of improperly stored ROTATEQ; Information has been received from a registered nurse referring to a patient of unknown age, gender, race or ethnicity. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 23-DEC-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, lot #, expiration date were unknown) orally for prophylaxis. On 24-FEB-2020, the patient received a second dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; lot # 1660112 and expiration date 18-OCT-2020) orally for prophylaxis. The vaccine was exposed to temperature excursion at 1.28 degrees Celsius for 2 hours and 30 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Around 4:30am on the day after administration of the vaccination, patient went into ventricular tachycardia and his ICD attempted anti-tachycardia pacing (ATP). Per electrophysiology note after interrogation of patient's ICD: "Multiple VT episodes beginning around 4:30 AM, and continuing intermittently through 10:15 AM, approximately. There were 19 treated VT episodes, mostly terminated with ATP therapy. There was a single 24J shock delivered at 9:43 AM after a VT episode lasting 1 min, 4 seconds, with average ventricular rate 171 bpm. This appeared to be an appropriate shock after exhausting 8 ATP attempts. On 5 other occasions the patient required 4 or more ATP sequences to terminate VT. The remainder terminated with 1-2 ATPs. Reviewing the far field electrograms, there appear to be 2 distinct VT morphologies. Average ventricular rates for both are about 170-180 bpm."  Patient presented to the emergency room, where he received amiodarone IV, and was admitted to an inpatient cardiology service. He was restarted on amiodarone and was noted to be hemodynamically stable and not in VT; however, he opted to leave the hospital AMA on 3/15. As noted previously (item 11), he has a history of VT and had discontinued amiodarone due to side effects about 6 weeks prior to this episode. As amiodarone has a half-life of around 45 days, it is thought that his rhythm control was suboptimal at the time of this vaccination, and there is no evidence that it was the vaccination that caused the VT episodes on 3/14.
Narrative: Patient with history of CLL and COPD present to ER on 09/22/2021 unresponsive after 6 days of progressive shortness of breath. Patient coded, was intubated, and then admitted to ICU with diagnosis of acute hypoxic respiratory failure, status post cardiac arrest, and covid pneumonia. Patient extubated on 9/24/2021 and placed on comfort measures. Patient was DNAR. Patient died on 9/25/2021.
left arm is red, warm, and tender to touch.  States LPN gave him injection at same spot.  running fever and chills.
SHOT WAS GIVEN IN RIGHT DELTOID BUT LOW .  PATIENT WAS CONCERNED WITH EFFECTIVENESS OF SHOT BEING LOW IN THE DELTOID.  THERE ARE NO ADVERSE EVENTS TO REPORT, PATIENT IS NOT EXPERIENCING ANY PAIN OR DISCOMFORT, JUST WANTED TO BE SURE THAT THE BOOSTER SHOT WAS STILL AS EFFECTIVE AS IT NEEDED TO BE.
Within 5 hours Body aches Feeling extreme cold in my feet My hands were warm After 8 hours chills and shaking.  Temperature of 109.1. Took two  500 mg Tylenol.  By my 2/25 21  at 10 AM temperature @ 97.8. Continued taking Tylenol every 6 hours. At 7 PM on 2/25/21 slight chills. As of 2/26/21 all symptoms were gone. Tylenol no longer needed.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 14-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959: