chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccination on 10/12 and pain started down arm, back, side, under arm and across chest sometime during the middle of the night on 10/12- 10/13.  On 10/14 the patient was still no better and she called a competitor pharmacy who told her to take Benadryl. The patient did not notice a change after taking the Benadryl. On 10/15 the patient notified Pharmacy where the vaccination was given and she was told to seek medical attention.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 11-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 4:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.75. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 30-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 36, 12 AM: 40, 1PM: 40, 2 PM: 39, 3 PM: 38, 4 PM: 40 and 5 PM: 40. On 31-Mar-2021 and 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 38, 9 AM: 32, 34, 10 AM: 40, 38, 11 AM: 42, 42, 12 AM: 43, 41, 1PM: 44, 41, 2 PM: 46, 41, 3 PM: 46, 40, 4 PM: 44, 40 and 5 PM: 44, 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Seven days after he recieved the Flu vaccine, he had 100% of his body covered in hives. He went to the hospital and they gave him Decadron.  He still has the hives and they come and go. They will flair up instantly and go away within 2 hours and then come back.
3 days of significant shoulder soreness, even worse than I normally get after flu vaccinations.   More significantly, on Saturday April 17th I began to experience "popping" sounds in my right ear. Overnight my ear began to ache a fair amount. It has subsided some since. This is my first ear ache since I was in elementary school in the 1980s and is not common to allergies. It seems clearly related to the vaccine,  This was my first shot with Moderna.
Received 2nd does of Moderna  vaccine via IM injection  upper left arm 8 am 2/10/21. The next day 2/11/21 around 10 am, I developed a rash about 3 1/2 inches below the injection site (not at the injection site itself), about midway between elbow and shoulder. The affected area is red, tender, firm, itchy and warm with muscle soreness in that area.  The affected area is approx 2 1/2 inches x 3 1/2 inches wide. Today is 2/12/21 and the rash is still present.
headache; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number: EN6202 and Expiry date was not reported) via an unspecified route of administration, on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's relevant Medical history and Concomitant medication were not reported. On an unspecified date in 2021, patient experienced Headache. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: Em9809), in left arm, on 10Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma related cough" (unspecified if ongoing); "Asthma related cough" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2021) Positive, notes: strongly positive; (Jun2022) test line very faint; (17Jun2022) Negative; (26Jun2022) Positive, notes: Still positive with dark line. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Other medication in 2 weeks product=Atorvastastin 40, stop date=10Jun2022, Encruse illipta, stop date=10Jun2022, Flovent 54, stop date=10Jun2022. Adverse event Paxlovid rebound. Original COVID test line very faint. Prescribed Paxlovid 11Jun. Finished Paxlovid 15Jun. Tested negative 17Jun. Started symptoms 22Jun which progressively worsened. Tested strongly positive 23Jun. Still positive with dark line as of 26Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous prospective pregnancy report as received from a physician assistant refers to a 27 year old female patient. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date, the patient became pregnant, last menstrual period; date of conception and estimate delivery date were not reported. On 18-OCT-2017, the patient was inadvertently vaccinated with a dose of VARIVAX (lot # N014366, expiration date 09-MAY-2019) (dose and route were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported. The pregnancy outcome was outcome pending.
Site pain, swelling and heat. Pain radiated into neck and ear. Had ear canal swollen with drainage. Subclavicular node swollen and painful. Hives on arm.
Tingling of tongue, lips, nose and cheeks lasted 5 hours .  No swelling Unusual taste in mouth  lasted only 5 hours
little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: I also take Flonase which is nasal spray for allergy; "Diabetes" (unspecified if ongoing), notes: Diabetes, Consumer stated, "I am type 1 diabetic for 33 years."; "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. Concomitant medication(s) included: IRBESARTAN taken for hypertension; AMLODIPINE taken for hypertension; FLONASE ALLERGY RELIEF taken for hypersensitivity; PRAVASTATIN. Vaccination history included: BNT162b2 (Dose:1, LOT# (first shot): EN6206., first one was nothing), administration date: 17Mar2021, when the patient was 60-year-old, for COVID-19 Immunization, reaction(s): "Nothing". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "unknown", described as "little tired". Relevant laboratory tests and procedures are available in the appropriate section.
As patient was waiting the required 15 minutes after receiving her COVID booster, the patient reported passing out in her chair. Neither her nor her companion alerted staff until she came to. The patient stated she did not fall out of her chair but slumped in it, came to, had cold sweats and felt like she need to vomit but did not. Once staff was alerted, we went straight to her to see how she was doing. Patient said she was "fine." Companion stated she had not eaten anything since early this morning. Gave patient a sucker for sugar and asked her to wait an additional 15 minutes. After the additional 15 minutes patient stated she felt better and left the property.
pt recv vax & exp 4-5 hr later urticaria involving face trunk arms;tx with meds
patient was given 2nd dose of moderna vaccine, felt throat closing. patient states after 1st dose she did have hives, no hives today. patient was given benadryl with full relief of symptoms prior to arrival
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M040423, expiration date: 03-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 Celsius degree for 1 hour 19 minutes. This is one of three cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005015: US-009507513-1706USA004996:
Pt had low grade temp evening of vaccine (L) leg swelling, dry heaving, spit up, mom gave TYLENOL & used ice packs. Temp was b/w 99.4-100.
Eight days after the first vaccination, the injection site became inflamed, reddened, and itchy in an approximate 3-inch area. I Will continue to observe.
Diffuse erythematous pruritic rash. Throat tightness ED treatment: Epinephrine, Solumedrol, Pepcid, Benadryl IV with resolution of symptoms Discharged home on prednisone, Pepcid, Benadryl and epipen
This spontaneous report as received from a company representative refers to a 58 years old female patient with prevention of shingles. The patient was vaccinated with, .65 ml ZOSTAVAX on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). On 25-OCT-2012 the patient experienced injection site erythema, 1 day after onset of therapy and itching at injection site. No treatment information was reported. The outcome of injection site erythema and itching at injection site is unknown. The relatedness for injection site erythema and itching at injection site is unknown for ZOSTAVAX. No other AE information reported.
Patient received the incomplete booster dose of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 28th June 2021, the patient received Boostrix. On 28th June 2021, unknown after receiving Boostrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that the patient received the incomplete booster dose of Boostrix since when taking the syringe from the vial, part of the liquid leaked, which led to incomplete dose administered. No patient's identifiers and no vaccine information were reported. The reporter did not consent to follow-up.
* Vision/Cognitive Issues (Ocular Migraine) started on April 30th (3 days after second Pfizer Covid-19 vaccine), treated with Tylenol, symptoms subsided same day. * Near Syncope events, light-headedness and numbness/weakness in right leg occurred in early May. No treatments prescribed but sent for lots of tests (see item #19). * Tinnitus, Brain Fog, Chronic Fatigue, Nausea, Palpitations, started in late May. Primary care doctor prescribed Prednisone and multiple Anti-histamines. Neither worked. * Brain Fog, Chronic Fatigue, Tinnitus, Dizziness continued during June-November). Paresthesia symptoms (pins and needles) started in feet, hands and arms in June. Initially treated the brain fog, fatigue and dizziness symptoms with N-acetylcysteine (NAC) which reduced the severity of the symptoms during the mornings. In September, new doctor prescribed Low Dose Naltrexone and Cromolyn Sodium to reduce inflammation and mast cell production, which resulted in brain fog, fatigue and dizziness symptoms subsiding significantly by late November. The Tinnitus and some Paresthesia symptoms remain. * Peripheral Neuropathy symptoms started in September. Symptoms included muscle weakness, aching and cramps in lower legs and feet, and swallowing problems (dysphagia). Neurologist prescribed Gabapentin which has reduced the severity of the symptoms related to the legs. ENT doctor diagnosed dry mouth and prescribed mouth rinse, nasal rinse and Nexium. Treatments for mouth/throat still ongoing and not working. * Autonomic Neuropathy symptoms started in October. Symptoms include bladder control (post micturition dribble), and semen being discharged from penis during bowel movement (no constipation). As of the current date (Dec 27th, 2021), waiting for ultrasound scan before being referred to Urologist.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 66-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number C9275, expiry date 31st May 2019) for prophylaxis. On 9th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 10th October 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced nausea and vertigo. On 11th October 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the vertigo was recovered/resolved. It was unknown if the reporter considered the nausea and vertigo to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The events were bad enough that the patient was sent home from work early. It resolved later that evening. The patient had denied permission to contact their physician.
Patient is a 71 y.o. male w PMH HTN, HLD, OSA who presented from home on 6/20/2021 with palpitations, dry mouth, and feeling disoriented.  Patient has been previously fully vaccinated but found to be be positive for COVID-19 infection.  Discussed with ID team and recommended full 10-day isolation to and on 6/30/2021.  Patient was also noted to have an elevated troponin and seen and evaluated by cardiology.  Patient's echocardiogram was normal and subjectively improved.  Patient was hypertensive and recommended increase his home amlodipine to 10 mg daily and continue his home Toprol-XL.  Plan for close outpatient follow-up with cardiology next Tuesday on 6/29/2021.    Discharge Diagnosis and Associated Hospital Course   Elevated troponin Possible myocarditis -Unclear etiology, suspect possible myocarditis or type II demand ischemia from hypertensive episode, troponin 40, 65, 64, 1612 and 48 on recheck, suspect spurious 1612 result  -Patient asymptomatic on discharge without chest pain or shortness of breath -Seen and evaluated by cardiology, echocardiogram without significant findings, no evidence of heart strain, was temporarily on heparin drip but no need for further anticoagulation with plans for close outpatient follow-up with cardiology next week, with strenuous job cardiology wishes to see you prior to return to work   COVID-19 infection Date of symptom onset: Unclear, possibly 1 week ago Symptoms: Fatigue, muscle cramping, dry mouth and palpitations Date of positive COVID-19 test: 6/20/2021 Location of positive COVID-19 test: RMH Oxygen status: Not requiring, saturating well on room air DVT prophylaxis: Temporarily on heparin drip, no further needed Decadron/remdesivir: No, not meeting criteria -Recommend 10-day isolation until June 30th, close outpatient telehealth visit plan with PCP   Hypertensive urgency -History of essential hypertension, on home amlodipine and Toprol-XL -Continue home Toprol dosing, will temporarily increase amlodipine to 10 mg daily, did have episode of hypertensive urgency per EMS with BP 240/40, currently stable SBP around 150s
Within a week of having the first injection, I began having upper back pain on the left side of my back.  I don't know if it is related to the vaccine, however was advised by the CDC to report it.  After 7 months, the pain continues at various times throughout the day.  I haven't had any tests or labs to find out the source of the pain.
The patient received  first dose of monovalent Pfizer on 7/1/22,  then received a Moderna Bivalent booster on 11/2/22. Thus, the primary series was not completed before the bivalent booster was administered and different manufacturers were administered.  There were no known adverse reactions as a result of this administration. The person submitting this form was not the person who administered the bivalent vaccine.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H018949, expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
Severe nausea and dizzy went to ER  -  lasted for 3 days. Pt felt chilled and was trembling as bad it scared her. Pt reported this to Dr. and I am reporting reaction . Follow-up: Pt reports 1 1/2 hr after vaccine throat began to feel swollen, reddened and pt felt light headed.
pt felt hard lump @ the site where pt recv vax;also reported that the lump appeared red;
Was recently diagnosed with Rheumatoid Arthritis..never had that diagnosis prior to my covid shot yet had tons of blood tests a year ago and tests came up negative for RA.
Narrative: Pt is a 68y.o male who died on 05/14/2021 w/ h/o COPD, DM-2, HTN, HLD and R ICA stenosis, and metastatic large cell neuroendocrine tumor with diffuse mets to the liver. Notable for 1 ppd smoker since age 10 with intermittent quitting periods (40 pack year smoker). Pt received Jansen Covid-19 Vaccination 1/2 on 03/13/2021. Pt admitted for inpatient hospice care on 05/10/2021 at wife request due to due to metastatic brain cancer, increasing jaundice and falls at home. Pt died on 05/14/2021 with calling physician reporting "Death was caused by: complications of malignancy from poorly differentiated Neuroendocrine carcinoma". Unlikely Jansen Covid-19 vaccine caused/contributed to pt death.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 86-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2011, the patient was prescribed and vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Low grade fever for 4 days w/fine red maculopapular rash. Local erythema at injection site MMR. Then 1 week after vaccine episode of emesis w/fatigue, last less than 24 hr.
Pt presented to clinic on 8/13/13 with complaint of redness to left arm at injection site. Knot felt to area and pt also complained of sharp pain. Pt educated on applying heat to area and verbalized understanding. Injection administered on 8/6/13.
This is a non-serious spontaneous case, initially received from pharmacist on 29-Oct-2018, concerning a 54-year-old, adult, female patient. The patient's current condition included rheumatoid arthritis. The concomitant medications included PLAQUENIL and CELEBREX. On 25-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 252659 and expiry date: 31-May-2019]. On the same day, in the evening after vaccination, the patient had an allergy (Thursday as reported). The patient's injection site was very itchy, and it became very itchy along with her wrist. The outcome was not reported.
11/21/09 - Patient received H1N1 vaccination. While exiting facility, developed chest tightness, SOB, lightheaded, cyanotic lips and nail beds. BP 122/64 - 88 - 16. Patient remained seated until leaving facility via ambulance to local Emergency Dept. No resolution in symptoms. Work up in ED was negative. 12/7 & 12/8/09:  ED Records recieved for dates of service 11/21/09. Dx:  Probable vagal reaction, acute chest pain.   Assessment:  Presented after H1N1 vaccine with c/o chest tightness, tingling, anxiety, lightheadedness, SOB, cyanosis of nail beds and lips.  SaO2 94%.  Medicated with Ativan 0.5 mg.  Pulse ox increased to 100% on room air.  Felt well to go home.
pt recvd vax 1AUG94 & had sore neck, stiff neck & h/a;3AUG94 pt had a migraine, w/vomiting, lights & h/a;was hospitalized for 5 days;treatment Demerol & Vistaril;currently pt has sore neck, & pins & needles sensation on rt side of face;