chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Unpleasant side effect, whole body aches for first 36 hours, slight temp, shivers, stomachache, red swollen arm from shoulder to halfway down to elbow. Thought feeling better by day 5, but last 2 days both calves started to ache a lot. Didn't sleep at night due to ache. Went to urgent care 10/3. Told Tylenol and stay hydrated, which didn't help. All side effects gone in 10 days.
fatigue; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for an unknown indication.    Concurrent medical conditions included Uterine cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 04-Feb-2021, the patient LENVATINIB MESILATE (LENVIMA) (unknown route) dosage was changed to 20 mg once a day. On 05-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and LENVATINIB MESILATE (LENVIMA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment medications were provided.   This case was linked to MOD-2021-111399.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional document was received on 07-MAY-2021. It contains identification number and follow up AER number. It contains non significant information.
During visit primary physician noted that he was cachectic, more confused and has been falling at home.  They have been trying outpatient management of his alcoholism but the patient is noncompliant. he has numerous electrolyte abnormalities and requires admission to the hospital for treatment. He should continue thiamine and increase oral intake.  Patient states he is going to quit drinking as he does not want to die and that this is motivation.   Patient has any electrolyte abnormalities resolved with replacement.  Should be monitored closely.   Patient had a neutrophilic leukemoid reaction though overall white count improved throughout hospital stay.  No signs of infection. ED to hospital admission within 6 weeks of receiving the COVID vaccine.
A report was received from a health care professional on 10/03/2003 concerning a 47 year old female vaccinee who experienced systemic skin rash, moon face, and eosinophilia requiring hospitalization one day after receiving Fluvirin on 09/24/2003.  The vaccinee has a history of hypertension and long term medication control, but no history of allergies.  Concomitant medications taken included nifedipine, irbesartan, acetylsalicylic acid, atorvastatin, allopurinol, and otenolol and chlorthelidone.  All were started at least one year ago except allopurinol which was started at the end of August 2003.  On 09/25/2003 the vaccinee developed a systemic skin rash which progressively worsened, moon face and eosinophilia.  The vaccinee was hospitalized on an unspecified date.  The vaccinee had not recovered that the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up to be requested: Diagnosis, treatment, date of onset of moon face and eosinophilia ? Outcome? The reporter has assess the relationship of the vaccine to the event as possible. Update 1, 23 February 2004: A follow up report was received from a distributor on 23 February 2004, which indicated that the vaccinee was dischaged from hospital on an unspecified date when her systemic skin rash was under control. The outcome of the moon face and eosinophilia was not reported. The batch number of the vaccine was also provided.
SWOLLEN ENLARGED LYMPH NODES DEEP IN UPPER ARM; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced swollen enlarged lymph nodes. Laboratory data (dates unspecified) included: Mammogram (NR: not provided) swollen enlarged lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen enlarged lymph nodes was not reported. This report was non-serious.
No Adverse Effect noted. Resident received expired Moderna vaccine, expired on 10/13/2021.
Redness and swelling at injection site, approx 2 days after receiving vaccine. 8 inch band around arm.
Patient called and stated she had a rash that she had tried to treat with benadryl.  the rash did not improve and in fact got worse.  The rash was in her hair and over her body.  She also had a fever of 101.5 and was concerned.  I asked her if anything had recently changed (medication, detergent, deodorant, etc) and she said no.  I asked her if she had any breathing problems and she said not yet.  I suggested she get checked out by a doctor since it had been 11 days and it was getting worse even though she was treating it.
Developed eryth. papular rash the day after receiving Pert/Pneu #2 - (R) thigh. Also occurred with 2nd set of shots.
Blurred vision, muscle & bone aches in most of the body, fogging brain, fatigue, & headache = 5/11/21   sick with very intense symptoms These same symptoms, much milder,  continuing most days, all day long since 5/11/21 and still present today 6/19/21
Heavy menstrual cycle post vaccine. I?ve had an ablation and I?m back to heavy periods that last 5 days
Itchy rash on nape of neck, right rhomboid/scapula area, and left hip. scaly. red spots.  The areas started pretty small - dime size and have grown to several inches is diameter.  Steriod creams makes it go away for 2 weeks. It comes right back.
exposed to COVID 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (Herself and her partner). This is 1st of two reports. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. It was reported that she and her partner received their first dose of the Pfizer COVID vaccine on 28Jan2021. Caller states they are both scheduled to receive their second dose on 18Feb2021. Caller states on this past Saturday night her granddaughter was there with them and she left this morning and her daughter called her and told her that somebody at her office tested positive for COVID. Caller states that someone who had tested prior and was negative also tested positive for COVID. Caller states she was unsure if her granddaughter being present in the house has exposed them to the virus. Caller would like to know if she should receive the second dose of the vaccine on 18Feb2021 if she was exposed to COVID 19. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201340 Same Vaccine/event, different  patient
An itch on the left side of his abdomen; A single 'hive'; This is a spontaneous report from a contactable pharmacist. An 86-year-old male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3247), via intramuscular route in the right arm from on 21Jan2021 08:00 (at the age of 86-years) as a single dose for COVID-19 immunization. Medical history included hypercholesterolaemia, hypertension, hypothyroidism. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (ATORVASTIN), metoprolol, levothyroxine sodium (SYNTHROID). On 21Jan2021 at 09:45, the patient developed an itch on the left side of his abdomen that became a single hive approximately 5 -10 mm. The patient was treated for itch and hive with levocetirizine 5 mg. The clinical outcome of the event itch and hive was recovered in Jan2021.
This spontaneous case was initially received on 28-Oct-2015. The case report was received from a Non Health Professional and concerns a 71 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Oct-2015 - 22-Oct-2015, Batch no: U50809, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 22-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Extremely tired/fatigue/Extreme tiredness, Have not been feeling good/feeling bad, Chills, Injection site was sensitive/injection site sensitive. Discontinued. For relevant test results see appropriate report section. Reporter's assessment: The reporter was not sure if these events were caused by AFLURIA.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Most likely toxin-mediated focal intertriginous bullous impetigo given stratum corneum on jelly roll procedure in a young otherwise healthy patient with normal renal function. Given the patient is afebrile and does not have diffuse erythroderma at this time, the likelihood of staph scalded skin syndrome is exceedingly low.  Also considered Stevens-Johnson Syndrome, which is also low on the differential given no observable mucosal involvement (assessment by ophthalmology and OB/GYN also showed no occular or vaginal mucosal involvement).
Narrative: COVID infection following COVID vaccine series 05/19 Janssen, dose #1 08/21 pt cc: myalgias, exposure: collegaue 08/24 COVID swab, result: detected 08/24 SARS-COV-2 Variant Sequencing result: pending
On 12/7/01, erythema with tenderness about 3-4 hours, post vax. Edema, erythema and tenderness continued the next day. Her husband came after pt and I checked affected area. There was firmness, edema, erythema and painful upon observance. Instructed to rest, elevate, use cold compress to area and seek medical care if conditions increase after 24 hours. Treated with anti-inflammatory RX. Telephone call to pt on 12/10/01 at 08:30 and pt completely recovered.
redness, pain, swelling at tetanus site started 6/26/08.  Bactrim DS called in.  Patient started it on 6/28.  Called in again on 3/30, sx still persisting.  appt scheduled for 6/30 to check on arm.
Fever day of vaccine; no fever in office at time of vaccination. Child appeared to be fine for next 3 days. About 3 days after 10/8, awoke with T 105, facial rash and left arm/shoulder pain. Seen in office 10/9 AM; lab evaluation. Transported to hospital. Care at ER and PICU.
wrist pain; wrist swelling; This case was reported by a pharmacist via call center representative and described the occurrence of wrist pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 12th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date the patient received 1st dose with no events.).   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced wrist pain and swelling of wrists. On an unknown date, the outcome of the wrist pain and swelling of wrists were recovering/resolving.   It was unknown if the reporter considered the wrist pain and swelling of wrists to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. The pain was alternate between left and right wrist. There were some improvement with events, at time of reporting. The reporter consented to follow up.
Onset of intense itching and acne-like bumps, primarily across back, up back of neck an above/behind ears.  Self treated with hydrocortisone.  This started to subside after about a week, but still not totally clear after 2 weeks.  Other than perhaps "stress rash" due to covid-induced lifestyle changes, it is not clear what may have caused this.
Information has been received from a licensed practical nurse concerning a 13 month old patient of unknown gender. On 22-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and routed not expected). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sore arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm on 29Mar2021 at 10:45 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 08:00, the patient experienced sore arm, headache and fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm, headache and fatigue were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hives developed 10/2/2015. Worsened over weekend.  Reported to urgent care on 10/5/2015.  Given 98mg Decadron via buttocks.  Symptom relief lasted 12 hours.  Symptoms returned 10/3 acutely.  Required emergency assessment due to chest pain on 10/8.  Adminstered EKG, prednisone, Zyrtec and Zantac by ER physician.  No heart issues on EKG.
Received 7 vaccines on 2/27/18. Reports not feeling well on 3/1 with redness, warmth, and pain in left arm. Redness reported as 6" elipse with redness extending to elbow. Reports 100F - 101F fever. Reports taking tylenol and ibuprofen intermittently with some effectiveness on fever.
2 wks post inject devel swelling all over body s/b MD-tested for lupus neg, decided to be virus
Post menopausal 2+ years, yet a few days after the 2nd COVID shot, I had a period for over 7 days.  Not 'spotting'; it required tampons with multiple changes throughout the day.  Also experienced shortness of breath for two weeks and fatigue lasting 5-6 weeks.
headache; muscle ache; mild intermittent cold; mild fever; Chills; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included infliximab (Remicade).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, myalgia, cold, fever and chills. On an unknown date, the outcome of the headache, myalgia, cold, fever and chills were unknown.   It was unknown if the reporter considered the headache, myalgia, cold, fever and chills to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient was on Remicade and wanted to know recommendation of acetaminophen or ibuprofen. The patent was a retired critical care hospital representative and realize legally can only advise accordingly. The reporter consented to follow up.
vertigo, room began spinning 8 hours after injection.  The info sheet handed out didn't mention the possibility of dizziness. If it had, I would have taken Meclazine as preventive given my history of BPPV and my risk of falling with osteoporosis. . The handout of what to expect only mentioned fever, body aches, chills, headache.
No additional AE details or PQC.; Inbound all from HCP stating VARIVAX experienced a supported temp excursion and then was administered to patients. No additional AE details or PQC.          ?    Names of vaccines involved (including lot/exp) VARIVAX T031383 09/15/2022        ?; This spontaneous report has been received from a medical  assistant referring a patient of an unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's medical history, concurrent conditions and drug reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number T031383 expiration date on 15-SEP-2022 for prophylaxis (strength, dose, frequency, and route of administration were not reported) that underwent a temperature excursion of 9 fahrenheit for 3 hours 50 minutes (product storage error). No additional adverse events were reported.
Sever Indigestion; vomiting for a month after the vac.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Sever Indigestion) and VOMITING (vomiting for a month after the vac.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history provided by the reporter. .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPEPSIA (Sever Indigestion) and VOMITING (vomiting for a month after the vac.). At the time of the report, DYSPEPSIA (Sever Indigestion) and VOMITING (vomiting for a month after the vac.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No other concomitant medical  provided by the reporter.
At 1047 patient reported back to the clinic that she was having difficulty swallowing. Angioedema present. 1048 Patient was given albuterol 2.5mg witth ipratropium 0.5mg nebulizer treatment. At 1049  Benadryl 25mg IM in right deltoid. 1053 BP 134/90 96.4 98% on breathing treatment. 1054 BP 131/90 HR 120. 1100 Benadryl 25mg IM repeated in right deltoid. 1112 137/92 HR 102 POX 100% on Room air. 1116 167/100 HR 104 POX 100% on room air. MD and pharmacist arrived. 1130 Patient given 2 tablets of 4mg (8mg) of Medrol . 1200 BP 128/86 HR 97 POX 98% Remained in clinic until 1230. Rx for medrol dose pack given.
Sore throat beginning 10/7 and resolving  around 10/10.  Developed head and chest congestion on 10/9. Mostly resolved around 10/22.