chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: Ring of red, painful blistered skin around the injection site, progressing to scabs during healing process.   Time-course: Symptoms first noticed upon removal of injection-site band-aid the morning after injection (under 24 hours).  Subsided without treatment.  Blistering took about 7-10 days to fully heal.  Blisters remained open for about 1-2 days after first being noticed.
77 yo Female, living alonge; no health issues or major health hx; was given shingles vaccine on 8/9/2021 at 2:45pm.  She felt fine afterwards, went to bed as normal. Woke up around 8:30 am on 8/10/21 with no issues.  After about 30 minutes, she felt nauseous. She went to the kitchen to get some soda and then passed out for approx 20 minutes; when she regained consciousness, paramedics were called and she was taken to the hospital; she suffered a 3.5 inch cut to the back of her head and a subdural hematoma.
BLOOD SUGAR ELEVATED/BLOOD SUGAR READINGS REMAINED FAIRLY HIGH; SORENESS IN HANDS/ SLIGHT SORENESS; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included flu shot in fall.  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 30-MAR-2021 on arm (deltoid) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced blood sugar elevated/blood sugar readings remained fairly high, and soreness in hands/ slight soreness. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in hands/ slight soreness and blood sugar elevated/blood sugar readings remained fairly high was not reported. This report was non-serious.
Booster dose administered one month early/Patient was administered the booster dose after 5 months; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered one month early/Patient was administered the booster dose after 5 months) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered one month early/Patient was administered the booster dose after 5 months). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose administered one month early/Patient was administered the booster dose after 5 months) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.
A few minutes after the shot i started getting dizzy. it increased with intensity so i flagged down an attendant for help. I started feeling weak and tired.  I went unconscious during which time i was told my breathing was irregular.  I think i was unconscious for 2 or 3 minutes.  I woke confused,  shortly after i woke the medic showed up to my care.  He took my heart rate and check my blood sugar.  He said my vitals looked ok. He asked if i was feeling better.  I was still very dizzy and nauseous.  i sat in the parking log for awhile before driving home.  I got home and went to bed slept most of the day.  I had a fairly bad headache the rest of the evening and a slight nauseous feeling.  The next morning i still have a slight headache still feel slight nausea but not bad.
I was feeling chilly and I went to bed early and got under the covers. At 3 in the morning, I had a fever - 99. something and aches and pains. I took ibuprofen. I got up at 7:00 am and my temperature had gone up to 100 something. My body ached really bad. It ached all day long ( and fever continued) and it felt like I had a really bad flu. I called my doctor (telemed appt) and she thought it would be over by 24 hours. It did go away after 24 hours.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Patient details was added.
As soon as the dose was administered the patient complained of pain. The dose was already administered and the needle was removed. I asked her if that had ever happened before, she said no, and that it wasn't from the needle, it was from the serum. She said it felt like it was tearing the muscle apart. I requested the patient stay seated with me. About 5 minutes later, I asked the patient to move her arm around, while moving her arm, she stated her elbow was a little tingly, but that passed quickly. About 15 minutes later, around 12:15 pm, the patient stated the palm of her hand was sore and tingly. Pt otherwise okay.
Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber ad expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine. The patient previously took morphine, and had allergies; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization, and had polymyalgia rheumatica, RS3PE, elevated ESR and elevated CRP. On an unspecified date in 2021, after the second dose of vaccination, the patient's developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened. The reported events have resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized on an unspecified date in 2021 for two days due to the reported events. The patient had received methylprednisolone (MEDROL) and prednisone as treatment for the reported events. The outcome of the events, 'developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had a nasal swab test in Mar2021 that was negative post-vaccination.  Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible temporal association, a causal association between the reported 'polymyalgia rheumatica and RS3PE including elevated ESR and CRP ' (aggravated, already reported after the first dose of vaccine) and BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Fever, diarrhea, severe chills, discomfort lasting 5-7 days
SIDE EFFECTS HAD BEEN HORRIBLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced side effects have been horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects have been horrible was not reported. This report was non-serious.
I had a sore arm for several days and itching. Very tired for a week. But last night I got a ring around the injection spot and pain in my lymph nodes under my arm. The injection site has also been hard and swollen.
Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid; Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL1283, Expiration Date: 30Apr2021), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021), in left arm and on 22Sep2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Caller completed her first, second, and booster dose of Pfizer covid vaccine/testing positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: The caller is a consumer who tested positive for Covid last Thursday. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with Paxlovid.  Clinical course: The patient did not received other vaccine on the same date as of suspect vaccine. The patient did not receive any other vaccine within 4 week to covid vaccination. The NDC number was unknown.  No follow-up attempts are possible. No further information is expected
Case number PHEH2014US004488 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 AUG 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Following an internal review on 18 AUG 2014, of the data received on 03 MAR 2014: It was identified th the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured  as  listed and hence the labeling  was now changed as  unlisted and added second indication off label use was added to case.
Patient said night after getting FLUVIRIN shot he felt lightheaded, dizzy, nauseous and even blacked out very briefly. Still feeling nauseous the next day. When moved head one direction. Spoke to patient 3:30 pm 10/27/13 patient feeling much better BP has been high for him 153/89.
I received a flu shot at this clinic on Nov 9, 2007 and 2 weeks later my hands started becoming numb, then my arms and by the next morning my legs were. I became very unstable on my feet, decided to go to the emergency room. I could not even lift my legs or arms to dress myself at this point so a family member hadto dress me. When I reached my front door, my legs gave out and I collapsed. Not able to stand back up, my husband called 911. In the emergency room I was given many test and a Neurologist was called in. He gave me some test and said I had Guillain Barre Syndrome. He gave me some sort of infusions in my IV to start reversing the adverse reactions of the GBS {18 bottles of this, I think} given only at night. I was in the hospital 23 days, receiving therapy daily. After being discharged from the hospital, I had in home therapy because of the paralysis to learn to sit, stand then walk all over again. I couldn't do much of anything for myself for literally about 5 months.  8/24/09 Hospital records recieved DOS 11/21/07 to 12/02/07. Assessment: Guillain-Barre. Acute inflammatory demyelinating polyradiculoneuropathy. Peripheral Neuropathy. Gastrointestinal reflux disease. Insomia. Obesity. Dependent on assistance for activities of daily living. Melanosis coli from chronic laxative use.  Patient felt her body start to tingle, weakness, could not stand up. Presents with difficulty with speech and vision. Tingling in hands. Rapid ascending paralysis, areflexia, and upper respiratory tract infection. IV immunoglobulin administered. C/O pain and anxiety. No bowel movement and has not slept for 11 days. Throbbing leg and back pain.
PATIENT IS 14 YEARS OF AGE AND RECEIVED THE PFIZER COVID 19 VACCINE
Immediately after my first of three anthrax shots I had muscle cramps, sore joints and muscles that continue to persist more than a month after the last shot. No treatment.
Patient felt dizzy, lightheaded, had chills, and a headache about 5-10 minutes after receiving her vaccine.  Her feet were elevated, blood pressure taken (87/76), temperature  taken(95F) at 5:15pm.  She was given a cold compress.  Since she hadn't eaten for several hours, she was given some orange juice.  After approximately 10 minutes, her blood pressure was taken again and it had elevated (98/76).  The patient said she felt better and was able to get up and move around without any other symptoms.  She left with her mother at 5:38pm.
Information has been received from a licensed practical nurse concerning a 37 year old female with no drug allergies who on 3/10/06 was vaccinated IM with a 0.5ml, first dose of Pneumococcal 23v polysaccharide vaccine (651320/1009P). Concomitant therapy included bupropion HCL Wellbutrin, fluticasone propionate + salmeterol xinafoate Advair and albuterol sulfate Proventil. On 3/10/06 the pt arm became swollen, red and warm to touch. The pt also experienced flu like symptoms and vomiting. The pt sought unspecified medical attention. At the time of the report, the pt was recovering. Additional information has been requested.
Reaction to MMR - 11cm x 9 cm area of erythema/mild edema, mild tenderness to palpation. Benadryl q 6-8 x 72 hours.
Patient broke in hives after receiving influenza vaccine. Rash decreased by ~70% within 4 hours. Discharged with medal dosepak on same day.
patient called on 02/11/20 , 1 day after getting shot, that she could not lift her arm. she was advised that it should sub-side in a day or 2. patient called back again on 02/17/20, she still could not raise her arm. and it was only 10% better than what it was on 02/11/20 when she called on it 1st time. patient has reached out to there md and awaiting respone
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 02-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
On evening following vaccine mother noticed raised  large red  hives on upper back extending to shoulder.  No tich and no fever noted . All redness and rash above bra line and no other parts of body. by 080907 decreaed redness and less raised welts. no itching and no other complaint. no previous dose of this vaccine
All of her skin peeling off; This case was reported by a pharmacist via call center representative and described the occurrence of skin peeling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The pharmacist reported that the patient experienced all her skin peeling off following a dose of Shingrix. The health care professional reported no additional details about the event.
Accompanied by Dad today (1-22-13) for (L) thigh knot onset since 1-15-13 after vaccination when home, has not worsen since onset, denies fever / redness / bleeding / drainage / irritability / change in activities. Monitor if worsen to f/u / ER. Initial eval today from sxs onset - f/u with mom on phone on 1-24-13 - improving. 1 cm superficial lesion - round - palpable. Superficial hematoma from injection site with the recommendation to massage area and cool compress for 20-30 min. period every 4-6 hour as needed. Observe for any redness, soft tissue swelling, worsen pain with irritability and/or changes in activities / appetite to call clinic and/or ER A.S.A.P. Counseled.
This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of PROQUAD (Merck) (Lot # not provided) which were exposed to unknown temperature conditions, had been administered to unspecified patients on unspecified dates since November 2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022).    No concomitant medications was reported. The patient received half dose of Moderna vaccine. They administered the vaccine to 346 patients after the 30 days by used and total Number of vials was 35. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected. No treatment medications was reported.
This spontaneous report as received from a physician refers to a 16 weeks old male patient. "Last week" in September 2012, the patient was vaccinated with the first dose of ROTATEQ (Lot#, dose and route not reported) along with other unspecified vaccines that were normally given for a 4 month old well visit. The patient was not experiencing any known symptoms. It was not known if the patient sought for medical attention. Additional information has been requested.
pt recvd vax;BP nl 130/80;shaking,nervous;graish color, confused;hands swollen;epi given;ativan prescription;events started w/in 5 mins of vax;
Pt. had gradually worsening redness, swelling, and pain at injection site.  She developed fever 2 days after injection and was seen in local ER.  She was admitted for presumed cellulitis and treated with IV antibiotics.  She improved quickly with antibiotics.  She received just one dose IV and the remainder orally.  Her symptoms resolved completely with 10 days oral Keflex.