chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26 hours after injection, the person had hives on bilat upper ext, pt's back had some redness
dose #2 02AUG22, #1 given MAR2020; headache; fatigue; brain fog, believed it was COVID; inflammation; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Shingrix. In March 2020, the patient received the 1st dose of Shingrix. In March 2020, 8 days after receiving Shingrix, the patient experienced headache, fatigue, foggy feeling in head and inflammation. On 2nd August 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, fatigue, foggy feeling in head, inflammation and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, fatigue, foggy feeling in head and inflammation to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter's comment: The patient stated that on the day of reporting, he received 2nd dose of Shingrix in left arm.  8 days after the 1st dose of Shingrix, the patient experienced headache, fatigue, brain fog and inflammation.  The patient believed it was Covid but he tested negative.   Spoken as per content and was sending package insert.  Referred to health care professional. Did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Erythema at injection site and distally. Provided Keflex for cellulitis.
1st dose on 2-sep-2021, has not received 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix more than six months ago. The patient asked did he/she need just another booster or did he/she need to start the series again with a first shot and then a booster within 6 months. The patient also stated that GlaxoSmithKline information indicated that the booster should be given between 2-6 months after the first dose, his/her question was what should he/she did now that the six month window has passed.  Additional supportive information:  Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Patient was given Pneumovac here 10 October 2013 and called on 11 October 2013 with redness, hot to touch at injection site. Patient went to ER and was treated for cellulitis with 2 doses IV abx and PO abx for 1 week at home.
Bloating & gas pain in the abdomen.  Began 18 hours after injection and has lasted 24+ hours now. Joint pain in the hips. Began 18 hours after injection and has lasted 24+ hours now. Local pain at injection site. Began 12 hours after injection but subsided 24 hours after.
Heart attack-like symptoms; 100 degree fever lasting one day with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on an unspecified date (Batch/Lot Number: ER8737) as 2nd dose, single dose for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient has no known allergies. The patient received the first dose of BNT162B2 on 24Mar2021 15:30 on the right arm (lot number: EN6205) for COVID-19 immunisation. The patient did not have other vaccine in four weeks and no other medication in two weeks. The patient did not have COVID prior to vaccination. The patient was not COVID tested post vaccination. On 29Apr2021, the patient had a 100-degree fever lasting one day with no symptoms. The patient was fine the next day. Then on 02May2021 at 20:00, she began having heart attack-like symptoms. She went to the ER and was having a heart attack. All of her testing from her angiogram to her chest x-ray to the CT of her lungs found nothing. She was a 100% healthy without any medical issues. She has no prior history of heart problems. The patient was hospitalized for a day for the event heart attack-like symptoms. Treatment included angiogram, chest x-ray, lung CT and blood thinners. The patient was recovering from heart attack-like symptoms and recovered from 100 degree fever.
Immediately after injection patient was light headed, drowsy, nauseous. Patient was given water and glucose tabs (potential low blood sugar) and rested with head down. Even after rest patient still complained head was "fuzzy" and seemed dazed. EMTs were called and patient was taken to local hospital for follow up care.
Unknown if the vaccine has any correlation to event. Patient was found unresponsive and not breathing on 4/11/21 @ approximately 3:45 PM outside on the grounds of the campus. A rented scoter was next to him. There was no sign of trauma. 9-1-1 was called and CPR initiated by passerby (there were no witnesses). He remained unresponsive and was intubated when the paramedics arrived. He was transported to hospital where he was pronounced dead.
Orbital edema; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown) via intramuscular in the left arm on 02Mar2021 09:00 AM at age of 51 years old at single dose for COVID-19 immunisation. Medical history included goiter, allergies to Sulfa. There was no covid prior vaccination. Patient was not pregnant. Concomitant medication included other vaccine in two weeks estradiol, norethisterone acetate (COMBIPATCH). Patient experienced adverse event included orbital edema on 04Mar2021 02:00 AM. Patient had doctor or other healthcare professional office/clinic visit. Patient received treatment with prednisone for event. There was no covid tested post vaccination. Outcome of event was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported orbital edema cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Severe soreness in injection site, dry heaves/nausea, fever, chills, body aches, headache, dizziness and fainting.  Fainting occurred after feeling nauseous and significant pain and pressure in head.  Passed out on floor after falling into a dresser.
Severe bruising around shot site. Extremely sore arm for a month after receiving first shot.  I am post-menopausal. I experienced heavy, thin, bright red bleeding both rectally and vaginally for 3 days and nights, once in May and again in July. Severe, constant sinus headache in middle of forehead coupled with brain fog and blurred vision (just started clearing  up in Jan 2022). A few instances of severe vertigo. Moderate throat swelling during the night for a few days.
I received my second vaccine on 03-15-2021. My shingles became more irritated. I apply a topical cream that soothes the burning sensation. I also noticed a lot of sweat profusely after my second vaccine. I sweated a lot, then my sodium level went down. I went to the hospital (in July), and I was there 4 days due to my potassium level. I also felt so tired. My sodium level was 110 and I was delirious when I went to the hospital. Today I still have the shingles on my back, and they hurt me a lot, and they irritate me so much. I do not have the lot# to provide.
Fever; chills; This is a spontaneous report from a Non-contactable Pharmacist (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN5318), via an unspecified route of administration on 01Feb2021 at 10:30 AM (at the age of 31-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) received on an unspecified date at single dose. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included anxiety and known allergies to Sulfa. The patient received no concomitant medications. On 01Feb2021 at 20:00 the patient experienced fever and chills. No treatment was given for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Patient is admitted into the hospital. Shortness of breath. weakness Symptomatic 5 days ago.
sick; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media. This case involves an adult patient with an unknown demography details who was sick (malaise), while being received vaccine influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  In approximately 1980 (40 years ago), the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unspecified date, (latency: unknown) after starting the suspect vaccine therapy, the patient was sick (malaise) for 3 weeks. Never got another one and knock on wood he didn't have the flu either.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
Extreme fatigue, chills, joint pain, muscle aches, fever, headache, pain at injection site
first dose in 2019, has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient received the first dose of Shingrix and had not received dose two. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, 2nd dose of Shingrix was not received by the patient, which led to incomplete course of vaccination.
Hep A was given to a 6 month old female during her routine well child check.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (injection, lot#, dose and route were not provided). No adverse symptom was reported. The temperature excursion with VARIVAX (Merck) was found to be a supported excursion with in-house stability data. Additional information has been requested.
Started with headache, body aches.  Then really bad chills with uncontrollable trembling/shivers.  Fever of 103 degrees, bad headache.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 21-AUG-2012, was vaccinated with a dose of ZOSTAVAX (lot number 670547/0659AA) (dose and route not reported) that was expired. The vaccine expired on 04-AUG-2012. No symptoms were reported. Additional information has been requested.
Pfizer Dose 1 3/11/21 (EN6204) Pfizer Dose 2 4/2/21 (EN6198) Pfizer Dose 3 10/26/21 (FF2593) COVID Positive 1/26/22  1/26/22: A 74-year-old female with past medical history of chronic atrial fibrillation on anticoagulation with Coumadin, hypertension, stage III CKD, CAD, PAD, chronic HFrEF, COPD not on home oxygen, hx ppm implantation is sent to ED by ambulance from nursing home for generalized edema.  Patient states that she does not remember why she is sent here but she states she was kept on oxygen at the facility.  At this time she feels much better, denies chest pain or shortness of breath, feels tired and weak.  As per the EMR she was blood culture generalized edema, she was saturating 93% on 2 L oxygen.  Patient is vaccinated for COVID-19.  She was recently discharged from the hospital on 01/21/2022 after she was treated for dehydration, diuretics were held at that time.   In the ED, she was afebrile, pulse ox 96 on room air, blood pressure stable.  Blood work is significant for mild elevation in BUN and creatinine, leukocytosis, elevated proBNP, with mild lactic acidosis.  Urinalysis positive for nitrate.  1/31/22: Patient was admitted and started on IV diuretics as well as empiric IV antibiotics.  She was diuresed and given increased doses of Coumadin for subtherapeutic INR and developed supratherapeutic INR.  Did not diurese well on intermittent IV Lasix and was switched to a Lasix infusion on hospital day 3. Urine culture was negative and antibiotics were stopped.  She was continued on the Lasix infusion.  Lasix infusion was stopped on hospital day 5. She was noted to have increasing confusion and CT head was obtained given her supratherapeutic INR and returned negative.  At approximately 6:55 a.m. in the morning on hospital day 6 she was found to be unresponsive and apneic and a code was called.  ACLS was started and patient received multiple doses of epinephrine and was intubated by the ED physician.  ROSC was obtained and she was transferred to the ICU, she soon went into PEA arrest despite being on 2 pressors and ACLS was resumed.  A pulse was not obtained after the 2nd arrest and time of death was called at 8:02 a.m. on 01/31/2022.  Pupils were fixed and dilated and no heart or breath sounds were present.
fatigue; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A or 0BM20A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) and COLECALCIFEROL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL, RIBOFLAVIN, VITAMIN B1 NOS (MULTIVITAMIN [COLECALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 experienced FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches). The patient was treated with HYDROCORTISONE, LIDOCAINE HYDROCHLORIDE (LIDOCAINE/HYDROCORTISONE) for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.            Treatment medications included antibiotic. No historical condition was reported.   This case was linked to MOD-2021-404412, MOD-2021-404309 (Patient Link).
Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; lot number C3177AA received on 17 March 2009, lot number C3305AA received on 04 June 2009, lot number C3431AA received on 07 August 2009 and lot number C3590AA on 17 August 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 11 June 2012, approximately 22 months after the last dose. On 18 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Redness, pain, hardness in the area, warm to the touch (all symptoms worsening)
HIGH FEVER; ACHY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced high fever. On 08-MAR-2021, the subject experienced achy. Laboratory data included: Body temperature (NR: not provided) 102.3 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, and achy. This report was non-serious.
Pt exp sx similar to pts who were dx w/fibromyalgia; details of these sx @ time o of the report were unk; No further details were provided;
Shivering and shaking, hot and cold flashes, fatigue, achey, whole body was sore and could hardly move.
Extremely heavy periods (soaking more than 1 pad plus tampon per hour) and heavy uterine bleeding outside of normal period.
Within 4 minutes of getting her second dose she complained of tingling from head to toe, feeling as if something was caught in her throat, chills and shaking
Unconsolable crying, abnormal EEG  Nurse follow up on 06/18/04 states: "ADD: Irritability, elevated urine amino acids."
April 29th patient started having ear pain and pressure in left ear.  May 6thsaw urgent care for pain and started antibiotics.  May 9th returned to urgent care after no improvement.  Mild dizziness started May 9.  May 10th went to ED for severe persistent vertigo, was discharged home.  Saw ENT May 11th and received diagnosis of Ramsey Hunt Syndrome.
positive sar covid test; positive sar covid test; This is a spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter in crosslinked case. A 67-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 23Feb2021 (Lot Number: EL9267) as DOSE 2, SINGLE and dose 1 intramuscular, administered in arm Right on 02Feb2021 (Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. Medical history included ongoing High blood pressure. Concomitant medications included lisinopril taken for hypertension from an unspecified start date and ongoing. On 26Jul2021 the patient experienced positive SARS-CoV-2 test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. The clinical outcome of the event positive sars covid test (COVID-19) was recovered on an unspecified date in 2021.  No follow-up attempts possible. No further information expected.
Patient hospitalized for cesarean delivery within 6 weeks of receiving COVID vaccination. Baby was breech presentation. "She advanced as anticipated and was discharged home in stable condition on postop day #3."
Case number PHEH2014US022447, is an initial spontaneous report from a medical assistant received on 06 Nov 2014. This report refers to a 7-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1413901) intramuscularly at a dose of 0.5 ml that was stored at a temperature of 31 F-47 F for two weeks from a multi vial dose on 01 Nov 2014. No adverse event reported.