chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 23Aug2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not aware of having any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication within two weeks of vaccination. On 25Aug2021 at 09:00, the patient experienced dizziness. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event dizziness was resolved on 25Aug2021.   No follow-up attempts are possible. No further information is expected.
Headache, Fever, uncontrollable shaking, chills, muscle aches Narrative:
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
A few weeks after the second dose my daughter got a white patch of skin on her vagina.  At first it was treated as a yeast infection but that treatment did not work.  She was just diagnosed with vitilago which is an immune disorder.  We do not have any vitilago in our family history and it came a few weeks after the second dose.  Vitilago is when the immune system attacks the wrong cells.
After I received my shot my arm started hurting for 2 weeks. I received really bad migraines and  I was taking Tylenol every other hour.
Had a Headache but went away after taking Tylenol; Dizziness but now can describe as slight; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had a Headache but went away after taking Tylenol) and DIZZINESS (Dizziness but now can describe as slight) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Had a Headache but went away after taking Tylenol) and DIZZINESS (Dizziness but now can describe as slight). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Had a Headache but went away after taking Tylenol) had resolved and DIZZINESS (Dizziness but now can describe as slight) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included dizziness patch.
HIGH FEVER; UNRELENTING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced high fever, and unrelenting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and unrelenting headache was not reported. This report was non-serious.
Breastfeeding after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for an unknown indication.    Co-suspect product included non-company product PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    The patient's past medical history included No adverse event (No reported medical history).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding after receiving the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
approximately one week later patient is experiencing strong soreness along with hot, red erythema along the entire upper arm area from deltoid to elbow
Patient developed a reaction two hours after receiving ZOSTAVAX, FLUZONE HD and PNEUMOVAX 23. She had no reaction to the ZOSTAVAX but her right arm where she received the flu and pneumonia shots had a fist sized red, tender area around the injection site. She also reported fever, nausea, and her throat was swollen.
Developed rash on 06/30 that started on her abdomen, then spread to behind the knees, up her legs, with a mild amount a rash on her back and her forearms, left greater than right.  Rash is not itchy, peaked around 7/9 and is slowly improving.
Mild to moderate cellulitis at and distal to the injection site, covering an area approximately 4" X 2".  Swelling, erythema and heat present, but no visible pustules or other signs of infection.  Mildly pruritic.    Signs began approximately 24hr after the injection, and progressed for the next 48hrs.  Patient is currently 5 days post injection with no signs of improvement.
C/o swelling and discomfort after imms. Sx decreased by day 3 after imms.
Long haul bronchitisis; the patient experienced Covid; COVID; Arm sore after first covid vaccination; Got big red rash afterward; Got big red rash afterward; Flu like symptoms; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168977-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 13Sep2021, outcome "recovered" (2021), described as "the patient experienced Covid"; DRUG INEFFECTIVE (medically significant) with onset 13Sep2021, outcome "unknown", described as "COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; BRONCHITIS (non-serious) with onset 04Oct2021, outcome "unknown", described as "Long haul bronchitisis"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Arm sore after first covid vaccination"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Got big red rash afterward". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown result. The action taken for risankizumab was unknown.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, was not provided.  Causality for BNT162B2 The reporter's assessment of the causal relationship of the event(s) of covid, flu like symptoms, long haul Bronchitisis, arm sore after first covid vaccination/got big red rash afterward/ache and shoot out pain onset in Apr2021, with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events COVID-19, Drug Ineffective, Influenza like illness, Bronchitis, Vaccination site pain, vaccination site erythema, vaccination site rash and the suspect drug BNT162B2.
Headache start early in the morning 3 to 4 AM daily, taking Tylenol seems to clear after about 2 hours. and then comes back in the afternoons around 1PM take more Tylenol, feels like a cluster headache.  Last for 9 days
then my son came down with the covid on the 15th of March and then I came down withit 6 days later; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program Pfizer Rx Pathways. A 69-years-old patient (gender unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 11Mar2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the first Pfizer shot on 11Mar2021 but then his son came down with the covid on 15Mar2021 and then patient came down with it on an unspecified date in Mar2021 (6 days later). Patient had a covid test on the 25Mar2021 and the Doctor told he could get the second shot after the 14 days. So, patient was hoping he can get the second shot today. The reporter was not the prescribing HCP. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received shingles shot a day before reporting and experienced sore arm and he felt like he had flu like symptoms. The reporter wanted to know how long patient's arm would be sore and also about the flu like symptoms. The patient did not have time for providing additional details. This case has been linked to the case US2018GSK216566, reported by the same reporter.
Initial report received from a healthcare professional on 24 June 2013. A patient whose, age gender, medical history and concomitant medications were not reported, had received an intramuscular dose of DAPTACEL (lot number was not reported) in bicep on an unspecified date. The patient had received DAPTACEL possibly into bicep of deltoid thus the vaccine was administered at an inappropriate site. On an unspecified date, after vaccination, the patient developed diminished arm movement. Relevant laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: None.
Hives; Extreme Body aches; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS) (Unidentified Immune condition). Concomitant products included HYDROXYCHLOROQUINE for Immune disorder (NOS).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), MYALGIA (Extreme Body aches), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            The patient reported that unidentified immune condition that was treated with steroid medication (unspecified). The patient treated the events by taking anti spasmodic (unspecified) and over the counter medications (unspecified).
Headache- began at 8pm the day of vaccination and has continued through present 4/17 at 11 am Fever- began at 3 am 4/16 and continued through 1 pm of 4/16. A slight fever again early morning of 4/17.  Body aches/ muscle and joint soreness- began early morning of 4/16 and have continued through 4/17
I am postmenopausal, yet this last week has been horrific.  I am experiencing night sweats worse than anything I went through with Menopause.  Last night was the worst one yet.  It affects my sleep, my migraines, and I can barely get up in the morning to go to work.  This is just nuts.  There was not list of any side effects relating to hormonal changes!
Patient complained of low grade fever, aches, and fatigue.  Symptoms lasted around 48 hours.
Case was vaccinated x2 for Covid by APril 2021, Then was hospitalized for Covid in January 2022. Hospitalized at: withheld Admitted to hospital for Covid pneumonia w/ Cough, dyspnea and diarrhea, requiring oxygen. Treated with Dexamethasone, Remdesivir and barictinib. D/c'd to home on Oxygen.
Rash, fever, headache, vomiting, left arm soreness, stiffness, and tingling
Information has been received from a physician concerning a 15 month old female no pertinent medical history, drug reactions or allergies who on 03-APR-2008 was vaccinated subcutaneously with a first dose, 0.5ml of MMR (Lot #657118/0865U). There was no concomitant medication. On 15 APR 2008, the patient developed a red, generalized rash, for which she was seen "in the office" the following day (16 APR 2008). There were no lab diagnostic studies performed. At the time of reporting the patient had not yet recovered. There was no product quality complaint. Additional information has been requested.
This is an observational study case initially received from other health professional on 17-Jan-2019, concerning a 35-year-old adult female pregnant subject enrolled in a prospective observational safety study. The subject had no maternal and paternal history of major congenital malformations. The subject had no history of offspring with major congenital malformations. The subject had 1 previous pregnancy which got spontaneous abortion. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Prenatal vitamins [minerals nos; vitamins nos] for pregnancy. The subject's pregnancy complication (risk factor) included advanced maternal age. The subject's last menstrual period (LMP) was on 05-Sep-2018. The type of pregnancy was singleton. On 29-Oct-2018, the pre-natal tests, the ultrasound was performed, the results showed no congenital malformation. On 05-Nov-2018, at gestation age of 08 weeks (first trimester), the pregnant subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF41708, dose, route of administration, anatomical location and expiry date: not reported) (coded as vaccine exposure during pregnancy) for an unknown indication. On 12-Nov-2018, the blood work (PNBW) and cystic fibrosis mutation analysis were performed, the results showed no congenital malformation. On 26-Nov-2018, 21 days after vaccination, the subject developed subchorionic hematoma. On 10-Dec-2018, the subject had recovered from the event subchorionic hematoma. The estimated date of delivery was reported as 12-Jun-2019.; Reporter's Comments: A 35-year-old pregnant subject with history of previous spontaneous abortion experienced subchorionic hematoma, 21 days after receipt of study vaccine (considered as vaccine exposure during pregnancy). Despite plausible temporal association of the event subchorionic hematoma to vaccine administration, there is no evidence for a biological mechanism that could cause the event and other factors such as patient's age and an early stage of pregnancy (both increasing the risk) and pregnancy history of spontaneous abortion provide a more plausible explanation of the event. Hence, causality assessed as not related to study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event drug exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The sponsor assessed the events (subchorionic hematoma) as serious (medically significant).
Pt. had a severe crying episode, crawled into a ball and was extremely upset. Temp 98.6, lungs clear, called Dr. who ordered 25 mg BENADRYL liquid by mouth at 5:30 P.
Patient took 1 capsule of VIVOTIF EC and experienced stomach pain for the next day. Patient's mother contacted Prescriber who discontinued the remaining doses upon hearing about the adverse event.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: pt had a seizer less than 1 minute after receiving the flulaval in the right arm. before that she received, Pfizer bivalent covid 19 in the left arm. pt reported she was dizzy, then began to seize in the chair. she urinated on herself and lost consciousness for about 15 to 20 seconds. when i called EMS and was on the phone with them she seized again for 15-20 seconds. EMS took over and took patient to hospital and was given vaccine record to be presented to er doctor.
Mild lump at injection site, non-tender, no erythema or drainage, no sign of infection. Warm compress prn for mild lump at vaccination site
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender who on 13-NOV-2013 was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, route and lot # number not provided). No adverse effects were reported. Additional information has been requested.
Husband called pharmacy at 7:30p on 1/29/18 and reported patient's arm still red where shot given.
Pain, large area, 10 cm of redness then tenderness. Now Rt arm/shoulder area is so painful she can't sleep. Saw an orthopedic who states the pain is most probably due to flu shot. Going to physical therapy.
Patient presented for 2nd dose moderna bivalent. Pink cap vial was used instead of blue cap vial. This resulted in patient receiving a lower than recommended dose. Patient received 10 mcg of bivalent moderna instead of 25 mcg.
Moderna COVID?19 Vaccine EUA given on 12/26/2020 - No allergic reactions or any expected side effects , except for localized dull back pain in the lumbar region.  Eleven days after vaccination (01/05/2021) the pain remains constant.  Patient is certain no physical activity or unrelated event caused the back pain. Primary care physician is not  knowledgeable if Covid 19 vaccine can cause such pain. Patient was referred to PT and/or acupuncture.
TC from PMD office on 4/28/05 informing on call nurse that my son had a red, swollen left arm to the elbow. Hot to touch. Diagnosed by PMD as cellulitis. TX: Rocephin and Keflex.
SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2U6A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 19-APR-2021, the subject experienced shortness of breath. On 19-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.