chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her husband got infected from Covid 19 that week she got the vaccine;She also got infected; her husband got infected from Covid 19 that week she got the vaccine;She also got infected; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 28Mar2021 and her husband got infected from Covid 19 that week she got the vaccine. She also got infected because of living in the same place and she got fever, pain in her body and malaise but she mentioned that her symptoms were mild. She has an appointment on 18Apr2021 for the second dose and she wanted to know if she should go to get the vaccine.  Information about lot/batch number has been requested.
A few hours after administration, employee experienced pain at injection site, worsening upon movement. Pain on a scale of 0-10 was a "5" lasting 24-48 hours. After that and through today, pain in a "3". It wakes her upon sleep when rolling onto that side (L). At rest, there's no pain today. Movement elicits pain.
Patient was meant to receive the updated Bivalent Booster, instead the patient received the regular booster.
@am Sun morn woke up couldnt get out of bed 2am felt like covid all over again fever, weakness, slept till6pm on Sunday  had been  in hosp in Dec for a week with long term covid. Spent Sun and Mon in bed up Tues, weak head going in circles.  Today, Wed is first  day ive felt like doing  anything  Daughter had to help me out of bed Sun and Mon just couldnt stand up.
Information has been received from a physician concerning a 65 year old female with drug reaction/allergy to Tiazac, Ultram, Diflunisal (MSD) (WAES # 0811USA01605), Cymbalta, Enablex, Lyrica, Mobic, Coreg, Topamax and Keppra who in approximately 2007 (reported as "approximately one year ago") was vaccinated with ZOSTAVAX. Concomitant therapy included Cardene, MSD, Vagifem, Atrovent, MSD, Astelin, Nasonex, Celebrex, Restasis, Cafergot, Midrin, Reglan, Lamictal, Lidoderm, vitamin A, vitamin D (unspecified), glucosamine, fish oil, folic acid, omeprazole and guaifenesin. The physician reported that on approximately 23-OCT-2008 (reported as "2 weeks ago") the patient was experiencing a mild case of shingles. At the time of reporting the patient had not recovered. No labs/diagnostic tests were performed. The patient sought medical attention: was seen by the physician. There was no product quality complaint. Additional information has been requested.
Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The reporter stated that lot of patients had reported pain after receiving a dose of Shingrix.
received a 3rd dose on shignrix today on 08/24/2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shignrix (first dose was on 3rd January 2022). Concurrent medical conditions included diabetes. Concomitant products included Herpes zoster (Shingrix).   On 24th August 2022, the patient received the 3rd dose of Shingrix. On 24th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) reported that a patient had received a 3rd dose on Shingrix today (day of reporting) on 24th August 2022.  The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received his 3rd dose, which led to Extra dose administered.
Unable to sleep, legs thrashing. Symptoms resolved after 24 hours. No treatment was sought.
BLOOD CLOTS IN THE LEG; BLOOD CLOT IN THE CHEST; This spontaneous report received from a consumer (calling on behalf of her husband) concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus, asthma, high blood pressure, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin: unknown, batch number: Unknown) on 12-APR-2021, into right arm, for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 18-APR-2021, the patient began experiencing pain and swelling in the left leg. His leg was very hot and red "like a fever" and the pain was radiating up to the chest and heart and also spread to the right side of the chest. The patient was experiencing a lot of pain and couldn't breath. On 19-APR-2021 the patient's wife called the doctor and he was admitted to hospital. An ultrasound was performed which confirmed blood clots in the leg and chest. At the time of this report patient was still in the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in the leg, and blood clot in the chest. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 60 year-old male with medical history significant for diabetes, high blood pressure, and asthma was hospitalized for blood clots in the leg and chest 7 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. Six days post-vaccination, the patient began experiencing left leg pain and swelling. His leg was red and hot and the pain would radiate from his leg to his chest. He was also experiencing difficulty breathing.  The following day (7 days post-vaccination), he was admitted to the hospital. An ultrasound confirmed blood clots in the leg and chest. Other diagnostic test results and corrective treatment were not reported.  As of the time of this report, the patient was still in the hospital. Based on the limited information, the relationship with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
THE DAY AFTER RECEIVING THE ZOSTAVAX VACCINE THE PATIENT REPORTED PAINFUL RASH AT INJECTION SITE BUT ALSO BILATERAL PERIORBITAL EDEMA. TREATED WITH BENEDRYL, TYLENOL AND COLD COMPRESSES.
Rash on back; This case was reported by a non-health professional via sales rep and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced red rash. The patient was treated with antihistamine and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had a rash on her back after vaccination. The reporter stated that her physician said she did not have shingles. The physician gave her an antihistamine and a steroid cream.
Dose was given after expiration date. Expiration date was 07/13/2022. Dose administered on 07/26/2022.
Jynneos vaccine administered intradermally; vial was punctured and stored in the fridge for a week; they gave a dose technically after it had been expired due to being previously punctured; Case reference number US-BN-2022-004514, is a spontaneous case report initially received from a healthcare professional via Communication (reference number: USBAV22-1778) on a 25-OCT-2022 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with an unknown dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose, intradermally (explicitly coded as 'Intradermal injection'), at an unknown anatomical site, for monkeypox prophylaxis.  As reported, the clinic had a vial that was punctured and stored in the fridge for a week and then they gave a dose technically after it had been expired due to being previously punctured (explicitly coded as 'Product storage error' and 'Product administration error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from a pharmacist on 04-Nov-2022 included the information that there were 18 patients vaccinated intradermally a total of 24 times.  This case is linked with US-BN-2022-004515, US-BN-2022-004521, US-BN-2022-004516, US-BN-2022-004517, US-BN-2022-004518, US-BN-2022-004519, US-BN-2022-004520, US-BN-2022-004529, US-BN-2022-004522, US-BN-2022-004523, US-BN-2022-004524, US-BN-2022-004525, US-BN-2022-004526, US-BN-2022-004527, US-BN-2022-004528, US-BN-2022-004530 and US-BN-2022-004513 (same reporter).  Non-significant case correction received from on 11-Nov-2022 included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos, applied intradermally (which is considered intradermal injection). It was reported that the vial had been previously punctured and stored in a fridge for a week (which is considered product storage error and product administration error). It was unknown if the patient experienced any adverse events. Intradermal injection, product storage error and product administration error are considered listed per company conventions. Medical history and concomitant medications were not reported. The events are assessed as not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos, applied intradermally (which is considered intradermal injection). It was reported that the vial had been previously punctured and stored in a fridge for a week (which is considered product storage error and product administration error). It was unknown if the patient experienced any adverse events. Intradermal injection, product storage error and product administration error are considered listed per company conventions. Medical history and concomitant medications were not reported. The events are assessed as not related to Jynneos, but to human error. The case is non-serious.
PROGRESS NOTE 2/06/2022 38 y.o. female with no significant past cardiac history, history of hypertension, depression and chronic kidney disease.  Patient was admitted with COVID-19 infection on 1/19/2022.  Her blood pressure was markedly elevated at 220/145.  Troponin level was increased.  Echocardiogram showed reduced left ventricular systolic function with wall motion abnormality.   Reason for cardiology follow-up is newly diagnosed cardiomyopathy, wall motion abnormality and elevated troponin.   Subjective: No new symptoms   Objective:  Blood pressure 126/87, pulse 85, temperature (!) 95.7 °F (35.4 °C), resp. rate 19, height 5' 1.5" (1.562 m), weight 80 kg (176 lb 5.9 oz), SpO2 99 %, not currently breastfeeding. General: comfortable, in no acute distress.   PLAN: Hypertensive emergency H/o noncompliance. Last se een by nephrology on an outpatient HTN/ chronic kidney disease in 12/2021.  They suspect that the etiology of her chronic kidney disease could be related to hypertensive nephrosclerosis and she did have some mild proteinuria.  Given her young age, they recommended work-up and follow-up for secondary causes  Resume Coreg 25 mg p.o. twice daily, chlorthalidone 25 mg p.o. daily, hydralazine 25 mg p.o. 3 times daily, and lisinopril 40 mg p.o. daily, Held BP meds in 2/4 BP on lower side.  Held lisinopril ( Cr bumped) , Restarted Coreg 2/5 , Hydralazine PRN  24-hour urine for catecholamines and metanephrines pending Renal artery ultrasound unremarkable      Acute LLE weakness / pain  R/o CVA ,decreased motor and sensation LLE  unknown onset  Discuss with Neurology seen  MRI / MRA w./o Cer w negative  Admit CT head no acute finding  US BLE r/o  DVT  PT/ OT , nurse report patient was able to ambulate to bathroom today    Elevated troponin Likely acute myocardial injury/strain from hypertensive emergency.   Echo mildly decreased, estimated LVEF 45-50%.Inferolateral and anterolateral hypokinesis. Aspirin, Coreg.  LDL 88 ( 3/18/20)  Consulted Cardiology  ?Coronary angiogram ( Cr 1.9 )      CKD stage III  Suspected due to hypertension  Last seen by Nephrology 12/21  Cr 1.5- 1.7 for the last few years  Admit Cr 1.68 -- > Cr 1.93  Avoid nephrotoxic meds       COVID-19 Multiple constitutional symptoms  Not on O2 currently  no indication for steroids Ddimer 5.34 , US LE negative.  heparin  Supportive cares    History of seizure disorder Continue Trileptal 300mgBIDPTA ( on 600mg BID  PTA )   Bipolar disorder Continue Risperdal
Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 03Feb2021 (at the age of 78-year-old) as a single dose for out of an abundance of caution/COVID-19 immunisation. The patient's medical history included muscle relaxer. Concomitant medication included methocarbamol (Strength: 500 mg) at 250 mg, as needed for muscle relaxer. The methocarbamol medicine was 500 mg, and she takes half which was 250 mg as needed, she took 250 mg the night of 03Feb2021. She has been using this medication for a couple of years now. Reporter was calling because she received the first dose of the vaccine about 22 hours ago and she was concerned about a side effect and she wanted to ask if this was a normal side, that side effect was dizziness, it just started about an hour ago on 04Feb2021. No investigation assessment. The outcome of the event was not resolved.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
has not gotten her second dose, yet.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten her second dose, yet.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitent informations were reported. No Treatment informations were reported.   Reporter did not allow further contact
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.      This case was linked to US-MODERNATX, INC.-MOD-2021-080319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080319:crosslinked
HYPERtension, Itchy throat, ears ringing, tingling lips Narrative:  Employee c/o of ears ringing, itchy throat, lips tingling after ten minutes post-vaccination. Denies shortness of breath, wheezing, or chest pain, A&O x 4. Employee transported via wheelchair to the ER for further evaluation.
Fist night: Sleeplessness 3rd day: dizzy 7th day: dizzy
Patient under 65 received Fluad QIV; Sore throat; Injection site pain; Headache; This spontaneous case was received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04820) and concerned a 28-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On an unknown date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced injection site pain, headache and sore throat. The patient started treatment with Tylenol (paracetamol).   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006081, 202006084, 202006085, 202006086, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097, 202006098 (the same reporter).  Company comment: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 28-year-old, female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving Fluad Quadrivalent, the patient developed oropharyngeal pain, headache and vaccination site pain. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Patient reports that 1 day after injection he developed redness, soreness at the site, swelling, itching. He states this was on his left deltoid and spread up to his shoulder and into his left pectoral muscle on his chest. He states it lasted about 1 week before symptoms had fully resolved.
did not get the 2nd dose (beyond day36 from 1st dose); slight fever; body chills; body aches; full body hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (full body hives) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (full body hives) (seriousness criterion medically significant), PYREXIA (slight fever), CHILLS (body chills) and MYALGIA (body aches). On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose (beyond day36 from 1st dose)). The patient was treated with EPINEPHRINE ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, PYREXIA (slight fever), CHILLS (body chills) and MYALGIA (body aches) had resolved. On 01-Apr-2021, URTICARIA (full body hives) had resolved. On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose (beyond day36 from 1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In ER patient was inserted intravenous line and given Epinephrine, Benadryl, Steroids, Zyrtec as a treatment. Patient was given Benadryl and Zyrtec as home medication to take for a week.  This report refers to a case of Product dose omission for mRNA-1273, and the AEs of Urticaria, Pyrexia, Chills, and Myalgia. Based on the current available information and temporal association between the use of the product and the start date of the AEs, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission for mRNA-1273, and the AEs of Urticaria, Pyrexia, Chills, and Myalgia. Based on the current available information and temporal association between the use of the product and the start date of the AEs, a causal relationship cannot be excluded.
child dad reported 18OCT97 pt recv vax 15OCT97;dad described boil like welt on lt thigh-itching w/rash that spread to back-rash looks like hives lasted less than 24hr & now is gone;DPH given per parents;child afeb;
Chills; Itchy arm; Sore arm; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and PAIN IN EXTREMITY (Sore arm). On 10-Jan-2021, the patient experienced CHILLS (Chills). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.        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.    No relevant concomitant medications were provided.   No treatment was reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Within several hours following Hep B vaccination, patient alleges she experienced weakness in Bilateral lower legs.