chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020   Improvement with ibuprofen and acetaminophen.  Resolved by 1/25/2021
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: En6201), on 10Mar2021 as dose 2 , single (Lot number: En6205), in left arm, on 29Nov2021 as dose 3 (booster) , single (Lot number: Fe3592), in left arm and on 14Apr2022 as dose 4 (booster) , single (Lot number: FK9896) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CENTRUM SILVER +50; MUCINEX, start date: 09Jul2022; SUDAFED 12 HOUR, start date: 09Jul2022; TYLENOL; VENLAFAXINE; XYZAL, start date: 09Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive; (18Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received Paxlovid, treatment from 09Jul2022 to 13Jul2022 for treatment of COVID-19.
From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient). On 20-Aug-2021, PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. The patient wanted to know if the case stands valid or not.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up received on 25-AUG-2021 contains updated narrative
HPI pt with rash x 2 days. Low grade fever, general malaise. Got varicella vaccine on 12/26 - presents today with rash (on an erythematous base of varying ages absolutely classic for varicella). Informed pt he is contagious until all lesions are dried/crusted, and none are forming. Pt to take FAMVIR 500 mg TID x 7 days. Symptomatic care. Remain home until no longer contagious. No contact with vaccinated children, pregnant pt's, and anyone immunocompromised.
The patient c/o dizziness. Has history of diabetes and HTN. Reported that she took her BP medication Losartan 80mg this morning prior to walking from her development approximately 1 .5 miles and has been waiting for about an hour and a half to receive the vaccine. BP initially 160/92 heart rate 98 then increased to 188/96. Patient reports that she feels as if she is going to pass out. Repeat BP166/83.EKG =Sinus tach. The patient requested to be transferred to the ED for further evaluation. 911called and patient transported via fire rescue/paramedics without incidence.
Patient came to clinic 3/27/23 for 18 month well child check. She was due for Dtap and Hepatitis A. Family was in agreement to proceed with immunizations. I went back to nurse's station and accidentally grabbed a Tdap vaccine instead of Hepatitis A. I was not aware of this mistake until I was charting the vaccines in chart. I then notified the Vaccine Coordinator who helped me look up potential side effects and potential adverse reaction. Dr. was then notified of the error. She instructed me to contact family and let them know of the error. Family was notified today (3/28/23) and was instructed to watch for adverse reactions and side effects. They were also notified that patient could not receive another vaccine for 1 month. Patient is feeling well and had no symptoms at this time.
This case was reported by a healthcare professional and described the occurrence of swollen lymph nodes in neck and axillary region in a male subject aged between 20 and 29 years old who was vaccinated with TWINIX. In January 2013 the subject received 1st dose of TWINRIX (1 "dose", unknown route, unknown deltoid). In January 2013, within hours after vaccination with TWINRIX (described as "later that night"), the subject experienced swollen lymph nodes in neck and axillary region, erythema neck area, neck tenderness and warm to touch. The events of erythema neck area, neck tenderness and warm to touch described the lymph nodes in the neck and arm pit areas. Per the reporter, the arm pit was "the arm where the injection was administered." The healthcare professional stated that the subject "returned to the office so they can see it" and "no medication was given." At the time of reporting the outcome of the events were unspecified.
Local reaction at site- redness. Patient states SOB.  Arm is drooping and leg feels funny.  States she feels as though she is going to faint.
Patient is 18months old and received his first Hepatitis A vaccine on 10/29/14 and came in for his second Hepatitis A vaccine that I gave on 4/21/15. This injection was given 1 week 1 day too soon.
I WAS DIAGNOSED WITH VITILIAGO. I DO NOT HAVE A FAMILY HISTORY. MY EXHUSBAND WHO WENT WITH ME TO HAVE THE VACCINE DONE...ALSO STARTED HAVING SYMPTOMS OF VITLIAGO. NO FAMILY HISTORY.
Red, swollen, tender - right delt. area. Entire upper arm affected. Benadryl advised.
Nausea and vomiting; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). At the time of the report, NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was unknown if the patient was treated for the reported events.
Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy.  Treatment was received for all events.  Patient had not tested COVID post vaccination.  The outcome of events was recovering.
Complete Vitreous Detachment(VD)  in right eye  Transient flashes of light and gray "floaters" began appearing 11/09/2021.   Emergency eye exam completed 11/12/2021.   I asked my doctor the potential cause, explaining my friend received the very same booster shot from the very same pharmacy on 11/05/2021 and she began experiencing same health side effects 11/06/2021.   He said no official studies have been done. But he noticed an notable increase in calls from his patients with the same symptoms beginning late 2020 after they received their COVID Vaccine  I believe this potential adverse side effect should be noted and communicated to the public.   In addition to the stress and cost of an emergency eye exam, I remain extremely anxious about the full loss of sight in my right eye if further retina damage occurs.   I have a follow-up appointment in 6 weeks and  have been instructed to monitor closely for additional symptoms.
Information has been received from a health professional concerning an 8 year old white male with a history of asthma who on 21-DEC-1998 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine administered on the same day included a third dose of poliovirus vaccine. On 03-JAN-2006 the patient experienced 10 lesions, a few with centered blisters. The patient was treated with acyclovir and diphenhydramine hydrochloride (Benadryl). Subsequently the patient recovered. There were no laboratory or diagnostic tests performed. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional information were provided as follows: The age at vaccination was not applicable. The medical assistant stated that she had observed a sore arm for up to 10 days in some cases.
No symptoms or additional adverse effects reported; patient received unspecified dose in ROTATEQ immunization series that was improperly stored.; Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication was not provided.       On 11-JUN-2020, the patient received unspecified dose in rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # 1660948, expiration date 22-MAR-2021; strength and dose were unknown) immunization series for prophylaxis, that was improperly stored (product storage error). The vaccine was exposed to temperature excursion at 50 degrees Fahrenheit for 34 minutes. There was no previous temperature excursion. The call was due to digital data logger. No symptoms or additional adverse effects were reported.
BREAKTHROUGH COVID: FULLY VACCINATED WITH PFIZER COVID POSITIVE . 92 year old female  Admitted to the Hospital for Acute COVID, Dehydration, Hypokalemia, Hypernatremia, Thrombocytosis, Hypertension - Uncontrolled, Hyperlipidemia, CAD, Schizophrenia, Anemia, Anxiety, Dementia, and Weakness. PT PROGRESSED TO ASPIRATION PNUEMONIA, REQUIRED A PEG TUBE PLACEMENT DUE TO WEAKNESS AND CONFUSION.
This spontaneous report was received from a pharmacist concerning a 63 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 12-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M037655 and expiration date 29-NOV-2017 for prophylaxis (dose and route of administration were not reported).  Other suspect therapies included sterile diluent (MERCK). On 13-SEP-2017, the patient noticed on her arm a two inch round circular rash that was slightly red and warm. The patient sought medical attention. However, no treatment was given for the adverse events, none laboratories were performed. The outcome of the patient's red rash and warmth was reported as not recovered. The causal relationship between the events and therapy with ZOSTAVAX was not reported.
No other adverse events reported; received Gardasil 9 after it had been stored outside of the recommended storage range; This spontaneous report was received from a certified medical assistant (CMA) concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/ allergies was not reported.   On 01-SEP-2020, the patient received a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) after it had been stored outside of the recommended storage range for prophylaxis (lot # T005928, expiration date: 12-APR-2022) (dose, dose number, route of administration, and anatomical location were not reported).   The vaccine was exposed to a temperature of 47.1 degrees Fahrenheit (F) for a timeframe of 30 minutes. There were no previous temperature excursions. It was recorded by a digital data logger. There were no other adverse events reported. 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: T005928; expirationdate: 12-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient given suboptimal dose and don't know where she went, we can't find or contact her. We tried called phone but no return call trying to call her work but not sure where she works. Will keep trying.
adverse reaction or side effect: none; date of vaccination: get every year; This spontaneous report was received from a consumer regarding a currently 68-year old female patient. The patient's concurrent and historical conditions, and concomitant medications could not be identified.  On an unspecified date the patient experienced neuropathy peripheral, vaccination failure and herpes zoster (all captured in MARRS# 1707USA010512).  It was reported that the patient was vaccinated every year with a pneumonia vaccine (manufacturer unknown) (vaccination regimen, lot #, and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration) with no adverse reaction or side effect (No adverse event). ; Sender's Comments:  US-009507513-1707USA010512:
Sore left arm injection site after second shot; Fever 99.9F after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site after second shot) and PYREXIA (Fever 99.9F after second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm injection site after second shot) and PYREXIA (Fever 99.9F after second shot). On 27-Feb-2021, VACCINATION SITE PAIN (Sore left arm injection site after second shot) and PYREXIA (Fever 99.9F after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 99.9 (High) 99.9 F fever.         No concomitant medications were reported  No treatment details were reported   This case was linked to MOD-2021-025243, MOD-2021-396422 (Patient Link).
Youth was vaccinated with covid-19 first dose on date 8/31/2021, covid-19 second dose on date 9/23/2021, covid-19 booster on date 10/14/2021. No adverse reaction
fever; I felt like (was drunk); unbalanced to dizzy; unbalanced to dizzy; sweating profusely; This is a spontaneous report from a contactable consumer (Patient) reporting for himself.  A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EW0170) via an unspecified route of administration on 08May2021 as 2nd dose single for COVID-19 immunization. Medical history included depression, type 2 diabetes mellitus and migraine. Concomitant medications included citalopram hydrobromide taken for depression, metformin hcl taken for type 2 diabetes mellitus, gabapentin taken for restless legs syndrome, muscle spasms, nortriptyline hydrochloride taken for headache, migraine, metoprolol tartrate taken for an unspecified indication. It was reported that, the patient had the vaccination the 2nd one on 8May2021 Saturday. On 08May2021 the patient experienced fever, I felt like (was drunk), unbalanced to dizzy, sweating profusely, and dizziness. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Fever to 104. Flu-like symptoms within 8 hours. Vomiting, dizziness and light headedness. Red small spots on the extremities (legs and hands). Plasma transfusion for 10 days. Major surgery for clot on right leg.  1/28 She was confined for disease call ITTP - Idiopathic Thrombocytophenic Thrombatic Purpura. 60 day follow-up dated 7/10/00 stated a change of age and states the pt has fully recovered. 06/16/2000 call to MD to review her app 2 prior request for this child's record to confirm DGX. Said she will sent the records and ger shot on recent appointments with the pt. 06/20/2000 record received via fax. DGX of TTP confirmed. Case complete.
All of a sudden I?ve been having lower leg cramps. Both legs. It?s like Charlie horse but severe where I have to get up and walk to fix it. Woke me up at night. Happened twice now.
still having left arm pain; Sometimes when I carry heavy stuff, it feels bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "still having left arm pain"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Sometimes when I carry heavy stuff, it feels bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; fever of 100.3; muscle aches; sweating; dizziness; feeling weird; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced weird feeling and dizziness. On 7th October 2020, the patient experienced chills, fever, muscle pain and sweating. On an unknown date, the outcome of the weird feeling and muscle pain were recovering/resolving and the outcome of the chills, fever, sweating and dizziness were recovered/resolved.   It was unknown if the reporter considered the weird feeling, chills, fever, muscle pain, sweating and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling weird.   The patient run and felt some dizziness afterward.  The patient around 3:00 AM, the symptoms of chills, muscle aches, sweating and fever of 100.3 presented and feels better at the time of reporting. The reporter did not consent to follow up.
body aches, chills, fever of 101, muscle cramps, fatigue, and rash with swelling of lymph nodes, topical steroids, antihistamines, steroid pack twice, still no resolution for fatigue, swollen lymph nodes and rash on full body.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient sneezed consistently for 12 hours. The patient sought unspecified medical attention. It was reported that the patient recovered "12 hours after it started" (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of GARDASIL (lot # not reported).  Subsequently, the patient sneezed consistently for 12 hours.  The patient sought unspecified medical attention.  It was reported that the patient recovered "12 hours after it started" (date unknown).  Additional information was received from the physician who reported that the patient did not return for follow-up.  The reaction was not typical (sneezing/runny nose for about 24 hours).  The events may or may not be related to therapy with GARDASIL.  No further information is available.
Patient was given Typhoid Vi vaccine on 10/18/21 that had expiration date listed of 09/18/2021. No immediate adverse reactions were observed after vaccination.