chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9); chills; Body / muscle aches; This is a spontaneous report from a contactable consumer (patient).   A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 03:15 PM (Batch/Lot Number: EN6201) at the age of 68-year-old; as single dose for covid-19 immunisation.   The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E29262) on 26Jan2020 01:15 PM, administered in Arm Left for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, glucose tolerance impaired from an unknown date and unknown if ongoing.  Concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL SUCCINATE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported.   The patient experienced temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9) (body temperature fluctuation) (non-serious) on 12Feb2021 with outcome of not recovered, chills (chills) (non-serious) on 12Feb2021 with outcome of not recovered , muscle aches (myalgia) (non-serious) on 12Feb2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: temperature fluctuations between 98.9 up to 104.2   on   temperature fluctuations between 98.9 up to 104.2 (normal temp is 97.9).     Follow-up attempts are completed. No further information is expected.
Pt's wife has reported a significant reaction of an all-over body rash that is suspected to be varicella zoster. Awaiting confirmation with physician, however the office seems to believe this to be the diagnosis.
ten minutes after second dose, she fainted. They fainted a second time on Aug 18th, prompting our urgent care visit. Urgent care pediatrician diagnosed with POTS, following up with pediatric cardiologist
Pt reports redness and swelling at injection site. Pt complaining of feeling hot and lightheaded. pt taken to MD's office.
About 8 days after vaccination noticed rash on underside of right forearm and rash on left side of body. Rash does not cross midline of stomach. Also smaller rash above right eye. Rash also under left eye near midpoint of nose. Applied Cali nine and hydrocortisone ointments. Took over the counter Benadryl but rash has not healed. Concerned as I may be scheduled for 2nd shot between Wed. April 21 and April 29th according to vaccine appointment card.
red in same arm of injection; Cellulitis; It started to itch; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (It started to itch). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red in same arm of injection). On 02-Apr-2021, CELLULITIS (Cellulitis), VACCINATION SITE PRURITUS (It started to itch) and VACCINATION SITE ERYTHEMA (red in same arm of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol and Clindamycin 300.   This case was linked to MOD-2021-082391 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
A report has been received from a physician concerning an 11 years old female patient. No information regarding the concomitant disease and concomitant drug was provided. Patient had received FLUMIST QUADRIVALENT (intranasal). It was reported that last year the patient received FLUMIST and contracted the flu last year which was confirmed by testing. The patient had received flu vaccine injection three (consecutive) years prior to last year's FLUMIST. The doctor reported the patient contracted the flu despite vaccination in the previous three years. The outcome of the event of influenza was unknown. The reporter assessed the report to be non serious by reporter.
slight swelling; discomfort in armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 16:00 (Lot number: 30155BA) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number EL8982, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 30Jan2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot Number : EN6201, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 20Feb2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 23Oct2021 17:00, outcome "recovering", described as "slight swelling"; DISCOMFORT (non-serious) with onset 23Oct2021 17:00, outcome "recovering", described as "discomfort in armpit". Therapeutic measures were not taken as a result of swelling, discomfort.  Additional Information: Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP RELATED HYPOVENTILATION DUE TO LOWER AIRWAYS OBSTRUCTION NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Headache (4 hours), migraine (20 hours, treated with 600 mg ibuprofen); fatigue (36 hours)
The night of having the shot my arm was throbbing severely, couldn't even sleep it hurt so much. Very swollen around the injection site also. After a few days the pain was gone but I have not felt right since having it. Very foggy brained and not feeling all there. And so run down and exhausted I cannot wake up. It has been a week now since having it and still feeling the same. A lot of all body muscle pain also.
Covid19 breakthrough.  1st vaccine received on 03/01/2021.  78y/o PMH HTN, DM, CKD stage 4, IVC Filter and bowel resection with colostomy presents to ED by EMS from NH for abnormal renal fx/lab values.  Upon arrival, noted liquid black stool in colostomy and pt with c/o N/V.  Elevated creatnine and potassium treated and pt on IV ABX.
Information has been received from a nurse via a field representative referring to a 15 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On approximately 24-AUG-2018 (reported as about 2 weeks ago) the unspecified 15 year old patient was vaccinated with PROQUAD (subcutaneous, strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis due to no history of mumps measles and rubella vaccination and varicella vaccination (Inappropriate age at vaccine administration). The reporter stated prior to PROQUAD administration the "patient tested negative for varicella titer and mumps measles and rubella titer" on unspecified date. No adverse effect was reported.
Site: Redness at Injection Site-Medium, Additional Details: Pt had fever for two days and bruise at injection site for two weeks.
Sick for 3 days with headache, fever, chills, and weakness/ fatigue. On day 5 woke up with left side lymph node in neck inflamed, sore, and knotted. Went to Urgent care where I was transferred to Emergency Department for further evaluation and treatment.
Patient observed for 15 minutes post vaccination felt fine, left the area; however, as she was driving home she felt lightheaded, anxious, feeling flushed, tingling in head that comes and goes.  Patient cleared by EMS.  Instructed patient to sign up for v-safe, contact her primary care physician for direction. Patient advised to call 911 or go to the nearest emergency room for any further issues.
Pt was given Comvax on 07/12/2002 and reacted with Hives- treated with Benadryl.
Case number PHEH2015US026893, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 22 year female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 06 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). No adverse event was reported following this medication errors (incorrect storage of drug). Reporter stated she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day, and when she arrived the next day and the temperature was fine. It was a new refrigerator, and there have not been any problems since the temperature excursion. No further information provided. Follow up information was received from a nurse on 26 Jan 2016: Nurse comment added.
Pt.'s Wife states that after Husband received the 3rd Booster of Moderna 08/27/2021, started experiencing symptoms 15mins later of shortness of breath and chest pain. EMT called transported to Hospital. EKG, Chest X-Ray, and Blood Work. Outpatient/Self-Discharged. Symptoms have submitted.
metallic taste in mouth, tongue began to swell, throat felt "thick", light headed.  Called 911 and headed to hospital via ambulance.
Patient reported extremely swollen arm starting the evening of the shot, to the point where his shirt fell tight on the area. He also said it was extremely bruised. He had to go to the hospital where they are currently checking it out.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, facility took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna medical information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a county medical director and based on this information from Moderna, no re-vaccination is needed.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced mild breakthrough chickenpox. The pts symptoms lasted for 6 days with no complication.
The patient was sitting on the examination table and the four vaccines were administered by the primary care, two in each arm. The last vaccine that was applied was HPV. One minute after the application, the patient fainted and fell to the floor. The patient fell on the left side of her body. She didn't hit her head. The patient regained consciousness a few seconds later. She was oriented in time, space and person. Patient was left on the floor for 2-3 minutes and was helped to move onto the stretcher. There were no more incidents. The neurological examination after the incident was normal. There was no evidence of significant trauma that could be seen on physical examination.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: redness, rash on arm localized to right deltoid area, warm to touch
- Body aches: started around 24 hours after injection and ended around 48 hours after injection - Fever: started around 28 hours after injectin and ended around 40 hours after injection - sore arm: started 24 hours after shot and ended around 4 days - armpit soreness and slight swelling: started around 30 hours after injection and lasted 5 days - Headache: started around 24 hours after injection  and lasted about 1 day **no treatment for adverse events **adverse events eventually cleared
I had a negative reaction to GARDASIL 9 the first shot and got a swollen arm and a lump. The second time the doctor recommended I take BENADRYL (we did) before the shot. About 12 hours later I was in excruciating arm pain and my tongue and lips were swollen and my chest tightened. I required an EPIPEN, steroids, and a 6 hour hour observation in the ER.
On day of vaccinations, pt had slightly increased temperature. Two days after vaccine, pt became fussy and exhibited screaming/ crying/ decreased appetite/ stiffening / eye rolling.
On 5/25/00, the pt began a temperature of 99-100; and it kept going up. On 5/27/00, the temperature was 103.9 and rash developed across nose then on trunk and abdomen. Today, a fine, red rasied rash resembling measles covering most of body.
MENSTRUAL CYCLES STOPPED FOR MORE THAN A YEAR; HOT FLASHES; REPETITIVE HEADACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual cycles stopped for more than a year, hot flashes, and repetitive headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual cycles stopped for more than a year, and the outcome of hot flashes and repetitive headaches was not reported. This report was non-serious.
My father went to the pharmacy for his second dose today. His first dose was Pfizer, his second dose was supposed to be Pfizer as well. Pharmacy gave him his scheduled second dose today without confirmation of the the vaccine manufacturer and  gave him Moderna . He now has two different vaccines in him. Very concerned.
Patient had a reaction immediately after receiving 4 vaccines. RN noticed patient looked pale and felt dizzy. Patient's father reported patient had no breakfast before vaccines were administered. Patient was given juice, oatmeal and water before leaving office in stable condition and patient also reported  she felt better.
fever; Nasal allergies; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included allergic rhinitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and allergic rhinitis. On an unknown date, the outcome of the fever and allergic rhinitis were unknown.   It was unknown if the reporter considered the fever and allergic rhinitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had initial shinglix vaccine and the patient temperature spiked to 102 and had been experiencing heightened issues with nasal allergies after taking this vaccine. The patient was expecting the temperature rising, the fatigue, etc.  The patient asked there a correlation between the vaccine and nasal type allergies. This had been difficult.      Lab Comments: lab test performed on an unknown date
Went for mammogram the  week following vaccination and had swollen lymph nodes in the armpit area. Was told that other women were experiencing the same thing.
Rash on legs, groin, back and arms with pruritus. Onset 6-8 hours, post vax, lasting about 72 hours. Treated with Benadryl.
Wife called for help stating patient became unresponsive. At patient he was responsive to verbal stimuli, Skin was pale cool and diaphoretic. Radial pulses were normal and equal.  Eyes were PERRL. During assessment patient become unresponsive but still breathing and with a pulse, event lasted 30 seconds. Patient slowly recovered and became A&Ox4.
Information has been received from a Nurse Practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history or drug/allergies reactions, who was vaccinated with the first and second dose of GARDASIL (dose, route and lot # unspecified) on 18-AUG-2010 and 20-JAN-2011 respectively.  There was no concomitant medication.  The nurse reported that the patient discovered to be pregnant the same day (on 20-JAN-2011) GARDASIL was received, through urine pregnancy testing.  It was reported the last menstrual period (LMP) was on 29-DEC-2010 and the estimated delivery (EDD) date on 05-OCT-2011.  The nurse also mentioned patient was tested because she was being followed for an IUD, and the IUD was found to have been expelled.  No adverse effects were reported by the patient.  In follow up information the nurse practitioner reported that the 20 year old female patient had two previous pregnancies with two live births in the last two years of which neither had any birth defects in 20-JAN-2011 (also reported as 20-JAN-2010) received intramuscularly into the right deltoid the second dose of GARDASIL (Lot # 666118/1539Y).  On 25-JAN-2011 the patient underwent an ultrasound to clarify the estimated delivery date (EDD), result which 10 wld IUP, which was reported as 22-AUG-2011.  On 02-FEB-2011 the patient terminated her pregnancy at 4 weeks from LMP.  The EDD was reported as being 22-AUG-2011.  It was stated that the patient did not want a third baby in 3 years.  She got pregnant due to spontaneous expulsion of MIRENA.  It was unknown if the products of conception were examined.  It was unknown if the fetus was normal.  The nurse practitioner stated that the patient had an elective termination which was not at all related to GARDASIL.  Upon internal review, patient had terminated the pregnancy was determined to be an other important medical event.  The patient sought for unspecified medical attention.  Additional information has been requested.
developed what almost looks like a Niacin rash; rash on her chest and upper neck - the area is red and warm; rash on her chest and upper neck - the area is red and warm; body aches; body aches are mostly upper body, in the upper arms; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: 33130BA) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "mild crohn''s colitis" (unspecified if ongoing); "Neuralgia" (unspecified if ongoing); "autoimmune disorder" (unspecified if ongoing); "Overweight" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 27Nov2021; ENBREL taken for autoimmune disorder, overweight. Past drug history included: Niacin, reaction(s): "rash". Vaccination history included: Bnt162b2 (Dose:1, lot EP6955), administration date: 21Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, lot ER8737), administration date: 11Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; DRUG ERUPTION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "developed what almost looks like a Niacin rash"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious) all with onset 05Dec2021, outcome "not recovered" and all described as "rash on her chest and upper neck - the area is red and warm"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "recovering", described as "body aches are mostly upper body, in the upper arms". Therapeutic measures were taken as a result of drug eruption, rash erythematous, feeling hot.
pain starting on her lower back and progressed to her left side; rash with clear blisters; pain starting on her lower back; pain progressed to her left side and stomach; This case was reported by a consumer via call center representative and described the occurrence of pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 3 days after receiving Shingrix, the patient experienced pain, blistery rash, back pain and stomach pain. On an unknown date, the outcome of the pain and blistery rash were not recovered/not resolved and the outcome of the back pain and stomach pain were unknown.   It was unknown if the reporter considered the pain, blistery rash, back pain and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced approximately 3 to 4 days after the injection noticed a rash with clear blisters and pain starting on her lower back and progressed to her left side and stomach.  The reporter did not consent to follow up.
This spontaneous report was received from a female pharmacist of unknown age, who was reporting on herself. The patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies were not provided. On 19-JUL-2017, the patient got some of the reconstituted ZOSTAVAX (lot # N010494 with expiration date on 16-MAR-2017) on her hand when it leaked from the vial. No diluent information was reported. On 31-JUL-2017, in the evening, the patient noticed she had small raised bumps around her forehead and hairline. The outcome of the event was reported as not recovered at the time of this report. Product quality complaint was filed for this case. She thought there might be some correlation to being exposed to the ZOSTAVAX, because she did not wash her hands. However, she also recalled that she was wearing gloves and really did not think she got any of the product on her skin. The patient also stated that she was uncertain about the relatedness between the event of small raised bumps and ZOSTAVAX. Additional information has been requested.