chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported swelling and redness from a little below shoulder to a few inches above elbow starting the day after immunization was given. Also reported fever, and feeling "out of it". When patient came into the pharmacy 4 days later it had improved (red area had lessened in size and swelling had gone down) but was still warm to touch. Patient also said felt better.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On an unknown date in March 2007 (also reported as about 7 years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced shingles, it was reported that the patient has continued to get cases of shingles about every two months and has developed shingles in the eye. It was reported that the patient sought medical attention and contacted a pharmacist (details unspecified). The outcome of shingles and shingles in the eye was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Spontaneous active bleed in right calf started in the early morning hours the day after the injection (less than 24 hours).  Extremely tender to touch, unable to put weight on right foot.  Visible, pulsating red bulge appeared, approximately 2" in diameter.  Continued for 3 hours.   Gave Arnica 200c, applied trauma cream.  Bleeding slowed within 30 minutes after dose and had stopped 6 hours later.
01/19/2021 - Chills and night sweats 01/25/2021 - One week after injection, the injection site swelled up, became red, ithcy and had rashes. I took Benadryl every 8 hours and kept an eye on the swelling. Most of the swelling went down within 24 hours. Redness and slight itchiness is still present today (1/27/2021)
TINGLING IN BOTH LEGS; NUMBNESS IN BOTH LEGS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use and no diagnostic data available. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: 06-SEP-2021) .5 ml, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced tingling in both legs. On 01-JUN-2021, the subject experienced numbness in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in both legs, and numbness in both legs. This report was non-serious.
pt was given 0.5ml of bivalent moderna covid 19 vaccine in stead of 0.25ml of dosage. Patient's father was notified, he was okay with the incident. No reaction to the patient notified from the father as of now
Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 03-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored Merck Sterile Diluent (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (degrees C) to 8 degrees C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1812USA010605; US-009507513-1812USA010604; US-009507513-1812USA010606; US-009507513-1812USA010603.
Aches, pains and swelling from shoulder down to elbow. Benadryl and ice.
This spontaneous report as received from a pharmacist refers to a 77 year old female patient with latex allergy. The patient's medical history included chickenpox. On 23-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J003806, expiry date 03-JUL-2014, dose reported as 0.7 ml, subcutaneously in the left back of upper arm. On 24-AUG-2013, the patient experienced spotty red rash on legs and burning sensation in legs at site of rash. The rash did not occur at the site of injection post-vaccination. The patient was not recently exposed to chickenpox and shingles. The outcome of adverse events was unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
No adverse event; PROQUAD administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U028180, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  On 24-AUG-2022, administered dose of vaccine experienced the temperature excursion of 23.73 degrees Celsius for 28 hours 45 minutes.  No adverse event reported.  This is one of 2 reports received from the same reporter.
Patient is a 61 y.o. male with hx of HTN presented to the ED with severe chest pain and was diagnosed with NSTEMI. Chest pain NSTEMI vs myocarditis. Essential HTN. Covid 19 infection - saturating well on RA-CXR - clear lung fields. No pneumonia.
pt recved vax 930AM 12JUN92 began w/high shrill crying 1PM cried 3 solid hours, very irritable & pale taken to way; hosp ER; instructed to continue;
Body chills; Body fever; Muscle pain in injection arm  (Left); Muscle pain in injection arm; Body shakiness; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received third (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Nov2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and pulmonary resection. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified prescribed medicines within two weeks of vaccination on unknown date for unknown indication and unknown if ongoing. The patient received other vaccines within four weeks prior to the vaccination, which included influenza vaccine (reported as flu shot) (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 at 10:45 (at the age of 40-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Mar2021 at 11:00 (at the age of 40-years-old); both as single doses for COVID-19 immunisation. On 09Nov2021 at 22:00, the patient experienced body chills and body fever, muscle pain in injection arm (left) and body shakiness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body chills, body fever, muscle pain in injection arm (left) and body shakiness was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Parents reported that pt. had a seizure after receiving PENTACEL and VARIVAX on 8/8/13 - his seizure occurred on 8/12/13 in conjunction with fever. Pt was evaluated at ED and released. Dx'd with febrile seizures. On 12/18/2015 pt was found unresponsive in his bed and was DOA after transport to Medical Center.
Chills, nausea, muscle aches, joint aches, fatigue, feve 102.0  Taking Tylenol, ibuprofen, promethazine.
An acute generalized exanthematous pustulosar rash severe pain down to the hand lasting over a week Low body temp, diffuse rash on arm, back, chest, neck and scalp, shaking chills, bad headaches severe nausea.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, route and lot number not provided). No co-suspect concomitant therapies were reported. On an unknown date, after receiving ZOSTAVAX, the patient developed an "outbreak of shingles". At the time of the report, the outcome of the event was unknown. Additional information has been requested.
I got a flare up of arthritis in right leg about 24 hours later. Physical therapist did physio for a few days. 5/1 Got a cortisone shot into the knee. At time of reporting, this was much diminished and participant is able to walk on it. 5/3 in the afternoon I had a headache, sinus pressure, and sneezing. 5/4/2023 tested with an at home COVID-19 test, positive. That afternoon, I had a telehealth with my doctor. Doctor prescribed PAXLOVID and recommended using FLONASE. Otherwise treat symptomatically. AIRBORNE was also used to combat the illness. Symptoms diminished rapidly to the point that by 5/5 I had just a mild headache, that lasted only a day or so longer.
16jul90 pt vax hepta B. w/ m-m-r II. pt devel flulike illness w/ fatigue, cough, and neutropenia, w/ white blood cell count bet. 1500-1800. sx remitted in 5 days.  17aug90 pt vax 2nd hepta B. pt devel erythematous butterfly rash on face.
Patient felt like going to pass out and she did then, she was probably out less than in a minute; Severe headache; Nauseous; Throwing up/Vomiting; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient (weight: 81.65 kg, height 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) at single dose, on 22Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder form an unspecified date. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder. On 22Feb2021, the patient experienced sore arm. On 25Feb2021, the patient developed severe headache, nauseous, and vomiting (throwing up) and the patient felt like going to pass out and she did then, she was probably out less than in a minute. The patient described as following: so, on 25Feb2021, the headache increased throughout the day and her nauseousness continued throughout the day and in the afternoon with the pain of the headache she thought she passed out, she vomited that gave her little bit of relief but then she took "two (not clarified) Advil and went to bed". Clinical outcome of the adverse events was unknown at time of this report. Patient asked if should be expected the same kind of reaction when she got her second shot.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported.  Full dose was administered on 9-20-22
About 9 am on 1-21-2021 started to ?feel off?,  between this time and 11am I would get light headed at random. At 11am I started to see ?black floaters? and developed a slight headache. Coworker (another ICU RN) took blood pressure: 234/148 and tachycardia. Was made to rest while arrangements could be arranged and given 4 chewable baby aspirin.  Was then sent to urgent care.
eyelids swelling; eyelids swelling and becoming painful; This is a spontaneous report from a contactable other health professional.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE at the age of 55-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient started having a reaction of her eyelids swelling and becoming painful and she says she lost her memory. She says that this all started around the time she got her COVID vaccine. She says the memory loss started just before the vaccine and the swollen eyelids was after the vaccine. The outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
10/30/13 FLUZONE administered approximately 1:30 pm. Approximately 5 to 5:30: felt cold, stiffness, strain to swallow. Pharmacist recommended going to ER for any throat closing issues pt went to bed. Felt fine next day.
Severe headache that lasted over a week.  Chills, body aches, fever,  and severe fatigue lasted three days which kept me from working.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 19-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Pt exp fever to 104; mom also noticed pt became stiff; ther were no real sz movements like jerking movements; pt was sort of holding breath but did not turn cyanotic & did not stop breathing; MD felt pt should not recvd Pertussis in future;
Patient fully vacinated. Admitted to hopital on 09/02/2021. Expired on 09/16/2021
Lethargy, increase in bowel movements, headache. Redness about a quarter size at injection site with soreness. Painful use of arm. Sx were resolving on their own.
On Day 10 after immunization: Small bruise measuring 1cm tall and 2cm wide, light green in color at injection site. Just distally from there is a 5.5cm wide and 11cm long  (from shoulder to elbow direction) red area that is warm and tender to palpitation. The red color is slightly lighter on Day 10 than it was on Day 8. Patient reported that the redness had increased in size and tenderness from Day 2 onward.
INTENSE ITCHING AND REDNESS NEAR INJECTION SITE LASTING A 2 HOURS (PATIENT WAS GIVEN BENADRYL 50MG AND APPLIED ICE PACK TO AREA.
Headache, chills, soreness night of vaccine In the morning, lightheadness when standing up resulting in blacking out, hitting head against wall, involuntary incontinance, excessive sweating, shaking, in and out of consciousness, looked like a seizure.
Swollen arm; Red arm; Flu like symptoms; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and LYMPHADENOPATHY (Swollen lymph nodes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and LYMPHADENOPATHY (Swollen lymph nodes). On 13-Feb-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Developed cluster of small bruises in the antecubital area of the arm that had the vaccine given in the day before.  Photo available in chart
Information has been received from a registered nurse concerning a 43 month old white female who on 2/5/02 was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot # 640090/1147L). On 8/31/04 the patient presented with about 30 vesicular lesions. No other symptoms were noted. It was reported that the patient was recovering. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that on 8/31/04, the patient presented with about 30 vesicular lesions on the stomach and back and one to two on each arm. The patient was afebrile and only complained of itching. Symptomatic treatment was advised. The patient subsequently recovered. No further information is expected.
I believe the vaccine was injected too high into my arm. As a result, I seem to have suffered a SIRVA injury. I can't lift or move my arm without intense pain, and the pain has not diminished in the days since my vaccination. I'm having trouble dressing myself, sleeping, driving, and really doing anything that requires me to lift my right arm.
achy joints, aching all over; started feeling bad, but no fever; feeling achy and had a little diarrhea; feeling achy and had a little diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old female consumer (patient) received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on 25Jan2021 as 1st dose, single dose for covid-19 immunization. The medical history and concomitant medication were not reported. Patient reported that she had the first Covid vaccine a week ago this past Monday. This past Saturday, she started feeling bad, but no fever. On 30Jan2021 she started to have achy joints and aching all over and had some diarrhea on Sunday and Monday that is all the symptoms she had. Also patient went to have the Covid test done to see if she had it and just wants to know the vaccine after a week show any Covid symptoms. The outcome of the event was unknown.  Information on lot/batch number has been requested.  Follow-up (16Apr2021): 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.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender who on 29-MAY-2015 was vaccinated with a dose of GARDASIL (lot # K006960) expiration date, dose and route not reported) that was 63 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Rash all over; Swelling in arms and legs; Diarrhea; Throwing up; Chills; Numb on body on right side; Dizzy; Headache; Extremely tired; Nausea; This is a spontaneous report from a contactable consumer (patient's sister) A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05May2021, as dose 1, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient experienced a rash all over, swelling in her arms and legs, diarrhea, throwing up, chills, numbness on body on the right side, dizziness, a headache, nausea, and was extremely tired on an unspecified date following her first dose of the Pfizer Covid-19 vaccine. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shortly after the patient received Flu vaccine she complained of tightness in her throat & the inability to swallow with no other apparent signs of distress. 0.4% normal saline was running & the patient was given oxygen, BENADRYL 50 mg IVP and SOLU-CORTEF 100 mg IVP. She tolerated the meds but felt lightheaded shortly after BENADRYL administration & still complained of throat tightness. She was admitted to urgent care for further observation. About 1 hour after meds were given her symptoms had fully resolved. The patient was monitored for 1 more hour (2 hrs total) until she was discharged. She had never received flu vaccine before.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN9582), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2022, stop date: 02Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) positive, notes: Tested positive on 03Jun; (16Jun2022) positive, notes: I retested positive for Covid 19 on 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Recurrence of Covid 19 symptoms 12 days after original symptoms appeared. Tested positive on 03Jun2022, began Paxlovid on the evening of 04Jun2022. The patient took the last dose of Paxlovid the morning of 09Jun2022 and he was symptom free for 4 days. Symptoms returned on the evening of 13Jun. He retested positive for Covid 19 on 16Jun2022.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to three patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 14-SEP-2015 the patients were respectively vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.