chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives popped up on face, Hives popped in some other parts of body; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives popped up on face, Hives popped in some other parts of body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives popped up on face, Hives popped in some other parts of body). At the time of the report, URTICARIA (hives popped up on face, Hives popped in some other parts of body) 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 treatment information was provided.  No concomitant medication was provided.
Information has been received from a physician concerning a 72 year old male patient who on 24-SEP-2007 was vaccinated with a 0.65 mLdose of ZOSTAVAX. Concomitant therapy included HYDROCHLOROT, MONOPRIL, RANIDINE, simvastatin (MSD), naproxen, metoprolol tartrate,  COUMADIN, XALATAN, COMBIVENT and FLOVENT. In approximately January 2008, the patient experienced shingles. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No diagnostic labs were performed. No product quality complaints were involved. Additional information has been requested.
Cerebellar stroke, ICU at Hospital from 12/18 until 12/24/2022. Still in follow up protocol.
Been having more and more chest pains.  Especially when i first wake up.  They pain generates in the center of the chest and "flashes" out to the arms.  It has become more nagging in nature when not flashing.  I had my blood pressure checked and it has been high for the first time in my life.
she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6700, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half.".  Additional information: A syringe broken for Prevnar 20. She had taken a picture of that it occurred earlier but she said she was just tapping it to get the air out in the syringe with her finger not like tapping 'with anything'. The needle of the syringe not exactly and little bit of the syringe left and 'damaged' in 2 separate parts. The one that administers the vaccines and prepare them for administration, and she said that she had a syringe of Prevnar 20 that she was flicking with her finger to get the air bubbles out like she typically do and then the syringe just broke in half. A portion broke off with the needle attached and some of the syringe attached and then there was another portion that contain the plunger at the other end. She was not trying to administer it; she was just preparing it to administration. No patient was affected. She was getting the air bubbles out of it.
general unwell feeling; brain fog; fatigue; occasional shortness of breath; fast heart that comes & goes,; sore muscles; bad leg pains; calf cramps/leg cramp; headaches; chills; night sweats; heavy; tingly/burning/prickly pins/needlessensation in legs, feet, hands,forearms,; /burning/prickly pins/needlessensation in legs, feet, hands,forearms; tight calf muscles; stuffy nose; pain at injection site; extremely dry eyes; extremely puffy eyes; red flushed face, neck,and chest; red flushed face, neck,and chest,; stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergy. Concomitant medications included levocetirizine dihydrochloride (XYZAL), fluticasone propionate (FLONASE), famotidine (PEPCID), vitamins nos (MANUFACTURER UNKNOWN), ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 11:45 the patient experienced tight calf muscles, stuffy nose, pain at injection site. On 31Mar2021, the patient experienced extremely dry puffy eyes, red flushed face, neck, and chest, and stomach ache. On 01Apr2021, the patient experienced general unwell feeling, brain fog, fatigue/exhaustion, occasional shortness of breath and fast heart that comes & goes, sore muscles, bad leg pains and calf cramps; bad headaches, stuffy nose, chills, night sweats. On an unknown date in Apr2021, the patient experienced heavy, tingly/burning/prickly pins/needles sensation in legs, feet, hands, forearms, bad leg pains and cramps, occasional shortness of breath and fast heart that comes and goes, stuffy nose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tight calf muscles, stuffy nose, pain at injection site, extremely dry puffy eyes, red flushed face, neck, and chest, and stomach ache, general unwell feeling, brain fog, fatigue/exhaustion, occasional shortness of breath and fast heart that comes & goes, sore muscles, bad leg pains and calf cramps; bad headaches, stuffy nose, chills, night sweats, heavy, tingly/burning/prickly pins/needles sensation in legs, feet, hands, forearms, bad leg pains and cramps was unknown.   No follow-up attempts are needed. No further information is expected
This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-SEP-2017, the patient was administered GARDASIL (strength, dose, lot number and expiration date were not reported) for prophylaxis. On 25-OCT-2017, the patient was administered GARDASIL 9 lot number N108273, expiration date 17-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Patient presented to the ED and was subsequently hospitalized for speech disturbance, metabolic encephalopathy within 6 weeks of receiving covid vaccination.
Pt. states high fever up to 103 for 24 hours, starting 2 hours post administration, body aches and headache. Large red area around site. Left deltoid 6cm x 7cm, warm to touch and painful. Also c/o persistent backache since vaccine administered.
Patient was seen in the office for his 12 mth well check appt. It was written in our huddles that he was getting MMR, VARIVAX and KINRIX (Dtap and IPV) vs. MMR, VARIVAX and PCV13. KINRIX is given at 4 yrs. well checks but the Medical Assistant followed the huddle and give MMR, VARIVAX and KINRIX. Per CDC Dtap dose counts as his 4th dose but he got 4th dose of IPV before needed and will need another dose at 4 yrs. old. Age of patient at time of event: 1 years.
sensorineural hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 23-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered a sudden left-sided hearing loss and was diagnosed with sudden  onset sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event sensorineural hearing loss was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the event sensorineural hearing loss to be disability.  Upon internal review, the event sensorineural hearing loss was determined to be medically significant.
C/O redness, swelling over (L) arm where varicella vaccine was given. Pt. c/o itching, SOB, has hx of asthma. BENADRYL, ORAPRED and breathing tx in ED.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a M-M-R II lot # reported as J014875 (therapy type, dose, route, and expiration date were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
9/23/03 Pain and swelling day after. Seen by physician and given Prednisone and Ibuprofen for pain. T 97 P58 R18 Bp 118/78.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Upper arm extremely swolloen and inflamed , lower neck area hurts, left eye inflames, red,swollen, area around too!
I was out on April 16th because I had to email my advisor.  Initially it was pain in my arm. It felt like had been punching in my arm. I could not lift my arm. It was red and puffy. I had joint aches like my knees did not want to bend. Then the itching started. After I got out the shower my entire torso was red. It spread to back I used witch hazel, alcohol and a steroid  Triamcinolone For itching and inflammation. I scratched so hard I had scars. I could not sleep, I felt so worn out. I could not eat. I was itching, hard to walk and coul not sleep. Luckily this was all on my second shot.
Reported headache, chills, greater than 6 loose stools overnight. Symptoms have resolved.
Information had been received concerning a pt who was post vaccination 1 day and she experienced 5 inch area on upper arm that the skin was red, hot, and swollen.  The pt recovered.
Patient was diagnosed with COVID-19 within 24 hours of administrating vaccination. Patient is hospitalized.
The pt experienced a localized redness 2 1/2 inches around the injection site. There was a red halo around the site and white with middle with warmth to the touch. and a hardness at the injection site.
Tachycardia, legs burning hot, , temp was 99.4,  body aches including hip pain for 36 hours.  Arm pain as well.  Today, I was seen in Urgent Care, and now have Shingles.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored PORQUAD (Merck) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
diffuse itchy rash, short of breath (does have h/o asthma), wheezing.  took his albuterol inhaler. went to ER. received steroid, benadryl, fluids. discharged home with short course of prednisone and benadryl.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Coldness, chills that became full body convulsions for 20 minutes with vomiting . I went into hot shower and after 5 minutes, the convulsions stopped. After shower, I checked my temperature and it was 96.8, so I can only assume it was lower before the hot water.
Information has been received from a physician concerning a patient who in 1995 was vaccinated with one dose of varicella virus vaccine live (lot 608582/0410B). Three to four years later, the patient experienced herpes zoster. The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional patients were reported with adverse events following vaccination with varicella virus vaccine live (WAES01032473 and 01071648-01071649).
Hyperventilation within 1 hour of vaccine dose. Very weak for the next three days. Loss of appetite, headache- severe, unable to attend school due to symptoms. 02/07/07-records received and reviewed for DOS 12/11/06 and 2/1/07 Visit of 12/11/06- URI, abscess to left axilla healing. Suspect Asthma.  Visit of 2/1/07-not involved in PE or school sports. uses albuterol as needed. DX:asthma.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 14-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles which lead to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Patient reports: Vaccine reaction symptoms (swelling, redness, warmth, itching) have completely resolved. She states she is "back to normal". Thursday 12/1: Lot of swelling all over arm and shoulder and warm. Monday 12/5, a week after the vaccine they have redness spreading 4 inches in diameter from injection site and itchy. Taking Benadryl helped a little bit, but mostly time allowed the symptoms to resolve.
A 64 year old female pt was diagnosed with bladder cancer in Aug 2005 for which bladder surgery (unspecified) was performed. BCG treatment (brand unk) every 3 months was started in 2005. Reportedly after the first dose she experienced increased urinary frequency.
pt reports sx of nasal congestion, sneezing, chills, nonproductive cough, loss of smell, fatigue, sinus pressure
On 2-22-13 pt received a PROQUAD vaccine; returned to clinic on 3-5-13 with complaint of rash; she had a fine maculopapular eruption all over, with no vesicular lesions.
I had chronic diarrhea for 2 days. Extreme exhaustion, very tired and very weak. I drank a lot of Pedialyte and it cleared up after 2 days. I was still feeling tired and fatigue. All symptoms subsided after 1 week. I went to see my physician and he advised me that he had similar symptoms.
No treatment need. I am to premediated with Benadryl for my next dose and bring my EpiPen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical course: Patient had Paxlovid Treatment from 23Jun2023 to 27Jun2023  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300239328 Same reporter/patient, different product/AE.;
Flu shot given then approximately 5 minutes later patient complained of seeing black, then fainted. I (intern) then quickly checked for signs of breathing and pulse. Patient's pulse & breathing seemed normal. During checking pulse & breathing the patient opened her eyes & seemed alert. Approximately 3-5 minutes later the patient fainted again. After second episode, the patient was moved to be lying on the floor & feet elevated emergency resource was called after second episode. EMT took patient BP & was normal. Pt was told she could go home by EMT.
Information has been received from a pharmacist concerning a patient in their late seventies with no medical history who, on an unspecified date, was vaccinated with a 0.65 mL dose of Zostavax. There was no concomitant medication. Subsequently the patient experienced a red mark of 1 to 2.5 cm at the injection site. It became worse on the third day and was 4 by 4 cm. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
After the first dose, the girl suffered a syncope. She felt chest tightness and saw everything dark and collapsed. After that event, she reports that with the slightest effort her chest felt tight, and she lacks oxygen.
He loss his appetite and was running a fever.  The night of the seizure he woke up with 103 temperature.  The seizure lasted for about 8-10 minutes and the fever lasted another three days afterwards.
At first I felt slightly light headed which lasted about 2 hours. At around 7 PM that night, the arm pain started. I had a very bad nights sleep due to this arm pain. I would rate this 8/10. The next day, I had significantly less arm pain, about 4/10. I felt light headed the whole day. After 36 hours, all of my side effects were gone.
Pt recvd vax & w/in 45 mins devel rash, itching, nausea & vomiting;
I had severe dizziness; 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 received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetic; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Date of first shot: 19Feb, LOT# for first shot: EN6198), administration date: 19Feb2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "I had severe dizziness".  Additional information: The patient stated that right now she was in remission for other conditions. The patient wanted to report an allergic reaction after second dose of vaccination. Weight was reported as 326 pounds (not clarified). Severe dizziness but anyways it lasted for 3 days.   No follow up attempts are possible. No Further information is expected.
Breakthrough COVID-19 case. Hospitalized 8/29/2021-9/2/2021. Pneumonia, ARDS, abnormal chest x-ray
Red, warm, slightly raised, itchy, rash on right deltoid, 5-6 cm wide and about 9-10 cm up his arm-treatment was BENADRYL.
Patient reports the evening after receiving the shot she had fever, was unsteady, fell 3 times, dropped items, hand tremors, bladder issues 3 times (urinated on self). Patient states she did not go to the MD, she lives alone and she friends who checked on her.  The next day she felt normal.
Taken to ER, L leg swollen and child crying.  Given Motrin at ER.
This spontaneous report as received from a 69 year old male patient with cholesterol abnormal, diabetes and no known drug reactions or allergies refers to himself. The patient's medical history included chicken pox as a boy. In approximately July 2013, "2 to 3 months ago", the patient was vaccinated with a dose of ZOSTAVAX for to prevent shingles. Concomitant medications included unspecified cholesterol and diabetes medication. On approximately 03-OCT-2013, about a week ago, the patient had shingles. It started with soreness on the right side of his abdomen, then a rash that spread to the navel area. He had sharp pain internally and externally and could not sleep for 4 days. Currently the pain was gone but he still had some rash and soreness. The patient sought medical attention by doctor visit. CALAMINE LOTION, unspecified psychotropic was given for the patient. Blood work was performed but the result was unknown. At the time of the report, the outcome of events was reported as recovering. Additional information has been requested.
Red and Swollen circular itchy rash at injection site. About 2-3 inches across. Appeared 7 days after injection. Very itchy. Sore. Red. Hard. Hot to the touch.