chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcer, hypertension and pollen allergy. Concomitant medications included ADVIL, herbal enzyme supplements, and famotidine. The patient previously received fluorescein dye on an unknown date and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 12:00, the patient experienced arthritis-like pain in several joints, bilateral. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of these adverse events. On an unknown date, the patient underwent Nasal Swab test and the result was negative. The clinical outcome of the events arthritis-like pain in several joints, bilateral was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Huge, urticarial hives same day as vaccine given. Largest amount of swelling at HIB site.
Information has been received from a physician and a registered nurse concerning a boy who on unspecified dates was vaccinated with his second doses of VARIVAX (Merck) (lot number not reported). On an unspecified date the patient broke out in hives around the injection site. No medical attention was sought. "After a few days", on an unspecified date, the patients recovered. This is one of several reports from the same source. Additional information is not expected.
This report of dermal hypersensitivity reaction and rash is being submitted in an expedited time frame as requested by the FDA. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 34 year old male patient who experienced an explosive itchy red maculo-papular rash. The patient received the first dose on 1/10/04. The patient's concurrent illnesses include depression and psoriasis. Indication for Flumist was immunization. Product was administered on 1/10/04. Dose regimen was 1 dose. Additional suspect medication included Wellbutrin. On 1/16/04 the patient developed a dermal hypersensitivity reaction characterized by an explosive itchy, red maculopapular rash on his palms, fingers, arms and one ankle. The rash was thought to be erythema multiforme and the patient was treated with a dose of Celestone. He was continued on steroids until 1/22/04. The reporter also indicated that the patient started Wellbutrin on 12/22/04; it was discontinued on 1/22/04. The rash resolved on 2/15/04.  Test results: Hinkology (results: Microscopic description: histologic features are most consistent with those of a dermal hypersensitivity reaction possibly related to a medication or arthropod assault) was done in 2004. No additional information was available at the time of this report.
dizzy; hard to move; fatigue; muscle ache; chills; bad taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad taste in mouth), DIZZINESS (dizzy), MOVEMENT DISORDER (hard to move), CHILLS (chills) and FATIGUE (fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DYSGEUSIA (bad taste in mouth), CHILLS (chills) and MYALGIA (muscle ache). On 11-Mar-2021, the patient experienced DIZZINESS (dizzy), MOVEMENT DISORDER (hard to move) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (bad taste in mouth), DIZZINESS (dizzy), MOVEMENT DISORDER (hard to move), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment included: some pills to sleep. No concomitant medications reported.
24 hrs after 2nd shot. Whole body hurt for about 3 hrs then went away.
sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; Sore throat; Ringing in ears/ My ears has been ringing; sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101557359 (Pfizer).  A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 11:00 (Lot number: 320308D) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Flu vaccine (she has a reaction to a flu vaccine 17 years ago). The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "sore arm that went up her shoulder and to her neck"; OROPHARYNGEAL PAIN (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Sore throat"; TINNITUS (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Ringing in ears/ My ears has been ringing"; CONDITION AGGRAVATED (non-serious) with onset Nov2021, outcome "not recovered", described as "sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, neck pain, oropharyngeal pain, tinnitus, condition aggravated.  Additional information: Patient is taking Multi Vitamins. She wanted to know if ever she receives the 2nd dose, will the ringing of ears be worse and if it will go away. Any AE(s) did not require a visit to Emergency Room/Physician Office. No Prior Vaccinations (within 4 weeks).    Follow-up attempts are completed. No further information is expected.
I developed a fever to 101.5, pain at injection site, area of erythema measuring 6 inches x 2 inches.  The symptoms persisted for 3 days.
Got covid toes on two toes on my right feet. Itchy clusters of blisters; Got covid toes on two toes on my right feet. Itchy clusters of blisters; Got COVID toes on two toes on her right feet; Got COVID toes on two toes on her right feet; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: Er8732), via an unspecified route of administration, administered in Left Arm on 25Mar2021 17:00 (At the age of 28-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included POTS, migraines, post concussive syndrome from an unknown date and unknown if it ongoing. Concomitant medications included Fludrocortisone, metoprolol, midrodrine, Adderall from an unknown date for an unknown indication (within 2 weeks of vaccination). Patient previously took Hibiclense and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 31Mar2021 20:00 patient Got COVID toes on two toes on her right feet. Itchy clusters of blisters. Patient did not receive any treatment for the events. The events were non- serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Eight days after the first injection, the injection area displayed redness. The affected area is roughly 2 inches in diameter and warm to the touch. No itching or other discomfort.
client is a 34 year old female with history of asthma and allergy to ibuprofen. she started exhibiting apprehension, shortness of breath and difficulty breathing at 10: 40 am; Initial vital signs assessment revealed a blood pressure of 160/102; O2 sat 100%; pulse 82; RR: 20;  temp 97.7 F; lung sounds were normal; orbital cavity was in tact without signs circumoral of edema; pt began to have trouble speaking during assessment;  pt used her albuterol inhaler and epinephrine IM was given in the left thigh at 10:42 am; Blood pressure at 10: 52 am was 128/92; pulse 84; Pt stated that she felt better immediately after epi was given; EMS was activated at 10: 40 am and arrived at 10:55 am; pt was escorted by ambulance to a local hospital in stable condition.
Patient stated his lips swelled and were numb the next day after the vaccination. He is allergic to Benadryl so he could not take that. Stated he took Claritin.
Patient described pain, intense soreness, inability to use the arm, headache and nasuea for the first 36 hours after her second dose of SHINGRIX. The soreness persisted for approximately a week, although her other symptoms reportedly subsided after the initial 36 hours.
Patient was extremely exhausted. Had no energy. Unable to finish baseball games due to lack of energy. Pale and no appetite. Saw provider and had labs.
pt recv vax; T 105.8; lethargy & malaise in eve p/ vax;hands & feet were turning blue per mom;however no discoloration action noted in ofc;2 days later less lethargy;
last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; last one had her experiencing really bad arm pain, red, and lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump). At the time of the report, ERYTHEMA (last one had her experiencing really bad arm pain, red, and lump), VACCINATION SITE MASS (last one had her experiencing really bad arm pain, red, and lump) and VACCINATION SITE PAIN (last one had her experiencing really bad arm pain, red, and lump) outcome was unknown.            No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-328266, MOD-2021-328331 (Patient Link).
Chills; leg cramps; cold feet and hands; headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, leg cramps, cold hands & feet and headache. On an unknown date, the outcome of the chills, leg cramps, cold hands & feet and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, leg cramps, cold hands & feet and headache to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and experienced chills, leg cramps, extremely cold feet and hands, headache. The patient did not experience fever. The reporter was just wondering if GlaxoSmithKline track side effects. Consent to follow up was requested.
Red papular exanthem/rash developed on patient approximately seven (7) days after vaccinations were given.  Low grade fever for 1 - 2 days, which started three days after vaccines were given, then resolved.  Rash has been persistent.  No supportive care or medications other than children's Tylenol given.  Otherwise, child is smiling, happy and playful despite rash.  [Rash is located in the face, neck, trunk, upper and lower extremities.  No lesions seen on the palms, soles or oral mucosa.
feeling crappy; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient had his first injection and did not have any side effects except  feeling crappy. The reporter did not consent to follow up. This case is linked to case US2020164435, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020164435:same reporter
Information has been received from a registered nurse who on 14-JAN-2009 was administering MMR II and some vaccine splashed into her eyes. The nurse rinsed her eyes. At the time of reporting, her eyes were "stinging". The nurse spoke to physician, and was recovering from the events. No further information is available.
Day 8- New local erythema, itching at injection site.  L arm  2" X 3" area.  Past V-Safe.cdc check in.
Patient woke up 5 days later with red, raised, painful spots on wrist, this then started on hands 5 days later and then several days later on the legs. These spots eventually turned black and blue.
About 24 hours after the vaccination was given I felt a terrible pain in my left arm at the site of the shot.  When I looked at the site it was red, hot and swollen.  I then became very cold (chills) and went to lay down.  I had the chills for several hours.  I then began sweating previously.  At this time my husband took my temperature it was 100.8.  My chest felt tight, my body ached.  My fever lasted for several hours. Through out the whole time I was very nauseous and I had a terrible headache.  By the next morning my fever had broke but I was weak and tired.  My body still ached and I still had a headache which last several more hours.  This is how I felt when I had Covid.
Chills  Hands & feet extremely cold & with numbness Very bad headache  Joint aches  Mild nausea  Fatigue   Headache & joint ache & fatigue lasted 4-5 days
pt recvd 2 doses of Engerix-B; 2nd dose given 2JUL92 & 20AUG92 pt exp hypomelanosis @ inject site;
Pt received HPV #1 at 1 yo physical. Approx 1-1 1/2 hrs after vaccine, pt started feeling lightheaded, nauseous, vomited, without temp went to ED - seemed better. Next day low grade temp, nausea, HA.
Patient described having pain in area of injection the started after the injection was given. Now the pain is radiating to the finger tips and to the neck.
pt recv vax 27FEB95; 9MAR95 exp a rash; No further details were provided;
Case number PHEH2015US026900 is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 24- year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse reaction was experienced by the patient following the maladministration. Follow up report received from nurse on 26 Jan 2016. Updated reporters comments.
WEEK 1 = 4/7 - 4/13/21 1 day - tired 6pm, sore arm at injection site 2-5 day - very tired, shortness of breath, very sore arm, hurt to move arm laterally or vertically  5-6 day - extremely tired, no amount of sleep makes me feel awake, shortness of breath  WEEK 2 = 4/14 - 4/21/20 7- 9 day - shortness of breath, extremely tired, no amount of sleep makes me feel awake, dizzy, brain fog, headache that aspirin/Excedrin fixes, chills/hot flashes, muscle cramps, period came 2 weeks early
started as a pain but now it's a little worst today and more of a muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A or 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Cholesterol pills, 2 Blood Pressure pills, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
received shot at 3pm on the 31st. next morning at 6am woke up with bad headache like a migrane with nausea which I never get.  on left side of my head and into my teeth. was very tired and able to sleep off.   Also had a lot of loose stools.  felt better late afternoon and then headache returned and stayed with me all night and until about 10:30 next day and went away. on the 8th day I woke up with a swollen lower lip. I had also noticed during the week some dizzyness if moved my head too quickly. then on the 11th day that evening got a migrane and it went away in the afternoon and then came back the next night and did not sleep. was so strong down my left side of headand down my neck and nauseous and I threw up.  I  went to the doctor and he gave me a shot of toradal and a muscle relaxer which seemed to help.  I never get migranes so concerned this is a continued reaction to the shot. the loose fiberous stools seemed to continue for most of the week.
Pt developed swelling in her arm.  No redness or warmth.  No evidence of hematoma, just a golf ball-sized area of firmness.
Vaccine ordered and administered 1/25/23, had received already received recommended prenatal dose 1/11/23. Patient G1 P000 at 29w 4d GA at the time of the incident.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL and was fine. However, on an unspecified date, after receiving intramuscularly with the second 0.5 mL dose of GARDASIL (Lot# not reported) the patient experienced muscle atrophy. Concomitant therapy at the same time included an intramuscular injection of steroid (name and manufacturer unspecified). The patient did not want to get the third dose of GARDASIL. Unspecified medical attention was sought. At this time of reporting, the patient's outcome was unknown. As of 02-SEP-2010, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient describes having a tingling in their tongue upon receipt of the vaccine that went away. Then approximately 45min to an hour later started to experience an itchy rash at/around the injection site that progressed to a rash and hives that spread to her trunk and back. She was able to manage this with Benadryl and was fine the next day.
Full body urticaria (hives) that lasted for more than 3 weeks. Extreme itching.
lost 50% hearing; ringing in ears; rash under eyes; insomnia; headaches; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had lost 50% hearing; experienced ringing in ears, rash under eyes, insomnia, and headaches. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Guillian Barre syndrome; This is a spontaneous case initially received from other non-health professional on 30-Mar-2020, concerning a 44-years-old male patient.  The patient's medical history included borderline diabetes, hypertension and gout.  The patient's concomitant medications included lisinopril and allopurinol both for an unknown indication.    On 14-Feb-2020, the patient was administered Afluria Quadrivalent [influenza vaccine; route of administration: intravenous; anatomical location: deltoid; dose: 0.5 ml, batch number and expiry date: not reported] for influenza prophylaxis.  On 05-Mar-2020, 20 days after vaccination, the patient experienced tingling numbness in legs and hands. Patient was diagnosed with Guillian Barre Syndrome.  On 16-Mar-2020, the patient was admitted to the hospital.  On an unknown day in Mar-2020, the patient was treated with unspecified intravenous immunoglobulins (IVIGs).   On 22-Mar-2020, after six days in hospital, the patient was discharged.   At the time of his case, the outcome of event was not resolved.  The event of 'Guillain Barre syndrome' was considered serious due to criteria of hospitalization and medical significance.   Causality assessment per reporter was not provided.  Company comment: The patient developed Guillain-Barre syndrome 20 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with concomitant medication lisinopril. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed Guillain-Barre syndrome 20 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Causality may have been confounded by treatment with concomitant medication lisinopril. Based on provided information, causal relationship between the suspect product and the event is assessed as possibly related (defaults to "related" in the safety database for reporting purposes).