chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Plaintiff suffered sudden vision loss and burning of her eyes. Plaintiff was diagnosed with acute iritis and reoccurring uveitic flares; acute iritis; post herpetic neuralgia; Sudden vision loss; shingles; This spontaneous report has been received on 20-MAY-2020 from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden vision loss and burning of her eyes. She was diagnosed with acute iritis and reoccurring uveitic flares. She also suffered shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using it. She also experienced 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, she 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of sudden vision loss and reoccurring uveitic flares were considered to be medically significant. All events were determined to be disabling by the reporter.
I wasn't feeling good on October 31st, but I was really tired the next day I had some dull chest pain discomfort and my right arm felt the same with some numbness in my left fingers. It continued all week. I called the doctor early the next week and got an appt. She did an EKG and it was normal, and she also ordered a new prescription for me for amlodipine besylate to use for what she said was Angina and High blood pressure and some nitroglycerin pills that I haven't taken yet. After that I felt better. I do still have some left arm discomfort occasionally but my blood pressure has gone done since taking the high blood pressure pills. She referred me to a cardiologist who I saw yesterday, 1/10. He said he thought it was fine but wants me to do a stress test soon.
Information has been received from a pharmacist and a 62 year old physician reporting on himself who on 17-MAY-2007 was vaccinated with Zostavax. On the morning of 19-MAY-2007 the patient developed severe, painful, peripheral edema of the left hand. There was swelling, numbness and stiffness of the hand. The hand looked like there was potential for infection so the physician started himself on intravenous (IV) ROCEPHIN on 22-MAY-2007 with no improvement. The physician has been treating the hand with elevation and warm soaks, as per the advice of an infectious disease doctor. Treatment has also consisted of ASPERCREME with little relief and ADVIL, however, the hand is still the same. As of 24-MAY-2007, the physician described the event as a severe reaction. As of 25-MAY-2007, approximately eight days after the swelling in the hand began, it still persisted and was still painful. As of 08-JUN-2007, the swelling had resolved. The physician mentioned that the swelling could have been from a spider bite. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
The patient reported feeling a rush of blood to his head and then head pain localized in his forehead about 10-15 minutes after receiving the vaccine which lasted for about 5 minutes. He then reported having a strange taste in his mouth about 15-20 minutes after receiving the vaccine which lasted for 10-15 minutes. All of these reactions resolved on their own by about 30 minutes after the vaccine before he left the facility.
At 6:45pm immediately after vaccination client stated she had an itchy tongue, ears, face, and hands. 3 sets of vital signs taken, water provided, Benadryl PO 25mg provided. Client observed for 45 minutes. No signs of distress or difficulty breathing. After 45 minutes client verbalized she felt okay, itching lessened, and she would like to go home.  Advised and educated client that if conditions persists or worsens she should seek medical attention. Client left with cousin in no visible distress normal gait.
After receiving my flu and tetanus shots on 9/21/15 I began to develop tenderness and pain in my muscle under my arm - below where vaccinations were administered. This has continued to hurt since vaccination with no relief. The pain is described as an ache and pinch loaded under my right upper arm, where both vaccinations were administered. The pain is a noticeable pain that has bothersome and unchanged since administration. This in no way prohibits me from performing my job duties or ADL.
Red and inflamed area approx 2 inches below and away from injection site. Pt approached pharmacy 2 day after injection. Suggested BENADRYL and F/U with MD if gets worse or no improvement.
headache; had a little fever and felt warm; had a little fever and felt warm; chills; felt light headedness; her blood pressure dropped; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from 01Feb2021 to an unknown date Verbatim: tested positive with the covid-19 virus on 01Feb2021. The patient's concomitant medications were not reported. On 10Mar2021, the patient experienced felt light headedness, her blood pressure dropped. on 11Mar2021, the patient experienced a little fever and felt warm, chills. on 12Mar2021, the patient experienced headache. It was reported that patient called in because she got her 1st dose of the vaccine on 10Mar2021. She said, a few minutes after her first dose, she felt light headedness and her blood pressure dropped. They waited like 10 minutes; she drank water then her blood pressure went back to normal. Thursday morning, 11Mar2021, she had a little fever and felt warm. She also had chills, but it just came and went vaguely and in a very short period of time only. She also started having a headache on Friday, 12Mar2021, and the headache just comes on and off. She wants to know if it was normal. She also said that she tested positive with the covid-19 virus on 01Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on an unspecified date, Sars-Cov-2 antibody test: positive on 01Feb2021. The outcome of the event headache was reported as not resolved. Outcome of event chills was reported as resolved on 11Mar2021. Outcome of the rest of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
on day number 12 at 5am she noticed some pain at the injection site. It had a small amount of redness around the insertion site (6 cm in size). At 9am it continued to hurt, it was read and warm to touch. She was reluctant to move, applied lidocaine cream with minimal relief and the redness continued to about the size of 14 cm in size. It was very painful, and warm to touch.
Mom gave report of events to this nurse over the phone.  Mom states patient was fine when went to bed at 10:00 PM.  Woke up at 1:00 AM and baby was making grunting noise, dad picked up to rock him and noticed he was "burning up".  Used digital thermometer that is used across the forehead, but mom states can be used in the ear.  They used it in the ear and say they got 106 or 107 degrees.  Then used across the forehead and got 102.  They then gave him motrin and tried to give him a bath when within 2 minutes of receiving the motrin eyes rolled back in his head and was shaking. Then went limp and unconscious for approximately 5 seconds.  Mom called 911.  When ambulance arrived mom and dad went outside with him and state he began vomiting. Then was transported by ambulance to Medical Center.
Experienced the following symptoms in the 24 hours after receiving the second dose: Elevated temperature, diarrhea, sore throat, cough, headache, sinus inflammation, dizziness, nausea, muscle pain, weakness, body aches and muscle spasms, lack of energy, trouble breathing, insomnia.
Hashimoto's thyroiditis; Subacute thyroiditis; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (feeling ill). In June 2021, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis) (seriousness criterion medically significant) and THYROIDITIS SUBACUTE (Subacute thyroiditis). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis), THYROIDITIS SUBACUTE (Subacute thyroiditis) and MALAISE (feeling ill) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  The patient started feeling ill in Apr2021 and was diagnosed to have Hashimoto's thyroiditis and subacute thyroiditis in Jun2021. She was currently being followed up by an endocrinologist with regular ultrasound. No medications are being taken.  Company comment This case concerns a  54-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hashimoto's thyroiditis. The event occurred approximately 4 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after the second dose. This patient's age and sex remains a risk factor in the reported event. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  54-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hashimoto's thyroiditis. The event occurred approximately 4 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after the second dose. This patient's age and sex remains a risk factor in the reported event. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Severe pain at injection site and area, palpitation type problems (already under physicians care for a sometimes overactive thyroid), headache and recent long term bout of polyarthritis.
Fever, chills, loss of taste, throat congestion, arm pain, fatigue, body aches
Chief Complaint Patient presents with ? Cough ? Shortness of Breath     HPI  is a 76 y.o. male presenting to the ED for assessment of approximately 2 weeks of shortness of breath and cough that has been progressively worsening.  Patient's wife did test positive for COVID-19 2 weeks ago.  At this time patient has been taking over-the-counter cough and cold medications with no relief of symptoms.  Patient does have a history of atrial fibrillation.  Patient does take Lopressor daily.  At this time patient denies any headache dizziness confusion chest pain nausea vomiting diarrhea abdominal pain dysuria rashes leg pain leg swelling.   PCP: , DO
ipsilateral axillary lymphadenopathy; Lymphangitis; Injection site cellulitis; Injection site streaking; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LYMPHANGITIS (Lymphangitis) in a 35-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.     Concurrent medical conditions included Lymphadenopathy axillary (from the first moderna vaccine on 1/8/21) since 08-Jan-2021.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced LYMPHANGITIS (Lymphangitis) (seriousness criterion medically significant), INJECTION SITE CELLULITIS (Injection site cellulitis) and INJECTION SITE STREAKING (Injection site streaking). On an unknown date, the patient experienced LYMPHADENOPATHY (ipsilateral axillary lymphadenopathy). At the time of the report, LYMPHANGITIS (Lymphangitis), INJECTION SITE CELLULITIS (Injection site cellulitis) and INJECTION SITE STREAKING (Injection site streaking) had resolved and LYMPHADENOPATHY (ipsilateral axillary lymphadenopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
redness got bigger; itching at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness got bigger), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history was not reported.  Concurrent medical conditions included Osteoarthritis (new diagnosis of possibly rheumatoid or osteoarthritis). Concomitant products included MELOXICAM and CIPROFLOXACIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 10-Feb-2021, the patient experienced ERYTHEMA (redness got bigger). The patient was treated with DIPHENHYDRAMINE for Itching, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness got bigger), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
flu vax given on 6OCT93; pneumococcal vax given 7OCT93; joint pain & stiffness noted on 7OCT93; 14OCT93 noted inc joint pain, chills & high fever to 103 & 104; 17OCT93 chest pain & SOB; 16OCT ER visit on 18OCT93 including lt upper abdo pain
Site of injection was sore, red, feverish, bruised. Induration measured by nurse practioner x4.5 cm
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient).  A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
Bell?s palsy in left side of face  Pain and tightness from under injection site to forehead Burning pain in left nostril when breathing in that travels up into left eye to left eyebrow
Client was administered VZV & MMR 12-14-09. She came back 12-18-09 stating she was pregnant.
After about a week a large 3 inch circle appeared at injection site has lasted 3 days so far doesnt necessarily hurt or itch but is hot to the touch.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      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.   No Concomitant medications were reported No treatment medications were reported    This case was linked to MOD-2021-100450 (Patient Link).
It was reported that a pt received TD vaccine during the last week of July. Reportedly, sometime after the vaccination, the pt's arm turned red and became tingly and itchy at the injection site. From follow-up #1 telephone conversation on 21-May-2001, the correct reporter address was provided.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 28-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Date of administration of vaccine: 24-OCT-2021 -  27-OCT-2021.
Rash in the right arm around the injection site; Burning sensation in the right arm around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and diabetes. The patient had no known allergies. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), metoprolol tartrate (MANUFACTURER UNKNOWN),  metformin((MANUFACTURER UNKNOWN) and atropine (MANUFACTURER UNKNOWN) taken for unknown indication from an unspecified date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 08Mar2021 at 14:30 ( at the age of 39-years-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 13:00,  the patient experienced rash and burning sensation on his right arm around the injection site (vaccination site rash ; vaccination site burning). The events happened 2 days after the shot (as reported). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events rash in the right arm around the injection site and burning sensation in the right arm around the injection site was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
no adverse event; dose of PROQU AD was administered after experiencing a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 25-MAR-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (at the dose of 1 dosage form, lot # T005404, expiration date reported as 24-MAR-2022, but upon internal validation established as 12-AUG-2021) was administered as prophylaxis after experiencing a temperature excursion (product storage error). The temperature was 37.2 F and the time was 3 hours. No previous temperature excursion was reported. The call was because of a data logger. No other adverse event (AE) was reported.
Pre-term labor and delivery (unknown if caused by vaccine, but the woman who called me and said it should be reported)  I was 6 weeks pregnant when I received the first dose of Moderna vaccine and 10 weeks pregnant at the second dose.  This was my first pregnancy and there were no complications during the pregnancy.  I had a normal ultrasound at 9 weeks.  My due date was 10/1/2021 and my baby was born 9/1/2021 at 5 lbs 8 oz.  He had an 8 day stay in the ICU and was discharged on 9/9/2021.
contracted COVID-19; sore throat, sinus congestion, headache, cough, low grade fever (100.2) for 2 days.  Took Tylenol for headache, Robitussin for cough.  Symptoms other than fever lasted 6 days, cough lasted 2 weeks. Had tele-doc call with my doctor.