chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fine after I was done with his shot. Per patient, he was feeling dizzy afterwards and fell in restroom. He came back to tell us in pharmacy. We gave him ice pack to apply to left arm (although there is no sign of swelling/redness). We gave him acetaminophen 500 mg OTC. Patient bought acetaminophen 500 mg and Benadryl 25 mg per our recommendation to take home with him for additional dose and to prevent allergic reaction. Told patient to wait for 15 mins to see if he feels better before driving home. 10 minutes later, patient just left on his own.
pt recv vax around 930AM by 5PM the arm was red & hot from the elbow to the shoulder w/a whelp @ the inj site;this lasted from 6AUG97 to 10AUG97;since 10AUg to present mom reports child gets whelps anywhere pressure is applied to the body;
On March 6, I had a mild stroke. Left arm, leg, and foot went numb for 15 minutes. Hospital performed diagnostic tests.  Stayed overnight for observation  and tests.  Symptoms went away.  I had an EKG, CT scan of brain, ultrasound of neck veins, brain MRI, and echo cardiogram.
sweating; congested; Hot flashes; Low grade fever; nausea; Pain in arm; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested) and HOT FLUSH (Hot flashes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (sleepy). On 14-Jul-2021, the patient experienced HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was given., No treatment medications were reported.
severe headache, severe full body aches, fever 103F. symptoms started all at once around 5-7hrs after vaccine injection. Treatment consisted only of Tylenol. It has now been 24hrs since vaccine injection and fever 100F, severe headache remains.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M002063 with expiration date at 12-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011133.
Came down with COVID, tested positive 10/31/22. Began Paxlovid evening of 11/1/22. Sore throat, cough, runny nose, teary eyes, tired. Feeling somewhat better 11/2/22, but symptoms continue.
Constipation has got worse; Has a sore arm; Sore neck/very painful; All of his teeth were sore; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation has got worse), VACCINATION SITE PAIN (Has a sore arm), NECK PAIN (Sore neck/very painful) and TOOTHACHE (All of his teeth were sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CONSTIPATION (Constipation has got worse), VACCINATION SITE PAIN (Has a sore arm), NECK PAIN (Sore neck/very painful) and TOOTHACHE (All of his teeth were sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Constipation has got worse), VACCINATION SITE PAIN (Has a sore arm), NECK PAIN (Sore neck/very painful) and TOOTHACHE (All of his teeth were sore) had not resolved.            The treatment medications includes roller ball with 5% menthol which helped also.   Reporter did not allow further contact
Fever of 101.1 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.1 F) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Oct-1900, the patient experienced HEADACHE (Headache). On 23-Oct-2021, the patient experienced PYREXIA (Fever of 101.1 F). At the time of the report, PYREXIA (Fever of 101.1 F) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101.1 f (High) Fever of 101.1 F.         No concomitant medications reported.  No treatment reported.   This case was linked to MOD-2021-362942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up  information received and contact information updated. On 28-Oct-2021: Follow up information received- email id updated
Kidney nephritis.  After 6 weeks, I am still currently being treated for this and no ETA has been given on how long the inflammation will last.  I start another high dose of steroids tomorrow to help with the inflammation.   So far the following medication have been prescribed for the pain in my right side from my paraspinal near my T4 around to the front of my ribcage are:  Cipro, Macrobid, 60mg Prednisone, anti-nausea medications, Flexeril, Naproxen ER, and Tramadol.
Patient was given shot and walked away to go get food, then came back within 5 minutes and sat in the waiting area. When approached he was pale and sweating. When asked if he was ok, he stated he felt like he was going to pass out. After sipping on some water and sitting on the floor, he never lost consciousness and spoke with us the entire time. After 10-15 minutes he was back up and feeling better, but still sweating. He was able to contact his fiancé who was waiting for him in the parking lot. He wanted to go grab food again and was last seen standing in line to purchase that food about 30 minutes after vaccination.
I then felt very fatigued & came down with w/a fever that night.; the headache was improved; I felt a lot of fatigue; a lot of arm pain; I felt some mild dizziness later in the day; irritable bowels throughout the day as well as a loss of appetite./My appetite is very much diminished; irritable bowels throughout the day as well as a loss of appetite.; I also started experiencing an odd ribcage/breast pain on the side of the injection (left side).; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EW0150), via an unspecified route of administration in the left arm on 02Apr2021 (age at time of vaccination: 55-years-old) at a single dose for COVID-19 immunization. Medical history included asthma, allergies to medications, food, or other products as Tree Nuts and NSAIDS. Concomitant medication patient received within 2 weeks of vaccination included zyrtec, vitamins C, Vitamin D, Vitamin E, Probiotic and Tylenol. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced about 90 mins after 1 vaccine dose on 02Apr2021 at 04:00 PM, she developed a strong headache. The patient then felt very fatigued and came down with fever that night. The next day (yesterday), the headache was improved still present but she felt a lot of fatigue and a lot of arm pain. She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. On 02Apr2021, a day after 2 vaccine dose, she again felt fatigued with mild headache. her appetite was very much diminished with still irritable bowels. She also started experiencing an odd ribcage or breast pain on the side of the injection, it was felt like deep shooting pains. There was no pain or redness or swelling. she not breast issues to date (last mammography was clear-Fall 2018). Facility where the most recent COVID-19 vaccine was administered was Clinic. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal swab was unknown on 02Apr2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Patient received vaccine on 8/16/12. The next morning RUA was very tender, sore, swollen, warm & red. Put cool compresses on it & took ALEVE. Became worse and followed up at clinic. Examination of injection site revealed edematous, hot, red arm. 4x3 inches, tender when touching. No drainage. Dx of cellulitis vs. reaction to vaccine. KEFLEX 500 mg tid PO x 10 days initiated.
Shingrix vaccination was administered to left shoulder. Pain a 6/10 requiring NSAIDs unable to bear weiht on left arm. Patient stated needle hit bone in arm and feels instead of the deltoid it may have hit the ligament.
Pt describes "can't get a breath in" Warm, dizzy, SOB, light headed, shaky  Assessed by AMR and transported to ED  Pt stated that she did not have any reaction to the first dose of the Moderna vaccine Pt stated that she was tested for COVID last week. Result was negative
pt recv vax;same day,devel localized swelling at inject site;pt felt sx related to vax;
Excruciating pain at injection site, diagnosed with Brachial Neuritis at Urgent Care facility.  Was given Vicodin and Naproxen for pain and inflammation.
Patient was given MMR and Varicella injection. Within 2 minutes of vaccine patient's legs swelled and a rash appeared. Was given 7.5 mg of BENADRYL. Patient's legs started to reduce in size and redness.
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VAQTA with lot # M038572 and expiration date on 11-MAR-2018 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA011485: US-009507513-1706USA011486: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011490: US-009507513-1706USA011484: US-009507513-1706USA011487:
03-26-2003- RN received a call from Dr. nurse stating that Dr. was having some patient and he has never had heart trouble before. The only thing different that he has done is get the smallpox vaccine. Nurse was directed to have MD call another MD.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 17-sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 17-sep-2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension NOS and Hypothyroidism.    On 17-Sep-2021 at 4:04 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 17-sep-2021). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 17-sep-2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 17-sep-2021) to be not related.    NO Concomitant & Treatment drug reported
Skin started pealing; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin started pealing) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LOSARTAN, TRIAMCINOLONE, CALCIUM and VITAMIN D NOS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PYREXIA (Fever). On 06-May-2021, the patient experienced SKIN EXFOLIATION (Skin started pealing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-May-2021, PYREXIA (Fever) had resolved. At the time of the report, SKIN EXFOLIATION (Skin started pealing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received vaccine to her Left Dominant upper arm
TEMPERATURE EXCURSION, vaccine was stored in freezer longer than manufactures recommendation. PATIENT DID NOT HAVE ANY REACTION TO THE VACCINE
This spontaneous report as received from a medical assistant refers to a 4 months old patient of unknown gender. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of oral, ROTATEQ lot # K011948 (dose, route and frequency were unspecified). No adverse events were noted. This is one of several reports received from the same reporter. Additional information has been requested.
The pt received vaccinations on 8/25/99, and that evening, developed an injection site reaction characterized by swelling, redness and warmth at the site. The physician noted that this event was related to Acel-Imune. IPV and Comvax were administered in the opposite arm. The pt recovered. This is 1 of 5 pt from this facility who experienced an adverse event following receipt of Acel-Imune.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, Vaccine brand: Pfizer / BioNTech, Vaccine brand unknown: False, Vaccine lot unknown AND Vaccine dose number unknown: False), on 10Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 026620A), in left arm, on 22Feb2021 as dose 2, single (Lot number: 011M20A), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: 014F21A), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: 056A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included [Other medication in 2weeks product]: VITAMIN D3 (Other medication in 2weeks brand); OMEGA 3 FATTY ACID (Other medication in 2weeks brand); CALCIUM supplement (Other medication in 2weeks brand). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022 at 12:00, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Report about COVID treatment: Yes. Anti viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 11Jul2022, Treatment stop date: 16Jul2022, Indication: Treatment of COVID-19. Known allergies: No. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer who is a 73 year old female patient with high blood pressure. On 11-MAY-2014 the patient was vaccinated with ZOSTAVAX, 1 dose (Lot no, unit not reported) in the arm. On 05-NOV-2014, vaccine was administered in the back of her arm. On 06-NOV-2014, 180 days after onset of therapy the patient experienced injection site reaction. Her arm was now hot, red and swollen where the vaccine was administered. The patient stated that she called the pharmacy where she received the vaccination to report her adverse event. The pharmacist who administered the vaccination, advised the patient to take either MOTRIN or ALEVE and use ice to alleviate her symptoms. The patient followed the same. No lab diagnostic studies were performed. Patient sought medical attention through the pharmacist who administered the vaccine. No hospitalization, product quality complaint was involved. The outcome of the event was not recovered/not resolved. The reporter causality was not reported. The patient had a history of allergy while on prior therapy with prednisone (case # MARRS# 1412USA000391). Additional information has been requested.
Vaccine recipient should have received Pfizer monovalent as primary series dose #1. The vaccine recipient received Pfizer bivalent as primary series dose #1.  Vaccine recipient was observed approximately 90  minutes post administration with no adverse  reaction signs noted, and recipients one-on-one school aid said vaccine recipient was "doing fine" and had not c/o any adverse reaction to vaccine.
Urticaria drug eruption on trunk of patients body. Itchy erythematous patches treating with Triamsinolone oin and antihistamines
I developed heart arrhythmia, tingling in hands and toes, hives on the 26th of September. I went to the ER 3 or 4 times a week up until January. They diagnosed me with thyroids. I was perfectly healthy besides me wanting to lose weight
5 days after being vaccinated I had terrible abdominal cramping and pain, so much so that I had to stay in bed. Since then I started noticing symptoms of bloating, gas, and cramping. Later this turned into constipation and loose bowels. My menses have also become irregular. They were very predictable before and now I have spotting days before, my periods are sometimes long, sometimes short. They are completely unpredictable, varying between 14-28 days between them. Shortly after having been vaccinated I also had issues with dry eye and was having frequent eye flare-ups. Not sure if any of it is related, but I never had these kinds of issues before this year.
back pain close to spine on opposite side of the vaccine - started 3-4 days after the vaccine
Patient presented with redness at the injection site about 1 1/2 inch in diameter he also complained of itchiness; this way approx. 15 minutes after injection. Patient purchased diphenhydramine and instructed for follow up care.
After 36 hours, side effects started including severe headache, vomiting, fever (101F), and fatigueness. I had two capsuls of Tylenol and two Ibuprofen. have very low appetite and overall not recovered after 72 hr.
Tingling, thoracic sensory level loss, urinary retention.  CSF protein elevated to 90.   Started approximately 3 weeks from time of vaccine.   Drug store  provided vaccine 04/06/2021 Admitted to hospital 04/27/21
11:38 AM - Hot flash over chest, arms, neck, and face. Elevated heart rate and anxiety that some thing bad was going to happen. Throat irritation and having the feeling to continuously clear throat. Labored breathing. 11: 55 AM - Hot flash over chest, arms, neck, and face. Elevated heart rate and anxiety that some thing bad was going to happen. Throat irritation and having the feeling to continuously clear throat. Labored breathing. 12:01 PM -  Throat irritation.  12:24 PM -  Took benadryl.  1:09 PM -  No symptoms.
Vaccine Meningococcal, Menatra from Sanofi Pasteur Inc. Lot U4237AA, expiration date 17 AUG 13 was administered tp the client, and after that, while sitted, she had a bried (1 min.) seizure, stretching the right leg and both arms, and rolling her both eyes. Client complained of being dizzy with blurred eyes.
Patient called on 11/22/2015 saying that she was concerned because her arm was swollen and "as big as a grapefruit" and very pink, hot, and concerned that the swelling was growing. Followed up with her on 11/23/2015 and she said that it was beginning to recede and that it was getting better but she had been very, very concerned on 11/22 and had symptoms from 11/21-11/22.
This spontaneous report as received from a pharmacist refers to a 57 years old female patient. There was no medical history, drug reactions/allergies. On 15-JAN-2013, the patient was vaccinated with ZOSTAVAX (lot # H018799; exp. date: 15-JAN-2014), (dose and route not reported). No other co-suspects were reported. Concomitant therapy included ascorbic acid, cyanocobalamin, ferrous fumarate, FERROGELS FORTE, acetaminophen, butalbital, FIORICET, amitriptyline hydrochloride (manufacturer unknown) and MAXALT. In January 2013 a couple of days after the administration of ZOSTAVAX, the patient experienced what seems to be nerve pain from her lower back down to the tips of her toes, a couple of days after administration of ZOSTAVAX. The patient went away within the last several days. The patient sought medical attention. No treatment was given for the event. On an unknown date, the patient recovered from the event. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: swellling and hot to touch at injection site-Mild, Additional Details: Patient stated that when she received the 1st injection she experienced a rash on her arm. As soon as this shot was injection she experienced swelling and the injection site was hot to the touch. Patient was given Benadryl and an ice pack was placed on her arm. I sat and monitored the patient until her parents arrived. She confirmed that she was not light headed or was not experiencing anymore side effects.
anaphylaxis  approx. 25 minutes after injection - took 50mg benedryl and recovered within 90 minutes of injection