chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states that after receiving the 3rd Booster of Moderna 10/29/2021, started experiencing symptoms 10/30/2021 of arm swelling (left) with heat and redness. Health Department communications recommendation to self-treat with Benadryl & Cold Compress. No noted Primary visit/communications.
Case number PHEH2014US003777 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 30 DEC 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Had a similar reaction with the Moderna covid vaccine as she did with the flu vaccine; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a similar reaction with the Moderna covid vaccine as she did with the flu vaccine) and HYPERSENSITIVITY (Allergic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a similar reaction with the Moderna covid vaccine as she did with the flu vaccine). At the time of the report, VACCINATION COMPLICATION (Had a similar reaction with the Moderna covid vaccine as she did with the flu vaccine) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient took Benadryl as treatment medication for the events.
Patient received her primary smallpox vaccination on March 4, 2004. On the third day following her vaccination, she reports that she developed a headache and a fever. These symptoms continued daily. Her fever was as high as 101F on two occasions. On day ten following her smallpox vaccination, she awoke with a rash involving her face, neck, arms, and legs. The rash was diffuse, red, slightly raised and pruritic on her face, neck and arms. The rash on her legs was annular and covered only her thighs. Some of the lesions blanched others did not. On this day she also experienced nausea and vomited twice. She went to the Medical Center and received Benadryl. She was scheduled to deploy on this day; due to the rash, she was placed on medical hold. She returned to the medical center on the following day and referred to the VHC. After examination by clinician and physician the patient was escorted to dermatology where a punch biopsy was performed.
Initial and follow-up information has been received from a physician concerning a 14 year old female patient, who on an unknown date was vaccinated with a first dose of Gardasil. It was reported that the patient experienced pain at the injection site after her first dose of the vaccine.  On 13-AUG-2007 (previously reported as 12-AUG-2007) at 16:20, the patient was vaccinated intramuscularly in the left arm with a second dose of Gardasil (Lot# 657872/0515U). On 17-AUG-2007 at 10:40 (previously reported as 16-AUG-2007), the patient experienced a low grade fever, pain, nausea, vomiting and flatulence. It was reported that the symptoms were believed to have been a viral infection as other family members had the same signs and symptoms about 1 week later. No medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. On 26-NOV-2007 the patient was vaccinated with a third dose of GARDASIL. The patient did not experience a reaction to the third dose. Additional information has been requested. Additional information is not expected.
Immediate temperature fluctuation, fogginess, it lifted fast and was able to drive home. About 30 minutes after I was home hives on my scalp, they disappeared in about an hour. 6 hours after the vaccine my hands broke out, and then I checked the rest of me, my chest was sunburn red, which is usually my first symptom when I?m having a reaction. I took an antihistamine and it all calmed down. No hives today, but I?m itchy. Pretty wicked headache. The antihistamine is almost out of my system.
Excessive crying for ~ 20 hours after 4 month shots. Admitted to clinic for 48 hours. Blood and urine culture were negative. Normal exam. No other symptoms.
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: positive, positive and positive.         The patient had not taken medications at all. He was active.  The patient had no taste or no smell. He was exposed to someone at work that had COVID.  This case was identified as part of a r etrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 59-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 days after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient was at 90% normal and had no taste or no smell. The patient tested positive for SARS-CoV-2 twice via COVID-19 rapid antigen tests and once via Polymerase Chain Reaction test. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Live Follow Up Appended. Patient demographics added. On 17-Jan-2022: Live follow up - Moderna suspect dose details and laboratory test date added.; Sender's Comments: This spontaneous case concerns a 59-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 6 days after receiving the third (booster) dose of the mRNA-1273 vaccine. It was reported that the patient was at 90% normal and had no taste or no smell. The patient tested positive for SARS-CoV-2 twice via COVID-19 rapid antigen tests and once via Polymerase Chain Reaction test. Treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
pt recvd vax 31OCT94 930AM & 1030 exp rash & hives on lt arm; no c/o SOB or breathing difficulty; reported itching & spreading of hives onto chest, abdo; contacted MD & was told to take DPH; 1NOV94 c/o soreness & redness in arm @ inject
Muscle pain; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced muscle pain and flu like symptoms on an unspecified date and wanted to know what to do. 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.
Disseminated vaccine - erythematous rash on chest and back.  Benadryl given for pruritis.
No significant event following vaccination except tired.  However, started with pain on trunk and abdomen on 5/14/2021. Progressed into lesions on right side of stomach, under arm and on back. Diagnosed with shingles. Dr. Teledoc as part of my  benefits.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions  were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) lot # N015977, expiration date on 20-MAY-2018 (properly stored). On 10-JAN-2018, the patient was vaccinated with a properly stored expired dose of VARIVAX lot # M000998, expiration date on 07-JAN-2018 (anatomical location and administration route were not reported) for prophylaxis. No adverse effects reported.
Covid19 vaccine: The patient received her second dosage of Moderna on 3/23.Patient called family medicine triage on 4/1 regarding arm/shoulder pain from her vaccine site that was not improving. Pain started out near injection site but last couple days has been spreading to shoulder, some possible swelling, per patient. Finding it hard to sleep. Denies redness, warmth. Feels warm but no chills, doesn't have thermometer at home.     The patient refused to call the COVID hotline.    She was calling for an in-person appointment and was triaged for her symptoms.  The next in-person appointment was not until Saturday 4/3, and it was given to the patient.  She did not want to go to the ED.  She suffered a witnessed massive heart attack the same day in her home and her partner called 911. Per parnter's report, walked around a little that day, in discomfort. Then came home and laid down with more arm pain. She had acute L arm pain and then agonal breathing - passed in order of 2-3 minutes. Likely cardiac arrest after MI for few days.  She was BIBA the EMTs continued CPR for ~20 minutes but was unable to revive patient. She was pronounced dead on 2023.
Approx 2 hrs after vaccine injection his speech was slurred and had a seizure. He was then taken to hospital.
no additional AE; HCP reported PROQUAD was inadvertently administered to a 16 year old patient instead of MMR II. No additional AE or PQC reported. No additional information provided.; HCP reported PROQUAD was inadvertently administered to a 16 year old patient instead of MMR II. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from the Medical Assistant, and refers to a 16-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 19-JAN-2023, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (recombinant Human albumin), lot # W019627, expiration date: 19-DEC-2023, for prophylaxis (anatomical location, strength, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (wrong product administered, product administered to patient of inappropriate age). No additional information was provided.
Pt fussy w/rash appearing 5DEC91; Seen by MD 6DEC91; pt had generalized rash; afebrile but has been on  Tempra; cough w/mild cold sx; ?viral vs MMR rxn;
Severe headache, chills (temporary), watery eyes, swollen tongue, great difficulty swallowing and difficult to eat due to inability to swallow (long-lasting). I have to mash my food to be able to get it down.
It started by extreme chills and extreme shaking. I sat down, Then the next time I tried to get up. I could only struggle to slid eto thefloor. Then I had to slither to the restroom because I could not effectively crawl do to zero muscle strength in my arms and legs. The extreme condition lasted about 24 hours. The next day I could walk short didstances butwas not stable. I anm finally close to normal on Friday Dec 10.
Five weeks after the vaccine I started to have sharp pain in spots on my legs. I felt like I need to rub them. The pain moves all over my legs. Sometimes one spot is worse than another. There is no visible sign of the spots that cause pain. I noticed that there were some spots at first and they would improve. Then when the pain returns it is in a different area. Originally I noticed it on my lower legs and currently it is on my thigh. It is painful to touch like a deep pain in the muscle. Some days it is worse than others. I used to walk on the treadmill for twenty minutes a day and now I cannot do any walking. It has not improved any and the areas where it hurts changes over the course of a couple of weeks.
Had a fever about a 102; This is a spontaneous report from a contactable consumer (patient's wife).  A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, at single dose on 18Dec2020 for COVID-19 immunisation. The patient did not have a relevant medical history and concomitant medications. On 19Dec2020, the patient had a fever about a 102. The outcome of the event was unknown.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with diabetes, hypertension, untreated hypercholesterolemia and penicillin allergy. On 11-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J003796 (Exp: 28-JUN-2014), 0.65 ml, subcutaneous. The concomitant medication included unspecified medications for diabetes and blood pressure. The pharmacist reported that on the morning of 13-OCT-2013 she woke up and noticed 5 to 7 rashes spots on her leg. Throughout the day of 13-OCT-2013 more rash spots developed on the patient's leg and she currently had about 12 rash spots presenting on her leg. The patient went to see an unspecified physician that told the patient it was not a varicella-like rash, however the pharmacist stated that it looked like varicella to her. The patient placed a warm heating pad topically to the areas of the rash. The pharmacist instructed to patient to stop using the heating pad. The patient was also using hydrocortisone topical cream (manufacturer unknown) on the areas of rash. No lab diagnostics studies were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Report of body aches, cough, congestion and sore throat.  No home remedies. Outcome: referred for testing.
Patient has redness, swelling and skin pulled off about the size of a quarter, some bleeding.
Pt had stroke 1 month post 2nd Pfizer vaccination. Symptoms began shortly after vaccination. Pt now on medications due to injury; ASA 81 mg PO daily, Atorvastatin 40 mg PO daily, lisinopril 10 mg PO daily, Plavix 75 mg PO daily, Pt hospitalized and did PT for months post stroke
Report 20000303341 describes dizziness in a 13 year old female who received Engerix-B for prophylaxis of hepatitis B. This report was received from the vaccinee's father and has not been verified by a physician or other health professional. Allergies, medical history, and concomitant medications were denied by the reporter. On 09/01/2000, the vaccinee received her third dose of Engerix-B. Subsequently, the vaccinee experienced fever, chills, headache, dizziness, and was required and unspecified treatment was given. As of 10/05/2000, the outcome of the events is unresolved.
This spontaneous report was received from a pharmacist via a company representative regarding a 60 or 61 years old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On approximately September 2015 (reported as within the last week (date unspecified)), the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately September 2015 (reported as date unspecified), the pharmacist noted that the patient came to the pharmacy after receipt of the ZOSTAVAX with extensive bruising , and a large hot welt at the injection site of the ZOSTAVAX. The pharmacist suggested to the patient to seek medical attention to her physician. It was unspecified if treatment was given to the patient. At the time of the report, the outcome of the extensive bruising and a large hot welt at the injection site of the ZOSTAVAX was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
On 5/20/22 Patient started getting a rash on the site of injection, the rash got worse as days past by. On 5/20/22 and 5/21 /22 she took Benadryl and applied Hydrocortisone. She called us on 5/23/22 to inform us of side effect. She mentioned that then her rash was now hives and wanted to know what to use. I advised her to use an antihistamine like Benadryl, Zyrtec or Claritin. Patient said she would try this. On Saturday May 28th I called her to follow up on how she was. She said her rash kept getting worse and that she went to the hospital on 5/25/22. They prescribed Prednisone and an antihistamine. Per patient she did not pick it up at pharmacy due to concerns since she is breastfeeding. I told her it was important to take those meds. She said she would pick them up on 5/25/22.
This spontaneous report was received from a nurse refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose and frequency not provided). No concomitant therapy was reported. On an unknown date the patient had a really bad reaction to M-M-R II when she was in college, that was almost anaphylactic. The outcome of the event was unknown. The causality assessment was not provided by the reporter. Additional information is not expected.
PT STATES 6 HOURS AFTER VACCINATION STARTED EXPERIENCING REDNESS, SWELLING, AND HEAT. OVER THE LAST 30 HOURS IT HAS SPREAD OVER THE ENTIRE UPPER ARM AND NOW HAS FEVER (TEMP 101).
Office Visit 7/8/2021 Family Medicine COVID-19 virus infection +2 more Dx Covid-19 Screening  Reason for Visit Progress Notes (Nurse Practitioner) ? ? Family Medicine ? ? Encounter Date: 7/8/2021 ? ? Addendum     Nontoxic 65 y.o. male presenting with viral symptoms for a week with known exposure to COVID-19 household member.  Reports periods of diaphoresis without chest pain or palpitations.  On exam hemodynamically stable without respiratory distress or hypoxia.  Appears well-hydrated with clear breath sounds.  Chest x-ray-no acute process.  EKG sinus rhythm ventricular rate 75 bpm.  No ischemic changes.  COVID-19 testing completed. Instructed to quarantine at home according to Department of Health guidelines. Symptomatic treatments reviewed. Red flag symptoms for follow-up reviewed.    Addendum: Covid 19 result positive.  Patient was contacted with test results.  Again encouraged symptomatic management with over-the-counter cough and cold medication, Tylenol or ibuprofen, stay hydrated.  Follow-up with PCP for shortness of breath, uncontrolled fever, uncontrolled vomiting.  Symptoms began July 6.  Last day of isolation is July 16th 2021.  Monoclonal antibody infusion discussed with patient but he feels that his symptoms are not severe enough at this point.  States he will call back if symptoms worsen.      1. COVID-19 virus infection  2. Night sweat  3. Cough      Patient was seen today for covid-19 screening.   Diagnoses and all orders for this visit:   COVID-19 virus infection -     X-ray chest 2 views; Future -     POCT COVID-19 PCR   Night sweat -     ECG 12-lead: URGENT CARE -     POCT COVID-19 PCR   Cough -     X-ray chest 2 views; Future -     POCT COVID-19 PCR
chills/ shivering and chattering teeth; shivering and chattering teeth to point where jaw hurt; severe headache; nausea; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizerep7533) via an unspecified route of administration at right arm on 25Mar2021 at 10:30 (35-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was reported as none. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications (other medications) the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizeren6199) at left arm on 04Mar2021 at 19:45 (35-year-old at time of vaccination) at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Patient experienced chills at 3 AM following the vaccine, shivering and chattering teeth to point where jaw hurt, severe headache and nausea (all from 26Mar2021 03:00) for four days following 2nd dose vaccine. Adverse events did not result in emergency room visit or physician office visit. Seriousness was reported as no. Since the vaccination, the patient has not been tested for COVID 19. No therapeutic measures were taken as a result of the event. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
I had terrible knee joint pain, more in my left than my right. Also pain on the outside of my left knee. I was limping and couldnt walk very well and so I went to the doctor on the Tuesday after my vaccine. Doctor told me to take NSAIDS but I cannot take them, I did not that then. She had me go get xrays. She said if it didnt get better I was to go see an orthopedic.  The following Monday I went to see an orthopedic. He said I have arthritis. I called the doctor back and said I need an MRI because the pain was still there.
C/o SOB, feels like throat closing and itchy.  02 99% RA.   Given Zyrtec 10mg, PO @ 1300.   Pt advised to make sure she speaks PCP prior to coming for 2nd dose.
Patient reported initial reaction - itchy, painful (non-swollen) eyes about 2.5 hrs after vaccine. This progressed into dry throat/mouth and eventually increased heart rate and vomiting.