chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Roof of the mouth sore; roof of my mouth is swollen; sore arm; Fatigue; Muscle ache; itching; rash spreading all over my torso and neck; rash on her thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm) and RASH (rash on her thighs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and DILTIAZEM (CARDIZEM [DILTIAZEM]) 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 RASH (rash on her thighs). On 16-Feb-2021, the patient experienced PRURITUS (itching) and RASH (rash spreading all over my torso and neck). On an unknown date, the patient experienced ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and MYALGIA (Muscle ache). At the time of the report, PRURITUS (itching), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), RASH (rash on her thighs), RASH (rash spreading all over my torso and neck), FATIGUE (Fatigue) and MYALGIA (Muscle ache) outcome was unknown and ORAL PAIN (Roof of the mouth sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
pt recv vax 29JAN96 & 30JAN96 pt exp flu-like sx, intermittent fatigue, h/a that didn't resolve, dizziness, aching all over & lethargy;
Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022; Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 5:34 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jan-2022 at 5:34 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022) outcome 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.  Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes.  On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point.  Patient notified of error and that a repeat vaccine was not required.  Patient denied any adverse effects.
On 5/3/99 (four years post vax), the pt developed breakthrough chicken pox characterized by typical rash with fever of 103 degrees. The rash was described as "pruritic vesicles on red base scattered on arms, legs, trunk, face, and mucus membranes". It was noted that the chicken pox was a mild case with total of 45 vesicles. The pt recovered from symptoms on 5/10/99. No further details were provided.
No reaction at time of treatment. Pt says she is having odd pain in jaw go up to ear. Dentist x-ray shows irritation to nerve. Redness at injection site. Eval spot.
A report has been received from a pharmacist concerning a 63 year old, female subject, who had been receiving QLAIV (intranasal), one dose was administered. FLUMIST Quadrivalent started on 04-Nov-2014. The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between wrongful administration and QLAIV. Company physician assessed the causality between event wrongful administration to be unrelated to the suspect drug QLAIV. Corrected report 21-Oct-2015: Key ingredient corrected. Initial unit corrected.
After 3-4 hrs fever 103 highest; muscle pains; swelling in joints. After 24 hours shortness of breath-severe, dizziness, extreme swelling, pleurisy. All lasted about 3-4 days.
Small rotator cuff tear; Extreme pain in her right arm all over; Difficulty lifting and putting behind her back/ could not move right arm; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration at the right arm on an unspecified date in 2013 (reported as 7 years ago) in the afternoon at a single dose for prevention because of age in  the doctor's office. Medical history included hypothyroidism from an unknown date. It was reported that hypothyroidism was the only endocrine disorder and it was diagnosed way before receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Concomitant medication included influenza vaccine administered on the left arm vaccinated on an unspecified date in 2013 (reported as 7 years ago; on the same day with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)) for immunization. There were no prior vaccinations (within 4 weeks). On an unspecified date in 2013, extreme pain in her right arm all over, difficulty lifting and putting behind her back. It was reported that 24 hours after vaccination, patient could not move her right arm. It was not just where the injection site was. The patient had excruciating pain and could not lift up anything or put her arm behind her back or anything. This went on for over 4 months. The patient then went from doctor to doctor not thinking it could be from the shot. She finally got to orthopedic sports doctor who does injections. The patient underwent MRI and found a small rotator cuff tear although it was not near the injection site. The patient further clarified that it was not the same location as the pain. The physician ended up giving her a cortisone shot in her shoulder and as soon as he gave it, the pain went away. The patient recovered from the events on an unspecified date. The patient has another concern with the COVID vaccine. She would like to know if Pfizer can tell her if there are any bits of the same ingredients in the injection for COVID that were in the Prevnar 13.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received FLUZONE at 0700, developed flushed face & palmar erythema approximately 1530. No SOB or wheezing, received CLARITIN 10mg po, PEPCID 40mg po in clinic, BENADRYL 25-50mg for bedtime use.
Near immediate metallic taste in my mouth.  Resolved after 36 hours.   Body aches developed within 8 hours.  Resolved in 36 hours
3 wks after returning from abroad in July 1998, pt developed atrial fibrillation of the heart.  He has had this problem ever since receiving the vax and his career is on the line because of this.
severe headache today/sharp headache; pain in his arm where he got the shot/soreness and pain in his arm where the shot was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) (at the age of 48 years) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "severe headache today/sharp headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in his arm where he got the shot/soreness and pain in his arm where the shot was administered".  Additional Information: Reporter was calling about the Pfizer COVID 19 vaccine. He said yesterday he got the shot both him and his wife, he has had soreness and pain in his arm where the shot was administered and that is supposed to be normal he understands that. He said he would like to skip the report and get him transferred to the other department for information. He says make it a warm transfer directly to an agent. Caller reported the following side effects: severe headache today and pain in his arm where he got the shot. Can he apply Bengay to his arm where he got the shot? Can he take Tylenol or Advil for his headache?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme fatigue 5 days, myalgia 5 days, chills 3 days, fever 3 days, pain at injection site 5 days.
Pt complained of pain at injection site over an hour after the injection. No swelling or redness noted. pt says it hurts when moving his right arm.
My son rather than cry he whimpered and his body went limp after receiving the rotavirus, PREVNAR and DTaP. When is was putting on his clothes he was still limp and was having trouble breathing. When I sat him up to get the doctor he vomited streaky blood in the vomit and stopped breathing. The doctor bagged him once and he started breathing again. The pressure from the bag caused him to have a pneumothorax and he received two chest tubes because they did not put the first chest tube in far enough. He was hospitalized for a week for more testing. They did an endoscopy and bronchoscopy which were negative. After being released he went to the allergy clinic to receive his vaccines to rule out what may have caused the reaction. They gave each vaccine individually without giving him the pertussis which is what they think is why he had the reaction.
Administering potentially spoiled vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled vaccine) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administering potentially spoiled vaccine) had resolved.        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.   Concomitant medication was not provided Treatment information was not reported
Nausea, severe headache, vomiting, chills, dry heaves, body aches
a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.            Treatment information was unknown Caller received the 1st dose of the Moderna vaccine on 31Mar2021 (no expiration date) on her right arm and had a sore arm. She received the 2nd dose on 28Apr2021 (lot #010M20A, no expiration date) on her left arm and a week later she had a bad headache on the frontal lobe like if she had an aneurism, ringing on her ears, she went to a neurologist, got a MRI done, has had migraines everyday ever since, lost hearing of her right ear, tinnitus, brain fog, vision problems. Caller says she was healthy before the vaccine. She says she's part of a 300,000 people group who has had issues with vaccines  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.     This case was linked to MOD-2021-305146 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Immediate burning sensation, within 5 minutes localized swelling, redness and nausea. Ice applied and 50mg BENADRYL IM. Has had flu vaccine annually since 1999. Is also on PROZAC 20mg daily and Vitamin E 400 IU daily.
Date and time adverse event started: march 31, 2021, tired, arm ache, nausea husband has ms for 7 yrs, stable, recent mri was ok april 1, 2021, mid afternoon, weak, difficulty speaking, unable to walk  4/2-Patient was admitted last night on 4/1/2021, currently receiving IV fluids and still taking current medications, no new medications ordered. Patient is stable, speech is back and  is ambulating with assistance.  Awaiting to be evaluated by his primary provider, will follow up on Sunday on his condition. 4/4-Patient's wife returned follow up called on 4/4/2021 at 3:58pm: She reported Mr. was admitted to Hospital on 4/1/2021 in the evening and discharged on 4/3/2021 approx. at 1:30pm. She reported no new medication prescribe upon discharged, and to follow up with patient's PCP and neurologist. Mrs. reported that patient is back to normal
Above Person recived 1st dose in another state at "Pet Clinic" on 3/13/21. Came to University and received 2nd dose Pfizer. Informed her of getting two differnt products and provided written information about situation from CDC website.
Tues, day after injection, pt had severe fatigue.  Shooting pains up back and neck into head and right temple... opposite side of when she had shingles years ago.  Terrible itching on the back.
Myalgia & NauseaVomiting Narrative: Slight nausea w/in 5 mins resolved in a few hours. Day 2 mild body aches Aleve.
On 1/10/22 Patient had axillary lymphadenopathy and was evaluated by Dr.  Her chest pain started around this timse as well. Around Jan 26 she had redness and swelling of her hands that lasted several days and then resolved for about a week and then recurred again on 2/5/22 -~ 2/14/22.  Her chest pain worsened and she was evaluated on 2.9/22 and found to have ventricular bigeminy.  She was admitted to hospital.  She was on telemetry which showed persistent ventricular bigeminy.  All ectopy was monomorphic and of right ventricular origin.  She was discharged on 2/12/22.  ECHO nl, CKR nl, Cardiac MRI nl, Resp viral panel neg, cardiac enzymes NEG.  She is scheduled for an outpt holter.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA304444. This case involves a 14 years old female patient and reported that administered doses of MENACTRA that were not stored in appropriate temperature ranges, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE). On 25-Oct-2018, the patient received a dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6015AA and expiry date: 06-Oct-2019) via intramuscular route in right deltoid. It was a case of actual medication error due to incorrect product storage. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chills, body aches, headache, and vomiting. All lasting about 20 hours
I received Pfizer-BioNTech, lot # ER8737 covid-19 flu shot Monday, April 5th in the afternoon.   I did have a severe case of Covid-19 flu in January 2021. It took 1 month and + few days to recover sufficiently from its many flu like debilitating symptoms!   I did not have any anaphylactic symptoms from the covid-19 flu shot within the first 15 minutes of observation.  BUT-  As I was driving home, my upper left arm, at the injection site and beyond-  up and down my right arm, began to hurt something fierce with pains and numbness and tingling sensations.  By around 7:00pm that same day, I began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches!  I was driven to bed after taking Tylenols po and OTC cold/flu medications.  I have had these symptoms,  on and off for 4 days now and counting!  I am going to report these awful prolonged side effects to CDC, and Pfizer, and anyone else who will listen.  I will NOT be taking the second Pfizer Covid-19 injection.   I reported this information to Pfizer on 4-8-2021 am via  their web site   THANK YOU YOUR REPORT HAS BEEN SUBMITTED
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 3:41 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.22 years for batch number 014M20A. The age of patient was provided as 62.30 years for batch number 019B21A.  Concomitant products were not provided.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, Vials were moved to clinic on 30-Mar-2021. 03 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 02-Mar-2021, Excursion time was 09 AM,10 AM,11AM,12PM,2PM,3PM and temperature was 27,29,32,33,35,36 respectively, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, Vials were moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Adverse administration of a vaccine which was not indicated. Accidentally given a dose of Rotarix despite not indicated at this age.
Extreme fatigue, chills, sweating, headache all was bad lasting  for 2 days  2nd does of AZ had similar symptoms lasting 1 day  Moderna 1st shot : 4/1/21 Lot # 008B21-2A?.similar reaction to AZ shot 2nd dose:  5/4/21  Lot # 006C21A.  10:05am ?. Similar reaction to AZ  2nd dose Booster: Moderna  12/18/21 Lot # 041J21A?. Slight reaction?all shots given in left arm.
Acute onset of chills and shivering which turned into back spasms due go severe prolonged shivering. Moderate headache. TMax of 101.8. Fatigue. Fever broke at 5am. Temp back to baseline. Fatigued through  16:00 on 3/14. Otherwise feeling good. 3/15 fatigue mild.  3/16 diarrhea mild.
Severe pain in arm and shoulder, reduced range of motion.  Continues 1 month after.