chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Whole body hives), VACCINATION SITE PAIN (Tender injection site), VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue). On 20-Mar-2021, the patient experienced URTICARIA (Whole body hives). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender injection site). The patient was treated with MONTELUKAST at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Mar-2021, VACCINATION SITE PAIN (Sore injection arm) and FATIGUE (Fatigue) had resolved. On 21-Mar-2021, URTICARIA (Whole body hives) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter.
Patient likely had a reaction to the influenza vaccine, with localized swelling, rash covering vaccine area and spreading around right arm. Symptoms began evening of 8/23/16 and worsened morning of 8/24/16. No systemic systems associated with the rash. I told the patient to take Benadryl, and I recommended an over-the-counter hydrocortisone 1% cream to use twice daily until the rash resolves. I told her that if the rash starts to spread, or if she has any other symptoms like facial swelling or difficulty breathing, to report to a physician immediately for stronger treatment. Symptoms have already begun to recede following a single Benadryl dose, and patient is expected to make a full recovery.
Nausea, headache 5 mins post vaccination, minimal epigastric tenderness No shortness of breath, no rash Patient drank water, no vomiting. Patient felt better, no more abdominal pain. Patient craved for fried chicken.
8 erythematous wheel lesions on arm, trunk and leg and back, oral antihistamine with marked improvement but no resolution
Chest Pains a month after receiving the second dose. Nothing found at ER.  I still experience chest pains occasionally.
stated involuntary movements in shoulders, neck, face, perspire profusely on skin, arms, shirt cold and wet, bp 180/100pulse 84, irregular pulse, look of fright on face, felt being pulled toward ceiling, skin was ashen, no apparent sob, no nausea or pain radiation, pain localized in chest and abdomnial area, tingling all over, took cetirizine 10mg (due to allergy and had received 2nd dose) within 15 mins got up then reclined bp was still  148/90 pulse still irregular but no distress, did not go to er, went through night with no further episodes,
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ by oral route (dose and frequency were not reported) lot # K023537, expiration date 22-JUN-2016. No adverse experiences were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
On evening of vaccine, patient developed arthralgias,right eye felt irritated, 30% vision loss with blurring . During the night, developed fevers, chills, substernal chest pain with radiation towards his back and bilateral arms. mild SOB. Next day, continued chest pain/angina, worsened with climbing a flight of stairs. Admitted to ED/ICU 2/16, general myalgias, Temp 100.7,  CP 1/10 on arrival to ED. Small abrasion to right eye noted after flouroscein stain.
Pox after immunizations, infant developed fever up to 102 degrees, and  inconsolable crying and abdominal pain. Blood cultures and urine cultures done fever resolved in 2 days. Abdominal pain continues.
This case was reported by a nurse and described the occurrene of inappropriate age at vaccine administration in a female patient who received KINRIX (batch number 95ZT7, expiry date 10th October 2015). On an unknown date, the patient received KINRIX. On an unknwno date, an uknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: A 7 months old was administere with KINRIX as her 2nd DTAP and 2nd IPV.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2016, the patient was vaccinated with dose of ZOSTAVAX vial 19400 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reported received from the same reporter. Additional information has been requested.
developed Covid-19 infection; developed Covid-19 infection; 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 26 year-old female patient received bnt162b2 (BNT162B2), administration date 26Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "developed Covid-19 infection".  Clinical Course: Patient received first dose of Pfizer Covid vaccine on 26Dec2021, subsequently developed Covid-19 infection. Caller is seeking information as to whether or not she can receive her second dose today.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (More than half of the dose was administered) and VACCINATION SITE DISCHARGE (Vaccination site discharge) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 02-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (More than half of the dose was administered). On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (Vaccination site discharge). At the time of the report, ACCIDENTAL UNDERDOSE (More than half of the dose was administered) had resolved and VACCINATION SITE DISCHARGE (Vaccination site discharge) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of Accidental under-dose and Vaccination site discharge for mRNA-1273 (lot# 013A21A) with no associated adverse events.
it was rpt fr MD concerning pt who was vax & devel breakthrough chickenpox. addl info req
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 30-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of vaccination and no adverse reaction reported since given vaccine.
Parkinson; This is a spontaneous report from a contactable consumer (wife) from a Pfizer-sponsored program. A contactable female consumer reported for a patient (husband) that: A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included fludrocortisone acetate (FLUDROCORTISONE [FLUDROCORTISONE ACETATE]) taken for an unspecified indication from an unspecified date in April. (patient was on fludrocortisone and started in April, wants to know if any drug interaction with steroid and the booster vaccine). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 25Jan2021 as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced Parkinson. Reporter stated her husband also has Parkinson, wanted to know if it was okay if he gets the booster vaccine (going to have his booster on the 22Nov). The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This is an instance of COVID-19 breakthrough disease after which death occurred.  The individual was vaccinated with the Pfizer product on 02/03/2021 and 02/24/2021. They became symptomatic approx 12/06/2021 and tested positive for COVID-19 twice on 12/13/2021. They presented to Emergency Dept on 12/06/2021, 12/16/2021, 12/18/2021, and 12/20/2021. After the emergency dept visit on 12/20/2021, they were admitted to hospital. They were transitioned to palliative care and remained hospitalized until their death on 01/04/2022.
I woke up around 0330 with a searing pain in my right shoulder area. I couldn't move or touch it and it even hurt too much to roll my sleeve up to look at it. I finally was able to roll up my sleeve and my whole shoulder was completely swollen. I took a couple of ibuprofen and iced it for about 2 hours. When I woke up it was still painful to lift my arm but the pain had subsided considerably.
5 minutes post injection, client c/o of itching every where; redness noted on upper chest, extending to face - just below the eyes and redness noted on upper back.  Client denied respiratory symptoms at this time.  Epinephrine 1:1000  0.5mg given IM @ 9:55AM.  EMS contacted.  Client transported to ER.
Two months after the second shot I began having what I thought was a sinus infection and cough..  As this persisted I went to my local doctor who prescribed a Z pack and antibiotics.  A week later I felt some difficult breathing  went back to the doctor who prescribed an inhaler. By week three I started to see improvements and by week four I was back to normal.
Anaphylactic reaction; A spontaneous report was received from a physician concerning patients (ages and genders not specified) who received Moderna's COVID-19 vaccine (mRNA-1273) or Pfizer's COVID-19 vaccine and experienced anaphylactic reaction.  The patients' medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown in Dec 2020, the patients received dose of either mRNA-1273 or Pfizer's COVID-19 vaccine (batch number unknown, route of administration, site of injection not provided) for prophylaxis of COVID-19 infection.  On unknown date in Dec 2020, the physician reported that patients (who were employees) received the vaccine and one of them ended up in intensive care unit for several days. Within a week or so, another 2 patients had less severe, but did have anaphylactic reaction to the vaccine. Initially was Pfizer, and Moderna came in later. There were a total of around 5 to 6 patients out of about sixty five thousand in which vaccines were administered. The physician emphasized that this was for both vaccines, not just Moderna.   Action taken with mRNA-1274 was not provided.   The outcome of event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of anaphylactic reaction, a causal relationship cannot be excluded. Further information has been requested.
POUNDING INCREASE HEART RATE; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (POUNDING INCREASE HEART RATE) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036M21A and 016M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (POUNDING INCREASE HEART RATE). At the time of the report, HEART RATE INCREASED (POUNDING INCREASE HEART RATE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 206 (Inconclusive) 206.         No concomitant products were reported. No treatment information was provided.  Action taken with the drug in response to events was not applicable.
I was dizzy for about 4 months after receipt of the shot.  My heart rate dropped to about 60 per minute.  My usual heart rate is about 98.  I worked from home for about 1 month to avoid driving and possible adverse effects.
Patient attested to immunocompromised status with high dose corticosteroid active treatment and received third dose rather than booster. Patient called today to update on reaction following vaccine administration. I spoke with patient on the phone for approximately 15 minutes. Patient explained that she received third dose on 11/05 and woke up feeling under the weather on 11/06. Patient fell asleep early afternoon, and husband unable to rouse. Patient believes she was febrile. Husband called an ambulance, and patient transported to hospital. As per patient, she was hospitalized from 130PM 11/06 to 11AM 11/08. I asked patient about tests, medications, treatments, etc. Patient claims she was COVID negative, and temperature decreased quickly after being admitted. Patient unable to recall many details from hospitalization including any of the above questions. Patient reports that she was not intubated and only on room oxygen; supplemental oxygen not required. Patient noted that her potassium was slightly low. Patient says she is still not feeling well but denies being febrile or other significant signs or symptoms.
NO adverse event. Nurse attempted to give client vaccine but almost all of the vaccine leaked out between the syringe and needle. Client was revaccinated as he did not receive a full dose of Moderna.
Information has been received from a licensed practical nurse concerning a 14 year old female with amoxicillin allergy who on 21-NOV-1997 was vaccinated subcutaneously with a first dose of VARIVAX (Merck). The licensed practical nurse reported that on 07-APR-2008 the patient experienced scincitial lesions 20-30, few scabbed, some milky vesicular papules, fever + pruritic. At the time of the report the patient status was unknown. No further information is available.
Mother brought patient in to have her school vaccinations updated. Per the school form the patient needed; HPV, Meningoccal and Dtap. On said date I administered the 3 vaccinations without incident. On 8/30/17 a billing issues came up for the Dtap vaccination due to the patients age. I consulted with Health dept to confirm which vaccination the patient should have recieved. Per HD patient should have recieved Tdap which is an adult dose vs Dtap which is a pediatric dose. No harm has come to the patient, the vaccination simply is a lower dose and patient does require an adult dose for the vaccination to be effective.
Wake up to son having seizure and not breathing. He was flailing his arms and legs and had stopped breathing. I picked him up and it seemed that I shocked him into breathing again. He cried and shook for another 2 hours. Called office and was told to give him liquid Benadryl. No fever.
Swelling, warmth & pain of upper extremity reported in pt who recvd flu vax, pt arm swelled to twice nl size & was sore w/ridge across the arm; tx meds; swelling & soreness lasted 2 wks;
Vertigo and heart racing. Employee reported today 6-23-16. States symptoms lasted a few hours and then subsided. 1st vaccine given 5-16-16 10:44.
Slight chest pains; More tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual). At the time of the report, CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had taken the first dose and was about to take the second dose. but felt chest pain before second dose and got confusion.  Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   Reporter did not allow further contact
Patient is 48 post pneumococcal immunization. Arm has become increasingly sore since received vaccine. Rates pain as #10 of 10 with #10 high. Using Ibufprofen 800 mg three times daily. Arm redness is 2 1/2 x 4 1/2, warm without identified swelling to the area. Pain with and without movement & very sore to touch.
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 11-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) 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 SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) 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. Treatment information was not provided.  Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
High fever (101), sore throat, phlegm in throat, coughing, body aches and pain, loss of appetite
This spontaneous case reported by a consumer, describes the occurrence of head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash) and tinnitus (ringing in the ear) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Previously administered products included for an unreported indication: hepatitis and typhoid vaccine. No concomitant medication reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 31, 2021, patient experienced head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear). At the time of the report, head discomfort (buzzing in the head), neuritis (inflammation in the nerves), dyspnea (shortness of breath), hot flush (hot flash), tinnitus (ringing in the ear) and otorrhea (fluid in the ear) outcome: unknown. Treatment medication included Aleve. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Pt is a twin, not identical. Both were nml & healthy for the first year of their life but since they had their 1 year shots, Pt is experiencing neutropenia. Developed a febrile E.Coli UTI, admitted to hospital with labial abscesses & low white count. Marrow tests show pt's antibodies are attacking neutrophils. Pt also had a rash on her chest that spread to the face before the appearance of the abscess. Pt developed impetigo on the buttocks. Pt had a left thigh pustule as well. Pt developed labial cellulitis on the right thigh. 3/30/00 Medical records received from PCP.
Patient states that she has a bump or a knot in her arm around the injection site since the vaccine was administered which flares up from time to time.