chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The side effects of Moderna were short lived and minimal; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient was taking blood pressure medication.  Concurrent medical conditions included Food allergy (Food allergies, all of which were avoid.). Concomitant products included DILTIAZEM, HCTZ, APIXABAN (ELIQUIS) and ATORVASTATIN for an unknown indication.   On 03-Mar-2022, the patient received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal). At the time of the report, IMMUNISATION REACTION (The side effects of Moderna were short lived and minimal) outcome was unknown. Not Provided          It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received other medications like Diltiazem, HCTZ, Eliquis, Atorvastatin within 2 weeks of vaccination. On 27-Jul-2023 at 2:30 PM the patient received Pfizer bivalent vaccine (Unknown batch/lot number) on left arm. On 29-Jul-2023 by 01:00 PM the patient had full of pressure in head, hearing was distorted, pressure in the ears. Patient was felt weak, general malaise and upper body aches and blood pressure was normal. Since the vaccination patient never been tested or diagnosed with Covid-19. No treatment medications were reported.
Back pain, dizziness, dry, non-productive cough, tension, headache, poor appetite.
Patient experienced chest pain and tightness as well as wheezing within one hour after receiving her flu shot. She was taken to the ER to rule out all other causes such as a heart attack and pulmonary embolism, which were all ruled. Patient already had several allergies listed, and she was given the preservative free version of FLUVIRIN.
Vaccines given 9-13-22. Same day of shots till noon the next day pt had tachycardia and grunting.
C/o tongue heeling heavy and big.  No resp. distress noted.  Resp. even and reg. (20).  C/o numbness in tongue. BP 134/77, Hr 66, O2 sat 100%\ 10:10 am client stated tongue continues to feel somewhat swollen but better, sensation remains.  Tongue observed and did not appear swollen by Paramedics.
pt recv vax early NOV96 & pt exp flu sx had a positive viral cult;pt tx w/rimantadine;reported indicated pt had been vaccinated w/on of the recalled lots but was unable to ID specific lot#
After the second dose she got hives on her face and arms.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 03Feb2021 (Lot number: EL9265, Batch number: FCBOH) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Had eczema since she was a child; "sensitive skin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, LOT: EL3249, Time: early afternoon, Had a rash after three days with the first dose., Batch: FCBOH, arm), administration date: 13Jan2021, when the patient was 73 years old, for COVID-19 Immunization, reaction(s): "rash on her torso", "hives".  The following information was reported: URTICARIA (non-serious) with onset Feb2021, outcome "unknown", described as "After the second dose she got hives on her face and arms.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Family Medical History Relevant to AE was none.  No follow-up attempts are possible. No further information is expected.
The pt experienced pain in bilateral arms with severe swelling and numbness to the right hand. The pt also experienced pain in the neck and right arm and then left arm with hot flushes and chills. On exam, the pt had a hot, red, edematous right wrist that was tender with decreased range of motion of neck, all fields. Remainder of exam within normal limits.
Swelling of lips with filler; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips with filler) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #036A21A and 015MZOA) 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) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling of lips with filler). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling of lips with filler) had not resolved.            Other concomitant medication includes Ice,
The issue is the Moderna Expiration date was 11/13/2022, Vaccination given 11/17/2022. No adverse reaction. Moderna has been contacted about the use of AR4504B and is checking to see if an issue. They will get back to me with a report.
The area is red and swollen.  Hard to touch.  Warm to touch.  Running low grade fever (99.0) soreness to site.  Went to a walk in clinic this morning.  Antihistamines, Advil, cold compresses prescribed.  States some better this afternoon.
This spontaneous report was received from a nurse referring to a 17 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with the third dose of improperly stored GARDASIL 9 intramuscularly, lot # N020353 with expiration date 28-APR-2020, for prophylaxis. No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 28 Fahrenheit degrees for 12 hours and to a temperature of 27 Fahrenheit degrees for 12 hours and 43 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Pt with severe localized reaction, redness, pain, and swelling 3-4 cm induration LUE fever 99.0 ax at home afebrile at exam. No limitations in ROM/full use of extremity (+) MSP.
A month and a 1/2 after I received my 4 dose of Moderna, I tested positive for COVID. Breakthrough case.
24 hours after injection she noticed an itchy rash on both arms that also stings. On Jan 22 she took Benedryl which helped with the itching but noticed that the rash got worse and now has appeared on her legs.
Patient developed a rash upper torso a week after receiving ZOSTAVAX. MD has not determined if rash is result of vaccine. Pending biopsy.
In March, 1999, the pt received her 1st dose of Lymerix and 3 weeks, post vax, she experienced fatigue, which continued and worsened. After her 2nd dose in April, 1999 and subsequently, her fatigue worsened. Additionally, she fell on her right shoulder and developed pain starting in June, 1999. In July, 1999, a physician recommended NSAIDS and an internist injected shoulder with steroids and confirmed dx of tendonitis. Outcome of tendonitis resolved but fatigue contintued. In April, 2000, the pt received her 3rd dose of Lymerix and her fatigue continued and she had pain in her left ankle and foot. An orthopedist evaluated her left foot pain as being a pinched nerve and casted it for 6 weeks. The orthopedist took cast off but the pain came back after 1 week, so he injected the ankle with steroids. In May, 2000, post vax, the right foot and wrist started to swell. The orthopedist prescribed Cataflam. The pt stated her joints were never warm or red, just swollen and painful. As of 8/7/00, the outcome of the event is ongoing.
Severe chills, weakness, dizziness, fast heartbeat, ringing in the ears,  Severe for 2 days, still dizzy on third day
There were no adverse events from the vaccination. Client received the High Dose Fluzone instead of the Regular.
Severe headache - right side - swelling at injection site. CT scan w/o contrast. MRI of brain. Headache so severe parents took her to E.R.
Booster dose of Moderna bivalent were given after the 12 hrs; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719303:Same reporter
Febrile convulsion; Pyelonephritis; Information has been received from regulatory authority (agency # AU-TGA-0000719447) on 12-SEP-2022.  This spontaneous report was received from a physician and refers to a 1-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-APR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose, dose number, lot #, expiry date and route of administration were not provided); meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX), administered for prophylaxis (strength, dose, dose number, formulation, lot #, expiry date and route of administration were not provided); and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) administered for prophylaxis (strength, dose, dose number, formulation, lot #, expiry date and route of administration were not provided).  On 26-APR-2021, the patient experienced two seizure episodes at home and on 27-APR-2022, presented with third episode (duration: 35 minutes) to emergency department (ED) (febrile with seizure) and admitted to the hospital. All seizures were self resolving. There was no past history of seizure, but it was noted that the patient had fevers daily since vaccines was given. At the hospital, the patient received antibiotics administered intravenously fot bilateral pyelonephritis. After discussion with neurologist, clobazam was continued. On 29-APR-2021, the impression was that there was a complex febrile seizure and urinary tract infection/ bilateral pyelonephritis. At the time of reporting, the outcome of the events was unknown.  The reporter considered the events of febrile convulsion and pyelonephritis to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
First nose bleed ever and it was a big one. I thought it was dry air but another one of my friends had the same thing happen to her; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his friend. This is the second of two reports.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced first nose bleed. It was reported that " First nose bleed ever and it was a big one. I thought it was dry air but another one of my friends had the same thing happen to her." The outcome of the event was recovered. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240217 Same report/drug/AE, different patients
10 days after the second dose, experienced minor chest pains, eventually almost fainted. Went to the ER and found troponin levels that peaked at 5.78, eventually trended down to 3.55 by the next morning. MRI revealed myocarditis in the left ventricle.
Shingles began 9 days after the zoster shot, treated with 10 day course of acyclovir. Gabapentin for the pain. Lesions persisted active for three weeks. Scabs formed by then. Neuralgia persists. Continuing to take gabapentin bid.
Cough and chest congestion today 2/1/21  (REPORT PROVIDED BY DAUGHTER)
Immediately following immunization, reported loss of vision, light headed, upset stomach, ringing in ears, loss of breath.  At 10:30 pm - identified small hives on skin on leg and arm.
Headache, Diarrhea, General Symptoms: Chills, headache- behind left ear, joint pains, muscle pains, fatigue, diarrhea, itchy eyes. Narrative:  Other Relevant History:
Pt was given vaccine that exceeded the 45 days allowed in the refrigerator. No symptoms were reported, patient has been notified of the error
I am getting hives. And very swollen injection site. It?s tender to the touch and burns. The hives are all day. Throughout my body. Mostly on the nape of my neck, ears, chest and arms.
Pt received rotarix and vomited after dose 2 / vomiting less than 15 min; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3594G, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd April 2021, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 2nd April 2021, less than an hour after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The office manager reported the case. After Rotarix administration and breastfeeding, the patient vomited in less than 15 minutes.  The reporter consented to follow up.
CALLER REPORTS PROQUAD WAS ADMINISTERED TO A 2 MONTH OLD. NO ADDITIONAL AE REPORTED.; CALLER REPORTS PROQUAD WAS ADMINISTERED TO A 2 MONTH OLD. NO ADDITIONAL AE REPORTED.; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unspecified gender. The patient's pertinent medical history, current conditions, concomitant medications, past drug reactions or allergies were not reported.  On 16-FEB-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number U022728 that was verified to be a valid lot number with an expiration date reported and established as 16-JAN-2023) for prophylaxis (product administered to patient of inappropriate age).  No additional adverse event (AE) was reported (no adverse event).
Suspected vaccination failure; She got the shingles real bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (to the sibling).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was received as follows: The case was reported by patient's sibling. The age at vaccination was not reported. The patient got the shot after the reporter had the shingles one year but the next spring the patient got the shingles really bad and she had the shingles shot. The patient had them worse than the reporter did and the reporter did not had the shot. The reporter stated that the shots do not keep people from getting the shingles. This case was considered as suspected vaccination failure since the details regarding the primary vaccination schedule, and laboratory confirmation for shingles was not reported. This case has been linked with the case US2021AMR130269 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130269:Same reporter. "People's" case.
Fever; Chills; Nausea; Diarrhea; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 09-Dec-2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 13-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injection site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were provided
This spontaneous case reported by a consumer, describes the occurrence of excessive eye blinking (couldn't stop blinking), myalgia (mild body aches) and pyrexia (mild fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A and 032L20A) for COVID-19 immunization. Concurrent medical conditions included high blood pressure. On Jan 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 22, 2021, patient experienced excessive eye blinking (couldn't stop blinking). On Feb 23, 2021, patient experienced myalgia (mild body aches) and pyrexia (mild fever). At the time of the report, excessive eye blinking (couldn't stop blinking), myalgia (mild body aches) and pyrexia (mild fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant products included high blood pressure medication for an unknown indication. Treatment provided: Benadryl. This case linked to MOD-2021-026210 (patient link).
6 days after the vaccine there developed a local erythematous  rash around the infection site.  within 24 hours, there developed diffuse total body hives that lasted for  >48 hours and  confluent erythema of the dorsal surfaces of both hands and feet with  severe joint pain of the  hands and feet
Began with fever 100.4 on 9/11/19 which persisted for 2 days. Had aches in my back, knees, headaches unrelieved by Tylenol Extra Strength or Motrin. Left arm was sore but not painful. Small area of acute redness at injection site on 9/11/19 enlarged to an area measuring 3 x 4 inches with the center swollen by that evening. Slight fading of the redness and decreased swelling noted on 9/14/19 but as of today on 9/15/19 the area is still visible. Itching extreme to the area where the vaccine was injected and still persists. I used Benadryl tablets and hydrocortisone cream to combat the itching and swelling/redness but did not go to urgent care since the symptoms responded to these medications.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter reported an unspecified number of patients received improperly stored ROTATEQ on an unspecified date. No adverse symptoms reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. Additional information has been requested.
Chills; body aches; This is a spontaneous report from a contactable consumer (patient parent). A 17-year-old (17-year-old age at vaccination) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 27Jan2021 01:00 PM at single dose in left arm for COVID-19 immunization at  clinic. Medical history was none. The patient was not pregnant at time of vaccination. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously took (at age 17-year-old) first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E1014D) on 06Jan2021 in left arm for COVID-19 immunization. The patient experienced chills, body aches on 28Jan2021 01:15 AM. No treatment received for the adverse events. Since the vaccination, it was unknown whether the patient been tested for COVID-19. The outcome of events was recovering.  Information on the lot/batch number for 2nd dose has been requested.