chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. The doses were administered before it was known if the vaccine was ok to use after the excursion. This case contains information for the 75th out of 77 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696122: Master case
Dizziness onset about 2 weeks after first Pfizer shot. Started as occasional dizzy spells, then increased in frequency and duration to several hours at a time, some days for most of the day. Ongoing now for about a month.
CLIENT ATTENDED CLINIC AND RECEIVED TDAP, MCV4, AND VARICELLA.  PATIENT WAS EXTREMELY ANXIOUS PRIOR TO INJECTIONS BUT APPEARED CALM WHEN LEAVING WITH MOTHER.  APPROXIMATELY 5 MINUTES LATER PATIENT AND MOM APPEAR IN CLINIC.  MOM STATES PATIENT HAS A SMALL SEIZURE LIKE ACTIVITY.  RN EXAMINED CLIENT AND SHE WAS IN STABLE CONDITION.  MOM STATES SHE WILL TAKE HER TO THE DR.
My daughter ran a temperature of 102 degrees, injection site was hot to touch, there was a a hard bump under injection site for a week, site broke out in a red rash running in a vertical line with the injection site and runny nose.
Woke up at 3:30 am with neck hurting badly and headache.   Could not go back to sleep.  Got up used heating on my neck got better.  Throughout day I had chills, low grade fever, body and bone aches, no appetite , no energy.  No reaction to shot site.  Just sore.Stayed in bed mostly.  During night I had 2 sweats that I had to get up and change clothes.  Sunday morning still slugglish  and no appetite.  Drinking plenty and took tylenol and advil
Mother related in a text child was crying very hard would not bear weight on legs, and is very pale. Areas where shots were given were welts and were red and hot. Child's arms and legs were just limp. Color had come back some and child was whimpering and looked exhausted. Mother related giving Tylenol just before 7:00 pm. I called mother and child was getting color back and started to move arms. Mom related he seemed to get better more all the time we talked. Talked to mom this am at 8:30 and she related child nursed well throughout the night and had several stool diapers. Child is very warm this morning but had just given him Tylenol and he was laying on mat and playing like normal.
Aching, fever, chills, tingling in fingers and hands, rash on trunk, difficulty taking a deep breath.
felt sick; nausea; acid reflux; migraine; dizziness; brain fog; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), NAUSEA (nausea), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), MIGRAINE (migraine) and DIZZINESS (dizziness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (felt sick), NAUSEA (nausea), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), MIGRAINE (migraine), DIZZINESS (dizziness), FEELING ABNORMAL (brain fog) and ASTHENIA (weakness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine, at an unspecified dose and frequency. On 29-Jan-2021, ILLNESS (felt sick), NAUSEA (nausea), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), MIGRAINE (migraine), DIZZINESS (dizziness), FEELING ABNORMAL (brain fog) and ASTHENIA (weakness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided
pt less than 12 months old exp abscess following vax w/DTP; incision & drainage was required; unk if cultures were taken;
Bad rash on body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on 04Jan2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient got her second vaccine on 04Jan2021 and then next day she got a bad rash on her body and she still having it, it has cost her lot of money to go to the Doctors and want to get something about this rash. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
cont crying p/vax w/in short period t101 & was given APAP;temp went to 103 child became listless;mom brought child to clinic approx 345PM to be checked by MD;MD felt probable rxn to DTAP;tx w/APAP;15AUG97 seen in clinic still running T, ras
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Gave Benadryl 25mg. BP 110/66, O2 SAT: 98. Patient was monitored for 30 minutes - had no further reaction.
Patient is a 19 y.o. male with a variety of minor past medical problems but without any significant PMH who presents with 24h of acute onset chest pains. He reports yesterday morning he was woken from sleep at 3-4 am with severe substernal chest pains that radiated to his arm and neck. This was worsened by laying flat and better if he waked around/pacing. He took ibuprofen and it got better so he went back to sleep. The pain returned about 6 hours later and was getting more severe so he went to see his doctor. There an EKG was abnormal so he was referred to the ED where a work up showed ST elevations c/w pericarditis and an elevated trop I of 24.   The night prior, he reported a low grade temperature. He has not had any more fevers for the past 12-18 hours. He denies any other symptoms such as palpitations, shortness of breath, cough syncope. He denies sick contacts but did have a sore throat 4-5 days ago without any other associated symptoms. He has had recent negative COVID tests while at college.    Of note he did receive the 2nd dose of Pfizer on 5/15 about 24-36 hours before onset of symptoms.    Of note, he does boxing at school and has been participating in work outs until about a week ago.   ED course: EKG w/ diffuse ST segment elevation in V3-V6, I, II, II, AVF. Troponin I 24. Creatnine 1.2 with baseline of 0.5 but BUN WNL (11). CBC WNL, CRP mildly elevated to 3.1, Transferred to another ED.   Second ED Course: BP 120/64  | Pulse 83  | Temp 36.7 °C (98.1 °F) (Temporal)  | Resp 18  | Wt 76.3 kg  | SpO2 97% exam non-focal, COVID ab notable for +spike neg nuclear capsid consistent with vax but no infection, D-Dimer, procal, ESR, ferritin, Coags all WNL, Trop T elevated to 1.46,, ECG with consistent diffuse ST seg elevations, seen by ped cards who did echo in ED and notable for EF ~50%, admitted to PCICU for further management and treatment  Admitted to the PCICU in stable condition. Placed on telemetry monitoring for the duration of the admission. Started on IV steroids and given IVIG on hospital day 1. Continued on toradol which was switched to motrin on hospital day 2. Cardiac MRI did not show signs of fibrosis. Troponin downtrended throughout his stay. At the time of DC echo showed normal function, ekg showed T wave inverions, and troponin was down trending to 0.57. Pt to be restricted from physical activity until cleared by cardiology. Infectious workup also sent, most of which was pending at time of discharge.
she has syncope and migraine; she has syncope and migraine; she did not feel good after the first shot.; This is a spontaneous report from a contactable consumer for herself.  A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation.  Medical history included cataract .  The patient's concomitant medications were not reported.  The patient experienced  syncope  on an unspecified date with outcome of unknown , migraine  on an unspecified date with outcome of unknown , she did not feel good after the first shot on an unspecified date with outcome of unknown.    No follow-up attempts are needed. No further information is expected.
headache; feeling sick in her stomach.; Nausea; This is a spontaneous report from a contactable female consumer reported for herself.  A 76-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) at single dose on 13Feb2021 13:50 via an unknown route in left arm for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL0142) on 23Jan2021 at 13:30 injection to left arm for Covid-19 immunization and reported that she did not have any problems with the first dose of the Pfizer-BioNTech COVID-19 Vaccine except for her arm was really sore and heavy the next day (on 24Jan2021 13:50) which lasted about 2-3 days until she recovered completely from event, and flu shot around Sep2020 for immunization. She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm was really sore and heavy, but also reported that she had no history of adverse events or reactions to prior vaccinations. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Family Medical History Relevant to events was none. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient experienced headaches and nausea on 15Feb2021, approximately 2 days after second dose administered. She reported headache lasting more than 7 days.  The clinical course was reported as follows: Having headaches off and on, had not been a constant day and night thing. It kind of comes and goes. The past weekend (as of 15Mar2021), on 14Mar2021 it was really bothering her. She took a Tylenol on 14Mar2021 after she got back from church and last night took 2 Benadryl and that seemed to help. That was the first time she has taken Tylenol for events. She had just been letting headache wear itself out. Regarding nausea, it was further described as sick to her stomach. Outcome of Headaches was not resolved. Seriousness for headaches was unspecified. No visit to Emergency Room/Physician Office required, not hospitalized. Outcome of the events was not resolved.    Follow-up attempts are completed. No further information is expected.  Follow-Up (13Apr2021): Follow-up attempts are completed. No further information is expected.
Had prior reaction after first dose of Pfizer mRNA vaccine but cleared by Allergist to get J&J.  Developed localized hives at injection site ~3 to 3.5 days after injection, improved with Benadryl.
This case was reported by a physician to a sales representative and described the occurrence of breath holding seizure in a 6 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. On 7/6/04 the patient received a dose of Pediarix (dose number not specified). Approximately three days after the administration of Pediarix, on 7/9/04, the patient experienced what was initially reported as a breath-holding seizure. the reporter subsequently stated that it was not like a typical seizure but more like a hyperventilating cry. The patient was also pale and non-responsive. The patient was seen in an emergency room. Laboratory evaluation revealed elevated liver enzymes. The outcome of the events is unknown. The reporting physician considered the events to possibly be related to vaccination with Pediarix. Comment: Seizure, unresponsive, and elevated liver enzymes were assessed as medically serious (OMIC).
Violent  shaking headache dizziness fatigue anxiety restlessness diarrhea pale bones was freezing fever loss of appetite and very very sleepy. And no this isn't a conversion disorder
Patient called on 10/20 and said that she had a fine grain rash and was itchy all over her body.
blood clots in the stool/bloody stools; the mother was 28 weeks pregnant when she received her Covid 19 vaccine; increased inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Private).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 28 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "blood clots in the stool/bloody stools"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "increased inflammatory markers"; EXPOSURE DURING PREGNANCY (serious), outcome "unknown", described as "the mother was 28 weeks pregnant when she received her Covid 19 vaccine". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: Increased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fatigue, insomnia Narrative: missed day of work following first dose of pfizer due to symptoms
Mid cycle spotting. First day of last period was 3/27/2021, and this unusual midcycle spotting occurred starting 4/11/2021 and lasted 3 days. Usual 33 day cycles are very regular and spotting mid cycle is abnormal for me.   ALSO, I experienced an enlarged and painful lymph node in my collar bone area which began a couple days after my vaccine dose and finally resolved as of 4/19/2021.
Difficulty breathing, red, itchy and watery eyes, dizziness. Purchased over the counter Benadryl, eyedrops.
Arrived at hospital with shortness of breath, cough, fever, weakness, and diarrhea O2 sat 68%. History of COPD Was given rocephin, decadron, remdesivir, alubuterol, pulimicort, ceftriaxone, azithromycin, and BIPAP No improvement after receiving maximum treatment with uncontrolled muculoskeletal pain. Passed away
VARlVAX was administered to a patient prior to discovering the temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a 7-year-old patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, lot # T022314, expiration date 30-JUN-2022 (dose number and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 31.8 degrees Fahrenheit for 5 hours and 30 minutes on 14-MAR-2021. There was no previous temperature excursion. Digital Data Logger was involved.
Moderate redness and swelling of Rt triceps after DTAP. Moderately tender. This is a minor side effect
(^) Pain and redness at injection site right deltoid.  Temperature highest 100.6F per mouth: starting 08/15 continue at 99F 08/18, tired, nausea.
One day post vax, the pt experienced headache, lethargy and generalized pain. These adverse events lasted a couple of weeks. One day after receiving the second dose of Engerix B the pt again experienced headache, lethargy and generalized pain. She was treated with Tylenol with uncertain effect. Engerix B is discontinued at present. The most recent information received reports the condition of the pt is ongoing.
10/01/20 The evening receiving the vaccine, started muscle stiffness in right arm, under arm to chest. 10/02/20 Red raised rash on right forearm, fatigue. 10/03/20 Red raised rash was found on right forearm, elbow, upper arm, under arm, and right upper back. pain on right arm where rashes, right hand  and, chest mid-sternum are with breathing. 10/03-07/20 self treated area of the rash with anti histamine gel and ointment, Made an appointment with a dermatology clinic. 10/08/20 Visited the dermatologist, By visual examination,  I was told that I have Shingles from the vaccine.  Anti viral medication "Valacyclovir, 1GM, #30. Started the medication on the day.
103 fever nausea vomiting general muscle aches Tylenol given fluids encouraged rest
right ear fluid on may may 1 .second vaccine was 5/13 and loss hearing .
This spontaneous report was received from a pharmacist and refers to a approximately 16 years old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions and allergies was provided. An unspecified physician told the reporter that on an unknown date in January 2014, the patient (16 years old at that time) was vaccinated with a first dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date in March 2014, the patient was vaccinated with a second dose of GARDASIL (exact dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that she was not sure which human papillomavirus (HPV) vaccine was given for Dose 1 and Dose 2 but she said it was "probably" the GARDASIL. The patient did not return for dose 3 until the day of the report (04-OCT-2018). The reporter stated that the patient was in the physician's clinic on 04-OCT-2018 (reported as right now), to be vaccinated and the reporter stated that the physician would administer GARDASIL 9 to complete the HPV vaccination series. No symptoms reported.
Extreme itch began by April 19; exact date of start not noted.  Noticed the rash the following Saturday, already fully established; it had probably been present for several days.  The rash is consistent with Shingles.  It progressed from itching, to later pain, and is still present now (5/10/21) but is beginning to clear up.
Patient immediately bled and developed localized hives. Benadryl given within 5 minutes and patient felt better 15 minutes after medication
have incurable cancer/ He also has a treatable form of cancer; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth 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 NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) (seriousness criterion medically significant). The patient was treated with Radiotherapy for Neoplasm malignant. At the time of the report, NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient was wondering if there was another shot out there that patient need to take. Patient have incurable cancer. He also had a treatable form of cancer and had been undergoing radiation treatment.  Company Comment: This is a spontaneous case concerning a 72 year-old, male patient no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred related to the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the fifth dose of COVID-19 vaccination schedule. The outcome of the event was reported as unknown. The company considers the causality as not related due to lack of biological plausibility and known safety profile of the vaccine. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. Event´s seriousness assessed as reported.   Reporter did not allow further contact
Patient came in for an additional dose of Moderna and was administered a dose of Pfizer.  Vaccine mismatch.