chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE/PQCs reported; administration of Improperly Stored PROQUAD; This spontaneous report was received from a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T021639, expiration date 21-DEC-2021) (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was -10 to 8 (-5.6) degrees Celsius for a time frame of 1 hour and 32 minutes without any previous temperature excursion. Digital data logger was involved.
pain is severe and disabling; severe myalgia to legs started next day after 2nd dose, then to shoulders, arms, with mild headache. Never resolved after 2 weeks.  gabapentin gave temporary relief but pain is severe and disabling.; mild headache; This is a spontaneous report. A contactable physician reported that a 37-year-old non-pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205), first dose via intramuscular on 06Feb2021 as single dose for COVID-19 immunization, received (BNT162B2, solution for injection, Batch/Lot Number: EM9810) second dose via intramuscular on 27Feb2021 as single dose for COVID-19 immunization and patient was non-pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included endometriosis, and patient had allergy for meloxicam, NSAIDs, blepharospasm and angioedema. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included norethindrone acetate (NORETHINDRONE ACETATE) taken for an unspecified indication, botulinum toxin nos (BOTULINUM TOXIN NOS) taken for an unspecified indication on 08Jan2021 to an unspecified stop date. The patient experienced pain was severe and disabling, severe myalgia to legs started next day after the second dose, then to shoulders, arms, with mild headache on 28Feb2021. Never resolved after 2 weeks. Therapeutic measures were taken as a result of pain is severe and disabling (pain), severe myalgia to legs started next day after second dose, then to shoulders, arms, with mild headache. never resolved after 2 weeks and gabapentin gave temporary relief, but pain is severe and disabling. (myalgia), mild headache (headache). The outcomes of the events was not recovered.  Follow-up information has been requested.
Hives the size of welts cover my body from head to toe on a daily basis. I've gone into anaphylectic shock twice and had to have an epi-pen injected during a five day span where I was unable to take any antihistamines because I was going to be allergy tested.  I have to get Xolair injections becasue the antihistamines have stopped working. Symtoms started after first injection. i have not been given a diagnosis yet, but I have been suffering for almost a year.
Mother described left arm swelling starting at the left shoulder and descending to left hand. She reported the arm was reddened and warm to touch.
Moderna COVID-19 Vaccine EUA  Redness and swelling at injection site which started 6 days after the vaccine (appears as  rash).   Also, some pain in the lymph node area in arm pit on the left side (vaccine side) with some tenderness left side of my chest as well. After two days, the redness & swelling has gone down, but can still see a faint discoloration in the area.  The tenderness and pain in the left armpit and left chest side is still there.
feel very sick (hit by truck feeling); pain in arm, leg sensation and pain; neck pain; no appetite; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease and Hyperlipidemia.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain). At the time of the report, ILLNESS (feel very sick (hit by truck feeling)), PAIN IN EXTREMITY (pain in arm, leg sensation and pain), NECK PAIN (neck pain), DECREASED APPETITE (no appetite) and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. On 06-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Presented on 8/2/11 with papulovesicular eruptions primarily on torso x2 days. Afebrile. Over 50 lesions. (R) PET with clear drainage.
patient's 12 mo old infant son experienced a low grade fever; patient's 12 mo old infant son experienced a low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother of the patient was 39 year-old. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown" and all described as "patient's 12 mo old infant son experienced a low grade fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA. Dark red rash on inner part of upper right arm. Not hot and does not itch.
pt recvd flu vax 10OCT95 & reported pt is hospitalized in ICU w/dx of GBS;No further details known as of the date of this report;
Diagnosed with a Breakthrough case of COVID-19; Diagnosed with a Breakthrough case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) and COVID-19 (Diagnosed with a Breakthrough case of COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) and COVID-19 (Diagnosed with a Breakthrough case of COVID-19). On 04-Aug-2021, DRUG INEFFECTIVE (Diagnosed with a Breakthrough case of COVID-19) had resolved. At the time of the report, COVID-19 (Diagnosed with a Breakthrough case of COVID-19) had resolved.            No concomitant medications were provided. No treatment medications were reported.  It was reported that the patient was fine now.  Company comment- This case concerns a 64 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred approximately 6 months 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. Drug ineffective was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 65 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI event of COVID-19. The event occurred approximately 6 months 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. Drug ineffective was considered as an additional event. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
start sick on Monday I deal sick; cofing; chase paint; with fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever) 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 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever). At the time of the report, ILLNESS (start sick on Monday I deal sick), COUGH (cofing), CHEST PAIN (chase paint) and PYREXIA (with fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported; Sender's Comments: This case concerns a patient without identifiers, who experienced the expected  event of pyrexia and unexpected events of illness, cough and chest pain . The event occurred after a dose of of mRNA-1273 Moderna vaccine. (onset date of events were unknown)  The events was considered related to the product per the reporter´s assessment.  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Powder component admin. with sterile water instead of with liquid component which is supplied with vaccine. (MENVEO).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On the unknown dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
1 week old vaccinated with Pediarix; 1 week old vaccinated with Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-day-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st December 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 1st December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   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 provided as follows: The patient accidently vaccinated with both Pediarix and Rotarix at the age of 1 week old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Vaccines given on 10/15/02. 3 hours post-screening x2.5 hours unconsolable.
16MAR92 c/o sore arm; 17MAR92 2AM pt had difficulty breathing, retracting, given Prednisone & breathing tx @ home w/no improvement; taken to hosp ER given meds; pt continues to have wheezy, croupy breathing & tight chest & freq cough;
Fever; Dizziness; Headache; Night terrors; Slept all day; This is a spontaneous report received from a contactable consumer (Patient's mother). A 13-year-old male patient (reporter son) received BNT162B2 (PFIZER-BONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182) dose 2 via an unspecified route of administration on 11Jun2021 16:30 (at the age of 13-year-old) as single dose for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder). The patient's concomitant medications were not reported. No prior vaccines (4 weeks), no other medical conditions. Reporter Stated, he did not have any other medical conditions besides ADHD. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BONTECH COVID-19 VACCINE, Lot number: EW0182) received on 21May2021 at 2:00 PM, administered in left arm via IM (intramuscular) route, and experienced night terrors and fever. On an unspecified date in Jun2021, the patient experienced fever, dizziness, headache, night terrors and slept all day. The patient, on Friday afternoon at 16:30 received his second Pfizer vaccination and he had the most he had common obviously he had the fever the next day, the dizziness, the headache, slept all day, he had the fever all day, around 6:30, he had a really bad night terror and he also had that with the first injection too. Reporter stated, she thought that he just had it with the first injection and that was gonna be it but she didn't think that he was gonna have the same results with the second injection cause he had it with the first one but he had it a really bad night terrors with the second one as well so he's pediatrician wanted her to report it again with the second one because his pediatrician hadn't been seeing that with any other children. She did not know if any other parents had been reporting these. When Probed if the patient was still experiencing these problems, reporter stated that, the symptoms were improved he did not have them since. Reporter Stated, she gave him paracetamol (TYLENOL) for the fever and the headache. It was 200 mg. The outcome of events was reported as recovering.   Follow-up attempts are needed. Further information is expected.
Redness inflammation at injection site. Seen at clinic by PA-C on 09/29/17. Diagnosed by provider as cellulitis.
pt recv vax 13JUN96 & 12DEC96 pt devel a runny nose;18DEC96 pt devel a rash w/15 to 20 papules/vesicles;19DEC96 pt presented to MD;@ that time pt had multiple red papules;runny nose;dx varicella w/apparent vax failure;upper resp infect;
Dose 2 was at time of period start.  11 hours after, all the tingling on arm, intense chills, fever, and headache kicked in.  Took tylenol and advil and went to bed (tylenol alone didn't seem to be enough).   Went to bed.  Woke up with INTENSE back pains almost like back labor.  There were a few moments that I could not walk well.  Ibuprofen all day his symptoms.  Period flow changed to heavier on the end dates when they are typically super light.    A couple weeks later, I was teaching online and suddenly, I started getting intense cramping (I have had cramps once before and then labor--that is it my entire life).   I was miserable.  I couldn't sit.  I took 600 ibuprofen and waited till the pain subsided and took a 2 hour nap, woke up exhausted.   Period arrives on time one month post second vaccine but is definitely heavier already and definitely more irritable.  I thought I was going through perimenopause symptoms till I saw an article on possible links.  It adds up perfectly.
Tested positive fo COVID; Shortness of breath; Tired; No eating; Diarrhea; A spontaneous report was received from the wife of a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for COVID (SARS-CoV-2 test positive) and experienced shortness of breath (dyspnoea), diarrhea, tired (fatigue), and no eating (decreased appetite)  The patient's medical history was not provided. Concomitant product use was not provided.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot/batch:030L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced shortness of breath, diarrhea, tired, and no eating.  He was hospitalized and tested positive for COVID.  The patient was discharged on 21 Feb 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events of tested positive for COVID, shortness of breath, diarrhea, tired, and no eating was unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 vaccine is assessed as unlikely related The vaccine is not known to cause COVD infection.  The other events are consistent with symptom of the disease.
Day 2  - sore joints, ankles, wrists, feet. Neck ache, slightly fatigued, headache. Day 3 itchy rash around ankles, on leg and behind knee.
Pain at site (scale 1-10: pain @ 10) alternate heat/cold; ALEVE 2 BID) physical therapy 2x/week. Some improvement over time (pain now at 5 or 6).
After receiving flu vaccine the next day area on arm a little smaller than the  bottom cm of a small coffee cup, was red and raised.  Patient was given Motrin every 6 hours. This lasted less than 32 hours.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and VITAMINS NOS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No treatment was reported. Action taken in response to mRNA-1273 was not applicable. Patient has implanted pacemaker.   This case was linked to MOD-2021-061155, MOD-2021-061159 (E2B Linked Report).; Sender's Comments:  MOD-2021-061155: MOD-2021-061159:
Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/24/2023 ATRIAL FLUTTER, PAROXYSMAL R57.0 CARDIOGENIC SHOCK 5/24/2023 ATRIAL FLUTTER, PAROXYSMAL J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/24/2023 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 5/24/2023 CARDIOGENIC SHOCK
From history and physical 12/26/21:  Patient is a 50 y.o. female with HO HTN, obesity, partial COVID vaccination who presented to the ED today with back pain after a tripping on ornaments. In the ED she was febrile to 102, COVID positive and hypoxic with RA sats in the 80s.  She is admitted for treatment of COVID pneumonia.she denies feeling ill prior to today.
Patient at 1440 patient wasn't feeling right. feeling hot and shaky. BP 149/72. 96% spo2. HR 63  other medical conditions was reported as no. but blood sugar was 63.  Patient given grape juice and sandwich repeat bs was 102 patient recovered with no further treatment.
Shortness of breath; cold sweats; Skin is crawling; not feeling good; sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good) and MYALGIA (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good), MYALGIA (sore arm) and NAUSEA (nausea). At the time of the report, DYSPNOEA (Shortness of breath), COLD SWEAT (cold sweats), PARAESTHESIA (Skin is crawling), ILLNESS (not feeling good) and NAUSEA (nausea) outcome was unknown and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes Blood pressure, Thyroid medicine, Food appetizer. No treatment information were reported.
I went into AFib and unabated get out of it.  Was cardio converted on January 27, 2021. Received second vaccine on January 28, 2021.  Went back into AFib on February 3rd. Remained in AFib until being converted again on  March 5,2021
Fever; Felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Felt really tired) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Felt really tired). At the time of the report, PYREXIA (Fever) and FATIGUE (Felt really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a licensed practical nurse regarding an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates since 02-JUN-2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (dose and route were not reported, lot # K018175, expiration date 10-JAN-2016). There were no adverse effects reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.