chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022; 2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) and POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Chronic kidney disease.    On 01-Mar-2022 at 2:45 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 01-Mar-2022 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40°F, Max T: 46.20°F Occurred: 23Feb2022) and POOR QUALITY PRODUCT ADMINISTERED (2 Patients were administered from vials that experienced a T excursion.  Min T:38.40degree F, Max T: 46.20 degree F Occurred: 23Feb2022) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not have any known drug allergies. It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.  No concomitant medication was reported.  Storage condition at the time of the excursion was Refrigerated. Excursion duration was at 9.56 for 10 min. Vials were discarded when they reported the excursion then continued using the vials out of range. Number of vials/doses impacted were 3 vials. 2 patients were administered from these vials. The first dose on 25-Feb-2022, 1 vial was discarded.  Patient did not report any adverse event. No treatment information was provided.   This case was linked to MOD-2022-512132 (Patient Link).
The same day I started having chills , fever, headache, By 6:00AM the next day I noticed redness and my arm was hot swollen and itchy in the exact spot and pattern from the 1st does of the vaccine  4in long red area... rash lasted a week and come and go. Ibuprofen worked for 48 hours then the rash returned.
assuming it was an allergic reaction; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling).; This is a spontaneous report from a non contactable consumer (patient). A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 14:30 (Lot Number: EW0176) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis and known allergies: All mammalian meats (alpha gal protein), shellfish, and tree nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 01May2021 02:45 PM, within a few minutes of receiving his first dose of the Pfizer vaccine, the patient became slightly dizzy and a bit sick to my stomach (likely from the dizzy feeling). Since it occurred within minutes, he was assuming it was an allergic reaction to the vaccine itself. He was obviously nervous about getting his second dose now. Often times anaphylaxis occurs the 2nd time you encounter a reaction inducing stimuli. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovered on May2021. This case was reported as not serious.   No follow-up attempts are possible. No further information is expected.
Developed urticarial large rash on (L) shoulder deltoid region - site of injection 8 days after vaccination. Treated w/ oral prednisone.
Chest pain, shortness of breath, rapid heart rate, painful breathing, symptoms developed 6 days after vaccine on 3/21/2021 and progressed rapidly.   3/22/2021 I was sent to  ER by my PCP.   My condition had worsened,  I was in a lot of pain with difficulty breathing and a very rapid heart rate.   I was admitted to Hospital through the ER after they diagnosed my condition as pericarditis.
Febrile seizure 7 days after HIB and FLUMIST. 11/25/09 Medical records received for date 9/1/09 and 9/4/09. DX: Wellness exam WNL. 9/4/09 Pt seen in office w/ c/o fever after vaccination. Rash on face, parent states started convulsing and was taken to ER and OV today for f/u. Assessment WNL except (+)fever, cough, rash, congestion. DX: febrile seizure.
Mother reported to our office that three days after receiving Menactra and Adacel.  Child complained of feeling light headed, dizzy and very tired.  Child had an episode of syncope.  Another sibling receiving the same immunization reported the same symptoms without syncope.
After vaccinations, baby was extremely lethargic, seemed "stunted", did not respond normally or even at all for about 4 to 5 days. Mother was worried that he would not come out of it. Did not smile and did not really cry, and seemed to "not be there". Mother thinks this also occurred with the 2 month shots but mom thought it was just him not feeling well, and it did not last as long the first time. Mother now feels like he has returned to normal. Does not want any further vaccines at this time since this was a very frightening event.
Booster was received on 11/04/2021.  By 11/18/2021, extensive itching and redness on hands, feet, limbs, and torso was noted.  Dermatographia / hives were also experienced.  Primary care doctor provided me with Prednisone, as we thought this may have been a reaction to Omnicif that I was taking for a sinus infection around the same time as the booster. The Prednisone removed the extensive itching and redness, but it later returned.  The overall itching and dermatographia has persisted to this day, but has been significantly reduced.  I am able to control the symptoms by taking Allegra once every few days.  I note the itching mainly at night around 7 PM.  The dermatographia and hives occur randomly every few days and fade after 30 minutes.  If I stop taking the Allerga, the symptoms will return to an uncomfortable level, including embarrassing red blotches and lines all over my face and body.
dispensed 28 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient was not diagnosed or tested positive for COVID-19. There was no diagnosed acute illness at the time of vaccination and up to one month before. There was no chronic or long-standing health conditions.     On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Vials did not undergone any temperature excursions. It was reported as expired vaccine was administered but results from the moderna stability study showed proper activity against COVID-19. No treatment information was reported.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 28-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (socially) in May 2010. Concurrent medical conditions included Sulfonamide allergy (Allergy sulfa drugs). Concomitant products included VITAFUSION PRENATAL for Prenatal care.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 18-Mar-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. On 13-Aug-2020, Ultrasound scan: inconclusive (Inconclusive) Inconclusive. On 08-Sep-2020, Ultrasound scan: inconclusive (Inconclusive) Inconclusive. On 23-Dec-2020, Glucose tolerance test: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was 25-Jun-2020, date of positive pregnancy test was 4-Jul-2020.  Treatment information was not provided.
Approx. 36 hrs. after vaccination, developed fever, flu-like illness, rash, vomiting, and shortness of breath. Rash started on right upper arm at vaccine site and spread to body. Was treated with IVF, IV steroids, BENADRYL and albuterol. Was discharged on steroid taper.
Patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.
9:29 pt recv vax 3JAN97 & 9:30 legs red @ inj site on thighs;slow inc in redness & crying;9:32 red splotchy areas noted thighs, arms, stomach, trunk & neck;resp 38;9:40 pt calming down, crying diminishing; trying to sleep;
Dizziness, Headache, Myalgia, Nausea Vomiting, hot flash, right side chest heaviness x 1 day
fever, chills followed by an erythematous vesicular rash on the left buttock and dorsal thigh/hamstring area
odd nasty taste in my mouth; tummy was upset; headache; really felt the injection this time; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (odd nasty taste in my mouth), ABDOMINAL DISCOMFORT (tummy was upset), HEADACHE (headache) and INJECTION SITE PAIN (really felt the injection this time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   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 DYSGEUSIA (odd nasty taste in my mouth), ABDOMINAL DISCOMFORT (tummy was upset), HEADACHE (headache) and INJECTION SITE PAIN (really felt the injection this time). At the time of the report, DYSGEUSIA (odd nasty taste in my mouth), ABDOMINAL DISCOMFORT (tummy was upset), HEADACHE (headache) and INJECTION SITE PAIN (really felt the injection this time) had resolved.            No Concomitants included. No Treatment was included.  Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-133792 (Patient Link).
After 9min of getting vaccine I experienced heavy breathing and dizziness which lasted for a minute and got normal. Again after 18minutes of getting the vaccine, same thing happened. I was in a sitting position for 20min. After 22min i felt itching on my left foot finger and neck for few minutes. I feel these are side effects of vaccine as i never had such feeling before for any medication.
Patient reports waking at midnight 11/29/20 about 10 hours after the shot with racing heart (reports about 105 bpm) and says this triggered her pre-existing a-fib.
A consumer report has been received concerning a 46 year old female patient. Medical history and concomitant medications of the patient were not reported. The patient had been received FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient received a full syringe of FLUMIST QUADRIVALENT in each nostril. Nurse giving vaccine stated beforehand this was the first time she was administering FLUMIST QUADRIVALENT. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of full syringe of FLUMIST QUADRIVALENT administered on both nostrils was unknown. The reporter considered the event full syringe of FLUMIST QUADRIVALENT administered on both nostrils to be non-serious.
Severe Nausea, severe vomiting, loss of appetite, fever 101.4, fatigue, muscle aches, injection site soreness
Swollen bump on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen bump on collar bone) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ALBUTEROL [SALBUTAMOL] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING (Swollen bump on collar bone). At the time of the report, SWELLING (Swollen bump on collar bone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Patient got very sick and was hospitalized; A spontaneous report was received from a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got very sick and was hospitalized.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported that that after receiving her first dose of the Moderna vaccine, the patient got very sick and had to be hospitalized. No further information was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event, patient got very sick and was hospitalized was unknown.  The reporter did not provide an assessment for the event patient got very sick and was hospitalized.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
The day after vaccination, the patient developed multiple blisters at the site of the injection. Patient is 20 weeks 5 days pregnant and is due 2/15/2019. Patient weight 202 lbs.
Information has been received from a registered nurse (R.N.) her 16-year-old son who was vaccinated with a second dose of Varivax. Subsequently, the patient experienced cellulitis. No further information was available at the time of this report. The patient's sisters also had adverse experiences following vaccination (WAES# 0609USA02450 and 0609USA04903). Additional information has been requested.
Temperature excursion total time: 25 mins, 3 excursions on dates 09-SEP-2022 for 8 minutes 16-SEP-2022 for 5 minutes 03-JAN-2023 for 12 mins; No issues, no adverse events on patient; This spontaneous report was received from an office manager and referred to a 11 years old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purchased with public and private founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter.
Narrative: 66 year old male with PMH significant for asthma, allergic rhinitis, hx of migraines, T2DM with neuropathy, sleep apnea, obesity, Barrett's esophagus, PTSD, insomnia. Received COVID-19 vaccine on 2/10/21. At pharmacy  phone appointment on 2/18/21 he stated he was "feeling sick" after vaccine and was instructed to call telephone nurse extension. Called facility on 2/23/21 with complaints of productive cough with green mucus, sneezing, headache, chills and malaise. Denied runny nose, loss of taste/smell, facial/lip/tongue swelling or hives. Stated that he had an episode of diarrhea "right after" vaccine but none since. Repoted temp of 98.0F. Denied exposure to COVID-19 positive individuals in past 2 weeks. Provider discussed isolation/quarantine, fluids, OTC meds, salt water gargle, and he was instructed to get a COVID test same day. 2/23/21 COVID test results negative; Temp 98.1, RR 16, SPO2 99%, HR 92. F/u mental health appointment he stated he had been feeling depressed since vaccine due to stress and feeling nervous about second dose and experiencing similar side effects. Unclear if pt took OTC medications/nonpharmacological therapy for treatment. Symptoms appeared to have resolved by 3/10/21 pharmacy diabetes f/u appointment as he stated he was feeling well. He received his second COVID19 vaccine dose on 3/10/21. Called Facility on 3/17/21 with complaints of muscle aches, wheezing and productive cough with white-green sputum starting 4 days prior and diarrhea for 2 days. Denied fever, chest pain, difficulty breathing, loss of smell/taste. Azithromycin, guaifenesin/dextromethorphan ordered for acute bronchitis/asthma exacerbation as well as methyl salicylate for muscle aches and pt instructed to use acetaminophen PRN, albuterol PRN, and lidocaine patches. At f/u PC telephone appointment on 4/13/21 pt stated that productive cough went away with antibiotics, but was returning with mild congestion. Treated for cough/PND/allergic rhinitis/asthma with continuation of antitussive PRN, albuterol PRN, and addition of singulair. At mental health appointment on 6/17/21 he stated that he still felt as if he had residual symptoms, though unclear as to which specific symptoms. Presented at PC clinic appointment on 7/19/21 with reports of on/off cough due to asthma and green sputum for past 2 weeks which he was prescribed empiric azithromycin for asthma/allergic rhinitis. Temp 98.6, HR 90, RR 20, BP 157/89. No notable symptoms on f/u notes to date.
t106 9OCT91 pt was life flighted to Hosp in extreme critical condition;
I felt fine the day I received the shot and the following day until that evening. when  I started feeling indigestion followed by very painful abdominal cramps and vomiting several times over a period of several hours.  The following days I felt some indigestion and was alright after that..
Giant  local reactions, Redness  and induration at injections site (6 cm with several  1 cm X 1.5 cm areas 7cm 6 (?) large lesions.
pt recvd vax 14JUN; 15JUN93 devel painful firm nonpruritic red swolling over thigh; mild mod erythema, sl firm non tender swolling inf to inject;
This literature report (initial receipt 13-Aug-2013) concerns a 71 year old male patient. The patient presented 5 months after initial symptoms with history of sudden onset of mild dysphagia to solids and liquids which became severe over a few hours and dysarthria. 24 hours later, the patient developed proximal upper extremity weakness and 36 hours later lower extremity weakness. Absence of sensory symptoms, autonomic dysfunction or pain. He had received a flu shot (batch and manufacturer unspecified) 3 weeks prior to the onset of symptoms. The patient required intubation, PEG (percutaneous endoscopic gastrostomy) tube. He was treated with 7 plasma exchange followed by IVIG (intravenous immunoglobulin) and intensive rehabilitation. Electrodiagnostic studies showed evidence of a diffuse polyradiculoneuropathy affecting predominantly the upper limbs, and cranial innervated muscles. A follow up visit at 8 month revealed improvement of arm strength with no dysarthria, minimal facial weakness. The event outcome was recovering. Reporter's comments: The pharyngo-cervical-brachial variant is a rare presentation characterized by oropharyngeal, neck and proximal upper extremity weakness, with sparing of the lower extremities. Sensory symptoms and autonomic dysfunction are absent. This patient findings on nerve conduction studies were not consistent with demyelinating pattern, and showed axonal loss and polyradicular movement.
had all three vaccines/ she got covid, that was after having fully vaccinated; had all three vaccines/ she got covid, that was after having fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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 25Feb2022, outcome "unknown" and all described as "had all three vaccines/ she got covid, that was after having fully vaccinated".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200342998 Sam e reporter/vaccine/event, differnet patient
Reddened area growing in size in first 24 hrs top of arm swollen hot touch, reddened. To ER given Keflex but now up to entire top of arm.