chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.; No adverse event; Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.).    Concomitant medication use information was not provided by reporter.  Patient administered expired vaccine on March 15,2023.  There was between 75 and 125 people vaccinated and then on 3/3/23. HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15MAR2023.   There was potentially a second lot number that was expired and was administered to patients on 3MAR2023, but HCP did not have any details on this event at this time.  Dose administered after 30-day use by date or after manufacturer date of expiry  Individual vials or intact cartons was unknown  Vial size was reported as 10 dose vial  Date the vial was initially stored in the refrigerator was reported as 14 March 2023  The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Developed a round pink area about 2.5in below injection site and another smaller one below that.
pt recvd vax & pt devel profuse vomiting; pt subsequently recovered by 17MAR93; No further details were provided;
Diarrhea; she had body aches; Tingling in her Jaw and in her mouth; Headache; Nausea; She is having extreme difficulties; not feeling well; Not sleeping well during the night; tingling in her Jaw; This is a spontaneous report from a contactable Consumer(mother). A female patient received (BNT162B2), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter was giving her daughter's name she was the respiratory therapist at the hospital and she received the Pfizer Covid Vaccine last Monday in Dec2020 and she was having extreme difficulties today. She had diarrhea, she had body aches, she had tingling in her mouth, headache, her nausea and all of the sudden it started with yesterday in Dec2020 and perhaps the day before it started with the tingling in her Jaw and in her mouth and she woke up today and not feeling well and she took a nap after not sleeping well during the night and when she woke up from the nap she had extreme body aches, diarrhea, nausea, headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Onset of provisional Tic disorder on June 28th, 2022. Symptomatic (chest pain)  sinus tachycardia, seen in ED for this on January 17, 2022
Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    This case was for patient no.14, who experienced Myocarditis after first dose of Moderna vaccine.  No concomitant or treatment medications were reported.  This study is based on a cohort evaluation of all adults administered =1 mRNA COVID-19 vaccine, including boosters, in the Health Administration between 14 December 2020 and 9 October 2022. From 14 December 2020 to 9 October 2022, 2 184 449 first and 2 036 948 second doses of mRNA-1273 (Moderna) were administered. In addition, 1 156 160 mRNA-1273 booster doses were administered. Among vaccine recipients in our cohort aged 1839 (predominately male, as expected in a VA-based cohort), estimated incidence rates of confirmed myocarditis/pericarditis ranged from 0.46 cases per million (for Moderna dose 1, all ages) to 19.76 (Pfizer dose 2, ages 1839). Of the 178 potential safety events identified by the RCA, only 33 were ultimately confirmed following an mRNA vaccine. Potential cases were ruled out after chart review for various reasons.  In summary, the incidence of myocarditis or pericarditis in veteran patients was low across >10 million doses of mRNA COVID-19 vaccines (primary or booster doses) administered in the VA.   This case was linked to MOD-2023-734758 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow up received by safety on 27-JUL-2023 has email with FTA that contains significant information: Reporter information, literature information, suspect information and event details were updated.; Sender's Comments: Company comment: This is a literature non-study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant AESI myocarditis. The event occurred after receiving the first dose of mRNA-1273 vaccine (event and vaccine dates were not provided). Concomitant and treatment medications were not reported. The outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. MOD-2023-734758:Same literature (Master case)
not feeling well; slept for 12 hours that day; 101 degree F temperature; tired,draggy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), SOMNOLENCE (slept for 12 hours that day), PYREXIA (101 degree F temperature) and FATIGUE (tired,draggy) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (not feeling well), SOMNOLENCE (slept for 12 hours that day), PYREXIA (101 degree F temperature) and FATIGUE (tired,draggy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, SOMNOLENCE (slept for 12 hours that day) and PYREXIA (101 degree F temperature) had resolved. On 01-Apr-2021, FATIGUE (tired,draggy) had resolved. At the time of the report, MALAISE (not feeling well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 (Inconclusive) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  After the day of vaccination, patient had a 101 degree F temperature, slept for 12 hours that day, was very tired, draggy until Thursday and had continued episodes of not feeling well intermittently (3-4 times to date). Sometimes it lasted for an afternoon, sometimes for a day.  Treatment information included ibuprofen
Product diluted with 1.2ml instead of 1.3 ml. No reported adverse event so far.
I felt weak; hard to focus; fatigued; This is a spontaneous report from a contactable healthcare professional (the patient). A 52-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 19Jan2021 at 12:45 (at the age of 52-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications included omeprazole (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 13:30, the patient experienced felt weak, hard to focus, and fatigued. It was reported that the shot was at 12:45 pm, the patient had to lay down until she went to bed. Felt 80% better in the morning. The patient did not receive any treatment for the events. The clinical outcome of the events asthenia, disturbance in attention and fatigue was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient was given a full dose of Fluzone  0.5mg. Provider was notified immediately after injection given. Poison control was called as well as Agency. Both were notified that the patient was 2 months old and received a full dose of Flu. We kept the patient in office for 45 minutes after vaccine administered and patient had no reaction. Pt's mother was advised to watch for flu-like symptoms for the next 24-48 hours.
On April 11 my injection site became hot and feverish and red. I woke up the next morning and on my entire left arm from shoulder to wrist all my skin was shedding on similar to a horrible sunburn and no I had not been in the sun.
I woke up in the morning with an itchy arm where I was vaccinated. At first it felt like a bug bite, just a small bump. About 12 hours later, it was a large red bump/raised area, with another small bumpy area close by. Sometimes it's incredibly itchy, other times I don't notice it. I read that it will go away on its own, so I'm not going to contact my doctor about it.
This case was reported by a healthcare professional and described the occurrence of itching in a 34-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 at 15:15 the subject received 1st dose of FLUARIX (unknown, right arm). On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced itching, elevated blood pressure and dizziness. The healthcare professional reported that the subject is a staff member in the office. The subject experienced itching, hives and elevated blood pressure. At the time of the call the subject was still in the office being treated; BENADRYL was given as treatment to prevent hospitalization. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the itching, elevated blood pressure and dizziness was unspecified. The healthcare professional considered the events were probably related to vaccination with FLUARIX. The healthcare professional reported another case, see also A0997590A.
pt recv vax 26JUN98 & 27JUN98 pt devel neuralgia, neck pain & arm pain;MD visit was required;pt was not treated for the event;
Bad diarrhea; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 27Aug2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to food, medications, or other products. On 28Aug2021 at 17:30, the patient experienced bad diarrhea, headache, nausea and fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad diarrhea, headache, nausea and fatigue was resolving at the time of this report.
Patient calling on 4/21/21, before her second dose, and reports about an hour after her first dose, on 3/24/21, she experienced dizziness, nausea, vomiting, throat tightness, itching in throat, and full body hives. Symptoms lasted a couple days. She treated it at home. Advised to not receive second dose
cough; swelling at injection site; redness at injection site; pain at injection site; itching at injection site; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 25th September 2019, 1 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, injection site swelling, injection site erythema, injection site pain and injection site itching. On 27th September 2019, the patient experienced cough. On 27th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the cough, injection site swelling, injection site erythema, injection site pain and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, cough, injection site swelling, injection site erythema, injection site pain and injection site itching to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient reported that her fever went as high as 103. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. There was discrepancy in the outcome of the events cough, injection site swelling, injection site erythema, injection site pain and injection site itching reported in source document as recovering/ resolving and in argus it was reported as not recovered/ not resolved.
Arthralgia Narrative: Employee noticed severe pain in her big toe which has not resolvedand may incidentally be an attack of CPPD or Gout.
Initial and follow-up information has been received from the Merck Pregnancy Registry via a certified medical assistant concerning a 27 year old female with a history of an abnormal pap with Atypical squamous cells of undetermined significance (ASCUS) (04-Aug-2007) and a 36.6 full term normal delivery, who on 16-October-2007 was vaccinated IM with a first 0.5 mL dose of Gardasil (Lot# 654540/0800F). The patient received a second vaccination of Gardasil, a 0.5 mL dose administered IM (Lot# 653938/0954F). Concomitant therapy included prenatal vitamins. On 03-Jan-2007, the patient reported that a home pregnancy test was positive. The patient's last menstrual period was on 01-DEC-2006 and the estimated date of delivery was 16-AUG-2007. On 18-JAN-2007 and 12-FEB-2007 ultrasounds were preformed, results normal. On 20-MAR-2007, the patient developed a vaginal infection and was treated with amoxicillin. On 10-MAY, the patient developed a sinus infection as was treated with azithromycin (Z-Pack). On 16-AUG-2007 the patient delivered a 7 pound 1 ounce, 20 1/4 inch normal male infant. The APGAR scores at one and five minutes were 9 and the head circumference was "12" cm. It was reported that there was a 2 vessel cord. The infant experienced neonatal jaundice. Laboratory diagnostics were performed on the infant (the results can be found in the laboratory results section). On 23-AUG-2007 the infant recovered from the neonatal jaundice. The infant was kept under light for two days. On 29-DEC-2007 the infant experienced cough and pharyngitis. On approximately 21-JAN-2008 the infant experienced constipation and ws treated with apple juice and water. On 11-FEB-2008 the infant was positive for respiratory syncytial virus bronchiolitis. The outcome of the infant's symptoms were unknown. At the time of the report the patient had recovered from the pregnancy, but the outcome of the vaginal and sinus infections were unknown. Additional information is not expected.
shingles; other health complication; allergic reaction; rash; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 66-year-old patient of unknown gender. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 29-SEP-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided). As a result of her receipt or zoster vaccine live (ZOSTAVAX), on 08-NOV-2016, the patient was caused to suffer a severe rash and allergic reaction. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient required and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also had suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The patient's past and future damages, including but not limited to pain and suffering for severe injuries sustained, health care costs, loss of wages and/or earning capacity, and medical monitoring. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.
Began at night, itching at the injection site. In the morning, it was swollen, red, hard and hot lump on my upper arm. It was also quite itchy and sore. The rash was about 3 inches in diameter and circular. It was hard to the touch and very warm. Lasted about 5 days then went away.
Narrative:  Several minutes after receiving the first Covid vaccination patient felt hot heard ringing in the ears and felt like he was going to pass out. Patient informed staff and they put him on a stretcher and transported him to the Emergency Room. Patient did not pass out and his symptoms passed quickly after lying down. Patient history and physical consistent with vasovagal/neurocardiogenic syncope. He was observed in ED for resolution of symptoms. He remained stable and was discharged home. Impression - Neurocardiogenic syncope
Consumer's husband has had unspecified polyps removed from his throat "multiple times."  His physician has recommended GARDASIL 9 in hopes of preventing the polyps from coming back. Consumer reported that the physician referenced an unspecified rese; This spontaneous report was received from consumer's wife and refers to a male patient of unspecified age. The patient's medical history included unspecified polyps, and throat polyps removal. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient's physician has recommended hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for preventing the polyps from coming back (dose, strength, lot #, expiry date, and route of administration were not provided) (off label use).
Redness and swelling locally both sides. Itchy, no pain. Size approx. 5cm. Pt reported the reaction to clinic 2 days after injection.
Information has been received from a person in a doctor's office concerning a 33 year old male with no past medical history who in January 2001 and on July 2001 was vaccinated with a first (lot @ 634178/1330K) and second dose (lot @ 636384/0408L) of hepatitis A virus vaccine inactivated, respectively.  There were no concomitant medications.  On 02/11/2003 it was reported that a "titer was drawn 2 to 3 weeks ago."  The titer was negative.  The patient sought unspecified medical attention.  Additional information has been requested.
SYMPTOMS NOTED BY PARENT THIS AM. RIGHT THIGH SWOLLEN, ITCHING AND VERY RED AND WARM TO TOUCH
Patient noticed soreness in her arm at the exact spot where she received her vaccine back in February.  Initially she had soreness but it resolved within 2 weeks.  Then this past weekend she noticed soreness and a knot in that same spot.