chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022). Concomitant drugs were not reported. It was reported that a 1.5 year of age patient received expired second dose on 22-Aug-2022 around 9AM which was initially stored in refrigerator on 18-Jul-2022 at 1:30PM. The 2 doses were given from 1 vial and the vial did not undergo any temperature excursions. Treatment medications were not provided. This case was linked to MODERNATX, INC.-MOD-2022-631757 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-631757:Patient-1 case.
mother's blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (mother's blood pressure went up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (mother's blood pressure went up). At the time of the report, BLOOD PRESSURE INCREASED (mother's blood pressure went up) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure went up (High) mother's blood pressure went up.         No treatment information was provided.  The action taken with response to the drug is not applicable.
Spiked a fever 11 hours after injection.  Temperature was 103.9 lasting 10-12 hours.  Not relieved by Tylenol or Advil .  Rash that spread on checks of face.  Muscle aches and pain throughout.  And hematoma at injection site . The size of a large egg.  Lymph node involvement to both armpits and neck.  Symptoms lasted 36-48 hours.  Fever 100 lasted 5 days.
Very swollen and red for three days. As the months went on it hurt (ached) when I'd move my arm backwards or laid on it. Its been 5 months and always in the area of the shot.
20 y/o male with a scattered morbilliform rash consisting of erythematous pustules and papules.  Nonpruritic, nontender.  Scattered diffusely across the arms, trunk, and legs.  No lesions on face.  Discussed case with Dr., diagnosis presumed to be non-viral pustulosis.  Patient stable with only mild upper respiratory symptoms.  The lesions subsided over the course of 2-3 days without treatment.
Per Nursing Phone Note: Pt stated she was here on 11/20 and seen by NP then received a flu vaccine. The next day the pt stated, she woke with a very stiff neck, affecting her ability to lift her head up or down or turn side to side. Pt has no other symptoms of a flu vaccine reaction. She did voice having a flu vaccine in the past w/ no adverse affect. She stated she has been using ice/heat, volteran cream with relief. pt stated the discomfort lasted about 3-4 days, now she still has a little " annoying discomfort." but it is tolerable, taking tramadol if needed for pain. The pt was instructed by 2 other Doctors to call and inform us of her issue. Pt was given a Script for outpt  PT for exercise and message. Pt had denied lifting any heavy objects and denied fall. She did report use of a new pillow which she thought may have caused the issue. Instructed pt to call back should any further symptoms appear. Pt v/u.
Information has been received from a License Practical nurse regarding a three patients of unknown age and gender. On unknown dates the patients received doses of (Oka/Merck) VARIVAX (dose, lot #, expiration date and route not reported), that were exposed to temperatures outside of the proper storage. No adverse effect reported. It was unknown in the patients sought medical attention. Additional information has been requested.
Information has been received from a physician concerning a female patient who on 15-AUG-2008 was vaccinated with the first 0.5 mL dose of GARDASIL. Concomitant therapy included MENACTRA and hepatitis A virus vaccine (manufacturer unknown).  On the same day, the patient experienced dizziness.  Subsequently, the patient recovered.  The patient sought unspecified medical attention.  No further information is available.
Pt received IZ on 7/25. Mother called today and told of itchy and local facial rash.
On day 6 after MMR vaccine, patient began a fever.  Fever progressed to 102 degrees.  Tylenol was given at regular intervals.  On day 7, fever was not controlled with Tylenol.  Fever progressed.  Patient had a febrile seizure and ambulance was called.  Patient was worked up in the ER.  ER diagnosis was febrile seizure.  Patient was worked up the next day in the physician's ofice and no obvious source of the fever was found.  All lab data was negative.  No other symptoms other than fever.  Patient was treated with Tylenol and Motrin until fever finally resolved.  Fever lasted 3 days.
MS; COPD; He couldn't feel his stomach. If he ate something, he could not tell if he ate it.; the shot almost killed me; Did not receive his second dose yet; Head felt it was as big as a Volkswagen/ had headaches/ really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a male patient of an unknown age 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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (MS) (seriousness criterion medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me), PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache). At the time of the report, MULTIPLE SCLEROSIS (MS), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company comment This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.
Patient seen in ED on 1/19/2022- with COVID- Left AMA  Patient returned to ED 1/20/22- discharged Patient returned to ED 1/22-22 and admitted for 2 days. Hospital course: Patient presented to the ER with hallucinations.  She recently tested positive for COVID-19 on the 19th of January and since then has been in self isolation.  During this time, the patient complained of worsening hallucinations both auditory and visual.  Specifically she states that she sees animals and people who were not there and has conversations with them in her room.  She denies any suicidal or homicidal ideations. She was largely asymptomatic for COVID-19 and did not complain of cough or shortness of breath. Initial workup including a CMP/complete blood count which were within normal limits.  Chest x-ray revealed no acute cardiopulmonary process.  The patient is being admitted for evaluation of hallucinations plus social work and care management for evaluation of her home situation.  On the night of 01/24/2022 around 8:30 p.m. I was notified by nursing staff that the patient was not on her assigned room and cannot be located in the hospital.  Nursing staff was able to reach the patient's daughter via phone and she stated the patient was home and sleeping in her bed.  We will discharge the patient from the hospital at this time with leaving against medical advice.  She did not have IV access at the time of discharge.  Patient was seen in the ED 1/30/22-Upon presentation the patient appears very anxious.  She is otherwise nontoxic appearing.  The patient is pacing in the exam room without signs of respiratory distress.  Oxygen saturations are adequate.  The patient reports concern as she continues to have some congestion and cough as well as a headache which she attributes to COVID-19 which she was diagnosed with on 1/19.  Chart review does indicate that the patient was symptomatic for approximately 3 days prior to her diagnosis.  I did inform the patient that based off from this time line she is technically out of her quarantine time frame.  She was reassured at her stable vital signs.  She reports that she has been very anxious about having COVID-19 as she has not wanted to transmit this to other individuals.  After reassuring the patient of her stable vital signs in adequate oxygen saturations as well as the fact that she is now outside of the typical quarantine.  She did report that she felt much relieved and is requesting discharge from the emergency department.  I did discuss further workup including labs and imaging with the patient.  However she declined and is requesting discharge with outpatient follow-up.  She was instructed to follow up with her primary care physician for re-evaluation.  She was instructed to return to the emergency department for any worsening symptoms including difficulty breathing.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L204 and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Pre-eclampsia (patient had high blood pressure during delivery and there was a live full-time birth) on 07-Jan-2019 and Hypertension in January 2019. Concurrent medical conditions included Postpartum thyroiditis since January 2019. Concomitant products included LEVOTHYROXINE for Thyroid disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021 at 8:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 28-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2020, Pregnancy test: positive (Positive) Positive. In 2021, Blood glucose: no glucose intolerance (normal) No glucose intolerance. In 2021, Prenatal screening test: normal (normal) normal. In 2021, Ultrasound foetal: normal (normal) normal.         No treatment were provided.  It was reported that, the patient's estimated date of conception was 28-Nov-2020. Her previous pregnancy included live full term birth on 07-Jan-2019.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Added lab data, medical history, concomitant medications and second dosage regimen.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
This started a few days after, I had severe chills all throughout my back, shivers, headache (specifically over the top of my right eye). This lasted for about two days, the third day I was able to manage it and by the fourth it was ok. I was having a difficult time moving around but kept moving to keep the circulation going.  I spoke with my Physician and they said it was side effects from the vaccine. I spoke to my Pomologists to make sure I was on the correct medication or if it was the vaccine.
Localized reaction, large red welt that is warm to the touch- no prior reactions to vaccinations.
Feeling nauseated at about 3 pm. Emesis x 1 at 5:30 pm. Chills/shaking after emesis continuing until about 11:00 pm. No fever reported. She was able to drink small amounts of water but food made her more nauseous. Injection site: Painful until about 8 pm. Swelling/inflammation 4 inches in circumference. No redness or bruising reported. 10/09/13 - Chills, nausea and shakiness have subsided but she reports that she feels tired, washed out with no motivation. She did not seek medical attention.  She feels that this is adverse event caused by the flu vaccine.
Vaccination site is red; Vaccination site swollen; Vaccination site warmth; Vaccination site pain; Vaccination site has a hard lump; Bloating; Cramps; diarrhea; Gas; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration on the left arm on 13Mar2021 at 04:30 AM (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. Medical history included urticaria. The patients allergies included pollen and dust. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine. On 14Mar2021 at 06:00 AM, patient noted that vaccination site was red, swollen, warm, painful, with a hard lump, bloating, cramps, diarrhoea and gas. No therapeutic measures were taken as a result of the events experienced. The clinical outcome of the events vaccination site red, swollen, warm, painful, hard lump, bloating, cramps, diarrhoea and gas was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10/3/02 Well child visit given DTaP #4. Temperature 102 at 11:30PM. Received Motrin at 10:00PM. Seizure at 2:30AM--transported by ambulance to ER. Given Tylenol Supp with good result.
fever 104.8 all noc & day; restless x 24 hrs w/high pitched crying; local rxn of swelling, redness, warmth & knots x several days;
Patient received Pfizer vaccines on 12/18/20 and 1/15/21. Known COVID 19 exposure; tested positive for COVID-19 by PCR on 4/20/21. symptoms of cough, myalgia, H/A, congestion/rhinorrhea, diarrhea
10 seconds after Hep B injection, client complained of blurry vision, fell faint, and upper extremities became rigid, tense and shaking, seizure-like activity less than 1 minute. Pt was pale, elevated heart rate. Responded 1 minute later.
got her two doses / gotten shingles 3 times since/Suspected vaccination failure; Shingles; lesions; rash / spread to her skull, hairline, right arm and both legs; infection; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin lesion, generalized rash and infection. On an unknown date, the outcome of the vaccination failure, shingles, skin lesion and generalized rash were unknown and the outcome of the infection was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, generalized rash and infection to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient called in to get additional information about getting an additional booster dose of Shingrix because she got her two doses, but she thought it was wearing off because she said she had gotten shingles 3 times since getting the vaccine.  The patient stated in 2018, she had shingles the first time the exact dates was unknown to the patient.  After the lesions cleared up, she stated about a month later they came back up and it came back a second time.  The rash was disseminated.  Her most recent infection started on 3rd December 2021 which started at her neck.  Now she said the rash had spread to her skull, hairline, right arm and both legs.  The infection had not gone away, referred to health care professional (HCP).  The patient verbalized understanding would place a call to her HCP. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Swelling at site of injection 1 day after it was given - fever-felt tired.
general aches and pains; malaise/not feeling well; stayed in bed; high fever; severe headache/headache was the worse of all the side effects; vomiting; nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (general aches and pains), MALAISE (malaise/not feeling well), MOBILITY DECREASED (stayed in bed), PYREXIA (high fever) and HEADACHE (severe headache/headache was the worse of all the side effects) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (general aches and pains), MALAISE (malaise/not feeling well), MOBILITY DECREASED (stayed in bed), PYREXIA (high fever), HEADACHE (severe headache/headache was the worse of all the side effects), VOMITING (vomiting) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 08-Apr-2021, PAIN (general aches and pains), MALAISE (malaise/not feeling well), MOBILITY DECREASED (stayed in bed), PYREXIA (high fever), HEADACHE (severe headache/headache was the worse of all the side effects), VOMITING (vomiting) and NAUSEA (nausea) had resolved.            It was reported that patient had to stay in bed the whole time as was not feeling well.   This case was linked to MOD-2021-047816, MOD-2022-609304 (Patient Link).
Bilateral adenopathy - Day 6 to present Severe arm pain - Day 6 to present Arm weakness - Day 6
Severe pain in the upper left arm very sharp the day of vaccination, now not as acute but still present and limiting use of arm without significant pain. Perhaps the vaccine was given too high and not in muscle.
Spot on the arm is getting bigger; Felt very sick; Awake at night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Spot on the arm is getting bigger), MALAISE (Felt very sick) and INSOMNIA (Awake at night) in a 69-year-old female patient who received mRNA-1273 (batch nos. 014C21A and 031B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced MALAISE (Felt very sick) and INSOMNIA (Awake at night). On an unknown date, the patient experienced VACCINATION SITE REACTION (Spot on the arm is getting bigger). The patient was treated with IBUPROFEN from 29-Apr-2021 to 30-Apr-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Spot on the arm is getting bigger) had not resolved and MALAISE (Felt very sick) and INSOMNIA (Awake at night) outcome was unknown.
This spontaneous report was received from a registered nurse regarding to unspecified number of patients. Patient demographics, concurrent conditions, medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L017142, expiry date: 13-MAY-2017 and lot # L026407, expiry date: 15-JUL-2017 (dose number, route, anatomical location, dose and units were not specified). Concomitant medication were not reported. No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Temperature at which the vaccines were stored was: -8.9C, for a total time of 41 hours. There was no previous temperature excursion done. This case is linked to case # 1602USA003059 via same reporter link. Additional information has been requested.