chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick at home with cough and COVID; sick at home with cough and COVID; feels likes crap; feels weak; not feeling good; sore left arm; nauseous; feels tired; Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish; having chills; This spontaneous case was reported by a patient and describes the occurrence of COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak) and MALAISE (not feeling good) in a 64-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills). At the time of the report, FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up appended :AE added. Patient DOB ,age and  Reporter address added. On 25-May-2021: Non-significant follow-up On 25-May-2021: AE updated
Vaccine vial stored for longer than recommended time post puncture (up to 28 days) No adverse effects
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient who experienced localized reaction, feels sluggish, flushing and redness in her face and felt warm but no fever, and achiness in her legs, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical treatment included ACYCLOVIR [ACICLOVIR] and PREDNISONE with for 4 days for another problem but is not sure which year.. It was also reported that she had Shingles twice this year in May and July. The patient's past medical history, vaccination(s) and family history were not provided. Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction (local reaction) four hour following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious feels sluggish (sluggishness) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (flushing) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious flushing and redness in her face and felt warm but no fever (erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious achiness in her legs (pain in extremity) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported she has never felt this tired. Her husband got the same type of injection and he had no problems but weighs more than she does. States the pharmacist told her they only had one other person with this type of reaction. (Other relevant tests included No lab data.) Final diagnosis was achiness in her legs, flushing and redness in her face and felt warm but no fever, feels sluggish and localized reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for flushing and redness in her face and felt warm but no fever, as Unknown for feels sluggish, as Unknown for achiness in her legs and as Unknown for localized reaction. List of documents held by sender: none.
the surgeon accidentally punctured her bowel; A stone was stuck in her bile duct; gallstones; short of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel) (seriousness criteria hospitalization and medically significant), BILE DUCT STONE (A stone was stuck in her bile duct), CHOLELITHIASIS (gallstones) and DYSPNOEA (short of breath). The patient was treated with Surgery for Bile duct stone and Surgery for Cholelithiasis. At the time of the report, INTESTINAL PERFORATION (the surgeon accidentally punctured her bowel), BILE DUCT STONE (A stone was stuck in her bile duct), CHOLELITHIASIS (gallstones) and DYSPNOEA (short of breath) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. After getting first dose of vaccine, by that afternoon, the patient was short of breath, had abdominal pain, and was found to have gallstones during ER visit.  A stone was stuck in her bile duct and while trying to remove the stone in her bile duct, the surgeon accidentally punctured her bowel. The patient was transferred to a different hospital. She had her gall bladder removed and was recovering at home. The patient was due for the second vaccine dose tomorrow, but was unable to get it due to her recovery process. Company Comment : Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for the  events of Dyspnea. The events of Intestinal perforation, Bile duct stone, Cholelithiasis and Abdominal pain are Unlikely related.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for the  events of Dyspnea. The events of Intestinal perforation, Bile duct stone, Cholelithiasis and Abdominal pain are Unlikely related.
Incapacitating Myalgias, arthralgias, hezdache, low grade fever. Tylenol, toradol,  hydration, sleep.  Lasted from  6pm 12/24 to 8am 12/26
Sore arm, swelling and redness increasing in size from 12 hours to 48 hours down to elbow and mid bicep width.  102 degree fever, excessive sweating, fatigue
No additional AE were reported; Medical assistant called to report that today on 8/25/2022, a patient was given MMR II via intramuscular route.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug allergies, and reactions were not provided.   On 25-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) for prophylaxis, intramuscularly (incorrect route of product administration) (lot number W011885 has been verified to be valid; expiration date reported and established as 04-SEP-2023) (dosage, vaccination scheme, and anatomical site of injection were not provided). No additional adverse events were reported.
Patient presented to the ER with shortness of breath for 1 week, got worse last few days with cough and change in his sense of smell and objective fever.  He came into emergency room on December 7, 2021.  His saturation was 88% on room air.  The patient was placed on oxygen.  Chest x-ray showed bilateral opacities. His O2 saturation was 88% in ER. He was given Decadron, remdesivir.  DVT prophylaxis. Procalcitonin negative.  Chest x-ray, bilateral infiltrate.  Home O2 evaluation upon discharge and COVID kit Care.
she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm; bruise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, and Expiration date: Unknown), intramuscular, administered in right arm (she was reported as right-handed) on 12Feb2021 07:30 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3302, and Expiration date: Unknown), intramuscular, administered in left arm on 22Jan2021 (at the age of 68-year-old) for COVID-19 immunization. The patient did not receive any other vaccine (within 4 weeks) since her flu shot which was in late Oct, early Nov, exact date was unknown. It was reported that the patient received both doses exactly 3 weeks apart, on 22Jan2021 and 12Feb2021. After the first vaccine she had no reaction, she could not even feel where the provider injected the shot in her arm. After the second one, on the other arm, "she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm". She realized when she went to raise her arm, she was like "geez, that hurts". She clarified it did not hurt, but she could feel something. The patient got the second shot at 7:30 am and the ache came in 6 hrs after vaccination (mid-afternoon), it lasted until next morning when she "couldn't feel anymore" at 8 am. This went away probably maybe by 26-28 hours. This ache in her arm was gone by noon the next day. It was nothing. She additionally experienced a sore arm and bruise 68 hours after her 2nd dose was administered, in Feb2021. She heard after the vaccines there would be a feeling and there would be a reaction, she was curious that to assure that her body was "creating a reaction" should she had a reaction. She was hearing everybody else having reactions and that having a reaction means your body was creating antibodies. She was wondering if she had antibodies and was protected. She was asking should she get a test. Investigation assessment was not provided. No further details were provided or obtained. The outcome of the event "she had just a "slight" arm ache when she tried to raise her arm/little bit of an ache in her arm" reported as resolved on 13Feb2021. The outcome of event bruise was unknown.  No follow-up attempts are possible. No further information is expected.
No reaction initially except next day a little red.  Over next days, some lumpiness at site.  Now at 12 days, large splotchy eruption.  2 inches by 3 inches.
After verifying 3 times (on the form, with the pharmacist and with the nurse administering the vaccine) the wrong dose was still given to me by this pharmacy. I requested 3 times, the 2nd dose of the Covid-19 vaccine. Instead, I was given the Bivalent booster. As I was told by the 2nd pharmacist when I returned later that day to get the Vaccination Record Card, because they had failed to give it to me when I was there for the vaccine earlier that morning.  **Section below will not allow the entry of the previous/1st dose date: 9/26/22.
Maculo papular rash starting on face spreading to trunk extremities, started day following vaccine administration and itching. No other systemic symptoms. Supportive treatment.
Itching everywhere: hair, chest, neck; Lethargic; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching everywhere: hair, chest, neck), LETHARGY (Lethargic) and FATIGUE (Tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (Morphine, Demerol, and Toradol,Tetracycline and Amoxicillin.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itching everywhere: hair, chest, neck), LETHARGY (Lethargic) and FATIGUE (Tired). On 06-Feb-2021, PRURITUS (Itching everywhere: hair, chest, neck) had resolved. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
History of HTN, left-arm numbness, and ipsilateral dilated (blown) pupil about 2 minutes post vaccine.  Transported to ED.  Patient left the ED without treatment.
I had been having breathing troubles since mid March, but since I am being evaulated every three months for recurrence of cancer, did not think too much about it. The shortness of breath has gradually gotten worse with even mild exertion . On November 25, I began to feel the symptoms of a common cold; sore and scratchy throat, fever, headache, sweats, labored breathing (worse than usual). By Nov 28, I felt like I might have had breakthrough COVID, so I submitted a PCR at pharmacy. That night, symptoms worsened, so I went to Urgent Care. A chest X-Ray and swab for pneumonia were taken, and both were negative. I was sent home with no medications and told to return if worse. On Nov. 29, I felt considerable worse, to the point that I called 911 for fear I would pass out driving. I could not catch my breath and my oxygen sats on my home oximeter were in the mid 80's. An EKG was obtained and I heard the paramedi state it was suspicious. I was taken to the hospital, and had a CT, bloodwork, breathing treatment and oxygen administered. I was sent home with Steroids, and a diagnosis of rhino enterovirus. The discharge summary states that I was in acute respiratory distress.
Ipol and the other vaccine, Pentacel and both have polio in the vaccine with no AE; Initial information received on 07-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who received a 0.5 ml dose of vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE] (lot: UJ146AAA, expiry date: 14-Feb-2021) and  POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) (lot number and expiry date unknown), both via unknown route at unknown administration site, on an unknown date (wrong product administered) as prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, and family history were not provided.  Concomitant vaccines included HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE 13V.  It was an actual medication error due to ipol and the other vaccine, pentacel and both have polio in the vaccine (Extra dose administered).    At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shortly after vaccination within 5 minutes.  Patient complained of lips tingling and numbing.  Patient was evaluated by EMS.  A few hives found on center of chest.   IM Benadryl and Pepcid given by EMS.  Patient was monitored for 45 minutes and released.
On 7/31 I experienced painful, heavy period-like cramps and a small amount of spotting, 10 days before the predicted start date of my period. I had no symptoms until mid afternoon 8/4 and my period began one whole week early.
I had normal side effects at first. My arm hurt really bad the next day but then never went away. Over a month I?m still in a lot of pain and can not use my left arm much because the pain right where the shot was. I am on steroids and using steroid creams to help with the pain. I have a 9 month old baby and I can not use my left arm with her. When I wake up it?s worse and it will keep me up at night so I have to take pain meds.
severe myalgias, fever, w/subsequent weakness/pain of lt upper & lower extremities; progressive weakness w/muscle atorphy; sx began 48 hrs p/vax;
5NOV91 reported t104.4 R down to 102 w/APAP supp; vomited x 1, h/a; 6NOV91 830AM; t102.6, still h/a, chill, urinates ok, stools norm;
itching & redness measuring 4x5 inches rt deltoid recommended warm compresses TID, atarax;
A non-serious, spontaneous report of administered full dose of FLUMIST to one nostril was received from a health professional concerning a six-year-old female. Medical history and concomitant medications were not reported. On 03-Oct-2010, the patient received a full dose of FLUMIST into one nostril. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Swelling upper part Lt. arm, redness, fever, edema elbow to shoulder.
Patient fainted after receiving vaccine. She was out for about 10 seconds before waking up.
I received a phone call at approximately 1:20 pm from the patient's mother stating that she had woken from a nap having a seizure. Patient was taken to ER and had another seizure there.
Major swelling at injection site, redness and pain; started night of injection; reported 3 days later.
Bells Palsy   Medicine prescribed: Valacyclovir 1GM tablets, Prednisone 20MG tablets, Doxycycline HYC 100MG tablets The meds have had no effect so far.
4.5 x 5.5 cm red, swollen, warm to touch and indurated right deltoid increased with ice application to 6.5 x 5.5cm and urticarial. Decreased O/P Zyrtec.
first dose on 18Jun2021, did not return for subsequent dosing; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th June 2021, batch number DK23D expiration date 08 February 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The pharmacist reported that the patient did not return for subsequent dosing. At the time of reporting, the patient was not yet received further doses.  The reporter consent to follow-up. The reporter gave permission for follow up but declined to provide email address. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of Twinrix which led to incomplete course of vaccination.
pt recv vax 25APR95 & 29APR95 pt devel rash consistent w/erythema multiforme;rash peaked on 30APR95 & was essentially resolved on 3MAY95;
Pt received Anthrax, Hep A, Hep B Typhoid. After receiving Anthrax (last imms) she became diaphoretic and described a loss of vision, ringing in her ears and dizziness. Treatment- 0947 - Patient taken to clinic - Vital signs - BP 90/62 - 1005 - Pt has returned to normal state - describes feeling mildly shaky - B/P-100/72 - HR=72. 1010 - Pt back to normal state. Called to report adverse event - healthcare professional aware.
Itchy swollen arm at injection site appearing the day after vaccine and lasting for four days. No reaction for a few days and then resurgence of swelling, redness, and itching at injection site one week after vaccination. Ice and hydrocortisone cream are somewhat effective.
Pfizer 3/23/21, 4/20/21, 12/6/21. Positive on 9/8/22
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 23-JAN-2017 (on the same visit), the patient had inadvertently administered a dose of VARIVAX (dose, route of administration, lot # and expiration date were not reported) and a dose of PROQUAD (dose, route of administration, lot # and expiration date were not reported), both for prophylaxis. There were no adverse events reported. No product quality complaint (PQC) was involved.    Additional information has been requested.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016518549) on 03-Feb-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of 0.5 ml of INFLUENZA VACCINE (Flu Shot) intramuscularly (batch number:UI62622, expiry date and dose in series were not reported) in the right deltoid muscle on 21-Oct-2016. It was also reported that the patient had received PREVNAR 13 intramuscularly into left deltoid muscle on 30-Aug-2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had developed fatigue, mild headache, pain and sometimes trouble in falling asleep (awaken every day between 3-5 am). Laboratory investigations included as X-ray and Magnetic resonance imaging (MRIS) was performed on an unknown date. The patient received corrective treatment as Ibuprofen and physical therapy. On an unknown day, the outcome of the event as mild headache was recovered (reported as headache is mostly better). The outcome of other events as fatigue, pain and difficulty sleeping was not reported. List of documents held by sender: none.
Joint ache, muscle fatigue, feeling close to fainting, louder tinnitus than usual.
Start with nausea and headache The next day feel heart beat abnormal, measured  heart beat rate 80/min. Usual 60-65/min. Feel breath not fluently (need some deep breath), a little bit faint
Pt pre-medicated with home benadryl and steroids due to initial vaccine reaction of itching.  Pt c/o itching, nausea, dizziness, flushing at neck/chest, and feeling light headed.   Sx did not improve during observation.  VS 122/60 HR 87 SaO2 98%.  Pt transferred to ER via w/c