chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Mar2023, outcome "recovered" (22Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Mar2023) Diagnosed Covid, notes: home test; (22Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Diagnosed with home test on 15Mar2023, symptoms started the night of 14Mar2023. The patient received Paxlovid for COVID-19 treatment from 16Mar2023 to 20Mar2023. Symptoms improved and resolved.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded.  This case will be reassessed should additional information become available.
Patient stated "I got dizzy one hour after I got the flu shot." Dizzy enough that I felt I shouldn't drive. That lasted approx. 10 hours. I also experienced a numbness in my arm, which has gone away except for a little numbness in the tip of my thumb.
grandma called 247PM concerned of pt severe h/a, vomiting that started about 11AM (approx 24hr p/vax);no fever, no cough or cold;looks pale & lying on sofa;also has dizziness;APAP was given;advised to have pt seen by MD;
presents to the Emergency Department as a medical resuscitation activation for presumed seizure found to be COVID positive.
Foster mom reports child had a seizure that started around 1pm at a department store where 911 was called and patient transported to  Hospital where she treated with a second dose of anti seizure medication then transported to another hospital where she continued seizure activity for over an hour. Foster mom report twitching all over body, eyes rolling and left side of body becoming limp toward the end of seizure. Child was drooling and nonresponsive to verbal stimuli.
At approximately 0933am client was sitting in chair in front of nurses station when she fell from chair into the floor without warning.  Client was unconscious for approximately 30 seconds at which time she appeared pale, cool and clammy to touch.  911 was called.  At 0935 vital signs were blood pressure 96/60, heart rate 66,  O2 Sat 97% on room-air color was pink at this time and client was aware of surroundings.  EMS arrived at 0939.  Client refused transport to hospital.
Moderna given to client under age 18.  No adverse events noted at date deviation was recognized (5/19/2021)
No adverse event reported. Found in paperwork that this person was only 16 years of age and should not have received Moderna Vaccine.
Fever, Sinus congestion type - large Headache, chills, fatigue & upset stomach
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported that patient had received expired FLUMIST QUADRIVALENT on 28-Mar-2014. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous report was received from a registered nurse referring to a currently 4 years old male patient. The patient has none medical history or drug reactions/allergies or concomitant therapies. On 10-JUN-2013, the patient was vaccinated with the first dose of PROQUAD subcutaneous (dosage, anatomical location, lot number and expiration date were not provided). No other suspect therapies were reported. On an unknown date, the patient was diagnosed with Pneumonia in an urgent care center however, the reporter stated that the patient did not hospitalization. It was also reported that the patient was currently on an unspecified antibiotic to treat Pneumonia. Additionally, the reporter also stated that the patient was scheduled "next week" to have an unspecified dental surgery for an unspecified reason. The outcome of pneumonia was reported as recovering. The relatedness between pneumonia and PROQUAD was not reported. Upon internal review, Pneumonia was considered as medically significant. Additional information has been requested.
11-21-07 Suddenly developed diffused eryth. rash ears, neck, and upper chest 5 min. post receipt of  vaccines. There were also few papular rash over the upper chest.  Rash gradually resolved  over 15-20  min. Left clinic without rash. No SOB, itching, no swelling of  lips. RX Benadryl 25 mg po now, 911 if dec. severe symptoms AD.
Pt vaccinated with DTP/OPV/HIB marked local reaction w/3X2 CM abscess at site, temp 103.9. Site is swollen, warm, tender, red.
Patient admitted for persistent diarrhea and presyncopal episodes. Patient tested positive for COVID and is still undergoing inpatient treatment.
pt reports swelling in right leg, went away after 3-5 days; mentioned to physician at next scheduled office visit, and symptoms had resolved
Dose administered out a vial that was not completely thawed out.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medications were reported.
Ever since the first dose, I have had a strong metallic taste in my throat/mouth and my upper teeth are starting to gray in the back. No other variables other than the vaccine. Have seen some data that others experience a metallic taste and that Covid can cause teeth Green, so thought I would report. I have never had a positive Covid test or any reason to believe I have had Covid. Just the vaccine
Raised, warm erythematous, small ecchymosis, aprox 6 cm in diameter.
Could feel going across my back in about one hour-(same as year before). Intense, terrible, neck, upper back pain 2 weeks. Diarrhea-2 weeks. Wiped out, tired-2 wks. Neuropathy-asleep-hands-esp. hand on arm of vaccine still have and feet!!!
This spontaneous report as received from a medical assistant refers to a 16-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, injected in the right arm (dose and route of administration were not reported). Concomitant therapy included influenza virus vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 03-DEC-2018, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number R012954, expiration ate was not provided, but upon an internal verification was established on 04-DEC-2019 (exact dose was not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1812USA002508: US-009507513-1909USA000370:
Stiff neck and arm. Neck stiff as a rock!! It went away though after one day.
fever; headache; lethargic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date and experienced headache).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), headache (Verbatim: headache) and lethargy (Verbatim: lethargic). Rechallenge with Shingrix was positive. The outcome of the fever, headache and lethargy were not reported.   It was unknown if the reporter considered the fever, headache and lethargy to be related to Shingrix.     It was unknown if the company considered the fever, headache and lethargy to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR111119   Additional Information: GSK Receipt date: 14-AUG-2023 This case was reported by a consumer via interactive digital media. The 2nd one hit me like a bat to the head. Headache, fever, lethargic etc. But it was worth it. The patient had friends who had shingles and they hated life.; Sender's Comments:  US-GSK-US2023AMR111119:
Rash started next day when he woke up it was painful and itchy and was warm to touch and swollen. Advised warm packs and can try tylenol if pt uncomfortable. The next day the swelling was improved, but the redness increased in size. Patient returned to clinic for evaluation.
shingles outbreak (rash); horribly sick; flu-like symptoms; Rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles, sickness, influenza-like symptoms and rash. On an unknown date, the outcome of the shingles, sickness, influenza-like symptoms and rash were unknown.   It was unknown if the reporter considered the shingles, sickness, influenza-like symptoms and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the same of vaccination, the patient was horribly sick with flu like symptoms. The patient also had shingles outbreak with rash. The reporter informed that as per all the information had been seen so far, it denies that this could happen.
HAD VERY VERY BAD Diarrhea  THAT WAS FOUL SMELLING AND LASTED FOR WEEKS.  i WAS USING OVER THE COUNTER MEASURES TO ADDRESS THE ISSUE.   IT WAS LIKE A FLU THAT YOU COULD NOT GET OVER.   FATIGUE AND SWEATS.   SLEEP A LOT.
Return of myocarditis and syncope  (dull chest pain continuously abs tight stabbing pain attacks a few times daily from the second day 11/10/2021- continues til now (28/10/2021)  Severe nausea (near constant lasting from the night of the injection until now - over 18 days- low rare is constant and several times each day I feel so nauseous I am faint ) and vomiting- for reference it is extremely unusual for me to vomit even with severe nausea.  There has also been reduced capacity to think clearly and exaxustion but this is probably from the stress of the above and not independently correlated to the vaccine  (I don?t have health insurance and so cannot go to doctor for care about this)
Redness, swelling and itching in bilateral hands that stopped at wrists.  Hives around midsection and back.  no issues with breathing or sob
Participant did not have any  side effects until 2 weeks after the 2nd dose of vaccine. Participant woke up and notice tightness in chest, allergies and runny nose.  Participant did not take any medication but went to the  doctor to seek care. Participant was prescribed an antibiotic (doesn't remember the name) and also receive a steroid shot.  She started to feel better after starting  the medications. After completing the course of antibiotics, she has fully recovered.
Admitted to hospital for TIA, NSTEMI, hypertensive emergency 4/11
Redness, edema size of 2 fifty cent pieces in length and 1 fifty cent piece in width at injection site.
3 people that have same issue of pinched nerve in their back after receiving 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose). At the time of the report, NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.
burning sensation in the vaginal area; Eyes dry out; Patient stated she put eye drops in her eyes, used it more times than before; This spontaneous case was reported by a health care professional and describes the occurrence of BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010U20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN, SEMAGLUTIDE (OZEMPIC), Tremidon, METHOCARBAMOL (ROBAXIN) and triamrenecholorathiazaide-diuretic for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before). At the time of the report, BURNING SENSATION (burning sensation in the vaginal area), DRY EYE (Eyes dry out) and EYE DROP INSTILLATION (Patient stated she put eye drops in her eyes, used it more times than before) 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.   Treatment details included eye drops.
Patient was incorrectly administered Pfizer COVID19 bivalent booster instead of the first monovalent dose.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 64 year old male with diabetes mellitus who on 11-APR-2007 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (lot 654977/0888F).  Concomitant therapy included AVANDIA.  Within 24 hours of vaccination, the patient developed a rash in the arm in which he was vaccinated.  He also developed redness, induration, and warmth of the arm.  Unspecified medical attention was sought.  The patient recovered 4 days later.  The physician requested that a lot check be performed on lot 654977/0888F.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  This is one of two reports from the same source.  Additional information has been requested.
Fatigue; body aches; headache; general malaise; This is a spontaneous report from a consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (lot/batch number and expiration date were unknown) via an unspecified route of administration at left arm on 05Feb2021 13:30 at single dose for COVID-19 immunisation. Medical history included idiopathic hypertrophic subaortic stenosis (IHSS). Unspecified concomitant medication used in two weeks. There was no known allergies. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not pregnant. The patient had fatigue, body aches, headache and general malaise on 06Feb2021 at 08:00 a.m. Patient did not receive any treatment for events. She did not have COVID tested post vaccination. The outcome of events was recovering.  Information on batch number has been requested.
This spontaneous report as received from a consumer regarding herself refers to a approximately 69 years old female patient height-5'7. The patient medical history included thyroid condition and drug reactions/allergies was reported to sulfa. It was reported that patient did not want to provide the names of concomitant medication. On 29-JAN-2013 the patient was vaccinated with ZOSTAVAX dose 1. On 04-APR-2014 the patient found rash on the right arm from armpit to elbow, rash was painful red rash accompanied by pustules. The reporter stated that she thinks injection was given in 1994 but feels this time the shingles was worse and in a different area than this episode. Investigations included labs done for thyroid (unknown date): unknown results. The events were treated by antivirals Famciclovir 500mg 1 tablet in every hours. The outcome of rash on the right arm from armpit to elbow and rash was painful red rash accompanied by pustules, shingles is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
throat tightening; This case was reported by a nurse via call center representative and described the occurrence of throat tightness in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included food allergy (very allergic to corn, wheat and maize).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than an hour after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was recovered/resolved.   It was unknown if the reporter considered the throat tightness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by the patient herself, who was also the nurse. Over the last several years she had experienced throat tightening after receiving a flu vaccine (unsure of brand).  It happened within the first 5 minutes of receiving the vaccine. They asked her to sit for 30 minutes following administration and then let her go since it didn't worsen.  She could not recall how long it lasted. The reporter consented to follow up.