chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2022) Positive, notes: tested strongly positive this morning 31Jul2022 with a home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient received no other medication in 2weeks. Patient received paxlovid for COVID 19 treatment. Treatment start date was 22Jul2022. treatment stop date was 27Jul2022. Adverse event: Patient completed a full course of paxlovid (last dose 27Jul2022 AM) with a good initial symptom response. He started to develop a sore throat on Saturday 30Jul2022 and tested strongly positive this morning 31Jul2022 with a home rapid test. He had moderate covid symptoms (sore throat congestion and cough) so appear to had experienced a paxlovid rebound infection.
Rash that started on scalp and spread to entire body except for face and neck, started on 28Aug and continues locally on fingers, outbreaks on arms and legs.
A non-serious spontaneous report of fever has been received from a non-health professional concerning a female child subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's past medical history and concomitant medications were not reported. The patient received one dose of FLUMIST given on 12-Oct-2010. On 14-Oct-2010, the patient experienced fever of 103 Fahrenheit. The outcome of the event of fever was unknown.
Pt reported lightheadedness, nausea and blurry vision at 1424. Patient laid down in anti-gravity chair and given water.  Vitals were BP 110/60, HR 79 bpm, and SpO2 98%. Patient advised to wait for further observation. Patient reassessed at 1505. Vitals were 105/70 BP, 70 HR, and 99% SpO2. Pt stated she felt better after standing up and left facility to self with steady gait and unlabored respirations.
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Weakness-Severe, Additional Details: Upon administering influenza vaccine and TB PPD skin test, patient became unresponsive with a blank stare. Patient was not breathing notably at this time and face turned red in color. Patient's head slumped back and hit the clinic wall. The provider quickly assisted the patient and sternal rubbed him. After this measure, the patient took in a big gasp of air and regained consciousness. Patient was lethargic but able to communicate. Skin was pale and diaphoretic. Shallow breaths brady and hypoten
Immediately with vaccination with MMRV noticed area of induration about size of quarter which was pink and raised. Called mom on 9/25/06, mom stated pt fine no complaints or concerns.
Intense swelling at injection site; raised ~6mm; pain; hot to touch; took OTC acetaminophen/ibuprofen combination
Pt reported pain throughout arm where Pneumovax was administered.  She also reported swelling throughout same arm and underarm, along with fever and chills.  Vaccine was administed at 1pm, signs/symptoms started around 6:30 pm, and lasted approximately two days according to patient.
MODERNA COVID VACCINE #3 GIVEN 11/9/21, LOT #076C21A; patient in local Center for Rehab and Healing has HX of lung CA; had a positive COVID test on 2/1/22; treated with ABX, Dexamethasone, Vitamin C and D, Zinc, Xarelto; O2 supplementation via NC; Eventually Airvo initiated; patient made comfort care; patient passed away in the center.
severe ringing in ears; elevated blood pressure; minor arm sorness; minor body aches; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia (blood work every six months; mutation remains low to zero) since 10-Jan-2014. Concomitant products included LOSARTAN POTASSIUM from 31-Aug-2021 to an unknown date for Blood pressure increased, DASATINIB MONOHYDRATE (SPRYCEL) from 12-Jan-2014 to an unknown date for Chronic myeloid leukemia, AMLODIPINE BESYLATE from 01-Jan-2005 to an unknown date for Elevated blood pressure reading without diagnosis of hypertension.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches). At the time of the report, TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (severe ringing in ears), HYPERTENSION (elevated blood pressure) and MYALGIA (minor arm sorness; minor body aches) to be possibly related.    No treatment information was provided.   This case was linked to MOD-2021-320005, MOD-2021-331185 (Patient Link).
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates in 2015 (reported as "starting on or after 13-OCT-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # K011804 with expiry date 21-APR-2016, lot # L013068 with expiry date 14-APR-2017, lot # L017142 with expiry date 13-MAY-2017, lot # L017145 with expiry date 13-MAY-2017, lot # L019127 with expiry date 27-MAY-2017, lot # reported as L023594 with expiry date 22-JUN-2017 and lot # reported as L026408 with expiry date 15-JUL-2017; dose and route were not reported). The patients experienced no adverse event. This is one of two reports received from the same reporter. Additional information has been requested.
pt recv vax 11AUG98 & 13AUG98 pt exp redness & warmth to touch @ inj site;tx w/advil & ice application;dx possible cellulitis inj site;
immed p/vax pt exp syncopal episode;pt had sz like disturbance;color  very muddy;MD called pt regained consciousness immed;VS BP 82/60, 106/62, P40-60;
Called patient for a follow up and patient states has been sick for 3 days.  Asked patient what sick meant and patient states has been vomiting and had cold chills every since he received the vaccine.  Asked the patient if he would like an anti-nausea medication and patient stated that it wouldn't hurt.  Sent in prescription for Zofran 4 mg po q8 hours as needed for nausea and vomiting x 5 days to patient's pharmacy.  Told patient to watch for s/s of dehydration and to go to ER if these occur.  Told patient to increase non-caffeinated fluids.  Told patient that a report would be made.
2-3 weeks post vax the pt experienced a generalized body rash and 6 lesions. The reporting physician noted it started with  few marks.,, looked like insect bites then spread, no fever - lasted about 1 week before scabbed, less than 25 lesions.
Narrative:  Patient also noted developing an itchy ~2x3 inch erythmatous rash over the initial injection site that started about an hour after the vaccination. It became indurated and warm to touch by the next day, prior to resolving after about 3 more days (~4 days in total). She did not try or apply any therapies other than ice at that time. Normalized reaction and reassurance provided. Advised conservative treatment with moisturizing lotion, ice, and short course of low dose topical OTC steroids are all ok. If no relief from conservative measures, to please touch base with office for further discussion as she has prior sensitivities to medications. -- Upon end of observation period, patient reporting itchiness over injection site. Arm evaluation, no rash was present. She was provided with an ice pack for application (son driving). S/sx concerning for immediate allergic reaction and when to seek emergent care reviewed.
t104 24FEB93, rash x 3 1/2 days, chest congestion & runny nose;
Routine blood draw on 24Feb2021 showed Eosinophil value as 0; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 08Feb2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, high cholesterol and atrial fibrillation. The patient had no known allergies to medications, food or other products. 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 vaccination.  The patient received unspecified medications within two weeks of vaccination. On 24Feb2021, the patient experienced routine blood draw that showed eosinophil value as 0. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. On 24Feb2021, the patient underwent blood test and the result was found to be eosinophil value as 0. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event routine blood draw showed Eosinophil value as 0 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented to emergency department on 4/22/2021 with symptoms of shortness of breath, fatigue, body aches, and fever. Patient was diagnosed with COVID-19 infection on  4/17/2021 with symptoms starting on 4/14/2021. Patient was treated with dexamethasone, remdesivir, and supplemental oxygen. Patient has clinically improved and was discharged from hospital on 4/28/2021.
No additional AEs; Vaccine was administered after temperature excursion; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 18-APR-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)), for prophylaxis (lot #W036135; expiration date: 13-MAY-2024) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 34.75 degrees Fahrenheit (F), for a time frame of 15 minutes, as recorded by a digital data logger. There was a previous temperature excursion of 35.2 Fahrenheit (F) for 30 minutes; 35.2 Fahrenheit (F) for 30 minutes. There was no adverse effect reported.
Information has been received from a physician concerning a 34 year old female with a history of polycystic ovaries, who on 14-AUG-2007 was vaccinated with her first and only dose of Gardasil vaccine, IM in the left arm. On 15-AUG-2007, the patient experienced swollen arms and face. She sought medical attention by calling the doctors office. The doctor told her to take Benadryl. Subsequently, the patient recovered from swollen arms and face 2 days after the vaccination. The patient mentioned she at shrimp on the same day as the vaccination, but never had a problem with shrimp. Additional information has been requested.
ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 235 pounds, and height was 65 inches. The patient's past medical history included skin boils, and pimples, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 at right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced acne on face, back and thigh. On 21-MAR-2021, the subject experienced arm sore. On 21-MAR-2021, the subject experienced run down. On 21-MAR-2021, the subject experienced injection site pain. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore, run down, injection site pain, fatigue, and low grade headache on 23-MAR-2021, and had not recovered from acne on face, back and thigh. This report was non-serious.
dry cough; body aches; fatigue; fever was 98.9.; chills; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, fatigue, fever, chills and pain in arm were not recovered/not resolved and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife.  On 30th July 2020 morning, the patient woke up with all symptoms.  The fever was 98.9. The arm soreness resolved in one day. All other symptoms still present at the time of reporting. The reporter consent to follow up. This case has been linked with wife case US2020159662 and US2020AMR160214, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020AMR160214:Same reporter
Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX in 2013 at a pharmacy in his residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 02-JAN-2014, the plaintiff was seen by a dermatology physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Patient had chills and low fever (99.4) 8 hours after vaccine.  Patient went to bed early (8 PM).  Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps.  Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues.  This may be a sleep walking or hallucination issue.  Patient has no previous history of sleep walking or hallucinations.
tiredness; headaches; This is a spontaneous report from a contactable consumer (Patient's mother). A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 20Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and headaches, its been roughly 2 days with side effects and patient taking Motrin yesterday and today. The outcome of the events unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
EXTRA VACCINE DOSE Narrative:  Patient had scheduled vaccine appointment, presented and received vaccine as scheduled at this facility. It was realized after patient received vaccine, that he had already received 2 doses of COVID vaccine (unsure if Pfizer or Moderna) at the facility where he lived. This was discovered by an employee that found the patient had a packet of information stated that he had received the vaccine from his facility (though the patient did not appear to have this packet with him in the vaccination room). Situation was complicated by patient having a trach and requiring a mic to assist with speaking. It is believed that a family member/caregiver scheduled the vaccine appointment at this facility without knowledge of patient's vaccination status at his living facility. No known adverse effect reported/discovered at this time.
pt recvd vax;2 wks later,dry spots appeared on skin;1st in the bends of her arms, now all over body;when new spots breaks out pt gets sick; MD said it was a rash
Sweating, fever, nausea, "cloudy" head, chills, vomiting.
Pain and swelling at injection site. Sweating, feeling ill though not nauseous. Pain in joints of arm and wrist lasting into second day and following day.
Pt. received rotavirus vaccine (and PEDIARIX, PREVNAR 13, HIB) on 4/8/13. On 4/15 he developed vomiting and fussiness diagnosed in office as prob. vomiting and pharyngitis. Following day he continued to feed poorly and had bloody stool. Presented to ED where he was dx'd with RUQ intussusception reduced with air enema. Required enema 2 more times.
Information has been received from two registered nurses for the pregnancy registry for GARDASIL concerning a 19 year old female patient with no pertinent medical history and no known drug allergies, who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (lot#660618/0572X) and on 03-DEC-2008 was vaccinated with the second dose of GARDASIL (lot#660618/0572X). No concomitant medication. Patient then found out she was pregnant. Last Menstrual Period 02-DEC-2008, estimated delivery date 08-SEP-2009. Patient sought medical attention via office visit. Urine pregnancy test performed. Pregnancy is normal to date. Follow-up information has been received from a registered nurse. It was reported that the patient has a history of an abnormal pap smear positive for Low Grade Squamous intraepithelial lesion on 9-OCT-2008 and "CPO" Cervical Intraepithelial Neoplasia grade I (CINI). This is her first pregnancy. On 15-JAN-2009 patient had an ultrasound done which showed the patient is 6 weeks and 4 days pregnant. Estimated date of confinement 6-SEP-2009. Follow-up information has been received from the registered nurse regarding the pregnancy outcome of the patient. It was reported that the patient delivered a healthy female on 31-AUG-2009 who weighted 3845 grams. The baby was "absolutely fine, with no problems". Her Apgars were 8 and 9 at 1 and 5 minutes respectively. "The only complication in the pregnancy was the development of gestational diabetes for the mother, but her BMI (body mass index) was 34 - she was obese prior to her pregnancy". There were no negative outcomes related to the GARDASIL vaccine.  Additional information is not expected.
9OCT97 pt recv vax 10OCT97 small nodule & itched & soreness devel cont to inc in size & severity of pruritus;used warm compresses;redness extends from 3 inches below shoulder to 3 inches above elbow;warm to touch;
booster; Received booster shot the same week tested positive for Covid; Received booster shot the same week tested positive for Covid; This is a spontaneous report received from a contactable reporter.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION, outcome unknown, described as booster; DRUG INEFFECTIVE, COVID-19, outcome unknown and all described as Received booster shot the same week tested positive for Covid. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Additional: It was unknown If patient was covid prior vaccination, Patient was tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after injection patient complained of extremely painful shoulder in injection arm. Patient was diagnosed with Parson-Turner Syndrome.
Around 8:00 PM (~7 hours after administration of rabies vaccine #2), I developed systemic myalgias and arthralgias, headache, and rigors. The symptoms worsened over the next hour, so I took ibuprofen and went to bed. I woke up in the middle of the night (~3 AM) with persistent symptoms that had not lessened in severity. I took ibuprofen again and went back to sleep. When I awoke around 7 AM, the symptoms had resolved. Of note, I had received the first injection of the rabies vaccination series the week prior and had no adverse reaction.