chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stated 2 1/2 hours after receiving flu vaccine she developed red, itchy burning eyes. Took off her contact lenses. Symptoms persisted. Then started feeling like she had swelling in her throat, cough and sensation of feeling short of breath. Took 2 tablets of BENADRYL and symptoms began to resolve after about 45 minutes.
numbness on left side of her face; tingly on left side of her face; itching sensation; mouth feels crooked towards left side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side) outcome was unknown.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
Information has been received from a licensed practical nurse concerning a 65 year old female with seizures, hyperlipidemia, osteoporosis, gastric ulcer and no drug reactions/allergies and a history of cerebrovascular accident in 2008 and syncope who on 27-JUL-2011 was vaccinated subcutaneously with a 0.5ml dose of PNEUMOVAX 23 (Lot # 667995/1150Z). Concomitant therapy included TOPAMAX, CYMBALTA, PLAVIX, aspirin, simvastatin (manufacturer unknown), fenofibrate, omeprazole (MSD), PERCOCET, gabapentin, vitamin D (unspecified) and calcium (unspecified). The nurse reported that the patient was hospitalized two days after receiving PNEUMOVAX 23 on 27-JUL-2011. The patient was seen in her primary care physician's office on 27-JUL-2011, and received a dose of PNEUMOVAX 23. The next day, the patient traveled to another city, a few hours away from her home. On 29-JUL-2011, the patient experienced syncope, and went to the emergency room. The patient was admitted on 29-JUL-2011, for episodes of syncope, fever, redness and swelling at the injection site. According to the report that was sent to the patient's primary care doctor, the patient was diagnosed with cellulitis and treated with IV antibiotics. Length of stay in the hospital and release date were unavailable. Patient was scheduled for a follow-up visit with her primary care physician on 04-AUG-2011. At the time of reporting, the patient had not recovered. Additional information has been requested.
Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment.
Pain in upper arm muscle that has lessened but not subsided 5 months later.  Limited range of motion in affected arm that has lessened but not subsided 5 months later.
cough, congestion, fever (100), slight sore throat, headache. starting 11/29/21
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.
the patient did not experience any type of adverse reactions; twins were given an "extra dose" of "varicella" due to receiving the PROQUAD vaccine; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) subcutaneous injection, 0.5 ml, lot number: W029547, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that this was an extra dose of "varicella" that was not needed (extra dose administered). The nurse reported that the patient did not experience any type of adverse reactions (no adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2301USA010043:Same reporter
she experienced a flare up of her arthritis after being in the sun.; sun sensitivity; This is a spontaneous report received from a contactable consumer. A 7-decade-old (in her 60s) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. Patient declined to provide exact age. Reported that after she had received the first dose of her Pfizer BioNtech covid 19 almost three weeks ago she had experienced a flare up of her arthritis after being in the sun. Seeking information if sun sensitivity had been reported with the Pfizer BioNtech covid 19 vaccine and wanted information about pericarditis following the Pfizer BioNtech covid 19 vaccine, whether it was more common in males or females. Patient again stated that she wanted to know had there been any reaction towards the sun for people who had received the vaccine. Clarified patient have received first dose of the vaccine and said she had some type of reaction but not quite sure if it was from the sun. The events were assessed as non-serious. The clinical outcome of events was unknown.  Information on lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable for this report. No patient or vaccine information was reported for this adverse event. The age group was not reported, but was captured as adult as per the vaccine indication. The health care professional stated the patient was hurt after receiving SHINGRIX vaccine. The reporter did not consent to follow-up.
Headache in afternoon. Chills and severe headache at 2 am (1/1/2021). Severe headache continued and nausea around noon.
no adverse effect; patient received improperly stored varivax; This spontaneous report was received from a registered nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 15-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), (lot # R019237, expiration date 04-JUL-2020 or lot # R019237, expiration date 19-FEB-2021 (the reporter did not know which lot was given to the patient); strength, route of administration and dose were not reported) for prophylaxis. Administered dose of vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as 9.74 C) for an unknown amount of time. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Sore arm; Headache; expired vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 16:15 (Lot number: FK5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL8095, Location of injection: Arm Left, Vaccine Administration Time: 04:15 PM), administration date: 10Jan2022, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 31Jan2022 16:15, outcome "unknown", described as "expired vaccine"; PAIN IN EXTREMITY (non-serious) with onset 01Feb2022, outcome "unknown", described as "Sore arm"; HEADACHE (non-serious) with onset 01Feb2022, outcome "unknown", described as "Headache". The events "expired vaccine", "sore arm" and "headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: ae treatment Tylenol. The patient was not diagnosed with COVID-19, Prior to vaccination, has not been tested for COVID, Since the vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medication within 2 weeks of vaccination. No follow-up attempts are possible. No further information is expected.
Lump in throat, heartburn, vomiting, hot/sweating couple hrs later. Couldn't get warm at night/bedtime. Headache next day.
This spontaneous report was received from an administrator and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in 2012, the patient was vaccinated with M-M-R II (dose, route, anatomical location, lot# and expiration date unspecified), then received a dose of VARIVAX (dose, route, anatomical location, lot# and expiration date unspecified) "about 2 weeks later" for prophylaxis (Inappropriate schedule of drug administration). The administrator was unable to specify the lot and expiration date for the sterile diluent(DILUENT MRK INJ) used to reconstitute the vaccines. No adverse effects were reported. No additional information is available. There was no product quality complaint (PQC) involved. Additional information has been requested.
Headache every day post Covid vaccine a week ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2020 (unspecified if ongoing), notes: Patient had COVID last year with a lot of sequelae. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache every day post Covid vaccine a week ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized (1.10.22);  COVID-19 positive (1.11.22);  Fully vaccinated PLUS booster DATE OF ADMISSION:  01/10/2022 DATE OF DISCHARGE:  01/13/2022 DISCHARGE DIAGNOSES 1. COVID-19 pneumonia with acute hypoxemic respiratory failure. 2. Acute drop in hemoglobin, lab error. 3. Acute on chronic diarrhea. 4. Episode of ventricular tachycardia, prolonged QTc. 5. Hypokalemia. 6. Multiple myeloma. 7. Papillary carcinoma of the thyroid. 8. Postsurgical hypothyroidism. 9. Anxiety and depression. 10. Gastroesophageal reflux disease HOSPITAL COURSE The patient is a very pleasant 60-year-old female with past medical history as listed above including multiple myeloma and bone marrow transplant x2, who presented initially to Urgent Care secondary to worsening shortness of breath and cough.  She initially developed upper respiratory symptoms, January 1st and with progression of symptoms, she proceeded to Urgent Care where her COVID test was positive.  She was sent to a local Emergency Department for septic workup.  She was hypoxic with ambulation down to 79% on room air in the ER.  Chest x-ray showed bilateral pulmonary opacities consistent with COVID pneumonia.  CT was negative for PE.  Peripheral ground-glass opacities bilaterally were noted.  She was placed on 2 L of oxygen.  Blood cultures were obtained and were negative for bacteria.  She was started on Decadron 6 mg and remdesivir.  Infectious Disease was consulted for possible compassionate use of monoclonal antibodies, although she was outside her window.  Infectious Disease discontinued broad-spectrum antibiotics as they felt there was no bacterial infection component.  The patient had acute on chronic diarrhea.  C diff was negative.  Diarrhea was felt related to her COVID.  This improved with Imodium and Lomotil.  Overall, the patient did very well and was weaned off oxygen at room air.  Pulmonary Rehab was consulted and recommended 2 L of oxygen with ambulation.  Her oxygen level dropped to 87% with ambulation.  We encouraged the patient to stay for at least 1 more dose of remdesivir.  However, the patient was very eager to get home as she has 2 sons at home, 1 with COVID and she is a single mother.  She discharged in stable condition on 01/13/2022.  The patient is encouraged to call our office or proceed to the ED if her symptoms should worsen.  She was sent home with a prescription for Decadron to complete a 10-day course.  Please see report for full discharge instructions.  Chemotherapy will be delayed at least 1 week and followup will be arranged in the Oncology office.
Initial event was hives that didn't itch appearing on elbows, they continued to spread for about a day. The doctor said to start Zyrtec, pepcid and ibuprofen. Hours later vomiting, diarrhea, and a blackout followed along with a fever of 102. This time ER gave IV fluids, acetaminophen, ketorolac, ondansetron, and sodium chloride .9%. At this time no mention or notice was made of the hives previously looked at. After this Zyrtec, Pepcid and acetaminophen were being taken regularly. Throughout the rest of that day the hives got worse along with pretty severe angioedema. Also, a feeling of swollowing around a lump in my throat. No change through the night into next day (Friday) for the hives,swelling and lump feeling in throat. Went to walk in clinic where I was prescribed prednisone tapered for 16 days. After the first day of steroids not much change. After 2 there was some improvement. As of today one week after receiving the 2nd dose of the vaccine approximately 90% of the hives are gone, only mild swelling and some muscle fatigue and pain left.
Injection was given and upon standing patient stated she could not breath and her throat was closing. Patient sat back down and EMS were called. Patient never lost consciousness, could always speak, never had any discoloration, and never began to perspire. EMS arrived and accessed patients blood pressure and oxygen saturation. Patient declined to go to the ER.
25y/o mom vax w/measles vax live 22AUG91; 5SEP91 10-mo-old PT devd t101; 6SEP91 t102; 7SEP91 t103-106.6 & PT hospitalized; 9SEP91 PT devd rash on trunk--spread to face, swollen cervical lymph nodes; 12SEP91 rash dec; dx: viral pneumonia;
Per MD very swollen and thinks allergic rxn per Pt very swollen, took Benadryl for 1 week. Vacines give in left deltoid
Death; This is a spontaneous report from a contactable consumer received from the Pfizer-sponsored program, COVAX US Support. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 04Mar2021 11:30 (At the age of 73 years) (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 via intramuscular on an unspecified date for COVID-19 immunization and experienced pain in her arm, bloating and pain. The patient died on 11Mar2021. AE required visit to emergency room, physician office and intensive care unit. The patient was admitted to the ICU for 1 day. It was reported that the patient received treatment for the event. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death
PT STATES THAT SHORTLY AFTER RECEIVING SHOT HAD A SHINGLES FLARE IN SAME AREA THAT SHOT WAS ADMINISTERED. TREATED WITH MEDICATION THAT SHE HAS AT HOME.
Patient called pharmacy & reported redness & swelling on left arm - described by pt to be approximately the size of a tennis ball. I recommended putting ice on the area & also contacted pt's doctor. Dr wants pt to contact her in a day or two if it does not get better. I called pt back to relay this information. I attempted to contact pt in the evening of 9/12/12 & 9/13/12 as a follow up. Left message both times.
Ringing in ears (tinnitus), Constant for 4 weeks (and still taking place) plus severe neck pain and pain in back of head.
tired; headache; back hurt; It has been more than 36 days days from 12Jan2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2DA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Relevant medical history not reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired), HEADACHE (headache), BACK PAIN (back hurt) and INTENTIONAL PRODUCT USE ISSUE (It has been more than 36 days days from 12Jan2021). At the time of the report, FATIGUE (tired), HEADACHE (headache), BACK PAIN (back hurt) and INTENTIONAL DOSE OMISSION (It has been more than 36 days days from 12Jan2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported.
Patient reported swelling in shoulder that moved down to elbow and lasted 5 days. On followup (10-6-17) patient reported symptoms resolved and full recovery.
Red, swollen, warm, itchy arm 24 hours after seasonal flu shot. Tx with BENADRYL, ibuprofen, DURICEF.
This is a prospective pregnancy case. This 34-year-old female subject was enrolled in an open label study titled Boostrix Pregnancy Registry, a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 19 SEPTEMBER 2014.  Co-suspect products included FLUARIX 2014-2015 season). The subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving OOSTRIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Other possible cause(S) of the vaccine exposure during pregnancy included Influenza Virus Vaccine Polyvalent.   Additional information:  The last menstrual period, the due date, and the number of gestational weeks were not reported. This is one of the 17 cases reported by the same reporter for the same vaccine.
On the left arm had hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 10-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 7N43B, expiry date 30th June 2021) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of FluLaval Tetra 2020-2021 season. On 22nd October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced hives. On 22nd October 2020, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The reporter stated that the Flulaval QIV was administrated to a female patient on the left arm had hives one days after receiving the vaccine. The reporter consented to follow up. This case has been linked with cases US2020211161 and US2020211159, reported for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211161:same reporter US-GLAXOSMITHKLINE-US2020211159:same reporter
Information has been received from a health professional concerning a female in her early 20's who was vaccinated on an unspecified date with a dose of GARDASIL.  Subsequently the patient called the office and reported her period was delayed following vaccination.  Subsequently, the patient recovered from a delay in her menstrual period.  Additional information has been requested.
Got the vaccine had shooting pain down the arm, about 10 days after she got ringing in her ears, which started pretty loud.  Then she got ear stuffiness, which comes and goes and comes when she's laying down at night and eases up during the day somewhat.  She then had pulsating tinnitus, both at the same time.  It's very scary, did it do permanent damage and doesn't allow her to sleep.  She went to an ENT last week on 4/15/21 and was informed that a few people had come in with the same.  He looked in her ears and had no wax in it.  Her hearing was impeccable for her age, and did not see anything abnormal.  Is going to send her for a carotid artery test in the middle of May.  There was not much that he could do for it.  She has an audiologist who is a friend and told her that it might subside over time if it was viral tinnitus.  The ringing is going down but the stuffiness feeling is still there.  She is going to get the 2nd vaccine, but scared that this is going to flare up again.
She began with a rash with red whelps, with eyes red and puffy, starting with one and then the other.  Her hands became erythematous and puffy.  She did not have cough wheezing, hoarseness, or difficulty breathing. She was advised to give a 5 ml dose of benadryl every 4-6 hours and to go to the ER if her symptoms worsened.  Called back the next day to follow up. Mom had given benadryl schedule for 24 hours, and she had improved.  The first 24 hours, the rash was constant and she had to keep her on hte benadryl.  On a visit with her on 3/14 (2 days later), mom reported she was continuing to develop whelps, white and red raised areas that started at her feet , moved up and then went down, multiple cycles. On 3/14 this happened 4 times. She had stopped the benadryl after the first day. Mom noted the shot sites were still swollen as well. The rash had also flared after eating some ice cream that she had never reacted to before. Mom had had to use albuterol just that day for some wheezing.  She was started back on benadryl and famotidine was added as well as a prednisolone taper.