chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluarix administred at 3month old; Crying; Fever; Irritability; This case was reported by a consumer via other manufacturer and described the occurrence of crying in a 3-month-old male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis and INFLUENZA VACCINE INACT (FLUZONE QUADRIVALENT) for prophylaxis.   Additional patient notes included Race   On an unknown date, the patient received Fluarix, Fluarix Pre-Filled Syringe Device and FLUZONE QUADRIVALENT .5 ml. On 28th September 2022, less than a month after receiving Fluarix and Fluarix Pre-Filled Syringe Device, the patient experienced crying, fever and irritability. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, fever and irritability were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   The reporter considered the crying, fever and irritability to be related to Fluarix and Fluarix Pre-Filled Syringe Device.   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: 01-NOV-2022 Reporter's Comments: The reporter reported that the patient was crying, had fever and irritability while receiving vaccine Fluarix and fluzone quadrivalent. The patient's past medical history, medical treatment, vaccination and family history were not provided. On 28th September 2022 the patient was crying, fever and irritability. It was not reported, if the patient received a corrective treatment for the event. Additional Supportive Information: The patient received Fluarix at 3 months of age, which led to Inappropriate age at vaccine administration. The reporter considered the crying, fever and irritability to be related to FLUZONE QUADRIVALENT.
04/13/2021 Began having irregular heart beat, lasted for 3 hours. 04/15/2021 Began having irregular heart beat again, extra and skipped beats. This continued all night. Visited ER  It finally subsided on the evening of 04/16/2021
A cough nonproductive, some central bronchial irritation; discolored greenish phlegm, they were continuous for four weeks now. The symptoms remained present but didn't escalate until the last ten days. The symptoms became more prevalent.  Not until ten days ago I started treating symptoms, I have developed nasal congestion. Since it progressed on the 18th, I started Erythromycin. Just stopped taking medication by the 21st of the month.  There is still cough but better than a week ago. It gets worse in the evening.  I do not believe this is COVID-19, I have not tested. I've seen many people with similar profiles, that are negative testing, as a Physician.
apprx 3 hours after receiving the 2nd dose of the covid vaccine pt reports a small area of her top lip swelled up; pt reports this area became discolored - purple & was tender to touch/sore. Pt advised to take OTC antihistamine.  Pt took 2 tabs of Benadryl.   Pts PCP updated.  Pt advised on the other s/sx of allergic reaction - of which pt denies- if noticed to immediately go to ED/call 911
PAINFUL FACIAL SWELLING ON LEFT SIDE OF FACE; DIFFICULT TO OPEN MOUTH; SWELLING IS UNDERNEATH THE EAR LOBE, ON THE NECK AND JAWBONE; This spontaneous report received from a patient concerned a 78-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and phenobarbital and ciprofloxacin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the subject experienced painful facial swelling on left side of face. On 28-APR-2021, the subject experienced difficult to open mouth. On 28-APR-2021, the subject experienced swelling is underneath the ear lobe, on the neck and jawbone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful facial swelling on left side of face, difficult to open mouth, and swelling is underneath the ear lobe, on the neck and jawbone. This report was non-serious.
Chills, could not get a full breath. Next day went to emergency ... I had pulmonary embolism in each lung.
Left sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Left sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MYALGIA (Left sore arm). On 08-Jun-2021, MYALGIA (Left sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  action taken for m-RNA-1273 Moderna COVID-19 vaccine is not applicable  No concomitant medications were provided  No treatment medications were provided.
Breakthrough case admission after 2 vaccines Moderna 11/17/21 Lot# 939909;  Moderna 5/11/22 Lot# 056M21A
3 year old female who received FLUMIST on Oct 31 and immediately started to stutter. Mom feels stuttering is secondary to FLUMIST.
This spontaneous report was received from a Licensed Vocational Nurse regarding multiple different unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (dose strength, route and lot was unknown). No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. had slightly raised, warm to touch pink area @ injec. site post getting VARICELLA vaccine on 3/30/09 14.5 cm X 7cm.  Reported by guardian on 4/1/09.
08/25/2021 patient received notification from a fertility specialist of possible low sperm count and this was present issue prior to the vaccination.  Immediately after the second vacination 03/30/2021 experienced aches, pains all over body, soreness at injection site, feverish, lack of appetite, fatigue and missed a day of work.
Patient fainted, hit his head on floor. Taken to hospital by paramedics. Grandmother said he had a concussion.
Stiffness in neck right side/ sore throat/ nausea/ fatigue/ muscle aches/ brain fog. Ongoing from night of booster vaccination to present. Physician advised diet high in nutrients including probiotics, fluids, rest.
Day after receiving vaccines parent called. Fever 102.8. Body aches. Diarrhea - persisted x 4 days. Nausea.
has problems with her knees; This is a spontaneous report from Pfizer sponsored program from a contactable consumer. A 74-Year-Old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6198) at single dose on 09Apr2021 for COVID-19 immunisation.  Relevant history was unknown. The patient received Flu shot for immunization on unknown date. The patient received the first dose of BNT162B2 on 08Mar2021 for COVID-19 immunisation. During the vaccine series they told her she needed a Flu shot and she asked the people in the hospital if that was okay and they said yes but then she ended up having to get the second dose late on the 9th because she had to wait 10-14 days. The 2nd dose was delayed because she had a flu shot in between doses of the vaccine and she was hospitalized. She would have had her second dose earlier, but she ended up in the hospital for something else, details not provided.  When hospitalized, she was offered a Flu shot.  When she asked, the Doctor and Nurse told her she could receive it even though she was getting a Covid-19 shot soon.  That delayed the 2nd dose. She also said that she needs to get a cortisone shot for her knee problem and she is asking if its okay to take the cortisone shot after the 2nd dose. Outcome of the event knee problem was unknown.   No follow-up attempts are needed as no further information can be expected.
Starting 05/25/2022, I started getting blotches on my skin 2 on the left arm and 1 on my right leg and 1 on my left leg. It looked like ring worm but it was not ring worm. They were no bigger than a "quarter", were itchy, raised and slightly warm to touch. They since have faded slightly and no longer are itchy or prominent (only a slight outline remains). I did try to treat the spots with hydrocortisone cream but it made them flare up more prominent and did not help with symptoms.
I had COVID 19 mid November 2020. 15 minutes after 1st  shot, extremely sudden nausea, muffled hearing, pain in kidney area, similar to when I had actual COVID 11 months ago.  Vision blurred and near feint.  Passed in 20-30 min.   4-5 days later I developed discomfort in leg that was diagnosed as Blood clots.  18 son, who had actual COVID simultaneously with me in Nov 2020-within 5 minutes of shots blacked out
Case number PHEH2014US009509 is an initial spontaneous report receive from a pharmacist on 08 May 2014: This report refers to a patient od unknown age and gender. She was given only the liquid component of MENVEO (batch number: unknown) without being reconstituted with MenA component, on an undetermined date. No adverse event was reported following this administration error.
Information has been received from a physician concerning a 19 year old female patient who "last week", on approximately 24-SEP-2009, was vaccinated with her second "standard dose" of GARDASIL. Secondary suspect vaccination on the same day included a dose of influenza virus vaccine (unspecified) (manufacturer unknown). The physician reported that "last week", on approximately 24-SEP-2009, after the patient received the GARDASIL the patient passed out. The patient sought unspecified medical attention. It was noted that the patient recovered the same day of vaccination. Follow up information has been received from the physician regarding the 21 (previously reported as 19) year old female patient with no known drug reactions/allergies or pertinent medical history who on 25-SEP-2009, was vaccinated in the right arm with a dose of GARDASIL. The physician reported that the patient had received the GARDASIL then when she was going to receive a flu shot (walked around the patient), the patient black out, falling to the right off the table. The patient was laid down, within a minute, the patient regained consciousness without nausea or vomiting. The patient was watched for additional 15 minutes and the patient was well. It was noted that the patient did not have any illness at the time of vaccination. On 25-SEP-2009 the patient had recovered. No further information is available.
We didn't realize that the patient had already recieved 2 doses of Pfizer so we gave her another which made it her third dose
On the day of the vaccine by 7:00 PM full body rash occured., arm sore at injection site as well. Took benadryl OTC 25 mg.  Following day 3/31/2021 through April 3, 2021 severe headache semi relieved with 1- 500 mg Tylenol, 1 - 200 mg Ibuprofen taken at the same time repeated for each day 2xs.   04/07/2021 9:30 A.M. Left arm at injection site swollen, red, warm, and itchy will continue to monitor over the next few days.
Guillain Barre Syndrome. Pain, tingling and paraesthesias in a stocking-glove distribution. Also proximal muscle weakness. EMG consistent with Guillian-Barre Syndrome. Responding to treatment with IVIG.
NO ADVERSE EVENT; product storage error; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 05-FEB-2021, the patient received improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T031820 with expiration date of 10-MAY-2022, 0.5 milliliter for prophylaxis.   The vaccines experienced temperature excursión of 47.7 degrees F for 30 minutes. No previous temperature of excursion. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Difficulty in breathing; Knot on neck; Chest pain; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty in breathing), NECK MASS (Knot on neck), CHEST PAIN (Chest pain), MYALGIA (Body aches) and HEADACHE (Headaches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Shortness of breath.    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 DYSPNOEA (Difficulty in breathing), NECK MASS (Knot on neck), CHEST PAIN (Chest pain), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, DYSPNOEA (Difficulty in breathing), NECK MASS (Knot on neck), CHEST PAIN (Chest pain), MYALGIA (Body aches) and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Pt jumped while needle was in left deltoid. Some medicine about half went in and half spilled out. Small Pfizer 0.1ml went into left arm and 0.1ml went out of arm.
Myelitis transverse; A spontaneous report  report was received from a physician concerning a male patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed transverse myelitis.   The patient's medical history was not provided nor was concomitant medication use.   On an unknown date, approximately nine days prior to the onset of the event, the patient received his first of two scheduled doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of Covid-19 infection.   It was reported that the patient, a physician, after an extensive neurological workup, was diagnosed with transverse myelitis.  His symptoms began, according to report, approximately nine days following vaccine administration. Treatment for the reported event was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, transverse myelitis,  was considered unknown.  .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Red macules, papules and vesicles on chest and back in different forms and shapes. fever 100.4.
extraordinarily high blood pressure; headaches; This is a spontaneous report from contactable consumers (patient himself and his wife) via a Pfizer sponsored program. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included blood cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took rituximab for blood cancer from an unspecified date (explained that he completed Rituximab almost 1.5 years ago). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (batch/lot number not reported) for covid-19 immunisation. The patient reported that he has always had normal blood pressure with routine checks every three months with HCP and or oncologist. He noted following the vaccine series he experienced headaches that went away and then headaches returned in 2-3 weeks with a number "sudden health issues"  on an unspecified date in 2021 but came back to extraordinarily high blood pressure found at the end of March2021. While under medical evaluation in end of Mar2021 he mentioned his blood pressure was 200/100. He has had various scan of kidneys, heart and lungs looking for a cause but none was found.  MDs can not find any triggering reason for hypertension. His wife further reported that the patient received a negative antibody test following full series of Pfizer Covid 19 vaccine. She is curious why a negative antibody test would result following complete vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unspecified date, blood pressure measurement: extraordinarily high blood pressure (blood pressure was 200/100) on Mar2021, sars-cov-2 antibody test: negative and scan: scan of kidneys, heart and lungs and none was found on an unspecified date. The patient did not recover from the events.   Information on the lot/batch number has been requested.
Sudden onset of deep chest cough without prior cold symptoms.  Did not begin in nasopharnyx like a normal flu.  By tues, began having aches and headaches and aching behind eyes.  Taking Tylenol & Mucinex in response.  No fever at this time.  Have had ordinary influenza vaccine (both inhaled & injected) for many years without reaction.  Had nasal inflenza vaccine in fall (I think Oct).
He developed mild cold symptoms the next day, no fevers, but coughing/congested.  Yesterday developed fever.  Left arm hurt so bad he could barely move it last night. Tylenol helping. Redness of arm just started yesterday evening--first began as a tiny little red bump, possibly at the site of his vaccine, then this morning it turned into a tiny little scab.  Mom drove 10 minutes to get here, and then she noticed upon arrival that his arm.  10 min later came here and his left arm was swollen and red.  Also, his left ear hurts since this morning. Other muscles sore yesterday too. Diagnosed as cellulitis.
A serious spontaneous report of cellulitis, insect bite, insect bite L 3rd toe.-separate rash and erythema multiforme have been received from a physician concerning a 16-year-old female subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medication have been reported for this patient. On 25-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. On 27-Jan-2010, the physician saw the patient; at that time she had a rash on left foot and separate rash on left 3rd toe due to insect bite. The patient was admitted to the hospital on 29-Jan-2010 for cellulitis. While in the hospital several more singular rashes appeared on lower extremities and trunk. Infectious disease doctor diagnosed her with erythema multiforme. Patient was discharged on 02-Feb-2010. The patient was sent home with prescriptions of ranitidine, hydroxyzine, diphenhydramine and Aveeno bath. The outcome of the reported events was resolving.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in an unspecified number of patients who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema, swelling and rash. On an unknown date, the outcome of the erythema, swelling and rash were unknown. It was unknown if the reporter considered the erythema, swelling and rash to be related to Influenza vaccine quadrivalent unspecified season. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the patient had experienced similar localized reactions such as redness, rash and swelling which were to the reactions experienced after being vaccinated with SHINGRIX vaccine (refer case US2018059343) as observed by the pharmacist. This case was linked with case US2018046768, reported by the same reporter.
Information has been received from the patient's mother referring to a 14 years old male patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medication. On 25-JUL-2016, the patient was vaccinated the third dose of GARDASIL 9 (lot#, expiration date, dose and route not reported). On 26-JUL-2016 (reported as "this morning"), the patient woke up at 4 am running a fever of 102 degree Fahrenheit and a terrible headache. The patient did not seek medical attention. Unspecified treatment was given to the events. No laboratory test was performed. The outcome of the events was not solved. The causality between GARDASIL 9 and the events was not provided. Additional information has been requested.
Information has been received from a physician concerning a 23 year old female.  It was reported that it was "not known if the patient was pregnant, if she was taking any other medications or had a history of drug reactions or allergies."  On an unspecified date, the patient was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient felt "light headed and dizzy" after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient also "turned very pale", but did not faint.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiry date, dosing details, anatomical location, route were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
I don't know the exact date, it seems to have been on going for the last 2-3 months. She complains of headaches almost constantly, also stomach aches/pain. She has periodic chest pain, leg pain (mostly knees and hips) and overall just not feeling well.
According to the patient, about 10 hours after her injections, she started having chills, sweating, and shaking.  Wednesday she had developed a low-grade fever, loss of appetite, and continuation of chills.  The fever and chills waxed and waned over the next couple of days.  On Saturday, she sought medical attention.  She believed they gave her IV fluids, a pain med and something else.  Out patient prescriptions were given, ketorolac and hydroxyzine and picked up Sunday morning.  Also her arm was red, and itchy.  As of Sunday, there was still about a 3" diameter red circle on her right deltoid with a 1/2" purple circle in the center of it.