chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Pharmacist concerning a 9 year old male. Medical history and concomitant medications were not reported. The patient received nasal FLUMIST, one dose, on Monday, 04-Nov-2013. On Tuesday he developed a rash which was red and itchy (no hives). The rash was all over his body (all over his arms and legs). His mother gave him BENADRYL (25mg each dose), and the rash improved. Once the BENADRYL wears off the rash returns; once administered the BENADRYL again the rash improved. The oral BENADRYL was not controlling his reaction as rash began to get worse, entire body. Patient visited hospital and was given injectable BENADRYL and advised to take REACTINE and BENADRYL orally. The patient recovered from the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash after another 24 hours. The reporter assessed the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash which is red to be serious as important medical events. The reporter assessed the events of itchy all over the body, rash which is red and itchy all over the body/ rash and rash which is red to be causally related with the suspect drug of FLUMIST. Follow-up information received by AstraZeneca/MedImmune 18-Nov-2013 from pharmacist upgraded this case to Expeditable as seriousness updated for events of itchy all over the body and itchy all over the body/ rash and rash, event of rash which is red separated. Reporter causality added. Outcome updated.
Pain and soreness in left shoulder and arm. Difficulty lifting arm due to the pain. Pain improved on third day, but still present.
Received less volume than recommended; Leakage during administration; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9TG4D, expiry date 30th June 2023) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced incomplete dose administered and product leakage. On an unknown date, the outcome of the incomplete dose administered and product leakage were unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The reporter did not mentioned about exposure to skin was done during the call. Product quality complaint was not mentioned by the reporter.  This could suggest that the vaccine leaked from the site of administration and not from the syringe itself (as a side note, leakage was a rare event that happens during injections that was related to the route, way or site of administration). The reporter consented to follow-up. Additional supportive information: The patient received less volume than recommended due to some leakage on a fluarix administration, which led to incomplete dose administered and product leakage. Suspect was coded as per reported expiry date. Product leakage was coded as event as per reported verbatim,' due to some leakage'.
Pt felt dizzy, weak legs and blurred vision. He lost all color in his face. Pt was sat down, given a cold compress and water he felt better by 4:50p.
DURING A ROUTINE PHYSICAL, I WAS GIVEN A TETANUS AND GARDASIL VACCINE SHOT.  APPROXIMATELY FIFTEEN AND A HALF HOURS AFTER THE FIRST INOCULATION OF THE VACCINE GARDASIL, I EXPERIENCED TWO ONSET GRAN MAL SEIZURES. SEIZURES OCCURED IN THE MORNING, WITHIN FOUR AND A HALF HOURS OF EACH OTHER. I WAS TRANSPORTED BY AMBULANCE AFTER BOTH EPISODES. AFTER FIRST SEIZURE, I WAS GIVEN A CT SCAN AND BLOOD WORK-UP. BOTH TESTS CAME BACK NEGATIVE. NO PRESCRIPTIONS WERE GIVEN. I WAS RELEASED FROM THE ER WITH INSTRUCTIONS TO FOLLOW UP WITH A NEUROLOGIST ASAP. AN HOUR AFTER RETURNING HOME, I EXPERIENCED A SECOND, GRAN MAL SEIZURE AND WAS TAKEN BY AMBULANCE BACK TO THE ER. I WAS GIVEN INTRAVENOUS DILANTIN, AND ADMITTED TO THE HOSPITAL WHERE I STAYED THURSDAY INTO FRIDAY. I WAS GIVEN MORE BLOOD WORK-UP, AN MRI, AND AN EEG. RESULTS ARE PENDING FOLLOW-UP VISITATION WITH THE NEUROLOGIST. IN THE HOSPITAL, I RECEIVED 300MG OF DILANTIN (PILL FORM), DAILY. ACCORDING TO THE TECHNICIAN AND NURSE, I WAS RELEASED FROM THE HOSPITAL BECAUSE THEIR INITIAL SCREENING OF MRI AND EEG DID NOT SHOW TUMOR, CLOTTING, OR BLEEDING IN THE BRAIN. THE NEUROLOGIST HAS PRESCRIBED 300MG OF DILANTIN (PILL FORM) TO BE TAKEN DAILY. I AM NOW RESTRICTED FROM DRIVING FOR A MINIMUM OF THREE MONTHS, PENDING MY RESPONSE TO MEDICATION. ALTHOUGH THE NEUROLOGIST HAS NOT SEEN THE MRI OR EEG RESULTS, I HAVE BEEN DIAGNOSED WITH HAVING COMPLEX-PARTIAL SEIZURE DISORDER. THE NEUROLOGIST IS RELUCTANT TO AFFIRM OR DENY GARDASIL AS A CATALYST TO GRAN MAL EVENTS.  6/16/09 Received hospital medical records for 6/11-6/12/2009. FINAL DX: partial complex seizures Records reveal patient experienced 2 tonoclonic seizures w/tongue biting on 6/10 lasting approx 3 min w/postictal period after.  Seen in outlying ER where w/u WNL & d/c to home.  Returned to ER after 2nd seizure, loaded w/antiseizure meds & transferred to higher level of care.  Neuro consult done & revealed pt had stereotype espisodes x 3 years. Tx w/antiseizure meds.  8/3/09 Received ICD9 codes: 780.39.
Pt came in for routine PE, Slight stuffy nose, given 2 months shots- went home,  expired early morning 11/14 after feeding . No temp. No irritability. The autopsy report states SIDS.
Case previously recorded as MA2009-4538. Initial case report received from a nurse via agency, on 18 NOV 2009. A patient 9-months-old male was accidentally vaccinated with FLUVIRIN 2009/2010 (batch no. 102126P1A) 0.5mL i.m on 17 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use is unexpected after vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008426.
Muscle weakness; nausea; tremors; chills. Within minutes of administration (+) chills, nauseated x 2 hrs; I felt 2 hours after (L) frontal headache x 2 hours.
Hives, temp 102.3, fussy-given steroids & BENADRYL, 9-10-09 pt had diarrhea, doing well on 9-10-09.
Sizeable bilateral pulmonary emboli and deep vein thrombosis Rt popliteal area discovered on July 12, 2022 .... no known preexisting conditions or family history of clots
I started noticing some swelling on my left jaw. I went to Urgent Care, and they prescribed Amoxicillin. The next day I woke up with a lot of pain in my right knee. The day after that I couldn't get out of my recliner and had to call the ambulance. I was hospitalized for 5 days, and they determined I had an auto immune episode. Then, shortly after that I lost my hearing for a while. They think that was autoimmune too. I am not blaming this on the vaccine but was wondering if it could trigger an autoimmune issue. Every time I get a COVID-19 vaccine my cheeks get very red.
This spontaneous report was received from a nurse via company representative and refers to a 1 year old patient (unknown gender). The patient's current conditions, medical history and concomitant medications were not provided. On 29-MAR-2016, the patient as administered with PROQUAD (Merck) and M-M-R II (overdose). The patient was inadvertently administered a dose of PROQUAD (Merck) (instead of an intended dose of VARIVAX (Merck)) concomitantly with a dose of M-M-R II (wrong vaccine administered). The nurse reported that another nurse who administered the vaccines mistook PROQUAD (Merck) for VARIVAX (Merck) for an unspecified reason. No adverse effects were reported. The patient did not receive any treatment. Product quality complaint (PQC) was not involved. Additional information has been requested.
4/10 - had mild fever with chills, normal migraine.  Took Butalb/acetamin/caffeine pill to help alleviate.  Migraines continued through the day so continued to take prescription as prescribed. 4/11 - Migraines continued, in the evening had massive muscle cramping in my full legs, nothing would alleviate them, lasted for at least 30  minutes.   4/12 and 4/13 - Migraines continued, had to work from home so could stay in dim environment, continued to take prescription med.  Legs now just really achy every time I try to stand up/sit down/move. 4/13 - Called Neurologist about migraines, she called me back on 4/15 and told me to just keep taking the same medication that they will go away that they are just from the shot. 4/15 to 4/16 - random migraines continued. I have also noticed that my forgetfulness of words has increased, my essential tremors has increased, and now I have also started to have typing dyslexia  4/18 - I had a stabbing migraine (took a pill), which then followed with numbness of  my left cheek and drooping of my lip, this lasted for about 10 minutes and went away .  I had no other stroke symptoms.  This happen again.  Same scenario.  This finally stopped early evening.  I did not go to the ER at this point. 4/19 - left ear felt clogged up most of the day. 4/20 - left side of my face kept going numb again, this time no drooping in my mouth though.  Called Neurologist.  She was out of town, was told to go to ER.  They did CAT scan and said no emergent danger.  ER doctor and stroke doctor said possible TIA and wanted me to spend the night in hospital for more tests.  Received MRI, TTE echo and Carotid Dopplers.   4/21 - All came back clear/fine.  Neurologist on call said that I did not have a TIA, that I had had a complicated migraine which mimics stroke. 4/22 to 4/30 - random headaches that last 5 to 10 minutes, numbness in cheeks, jaws, neck.  Occasionally lip/mouth, lip had drooped twice more since then.  These happen multiple times a day.  Normal migraine meds have no affect on them. 4/29 - Follow-up visit with normal Neurologist.  She has scheduled an EEG for 5/4.  Hot flashes that started with first covid shot are still continuing Still have achy muscles.  If I get a leg cramp, it still hurts days later.
Had like an episode of sleep apnea; My mouth was real dry; I was sleeping and it was like I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced like an episode of sleep apnea, mouth was real dry and patient stated that she was sleeping and it was like she couldn't breathe. Patient stated, "I am going to take the second vaccine today from the Pfizer for the COVID and I don't know, I had not reported this but before, like I said I don't know if this is the side effect or not of the first one but after I took the first one, maybe about a week later or so I had like an episode of sleep apnea and my mouth was real dry, I was sleeping and it was like I couldn't breathe you know and I had that in the past a long time ago and stuff. It happened twice." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt noted rash on lower legs after (about 2 hours after) receiving FLUZONE HIGH-DOSE vaccination. Non-itchy rash; no difficulty breathing or swallowing; no swelling itch face/neck/throat. Pt had applied hydrocortisone. Recommended ZYRTEC and urgent care or page PCP for further treatment. Call 911 if difficulty breathing/swallowing or swelling develops.
Approximately 20 minutes later had numbness in her fingers, once got home had blisters and hives in her arms.  Had night sweats very bad.  The following day, 1/6/21, saw a PA for the blisters and hives due to the itchiness and hydrocortisone was not helping.  Then had a headache, body aches and flushes for at least a week.  She did have shortness of breath and by the weekend she was feeling confused like the feeling of waking up from anesthesia.  She started loosing her balance, could not go up the stairs, trip and fall.  They did lab work, told her that she was fine.  She was having confusion and forgetful and let it run it's course.  She did have the 2nd vaccine, but is still having hot flushes from it.
I had shingles shot last February and only little pain in two days on my arm after no more; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2021, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingles shot and experienced little pain in arm in two days and after that no more.
pt recv vax in lt deltoid;next day pt devel a sharp, constant pain which originates in lt deltoid & radiates to fingers;ROM is limited;pt has been taking Advil & APAP w/o relief;
4-20-11 Patient had seizure and hospitalized. Given KEPPRA for petit mal seizures. Been seeing a neurologist to date. 9-29-13 Joint problems started - hands, arms, knees, etc. Seeing rheumatologist since 10/10/13. Diagnosis - Mixed Connective Tissue Disease.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAY-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had six temperature excursions: 80 hours (Highest recorded temperature was 49 F (9.444444444 Celsius); 80 hours (Lowest recorded temperature was 30 F (-1.111111111 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); 336 hours (Highest recorded temperature was 59 F (15 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius) and 393 hours (Highest recorded temperature was 47F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". No product quality complaint was involved. This is one of several cases from the same reporter Additional information has been requested.
Right arm warm to touch and big as a 2x4, red and tender, hard and hurts.
Patient needed first dose of Moderna Primary series however Bivalent was given. Patient was contacted and will be coming in 02/23/2023 for correct Moderna Primary Series. Patient does not report any adverse signs or symptoms.
"Pain and heaviness in arm began the evening I got the shot. Excruciating pain has been present ever since then in the shoulder/upper arm. Range of movement is decreased. Diagnosed with frozen shoulder by orthopedic."
None. Patient is 17 years old and received Moderna vaccine . Will moniter for reactions.
1339 9/21/11. Pt came back to clinic with complaints of tingling on the (R) side of face at approx. 1330. She also complained palpitations and dizziness.. Pt states that "sometimes when I eat eggs. Sometimes my throat closes up... I don't go to the doctor... It will eventually go away.." VS 110/58, HR 80, R 14, T 97.4. 1357: VS 110/54, P 78, R 12. PT still complaining of tinglings no localized redness, swelling to site of injection. Head was normocephalic, no swelling or ache. Pt stated she has take "BENADRYL as sleep aid... I have taken stronger narcotics: BENDARYL 50 mg PO given @ 1400. Pt stated "I was already having a bad day". VS at 1415 95/50 R 16 HR 75. Pt states that she is feeling better. Advised her that she would need assistance driving home due to the side effects of the medication. VS at 1430 94/52 R 14 HR 60 T 98.2 Face "felling a lot better.." Stated that she ahs had allergy testing and is not allergic to eggs. 1440 --> patient states my face "is not tingling anymore.." Management coordinated ride for patient to safely get home.. Advised patient to call 911 if symptoms return at home. Also advised her to follow up with her primary care doctor about allergies and symptoms. Dr. contacted and he is aware of situation. No new orders given.
Moderna COVID-19 Vaccine EUA Fever - approximately 12 hours post-injection and lasted approximately 5 hours (resolved) Swelling of right side of the face (under eye area) - approximately 20 hours post-injection and still occurring 48 hours post-injection.
tested positive; tested positive; This is a spontaneous report from a contactable consumer via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose (Batch/Lot number was not reported) and first dose (Batch/Lot number was not reported); both via an unspecified route of administration on unspecified dates as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient who has gotten 2 doses of the vaccine, tested positive on 19Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
HEART ATTACK; This spontaneous report received from a consumer via a company concerned a 40 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  About 7 days after receiving the vaccine, the patient went to hospital regarding shortness of breath. On an unspecified date, the patient experienced heart attack and was hospitalized (date unspecified) and was later sent to intensive care unit (ICU). On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: 20210403505    -Covid-19 vaccine ad26.cov2.s -Heart attack. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: HEART ATTACK
PT WAITED 15 MINUTES HERE IN THE PHARMACY AFTER THE VACCINE AND FELT FINE. APPROX 30-45 MINUTES AFTER RECEIVING VACCINE, SHE BEGAN FEELING LIGHT HEADED AND DIZZY. SHE STATED HER BLOOD PRESSURE BOTTOMED OUT AND IT WAS 94/60 HGMM. SHE FELT THIS WAY FOR ABOUT 12 HOURS. THE NEXT DAY, SHE FELT NORMAL AND BLOOD PRESSURE WAS BACK UP TO A NORMAL LEVEL FOR HER. SHE ALSO HAD A RASH DEVELOP ON ARM AROUND INJECTION SITE.
Due to an administration error patient received the second dose of Moderna instead of Pfizer today; This is a spontaneous report from a contactable contactable Nurse. A 61-years-old female patient received first dose ofNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Batch/Lot Number: FD8448; Expiration Date: Oct2021)) via intramuscular, administered in Deltoid Right on 27Aug2021 at (at the age of 61 years old)  as, 0.3 mL, Single dose for COVID-19 immunisation; Patient received Second dose of covid-19 vaccine (mrna 1273) (MODERNA COVID-19 VACCINE, Solution for injection,(Batch/Lot Number: 006D21A; Expiration Date: 21Apr2022)),via intramuscular administered in Deltoid Right on 17Sep2021at (at the age of 61 years old), 0.5 mL Single dose for COVID-19 immunisation. Patient had no medical history. Patient had no allergies There were no concomitant medications. he patient experienced due to an administration error patient received the second dose of moderna instead of pfizer today. The patient did not receive any treatment for the events.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.
Pt presented with complaints of redness and swelling in L arm.  There is positive induration and edema around injection site.  Slightly warm to the touch.  Pt has full range of motion.
Sore arm, fever, chills & body aches, migraine type headache, nausea.  These symptoms lasted 48 hours.  It was followed by feeling of shortness of breath  the feeling of a racing heart & easily winded with a tickle in lungs that makes me cough (These symptoms started tuesday 9/7 & I'm still dealing with them)  I needed to use  the inhaler that was prescribed to me after the 1st dose of vaccine when I had same reaction & symptoms.   I also have had digestive issues  since 9/8 w/loose stool to date.
R swollen L deltoid size of half dollar- warm to touch. Child received Zoster instead of varicella (chicken pox) vaccine.
Information has been received from a nurse practitioner via a company representative referring to two 20 year old female patients. Information regarding the patients' current condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were unknown). On unknown dates the patients each developed an unspecified type of HPV. Outcome of the events was unknown. Additional information is not expected since we have no consent to contact the nurse practitioner.
Pt received both doses of the Moderna COVID-19 vaccines, one on 1/19/21 and the second on 2/16.  No lot number is located either in patient chart or state vaccine electronic registry (WIR).  For location, there was only a number listed, "11029", on both entries.  Writer will be unable to obtain any further vaccination information.  Pt then tested positive after a trip.  Pt was negative on 5/27/21, and then tested positive via PCR on 6/4/2021 at an outpatient drive through testing site.   Pt reports chest congestion, altered taste and smell,  and fatigue, since 5/31/2021.  No other symptoms, pt was not ill enough to be hospitalized.  Sample will be submitted via state testing for variant testing.
Information has been received from a registered nurse concerning a 16 year old female with seasonal allergies who on 09-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot # 657617/0384U).  Concomitant therapy included YAZ.  In April 2007 "a couple of days after vaccination the patient developed canker sores.  The patient was treated with "Magic Mouthwash".  Subsequently, the patient recovered.  On 18-JUN-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 657868/0523U).  In June 2007 "a couple of days" after vaccination the patient developed canker sores.  The patient was treated with "Magic Mouthwash".  At the time of the report, the patient was recovering.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Vaccine received 6/12 in L deltiod. On 6/14/2021, she noted a burning pain from mid-upper arm (distal to vaccine site) to mid lower L arm. It only occurs when