chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous unconfirmed report refers to a male patient, currently 24 years old, with autism. On an unknown date the patient was vaccinated with M-M-R II (therapy type, route of administration, lot number and expiration date were not reported). On an unknown date (reported as "eight months before he was given the M-M-R II") the patient experienced convulsions, rolling on the floor, freezing in a catatonic state and vomiting. It was reported that the patient's mother embarked upon an odyssey of often costly remedies and responses, ranging from wrapping electrical equipment in the patient's room with tin foil, through cranial osteopathy, reflexology, oxygen chamber sessions for six hours at a time and dosing him with handfuls of pills. The range of biomedical interventions being supplied to the patient included a probiotic, six vitamin supplements, four mineral supplements, five trace elements, fatty acids, amino acids, enzymes and a range of homeopathic remedies. The outcome of convulsions, rolling on the floor, vomiting and freezing in a catatonic state was not reported. The relatedness between the adverse events and M-M-R II was not reported. Additional information is not expected, because no contact information has been provided. This is one of several reports from the same source.
Patient had tingling in her lips 7 minutes after receiving her vaccine (11:07). She reported this to the vaccine clinic monitor who alerted me. 50 mg of diphenhydramine was administer at 11:08. Followed at 11:09 with an EPIPEN. Patient was transferred by me to Medical Center Emergency Room at 11:13. She was monitored at the ER and was given PEPCID and a steroid. She was discharged later that day.
This case was reported by a physician (subject's mother) and descried the occurrence of the hives in a 10-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On 30 October 2008 in the afternoon, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm), and experienced drug use for unapproved indication. On 30 October 2008, 30 minutes after vaccination with FLUARIX, the subject experienced hives, swelling of face, lip swelling, and swelling of eyes. On 1 November 2008, hives, swelling of face, lip swelling, swelling of eyes and drug use for unapproved indication were resolved. The physician considered the hives, swelling of face, lip swelling, swelling of eyes and drug use for unapproved indication were probably related to vaccination with FLUARIX. The physician reported that her daughter had received FLUARI at a local fire station on 30 October 2008 and 30 minutes after administration she had hives, swelling of face, swelling of lips, and swelling of eyes. The physician treated her daughter with medications and monitored her after the events. The physician was also concerned that her daughter who way 10 years old had received FLUARIX.
Flushing, Sweating, Dizziness, BP87/50, HR70, RR18, given juice and monitored, left in stable condition
VACCINE ADMINISTERED AFTER BEING STORED IN THE FREEZER; VACCINE PLACED IN THE FREEZER UPON RECEIPT ABOUT 1 WEEK LATER; This spontaneous report received from a health care professional concerned multiple male patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine administered after being stored in the freezer, and vaccine placed in the freezer upon receipt about 1 week later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after being stored in the freezer and vaccine placed in the freezer upon receipt about 1 week later was not reported. This report was non-serious. This case, from the same reporter is linked to 20220146840.
Infection site tender as expected.  Ibuprofen was needed for pain.  The next morning 11/07/2021 early woke up to severe flu-like symptoms.  Temperature 104 full body aches, headache, nausea unable to function and do normal activities.  The doctor said that this is a normal reaction and if the symptoms don't get better in a few days to call back.  She was feeling a little better after a week of the initial day of the shot.
More clots noted; Menstrual period was eight days late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: Flg1611) as dose 2, single and administered in arm left (Lot number: FH8030) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "More clots noted"; MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "Menstrual period was eight days late.". Therapeutic measures were not taken as a result of thrombosis, menstruation delayed.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and the patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017; dose and route were not reported. The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & vomited, suffered a loss of memory; didn't know where was or that had vomited;
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 17-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
About 12 hours after receiving the vaccine exhaustion set in followed by a low-grade fever,  muscle aches and weakness, nausea, white spots on the throat and tonsils, headache, and dizziness.
3:07 pm, Client went to stand and leave the recovery area after completing 15 minutes stay, c/o LA to neck discomfort/soreness.  AAOx4, NAD, vss, no redness/swelling or skin color changes to neck region.  Remained in recovery for additional 15 minutes, monitored, felt better, no progression of symptoms, dc from recovery @ 3:30 pm
Pt recvd rubella vax in approx 1969 or 1970 following vax pt exp a severe rxn consisting of fever & arthritis which left pt unable to walk for a period of about 3 wks;
Covid arm,.   Also, sudden cystic acne breakout all over my face and back which I have not had. This began a week after the shot and has not gone away.
Moderna COVID-19 Vaccine EUA  7cm diameter of erythema, swelling, pruritus, and soreness onset 2 weeks after injection
Baby was given Prevnar vacc. last 4/15/03. Baby developed fever and swelling at site of injection. 5/16/03-fever was 104 and baby seemed to be in pain when L thigh is touched. Can't move L leg-sent to hospital for admission. 60 day follow up states pt has recovered.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: nose bleeding-Mild, Systemic: Weakness-Mild, Additional Details: pt wife called to report bleeding from nose observed for patient after recieving second dose of vaccine.
Patient received 2nd dose moderna vaccine 9/17/21. On around about 9/24 patient started having fatigue , lethargic, increased sleeping, confusion, bilateral axillary pain. Patient presented to clinic on 9/26/21 and had following: cbc, cmp, tsh, vitamin b12, ferritin, iron, covid pcr, procalcitonin, lactic acid, ammonia level & portable cxr. Test returned revealing very high ammonia level of 140, elevated TSH of 19, elevated liver function test and elevated blood glucose. Additional labs ordered including workup for elevated LFT's, TSH and BG. Patient referred for liver u/s and also gastroenterology consult. Additional workup revealed new onset diabetes with blood glucose getting as high as 700, A1c >11, Acute hepatitis (viral panel negative), anti TPO Ab of 269 (very high). Patient started on lactulose, insulin, synthroid. Patient also referred to oncology, had PET scan which was negative. Patient also underwent EGD and colonoscopy which was benign. Patient referred to rheumatology and endocrinology. Patient has had numerous follow ups in clinic to trend labs and clinical status. Dx following vaccination: new onset diabetes mellitus, autoimmune thyroiditis, acute hepatitis, hyperammonemia
This spontaneous report was received from a medical assistant and a nurse practitioner and refers to a 3-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAY-2018, the patient was vaccinated with GARDASIL 9, 1 injection (route of administration, lot number and expiration date were not reported) and subsequently on 21-MAY-2018, he was administered another dose of GARDASIL 9, lot # N020352 with expiration date on 10-APR-2020 (dose and route of administration were not reported) for an unspecified indication outside of prescribing information. No adverse effects were reported.
Patient received the vaccine Monday, December 21.  Patient started getting flu like symptoms on Thursday including cold, cough and headaches. Patient reports on Saturday the left ear and the left side of the throat began to hurt.  Today Monday , December 28th, the patient states to waking up with a sore throat and the left side of the neck was swollen as big as a golf ball and remains swollen.
Headache, Myalgia,  arm soreness, fatigue, sore throat Narrative:
Falling RBC and Platelet counts Bone marrow done on 9/13/21 Showed Bone Marrow suppression Blood counts con't tp fall Bone Marrow on 6/8/22
Thrombocytopenia and Presence of Schistocytes Thrombocytopenia and anemiaCBC reports schistocytes although this was not quantified, worrisome for microangiopathic hemolytic anemia (MAHA), such as TTP anemia and thrombocytopenia both improving, in this case it is a resolving etiology, such as adverse effect from vaccine - remained conservative - consider reporting as vaccine side efffect as the vaccine is the most likely cause due to temporal relationship - monitor  Thrombocytopenia  etiology is unclear but there is possibility related to drugs or Covid-19 Pfizer Vaccine she received
I had a sore arm for first couple days. On the following Sunday I woke up with chills, body ache and low grade fever (flu like symptoms).
Tuesday night 5/24/16-developed hives all over body. No resp symptoms or new exposures. Seen 5/25/16-with hives covering body. -given prednisone & BENADRYL.
Patient received second dose of covid vaccine on 6/22/21, then developed SOB and CP on 6/25/21.  He was seen in the outpatient clinic and had an EKG which did not show significant ST elevation or LVH.  His troponin could not be drawn at that time d/t difficult access- he had labs done on 6/27/21 which were signficant for troponin of 2.1ng./mL.  He had a repeat EKG on 6/27/21 which did show subtle ST elevation in the inferior leads.  He was diagnosed with myocarditis- Cardiology was consulted.  He is being admitted to the hospital for observation overnight- will get an echocardiogram and serial troponins- results not yet known at the time of this report.  He is currently en route to the hospital.
3 DAYS AFTER VACCINATION PATIENT DEVELOPED A LARGE RASH ACCROSS FRONT OF RIGHT LEG STRETCHING FROM THIGH TO ANKLE. PATIENT RECEIVED 7 DAY COURSE OF DOXYCYCLINE FROM PHYSICIAN WITH NO RESOLUTION TO RASH. WILL BE SEEING ANOTHER PHYSICIAN FOR SECOND OPPINION.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 years old patient (gender not reported) who received MENACTRA (lot number and Exp. Date not reported) twice on 06-Aug-2012 and then again on 23-Apr-2014. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due extra dose administered. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Fever 100.4,  body chills,  left shoulder injection site is red, swollen and tender.   Recovered from the fever and chills, but left shoulder is still red and tender next day
This spontaneous report as received from a health professional refers to a 4 year old patient. On 08-JUL-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J015503, EXP date: 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
This is a spontaneous report from a contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose; and received the third (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included prednisone for rheumatoid arthritis from an unspecified start date and ongoing. After receiving the 2nd vaccine, patient experienced 3 days of energy and no pain. Patient received the booster shot and the exact same thing happened. I get a boost of energy and pain relief for a few days on an unspecified date. The outcome of unexpected therapeutic response/immunization/off-label use: unknown. Information about lot/batch number cannot be obtained. No further information expected.
Per RN, patient reported tingling fingers and itchy palm on R arm during 15-minute observation period post-Pfizer COVID-19 vaccine (Lot # EL1283). Diphenhydramine 25 mg PO administered. No additional symptoms observed. Patient discharged ambulatory in NAD.
Severe muscle/body pains, exhaustion and fatigue lasting for 36 hrs. Then lessened but still present 40 hrs later
Painful knot in arm where injection was given; Painful knot in arm where injection was given; Painful Swelling in underarm and neck near collarbone; Painful Swelling in underarm; swelling in neck near collarbone leaving a painful knot; Flu-like symptoms; headache; dizziness; diarrhea; nausea; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:15 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes type 2" (ongoing); "known allergies Seafood" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC. Vaccination history included: Bnt162b2 (Dose 2, lot#:EP7533, Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot#:EN6205, Left arm), administration date: 10Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Nov2021 09:00, outcome "recovered with sequelae" and all described as "Painful knot in arm where injection was given"; SWELLING (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm and neck near collarbone"; AXILLARY PAIN (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Painful Swelling in underarm"; NECK MASS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "swelling in neck near collarbone leaving a painful knot"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "headache"; DIZZINESS (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "dizziness"; DIARRHOEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "diarrhea"; NAUSEA (non-serious) with onset 19Nov2021 09:00, outcome "recovered with sequelae", described as "nausea". Therapeutic measures were not taken as a result of vaccination site mass, vaccination site pain, swelling, axillary pain, neck mass, influenza like illness, headache, dizziness, diarrhoea, nausea.  Additional Information: The patient does not have Covid prior vaccination. The patient covid was not tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On unknown date in October 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and route of administration were not reported). The patient also received another dose of ZOSTAVAX (dose, lot # and route of administration were not reported) on unknown date in September 2014. No adverse effects were reported. Additional information has been requested.
Jynneos vaccine was administered intradermally; Case reference number US-BN-2022-002263 is a spontaneous case report initially received from a pharmacy student via Communication (reference number: USBAV22-1276) on 06-Sep-2022 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On 02-Sep-2022, also reported as in the afternoon, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating) was drawn up and accidentally left in the fridge over the weekend, however, the vaccine was stored correctly, as reported.  On 06-Sep-2022, the patient was vaccinated with the first dose of Jynneos (batch number not provided), administered intradermally (explicitly coded as 'inappropriate route of vaccination') at an unknown dose or site of administration, for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Non-significant case correction performed for information received from Bavarian Nordic on 06-Sep-2022 to include the local BN case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as inappropriate route of vaccination, at an unknown dose or site of administration, for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is no-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as inappropriate route of vaccination, at an unknown dose or site of administration, for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is no-serious.
Chills x  about 2 hrs; fever (100.2 F) x 1/2 day; moderate headache, mild nausea, mild dizziness for 1 day; as of now, still have mild headache.
The next morning was achy for 24 hours; Passing chills the night; This is a spontaneous report from the non-contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, lot number: ED6955) via unspecified route of administration in the left arm on 23Mar2021 at 09:00 am as a single dose for COVID-19 immunization. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 01Mar2021 09:00 am at left arm single for Covid-19 immunization (Lot number: EL3247). Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced passing chills the night after the 2nd dose on 23Mar2021. The next morning was achy for 24 hours on 24Mar2021. No therapeutic measures were received for both the events. The outcome of events "chills" and "ache" were recovered on an unknown date in 2021.
on 7NOV pt called hosp c/o dizziness, nausea, h/a w/in 10min p/getting vax;next day had flu-like sx;t101-claims had no rxn to hep B #1;
Swelling of Lymph Nodes under left arm and under jaw, sore throat, irritation to mouth, swollen gums.
pt recvd vax 14OCT93 & given APAP; pt became pale & seemed to stare; no one able to report if pt seizured; fever 100, sl struggle to breathe;
Headache, Myalgia, Fever, injection site pain, chills, fatigue Narrative: use d otc meds