chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up lost, confused, no memory at 11:00 pm.  Went to Emergency Room, had Brain CT, Received TPA beginning at 1:57 am 10/20/22 with completion at 2:25 am.  Memory started to return at 2:25 am.  Transferred to Medical Center via Ambulance.  In Emergency Department from time of arrival early morning (~3:15 am on 10/20/22 until approx. 3:00 pm on 10/21/22).  Received CT/CTa, of head/neck/soft tissue, brain MRI, Vascular Ultrasound throughout course of the day on 10/20/22.  Repeat Brain CT scan on 10/20/22  at 10:00 pm.  Early morning 10/21/22 had an EEG done.  Echocardiogram ordered, but never done (we will be having done as an outpatient).  Current diagnosis:  Transient Ischemic Attack Vs. Transient Global Amnesia.  Discharged at 6:00 pm on Friday, 10/21/22, memory issues resolved and back to baseline, with the exception of tongue turning to the right and a slight left-sided facial droop.
She experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She experienced soreness of arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0205L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (She experienced soreness of arm). At the time of the report, VACCINATION SITE PAIN (She experienced soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068579:CROSSLINKED WITH DOSE 2
Dizziness & Syncope Narrative: Employee reports she had vaccine on 2/11/2021 and the next day did not have much appetite. She reports on 2/13/2021 when she got up to get her coffee she developed hot flashes and felt dizzy. She reports she at in the floor with her hands on her head thinking she was ok. She reports she fainted. She is unsure how long she was out for. Employee reports she started to feel better by Monday 2/15/2021 and did not require any medical evaluation. Per out phone call today on 2/18/2021 she is back to baseline and no other issues.
Redness after 12 hours, continued to get bigger until 48 hours.  Still red at injection site,  very firm tissue  under the redness,.  Achy and extremely drowsy on day 2
pt recvd vax 22SEP92 & w/in 15 mins exp nausea, h/a, faintness, dizziness & generalized illness; taken to ER;
General malaise, low-grade fever (99.5F to 101F) throughout the evening of 9/21/00. Gave 2 Extra Strength acetaminophen about 20:30 for complaint of headache. Woke up about 02:55 on 9/22/00 with a pain in his right side and started shaking all over and was not able to talk or move for 5 minutes. Normal temperature at 04:15. Then at 100.4F by 05:00. Went down to normal a couple of hours later. He had no more symptoms.
pt recv vax 10AUG95 & 14AUG95 devel a fever, rash which looked like mumps, was not sleeping well & was crabby;no further details were provided;
PATIENT 15 AT TIME OF IMMUNIZATION - EUA FOR 16 AND OLDER
Three days after patient took the vaccine she felt light head and dizzy.  She went to the doctors and they did a number of test and eventually referred her to a cardiologist.  The cardiologist saw swelling or enlargement of her heart.  Patient took a stress test and afterward felt fine.  However, the swelling of the heart was concerning.  She never had any issues before taking the vaccine.  More tests scans are planned, to see what is going on.
pt recv vax 28MAR96 & w/in 5min pt exp dizziness & was diaphoretic, pale, feeling cold & woozy & had a weak, thready pulse;resp were noted to be 16, pulse was 80 & BP was 138/86;pt refused to go to ER;devel h/a & felt achy;
Patient developed fever/chills 101-103 degrees F with in 12 hours of getting the vaccine. Per spouse felt heaviness in the chest last night X 1 but no further episodes. Feels very shaky this morning. Denies SOB. Advised patient to be seen by his PCP for further evaluation or call 911 with any breathing difficulty. Spouse agrees with the plan.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 20-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 with an expiry date of (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
I got shingles almost a year after getting my second vaccine/suspected vaccination failure; I got shingles almost a year after getting my second vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 2nd Shingrix shot and almost a year after vaccination, got shingles. The reporter inquired that, it ever help prevent shingles or was this an indication that the vaccine did not work for him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
I am experiencing hives and rashes on my legs and arms; I am experiencing hives and rashes on my legs and arms; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 22:00 (Lot number: 3302180) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Fw0150, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07Apr2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6206, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 12Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 22:00, outcome "unknown", described as "booster"; RASH (non-serious), URTICARIA (non-serious) all with onset 07Dec2021 20:00, outcome "not recovered" and all described as "I am experiencing hives and rashes on my legs and arms".  Additional information: Patient did not had other vaccine in four-weeks. Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Swollen, red, splotchy left eye; Swollen, red, splotchy left eye; Moderate to severe headache every day; malaise; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 30135BA), via an unspecified route of administration, administered in left arm on 10Sep2021 14:00 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient has not had COVID prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). On 10Sep2021, the patient experienced Moderate to severe headache every day since day 1, fatigue and malaise. The patient also experienced Swollen, red, splotchy left eye on day 4, on 14Sep2021. No treatment was given in response to the events. The patient was not COVID tested post vaccination.  The outcome of the events was not recovered.
2 days after, redness 2-3 " down arm, warm to touch. Ached. 0 Fever. 3rd day stinging, less redness.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 79-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at administration was 79 years. The healthcare professional reported that the patient experienced redness and itching.
No additional AE reported / No known side effects or reaction; Given HPV instead of Hep B vaccine; Medical assistant prepared and administered the wrong vaccine; Medical assistant prepared and administered the wrong vaccine; A 9 month old patient was administered the GARDASIL 9 vaccine; This spontaneous report was received from a physician, referring to a 13-month-old male patient (also reported as 9-month-old). The patient's concurrent conditions included prematurity (born at 32 weeks of gestation) and plagiocephaly. His medical history and concomitant therapies were not reported. No illnesses were present at time of vaccination.  Per the reporter, on an unknown date, an hepatitis b vaccine (recombinant) (manufacturer unknown) was ordered via electronic system por the patient, but a medical assistant accidentally circled "hpv" vaccine on paper chart. Then, on 09-MAY-2023, another medical assistant prepared and administered to the patient the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W028573, expiration date: 06-JAN-2025, administered intramuscularly in the right thigh, for prophylaxis. According to the reporter, the patient received that vaccine instead of hepatitis b vaccine (recombinant) (manufacturer unknown) (wrong product administered, product dispensing issue, product preparation issue, and product administered to patient of inappropriate age). The mistake was realized after the patient left the reporter's office and the patient's parents were alerted of any side effects to occur; however, no known side effects or reactions were reported by reporter's knowledge. Once the vaccine was administered, the needle was disposed. Additionally, on that same day, the patient was vaccinated with the second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (batch number uj807aa with expiration date of 01-OCT-2023, administered intramuscularly in the left thigh), the second dose of pneumococcal vaccine conjugated (batch number fp2145 with expiration date of 01-SEP-2024, administered intramuscularly), and the first dose of influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) (batch nunber utTTurja with expiration date of 30-JUN-2023, administered intramuscularly); all given also for prophylaxis.
"tingling arms, legs and throat" Narrative: Employee complained of "tingling arms, legs and throat". Instructed to wait an additional 15 minutes for observation. Vitals signs WNL afterwards. Instructed to report to the ER if symptoms worsened or she felt it was warranted. She declined to go and left the clinic in no apparent distress.
Information has been received from a healthcare worker concerning a 77 year old female patient who on 05-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 22-MAR-2011 the patient developed a rash. No treatment was given for this adverse event. At the time of reporting, the outcome of the patient was unknown. The patient sought unspecified medical attention. Follow up information has been received from physician concerning a 77 year old female with diabetes, atrial fibrillation, hypertension and a history of cerebrovascular accident, transient ischaemic attack, basal cell carcinoma and chickenpox and no drug allergies who on 05-MAR-2011 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). The reporter stated that 18 days after vaccination ("on 22-MAR-2011"), the patient developed erythematous wheals on right buttock. They were linear without vesiculation. At the time of reporting, the outcome of the patient was unknown. The patient had sought medical attention by doctor visit. Additional information has been requested.
Pt c/o pain and swelling in L arm the next morning after receiving a Tdap in this arm.  States lymph nodes swollen and just felt ill with a bad taste in mouth.  States pain 7 on a scale of 0-10 yesterday and 5 and 1/2 today.  States did not see an MD or take anthing for the sx.
Toes hurt when she wore shoes; Both her big toes turned purple; Swollen spot on left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Toes hurt when she wore shoes), SKIN DISCOLOURATION (Both her big toes turned purple) and VACCINATION SITE SWELLING (Swollen spot on left arm at injection site) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0081321A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Toes hurt when she wore shoes), SKIN DISCOLOURATION (Both her big toes turned purple) and VACCINATION SITE SWELLING (Swollen spot on left arm at injection site). At the time of the report, PAIN IN EXTREMITY (Toes hurt when she wore shoes), SKIN DISCOLOURATION (Both her big toes turned purple) and VACCINATION SITE SWELLING (Swollen spot on left arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Patient did not use any treatment for events
I went to bed at 10pm on 3/27 after getting my vaccine around 3:20pm, and woke up at 1am on 3/28 trembling, convulsing, shivering, with teeth chattering and a sore arm. I had a fever of 101.3. Then, I began to experience muscle pain, dizziness, and nausea. I intermittently had chills and sweats, and a headache. I was so fatigued that I could not walk or even sit up. I could not get comfortable as I had body aches and muscle pain.  I took ibuprophen which brought my fever down to 100. My fever and severe side effects lasted until 3pm that day 3/28. I still had a fever by 1am on 3/29 but by morning the only remaining symptom I had was fatigue and headache. If it had not started to get a little better by morning, then I would have gone to the doctor. It was scary.
Vaccine administered was most likely up to 3 times more than recommended.  No dilution prior to drawing up 0.2 ml from vaccine vial into syringe. Additionally, 1.3 ml of diluent was drawn up into the same syringe. This entire volume was administered to patient. Patient had no complaints day after vaccination. Parent gave age appropriate Motrin the evening of vaccination.
Autism which showed the 1st signs at 2 years of age. Showed some possible signs earlier. Mother received MMR on 10/24/1995 while nursing. Per 1 year follow up: Pt did not recover. Pt has an "Autism" diagnosis which I believe was caused by his frequent and large number of vaccines- containing Thimerasol before 6 months of age.
Received flu shot Sunday, November 7th. Says it is very painful & she cannot move her arm. Claims she has nerve damage. Has not seen a doctor yet. Has no insurance.
entire arm was red/markedly red arm [entire arm],; entire arm was red and swollen/swelling; some induration.; Complained of some malaise; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, induration and malaise. On an unknown date, the outcome of the erythema of extremities, swelling arm, induration and malaise were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, induration and malaise to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix in an unknown arm. 24-hours after receiving Shingrix, the patient's entire arm was red and swollen. Provider examined patient approximately 48-hours after dose was administered, approximately 24-hours after onset of adverse event. The reporter described markedly red arm entire arm, swelling but movable and ambulatory, some induration.  The patient denied fever and complained of some malaise.  The reporter detected no fever and reported that, the patient was ambulatory. The reporter agreed to follow up with GlaxoSmithKline. The batch number of Shingrix was reported as 5HA2T, which was corrected to 54A2T as per sales data sheet.
Patient presented to pharmacy the day following vaccination with chief complaint of not being able to urinate after receiving vaccinations.
73 YO received Pedriatric dose of Havrix; 73 YO received Pedriatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   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: 12-Oct-2022 Reporter's comment: The pharmacy student reported that the patient received a pediatric dose of the Havrix.  No reactions was reported.  The reporter consented to follow up via email.  The vaccine administration facility was the same as primary reporter.  Additional Supportive Information: The 73 years old patient received a pediatric dose of the Havrix, which led to underdose and adult use of a child product.
Child had chest pains and rapid heartbeat.  Slowed down and pain subsided then pain and rapid hearbeat increased again.  Happened a total of 3 times.  Took him to the ER.
Right supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via intramuscular route of administration in the right arm, on 30-DEC-2020 at 11:30 AM (at the age of 29 years old) as a single dose for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced right supraclavicular lymphadenopathy - five freely mobile lymph nodes, tender to palpation, roughly 1 cm in size. The patient did not receive treatment for the event right supraclavicular lymphadenopathy. The outcome of the event right supraclavicular lymphadenopathy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
3 erythematous areas distal to site of injection. Non tender, non indurated 1 cm in diameter.
Driving home 40 minutes  after vaccination ears and throat started to feel tight and felt like a lump in my throat , almost 2 hours after vaccination ears ringing and lump in throat. I took 2 Benadryl and in about hour the lump feeling was not as bad, lump feeling subsided. I had muscle joint pain the next 4 days and stayed on Benadryl those days until throat and ears felt better. On day 5 my left arm started stinging and broke out in hives , some on torso but mainly vaccinated left arm. I went to primary care to talk to her about my reactions on day -7 . She documented in my records but told me to report through Vsafe  app. I did. I do not want to take 2nd dose after having this happened and no one able to tell me the 2nd wont be worse,