chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from consumer (Patient's mother) on 07-Mar-2018. This case involves nine years old female patient who was vaccinated with 0.5 ml dose of FLUZONE NP QIV (batch number: U5958AA, expiry date not reported) once, intramuscularly in deltoid on 31 Jan 2018. Reporter stated her daughter was in gymnastics until Nov 2017 when she sustained an elbow injury. Concomitant medication was not reported. On 1 Feb 2018, 24 hours post vaccination patient had dizziness and general malaise. On an unspecified date, three days post vaccination patient had lower back pain. Patient was evaluated by her pediatrician on 03 Feb 2018 and orthopod on 12 Feb 2018 and diagnosis was lower back spasms and treated with MOTRIN and Physical Therapy. Patient had two emergency department visit for this as well. Reporter stated her daughter has about 2 episodes a day. Patient had blood work and an MRI with normal results. Other corrective treatment was not reported. Patient was not recovered from event. List of documents held by sender: none.
Redness and swelling developed in left deltoid starting 07/09/02. Local reaction 2 hours to tetanus injection. Tx: Atarax 25 and qud #30 + Triamcinolona 0.5% applied tid.
Pt received her 2nd pfizer covid 19 vaccine on 4/3/21 without incident. She presented to the emergency room on 7/29/21 with complaints of sudden facial drooping, L sided weakness and slurred speech and suffered an acute parietal and frontal lobe stroke despite being on coumadin, aspirin and a statin. The cause for the stroke was unclear per neurology. she had no history of atrial fibrillation. Her gonadal vein thrombus for which she was taking the coumadin for since 10/20 was no longer present on imaging and therefore the coumadin was stopped during admission. She had 60 % stable/calcified plaque of her R internal carotid artery but neurology did not feel that was a causative factor. she was also discovered to have a small Patent foramen ovale on echocardiogram but that also was not felt to be causative. Her stroke was embolic in nature. She will continue to take the same dose of aspirin and lipitor on discharge as her ldl is at goal. she remains with L sided weakness, slurred speech and a left facial droop.
This spontaneous report as received from a registered nurse refers to an 82 years old female patient, with none pertinent medical history and none reactions/allergies, who on 19-AUG-2012 (reported as "two days ago') was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). No other co-suspects were reported. Concomitant medications included TENORMIN, MIACALCIN, FOLVITE, NEURONTIN, vitamin D (unspecified), LIPITOR and MIRALAX. Following the vaccination the patient experienced redness, body rash, itching, burning and hot to touch. The patient sought medical attention by an office visit. No treatment was given. None lab diagnostics were performed. The outcome of patient was reported as not recovered/not resolved. The relatedness for redness, body rash, itching, burning and hot to touch was not reported for ZOSTAVAX. Additional information has been requested.
On 9/25/19 @ 0800 employee arrives to occupational health clinic reporting concerns following the IM administration of her flu vaccine on 9/23/19.  Employee states symptoms of right arm stiffness when raising arm above head and discomfort radiating across rt back of shoulder and up neck began hours after the administration of her flu vaccine on 9/23/19.  Employee reports waking from sleep in the early hours of 9/25/2019 with "pins and needles" sensation of right arm and "slight tingling" of tongue.  Employee reports she has access to an Epi-Pen at home but did not require its use.  Arm was evaluated by clinic nurse and clinic manager.  One needle point scab noted on upper deltoid visually noted.  No swelling or rash visualized. Photos taken and uploaded to employee's electronic chart.  Employee encouraged to seek medical attention by MD if  signs and symptoms continue.  Employee to return to OHC/EH&S on 9/27/19 for follow up.   9/27/2019: Employee arrives for follow up.  Employee reports improvement with right arm soreness 3/10 pain scale. No tingling.  Employee taking Advil OTC , PRN (as needed).  Employee did not seek outside medical attention.
Sore arm at injection site.  Itchy throat and itchy body.  Extreme Fatigue.  Heavy and fast heartbeat with severe pressure and chest pain.   Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
Patient with dementia, daughter states patient has had increasing fatigue, lethargy, decrease in appetite with exertional SOB x past 5 days; wife positive for COVID-19 and in the hospital; patient positive for COVID-19; admitted to hospital; given antibiotics, Decadron, remdesivir, convalescent plasma, and O2 supplementation via mask; feeding tube (which patient pulled out several times during his hospitalization); heavy upper airway secretions; plans to be discharged to SNF or hospice; patient suffered cardio-pulmonary arrest with family at bedside and passed away in the hospital.
23 hours after getting the first Shingles vaccine I got extremely lightheaded and just about passed out.  I checked my blood sugar and I was 80; which is normal!  I went to bed and napped for 3 hours. I have felt off-kilter ever since (5 days later) The injection site is horrible. I have an intramuscular hematoma and will be seeing my doctor tomorrow again. The site is HOT and swollen - the redness is spreading and I have pain in my armpit.
About 3 minutes after receiving the vaccination the patient had a brief syncopal episode after he stood up to walk out of the room. The MA assisting patient believes he lost consciousness, she had to hold on to him and lay him down on the table. The patient stated he nearly passed out. He felt dizzy and nauseated. He had one emesis. His vitals remained normal. He recovered completely about 7-10 minutes after laying flat.
Increase blood pressure; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced HYPERTENSION (Increase blood pressure) and PALPITATIONS (Palpitation). At the time of the report, HYPERTENSION (Increase blood pressure) had resolved and PALPITATIONS (Palpitation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: unknown (High) increased. On 20-Mar-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 20-Mar-2021, Heart rate: unknown (High) increased. On 20-Mar-2021, Laboratory test: unknown (Inconclusive) Unknown.         Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  Intravenous fluid and some medicine was given as treatment medication  Patient experienced palpitation, increased heart rate and increased blood pressure in evening for that he visited Emergency room where he kept for observation for 5 hours and Lab investigations and EKG done to rule out heart problem. Intravenous fluid and some medicine was given. No information of concomitant medication. His blood pressure never high.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
One hour after vaccine was administered patient complained that her arm hurt.  She developed a red, raised area close to her wrist on the same arm.  Patient was taken to doctor.  Doctor couldn't explain, but didn't feel it was caused by the vaccine.  Patient given Motrin-an antibiotic.  Yes, after 3 weeks, bump disappeared.
Had MMR right deltoid.  Has 3x5" erythema, hot to touch.  Advised ice, APAP.
SHORTNESS OF BREATH; NUMBNESS TO BOTH HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 20 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced nausea. On an unspecified date, the subject experienced shortness of breath, numbness to both hands, chills, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105.0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and the outcome of headache, nausea, numbness to both hands and shortness of breath was not reported. This report was non-serious.
Approximately 6 hours after injection pt experienced swelling redness, pain at injection site. This persisted throughout the next two days. Pt received 8 mg Decadron.
pt recvd vax 31MAY94 & on 1JUN94 pt had fever of 104 APAP reduced temp; nurse advised luke warm baths-did not eliminate; 2JUN still had fever; arm sore & swollen; prescribed DPH; pt adm 2JUN94;
Subsequently the pt experienced a varicella like rash, fever, mild lymphadenopathy and headache.
Initial report received from a healthcare professional on 27 May 2012. A 43-year-old female patient whose medical history and concomitant medications were unknown, received a dose of TENIVAC (Lot number: C4114BA), intramuscularly in the left arm on 25 May 2012. On 27 May 2012, 2 days post vaccination, the patient complained of tingling and numbness in left arm, left leg and up into the jaw. She did not have any complain of shortness of breath or anaphylactic reaction. Corrective medication was not reported. As of May 2012, the events had not recovered. List of documents held by sender: none.
This spontaneous report was received from a pharmacist refers to a unknown number patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of MMR II (lot number, expiry date was unknown) which had been stored as high at 47 Fahrenheit for up to 63 hours and no adverse effect was reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Approx. 3 hrs after getting vaccine, mother took child to hospital.  Child with difficulty breathing and complaints of dizziness.  Dr. diagnosed child with vasovagal reaction to the immunizations given at 0915 that morning.  Child was released home, but still having some vertigo/dizziness.
Arm was a little sore; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 Information: GSK receipt date: 11-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media.  The patient got 2 shots because his/her doctor advised it. The patient had no side effects other that arm was a little sore for a day or 2 days. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR024105:Same reporter Same patient - 1st dose
Sore arm at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that he had no side effect after the administration of Shingrix vaccination just had injection site soreness.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019080481:Same country, Same product.
headache; head cold; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization and advil [ibuprofen] for sinus headache/neck aches. On 09Feb2021, patient experienced headache, head cold. Patient again stated a week before his first Pfizer Covid vaccine, he was on a course of Advil to treat sinus headache/neck aches. He heard on the news that taking these medications could decrease the immune response and made the vaccine less effective. He wanted to know if this was true. Patient wanted to know if there would be a 3rd booster shot to take to address the new variants/strains of Covid 19 and inquired if he could take advil after the vaccine. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received covid vaccine - while in waiting area, fainted suddenly and hit his head (rug burn on forehead). Got up and felt fine. Called EMS who then took patient away. Patient was alert when taken away. Previously has fainted when he's gotten blood drawn.
pt reports feeling warm sensation on right side of head and right side of eye after receiving first dose of pfizer vaccine at 1:22pm. Pt VS taken BP: 158/84, HR-67, 02-97% RA. Education of symptoms to look out for provided. Pt reports feeling better and go home to rest. Pt escorted out to car with daughter and RN.
Information has been received from a currently 72 years old female consumer concerning herself with a history of recurrent cold sores and being prone to "fever blisters (prescribed valacyclovir) who on 25-MAR-2012 was vaccinated with a dose ZOSTAVAX (lot# not reported). Beginning around 01-JUL-2012 the patient had noticed that her left side of her lips felt "puffy." She reported that she had a history of being prone to "fever blisters," and she was prescribed valacyclovir by her dermatologist for "flare-ups." She was not taking valacyclovir at the time that she received ZOSTAVAX. She stated that since the beginning of July, when she noticed her lips feeling "puffy," she had consulted her primary physician. The patient started taking her valacyclovir when she began to experience the sensation of swelling of her lips. The doctor told the patient that the sensation she was experiencing in her lips could be as a result of ZOSTAVAX. The patient stated that she had not experienced a rash. No treatment was given for the event. At the time of reporting, the patient had not recovered. Additional information has been requested.
Pt called 11/3/23 at 9:35am asking which vaccine she received in the lower quadrant of her right arm as she experienced redness and swelling around the injection site. She had received Comirnaty by pfizer in the lower position of her right arm with the flucelvax in the upper area. She said she woke up on 11/1/23 with redness and swelling at this site, and went to the emergency room. They prescribed her prednisone and referred her to follow up with her primary care doctor. She wanted to be sure which vaccine to report to her doctor that caused the reaction. She stated that the prednisone seemed to be working to remove the swelling and redness at this time.
One week after getting my third Pfizer shot, I suffered a vertebral arterial dissection around 27 OCT 2021 while back squatting. Symptoms initially presented as neck pain/stiffness. On 31 OCT I suffered an intense migraine, which led me to go to the hospital and receive diagnosis of the vertebral arterial dissection. The workout I was doing when I suffered the dissection was the same as I'd been doing for several years, and I have no underlying conditions. I don't know for certain that my arterial dissection happened as a result of the shot, but it seemed to be quite a coincidence at best.
This case was reported by a consumer and described the occurrence of influenza in a 66-year-old female patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for chronic obstructive pulmonary disease and BREO ELLIPTA inhalation powder (batch number R669743, expiry date unknown) and (batch number R669743, expiry date November 2015) for chronic obstructive pulmonary disease. The patient's past medical history included smoker and pneumonia (hospitalization for 12 days). Concurrent medical conditions included chronic obstructive pulmonary disease, esophageal hernia, dyspnea, spinal fracture and cataract. Concomitant products included carvedilol, enalapril, FOSAMAX, omeprazole and Vitamin D. On 8th September 2014, the patient received Influenza vaccine. In 2006, the patient started ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In October 2014, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 10th September 2014, 2 days after receiving Influenza vaccine , 8 years after starting ADVAIR Diskus and not applicable after starting BREO ELLIPTA, the patient experienced influenza, sore throat and pain in arm. In October 2014, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. In October 2014, the outcome of the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough were recovered/resolved. On an unknown date, the outcome of the influenza, sore throat and pain in arm were unknown. It was unknown if the reporter considered the influenza, sore throat and pain in arm to be related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. The reporter considered the runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough to be almost certainly related to influenza vaccine, ADVAIR Diskus and BREO ELLIPTA. Additional information: When she was taking ADVAIR, she hospitalized for 12 days in 2012 for pneumonia. In October 2014, at an unspecified time after receiving Influenza vaccine, 8 years after starting ADVAIR Diskus and less than a month after starting BREO ELLIPTA, the patient experienced runny nose, irritability, headache, cough, difficulty sleeping, dyspnea exacerbated and productive cough. The patient only took the BREO ELLIPTA for 16 days and also stopped taking ADVAIR. Please refer to case US2014GSK031987 for previous tolerance to ADVAIR.
Swollen lymph nodes in left axillary area and nodule in left breast. Breast MRI completed approximately 6 weeks post vaccination and inflammation was noted on MRI.  3D mammogram, breast ultrasound, and follow up MRI completed, within 4-6 weeks, which continued to show axillary inflammation and nodule. PET/CT scan completed 10/28/21. Inflammation and nodule still present but do not show signs of disease. Primary care provider and radiologist note inflammation likely effects of vaccine.
Varicella - Information has been received from a licensed visiting nurse concerning a 7 Year old caucasian male patient who on 21 Jun 1995 was vaccinated with first dose of varicella virus vaccine live sc.  There was no concomitant medication.  On 26 Apr 2000, The patient was diagnosed with varicella.  The number of lesions was not documented and the patient was afebriale.  Follow up information from a licensed visiting nurse indicated that nearly every student in the patient's class had chickenpox.  The patient had chickenpox for only 2 and a half days without; fever.  The patient's twin sibling and older sibling never developed symptoms.  Additional information has been requested.
2/7/19 - well visit - VARIVAX and FLULAVAL given. 2/8/19 - phone call from parent - fever "high" no temp avail. gave MOTRIN. 2/9/19 - ER visit high fever Tmax 102.5 exam normal d/c to home. 2/12/19 - phone call from parent - concern for vomiting at 4:30pm. Advice given.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101154145 different patient, same reporter/product/event
After 10 months, the patient is still experiencing pain and soreness in her arm where she recieved the injection. It is not debiliating or constant, but about once a week it gets to the point where she is unable to lift her arm due to the pain.
ABNORMAL MENSTRUATION PERIOD FOR ALMOST 2 MONTH A FEW TIMES.
After my second dose of Pfizer vaccine, I developed fever, chills, headache, tiredness, muscle pain, hypersensitive skin to touch (not a rash, but my skin is more sensitive and a light rubbing on skin all over my body could cause pain).  I also had several series of premature heart beat.