chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; VARIVAX was administered after temperature excursion; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On unknown dates, varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion with 6 Fahrenheit degrees up to 14 Fahrenheit degrees for (12.5 Fahrenheit degrees) for 1 hours 0 minutes 0 seconds and 14 Fahrenheit degrees up to 46 Fahrenheit degrees for (19.7 Fahrenheit degrees) for 1 hours 0 minutes 0 seconds. There was no previous temperature excursion.    On 10-MAR-2023, after temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (1 time dose, lot # W012166, expiration date 12-APR-2024; strength, route of administration, anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Patient awoke this morning with soreness at the site of injection; feeling of weakness in her upper body, tingling in her right leg; did work today and now all has resolved except for the tingling and tightness in her right leg, no weakness feels restless.
(R) arm upper aspect - noted with warmth, redness, some blistering. Rx: Diphenhydramine Syrup 6mL PO q 6 hours x 5-7 days, Triamcinolone oint BID x 7d.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) J18.9 - Pneumonia, unspecified organism
After receiving my vaccine, I started to feel pretty lousy. I had flu like symptoms, my blood pressure elevated and my heart rate increased. I called my doctor about my experience and ended up going to the ER, and they ran some tests. They checked my BP, did an EKG and checked my blood. I was referred back to my PCP for a follow-up. This feeling lasted about 1 1/2 -2 weeks.
Dry heaving; Very congested; Throat felt tight; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ew0186), via an unspecified route, administered in left arm on 15Jun2021 at 12:00 evening (age at the time of vaccination was 46 years old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included hypothyroid and food allergy (food allergies and this reaction was frightening); both were from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (CETRIZINE), diphenhydramine hydrochloride (BENADRYL), paracetamol (TYLENOL); all were taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (Batch/Lot Number: Ew0186), via an unspecified route, administered in left arm on 25May2021 at 12:00 evening (age at the time of vaccination was 46 years old) as dose 1, single for COVID-19 immunization and experienced hot, nauseous and heart was racing. The patient had the second dose and the onset was faster and more severe. On 15Jun2021, with 3 minutes, the patient experiencing dry heaving, very congested and throat felt tight. She could still breathe. That all happened even though she took Benadryl and a Tylenol 45 minutes prior to her injection. Again, the pharmacist gave a dose of Benadryl to help with the effects of the vaccine. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Benadryl and Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Extreme night sweats, waking up soaking wet from them. tired, hard to stay awake sleeping 10 to 14 hours a night, falling asleep at work
The next day after my arm at the injection site got really sore and painful for the next day and subsided by that Friday. By that Thursday it felt as if my whole body just shut down. I was extremely tired and couldn't do anything and by that Sunday I began to feel a little better. The next week I was still really tired causing me to lay around for an entire week or better. I feel a little better but still I feel extremely tired since receiving the vaccine.
The patient began feeling as if her chest was tight and she was going to have an anaphylactic reaction similar to the last time she had one.
48 hours after booster - Experienced runny nose, 102 fever, followed by body chills and muscle aches. Positive home covid test on 1/12/2022. (Believe unrelated to vaccine, reporting only per phone conversation with agent)
Patient was given IM dose of Moderna COVID-19 vaccine. Within 2-3 minutes the patient collapsed in his seat and fainted. Patient was non-responsive for 1-2 minutes then became responsive before intervention was given. 9-1-1- was called and EMS took patient to hospital.
feel better but now have blisters on my tongue.; received the vaccine on Saturday afternoon, had severe headaches and 101 fever; Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (feel better but now have blisters on my tongue.), HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE BLISTERING (feel better but now have blisters on my tongue.), HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.). At the time of the report, TONGUE BLISTERING (feel better but now have blisters on my tongue.) outcome was unknown and HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.  The treatment history was not provided.
Itchy hands and feet about a week after the booster. It progressed into increased body odor, hives and itching all over the body. Sometimes burning and hypersensitivity to the skin. Condition  progressively worse and continues as of 3/6/2022.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2016 the patient was vaccinated with an improperly dose of GARDASIL 9 lot # L011846 with expiration date on 16-JUN-2017, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Temperature/Time frame: 50.5 Fahrenheit degrees for 1 hour. Back in range? Yes. No prior excursions. Call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Presented for shortness of breath & R lower extremity pain. RA sat 85%. Admit for pneumonia due to COVID-19. Developed acute respiratory insufficiency and was intubated & placed in ICU. TX: intubation, ABX, amiodarone, steroids, levophed, Vitamin K. Extubated on 10/6 & transferred out of ICU. On 10/8 patient became hypotensive, poorly responsive & Code Blue initiated. CT of chest, abdomen, pelvis revealed significant hemorrhage involving L lower abdomen, extending to L psoas muscle & retroperitoneal area. 10/25 CT chest revealed large L sided pneumothorax & chest tube placed. 11/8 CT abdomen- pelvis showed acute cholecystitis; cholecystostomy tube placed. 11/16 Transferred to acute rehab in stable condition.
She received shingrix IM injection left deltoid on 4/29/2019.  First shingrix 8/9/2018-she describes a typical local reaction to the injection the first time-about 4cm area of redness at the site with mild tenderness and mild itch all of which resolved in a few days.  Yesterday she started with pain in the left upper arm and shoulder and had trouble changing her clothes to go to sleep, husband helped her. She had pain with movement of the left arm in the shoulder and upper arm area this am so got ready using right hand and tried to go to work but was sent home since she could not work with both arms. She has had some left upper chest pain, dull and sore to the touch as well as left neck with a small node at the left base of neck anteriorly. No fevers, some pain on and off in "gums" but points to the TMJs, no swelling, no itch. Some headache.
Pt received vaccine on 4/8 developed LLE calf pain/swelling (+) DVT.
1/4 vaccination. About 1 later, I had severe and weird sensation. Look at self in mirror, severely red, flushed. Itching back of throat, felt allergic reaction. Itching, coughing, first hour. Then pain over whole body, HA, nausea, diarrhea. 'felt like hit by a wall, severe HA'. Took benadryl and tylenol. Intense for 4 days, 'living off of benadryl'. The muscle and joint pain continued, nausea and diarrhea.  By sat, I could finally eat.  Sunday I could move again. But if I did anything, was hard to catch my breath with any exertion.
Sore arm 9/22/11 - 9/23/11. Headache 9/23/11. Vomited sx starting at 11:30 am to 4:30 pm.
Pt  stated had varicella vaccine on 10/30/2018 @ Clinic and then awoke next morning with swelling & reddness and hot to touch. Pt came to health services and was seen by provider. Diagnosis was local reaction and patient ordered to do warm compresses/take fexofenadine 180 1 tab QD given 15 tabs. and return to follow up with provider next day. Patient did not return for visit on 11/2/18 as directed.
Acute onset of neurological symptoms characterized by generalized weakness necessitating ventilator support. Weakness eventually localized to the waist down. Still undergoing physical therapy for it. Diagnosed with UTI with Escherichia coli, bacteremia with escherichia coli, Neurogenic bladder, possible transverse myelitis.
He is having shoulder pain ever since getting this vaccine in his arm. It is still hurting. It hurt when he got the shot, but by the time he got home it felt really bad. I had called him for his second vaccine in this series and he stated he didn't want it because he arm still hurts and has limited motion and it wakes him up with shooting pain. He says it doesn't hurt when he presses on it.
Dizziness / Fainting feeling; Cold sweat; Headache; Chills at night / Shivering; Felt Restless; Tenderness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site tenderness. On 21st October 2019, the patient experienced chills and restlessness. On 22nd October 2019, the patient experienced dizziness, cold sweat and headache. On an unknown date, the outcome of the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness were unknown.   It was unknown if the reporter considered the chills, restlessness, dizziness, cold sweat, headache and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Less than a day after vaccination, at night, the patient experienced chills and felt restless. One day after vaccination, the patient woke up next day at 5 am and experienced dizziness, cold sweat, fainting feeling, headache and shivering. No further details were provided. The reporter did not consent to follow up.
had different aches and pains anyways/ Especially in the arm that he received the covid vaccine in; Body aches; He did notice his arthritis seemed to be more intense; This is a spontaneous report from a contactable consumer (patient). This 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Apr2021 at 8:00 AM in left arm at single dose for COVID-19 immunization. Medical history was blood pressure abnormal. No family medical history relevant to events. Concomitant medications included blood pressure medication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at 12:00PM in left arm as single dose for COVID-19 immunization at the age of 73-year. No other prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. Patient received second dose of the covid vaccine on Thursday, 08Apr2021, had body aches on 08Apr2021. It is hard for him to personally know exact dates. Patient had different aches and pains anyways. Especially in the arm that he received the covid vaccine in because he pulled a muscle in that arm. He had issues with that arm before, so it was hard for him to tell. He did notice his arthritis seemed to be more intense on 08Apr2021. He did not have a fever. He was now back to his normal aches and pains. He did not have any medications, medical history or testing to add that he felt was relevant. He was a typical old guy with aches and pains and that sort of thing. This report was assessed as non-serious. The events did not require a visit to Emergency Room or Physician Office. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:32, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000237:  US-009507513-1704USA000485:  US-009507513-1704USA000486:  US-009507513-1704USA000487:  US-009507513-1704USA000488:  US-009507513-1704USA000489:  US-009507513-1704USA000490:  US-009507513-1704USA000491:  US-009507513-1704USA000492:  US-009507513-1704USA000493:  US-009507513-1704USA000494:  US-009507513-1704USA000495:  US-009507513-1704USA000496:  US-009507513-1704USA000497:  US-009507513-1704USA000498:  US-009507513-1704USA000500:  US-009507513-1704USA000501:  US-009507513-1704USA000502:  US-009507513-1704USA000503:  US-009507513-1704USA000504:  US-009507513-1704USA000505:
Sudden onset of pain and breathing from her right hip to right anterior thigh, down to her right foot with numbness, tingling, and weakness to her right lower extremity.
This is a spontaneous report obtained from a contactable Other Health Professional. And the subsequent information is from a contactable physician. A 79 year old female patient received PREVNAR 13 (lot# F45137, expiration date: 31Mar2014) on 16Aug2012 at a dose of 0.5 ml IM in left arm. Relevant medical history included type 2 diabetes and hypertension (both ongoing). The patient neither received any other vaccine on 16Aug2012 nor four weeks prior to that along with PREVNAR 13. Relevant concomitant medication included metformin 850 mg two times a day for type 2 diabetes, amlodipine at 10 mg daily for hypertension, chlorthalidone tablet at half tablet of 25 mg daily for hypertension, simvastatin at 20 mg daily at bed time for an unknown indication and potassium at 20 mEq daily as supplement, all since an unknown duration. On 16Aug2012, after receiving PREVNAR 13, the patient had a severe reaction, had high fever of 102 degrees, had chills, she was very weak and her arm was swollen, rapid Pulse 120/min, local large inoculation (tender and hot). The patient was admitted to hospital. Relevant laboratory tests were unknown. The therapeutic measures taken for severe reaction included ATARAX at 25 mg two times a day and cimetidine at 800 mg two times a day. The therapeutic measures taken for other reported events were unknown. At the time of the report, the patient was recovering from the reported events. The reporter considered there was a reasonable possibility that the event fever was related to PREVNAR 13. Follow-up (10Sep2012): New information reported from a contactable physician includes: patient age, vaccination details (route, date, expiration date and lot #), onset date and outcome of events, additional events (rapid Pulse 120/min, local large inoculation), seriousness (admitted to hospital) and causality assessment for the reported event (fever was related to PREVNAR 13). Follow-up attempts completed. No further information expected.
patient came in for a well child visit on 12/21/2023. Was supposed to receive quadracel and Proquad. Patient received quadracel and pentacel instead.  Called and reported error to the state and was advised patient may experience an exaggerated reaction (Increased tenderness, swelling, redness), adverse event brought to the attention of the covering provider. Per the state and Dr. parent was advised no harm in receiving extra dose of vaccine, just may see an increased risk for exaggerated reaction (above reaction discussed in detail above) Parents verbalized good understanding and will call with any additional questions or concerns. Patient is scheduled to come back for the proquad in December.
my heart rate became elevated to a range of 120-165; severe allergic reaction; I started feeling jittery; I also had injection site pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient got her first Pfizer Biontech Covid vaccine yesterday, 13Apr2021, and approximately 7-8 hours after the dose, patient started feeling jittery and heart rate became elevated to a range of 120-165 throughout last night and into the morning in Apr2021. It was currently ongoing at the time of report. Patient also had injection site pain in Apr2021. Overall safety summary reported it as a common side effect but reference to "a fast heartbeat" as a possible sign of severe allergic reaction in Apr2021 along with other symptoms. The outcome of event heart rate increased was not recovered, while for others was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The concurrent condition, medical history and concomitant medications were not reported. On 27-May-2016 the patient was vaccinated with an expired dose of VARIVAX (lot #K002927, Expiry: 26-FEB-2016). No adverse effects were reported. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of extra dose of administered in a 12-month-old female patient who received ENGERIX B pediatric (batch number AHBVC190BA, expiry date 31st January 2015). Concomitant products included ENGERIX B pediatric. On 22nd September 2014, the patient received the 4th dose of ENGERIX B pediatric. On 22nd September 2014, an unknown time after receiving ENGERIX B pediatric, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown. It was unknown if the reporter considered the extra dose administered and wrong vaccine administered to be related to ENGERIX B pediatric. Additional information: Medical assistant reported on 22 September 2014, she vaccinated the patient and instead of getting a Hepatitis A vaccine, the patient received an 4th (extra dose) of ENGERIX B. No adverse event was reported.
time for the shot, walked to the chair to wait; started back of tongue could be felt on both sides of my month rubbing my teeth.  Sat waiting 15 minutes, time to leave, explained to staff, Seen immediately, given 2 doses of ligiid Benadryl. while talking with staff noticed from on tongue numb, them face and left hand fingers went numb, blood pressure elevated. Taken to the ER, given IV and monitored. given methyIPREDNISolne through IV.; sent home later with 3 days of predniSONE and 5 days diphenhydrAMINE . Next 2 days had ; headaches, talked with my General GP, started Tylenol and Pepcid ; by Sunday having chest pain and tightness, used Albuterial HFA 200 meter, relieve tightness, happened again on Monday - did not sleep till 4 AM; Saw GP on Tuesday, test ordered,
Vaccine was a multidose vial that was reconstituted. Expired 1 month after reconstituted, but vial expiration date was noted, not 30 days reconstitution date. Vial expired 3 months prior to dose given. Company notified. Concern for bacteremia/subtherapeutic dosing noted from company. Called to notify patient and the following symptoms reported a few days after vaccine given (1 week): paresthesias upper extremities, dizziness, LE pain, headache, fatigue.
After injection - 3 inch of red circle, sore skin. Top layer sloughed off. Has been getting increasingly more painful to touch. Unable to have full ROM without pain. Area warm to touch.
Per the patient's mother, the patient became dizzy and must have blacked out, fell off the bench and hit the right side of her head on the ground. A loud "thump" was heard. The mother immediately picked up her child and witnesses stated the patient started to seize in her mother's arms. This occurred about 8 minutes after being vaccinated. As soon as I ran out, the patient had appeared to have stopped seizing. We laid her on the bench in a supine position. Patient stated her head was sore. No bleeding or inflammation of the area was present at the time. The vaccine was given around 12:32pm. A cold compress was applied to the right side of her head around 12:42pm. At this point, patient stated her head wasn't sore anymore so the compress was removed. Around 5 minutes later, patient stated her right eye was sore and it appeared to be turning red with a little inflammation forming so the cold compress was placed on her right eye. Patient stated the cold compress made it feel better. Management and EMS were alerted when the event had occurred. EMS had arrived approximately around 12:50pm and transported the patient to the hospital. Spoke with the mother an hour later and she stated patient is doing okay and is waiting to get released from the hospital.
REALLY, REALLY FUSSY X 1 FULL WEEK AFTER DTAP AND HIB VACCINE; WAS ALSO REALLY TIRED FOR A FEW DAYS