chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme discomfort in chest; Burning; Heavy feeling in her head; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Extreme discomfort in chest), BURNING SENSATION (Burning) and HEAD DISCOMFORT (Heavy feeling in her head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) and Barrett's esophagus. Concomitant products included VALSARTAN, SIMVASTATIN and LABETALOL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (Extreme discomfort in chest), BURNING SENSATION (Burning) and HEAD DISCOMFORT (Heavy feeling in her head). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Burning esophagus, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Burning esophagus, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Extreme discomfort in chest), BURNING SENSATION (Burning) and HEAD DISCOMFORT (Heavy feeling in her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       extreme discomfort in chest which is not intolerable but noticeable and a heavy feeling in her head.  She wanted to know what to expect with 2nd dose.
nose bleed, decrease in hemoglobin by 0.7 in 1 day 6/4 Nose bleed,  6/8 another nosebleed, hgb dropped from 12.8 to 12.1 in 1 day, needed TXA to stop the nosebleed in the clinic, sent home with Afrin, hold aspirin due to bleeding
7 persons received the Pfizer monovalent Covid-19 vaccine and 1 person received the Moderna monovalent Covid-19 vaccine after advice received to only give the bivalent vaccine as a booster.
Patient was seen in the office on 2/9/23 for a one month well visit and second hepatitis B vaccine was ordered and given. However, pt was given the first dose on 1/8/23, so it was given too early by 1 week.
Very sore left arm for about 3 days Generalised fatigue, nausea, anxiety for about 10-14 days. Dizziness and dissociation starting about one week post injection and continuing until about 3 weeks post injection.
Grandmother (guardian) noticed child limping (R) leg 6/25/13 about 5 p.m. When child ran, her leg buckled under her. She asked for help to climb stairs. No complaint of pain. 6/27/13 (TC) to grandmother -  symptom is gone now.
Right arm red/swollen/itchy/sore from elbow to shoulder. Applied ice pack/took ibuprofen. Redness gone, swelling down by 3/26/11, 1000. Declined visit to M.D.
pt recv vax 17FEB99 devel fever, irritability, emesis w/in 14hr;
This spontaneous report as received from a medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. 16-FEB-2018, the patient was vaccinated with M-M-R II (albumin status was not reported) lot # N001532 with an expiration date 13-JAN-2019 for prophylaxis (dose, route of administration and anatomical location were not reported) that was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of M-M-R II experienced the temperature excursion form 47 degree Fahrenheit to 77 degrees Fahrenheit for 40 minutes. It was not reported if the was previous temperature excursion. A digital date logger was not involved.
My annual physical exam was on 5-7-18. Excellent and all blood work, etc. came back stable. Just as I was leaving the room, Dr. suggested I get this SHINGRIX shot. He is a firm believer in preventative procedure. I got the first shot on 6-8-18. I noticed my left ear felt plugged-thought it was earwax. It was a slow, gradual feeling much like swimmer's ear. After cleaning the ear for normal wax a hearing test determined the left ear had significant hearing loss.  would like to know if you have received other people notifying your office about this vaccination. I am scared to go bac for the second shot of this SHINGRIX 2 step process. This problem with my left ear is so much worse. Right now my right ear is far better than my left ear. I (since this happened to me) have heard of 2 other people who had Adverse affect - I only wish I would have hear about the problem before I got the SHINGRIX 1 shot. Was this vaccine fully tested on a large group of people before being put out to the public.
This spontaneous report was received from a pharmacist regarding a 59 year old male patient. The pharmacist did not have access to the patient's medical history. In approximately 2014 ("about 2 years ago"), the patient was vaccinated with ZOSTAVAX (lot# and expiry date unspecified). No concomitant medications were reported. The reporter stated that, since an unknown date, the patient got a rash every year and had one currently. The patient sought medical attention. Since approximately 2014, ("since the patient received the ZOSTAVAX about 2 years ago"), the rashes seemed to be lessening (unexpected therapeutic effect). No Product Quality Complaint (PQC) was reported. The outcome of rash was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Breakthrough Covid infection in June 2022.  Infection caused diarrhea that lasted for about 1 month, accompanied by loss of appetite and early satiety.  Now, 4-1/2 months later, I have lost 17 pounds for otherwise unknown reasons, bringing me to 110 pounds from prior 127 pounds.  The weight loss is 15% of my current weight, and 13% of my prior weight.  Also resulted in elevated liver enzymes.
Information has been received from a female who on 04-Sep-2007 was vaccinated with Zostavax.  On 06-Sep-2007 the patient experienced injection site elevation with redness.  The elevation was swollen and itchy.  As of 06-Sep-2007, the patient's adverse experiences persisted.  No further information is available.
Swelling- bicep is swollen, redness- the size of a baseball, itching-slight, mild, hard lump-the size of a quarter, pain- 2 of10 most of the time.
Fever 100.5 F ........ chills ....... dry cough ...... headache ...... body ache ....... all lasted 6+ hours.
first shot in Sept 2021; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The case was received from consumer via  interactive digital media. The patient had first Shingrix shot in September 2021 and asked if it was too late to have the 2nd shot. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient was pre-treated with zyrtec and triamcinalone cream and given her fourth dose IM for large local reactions.  She now has arthralgias and headaches that caused to miss work and go to emergency room
Pt stated she developed an uncomfortable red itchy rash warm to the touch on the right side of her neck a couple days after receiving the vaccine. It kept spreading and also started across her lower back and upper right thigh when she came to the pharmacy about 10 days later on 4/25. She also reported feeling fatigued. Reported arm pain for 1 to 2 days after vaccine.
increased seizure activity/mini seizures; increased seizure activity/mini seizures; confusion and memory issues; confusion and memory issues; fatigue/tired; This is a spontaneous report from a contactable consumer. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:00 (Lot Number: EW1064) as SINGLE DOSE  (at age of 17 years old) for covid-19 immunisation. Medical history included epilepsy (interactable epilepsy) from an unknown date and unknown if ongoing.  There were no concomitant medications.  Historical vaccine information included BNT162B2 dose 1 on 25Mar2021 09:00, lot number as ER8733,  in the left arm for COVID-19 immunisation(at age of 17 years old). On 17Apr2021, the patient experienced increased seizure activity, fatigue/tired, confusion and memory issues. After the 2nd shot, about 4-5 hours, he experienced increased seizure activity and it has progressed to today, today he is a little bit better but it has progressed to point he is having a lot of confusion and memory issues. He has several different types of seizures but he has what are called mini seizures, the blank stare, the confusion. Nothing has stopped completely, he isn't back to his baseline as far as his seizures. He always has seizures, daily so she is calling about the increased activity and when she says his baseline she means he has not returned back to his baseline activity, but he is doing better than yesterday.  Saturday, Sunday, and Monday were horrible. Today he started to get back to his normal self. The events did not require a visit to the Emergency Room or Physician Office. Outcome of the increased seizure activity/mini seizures, confusion and memory issues were recovering. Outcome of fatigue/tired were not recovered.
Sore arm after injection on Friday AM- by Friday afternoon, she had basic fever, chills- and her arm had swollen up, turned beet red, size of a lime- pt reported. Pt unable to move the arm. By Saturday evening, no more fever or chills but arm was still swollen. Still could not move her arm and it was itching.
Vaccinations were adm. on 6-15-10. Pt. returned to clinic on 6-28-10 to see FNP with c/o pt. stumbling when walking and discomfort of the leg. Pts. caregiver stated that the discomfort and stumbling started after vaccinations were given. No redness, swelling or warmth noted around inj. area. Good muscle tone and no dimpling noted.
p/vax pt had onset of acute rt upper quadrant abd pain described as deep, gassy, bloating, unremitting pain;
booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   injected intramuscularly in deltoid muscle. No concomitant medication details was provided. No treatment medication details was provided.
pt recv vax & devel rt lower extremity weakness, resulting in the loss of ability to ambulate;LP produced CSF w/ 11 white cells & elevated protein;spinal cord MRI was nl;electrodiagnostic studies were consistent w/anterior horn cell disease
wrong dose/ The 1 ml vial was administered/ instead of the 0.5/ Havrix wrong dose administration; This case was reported by a other health professional via media and described the occurrence of overdose in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix 1 ml. On an unknown date, unknown after receiving Havrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter wanted information on providing the wrong dose of Havrix to the patient, as the 1 ml vial was administered to the patient instead of the 0.5 ml vial, which led to overdose. The follow-up would not be possible as no contact details were available.
Woke up with chills at 1:30am. Hands shook, ran a temp 100, arm hurt, teeth hurt, severe headache. When I got up I fell from dizziness at 8:30 am. Uncontrolled diarrhea. Threw up water that I drank earlier. Temp came down by end of the day. Hip pain from the fall. Spent the day in bed. Headache, teeth ache, arm ache all stayed for days. Symptoms lingered for a solid week but with less intensity than at initial onset of symptoms. Went to the doctor after 10 days because I couldn't get in.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Negative, notes: I tested negative after the 5 day course of Paxlovid; (30Jul2022) Positive, notes: 6 days after finishing the treatment, I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient tested negative after the 5 days course of Paxlovid. Was feeling good. Minimal symptoms. 4 days later, I became very stuffy/congested. 6 days after finishing the treatment, I tested positive for Covid again. No known allergies. Covid-19 was treated with Paxlovid (Treatment start date= 20Jul2022, Treatment stop date= 24Jul2022).
Red at site 5-13-22, took 2 Tylenol, swelling and increased redness 5-14-22 Took 2 Tylenol twice, swelling and increased redness 5-15-22, Took 2 Tylenol twice, Swelling & increased redness 5-16-22., Took 2 Tylenol twice, Sent email & picture of arm to Doctor 5-16-22, Redness & swelling less 5-17-22, Redness & swelling almost gone 5-18-22, bruise size of dime on left arm 5-18-22.
Nausea, fatigue, and headache beginning around 09:00pm.  2 bouts of vomiting between 10:00 and 11:00pm and diarrhea around 11:00p,m.  Continuing with body aches, chills and headache until following morning.  Headache resolved around 11:30am 12/13/2021.  Body aches and fatigue improved.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was unknown. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that she did not have any local adverse reactions with SHINGRIX after the first dose. However, the patient just received her 2nd dose of SHINGRIX and had tenderness and soreness at the injection site. No further information was provided.
1544 Patient fainted after HPV vaccine given. Patient awoke quickly, icepack wrapped in towel placed on back of neck. B/P taken, 111/69 at 1558 while pt lying down. B/P 99/65 at 1610 while pt sitting. B/P 100/66 at 1630 while pt sitting. No other S/S of distress noted. LPN.
Information has been received from an unspecified source who reported that a 17 year old female with shellfish intolerance, decreased hearing in the right ear and who required glasses to see distant objects on 30-AUG-2007 received her second dose of Gardasil 0.5 ml, intramuscularly.  It was the patient's second dose of Gardasil 0.5 ml, intramuscularly.  The date of the patient's first dose and lot numbers were not known.  There were no concomitant medications.  On 30-AUG-2007 the patient experienced pain at the injection site in her left arm.  On approximately 30-AUG-2007 the patient experienced knee pain.  On approximately 02-SEP-2007 the patient recovered from the pain at the injection site.  On 03-SEP-2007 the knee pain resolved.  Additional information is not expected.
On 11/8/99, the pt developed greater than 20 lesions of varicella with itching. The pt was treated with Benadryl. Subsequently the pt recovered from varicella. No further information is available.
Information has been received from a nurse concerning a 25 year old female with no medical history or drug allergies who on 26-DEC-2007 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot *659441/1446U). There was no concomitant medication. The patient called the office and reported that on 26-DEC-2007 she felt shaky, lightheaded and like her heart was racing. The symptoms lasted several days and the patient went to the emergency room. The ER stated that her vital signs were all normal and the patient was sent home. No other laboratory diagnostic studies were performed. On 31-DEC-2007, the patient recovered. No PQC was involved. Additional information has been requested. 02/12/2010 Follow up was received from a nurse practioner who reported that she hasn't had any patient's with adverse experiences.  Additional informations has been requested.
1 week after injection my arm looked like it did the first two days after the injection. My arm has a red spot that is sore and hot to the touch and extremely itchy. There is also a lump in the red area.
pt recvd vax; c/o pain to deltoid; arm looked dislocated & swollen w/ redness to elbow area; to hosp & was told in er probable rxn to vax;
Headache, Myalgia & Angina Narrative:  Employee reports headaches, body aches, "chest wall pain", and "head pressure." Reports symptoms began about 6 hours after receiving second dose of vaccine. Reports using an "antihistamine" for symptom relief. No information on drug name, dose, frequency or duration. Reports has fully recovered as of date of this report.
Patient reported a pounding headache for 1 day followed by local muscle soreness at the injection site following his 1st dose of his Pfizer COVID vaccine.
Pt felt flushing and dizzy feeling after vaccination. BP 125/92 , pulse 88, O2 100. Patient wasited an aditional 30 mins and was cleared by nurse.
itchy at the injection site.; in the past few days my arm is red; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy at the injection site.), VACCINATION SITE ERYTHEMA (in the past few days my arm is red) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Shot administered 11 AM. Severe tremors and shaking started around 6:30 PM affecting the torso, hands and arms.
Patient states he was treated for double pneumonia a couple weeks ago.  He completed his course of antibiotics but he has been getting worse.  (He received cefdinir in December, and cefuroxime in January as well as doxycycline) . He feels that the antibiotics have not been helpful.  He describes worsening shortness of breath and difficulty breathing.  He states he is sometimes gasping for breath.  He denies fever.  He states he feels very weak and has had worsening weakness over the past week or so.  He also has right upper quadrant abdominal pain that improves when he lies back. He apparently had a history of COVID last year and received monoclonal antibodies on October 31.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2022 11:15 (Lot number: FK9894) at the age of 62 years as dose 4 (booster), single for Covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose=3, Manufacturer name unknown.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer name unknown), for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 27Feb2022 17:00, outcome "recovering", described as "9 days after my #4 vaccine I got Bell's Palsy on the right side of my face. My mouth was opened more to the right side, my right eye didn't blink automatically, my right eye brow didn't move". The event "9 days after my 4 vaccine I got Bell's palsy on the right side of my face, my mouth was opened more to the right side, my right eye didn't blink automatically. my right eye brow didn't move", was evaluated at the emergency room visit. Therapeutic measures were taken as a result of Bell's palsy. The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination not tested post vaccination. The patient was treated with Prednisone for 11 days. Follow-up attempts are completed. No further information is expected.
Patient inadvertently received 1st dose of Moderna and 2nd dose of Pfizer.