chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleepy/if sits down for more than 5 minutes, he falls asleep; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy/if sits down for more than 5 minutes, he falls asleep) and FATIGUE (feeling tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included FENTANYL (FENTANYL PATCH) for Back pain, PIOGLITAZONE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced SOMNOLENCE (sleepy/if sits down for more than 5 minutes, he falls asleep) and FATIGUE (feeling tired). At the time of the report, SOMNOLENCE (sleepy/if sits down for more than 5 minutes, he falls asleep) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant include vitamin Treatment medications was not provided
Pt with pleuritic chest pain treated with Toradol and Motrin. Required being sick in quarters for 48 hours.
Chill x1week, fever x1 week, fatigue x1 month, joint aches x2-3 months, lymph node pain 3 weeks, headache x4 months and ongoing, dehydration x1 week
Vasovagal Syncope was suspected. Patient felt lightheadedness and appeared pale a few minutes after receiving the vaccine.  He was sweating profusely.  911 was called and patient was helped to lay down flat on the floor with his feet raised.  His blood pressure was 97/45 with pulse of 44.  Patient was responsive.  Ammonium salt was given for patient to inhale to keep patient from fainting.  Blood pressure and pulse was continually monitored. After about 10 minutes, patient was able to speak.  His blood pressure was improving to 109/58 with pulse of 57.  After about 15 minutes, patient was able to sit in a chair and appear alert.  911 has not arrived and patient was eager to leave.  Final BP 115/69 with pulse of 63.  Patient left store after about 20 minutes. 911 was cancelled.
Pt had very low white blood cell count and also had effects to his liver. Admitted to hospital after being found to have significant blood abnormalities reflective of bone marrow dysfunction and/or hemolysis. He was jaundiced and had evidence of acute hepatitis. Later on he tested positive for COVID and was placed at a negative pressure room at the hospital. His white count got as low as 1.6 but has improved to2.7 when he was discharged. His platelets at the time of discharge were 120. his hemoglobin was 10.9. his liver function tests were improving down about 200 points the following day compared to when he was admitted.
Client Fainted ~5min after the vaccine.  BP 86/42, repeat 97/40, HR 71, 99% pulse ox.  Patient lowered to the ground, vitals obtained, wheeled to Health office.
Pt. started to cry (high pitched sustained cry) about on hour after receiving vaccines. Continued crying for 4 hours at which time mother called our office. Had administered TYLENOL at onset and again 4 hours later.
pt had a positive COVID test on 3/29/22; 4/12/22 pt had a laparoscopic left colectomy in the hospital; she developed hypotension; given IV fluids; appearance of generally ill; c/o nausea; 4/14/22 had abd CXR which showed underlying ileus; pt progressed to shock; became septic; transferred to ICU; DNR; pt's condition worsened and she died in the hospital
sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: This case was reported by patient herself. In September or October 2020 (unsure for specific date), the patient received 1st dose of Shingirx and had experienced a sore arm. The patient stated that all the symptoms had resolved. The reporter gave permission to contact her healthcare professional. The reporter consented to follow-up. For tolerance of 2nd dose refer case US2020253841.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020253841:same reporter
Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barely able to turn my neck to the right. A lot of pain and discomfort. Limited mobility of neck.
Information has been received from a registered nurse concerning her daughter, a 14 year old female who at 4:00 pm on 21-AUG-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot# 657786/0717U) SQ in her left arm. Additional suspect vaccine included a first dose of GARDASIL (lot# 655620/0171U) IM in her left deltoid. Concomitant vaccination included a second dose of BOOSTRIX (lot# reported as AC52B015BA) IM in her right deltoid on the same day. A few hours after the injections (also reported as at 5:30 pm on 23-AUG-2007), the VARIVAX (Oka/Merck) injection site developed minimal swelling for 24 hours and small quarter size amount of redness. Two days later, the swelling and redness were 1.5 to 2 inches above and below the injection site. The injection site developed lots of heat, the swelling spread to at least 2 inches outward and it looked like the patient had 2 arms. The swelling made it difficult for the patient to move her arm. The swelling stayed for one week, then gradually decreased over 3 to 4 days. The redness disappeared after one week. No other problems had occurred since the swelling resolved. Additional information is not expected.
2/28-  1am: chills, muscle ache, stiff joints - hard to sleep 7am-5pm: headache, nausea, fever, muscle aches, stiff joints (neck and back), chills 6pm-9pm: only nausea went away (Went to bed)  2/29 (all day) Woke up with a really stiff neck/upper body, shortness of breath and chest pain while breathing, exhausted, headache. Shortness of breath getting better throughout the day, headache didn?t leave. Still exhausted
Community member recieved 2nd dose withinn 17 days of first dose of Pfizer.
Cellulitis at vaccination site, erythema, swelling, warmth, induration.
Tiredness after 10 minutes, letharty reduced after vitals taken. BP 133/81 HR80, RR18. Resolved within 30 minutes
PT CAME FOR SECOND DOSE OF PFIZER AND NURSE WHO STATED THE PATIENT WAS ADAMENT TO GET THE 2ND DOSE OF PFIZER. PATIENT SAID IN 15 MIN WAITING THAT SHE HAD THE EXACT SAME SYPMTOMS AFTER THE FIRST DOSE AND REFUSED TO GO TO THE ER AT THAT TIME AS WELL. PT C/O SOME CHEST TIGHTNESS, AND PAIN IN NECK AND RIGHT SHOULDER. ABLE TO TALK AND DID NOT APPEAR IN ANY RESP DISTRESS. PT ABLE TO SIT UP IN CHAIR AND NEVER LOST CONCIOUSNESS. EMS EVAL PT AND WANTED HER TO GO TO ER SO CALLED THE AMBULANCE. THE PT REFUSED AND WALKED TO CAR WITHOUT ANY DISTRESS OR CHANGES. HER FAMILY WAS IN THE CAR AND WE REQUESTED HER TO GO TO THE ER OF HER CHOICE. ALSO ENCOURAGED TO CALL HER PRIMARY TO LET THEM KNOW  VS 186/108 PULSE 80  R 20, RECHECK BP 139/68
Expired vaccine administered , with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient whom  expired vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] administered , with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for Prophylactic vaccination.  On 09-Oct-2023, the patient received a dose 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ807AA expiry date: 01-Oct-2023 via intramuscular route in the left deltoid for immunization.  On 09-OCT-2023 the patient developed expired vaccine administered , with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Reportedly, :Nurse mentioned that nurse misread the expiration date on a PENTACEL vaccine, nurse though the expiration date was 10Oct2023, but it was 01Oct2023, nurse was asking if they should repeat the dose  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired vaccine administered , with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I received my first shot in the right arm - No problems The second shot in the left arm and that night I got the chills, body aches and extreme headaches which woke me up from sleeping. The 3rd day I couldn?t taste, smell just didn?t feel myself still body aches. Got  3 Covid test that week 2 different test 2 different locations. All came back negative Than  I started with blurry vision, brain fog big time, words come out different what I want to say and I start falling. I fall standing for no reason. I don?t black out, no dizziness. This is crazy End of November my left hand is having a tingle and I drop things with that hand. My right thumb yesterday started to tingle
Tingling and sore throat, headache, left sided tongue nimbleness and loss of taste, nausea/diarrhea, neck pain
A nurse reported the occurrence of cellulitis in a child of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The reporter stated that local health dept would submit another report directly. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, "a child was administered an injection of Havrix w/a 5/8 inch needle and subsequently developed cellulitis."
Around 9pm on the night of 4/13/21, I started having bad abdominal pain, nausea, and chills with no fever. Right after the shot I did have normal side effects; my arm was swollen and red. This lasted for a week. But on 4/13, I did not think this was a normal side effect. I went to the ER after about 30 mins of this. I was taken to Hospital. In the ER, I waited a long time. I was checked out and given something for nausea and pain. They did a urinalysis and an abdominal CT without dye. They told me it was diverticulitis. I was sent home with antibiotics, pain medicine and anti-nausea medication. Over the next few days, I improved. I also finished the antibiotics. I did not have to take all the pain medication. I did not go to a gastroenterologist because I go for a colonoscopy every 5 years and I do know that I have diverticula in my colon. My doctor suggested that since I do have this, and I do not have any other issues, it wouldn't be necessary to see the GI.
Sore arm muscle; Overall body achiness; sore arm; This is a spontaneous report from a contactable consumer. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration in the left arm on 23Apr2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medications within 2 weeks of vaccination which are not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 02Apr2021 at 14:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 19:00, the patient experienced sore arm muscle and overall body achiness. Therapeutic measures were taken as a result of the adverse event sore arm muscle and overall body achiness included the treatment with acetaminophen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm muscle and body achiness were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car while driving and had to be taken to the Emergency room where he later passed away. Cause of death on the death certificate per the coroner is Pulmonary Embolus. Patient was just seen my his family physician in January and was in good health no medications taken other than eye drops.
Subsequently post vax, the reporter noted wifes two sisters developed ulcerative colitis 6-12 weeks after receiving vax. The pts sought unspecified medical treatment.
Headache, Myalgia & Arthralgia Narrative:  Took Benadryl in clinic preventatively after reported "welts" from first vaccine to arm. CANNOT verify Benadryl medication, therefore not listed in the meds section below.  Other Relevant History:
welts/ she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; welts/she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; Itching; This is a spontaneous report from a contactable consumer. a 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021, NDC number: 5926710001) on 14Jan2021 at right arm at single dose for covid-19 immunization. Medical history included Welts. Concomitant medication was not reported. Caller is a Pharmacy Tech and a patient had the first dose of the Covid 19 vaccine and had itching (15Jan2021) and whelps (17Jan2021). She would like to know if these are normal side effects and if the patient can get the 2nd dose. Pharmacy Technician is calling about the Covid Vaccine. It was administered to a patient and the patient experienced an AE. Pharmacy Technician clarifies that she is calling on behalf of the patient. She started itching a little on Friday 15Jan2021, then Sunday she started getting welts that were the size of pencil erasers to a dime. She would take Benadryl and when she took it, she was fine for 24 hours. Then welts every day, in different areas, she had the welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs. The added that she has had welts before in the past but she was not sure what caused them in the past. Reporter does not know if the itching and welts are still ongoing or when it stopped. The Patient did state that Itching went away with Benadryl however reporter does not know when or if that is still the case. Not sure when it stopped. Patient didn't provide end dates or if the adverse events ended. The Patient did not list any allergies. When queried if the patient had any positive covid or antibody test prior to the vaccine, caller states that all of the patients that they vaccinated, they ask them if they had any positive test within 90 days, all stated no, if they state, they do not give the vaccine and make then wait. Caller asks if there is any information about if these side effects are normal, as well as if the patient is still able to receive the second dose. the last outcome of the events was unknown. It was reported as non-serious.
Taken to hospital ER for right thigh red, swollen, on 1/23/10 and again on 1/24/10 due to increasing redness and hot to touch. Started on KEFLEX (1/23), and later on BACTRIM (1/24) with one dose of ceftriaxone given in ER. Today (1/25/10)- seen in physician office. Family reports has been taking BENADRYL for itch. Dr dic'd KEFLEX. Her diagnosis is localized allergic reaction to immunization.
Patient experienced numbness of face and tongue; she said it felt like after the dentist. Onset was 15 minutes after administering the vaccine. Per patient was mostly gone after 1 hour of waiting and 50mg benadryl. at 6pm follow up phone call she said it was 90 percent better.
Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis A virus vaccine inactivated. Subsequently the patient does not have a titer count. There was no product quality complaint. Additional information has been requested.
swelling of tongue; swelling of the throat; This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the covid vaccine. It was unknown if the patient was diagnosed with covid 19 prior to vaccine. It was unknown if the patient tested for covid 19 since the vaccination. On unspecified date, the patient experienced swelling of tongue and swelling of the throat. The events were assessed as non-serious. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5/27 2:30pm - received vaccine  5/28 8pm - 1st hives appeared on face cheeks while sitting on toilet with diarrhea. Gave 8ml of Benadryl. Face cleared. Called pediatricians office who referred me to the nurse line. Told to give 7.5 ml of Benadryl if needed, but no sooner than 6 hours from first dose.  5/29 2pm - Hives appeared on back of legs, buttocks, forearms and biceps (About 2-3 inches in size). Gave 7.5ml of Benadryl. Hives cleared. Called nurse line again. Told again to give Benadryl but no sooner than 6 hours since last dose.  5/29 4:30pm - Hives reappeared on forearm (2-3inches in size)..  Called nurse line and told to go to Urgent Care because he may need a steroid. Hives would disappear and then reappear all over body (none on stomach or back).  5/29 6:30pm - At Urgent Care.  More hives appeared on forearms, biceps, legs, face and began to have a hoarse voice. He was given an oral steroid (Told it should last 3 days) and Benadryl. Prescribed Zyrtec every 24hours. Dr told me it was a systemic reaction and to folllow up with pediatrician on Tuesday after the Holiday weekend.  5/30 8:30pm - hives appeared on face. Gave 7.5ml of Benadryl. Gave Zyrtec as prescribed at midnight.   5/31 midnight- gave Zyrtec as prescribed   6/1 - followed up with pediatrician. Told to continue Zyrtec for one week and to follow-up with an allergist for further testing.  6/14 - Allergist appointment.   7/21 - allergist appointment
Patient called to clinic on clinic to report bruise and "small bump"  and soreness at injection site. Jynneos given on 1/20/23, 1st shot. No report of symptoms of anaphylaxis. Encouraged to rotate ice and heat for comfort and to continue to monitor site. Encouraged if further symptoms occur or current symptoms worsen, seek medical attention.
Mother reported vaccine reaction to our practice 8-8-12, first visit to office. Reported fussy, fever 100 degrees within 1 hr of vaccine up to 100.7-102.1 (R), vomiting some on first day. To ER at midnight on 4-25-12. Mother reports admitted, fever, hair fell out, mother reports hospitalized x 3 day. Took 1 week before back to normal - ER diagnoses viral vs vaccine reaction.
Per office note of 4/26/23 of Dr: Patient states the next day she woke up with a very bad headache and stiff neck that she initially thought were reactions to the vaccinations. She then started having issues with her ears and ear pain, which she thought was an ear infection. When she lays down at night she get a bit of vertigo. Her blood pressure has been high again, which she states it has not been high in 10-15 years. At the time she was getting the vaccines she also had increased the dose of antidepressants.
approx 5mins p/vax pt felt heat @ site radiating into shoulder;skin in area blotchy-not hot to touch; DPH given-ice to site;
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 20 Patients in the exposed cohort experienced, anaphylactic /other while 22 of the unexposed cohort experienced anaphylactic /other. Of the 20 exposed patients Age Group: 1 was 18; 18 were in age group 20-24; 1 was in age group 25-29. Sex: 6 Female, 14 male. Of the 22 unexposed patients Age group 3 were 18; 15 were 19-24; 4 were 25-29. Sex: 6 female; 16 male.
Observation 7/14/22-7/15/22 SOB, PE, dyspnea, PNA,
"Moderna COVID-19 Vaccine" Patient received 0.5ml instead of 0.25ml as COVID booster.
Flu-like symptoms for 48 hours, extreme fatigue and sleepiness for 3 weeks post-vaccine
Soreness - inability to raise arm redness and heat extending approximately 2/3 of upper arm - To talk to physician today - attempted PC.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT REPORTED FEELING DIZZY AND HOT. PATIENT WAS LOWERED TO A SUPINE POSITION, LEGS ELEVATED AND GIVEN COOL CLOTH. WHEN PATIENT FELT ABLE SHE WAS ASSISTED TO A SITTING POSITION THEN A STANDING POSITION. PATIENT WAS PROVIDED AN ORANGE JUICE. PATIENT FELT FINE FOR REMAINDER OF OBSERVATION PERIOD AND WAS ESCORTED TO EXIT TO ENSURE TO ADDITIONAL SYNCOPE UPON STANDING.
pt sent letter w/following account-difficulty in walking from clinic to car, diaphoresis; p/eating breakfast, devel the runs; several days later devel ha/ @ base of skull, in bed for 6 days; pain spread into back & hips; neck stiff;
she had a sore arm after the first vaccine, described as being a little heavy at injection site; she had a sore arm after the first vaccine, described as being a little heavy at injection site; This is a spontaneous report from contactable consumer (patient, self-reported).  A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0170 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 23Apr2021, as DOSE 1, SINGLE for COVID-19 immunization at Workplace Clinic (age at vaccination: 44 years). The patient medical history included carpal tunnel and she had it for approximately 10 years. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a sore arm after the first vaccine, described as being a little heavy at injection site and it lasted about a day or two. She went with her husband and son to get the first vaccine and she felt nothing when she got the shot and even asked the pharmacist if she got the shot. No additional details provided regarding this statement. Outcome of the events were recovered on an unspecified date.   Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.