chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Student was drooling, and had an altered state. Speech was mumbled, student was able to smile and it was equal. Student's heart rate was in the 50s, Sp02 98-99% , EMS/911 was called, student transported to hospital after monitor showed 3rd degree heartblock. EMS took student to hospital where a code stroke was called. student had a CT and an MRI, student then was taken to surgery to remove clot from brain.
1-2 minutes after shot she felt nauseated. Within 3-4 minutes, she was stiff, tonic and clamy (eyes not noticed), lost consciousness for 30-45 secs.. She turned white and did not remember what happened. When brought back to office she was pale. B.P 110/50 and alert. She was sent for tests we haven't got results.
Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than Recommended Interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The pharmacist inquired if the patient needs to restart the series. The reporter consented to follow-up. Till the time of reporting, the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination.
bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad body aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (bad body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (bad body aches) outcome was unknown.            treatment details included Tylenol.   This case was linked to MOD21-051352, MOD21-052525, MOD-2021-041187, MOD-2021-041187 (Patient Link).
Constant nausea and vomiting. Unable to keep any food down. Fever. Tingling and numbness in hands and feet. Dizzy and lightheaded, difficulty walking. Difficulty breathing. Pale.
Patient got fevers to 101, chills, the night of the immunization, that lasted 2 days.  2 days after the shot, she got hives.  She also got bodyaches, which lasted 4 days, headaches, which persistent at day 13, fatigue, which persists at day 13, and head congestion, which persists at day 13.  She feels like she had COVID all over again, although she is improving.  She is very hesistant to take the second immunization, for fear of what it might do to her. Of note, she had moderately severe COVID starting on July 10, 2020.  She was almost hospitalized.  She had long hauler's syndrome, and it took her 11 weeks to feel well enough to be able to work full time again.
This case was reported by a healthcare professional and described the occurrence of localized erythema in an unspecified number of subjects of unspecified ages and genders who were vaccinated with a Havrix (GlaxoSmithKline). The reporter indicated that some of the subjects may have received concurrent Menactra (Sanofi Pasteur) "because that was common". The reporter also indicated that there were probably other concurrent vaccines "but did not know exactly which" vaccines might have been concurrently administered. On unspecified dates the subjects received unspecified doses of Havrix (.5 mL/ 720 elisa units, unknown). At an unspecified time after vaccination with Havrix, the subjects experienced localized redness and/or localized swelling. The reporter questioned whether "there had been any recall on any lots of Havrix" due to an increase in reports of redness and swelling in subjects who had been vaccinated with Havrix. At the time of reporting the outcomes of the events were unspecified.
After thirty minutes of weight training, was on the treadmill and in one to ten minutes I had cardiac arrest and a couple of guys that work there performed CPR and used a portable defibrillator.
Having GI issues of constipation and nausa and guggling stomach at night lining of stomach appears to be inflammed. taking pepsid
Ring and pinky finger on left hand have been numb/tingling since I woke up on morning of April 4th with decreased feeling .
chills; Diarrhea; Dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, CARVEDILOL, FUROSEMIDE, MAGNESIUM, MONTELUKAST and POTASSIUM for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (nausea). At the time of the report, CHILLS (chills), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Return of redness 3 weeks and 1 day after having the Covid booster. Large circle!! With a knot and rash and raised bump was first noticed in the shower. No changes today
The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023; No adverse event; Booster Bivalent dose administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (lot number: 206A21A) on 14-May-2021 and COVID-19 VACCINE JANSSEN (lot number: 213D21A) on 12-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN.    On 20-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any side effects after receiving initial booster dose of Moderna COVID-19 vaccine, Bivalent.   No treatment medications were reported.
pain in my spine; My typing is really off; Neurological issues; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache). At the time of the report, SPINAL PAIN (pain in my spine), VACCINATION COMPLICATION (My typing is really off), NEUROLOGICAL SYMPTOM (Neurological issues) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: fallow up  received on 19-apr-21 contains no new information
Pt reported post 1 day shot - cutaneous semi- circular erythema line developed, below injection site. After 2nd Hep B same thing happened. These cutaneous lesions are smooth (left thigh) and haven't faded in 4 months.
None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 23-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Information has been received from a registered nurse concerning a female who on an unspecified date, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 02-JUL-2007, the patient experienced a rash with less than 50 lesions. On 07-Jul-2007, the rash and lesions were all scabbed over and the event was considered to be mild-per a telephone conversation with the mother and the doctor's office. It was unspecified if medical attention was sought. Follow-up information indicates that no laboratory or diagnostic tests were performed. Additional information is not expected.
Patient reported felt injection site was red, hard, painful and itchy 8 days after injection. She was seen by her provider and he ordered her antibiotic Augmenten which she has not yet picked up from pharmacy.
This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site induration, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site induration, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site induration, injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced firmness at the injection site, extreme pain, and swelling which was 2 fingers length after receiving a dose of BEXSERO. The lot numbers were unknown. The reporter would like be contacted. This is 1 of the 3 cases reported by same reporter.
Developed ringing in theirs ears after the first Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of TINNITUS (Developed ringing in theirs ears after the first Moderna shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Developed ringing in theirs ears after the first Moderna shot). At the time of the report, TINNITUS (Developed ringing in theirs ears after the first Moderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not reported concomitant drugs were not reported   Reporter did not allow further contact
This spontaneous report was received from a registered pharmacist concerning a 20 year old patient of unknown gender. On 10-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) instead of VARIVAX (Merck). No concomitant medications were reported. The patient was not experiencing any symptoms at the time of reporting. Additional information has been requested.
After IM injection pt became pale, diaphoretic and reported feeling dizzy. Pt was assisted from chair to floor to lay down and during transfer had positive LOC  which resolved in less than 5 seconds. BLEs were elevated on a chair and VS were as follows: BP 86/55, HR 80. Pt was given water, snacks and cold compress was applied to forehead. After 5 mins pt was assisted to seated position and VS were as follows: BP 107/75, HR 85. Pt recovered within 10 mins and ambulated out of clinic in NAD. Was escorted to car by staff and was driven home by a friend.
Fourteen hours post vax, the pt developed a fever and became difficult to console with excessive crying. Pt was evaluated in the clinic the following day.
Localized reaction at site of injection 2 hours after injection. Pt c/o pain @ site. Found to be swollen and hard. Ice applied. TYLENOL x2 given. Still painful.
This was not reported to my Dr. but I felt it needed to be report to FDA.  My symptoms began around 3 am (~13 hours after injection, early Saturday morning) with joint and muscle aches and pains along with injection site pain and slight nausea.  I took  tylenol 2-500 mg capsules at ~4:30 am.   Severe chills started around 8 am.  I took tylenol 2-500 mg capsules at 10 am and went to  sleep covered in blankets to try to keep warm.  I woke up around 1:45pm sweating and very warm.  I took my temperature and it was 101.8F.  My "normal" is around 97.7F.  This worried me very much since I was on tylenol. I made sure to drink plenty of water (iced).   The fever dropped to 100F around 6 pm and stayed there.  I could not take more tylenol due to stomach upset.   The fever continued into the second day (Sunday)post-injection staying around 99-100F without tylenol.     By later Sunday, the aches and pains had subsided significantly.  Sunday night I had more bouts of chills with fever off and on all night.  This continued into Monday all day.  By Monday night, i was feeling more normal.   Had I not been feeling better I would have sought medical care.  I am left with slight nausea and an acid-y feeling stomach today, Tuesday. I am a DVM who has worked in the pharmaceutical and medical device industry and wanted to express my concern with this type of reaction to a vaccine.  In my humble opinion having a vaccine that causes a person to be sick for nearly 3 days after is unacceptable!  If it weren't for the pandemic, I don't think this would be approved due to the severity of the reaction.  The mRNA platform should not be  used due to the known effects of causing cytokine release which can lead to these severe reactions.  We need to find something better!
After receiving vaccine, patient was asked to sit on the bench in the front of the pharmacy for 10-15 minutes before leaving. I came back to the pharmacy to copy his paperwork and when I went back to check on him he stated he had passed out. I did not see him in the floor, but customers standing by in the store were helping him back to the bench. Once he was sitting again, we offered to call an ambulance and he declined. We gave him a cold water and just asked him to remain seated and to breathe slowly. In just a few minutes, he was fine. He stated he sat down on the bench, looked down at his phone and that was the last thing he remembered.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his daughter had a bad reaction and was in the hospital. The reporter also stated that as he wrote this so people should think twice before getting a vaccine.
Pt. contacted us on 8/17/13. has had zoster-like rash on left sid eof body previous - was resolved at time of immuniz. Rash developed in area of inj. on Rt. arm 2 days after inj - resembled previous zoster outbreaks.
got the first moderna shot in right arm.   by 10 pm, it felt like my arm had been hit by a hammer at injection site.  I figured that was pretty common, and to be expected.  Sore, but, not alarming.   Then my knee joint on left leg and a bit on right leg began to ache terribly, to the point that I almost buckled on them.   The joint aches moved from a 7 pain on a scale of 10,  down to a 3, and moved to a diffuse body ache for 12 more hours.   Then, the fatigue hit.  I would wake up tired.   go to bed at 10, wake up at 7am,  fall over sideways on couch unexpectedly. and sleep for an hour or two.    It felt like i was severely fatigued.  The fatigue on a scale of 1-10 was about a 7.   It was really debilitating.   The fatigue lasted at a 7 for a full 3 weeks, then a week of 5 level,  then right at 4 week mark lifted quickly in a day.   It was very strange      The fatigue for a month was concerning to me.  I would not want to experience that again.   The shoulder pain was probably what most people experience.  Others I have spoken to have had the joint pain.   But I dont know anyone who had felt 3 weeks of fatigue.
severe pain in her upper back; moving around made her cranky/moving around made her nasty; pain down her left arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe pain in her upper back), PAIN IN EXTREMITY (pain down her left arm) and IRRITABILITY (moving around made her cranky/moving around made her nasty) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain down her left arm). On 04-Apr-2021, the patient experienced BACK PAIN (severe pain in her upper back). In April 2021, the patient experienced IRRITABILITY (moving around made her cranky/moving around made her nasty). The patient was treated with MENTHOL (BIOFREEZE PAIN RELIEVING) ongoing since an unknown date at an unspecified dose and frequency. In March 2021, PAIN IN EXTREMITY (pain down her left arm) had resolved. In April 2021, BACK PAIN (severe pain in her upper back) and IRRITABILITY (moving around made her cranky/moving around made her nasty) had resolved. Not Provided    no concomitant medications were reported.  Treatent details reported as Biofreeze, hot and cold packs, laid in bed.
THROAT AND FACE STARTED GETTING RED AND SWOLLEN.. BY SAT. MORNING ONE EYE WAS ALMOST SWOLLEN SHUT... STILL SAME ISSUE ON SUNDAY AND MONDAY MORNING. I STARTED TAKING BENADRYL ON SUNDAY.
47 YO developed erythematous, pruritic rash on eyelids and face after receiving flu vaccine on 11/21/06.  He had received flu vaccination previously without complications or reaction.  The rash was treated with PO diphenhydramine.
PT CLAIMS TO HAVE FLU AFTER 3 DAYS OF RECEIVING VACCINE AND ABOUT AFTER 5 DAYS SHE DEVELOPED TINNITUS AND PATIENT THINKS THAT THIS MIGHT BE RELATED TO THE VACCINE
This spontaneous case, initially received from other health professional (nurse) on 30-Apr-2018, concerning a 05-year-old, female child patient. The patient had no medical history. The patient did not receive any concomitant medications. It was reported that, on 15-Mar-2018, the vaccine underwent temperature excursion of 34.3-degree F for 820 minutes, which was the first temperature excursion. On 18-Apr-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195244, expiry date: 30-Jun-2018 and anatomical location: not reported) which underwent temperature excursion of 34.3-degree F for 820 minutes. It was reported that, patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. This case was cross-linked to case 201801689 from same reporter.
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 16-MAR-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S028920 and expiration date 16-SEP-2021). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was stored properly.    According to the reporter, the temperature excursion was not reported and was for a time frame of 1 minute on an unspecified date (product storage error), with previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for a time frame of 28 minutes; which was detected by a digital data logger.
Red, raised, itchy area at location of injection.  Perceived inflammation over large portion of right arm.