chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VISUAL AND AUDITORY HALLUCINATION  (Audio and visual hallucinations, Hallucinations,  mixed)  BODY ACHES  (General body pain, Pain)  HEADACHES (Headache,  Headache) This spontaneous report received from the patient and concerned a female of unspecified age The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad.26.cov2.s  (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) administered on 11-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced visual and auditory hallucination, body ache.  On 12-MAR,  the patient experienced headaches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches,  and body ache, and the outcome of visual and auditory hallucination was not reported.  The reporter provided no causality assessment.  Company causality between AD26.cov2.s and visual and auditory hallucination, body ache and headache and company causality was possible.  This report was serious  (Other Medically Important Condition).
Severe flu like symptoms occured approximately 12 hours after 2nd dose of Moderna vaccine.  Blood Clot formed approximately 2 weeks later and created stroke on 4/23/2021.
The freezerdidn't get below regular freezingtemp, which should be -25 to -15.; This case has been considered invalid as there is no indication that the patient experienced an event under suspect product BNT162B2.  This is a spontaneous report received from a contactable consumer via Pfizer- sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Powder for solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller says their Ultra-Low temperature freezer went out of range this weekend and it's come back into range. The freezer did not get below regular freezing temp, which should be -25 to -15. As she put it back at the ultra-low temp it will still be good until it's actual manufacture expiration date? The outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.  Amendment :This follow-up report was being submitted to amend previously reported information: the case is invalid as it was unknown if the patient received the incorrectly stored vaccine per Vaccine guidance.
Starting on 03/15/2021, I started experiencing chest pain. Then, it went away on its own. It popped up again in June, but worse than the last time. It occurred more frequently and I went to my PCP. They did an EKG which showed normal sinus rhythm. Then, we waited a bit to see if it would go away on its own. It started worsening in October/November. I got the echo in November and I wore the heart monitor in December. I got the preliminary results of the heart monitor but am waiting to review them with the doctor. The heart monitor showed first degree heart blockage.
Joint swelling hands; nausea; diarrhea; body aches; first dose: 31Dec2020/second dose: 17Jan2021; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 17Jan2021 08:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history was none. No other medications received in two weeks. The patient previously took first dose of bnt162b2 (lot number=EL1284), via intramuscular on 31Dec2020 09:30 at single dose on the right arm for COVID-19 immunization, took erythromycin and experienced allergies. No other vaccine received in four weeks. Facility type vaccine was hospital. Patient was not pregnant. The patient experienced joint swelling hands, nausea, diarrhea, body aches on 20Jan2021 01:00. No COVID prior vaccination. No COVID tested post vaccination. No treatment received. Outcome of the events joint swelling hands, nausea, diarrhea, body aches was recovering.  Information on the lot/batch number has been requested.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient did not show any signs or symptoms of a reaction from the vaccine after receiving it. Patient was in the ER on 07/12/22, but that was due to an accidental medication overdose at home. Otherwise patient seems to be in the same health as before the vaccine. Family is being notified of the incident and will be advised to bring patient in to get covid-19 bivalent booster due to needing the bivalent booster and for revaccination from the incident.
Malaise; puffiness/swelling; redness; Pain; This case was reported by a pharmacist via other manufacturer and described the occurrence of malaise in an unknown number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Prevenar 13) for an unknown indication.   On an unknown date, the patient received Shingrix at an unknown dose and Prevenar 13 at an unknown dose and frequency. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise, tissue puffing, erythema and pain. On an unknown date, the outcome of the malaise, tissue puffing, erythema and pain were unknown.   It was unknown if the reporter considered the malaise, tissue puffing, erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that with Prevnar a patient experienced puffiness, redness and swelling post vaccination. The pharmacist compared it with Shingrix and most patients experience malaise with Shingrix. The reporter had no patient details to provide.  The reporter added this was the reporter's general experience with the vaccines. No additional details were provided. The reporter stated that the most common side effects were pain, redness and swelling.
fever to 103-febrile sz brought to Er-adm to hosp fever cont-observed until 12MAy-discharged;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with RECOMBIVAX HB (dose and lot # not reported) which was improperly stored, intramuscularly. The patient received an intramuscular dose in accordance with the prescribing information. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
Sore arm after first dose; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: EP-6955), via an unspecified route of administration on an unknown date (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient had experienced sore arm after first dose. The clinical outcome of the event sore arm after first dose was unknown. No follow-up attempts are needed. No further information is expected.
48 hours after vaccination, developed Nausea with vomiting, migraine like headache, chills, hot flashes. Seen in clinic 24 hours into symptoms, 72 hours after vaccine.  Was seen in clinic. Suspect future outcome is she will be OK.
Information has been received concerning a male baby who on 23-JAN-2009, during gestation, was exposed to GARDASIL. The baby was also exposed to vitamins (unspecified) and influenza virus vaccine (unspecified). The baby was born at 41 weeks 5 days gestation. The baby was reported as normal with no congenital anomalies. The baby weighed 9 pounds 1 ounce, 12 inches in length, had apgar score of 7 at one minute of life and 9 at five minutes of life. It was reported that the baby was admitted to the neonatal intensive care unit for respiratory distress. No further information is available. The mother's adverse experience has been captured in WAES# 0903USA01999.
Hives on lips and bradycardia, treated with benadryl x 2 and then epinephrine as well as prednisone.
Bloody nose; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose) and HEADACHE (Mild headache) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Bloody nose) and HEADACHE (Mild headache). At the time of the report, EPISTAXIS (Bloody nose) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was reported .
Sore arm in area of shot only. Ten days later woke up with fever of 102. Took TYLENOL for fever and drank fluids (water, freshly squeezed orange juice).
5 Minutes after injections pt states he didn't feel right, cannot see anything, black. Checked pupils and dilated 5-6 mm and no reaction to light. Stated stomach did not feel good and funny feeling in ears. Felt like he was going to have headache. Client was pale, BP 98/56 HR 84 Resp 20. Pt sat in chair for 10 minutes and stated he could see again. Checked pupils again 2 mm and reacted to light, whites of eyes were a little blood shot. Monitored pt. for 20 minutes and no problems. Asked mother if she wanted me to contact his PCP for eval she declined. Recommended to watch pt. have him lie down for a while give ibuprofen. If problems occur call EMS or PCP.
Itchyness on left side only of scalp, eyebrow, eye and forehead without any swelling or redness. Pressure around the left ear and tiredness.
Pt received 2 vaccines at 4:51pm. Pt aware and alert. Upon checkout patient told his mother, "I don't feel good, I think I'm going to pass out." Mother attempted to sit patient down and he fell to the ground. Upon entering the room, RN found patient on floor at 5:06pm on left side. Pt eyes and arms twitching slightly. Patient's eyes were open, but non-responsive to name. Patient came back to consciousness at 5:07pm and was able to identify self, surroundings, and reason for his appt. Pt does not recall moments up to the event. EMT services declined by parent. Patient was sat in a chair, given a juice box and monitored closely. At 5:25 patient was fully alert and speaking to his mother about their plans after leaving.
Patient received both doses of Moderna Vaccine and he is under 18 (17 years 8 months),
body was burning up and face became very red. Had no temperature but was extremely hot after on weer. Now have temporal pain in right hs hand temple with intermittent shooting pains
client completed 15 minutes but then switched to 30 minutes, client complaint of itching around neck and increased salivation and  jaw tension; denies any difficulty with breathing or tightness in throat, denies hx of anaphylaxis. BP 126/90 pulse 71. At 1620 50 mg diphenhydramine given IM Right deltoid per protocol . EMS called, arrived. AT 1632 client reports symptoms improving. BP 159/104, pulse 76. EMS took over medical care. Client declined transport from EMS
Fever body aches loss of appetite fatigue. Treated with rest ibuprofen staying hydrated. Same thing happened with the 1st dose of ZOSTAVAX. Better prepared this time because I thought the same would happen the 2nd time. Unable to participate in normal activities for 2 1/2 days the 1st time.
Either vasovagal syncope or possible drop in blood sugar following Janssen immunization.  Patient very unresponsive "coming in and out," relayed that her blood sugar dropped but did not want blood sugar checked.  Patient was not responsive enough to take glucose shot.  Paramedics responded and took patient to Hospital. Outcome unknown as this time.
Administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date). In December 2021, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that they administered the Moderna COVID-19 vaccine which was beyond the use date which was 09-Dec-2021 at 10:00PM and expiration date was 31-Dec-2069.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route not reported) on 03-JUL-2013, lot # H010915 expiration date: 13-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
NAUSEA, HIGH BLOOD PRESSURE, UNABLE TO BREATHE, VOMITING, DIARRHEA.
pt c/o pain & stiff tissue swelling x 3 days then sx resolved on PE
Non-verbal autistic child improperly restrained by parent was able to free one arm and grab at syringe resulting in a superficial 2" long abrasion to the skin. Pharmacist cleansed area, applied triple antibiotic ointment and bandaged due to very minor bleeding
11/16 numbness, pins & needles in (R) foot progressing to (L) foot 11/17 numbness in bilateral hands, progressing into muscle weakness, feeling of heaviness in legs 11/18 facial paralysis, core weakness 11/20 unable to walk 11/21 admitted to hospital IVIG treatment through 11/28.
STARTING ON FRIDAY NIGHT, 03/12/10, HE BEGAN RUNNING A FEVER, FELT ACHY ALL OVER, DEVELOPED REDNESS AND SORENESS IN THE LT. ARM. HE STATED FRIDAY THROUGH THE WEEKEND HE WAS RUNNING A FEVER OF 104 TO 105. HE HAD ACHINESS AND SORENESS ALL OVER, HE COULDN'T SLEEP. HE DID TAKE TYLENOL FOR THE FEVER, USED COLD PACKS, AND APPLIED COLD PACKS UNDER HIS LT. ARM ALSO. HE STATED HIS TEMP THIS AM WAS 101. HE HAS TAKEN SOME TYLENOL. TEMP AT THIS TIME IS 98.7. PT'S LT. UPPER ARM HAS A RED BAND APPROXIMATELY 2 INCHES WIDE NOTED, IS WARM TO  THE TOUCH. NO REDNESS NOTED UNDER THE ARM, NO SWOLLEN LYMPH NODES FELT. PT. STATES THE ARM DOES HURT WHEN HE RAISES THE ARM OR IT IS TOUCHED. tX: PRED TAPER 3/15/10
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 21-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician via a sales representative and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included MMR II (strain not specified); Merck; unknown given on 12 October 2010; MMR II, strain not specified ; Merck; unknown given on 12 October 2010; FLUMIST (non-gsk) ; Medimmune; intranasal, given on 12 October 2010; VARIVAX (non-gsk) ; Merck; unknown given on 12 October 2010.  There were no concurrent medications.  On 12 October 2010, the subject received unspecified dose of KINRIX (.5 ml, unknown, unknown arm).  On 13 October 2010, 1 day after vaccination with KINRIX, the subject experienced 5 cm x 2 cm swelling at injection site.  The subject required medical attention at the doctor's office.  On 15 October 2010, the event was resolved.
ADMINISTRATION OF EXPIRED  VACCINE TO A PATIENT; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported. On 26-APR-2021, the subject experienced administration of expired vaccine to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to a patient was not reported. This report was non-serious.
Tummy ache followed by vomiting followed by rash all over body. Itchy eyes and ears.
General malaise lead to hoarseness and wheezing on 8/19/13. Developed back pain.
Left thigh- reaction vs cellulitis- swelling about 6 inches x 8 inches- plus erythema.
Patient presented to  Emergency on 8/9/21 ,  Patient states he tested positive 4 days prior to admission, and had been feeling sick for about a week.   we do not have a copy of the lab report, unknown source. patient presents with symptoms of fatigue, body aches, and shortness of breath. no hypoxia
Symptoms started as the severe itching/burning sensation on the hands and feet with red raised skin wheals. Symptoms progressed after one week into daily severe hives and itching on the whole body especially on the upper body part :face ; neck; scalp; Another daily symptoms I experience are angioedema of the  face especially of the  lips and nose as well as throat closing sensation;
Memory problems, some increase in headaches.  Also issues with balance and bumping into walls.  Still to not have smell or taste.   These symptoms have continued for 3 months after vaccine.  Initially after vaccine became acutely ill with high fevers 102-104 f.  Also became severely weak with severe muscle aches and  severe headaches.  This lasted for 7 days with worst at the beginning.  Then I have had the memory loss and equilibrium and loss of ability to spell simples words that I had no issues with before.  I have had these symptoms for 3 months.  I thought it would all get better but it has not.  I thought I better let you know these problems.  I did not want to but because they have continued I thought I better tell you.
She had rashes and hives all over the body for 3 to 4 days. She took some Benadryl and now is all gone.
Crying, tossing & turning. Appeared to be in uncontrolled pain in mom's arms. Breath holding spells last 5-15 seconds. Pale in color. Head cold. Eyes rolling back episode & projectile vomiting.
Pfizer 3/15/21, 4/5/21, 4/6/22 (+) 6/23/22
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced syncope. No treatment information was reported. The outcome of syncope was reported as recovered/resolved with sequelae. Syncope is related to GARDASIL. Additional information is not expected.
Information has been received regarding a case in litigation concerning a female pt who was vaccinated with a dose of MMR II. Subsequently the pt was diagnosed with epilepsy. Upon internal review, epilepsy was determined was to be an other important medical event (OMIC). No further information is available.
SBO (small bowel obstruction). ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
pt to ER w/ c/o rash/swelling both hands & had indicated had immun 23APR98;27APR98 phone call to mom stated pt hands had swelling & described rash as hives;
At 9:45 PM, on 11/03/2021, my hands became very cold and I began to shake uncontrollably. I got in bed and put six layers of blankets over me trying to get warm. This lasted until 12:45 AM on 11/04/2021. On that day, I had to travel out of town. At 2:45PM, I had a relapse that lasted for one and a half hours. At 1AM on 11/05/2021, I broke a sweat that trenched the bed as though I had broken a flu fever. After that, I was fine. Back in March of 2021, I had the same type reaction to my 2nd Medena vaccine, which I filed a report on.
Pt arrived at the pharmacy to receive his first COVID-19 shot. After checking in, technician proceed to administer the shot to patient's left deltoid. During the injection, the syringe broke off or detached from the needle. The vaccine came out of the syringe and splattered onto the administering technician. The technician informed the pharmacy the situation. Pharmacist determined that patient didn't received the full 0.3ml dose of the vaccine, which means the shot he just received is invalid and he needs to get another shot. The pharmacist explained that to patient. Pharmacist also about potential side effects of the vaccine. Patient agreed to have the 2nd shot in the right deltoid. Pharmacist administered the shot to the right arm. Patient was observed for 15 mins and didn't have any symptoms after. Patient was allowed to leave the store.
got covid 3 months after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid 3 months after vaccine) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (got covid 3 months after vaccine). At the time of the report, COVID-19 (got covid 3 months after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-significant follow up received and stated that patient got COVID after 3 months of vaccination
Fever SORE ARM, CHILLS, FATIGUE Narrative:  Other Relevant History:
pt recv vax & w/in several hr post vax exp a severe h/a;h/a was treated w/APAP & resolved in 24hr;