chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L018351, expiry date 11-AUG-2017 and lot # L020015, expiry date 16-AUG-2017 (route and site of administration were not reported). The vaccines were exposed to temperature of 33.8 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of two reports received from the same source. Additional information has been requested.
Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high; Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and Coronavac. Past adverse reactions to the above products included No adverse event with Coronavac and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me). At the time of the report, DISCOMFORT (Discomfort was due to a vaccine which was so high/discomfort caused by a vaccine is so high), TREMOR (Tremors caused by the fever/had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) and PYREXIA (Terrible fever/ had terrible fever, to the point that it was difficult for me to keep calm with the tremors that the fever gave me) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to MOD-2023-726767 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2023: Live Follow up received historical vaccine updated.
Patient experienced significant swelling around injection site. Saw MD on 11/15/16 and was treated for cellulitis MD believed related to vaccine administration.
progressively got worse over the next day; feeling bad; heart rate that hit 175; My oxygen saturation was 90-91%; spasms; body aches / sore; diarrhea; fever; muscle pain; headache; severe chills; tired / exhausted; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiration Date: 31May2021), via an unspecified route of administration on 03Feb2021 as 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient started feeling bad on 04Feb2021 and progressively got worse over the next day. The patient had severe diarrhea, fever of 102.8, heartrate that hit 175 at one point and then settle down to 130's for 16 hours. The patient had severe muscle pain with spasm, headache and body aches along with severe chills. The oxygen saturation was 90-91% during that time. The patient was a registered nurse and did not go to the ER but the patient would admit it was a frightening 48 hours. The patient was left so tired, sore and exhausted. Needless to say the patient would not be taking the second vaccine and would truly be scared for the life if things were to be any worse than the first one. The outcome of all the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event : heart rate increased and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as  part of Pfizer procedures for safety evaluation, including the review and analysis of  aggregate data for adverse events. Any safety concern identified as part of this review,  as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like coming down with the flu) 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 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like coming down with the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like coming down with the flu) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
He got his vaccine, was doing OK, and within 4-5 months he started to have imbalance issues and dizziness.  After that he started out with very slightly and steadily getting worse every day with the dizziness, tinnitus in his ears.  He does not feel right after getting in and driving his car with the imbalance, tinnitus and occasional unexplained sweating.  He has been to the doctor, has had lots of blood work, EEG's, ER visits.  No one has been able to pinpoint what this is.  He has spoken to quite a few other people who are experiencing the same symptoms with the off-balance issues and the tinnitus.  His doctor prescribed some medication for dizziness, Meclizine which did not help.  He is very dizzy right now and it's to the point that he is still dizzy.   He is scheduled to see an ENT on 9/21/22.    The symptoms he is experiencing are getting worse every day and worries that this may get to the point that he will not be able to drive or work.  He is very susceptible to being on the water or heights, which make him extremely worse as far as dizziness, magnified symptoms.  He has not had this happen prior to the vaccine. His nerves are now on edge to the point that he jumps when the phone rings, and becoming light sensitive to car headlights, etc.
Patient received 2 vaccines. Nurse left room and 5 mins later heard loud noise. Nurse returned to room and found pt on floor, eyes open. Pt stiff not flaccid. Pt had mild tremoring in her extremities. Pt monitored for 20 min. Rechecked BP 110/60, tremor had resolved. Pt was A-Ox 3, EDMI, PERRLA. Pt advised to contact office with any problems.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 16-DEC-2015, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
pt c/o subjective dizziness and HA 8/10. pt speech clear, MAE well, grips equal. pt denies sob/cp/itching/rash,. Pt tolerating po well. pt provided wet washcloth for forehead and juice and crackers. Lung sounds CTA. HRR, s1 and s2 crisp and regular. Initial BP 163/82, HR 105, oxygen sat 98%.Pt observed from 1447-1620.  HA improved to 4-5/10 upon discharge. pt was alert and oriented, no cp, no sob, no n/v/d. pt wheeled to spouse's car by transportation.
My son was getting ready to shower and felt something weird. Showed me the mass on his left clavicle. No fever, no diversion from normal life schedule.
no reactions after first dose except slight local pain at injection site. for second dose, 24 hours post dose (approximately noon April 1st), started feeling run down. At 30 hours post dose (approx. 6pm April 1st) had slight elevated fever. Took tylenol, went to sleep, slept fine, woke up next day with no fever, except mild-to-severe tinnitus now present (morning of April 2nd). Tinnitus has not improved at all in over one month. Hearing acuity also seems to be impacted.
CDC called us from our safe and said to report the following: 104.6 degree fever for 28 hours, 101.3 for next 24, fever resolved by 72 hours. Felt like leg bones were breaking from the inside. Also, difficulty taking deep breath, would cause cough. Cough and inability to take a deep breath lasted for 9 days. No other signs or symptoms of illness, but we did a covid test in case he was exposed at the vaccine site, negative.
Patient felt light headed and started "seeing Spots". Patient reported extreme fatigue to observation RN in Observation area at 1045 am.   RN elevated patient legs, gave juice, crackers, and water. After 30 min of observation and interventions, patient was still very fatigued and dizzy and was sent to the ED for follow-up
Covid breakthrough. I started with a low grade fever. They were cold like symptoms. I was very exhausted. I was prescribed Paxlovid for treatment. When I showered my skin was ultrasensitive, which is consistent with my normal flu like symptoms.
This spontaneous report was received from a consumer's daughter, regarding to her mother, an 84 year old female patient with hypertension, a little arthritis and allergy to propylene glycol. On an unknown date approximately in 2012 report as "over a year ago" the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (1 shot, dose and route not reported). No other suspect therapies were reported, concomitant medications included an unspecified blood pressure pill. Approximately on 26-JUL-2012, reported as "13 months ago" after receiving ZOSTAVAX, the patient started itching and then developed a bright red rash all over her body. The patient had been to an allergist, a dermatologist and her regular physician regarding this issue. The allergist stated that the patient was allergic to propylene glycol, and her adverse reaction seemed be triggered by unspecified foods as well. This is because the patient's adverse reactions seem to become better, but then it flared up again. The outcome for itching and bright red rash all over her body was unknown at the time of the report. Treatment with BENADRYL, ZYRTEC, and CLARITIN was given to the patient. Unspecified allergy tests were taken (results not reported). Additional information is not expected.
AWOKE UP FROM SLEEP AT ABOUT 2:30AM FEELING FATIGUED,  ACHES AND PAINS THROUGHOUT BODY,  HEADACHE, WEAKNESS AND DIFFICULTY STANDING TO GET TO THE BATHROOM. SAT TO URINATE AND MY EARS STARTING RINGING VERY LOUDLY AND FELT VERY NAUSEOUS, THE ROOM STARTED SPINNING AND FELT VERY DIZZY AND LIGHTHEADED.  I STOOD TO WASH MY HANDS AND EXPERIENCED EXTREME VERTIGO AT THAT POINT COULDN'T RETURN TO MY BEDROOM SAFELY SO I HAD TO LAY ON THE BATHROOM FLOOR FOR FEAR I WOULD FALL AND GET HURT.  STRUGGLED TO VOCALIZE AND CRY OUT FOR MY HUSBAND TO COME HELP ME.  I COULDN'T GET UP FOR ABOUT 15 MINUTES- ONCE UPRIGHT WAS EXTREMELY PAINFUL AND ACHY.  TOOK A WARM SHOWER TO RELAX MY MUSCLES THEN GOT BACK TO BED.  ABOUT AN HOUR LATER WOKE WITH ALTERNATING CHILLS AND SWEATS.   AFTER I AWOKE IN THE MORNING AFTER THE VERTIGO PORTION OF THE EPISODE I HAD BODY ACHES AND HEADACHE FOR ANOTHER 24 HOURS.  I ROTATED TAKING TYLENOL AND IBUPROFEN THROUGHOUT THAT PERIOD IN ORDER TO REST.  FROM THE START OF THE EPISODE UNTIL I WAS BACK TO NORMAL WASA TOTAL OF ABOUT 36 HOURS.
10 days after 1 year old vaccine. Parents noted pt with rash, itchy, macular papular rash on abd, back, neck and arms.Within first 24 hours.  4 days prior pt had fever Tm 101 approximately 24 hours. MMR given (another physician office).
t105 evening following DTP inject 3MAR92 mom gave APAP cont w/t100-101 x 5-6 days following; also fussy during 5 days following DTP & flushed as well; high pitched crying, locally had knot on lt thigh that dec in size 3 wks following vax;
Woke up with a rash all over her body, both thighs/rash all over her skin/the rash is all over her legs, both legs, especially on the thigh area between knee and hip, a little bit below the knee; soreness at injection site; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 17:45 (at the age of 52 year) as dose 1, single for COVID-19 immunisation. Medical history and family medical history reported none. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient's concomitant medications were not reported. On 15Apr2021, patient stated this morning she woke up with a rash, states maybe a flea got into her pajamas and bit her all over her body or was wondering if this was a reaction. Consumer stated the rash was all over her legs, both legs, especially on the thigh area between knee and hip, a little bit below the knee, there was some on her breast, some on left elbow, nothing at the vaccination site. Also stated that she concerned that the rash was all over her skin and thought that maybe her dogs could have given her fleas. Stated that she rubbed some Caladryl and the rash seems to be going away. On 14Apr2021, patient stated that she has a little soreness at the injection site, in the left arm, has been taking Tylenol for that soreness. Treated the rash with Zyrtec, rubbed Caladryl clear topical. Patient did not visit Emergency Room and Physician Office. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning an 81 year old female patient. The patient's concurrent conditions included hypertension, high cholesterol and diabetes. She had no drug reactions or allergies. No pertinent medical history was reported. Concomitant therapies included unspecified high blood pressure medicines, unspecified diabetes medicines and unspecified high cholesterol medicines. On 11-OCT-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (lot # M026317 with an expiration date of 11-JAN-2018) (dose, route and anatomical location of administration were not reported). On an unspecified date in 2016, after receiving PNEUMOVAX 23, the patient experienced redness and swelling around the injection site and was diagnosed with cellulitis. The patient sought medical attention by visiting the physician's office and she was treated with an unspecified antibiotic. No laboratory studies were performed nor product quality complaint was involved. On unknown date in 2016, the patient recovered from the cellulitis (redness and swelling at the injection site). The relatedness between the event and therapy with PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was determined to be a medically significant event. This is one of several reports received from the same reporter. Follow up information has been received from the reporting registered nurse on 20-DEC-2016. The report referred to a female patient. On 11-OCT-2016 at 11:31, she was vaccinated with PNEUMOVAX 23, intramuscularly, in right deltoid. On 13-OCT-2016 at 11:30, she was diagnosed with cellulitis of the right arm (injection site cellulitis). She was treated with KEFLEX, 500 mg three times a day for 10 days. She was also advised she could take BENADRYL 25 mg. The patient recovered on 23-OCT-2016. Additional information is not expected as all scheduled correspondence has been received. This is a downgraded report. The event of cellulitis was changed to injection site cellulitis and therefore is not considered as medically significant event. Sender's Comments: US-009507513-1611USA007073: US-009507513-1611USA007077: US-009507513-1611USA007096: US-009507513-1611USA007131: MERCK 1611USA007088:Mfr number.
right arm pain/ numbness; Numbness; Breast pain; Tingling in toes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain), PAIN IN EXTREMITY (right arm pain/ numbness), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling in toes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN (ZITHROMAX) for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PARAESTHESIA (Tingling in toes). On 14-Feb-2021, the patient experienced BREAST PAIN (Breast pain). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm pain/ numbness) and HYPOAESTHESIA (Numbness). At the time of the report, BREAST PAIN (Breast pain), PAIN IN EXTREMITY (right arm pain/ numbness), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling in toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: patient reported persistent pain in the arm and tingling in the toes since 07, FEB 2021.
onset of fevers/chill 24-48 hours after 2nd vaccine, then 8-9 days of intermittent vertigo symptoms, mild headache. Suspect BPPV though pt believes is due to vaccine.
MODERNA COVID-19 EUA: Patient did not have her COVID-19 vaccine card when she presented for a booster dose appointment. Available immunization history revealed only 1 dose had been given. She was given Moderna 0.5mL IM x 1  as a second dose. Afterward, the patient was able to produce confirmation of a previous second dose.
Pain; Redness; Swelling; Muscle aches; Fatigue; Headache; Shivering; Little stomach upset; Sweating profusely at night; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating. In October 2020, the outcome of the pain, erythema, swelling, muscle pain, fatigue, headache, shivering and upset stomach were recovered/resolved. On an unknown date, the outcome of the excess sweating was not recovered/not resolved.   It was unknown if the reporter considered the pain, erythema, swelling, muscle pain, fatigue, headache, shivering, upset stomach and excess sweating to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Wednesday, the patient received Shingrix on right arm. The patient experienced pain, redness, swelling, muscle aches, fatigue, headache, shivering and a little stomach upset. The patient also experienced sweating profusely at night which continues at the time of reporting. The reporter did not consent to follow-up. The reporter did not give permission to contact.
COUGHING; DULL CHEST PAIN; TINGLING IN ARMS DURING THE NIGHT MORNING; WAKE UP IN THE NIGHT IN PAIN; CANNOT USE ARMS; PAIN IN UPPER ARM TOWARD NECK, UPPER LEGS AND FINGERS; WEAKNESS IN ARMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, dull chest pain, tingling in arms during the night morning, wake up in the night in pain, cannot use arms, pain in upper arm toward neck, upper legs and fingers, and weakness in arms. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in arms during the night morning, had not recovered from pain in upper arm toward neck, upper legs and fingers, and coughing, and the outcome of dull chest pain, weakness in arms, wake up in the night in pain and cannot use arms was not reported. This report was non-serious.