chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1740: Patient received the first dose of the Pfizer vaccine Lot #EW0168 at approximately 1725. At 1740 pt states "my throat and tongue feel weird. Its hard to swallow and my tongue feels bigger than it normally is". Pt taken to the observation area to lay down.    Pt has previous history of severe allergic reaction to flu vaccine that required epinephrine and admission to the emergency room. Allergic reaction symptoms for flu vaccine were throat tightening and tongue swelling.    Vital signs at 1742 BP: 150/103  HR: 121 SPO2: 100% RA RR: 22 Temp: 99.6 F Pain: 0/10   Doctor called in the emergency department and explained patients symptoms. Doctor advised to call 911.    Vital signs at 1748 BP: 145/94  HR: 121 SPO2: 100% RA RR: 24 Pain: 0/10   1755 911 called and advised to administer patients own epinephrine.  Pt's own epinephrine administered IM into left vastus lateralis.    Vital signs at 1755 BP: 152/90  HR: 115 SPO2: 100% RA RR: 24 Pain: 0/10   1758 Paramedics arrived and patient was taken to the emergency room.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that a patient received two doses of GARDASIL (each dose administered on a separate unspecified date) in "2013". The medical assistant stated that the patient received a third dose "to complete the HPV series"  today, 01-AUG-2016, in which GARDASIL 9 was administered to the patient. No adverse effect reported. The outcome of the events was unknown. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Had vaccine at 310p on 1/26/21. On 1/28/21 around 9p, noticed a red rash/welt on left upper arm near injection site. Warm to touch, not itchy. Unchanged in 12 hours. Some tenderness in left axilla.
Sluggish; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish) and FATIGUE (Tired). At the time of the report, SLUGGISHNESS (Sluggish) and FATIGUE (Tired) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-353257 (Patient Link).
Had extreme burning at time of flu shot. Then could not move arm without pain for 6 hrs. Its been a month and Im still in pain and can not lift arm.
Injection site became itchy 7 days after first dose of the COVID 19 Moderna vaccine. Looking at the site, it's slightly pink. Unsure if it's because of initial scratching or a separate color change in the area.
Had shot at about 2 pm on 8/11. 12:45 am on 8/12 woke up with arm throbbing. 8/13 developed hives and red rash on torso.
TOOK TWO UNREFRIGERATED DOSES; A spontaneous case report was received from a pharmacist on 06-Sep-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201909-000723 (PVX2019-2277; husband) and PVX201909-000724 (PVX2019-2278; wife) were created and cross-linked in the database.  This spontaneous case (PVX2019-2278) described a female consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif, which were unrefrigerated for 2 weeks.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable. US-PaxVax Berna GmbH-PVX201909-000723:
Pain in arm Exhausted slept 18 hours Chills 15 hours Headache
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired vaccine used) in a 77-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 021B21A) for COVID-19 immunization. No medical history reported. On Nov 4, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On Nov 4, 2021, patient administered expired product (expired vaccine used). On Nov 4, 2021, administered expired product (expired vaccine used)resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Injection was painful - arm numb and tingled to fingers.      10:45b/p 116/62 pulse68 respirations 16  Normal movement,color and temperature in fingers. Capillary refill <3 seconds.  Client refused further medical treatment.
vertigo is debilitating. Caller wanted to know if there have been reports of vertigo; he could not drive. Caller stated he was ok when laying on the couch but when he got up he could not walk without falling down; vertigo is debilitating. Caller wanted to know if there have been reports of vertigo/Vertigo; staggering and unable to walk on his own without someone helping him; complain of being dizzy/slight dizziness/dizziness; This is a spontaneous report from a contactable consumer (wife) on behalf of a 77 years-old male patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm Left on 3Mar2021 at single dose for COVID-19 immunization. The patient medical history included ongoing Peritoneal dialysis from 2018, ongoing Heart bypass from Jan2019. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17mar2021 or 18Mar2021, the patient complained of being dizzy. By 20Mar2021 he was staggering and unable to walk on his own without someone helping him and ongoing vertigo from 20Mar 2021 and reported as vertigo worsened. By 21Mar2021 he could not drive. The patient was ok when laying on the couch but when he got up he could not walk without falling down. The patient had extreme vertigo that started about 2 weeks after the vaccine and is debilitating. The patient is just under 6 feet, he shrunk a little. The events dizziness resulted in hospitalization from an unspecified date. The event vertigo resulted in ER visit and hospitalized from 22Mar2021 to 28Mar2021. The lab test included CT scan and MRI, results: negative; He also had lab tests, but nothing showed a reason why he has the vertigo. No further details provided about lab work. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected
whelps on 1 arm & both legs 1hr p/vax;mom tx w/DPh & cortisone cream;c/o h/a & redness & soreness @ site of inj
Within a couple minutes of admin, she verbalized she felt faint, slumped and hit head against exam table mirror, became pale, clonic arm movements x 4 per mom. Administered O2, elevated feet gave water, pretzels. Hypotensive in ER where she was sent with 1 hour in office.
After the 1st dose of the vaccine I had a swollen, painful, itchy, red rash appear at the injection site 5 days after vaccination. The rash persisted for 3-4 days before disappearing.  The rash reappeared immediately after the administration of the 2nd dose of the vaccine. I became flushed and dizzy during observation and was kept for a longer observation period. My vitals were normal and I was cleared by a nurse after drinking some water and apple juice. The rash has persisted and is about 4 inches in diameter at this time and remains painful and swollen.
6X6 CM AREA OF LOCAL REDNESS AND TENDERNESS AT VACCINE SITE
Fever; headache; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (reported for her daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced fever and headache. Therapeutic measures were taken as a result of events included treatment with Tylenol. The second dose was scheduled on 01Jun2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After speaking with doctor, patient had no history of pneumonia vaccination. After we gave patient PREVNAR 13, doctor discovered he already had PREVNAR shot on 10/9/15 but doctor's computer system did not provide proper info.
Lot of side effects that lasted a long time after the 1st two Moderna vaccines.; Swelling at the site of injection (Left Arm); Nausea; fatigue that lasted for 4-weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (Swelling at the site of injection (Left Arm)), NAUSEA (Nausea) and FATIGUE (fatigue that lasted for 4-weeks) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-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 VACCINATION COMPLICATION (Lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (Swelling at the site of injection (Left Arm)), NAUSEA (Nausea) and FATIGUE (fatigue that lasted for 4-weeks). In February 2021, FATIGUE (fatigue that lasted for 4-weeks) had resolved. At the time of the report, VACCINATION COMPLICATION (Lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (Swelling at the site of injection (Left Arm)) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-418071 (Patient Link).
Clinic was serving patients and their was a gift card incentive. Patient was screened and he stated that he was eligible based on the last date of his covid vaccination. After patient received vaccine, found out patient received a bivalent booster on 11/1.
In the midst of sexual intercourse as he was about to climax he started bleeding from the private area. Went to ER and got blood work done and everything came back good.  A few weeks later he was masterbating and he nothing but blood that came out. Nothing in his urine. He started reading where men was having the same problems after taking the vaccine.
Complained of tight feeling in chest, sore neck, coughing, wheezing. Injection site right arm red, swollen, tender. Afebrile, heat rash. Rash on Right arm spreading to chest. Recently diagnosed with immune deficiency. Slight wheezing noted.
Pt received Flu vaccine lot UI625AA on 8/29/16. Within 24 hrs developed severe headache within 48 hr developed mental "fogginess", poor Focus/concentration, ear difficulty. Required 2 office visits. CBC WNL, EBV titers Negative. Parent requested reporting due to persistence of sx to present.
Felt like a cold for exactly 12 hours. I slept for 11 of them. Fever, chills, body aches.
I got a menstrual period 2 days after 2nd Pfizer dose. It had been 8 months since last period.; This is a spontaneous report from a non-contactable consumer.  A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0153),  via an unspecified route of administration, in Arm Left on 12Apr2021 10:15  (at the age of 50-year-old ) as single dose for covid-19 immunisation.  The patient had received the first dose of bnt162b2 (lot number  EP7534) on 22Mar2021 at 10:15 AM in Left arm. The patient was not pregnant. No other vaccine was received in four weeks. The patient had not Covid prior vaccination. Medical history included Major depressive disorder. Other medications in two weeks included anti depressants. No known allergies. The patient had a negative Covid Nasal Swab test on 13Apr2021. The patient reported to get a menstrual period 2 days after 2nd dose of Pfizer vaccine on 14Apr2021. It had been 8 months since last period. No treatment was received. She was not Covid tested post vaccination. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Approximately 5 minutes after shot was administered into my left upper arm, as I sat down to wait my 15 minutes as required, I started to feel a racing heart, lightheaded, shaky, nauseous and strange sensation in my body.  I was with my mother and my husband.  My husband noticed I was struggling and called over the paramedic on staff.  He came over and asked me questions, as to what I was feeling, he brought over a bottle water and asked if I wanted some Cola for the nausea, apparently it helps with nausea.  At first I didn't want it, then  I ended up taking a few sips.  The entire episode lasted approximately 30-35 minutes, and I felt my heartrate returning to normal, however, I continued to feel out of sorts, shaky.  Upon returning home, the entire evening of the day in question, I felt a heaviness in my head, ache over my eyes, then my body continued to feel strange, I was very tired, and of course, my arm began aching, I barely slept through the night, feeling strange sensations in my body, aching arm, and headache, nauseated.  I had taken Tylenol  after getting home from the vaccine shot.  I finally got what I remember, maybe 2 hours of sleep, waking up to go to the bathroom, and my legs felt like cement! I could barely walk! Pain was radiating up the back of my legs, thighs, and buttocks.  I held myself along the wall to the bathroom and could barely bend.  After using the bathroom, I once again felt a tremendous heaviness, cement-like legs, barely making it back to the bed.  Throughout the entire day I could barely walk, severe muscle spasms lower back, thighs stiffness, down the back of legs, severe pain.  I contacted my doctor, told him of what was happening and he stated not to go back for the 2nd shot due to my issues with the 1st.  This has been ongoing since April 28, 2021, today is May 24, 2021 almost one month later and I am no better.  Although I have had Fibromyalgia for several years and Chronic Fatigue Syndrome, since the vaccine, it has triggered a complete relapse of my condition, making it unbearable, painful.  I have been living on pain meds, and icing/heating on and off.  Now requiring physical therapy.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, 9 improperly stored doses of RECOMBIVAX HB, injection, lot # K020216 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not provided) and 17 improperly stored doses of RECOMBIVAX HB, injection, lot # K021444 and expiration date 17-SEP-2016 (dose, route of administration and anatomical location were not provided) were administered to an unspecified number of patients. There were no concomitant therapies reported. No adverse experiences were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
headache, diarrhea, nausea, aches and pains, fatigue ,   high blood pressure, chest pains requiring nitro.
Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right arm pain where I received the injection.  That evening/night the symptoms progressed to headache and severe chills through the night.
Ringing of ears (tinnitus) starting hours after vaccination and continuing into day 3 after vaccination
VERY NEXT DAY AFTER RECIEVING 2ND DOSE OF PFIZER COVID-19 VACCINE, I NOTICED MYSELF RUNNING TO THE BATHROOM TO PEE ALOT.  NOW A WEEK AND ONE DAY LATER, I HAVE MADE A TRIP TO THE LOCAL ER, PCP AND UROLOGIST.  BEFORE THE SECOND DOSE OF VACCINE, MY BASELINE URINATION PATTERN WAS 4 TO 5 TIMES DURING THE DAY.  NOW IT IS UP TO 13 TIMES A DAY.  AT ONE POINT I WAS GOING TO THE BATHROOM EVERY HOUR TO HOUR AND A HALF.  THIS MOST CERTAINLY IS RELATED OR CAUSED BY THE VACCINE.  YES, I AM 50 YEARS OLD.  HOWEVER, THERE WERE NO SIGNS OF ANYTHING BEING WRONG WITH MY BLADDER.  THIS IS NOT A COINCIDENCE, BUT AN ADVERSE REACTION.  PLEASE REPORT THIS SO THAT OTHER PEOPLE WILL BE AWARE OF THIS PROBLEM.  THIS CAN BE DEBILITATING.
Patient received a second dose Pfizer on 04/30/21   First dose was a Moderna
Fatigue, 8 hours after shot, no treatment Fever, chills, headache, body aches, arm pain;12 hours  after shot and lasting about 16 hours ; Advil Edema and redness at injection site covering half of upper arm, ongoing, Benadryl per doctor
Beginning 08:00 4/28 I began experiencing body aches and fever. When I checked my temperature at 18:00 4/28, it was 102.5. I had chills and body aches until around 03:00 4/29. Feeling good now.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021 at 9:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 19-Aug-2021 at 9:35 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
As soon as I woke up I felt very dizzy almost passed out. Called 911 when I went to hospital my blood pressure was high. First time I saw high blood pressure. Always perfect at doctor visits. I was told Potassium was low, Never happened before. few weeks later same happened and drove to hospital. again high blood pressure. I followed up with my doctor. Gave me medicine for high blood pressure and dizziness. **Most importantly he told me I have irregular heart beat. ** All my life I exercised , never had this issue. There is nothing in my life to think why this happened.
Patient woke up the morning of 2/19/09 to find she had alot of itching on her left hip and discovered 5 raised spots. This was the same side she had Shingles on July of last year.  No treatment at this reporting time.  Patient said she would be getting a Dr. appointment.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-OCT-2018 the patient was administered an improperly stored dose of PROQUAD therapy type: recombinant Human albumin (rHA) (lot # N023968 and expiration date 28-FEB-2019, route, strength and frequency were not reported) with properly stored Merck Sterile Diluent for prophylaxis. The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 days and -9 degrees Celsius to 8 degrees Celsius for 3 days. There were no previous excursions reported. The call was not because of a data logger. No adverse effect was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA004588; US-009507513-1810USA006947.
Beginning on 2nd day after 2nd vaccination (on 2/13/21), I experienced swelling in my upper right gum area.  I presumed it was a tooth abscess.  Swelling significantly increased over next two days.  Finally had dental appointment on Monday, 2/15/21.  Dentist determined it was probably NOT an abscess.  He sent me to ER for an antibiotic IV drip.  After labs and CT scan of my head I was diagnosed with cellulitis.  I had an IV drip of antibiotic clindamycin for 4 hours and was sent home with 7 day prescription of oral clindamycin and 3 day presciption of ibuprofen.  Over next two days (2/16-2/17) face swelling diminishedas of today (2/19) it's not completely gone.
Rash, vomiting, dizzy, headache, nausea, light-headed.
Pt developed redness, swelling of right arm from deltoid muscle down to wrist involving all but inner aspect of upper arm. Fluid accumulation around elbow and discomfort on moving started evening after shot lasted 3-4 days. Advised elevation, ice, Advil.
big sore neck; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "big sore neck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I saw patient today and she is having some symptoms consistent with shingles or herpetic attack but the eye itself is quiet.
His arm (from elbow to fingers) started tingling 15 min post receiving first dose of pfizer vaccine. Lasted 10 min then it went away. Patient left after 30 min total of observation
received phone call that infant had expired.  2/5/08 Reviewed Autopsy Report & death certificate which accompanied autopsy report which states COD consistent w/Sudden Infant Death Syndrome (Group B) in co-sleeping infant.  Findings included: sudden death in 2 mo old co-sleeping infant; hx of parental drug abuse (opiates per parents); post mortem tox exam neg for drugs or alcohol; hx of preemie, 36 wk, 5 lbs, 4 oz.