chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9hrs post vaccination pt presented to the ED w/ shakiness, sob, pruritic rash to chest and arms, nausea.  Pt had Moderna  Booster dose  @ 11:45 , an hour after pt started to have a Fever, then chills and now  broke out with diffused rash, also having Nausea. Pt said 1st dose no problem , 2nd dose had all the above symptoms except hives.  12hrs post vaccination Pt then with itchy rash to neck/chest/extremities. No tongue/lip swelling, no sob or wheezing  No chest pain or palpitations + nausea, + vomiting, no diarrhea  Pt given dexamethason 10mg IM x1, Diphenhydramine 25mg PO x2, Zofran 4mg ODT x1 and discharged home. 12/18 Pt re-presents to ED now w/ hives extending all over body.  Reports itchy throat but denies fever, SOB, troubles swallowing.  Also notes that she feels like there is a lump developing on the right side of her neck and that the rash is much worse over her neck.  She denies any lip/face/tongue swelling, wheezing, shortness of breath, nausea, vomiting, diarrhea.  Pt was given methylprednisolone 125mg IV x1, Epi 0.3mg IM x1, famotidine 20mg PO x1 Prednisone 40mg POx1, Cetirizine 10mgx1, calamine lotion and triamcinolone 0.1% ointment.  Pt was admitted for observation. 12/19  Pt developed dizziness and fever to 38.3C She calls a rash as hives but never had wheels.  Rash was always a lacy pattern with extreme itching and burning sensation.  Initially noted it on her arms and spread all over her body now involving her groin, hands and feet on the palmar/plantar aspects.  Her last temperature was 100 °F at home last night.  Had vomiting on 1217 but none since.  Having right-sided neck swelling that is causing some discomfort from outside but denies any shortness of breath or hoarseness of voice or sore throat.  She feels like her fingers and toes are also swollen.  Did not notice any rash or burning sensation in her mouth.  Currently not having any urinary symptoms of burning micturition, frequency. Patient had already noted much improvement in her rash after she got the cocktail in ED. Likely reactive rash to Moderna booster vaccination.  Unlikely DRESS to Bactrim as no indication for such on laboratory evaluation and also timing correlates more with the booster vaccine.  Patient with significant improvement after she received Cetrizine, Pepcid, prednisone and epinephrine in ED.  No concern for mucosal involvement.   Patient had already noted much improvement in her rash after she got the cocktail in ED as mentioned below. Pt discharged w/ the following: calamine-zinc oxide 8-8 % topical susp Apply to affected areas as needed for Other (itching). cetirizine 10 MG tablet Take 1 tablet by mouth daily. famotidine 40 MG tablet Take 1 tablet by mouth daily for 10 days. hydrOXYzine HCL 25 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Itching. predniSONE 20 MG tablet Take 2 tablets by mouth daily for 4 days. triamcinolone 0.1 % ointment Apply to affected areas 2 (two) times daily as needed for Other (itching).
Swollen left deltoid, erythema in area 13x14cm outer deltoid 2 1/2 x 2cm. Right deltoid 21cm, left deltoid 26 cm around.
Patient inadvertently given 0.15 mL dose instead of required/recommended 0.3 mL dose. CDC contacted and advised to have patient return ASAP to receive correct dose. No adverse affects reported per patient. Parent contacted to have patient return for repeat of COVID19 (Pfizer-BioNTech) dose #2.
C/O headache after inj, in front, dizzy, stomach ache. Monitored for approx 20 min. Gave juice and crackers. Stated feeling better. Requested to go back to class. Released with instructions to return if sx increase/change.
Pain in left arm radiating up neck into jaw and temple. Within 10 minutes a very bad headache. Within 1 hour body aches.
Unclassified arrhythmia on mobile app all day on the 24th continues today on and off.  Wore a monitor for 3 days in July.
ON DAY 2 POST PNEUMOVAX VACCINE, A SWOLLEN BULGE AND REDNESS IN AREA ERUPTED AT SITE OF INJECTION. PAIN THROUGH LARGE PART OF UPPER ARM AND UNDERARM. SWOLLEN BULGE CONTINUED TO SPREAD AND MOVE TOWARD INNER ARM WITH A CLEARLY DEFINED MARGIN THAT HAD A BRIGHT RED COLOR AROUND PERIMETER. ENTIRE AREA WARM AND TENDER TO TOUCH. STARTING TO LOOK BETTER ON DAY 3. A "KNOT" NOW APPEARS AND SWELLING NOT MOVING FAR BEYOND BORDER OF PREVIOUS EVENING (WHICH WAS MARKED WITH PEN BY PATIENT BEFORE GOING TO BED).AREA DOES NOT ITCH AND BODY DOES NOT ACHE.  PATIENT SELF TREATED WITH SALON PAS PATCHES TO SWOLLEN AREA AND ORAL IBUPROFEN ON DAYS 1 & 2.
Racing heart.  160 bpm while at rest.  Went to ER.  Happened again on  3/24 and 3/30 took Ativan given to me at ER, which helped.  Had not happened before vaccination.  Palpatations feeling  of skipped heart beats 4/3.  After secon shot on 4/20 had chills night sweats achy muscles headache.  On 4/22 began experiencing extremely stiff sore neck.  Now neck  sore and stiff just on the left side.  Can barely tilt head without pain.
Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with the first dose of rotavirus vaccine live (human-bovine). The physician reported that the patient threw up after the vaccine was administered and the nurse administered a second dose right away. At the time of this report, the outcome was unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician and a healthcare professional concerning a 17-week-old Hispanic female with no medical history who on 22-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #656101/1231F).  There was no illness at the time of vaccination.  At approximately 11:00, immediately after being vaccinated on 22-MAR-2007, the patient threw up/vomited.  The nurse administered a second dose right away.  No laboratory/diagnostic tests were performed.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Excessive vomiting starting about 24 hours after injection lasting around 8 hours. Vomited about 16 times in those 8 hours.
Child received Varivax on 01/30/06 and experienced a febrile seizure on 1/31/06. Child was admitted to the hospital.
Received pediatric Pfizer when they should have received the adult (12+ yo) pfizer dose
This spontaneous report was received from a 80 year old female patient regarding herself. Concurrent conditions included diabetes and high blood pressure. No information about drug reactions and allergies was specified. On an unknown date in 2012 (reported as around two years ago (unspecified date)) the patient was vaccinated with ZOSTAVAX 1 injection. Concomitant therapies included nateglinide. On an unknown date the patient developed a big blister, about as "round as a quarter" which her physician diagnosed as shingles. The reporter says the rash looks as if it is healing; the scabs fall off, then it shows up again. She says the spot is getting smaller now, however, The patient sought medical attention and treatment was given for the event. There was no product quality complaint. The outcome of shingles was reported as recovering. The causality of the event was not specified by the reporter. Additional information has been requested.
fever of 102; sz that lasted 10-15mins wasn't stopped until medicine given; eyes twitched, arms tense & against chest, jerk all over body; sz lasted 10-15mins;
Patient stated she started experiencing vertigo after receiving the vaccine that was so intense that it woke her from sleep.  She stated she required hospitalization for several days.
I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92; I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out; Very agitated; Brain fog; psychotic state; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE,SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out, elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92, very agitated, brain fog and psychotic state all on unspecified dates. Reporter stated "On 16Apr2021, I got the Pfizer shot, 2nd dose, went to the hospital.  Friday afternoon, went to a friends house, I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, I kind of just blacked out, I passed out. I lost it, the ambulance came. My alcohol level was elevated, and the ambulance took me to the hospital, hospital reporting that  I had a high alcohol level content. This has never happened to me before. I could understand if I had had 7 or 8 cocktails." Reporter also stated, "On Wednesday morning I had the vaccine, and Thursday and Friday, had brain fog, very agitated, I was just working on some deals, I couldn't get any thing right, it was strange, never had anything like this before. To have had two glasses of wine and one sip of friends drink, this doesn't make sense. My alcohol level was so elevated 1.92, it was ridiculous, I went into some kind of psychotic state. I can't recall any of it, I'm going by what I've been told. The ambulance gave me an amnesia drug, I'm 64 years old, It was frightening, I am emotional, I want some kind of explanation. I would like to have drank a whole bottle for this to happen, The only thing I think was on Wednesday I had the vaccine." The patient underwent lab tests and procedures which included alcohol test: 1.92 on an unspecified date (My alcohol level was so elevated 1.92, it was ridiculous). Therapeutic measures were taken as a result of I had 2 glasses of wine, had a sip of my friends cocktail and  within half hour of that, i kind of just blacked out, i passed out and elevated alcohol/alcohol level was elevated/alcohol level was so elevated 1.92. Outcome of the events was   Follow-up needed. Information about batch/lot number has been requested.
Reports all over body rash, headaches, muscle cramps. Headaches, muscle cramps developed day after vaccine; rash started 2 days after vaccine.   Took Benadryl rash almost resolved but returns after medication wears off.  2nd dose due May 21
Patient came to pharmacy on 9/11/19 claiming flu shot was given too high on his arm that caused pain to radiate down his arm & up to his neck. He said he had bursitis. Patient was seen at urgent care 9/13/19 and mentioned he is going to orthopedist on 9/16/19
No adverse event; given bivalent booster from a vial punctured >12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster from a vial punctured >12 hours).    No concomitant medications were reported.  Nurse reported that they inadvertently administered the bivalent vaccine from a vial punctured for more than 12 hours. The vial was a 2.5mL vial. It was initially stored in the refrigerator on19-Oct-2022. The vial was first punctured on  20-Oct-2022 between 9-12 noon. The vial was stored in fridge post puncture and it did not undergo any temperature excursions.  No treatment medications were reported.
Pt received Moderna covid vaccine. Vaccine Placed into Left deltoid. During vaccine administration, pulse ox was placed to Pt's right index finger, HR showed 122-156, 98% RA. Pt stated she was nervous and anxious and was noted to be diaphoretic. Pt stated she got the vaccine because her spouse wanted her to.  At approximately 1646 Pt's HR 138. Pt denies chest pain and sob and stated she was feeling anxious because of all the attention she was getting. O2 at 2 lpm placed via nasal cannula.  At 1649 HR 141, O2 at 99% @ 2/LPM.    1653- Pt's HR 120, O2 sat 99% @ 2 lpm. At 1655- HR 126, O2 sat 99% @ 2 lpm.  1700-HR 147,  98% O2 @ 2/LPM. BP 138/89, HR 142 at 1704. BP 137/90 HR 142 at 1710. Pt advised that Paramedics will be called. Pt upset and stated she was fine and declined to have paramedics called. Pt signed AMA at left clinic at 1714 with husband. Advised Pt and spouse to call paramedics if Pt becomes SOB, difficulty breathing and/or having CP. Pt and Spouse verbalized understanding.
pain in arm; I had a deep blue black bruise about the size of a quarter; Inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter). At the time of the report, PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-081474 (Patient Link).
Itchy skin; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy skin) and FATIGUE (Fatigue) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy skin) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Itchy skin) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient states is it Itchy skin and fatigue symptom of booster shot?   Reporter did not allow further contact
Headache, strong dizziness, nausea, vomiting, stomach pain, diarrhea, nasal congestion
Patient received diluent of ROTARIX, but did not receive actual vaccine due to it not being mixes before administration. No negative effects noted or reported. No treatment necessary.
Within 12 hours I developed facial swelling - mostly of the eyes/eyelids that lasted for 3 days.  Within 60 hours I had my first bout of what we now believe is POTS though I did not know it at the time - I experienced a sudden onset of feeling as if I was going to pass out with shortness of breath, weakness, tunnel vision and the need to immediately lay down - I went to bed and when I woke I was weak but better.  At the 72 hour mark I woke with a rash on my left torso - it receded 2 days later. On 8/13/21 I had my major episode of what we believe it POTS.  I was working and it was the first day of my period.  At 10:30am I was standing and quickly realized I was going to pass out if I didn't lay down.  I was able to leave the room I was in, walk about 5 steps and then had to lay down.  I was unable to get up or lift my head for approximately 30 minutes.  I had extreme shortness of breath, was profusely sweating, tunnel vision, was barely able to speak, if I tried to sit up or lift my head I would almost pass out again.  I was experiencing some menstrual cramping that had begun 10 days earlier which was strange for me as I don't get cramps but the pain level was maybe a 4/10 so it didn't seem as if I was passing out from pain but I wasn't sure.  I asked the person with me to get me electrolyte water and advil.  30 min after ingesting I was able to sit up.  I was exhausted after wards and went home.  About 6 hours later I had another bout of feeling like I was going to pass out - took Advil and drank electrolyte water and it abated.  My period was just one day that cycle and was really just clots which is also unusual for me. I reached out to my gynecologist to see if this may be vaccine related and she referred me back to my primary.  Once I spoke with my Dr - he stated he believed it was POTS but to have a wait and see approach to see if it clears on its own.  He suggested daily electrolyte water and salt. Since then, every  cycle I have several bouts of POTS that could begin anywhere from about 9 days prior to my period lasting through cycle day 3.  They can vary on their timing but I have found if I drink electrolyte water daily I can keep them from becoming a full episode.   I also eat Celtic Sea Salt when I become shaky just to try to prevent an episode.
iTCHY RASH RIGHT SIDE OF FACE STARTED ON 8-26-08.  SHOT GIVEN IN LEFT DELTOID ON 8-25-08.  TREATED WITH BENDRYL AND XYZAL.
Nausea, vomiting, diarrhea, muscle aches, joint pain, neck stiffness began 12 hours after HBV #3 injection.  Returned to clinic 24 hours after injection.  Referred for immediate assistance; treated in local ER with fluids and antiemetic IV.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of VARIVAX (lot # N002204 and expiry date 19-JAN-2019) or PROQUAD (lot #N010247 and expiry date 25-SEP-2018) for prophylaxis (strength, dosing details, anatomical location were unknown). The vaccines were reconstituted with sterile diluent (lot number and expiry date unspecified). The vaccines were exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit, for 15 hours. Previous temperature excursion included, exposure to 6 degree Fahrenheit to 14 degree Fahrenheit, for 179 hours. A data logger was involved. No adverse effects reported. No PQC present.
Nausea; Through away; Chills; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Through away), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE (CLARITINE) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced NAUSEA (Nausea), VOMITING (Through away), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever). On 14-Apr-2021, NAUSEA (Nausea), VOMITING (Through away), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up information received contains no new significant information
PT WITH PREVIOUS KNOWN REACTION FROM 1ST DOSE COVID-19 VACCINE. PT CONSULTED WITH HER PHYSICAIN WHO ADVISED TO RECIEVE 2ND DOSE. STAFF AND EMS AWARE OF PT'S HISTORY. PT PRE-MEDICATED WITH 1/2 TABLET OF 25MG OF BENADRYL. PT VACCINATED 20 MINUTES POST ADMINISTRATION OF BENADRYL. DIZZINESS/SOB REPORTED BY PT 30 MINUTES POST VACCINE. EMS EVALUATED PATIENT. VITALS TAKEN. PATIENT OFFERED SUPPLEMENTAL OXYGEN FOR EASE OF BREATHING. 2L NC GIVEN. PT COMPLAINTS OF CHILLS, HEADACHE, CONTINUED SOB, SORE THROAT. OXYGEN INCREASED UP TO 6L NC. DISCUSSED PT BEING TRANSPORTED FOR EVALUATION. LUNGS CLEAR. PT STATED FEELING BETTER. OXYGEN DECREASED DOWN TO 4L NC. PT OBSERVED FOR 2 HOURS POST VACCINATION.
I had really bad nausea, dry cough, body aches, and a headache. I did not have a fever. A couple days later I went to urgent care, and I was prescribed a Z-Pak, Steroids, cough syrup, and Tylenol for pain. They also did a COVID-19 test that came back positive. They advised I drink fluids and get rest.  A few days later I started to feel better, but my cough lingered. A couple days later all of my symptoms came back, and my cough got worse.  My doctor called to follow up with me and they prescribed another cough syrup. I am still experiencing a cough.
Patient reported to pharmacy the day after receiving vaccination and stated that the skin near/around injection site is red, swollen, and warm to the touch. Upon inspection of left upper arm, this was confirmed. The patient then returned the following day (two days after the vaccination) and stated that it is still red. The size of the irritation appeared the same. However, the patient stated that it was no longer warm to the touch and hurt less. She had been taking Benadryl and icing the location over the past 2 days and stated there was some relief.
pt recv vax 10FEB97;w/in 1wk exp muscle aches & scratchy throat;the outcome is reported as unk;
5 days after vaccination developed bilateral hand weakness. Next day bilateral facial weakness.  Subsequent days weakness worsened and spread to shoulders, arms, upper legs.  Plateaued after about 7 days then began to improve around day 10, symptoms continue to resolve.
Fever over 101° for 3 days, extreme body aches, chills, horrible headache, foggy feeling, congestion and I developed a cough