chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient pre-medicated with diphenhydramine, albuterol, Claritin, and singulair.  After roughly 10 minutes after administration the patient reported tingling  in her lips and "felt like she needed to use her inhaler".  Our administration station is in our front lobby, when the patient reported her side effect she was taken to the Emergency department for observation.  The patient was hooked up to the monitor and a set of vitals were taken.  On arrvial she was tachy in the 100's wtih a BP of 140-90.  On the repeat vitals in 15 minutes she was within normal limits.    The patient was treated with Diphenhydramine 12.5 mg PO and Albuterol 2 puffs via spacer.  The patient was observed for ~3 hours, the patient had mild angioedema and a numb tongue/lips.  After resolution symptoms the patient was discharged from ED.
Fever, chills, nausea, headache, neck and back pain, muscle aches.
Breakthrough Covid-19 Hospitalization: A 63-year-old FEMALE presents to Emergency Room on 12/02/21 11:07 with Chief Complaint: sob, + c.         Active Inpatient Medications                           Status   1)   ACETAMINOPHEN TAB  2 TABLETS PO Q6H PRN FOR MILD PAIN  ACTIVE          OR FEVER. ALTERNATE WITH IBUPROFEN IF USED FOR          FEVER (max 4,000mg APAP/24hrs from all sources)   2)   ALBUTEROL HFA INHL,ORAL  2 PUFFS PO Q4H PRN for        ACTIVE          dyspnea or wheezing (use with spacer)   3)   ASPIRIN TAB,EC  81MG PO DAILY                          ACTIVE   4)   BARICITINIB TAB  2MG PO DAILY                          ACTIVE   5)   BENZONATATE CAP,ORAL  100MG PO Q8H PRN FOR DRY COUGH   ACTIVE   6)   ELECTROLYTE POWDER,ORAL  1 PACKET IN 1 QUART OF WATER  ACTIVE          AND DRINK PO BID PRN FOR DIARRHEA   7)   ENOXAPARIN INJ  40MG/0.4ML SQ Q24H                     ACTIVE   8)   FAMOTIDINE TAB  20MG PO HS                             ACTIVE   9)   IBUPROFEN 400MG UD TAB  400MG PO Q6H PRN FOR MODERATE  ACTIVE          PAIN OR FEVER. ALTERNATE WITH APAP IF USED FOR          FEVER   10)  MOMETASONE FUROATE 220MCG INHL,ORAL  1 INHALATION      ACTIVE          INHL ORAL DAILY   11)  MONTELUKAST TAB  10MG PO DAILY                         ACTIVE   12)  ONDANSETRON TAB,ORAL DISINTEGRATING  4MG ODT BID PRN   ACTIVE          PRN FNV   13)  REMDESIVIR INJ REMDESIVIR 100 MG in SODIUM CHLORIDE    ACTIVE          0.9% 100 ML  INFUSE OVER 30 Minutes IVPB Q24H   14)  diphenhydrAMINE CAP,ORAL  25MG PO Q6H PRN FOR          ACTIVE          COUGH/INSOMNIA/RASH/ITCHING   15)  guaiFENesin TAB  ONE (1) TABLET PO Q4H PRN FOR WET     ACTIVE          COUGH  Patient is being discharged from HOSPITAL to Family  Care Unit today DEC 06, 2021.
site of monkeypox vaccine was red for two weeks following the injection and is currently black, with a green line (most likely a vein) seeming to run through it. no pain but somewhat discomforting
R upper arm - erythematous,warm, edematous 15x20 cm area non tender began within 24' of imm, progressed at 48 hours after immunization. tx'd w/omnicef, Benadryl, F/U - much better within 24 hours.
patient experienced sore throat, fatigue, cough, phlegm.  those symptoms persisted for 5 days when the patient called us. I advised the patient to seek medical attention from his primary care provider.
6 month old child accidently given GARDASIL vaccine by medication assistant. No adverse reactions noted other than localized redness. Child observed for 15 minutes. No additional reactions to medication.
In addition to pain and swelling at the injection side (upper left arm), pain experienced in the under arm and arm pit of left arm.
Had seasonal flu shot in 9/25/09 - woke up next morning feeling bad + very dizzy. This lasted until about 2pm then went away.
mom phoned 23JUN94 AM state pt in hosp adm thru ER w/szs; phoned mom @ hosp 23JUN94 who state pt recvd APAP til 22JUN94 12PM sitter didn't give APAP @ 4PM or anytime p/last dose; pt had EEG 23JUN94 results pending; dx febrile seizure-t103.2
Narrative: Symptoms:  & FATIGUE AND SORENESS AT INJECTION SIRE Treatment:
Headache/High Blood Pressure.  186/101.  May not be connected but mine is never high.  I also couldn't sleep after injection, so maybe the excitement of getting the shot.  Blood pressure progressively  went down to normal with no treatment, in 1-2 days.
Just recently started to feel aches in my left arm near or at the injection site where I have received all my COVID-19 vaccinations.  My 3rd vaccination is my booster that I received at the Pharmacy Store (There was no option on the first page under Item 4 to list that I received my booster).  I also received my flu shot (quadrivalent Lot# FD723) on 9/24/2021 from the same pharmacy in the same route and sites as my COVID-19 vaccinations.
my period became very heavy and painful after I completed my vaccination; my period became very heavy and painful after I completed my vaccination; became less predictable; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), via an unspecified route of administration on 07May2021 (at the age of 31-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination and no known allergy. Patient medical history and concomitant medications were not reported. The patient stated that on unspecified date May2021 my period became very heavy and painful after I completed my vaccination. And overall cycle that has always been regular became less predictable. Since it's only been under 2 months since I completed my second shot. Prior to vaccination, the patient did not diagnose with COVID-19, since the vaccination, the patient not been tested for COVID-19. The patient did not received treatment for the adverse event. The outcome of event unknown.  Follow-up attempts are completed. No further information is expected.
got a double booster making it a full shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (got a double booster making it a full shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got a double booster making it a full shot). At the time of the report, ACCIDENTAL OVERDOSE (got a double booster making it a full shot) outcome was unknown. Patient stated that for his first booster shot, he got a double booster making it a full shot. He wanted to know can he get the second booster dose. No concomitant medications details were reported. No treatment medications details were reported.   Reporter did not allow further contact
This case meets criteria for vaccine breakthrough review. SxS include, continued cough.  Possible COVID infection weeks ago but was not tested.  Was admitted for CVA, no specific COVID related symptoms.
ANKYLOSING SPONDYLITIS FLARE-UP; HEADACHE; LIMITING MOBILITY BEFORE NEXT INJECTION; This spontaneous report received from a consumer concerned a 23 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 20-AUG-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled injector, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On OCT-2021, the patient experienced limiting mobility before next injection. On an unspecified date, the patient experienced ankylosing spondylitis flare-up, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, recovered with sequelae from ankylosing spondylitis flare-up, and the outcome of limiting mobility before next injection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211259731-COVID-19 VACCINE AD26.COV2.S-Ankylosing spondylitis flare-up. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
Felt warm to touch; Arm has red spot the size of the palm of the hand; Iitchy; Arm felt thick and firm around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site). At the time of the report, FEELING HOT (Felt warm to touch), RASH MACULAR (Arm has red spot the size of the palm of the hand), PRURITUS (Iitchy) and VACCINATION SITE INDURATION (Arm felt thick and firm around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event's outcome updated to recovered/resolved.
recieved first dose of pfizer covid vaccine on 1/14/2021. 48 hours later I began to feel weakness, extreme fatigue, sore throat, chills, headaches and body aches. Today is 10 days s/p first vaccination dose and still symptomatic. Tylenol, Motrin, Dayquil, Vitamin C, Zinc have been taken with no relief of symptoms.
After receiving the dose of Moderna, later that evening injection site became red, hot and hard. During the next day started to have headache, chills, shortness of breath, fatigue and body aches. Prior to getting COVID vaccine was having issues with breathing and contacted PCP on 1/23. She then came in to get shot on 1/25. Was seen by PCP on 1/29. Had started taking prednisone after receiving Moderna. Symptoms of chills, shortness of breath, aches lasted a week. Headache and tiredness lasted 2 1/2 weeks. Breathing improved after 1 week of prednisone.
With first MMR, patient got a large red area (approx. 3 in diameter) - within a day of vaccination that lasted a few days - since redness was a side effect, employee health couldn't find that this was a contraindication to a second dose. Within a couple hours of the second dose that was given 2 months later, employee again got a large (approx. 5-6 diameter) very red, indurated area with a 2 blisters approx. 2 cm x 1cm, & 0.5cm x 0.5 cm where injection was administered
Narrative:  COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/05, Pfizer, dose #2 09/01 COVID swab, result: detected 09/01 pt cc: exposure: unknown 09/01 SARS-COV-2 LINEAGE result: AY .3 09/01 SARS- COV-2 CLADE result: 21 J (DELTA)
"Reports going to Agency on Saturday, NEG for COVID-19, was told she had pharyngitis, and bronchitis. "
Racing heartbeat for ~3 days. Went to doctor 3/30/2021 but symptoms subsided.
Red spots on her right arm where she got the the injection; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red spots on her right arm where she got the injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received the first planned dose of mRNA-1273 (lot/batch: unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event red spots on her right arm where she got the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event red spots was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient reported that he developed a high grade fever and had to go to the hospital. He did not give any additional information
PATIENT DIAGNOSED WITH CELLULITIS. PRESCRIBED DOXYCYLINE HYCLATE 100MG 2 TIMES A DAY FOR 7 DAYS.
Swollen lymph nodes under injection arm.; Severe pain for three days; The patient received the third dose/booster dose of BNT162b2; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Dec2021 at 18:00 (Lot number: unknown) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish; "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: Nuts and "Peanut allergy" (unspecified if ongoing), notes: Known allergies: Peanut. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Administration time: 15:00), administration date: 05Apr2021, when the patient was 28 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Administration time: 15:00), administration date: 15Mar2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 18:00, outcome "unknown", described as "The patient received the third dose/booster dose of BNT162b2"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021 at 23:00, outcome "recovering", described as "Swollen lymph nodes under injection arm"; PAIN (non-serious) with onset 01Dec2021 at 23:00, outcome "recovering", described as "Severe pain for three days". Therapeutic measures were not taken as a result of lymphadenopathy and pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Ischemic Stroke requiring hospitalization. Significant reduction in field of vision.  Loss of nearly all Left Side peripheral vision
3 cm by 4 cm hard area on left upper arm. Hot to touch, pain scale from 1-10 is a 7, no discharge, no open skin. MOD difficulty moving left arm sue to pain. Motrin, hydroxyzine and motrin given to patient for pain and itchiness.
Was reclining in chair; suddenly felt real fast heatbeat.  Sat up and tested my oxygenation saturation with my pulse oximeter.  Readings were 174, 153 and other high readings.  Spouse listened with stethoscope and heart was skipping a beat, then skipping two beats.  Pulse oximeter readings began to go down slowly.  Was going to go to hospital via ambulance, but reading kept going down.  Was very scared, and could not attribute this sudden onset of rapid heartbeat to nothing but a reaction to my flu shot earlier that day.
This spontaneous report as received from a nurse practitioner (N.P.) via a representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, intramuscularly (dose and lot # not provided). After the patient received first dose in the series with GARDASIL, she had a seizure. The outcome of seizure was unknown. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a physician refers to at least five patient of unknown age. On unknown dates in the past year in 2012 at least five patients were vaccinated with GARDASIL injection (lot # not reported) off schedule. The physician reported the typical scenario was that the patient received the first dose at unspecified provider's facility and presented to her office after "about one year" and was administered a second dose at that time. No adverse effects reported from any patients. Physician did not have specific patient information. Additional information has been requested.
Child woke at midnight crying with left arm very sore. Mom states child had difficulty moving arm. Mom says she administered TYLENOL. As of 10:45am on 9-16-10, child seems to be feeling better.
This spontaneous report was received from a registered nurse reporting on a 17-month-year old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose, frequency and route of administration were not reported, lot # either L050561 with expiration date of 14-DEC-2017 or M019841 with expiration date of 20-APR-2018), for prophylaxis. The Merck (MRK) sterile diluent (lot # and expiration date were not reported) used to reconstitute the VARIVAX was properly stored. The temperature excursion ranged from 6 to 14 degrees Fahrenheit and lasted for 30 minutes. It occurred on 03-FEB-2017, and then again on 18-APR-2017, and was detected by a Digital Data Logger. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010916: US-009507513-1704USA009837:
SWOLLEN LYMPH NODES UNDER ARM (PAINFUL); HEADACHE; This spontaneous report received from a patient 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: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced swollen lymph nodes under arm (painful). On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes under arm (painful) on 10-MAR-2021, and headache on 09-MAR-2021. This report was non-serious.
arm pain; shoulder pain, knee, hip pain; Polymyalgia rheumatica; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Osteoarthritis since 2012, Eczema (Exacerbated since Mar 2021) and Polymyalgia rheumatica since 2020. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema, IRBESARTAN for Hypertension, CELECOXIB (CELEBREX) for Osteoarthritis.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain). The patient was treated with METHYLPREDNISOLONE (oral) on 25-Feb-2021 for Polymyalgia rheumatica, at a dose of 4 milligram twice a day. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain) had not resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated Event onset date of event - polymyalgia rheumatica. Updated  concomitant medication - Celebrex and onset date of treatment medication. Updated patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a healthcare workers referring to a 30 to 40 patients of unknown age and gender. Since an unknown date in September 2015 (the vaccinations occurred within the past 2 weeks) the patients were vaccinated with improperly stored doses of ROTATEQ (orally, dose and frequency were not reported, lot #K023537 with expiration date: 22-JUN-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected. Reporters did not wish to be contacted.
no immediate symptoms.   Three months after vaccination, I began experiencing what is called Exploding Head Syndrome.  Loud banging/screeching noise in prevalent when first drifting to sleep - and just prior to awakening.   I am in strong and in excellent health - and have never before experienced anything like this.
Drank lots of liquids starting 1 hr before vaccine and throughout the following 24hrs including pedialyte, water and tea. Sore arm, fever that increased to 101.3  at 3am 05/04/21.  Body aches that started 7 hrs after the shot. Did not take any pain reliever until 1 hr before bed, (8pm 05/03/21)then took 1 Motrin and 1 Aleve, at 3am when I awoke with a fever, I took 2 aleve, awhile at 7am with no fever and much milder body aches. Throughout the day in 05/04/21 I would have bouts of a Aches, and tiredness, but also bouts of feeling great with no symptoms. By 7pm the night after the shot my arm really started to hurt, and I was feeling feverish again 99.5. Ives down my arm, took 2 Motrin, went to bed and woke up 05/05/2021 with 0 symptoms of aches, tiredness etc. only a sore arm to touch