chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from an observational study. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male between the ages of 19-24 years old experienced OTHER ANAPHYLACTIC SHOCK, NEC (Serious, since 20-Jun-2012, until 20-Jun-2012) while enrolled in a study. Adenovirus Vaccine was administered on 01-Jun-2012 LOT # 34600029. The event occurred on 20-Jun-2012. Treatment was given at an outpatient visit, the patient received medication and non drug treatment. The severity was not assessed. The patient was seen for an Allergic Reaction follow up on 21-Jun-2012 as an outpatient visit and treated with medication. The outcome, severity and seriousness of this visit was not assessed. Treatment provided: Epinephrine, ZOFRAN, and BENADRYL given on 20-Jun-2012; ZANTAC 150 mg IV push, Prednisone/Solus Medrol 125 mg IV push also given 20-Jun-2012. LORATADINE 10 mg BID oral given 21-Jun-2012; Ranitidine 150 mg oral started 21-Jun-2012 and last dose 28-Jun-2012; Penicillin G 600 mL injection started 19-Jun-2012 and last dose 08-Jul-2012; Polyvinyl Alcohol 1-2 gtts optical on 21-Jun-2012. At the time of the report the outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: not recovered/not resolved. The patient's medical history was not reported. The patient's concomitant medication included DIPHTHERIA-TETANUS-PERTUSSIS VACCINE (on 01-Jun-2012); MENINGOCOCCAL VACCINE (on 01-Jun-2012); INFLUENZA VACCINE (on 01-Jun-2012); POLIO-VACCINE (on 01-Jun-2012). The patient's past medications were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This medical monitor's causality assessment; No reasonable possibility that Adenovirus vaccine is related to event OTHER ANAPHYLACTIC SHOCK, NEC.
The initial shot was painless and bled quite a bit. Approx 2 hours after injection as I was driving I felt numbness and tingling in my left lower jaw and cheek area.  I was concerned so when I could safely pull over I called the pharmacy.  While waiting on hold for about 13 minutes, the numbness and tingling  traveled across to the other side of my face, chin and  lips. When I was able to speak to someone I was instructed to take 2 Benadryl when I got home, which I did and the symptoms subsided. When I took the band-aid off, it was saturated with blood and I had a quarter size bruise at the injection site for almost 2 weeks.  Since then the symptoms have continued to reoccur, now happening several times a day.  It feels like a tightening across my face, numbness and tingling similar to having novacaine. The episodes seem to be increasing and affects the whole loer half of my face.
sore arm and neck on right side with headache for 5 days Moderna COVID-19 Vaccine EUA
on 5/7/99 3:45PM mother rpt pt developed hives & temp 99.5-100. screamed all night;mom insistent that rxn to HIB;
Narrative: COVID infection following COVID vaccine series completion 01/04 COVID vaccine dose #1 01/25 COVID vaccine dose #2 04/26 pt tested for covid due to symptoms of loss of taste (smell intact), myalgia since "last wednesday,"reports close contact with someone with respiratory illness; tested positive
This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant to an 17 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 24 year old female registered nurse with an allergy to clarithromycin (BIAXIN) who was about to vaccinate a pt with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #639914/0023M) when the vaccine leaked between the bevel and the syringe and splashed into her eyes. The pt did not receive any vaccine. The nurse's eyes were flushed with water and saline for 15-20 minutes. The nurse reported that there was no redness, but one half hour later and pt's eyes were still burning. In follow-up the registered nurse reported that the pt experienced burning and itching of her eyes, and that the pt's eye burning and itching from the accidental exposure to the vaccine lasted for 2 days. The registered nurse also reported that an ER/doctor visit was not required. No further info is expected.
Heart fluttering and pulsing several times a day.  Seemed to be getting better but still happening 1 or 2 times a day. On 4-21-21 had aches, shaking, and felt flu like symptoms plus the heart fluttering and pulsing.  After 24 hours everything but the heart issues subsided.  It happens sporadically. I held off notifying my doctor because I seemed to be getting better.  It just happened again and it is becoming a concern.
While the patient was sitting in the observation room after receiving her vaccination at 1050, She started to experience some adverse reactions. The reaction was described by the patient as " whole body flushing, tremors, fast heartbeat, heart pounding, and anxiousness". The patient flagged down the EMT on duty in the observation room. EMT assisted the patient to the treatment room to begin an evaluation. The patient was evaluated by  , vital signs were taken and listed as BP:190/110, P:128, Resp: 18, SpO2: 99% RM. While interviewing the patient, she told EMT  that she had never had a reaction like this before to any vaccinations. She did advise that she was allergic to a lot of different-
I had sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0186) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: On an unspecified date the patient received first dose of BNT162B2(COMIRNATY, Solution for injection; Expiration date: Unknown) Other Products detail, Patient History and Investigation Assessment reported as No. Consumer stated, I am Pfizer employee actually and I have been trying to report safety event from a COVID website, but it kicks me out every single time. Consumer stated, I need, myself and my daughter got vaccinated with the Pfizer vaccine and we have adverse event. Consumer mentioned after the first dose she had swollen was just a sore arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2018, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB, lot # reported as L014426, expiration date: 08-MAR-2018, intramuscularly for prophylaxis. No adverse effects were reported. Lot number L014426 is an invalid lot number for hepatitis b vaccine (recombinant).
Rash on arms, legs, back and stomach beginning 3 days after vaccination. Patient received 2 rounds of MEDROL dose-pak, but after completion both times the rash returned.
Otherwise healthy 20 yo female presented to observation area after her first vaccine dose. Within first 5 mins while seated, talking on phone to Mom he then fainted, falling on floor.  Fall witnessed, witnesses deny patient hitting head.  Patient immediately regained consciousness, and appeared to be shaking.  Placed in WC, while in med eval tent vitals: P 88, R16, BP 120/75, Glucose via fingerstick glucometer is 98.  Patient alert, oriented.  drinking apple juice.  Patient admits to history of fainting after procedures such as injections.  Advised her to inform healthcare personnel before vaccines or blood draws.  Denies Chest pain, SOB, nausea, or pain anywhere.  Denies visual changes.  Patient felt well enough at 12:45, stood and walked without difficulty.  Departed with friend without incident, who drove her back to dorm.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: after waiting 15 minutes after second moderna vaccine patient felt dizzy upon standing. Had patient wait another 15 minutes and took blood pressure twice while she was in the store. Both times the BP was greater than 150/100. Offered patient benadryl for the dizziness but she refused. after the additional 15 minutes passed she was able to get up and walk.
Patient intended to receive Pfizer COVID Bivalent vaccine but received a booster of Pfizer COVID vaccine. No harm occurred.
The patient stated she fainted at home after the  fluad immunization.  She also stated she felt a tingling sensation from her arm to her fingers.
Hospitalized (11.9.21 - currently still admitted);  COVID-19 positive (11.3.21);  fully vaccinated CHIEF COMPLAINT: Pneumonia due to COVID-19 virus HISTORY OF PRESENT ILLNESS: PT is a 80 y.o. female with past medical history of adrenal insufficiency, PMR, lupus who is presenting today with pneumonia due to COVID-19.  Patient has received COVID vaccine and booster, she states that last week she was scheduled to get her 2nd booster.  She has no idea where she was exposed.  She states on Tuesday 11/2 she started becoming symptomatic.  She complains of fatigued, generalized weakness, headache, nausea, shortness of breath and cough.  She states that she feels like the cough is wet in her chest but she cannot cough anything.  She has been taking Tylenol and cough drops.  She states she has not been stress dosing her steroids, and back she has missed a couple days but did note she took Cortef 20 mg this morning.  She states today she was so weak she could not get out of bed prompting her to come to the ER. In ED pt was afebrile, mildly tachycardic and tachypneic, she briefly desaturated with ambulation to 89%, no saturating in 90s on RA. CXR showing bilateral airspace disease. CBC showing leukocytosis, low abs lymph, stable anemia. CMP showing mild hyponatremia and stable CKD stage 4. EKG showing RBBB w/ occasional PVC and PAC. Hstrop of 35-> 33. Pt was given dose of zofran and decadron and admitted for further treatment.  Progress Note from 11.16.21: Pneumonia due to COVID 19 Acute respiratory failure with hypoxia - improving - hypoxic with ambulation. Given this, does not qualify for monoclonal antibodies per mAB liaison.  - symptom onset 11/2/21; positive test 11/3/21 - CXR: bilateral airspace disease - on cortef, holding decadron - start remdesivir 11/11. Monitor labs.  - supportive care, prone as tolerated - pulse ox  - decreasing CRP, decreasing D-Dimer - wean oxygen as able - down to 3L
Pt developed Varicella in spite of Varivax given (9 mo after vax).
This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse reported that the patient was inadvertently administered PROQUAD and VARIVAX (Merck) concomitantly on 12-SEP-2014 (reported as today). No adverse effect reported. Additional information is not expected.
Headache, Myalgia, NauseaVomiting, pain in injection, left neck pain, chills
The area of concern on the right thigh is 5 inches by 6 inches. It is red, warm, and hard to the touch. Patient states it is not painful, however it is itchy. Patient was prescribed Banophen for itching. The patient will return 6/20/2019 for a recheck.
Shingle vaccine hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain.
band-aid mark on the injection site (right arm); pea-size lymph node on her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) and LYMPHADENOPATHY (pea-size lymph node on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (pea-size lymph node on her neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) had resolved and LYMPHADENOPATHY (pea-size lymph node on her neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358991 (Patient Link).
Upset stomach; Gastritis; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), GASTRITIS (Gastritis) and DIARRHEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated the lining of stomach had gotten inflamed due to the vaccine. The stomach, gall bladder, or something else the vaccine was aggravating. Concomitant medication was not provided. Treatment incuded Probiotics and stomach lining repair pills. Any delayed side effects of upset stomach, gastritis, or diarrhea after 2nd moderna vaccine was not conformed     Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13-JUL-2021: Updated patient gender. Added treatment details in I-narrative.
Vaccine had been stored at temperatures 35-45 degrees Fahrenheit for greater than 10 weeks prior to being discarded. Discard date was 9/2
Increased spotting, cramp pain, bloating, and other period side effects post vaccination. Prior to vaccination, no symptoms occurred with IUD insertion. No change in birth control method or type from pre to post vaccination. Cramps are now almost unbearable and spotting occurs every 2-3 weeks. Before vaccination there were minimal to no cramps and no spotting since IUD was inserted in 2018. Doctor has been booked for follow up and patient has appointment set for future date.
Symptoms started around 7:00 PM and gradually increased. The first symptoms were chills and body aches which gradually increased and also led to a fever of 103 F,  confusion and lower back pain level 10/10. The fever and chills subsided the next day however fatigue and soreness followed the next couple of days. I still have lower back pain that comes and goes.
felt like someone punched me in the arm/ arm pain; sweaty; mild fever feeling; tired-fatigue; soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), HYPERHIDROSIS (sweaty), PYREXIA (mild fever feeling), FATIGUE (tired-fatigue) and MYALGIA (felt like someone punched me in the arm/ arm pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm) and FATIGUE (tired-fatigue). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (sweaty) and PYREXIA (mild fever feeling). On an unknown date, the patient experienced MYALGIA (felt like someone punched me in the arm/ arm pain). On 27-Mar-2021, PAIN IN EXTREMITY (soreness in her left arm), HYPERHIDROSIS (sweaty) and PYREXIA (mild fever feeling) had resolved. At the time of the report, FATIGUE (tired-fatigue) and MYALGIA (felt like someone punched me in the arm/ arm pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported   This case was linked to MOD-2021-244615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and  contains no new information
pt recv vax 3AUG95 930AM pt was a little irritable @ first; took pt home, fed pt lunch, gave pt a bath, put down for nap 230PM; mom gave pt APAP 230; 430PM pt woke up screaming; mom noticed pt had hives all over & facial edema; pt tired;
Nausea, Vomiting, Heache Dose was on 12/14/2021 and the first day I was able to keep food down after the shot was 01/02/2022
rash, difficulty breathing, swelling of legs, arms, belly (around skin graft). Went to MD on Sunday + they started her on Methylprednisolone. She got better
LPN administered Hep B and PREVNAR into right thigh. Immediate swelling noted to area. Quarter sized. Observed for 20-30 minutes. Dr in room to see patient. Swelling had gone. Patient home with Mom. (Patient also received PENTACEL on same day but in left thigh, left thigh with no reaction.)
pt recvd vax & had an erythematous rash urticaria on arms, legs & trunk & a h/a; 15OCT92 seen by ER MD; pt took APAP w/Codeine;
Left thigh red, swollen, hard and hot.  child gets irritable at times.  child had fever wednesday only.
Received vaccine 10/21/04.  Sleepy, tired by early evening. Temp 96.1 rectally.
Peripheral Edema, tingling  nerves + numbness, swollen joints (Right Knee & ankle), pain behind the knee working down to the calf, swelling discomfort with or without shoes on.
Pt recv vax in 12/95; in 2/96 pt exp arthritis, muscle aches; dx=spondylitis (undifferentiated)
pt recvd vax 14OCT93 & approx 15 mins later pt lightheaded & hypotensive; Epi administered; pt transferred to ER: pt exp low BP, clammy, difficult to arouse;
pain and tenderness at upper arm injection site, worsening pain overnight, excruciating pain on 1/19 with nausea, lethargy, swollen arm, puffy red splotches on arm below injection site, pain in armpit and on back on the side of the injection.  Fever developed evening of 1/19 and was at 100 degrees morning of 1/20.  Saw doctor at 7pm on 1/19 and was told to use Motrin, ice the shoulder, and drink fluids.
Patient had sore arm after vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Patient had sore arm after vaccination) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had sore arm after vaccination). At the time of the report, PAIN IN EXTREMITY (Patient had sore arm after vaccination) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Reporter stated that her husband had sore arm after vaccination.   Treatment information was not provided.
Internal chills that run up my right arm and through my shoulders and down my left arm.  I had the first internal chill experience when I got my 1st Pfizer vaccine on 1/2/21.  Internal chills have been ongoing and increased in frequency after my 2nd Pfizer vaccine on 1/21/21 and again with my Pfizer booster on 9/30/21.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED, NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Right upper arm - red = swelling approx. size of orange 1/2 inch high hot to touch - shot given on 11/2 - was informed of reactions on 11/4/10 by patient - was checked & I called local health dept & then I notified drug company all done 11/4/10.
Migraine appeared 9 hours after vaccine. Nausea, tiredness, weakness appeared the next day and resolved by Monday.