chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness; Extreme body aches; Headache; Nausea; Chills; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD) stage 3, recent surgery of brain aneurysm, COVID-19 and penicillin allergy. The patient previously received BACTRIM on unknown date for unspecified indication and patient experienced drug allergy. The patient had received concomitant medications within two weeks of vaccine included clopidogrel bisulphate (PLAVIX) and acetylsalicylic acid (ASPIRIN) started on unknown dates and for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 (at the age of 61-years-old) and experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 19:30 (8 hours 30 minutes after the vaccine), the patient experienced arm soreness, extreme body aches, headache, nausea, chills and sweating. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for reported events. The clinical outcome of the events arm soreness, extreme body aches, headache, nausea, chills and sweating was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
seizure; passed out due to extreme vomiting as per doctor in ER; vomiting every 40 minutes; stomachaches; body pain; Sweating; Headache; This case was received via an unknown source no reference has been entered for a health authority or license partner on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) and LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) (seriousness criterion medically significant), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided. Patient used ibuprofen for treatment of headache.  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.; 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.
pt stared & seemed to be in a daze;leg swelled;fever 102 approx 1 1/2 days;bloody diarrhea started 1 day p/vax, gradually blood has disappeared, but diarrhea has been ongoing now 4wk later;
24 hours later bloody diarrhea and occurred a few times with fussiness and decreased appetite.
Patient received 0.2 mL of undiluted Pfizer-BioNTech Covid vaccine for ages 5 years to under 12 years - the vial was not diluted with sterile 0.9% sodium chloride prior to preparing the dose. Patient without complaints other than a sore arm
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 19-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
two days after I started to experience  irregular menstrual cycles after getting Covid injection.?  The is not the 1st time this has happened. it happened when I got my 1st Covid injection as well.  And both times times last longer than my usual menstrual cycle and i have passed several blood clots.    Is that normal for me to experience it both times?
11/2/21 pt to ED with c/o SOB; states had a positive COVID test 4 days earlier; pt tested positive in ED; CXR showed COVID pneumonia; O2 supplementation; O2 sats began to drop; transferred to MICU; given Decadron, ABX, Combivent Inhaler; suffered cardiopulmonary arrest and passed away in the hospital
suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got Shingles shot and got the shingles on his/her forehead, It was very painful. The patient said, he/she hope never get it again. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Severe headache with nausea; Severe headache with nausea; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 16Apr2021 at 09:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies. The patient previously received nicotinic acid (NIACIN) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included insulin (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), metformin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267100001) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 20:00, the patient experienced severe headache with nausea, lasting 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with paracetamol (TYLENOL) and sumatriptan (IMITREX). The clinical outcome of the events severe headache with nausea were recovered on 18Apr2021.   No follow-up attempts are needed. No further information is expected.
Extreme arm pain that has continued for the last four weeks.  Difficulty moving and lifting objects with that arm.  Limited mobility.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 10:30 as dose number unknown, single (Lot number: FD8448) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Apr2022 at 10:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: It was reported that Other medication in 2weeks: No. Anti-viral details: Product=COVID 19 Treatment, Brand=Pfizer, Treatment start date=29Jun2022, Treatment stop date=04Jul2022, Indication=Treatment of COVID-19. Adverse event: Cough, congestion, runny nose, and rundown feeling. Adverse event, Adverse event start date: 07Jul2022. Ae resulted in: None of the above. If patient: recovered: Recovering. If treatment ae: No. Known allergies: No. Other medical history: No.
Received smallpox vax 2/10/03 and 2/17/03. Started to feel chafing of legs, redness bumps, treated w/lotion - no results. AM of 2/19 noticed redness on back of left knee, left hip under right arm, splotches on stomach and back. Site of vax redness size of donut. Redness and dark. Seen in ER  this a.m. 2/19/03. Tx w/hydroxycine and acetaminophen. Dx'd w/general vaccinia.
Patient to Labor and Delivery for premature rupture of membranes, admitted to L&D. Given penicillin for GBS+. Labor augmented with cytotec and pitocin. Patient received epidural. Patient had several prolonged decelerations requiring terbutaline, with minimal cervical change. Patient to OR for failure to progress. Her post operative course was complicated by a spinal headache which resolved with a blood patch. Patient had an unscheduled Cesarean Section.
Parents report to MD on 7/29/03 pt had 6 month immunizations on 7/25/03 (Friday). That evening they noticed episodes of uncontrollable jerking spells and stated he had all weekend on and off. They did call MD on call over weekend. On 07/29/03 they saw MD and he has ordered EEG 8/12/03 and MRI 8/6/03.
pt recvd vax & 9 day p/vax, pt awoke 3AM w/bad shakes, high fever, crabby same day; 9PM fell asleep & 15 mins later had sz lasted approx 1 min, 30 min later had 2nd sz;
She was afraid it's going to kill her, her heart beats fast too; Shaking uncontrollably for a few hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (life threatening), outcome "unknown", described as "She was afraid it's going to kill her, her heart beats fast too"; TREMOR (non-serious), outcome "unknown", described as "Shaking uncontrollably for a few hrs". The patient underwent the following laboratory tests and procedures: Heart rate: increased.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Neuropathy. Numb-burning. Pericardial effusion. Muscle weakness.
Patient passed out about 5 minutes after receiving the vaccine. He was caught before hitting the floor and was slowly lowered to the floor. 911 was called and town rescue was dispatched. Patient refused ambulance service to the hospital because he only has catastrophic health insurance. Both myself and EMT insisted that he should be checked out. His blood pressure, pulse and oxygen was checked. All in normal range. His coloring was gray at first but did improve before he left the pharmacy. He called friends/family to drive him.
The shot was given directly into a nerve. I have had limited use of my left arm since the vaccination.
Low blood pressure, fainting, dizziness, headache, and numbness of the entire injected arm  on day of the vaccination. Fatigue, muscle aches, headache, fever, injection sight soreness, and feeling unwell the entire day after the vaccination.
48 hours - pain in upper arm, numbness lower arm and hand. Red raised site (golf ball) size, red-purple rash on entire upper arm. Headache, joints and body ached.
PT was administered Moderna vaccine with expiry date 10/15/2021.  She was observed 15 min after injection, tolerated the injection well.  No complications or adverse effects noted.
Pain at injection site within hours same date Pain in armpit on same side of inject developing on first day but more severe day 2 (2/27)and resolving by end of day 3 (2/28) Body aches and fatigue day 2 (2/27) managed with 800mg ibuprofen resolved mostly by afternoon Virtigo from  early morning on day 4(3/1) -day 5(3/2) worse while laying down when turn head Woke with left sided flank pain this morning (3/3) but had a physically stressful day prior while moving so not sure if this is related to vaccine, moving or UTI will notify primary if persists.
On the evening of 01/10/2018, I noticed 2 small, itchy, bumps on the back of my neck, just under the hairline. The next day there were 3 or 4. On 01/12/2018, I began coughing, sore throat, sinus drainage and headache. Over the next couple days, I noticed the rash was spreading. It was itchy and painful. I also had a low grade temp with cough, sore throat, headache, and sinus drainage. On 01/16/2018, I went to urgent care due to the rash had spread significantly. It was on the posterior neck, in the scalp, back, chest, left leg, and groin area. The rash continued to be itchy and painful. Treatment was BENADRYL or ZYRTEC, Calamine Lotion or Hydrocortisone Cream. Today there has been a decrease in the rash but remains present, continues to itch.
This child developed Opsoclonus Myoclonus Syndrome 3 days after receiving vaccines.
Fever; Real bad sweat; throwing up and it lasted for 9 hours; This is a spontaneous report received from a contactable consumer (patient) reported for himself.  A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiry date: unknown) intramuscular, administered in left arm on 22Apr2021 at 11:00 am (age at vaccination was 62 years) at a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, heart disease, kidney disease and COPD for which the patient had taken lot of medication (Further clarification unknown). Concomitant medication was not reported. The consumer stated that he had his first Pfizer shot on the 22 which was last Thursday at 11 clock in the morning and at 6 'o' clock that night he started running the fever, having real bad sweats and throwing up and it lasted for 9 hours and but the next morning he was okay and his concern was, whether he should take the next shot or not. The consumer stated that he didn't have any computer, so he didn't have smartphone so he didn't have any email, they could text message him at the phone number he had given them. Reporter seriousness for events was unspecified. The consumer stated that the scheduled date of second shot was 13May2021. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
On 11/24/2000 the patient's mother phoned the office and reported that her child had a rash with approximately 150 pox. She had no other symptoms. Unspecified medical attention was sought. Additional information has been requested.
Received immunizations at check up and about 1 1/2 hrs later had redness & swelling of lips, circumoral area, & congestion in back of throat. Treated at home with BENADRYL & recheck in office about 1 hr later and much improved.
Patient tolerated injection well, after approximately 10 min in waiting room, patient states felt like passed out for 1 second, dropped phone, began to vomit, entered clinic area, moved patient to room, continued to vomit several times, (food/liquid), some diaphoresis noted, incontinence of urine (states happens when vomiting) moved to recling/bed chair, layed flat, BP 104/70, PR 88, given water, states starting to feels better, still clammy, rechecked BP about 20 min later 124/70, then 1130 120/60 sitting up, patient states feeling better, had similar occurrence about 6 yrs ago at eye doctor, was eval by ED, no abnormal findings, had family member pick up and transport
THE PATIENT RECIEVED A SINGLE DOSE OF FLUZONE FROM A MULTIDOSE VIAL USING THE NEW PHARMAJET NEEDLE-FREE MACHINE ON FRIDAY, SEPTEMBER 9, 2011 AND BY SATURDAY HER ARM HAD A LARGE HOT RED RASH FROM THE SHOULDER DOWN ABOUT 6 INCHES AND IT WAS PAINFUL AND THE ACTUAL INJECTION SITE HAD A ROUND HARD LUMP ABOUT A CENTIMETER IN DIAMETER.  THE RASH WAS GONE BY MONDAY BUT THE HARD LUMP WAS STILL PRESENT AT THE INJECTION SITE AND THE AREA WAS STILL HOT.
Vaccines given on 10/7 On 10/9 - developed fever & rash - taken to ER on 10/10 & 10/11 brought to clinic with worsening symptoms. diagnosed with active varicella - moderate
Numbness (B) arms, (B) legs, mouth. Dry mouth, dizzy, short of breath.
Fever, malaise, decreased appetite. Responded well to single dose of Tylenol and good night?s sleep. Resolved next day
Pt states severe pain to left arm at site of vaccination. States so severe she could barely move arm. States lasted 2-3 days. Evaluated by APRN. No other significant reaction.
During the night that he got the vaccine my son woke up with hives and I gave him some Benadryl. I gave him his rescue inhaler in the afternoon. He has not used his inhaler for over a year. The next day he had hives were much worse and his fever was going up. The hives were worse on his left arm and his arm was red around the vaccination site. He also had swelling in his face and he was having a little trouble breathing. I gave him Benadryl and Zyrtec which helped as well as Pepcid. The breathing difficulty subsided after that. He got a different rash on his back that was different from the original hives. We continued the medications and he was still Febrile until the sixth day. The sore throat is still present after nine days but the fever and hives are gone.
5 x 6 cm area of heat & redness & mild induration at site of injection on (L) thigh - not tender. Started about 24 hours after admin.
Arm was read and warm. Patient was told to see her md and after calling her she said that she was given a course of antibiotics.
Severe shoulder and arm pain where shot given. Pain has lasted to date - 23 days. Pain is less but has still hurts and shoulder "crackles" when moved. Painful.
NauseaVomiting chills, congestion, sore throat Narrative:  Other Relevant History:
ball between shoulder and neck; redness; discomfort; itching; Swelling; swelling; pain; discomfort; redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (Swelling), SWELLING (swelling) and INFLAMMATION (ball between shoulder and neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness). On 26-Feb-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness), the second episode of DISCOMFORT (discomfort) and PRURITUS (itching). On an unknown date, the patient experienced INFLAMMATION (ball between shoulder and neck). At the time of the report, PAIN (pain), SWELLING (Swelling), SWELLING (swelling), INFLAMMATION (ball between shoulder and neck), ERYTHEMA (redness), the last episode of DISCOMFORT (discomfort), PRURITUS (itching) and INJECTION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include birth control pill and diuretic medication.  treatment information provided as, On day 3 I put some ice. I did not take medications
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved. It was unknown if the reporter considered the allergic reaction to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 1998, the patient received a flu vaccine of unknown manufacturer and had an allergic reaction. The patient called to see if she would have an allergic reaction to SHINGRIX based on this previous reaction. The caller was transferred to medical information.
Within 2 days of receiving the MMRV vaccine, the child had a high fever of 104.4 and febrile seizure.  No other signs or symptoms of illness other than irritability.
Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they felt sweaty and thirsty and said they felt like they were going to pass out, then said they felt fine once they took their sweater off and were given some water. EMTs were called and escorted patient out of the pharmacy. She refused epinephrine injection and did not want EMTs called.
1015 upset, yelling & screaming; calmed enought to give injects; c/o being faint; ammonia inhalant given 1030; pt left clinic; pt still sick; seen in car nervous, tremors hyperventilating yelling; no signs of reaction from inject;