chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Company Comment: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.           This case was linked to US-MODERNATX, INC.-MOD-2022-673548 ( Linked Report).; Sender's Comments: This literature non-study case concerns a male patient of unknown age, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-673548:Male, patient 1
This spontaneous report as received from an Office manager registered nurse refers to a patient of 1 years old. The office manager reported that on 27-AUG-2012, the received 0.5 ml dose of GARDASIL injection 120 Y  (Lot#H010428; exp. date: 20-JAN-2012) inadvertently. No adverse effects reported. The outcome of the event was unknown. The event was not related to GARDASIL. Additional information has been requested.
22 y/o male pt.  presents to clinic with "infection at primary SPV site."  Pt. reports receiving primary SPV (left upper arm) on 7/14/08, at same time with Typhoid IM (right upper arm) and Hep A/B, per DEERS.  Note:  Discrepancy SPV date documented in DEERS as 06/03/08- may represent error in documentation.  Patient reports receiving SPV alone with other vaccines on 7/14/08 and Jennerian Pustule is consistent with 2-week evolution.  Symptoms:  erythemic papular rectangular rash where op-side bandage was applied over SPV injection site.
Information has been received from a licensed practical nurse concerning a 10 weeks old female patient with no pertinent medical history and no drug allergy or reaction who on 18-AUG-2011 was vaccinated with the first dose for ROTATEQ (Lot Number not reported). Concomitant therapy included PEDIARIX, PREVNAR and Hib conj vaccine (unspecified carrier) received on the same day. On 18-AUG-2011 the patient spitted up after receiving her first dose of ROTATEQ in the office. No lab diagnostic study was performed. On an unspecified date, the patient recovered. Additional information has been requested.
PATIENT PRESENT TO  CLNINC TO RECEIVE HIGH DOSE FLU VACCINE DUE TO AGE INDICATION.  CLINIC STAFF ADMINISTERED FLU VACCINE INDICATED FOR AGES 65 AND  YOUNGER.
The day following the vaccine I began to feel stomach pain and my stomach was upset after eating. I vomited that night.  The same thing the next day. I could only eat a very small amount of food and felt very very full. I vomited again then next day. Stomach pain and upset stomach pain continued for three weeks. I felt pain and digestive issues at each meal.  It would come in waves. I saw the doctor after week 3. I was prescribed Pepcid.
Patient began feeling hot and dizzy minutes after receiving injection. She was not 100% alert and then was unresponsive for about 7min. Patient had tachycardia. Ambulance was called and patient became more alert after laying down, drinking juice, and resting. Patient was transported to ED.
Vision darkening Hearing diminished Bradycardia Diaphoresis Junctional arrythmia
Client was vaccinated at flu clinic/school with FLUARIX (L) arm. She came back to clinic area after recess c/o "tingling" in her hand (L) and part of (L) FA. Exam WNL - pink, (+) radial pulse, equal strong grasp both hands. Both hands cold "I just came in from recess". Wearing nail polish - cuticles/pads pink - with blanching/refilling WNL. Able to use (L) hand/arm without difficulty. Reexamined x 2 - sx remain. Fa contacted via pc. - told to take her to PCP if no relief - he decided not to pick her up at this time since she had her cell and could call him if sx worsen.
Negative antibody serologic testing; This spontaneous report as received from a physician refers to a 40 year old male patient.    On 13-MAY-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 for prophylaxis.       On 13-MAY-2019, 1 day after onset of therapy the patient experienced serology negative.    The outcome of serology negative is unknown.
Tinnitus, joint pain, muscle pain, migraines , left arm expressly sore
Expired vaccine used; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982 and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Patient received the COVID19 pfizer age 12+ vaccine instead of the COVID19 pfizer pediatric age 5-11 vaccine
Sweating; Dizzy; Diarrhea; Body hurt; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), PAIN (Body hurt) and PYREXIA (Fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), PAIN (Body hurt), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (Sweating), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), PAIN (Body hurt), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included BC powder. No concomitant medications were reported.
Persistent dizziness started 2 days after vaccine and has not gone away since, it has been 3 weeks.  The dizziness reminds me of getting motion sick or after you found the boat for a very long time but feeling when you get when you're off the boat at first.   They have tried taking vitamin c and d they have not helped so far.  The dizziness sometimes does get worse when doing certain motions
Heavy menstrual bleeding; Period much longer than normal; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, hypertension. The patient was allergic to pineapple fruit. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN) amlodipine besilate (BESYLON) and norethisterone (NORETHINDRONE) for unknown indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 07Mar2021 at 12:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 04:00, the patient experienced very heavy menstrual bleeding with a lot of blood clots, period was much longer than normal. The patient did not receive any treatment for the event. The event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event heavy menstrual bleeding, prolonged periods was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt received first dose of pfizer covid-19 vaccine and experienced vasovagal episode within a few minutes. Pt endorsed lightheadedness and dizziness, was escorted out of her vehicle, and was guided to lay down. Pt was then offered juice and ice cream, and made a full and spontaneous recovery.
Baseball size rash noted to right arm - non raised -erythematous Pt did not come in to be seen for the rash . She came in for her regular appoitnment and then notified PCP
Patient with Covid between their first and second doses of the Covid vaccine; Patient with Covid between their first and second doses of the Covid vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable Pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got Covid between first and second doses of the Covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (got COVID between first and second doses) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2021011515 same reporter/drug/AE, different patient
Body ache; really weak; chills; woke up today with a minor headache / a severe headache later; Fever 103; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), ASTHENIA (really weak), CHILLS (chills), HEADACHE (woke up today with a minor headache / a severe headache later) and PYREXIA (Fever 103) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), ASTHENIA (really weak), CHILLS (chills), HEADACHE (woke up today with a minor headache / a severe headache later) and PYREXIA (Fever 103). At the time of the report, PAIN (Body ache), ASTHENIA (really weak), CHILLS (chills), HEADACHE (woke up today with a minor headache / a severe headache later) and PYREXIA (Fever 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
sore arm/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 14:30 (Lot number: EP6955) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021 14:30, outcome "recovered" (28Mar2021 14:30), described as "sore arm/pain in arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355806 Same reporter/drug/AE and different patient
after the administration of the first dose of the Covid Vaccine presented a leakage of about 2-3ml; the patient was administered Subcutaneously instead of Intramuscularly/maybe the product had been injected Subcutaneous rather than Intramuscular; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient after the administration of the first dose of the Covid vaccine presented a leakage of about 2-3ml, the patient was administered subcutaneously instead of intramuscularly/maybe the product had been injected subcutaneous rather than intramuscular.  Information on the lot/batch number has been requested.
A few minutes after being vaccinated with first dose Moderna, client came back to vaccination area complaining of feeling dizzy. Client taken to lie down. After lying down, he complained of having trouble swallowing. He denied SOB. BP 140/80, P 72, R 24. No respiratory distress. Drank a few sips of juice. Client continued to rest and drink sips of juice for about 45 minutes. BP 148/78, P 78, R 24. Swallowing felt normal and he said he was "fine." Left with group housemates on his own.
I have been have abnormal episodes of migraine since the vaccine.  Several a week that have been severe. One lasting 3 days.  It is not unusual for me to have several mild migraines a week but the ones since the vaccine have been worse than normal. I've never had them put me in bed for over 2 hrs.  On July 16th I had one for 5 hrs and in bed for 16 hrs.  Another one I had for 3 days, the 1st day I was in bed with the migraine for 15hrs, 2nd day my head hurt but no migraine, 3rd day head still hurt with no migraine, finally felt better after 6hrs into the 3rd day.  I WILL NOT get the 2nd dose of the Moderna vaccine till these migraines go back to MY normal.
Physician reports post vaccine pt developed a rash on her back that recurred from time to time over the last 5 months, subsequently the pt experienced fatigue. F/U no additional info was reported.
11/12/22 Patient admitted with NSTEMI with  acute kidney injury, hypokalemia, generalized weakness, acute cystitis.  11/14/22 AM Evaluated for potential stroke 11/14/22  PM Patient went into cardiac arrest with no ROSC.
Leg on the knee and below is numb; Is feeling tingling on the other leg too; Feeling like asthma; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma). At the time of the report, HYPOAESTHESIA (Leg on the knee and below is numb), PARAESTHESIA (Is feeling tingling on the other leg too) and ASTHMA (Feeling like asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided.
Pt. felt palpitations about 5 minutes after vaccination while seated. Pulse check revealed rapid regular rhythm at about 130 bpm
The patient stated she had a rash develop on the right arm, and a zit like bump on the palm of her left hand. She stated they were both itchy.
Patient fainted, hit head upon falling to ground, regained consciousness within seconds. Elevated feet, blood pressure 112/62, HR 47, applied ice pack to head injury. Patient had history of fainting 3 times prior, never with vaccination. Recommended treatment to assess possible concussion, though wound looked superficial and did not bleed. Patient rested on floor for 5-10 minutes then sat up and drank water for 10 minutes. Patient stated he felt better, just shaky. We assisted him to standing and they exited the store. At 4:30pm Mom called pharmacy to report that she followed up w pediatrician who said to watch patient and keep icing head injury.
I never had arthritis in either of my hands. Now I have it in both hands. My right hand is worse than my left hand. I play 6 string guitar and Bass guitar.  This new condition makes it very difficult for me to play either of these instruments.  I feel pain in both hands but more so in my right hand.
area became red & swollen feverish to touch;on 12JUL97 body aches, fatigue;
2-3 MINS after vacciNE Administered SHE BEGAN TO EXPERIENCE SHORTNESS OF BREATH FEELING OF A FUZZY TONGUE & DIFFICULTY SWalloWING. SHE WAS SEEN IN ED WHERE SHE gOT Benadryl & DECADRON
ED VISIT FOR ITCHY PALMS, TIGHT AND ITCHY THROAT, SWELLING AROUND RIGHT EYE, WHEEZING;  TREATED WITH METHYLPREDNISOLONE 125 MG, DIPHENHYDRAMINE 12.5 MG X 2; ALBUTEROL TREATMENT;  DISCHARGED ON PREDNISONE 20 MG BID X 2 DAYS AND ANTIHISTAMINE OF CHOICE; HAS PREVIOUSLY RECEIVED INFLUENZA VACCINE WITHOUT REACTION
patient received all 3 doses outside of hospital-no vaccine information provided Referred for evaluation of skin itch and swelling. Pt c/o 2-3 yr hx of intermittent itching, red, blotches, raised on her arms, face, legs, abdomen, legs. Warm to touch. Had episodes of eyelid swelling, no tongue swelling, no lip swelling, no throat tightness, no shortness, no dysphagia, occurs about couple times per month. Each lesion lasts less than 24 hours, no burning on painful lesions. When lesions resolve, skin is normal appearance. She takes loratadine when hives occur. Noticed 3 year hx of alcohol will make her have skin itching. Occurs within minutes of taking one sip of alcohol. Has been avoiding and hives until occur. She can take NSAIDs without any hives trigger. Does not notice any correlation. No correlation to any foods. All three Covid vaccine she developed hives throughout her body within a 15 minute and progressed to full body hives, lasted for two days. Covid vaccine, hives at injection site, Third dose, 1 week later developed hives and increased HTN.
Widespread body aches- 13 days Intense chills without a fever- 12 days Nausea- 10 days Stomach pain/vomiting/diarrhea- 1 day Diarrhea- 10 days Severe exhaustion-12 days  Bad headache- 3 days Light headedness- 6 days Neurological issues- 10 days
legs swelled; leg muscles swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled) and MUSCLE SWELLING (leg muscles swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled) (seriousness criterion hospitalization) and MUSCLE SWELLING (leg muscles swelled up) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (legs swelled) and MUSCLE SWELLING (leg muscles swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported a female patient had received Moderna's COVID-19 vaccination and her legs and leg muscles swelled up and she was hospitalized for two days. The reporter also stated that she was a "runner" and had strong leg muscles.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
pt recv vax 20OCT97 & 18NOV97 pt exp h/a, fatigue, nausea & noc sweats;
Red circular rash around injection site showed up 10 days after vaccine. Hot to touch but no other symptoms
Numbness of lips; Tingling of the tongue.; A spontaneous report was received from a nurse concerning, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed numbness of lips and tingling of the tongue .  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot 037K20A) on 26 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. Forty minutes after administration, the patient started to experience numbness on her lips and tingling of the tongue. Treatment and duration of symptoms information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of hypoaesthesia oral and paraesthesia oral. The events occurred 1 day (approximately 40 min.) after first dose of mRNA-1273, lot # 037K20A.  No treatment was administered, and the event was ongoing.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Paralysis (L) side of face started Prednisone 60mg x 5 days & taper.
Patient presented the emergency department with chest pain radiating to left arm on 6/12. Studies indicate myocarditis. Patient will be transferred to specialty hospital for cardiology.