chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included COPD. Concurrent medical conditions included Blood pressure high. Concomitant products included GUANFACINE HYDROCHLORIDE (TENEX) for Blood pressure, POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), HYDROCHLOROTHIAZIDE, VITAMIN B COMPLEX and VITAMIN D NOS for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store). At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure), MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION (mood behaviors/Had discussion with sister and it's unusual to hung up the phone), ANGER (short tempered) and AGGRESSION (turned into argumentive/Went into argument to a stranger guy in a store) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I experienced for 12 hours after my vaccine, I started shaking violently, not the chills it was very violent shaking and I was also freezing. I took a warm, very hot bath which alleviated the shaking. For about 24 hours I had, like midnight on 04-30-2021, I had horrible body aches, in bed with horrible body aches. I finally took Benadryl which I think might have helped. Then I had an extreme rapid heart rate, it was not anxiety, it was like physical rapid heart rate, went from about midnight to 6 in the morning on Sunday 05-041-2021 and that finally subsided by 7am. On that morning I had shooting pain, migraine headaches and this went on and off on Sunday. I woke up on 05-02-2021, I had vertigo that I could not walk downstairs and called my doctor. The vertigo also happened on my first vaccine. They prescribed me a vertigo medication but I did not take the medication and tried to rest. On 05-03-2021 and 05-04-20210, I had intense nausea, horrible nausea but did not vomit. Finally by Friday, I felt better and was able to get out of my house.
07-14-08, approximately 8.5 cm diameter area, red, indurated, painful, hot to touch at injection site right arm. 07-17-08, red area extends to mid forearm, with edema, less indurated. Using ibuprofen, cool compress and elevation. 7-16-08, sore throat and fatigue. 07-30-08, area resolved.
Sore arm; Headache; This is a spontaneous report from a non-contactable consumer. A female patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm and headache. The clinical outcome of the events sore arm and headache were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I never considered it as an adverse effect. I did wonder if by stimulating my immune system if it stimulated the shingles. I had pain in my shoulder and going up the side of my bed. It wrapped around my head and behind my eye. I had had shingles before and it felt like shingles pain. I noticed I was breaking out on my shoulder and starting up the side of my neck. I went to the urgent care and they diagnosed me with shingles. They gave me some medicine and it went away 2 weeks later. It didn't affect my eye itself, but it did affect my eyelid and around my eye. I saw my regular doctor later on. I just had a prescheduled appointment with her. I did tell her about it. She looked at the area and said I was healing up nicely. She suggested I get the shingles vaccine.
patient felt drowsy at 2 pm, with increasing fatigue. Noticed hives on right arm at 530 pm, took 25 mg of Benadryl at 630 pm. On 4/24/22 woke with body aches, bilateral eye swelling, fatigue and some facial swelling, fever of 101 in the evening, took Tylenol on 4/25/22 , eye swelling was worse, feels like extra fluid in her head, head hurts to bend over
I received my first vaccine dose in April in my right arm - felt off balance for a few days and had a low grade fever the day after.  I immediately felt pins and needles in my right side of my body after the shot and this didnt really go away for a week or two but was very slight and not really bothersome.  I received my second dose in May, in my left arm.  Oddly, felt the same pins and needles on my RIGHT side again. I thought this was immediately odd because I used a different arm.  I woke up the next day stiff, unable to comfortably move my neck on the right side  for about a week and a half. My right arm has constant pins and needles, my right shoulder is painful 50% of the time, I have wrist problems on my right hand side and loss of some motion of my arm.  Mostly muscle pain when I lift my arm up or across my body.  Constantly hearing cracking or crackling noises. After not being able to put weight on my knees to walk up stairs I visited my doctor who diagnosed me with arthritis, which has never been an issue previously. She tested me for lyme, lupus and auto immune disorder but all test returned negative results.
Patient was nervous about receiving vaccine due to knowing it will cause a sore arm. She wanted to use the restroom after getting the shot. She walked with mom down aisle 16 to go towards the restroom when she felt faint and mom was able to catch her. They both stated that she did not hit her head at all. Mom came and got our attention and I, pharmacist, ran to help. She was laying on the floor when I got to her and she was awake. She said she could hear and see perfectly fine. When she felt better, we got her up and walked to a chair outside of the pharmacy. We got her an orange juice to drink. She stated a few minutes later that she was feeling faint again. Mom and I got her to lay down on our bench. She was feeling better and her color returned about 10 minutes after that.
Started walking to my bedroom in the rear of the house and my legs began to get weak and I lost my balance and had to lean against a bookcase with the help from my wife
gross hematuria Fever  Chills Joint pain Muscle pain Headache Fatigue High heart rate
L deltoid-subcutaneous skin red, hard, swollen, size 5 in by 5 in diameter area.  Provided patient with 3 day steroid burst, Orapred 15mg/5ml, 10ml PO QD x3 days and topical hydrocortisone 2.5% topical QD x7 days.
Patient describing a feeling of dizziness, light headedness, headache at date of immunization. Began feeling better before leaving pharmacy. Three days later patient still has complaint of soreness, swelling at injection site and dizziness.
patient developed COVID-19 infection after being vaccinated; patient developed COVID-19 infection after being vaccinated; This is a spontaneous report from a contactable physician. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unknown date in 2021, as unknown dose number, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jul2021, patient developed COVID-19 infection after being vaccinated. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment in response to the event. Outcome of the event was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Covid 19 and suspect drug BNT162B2 cannot be excluded
Blood test performed 14 days after Moderna vaccine showed elevated alpha and kappa light chains suggesting a diagnosis of Myeloma.  3 weeks later a repeat blood test showed no elevations  caused a referral to a cancer specialist who told me that I did not have myeloma and that the elevation of my light chains was due to stimulation of the cells that reacted to the vaccine.  Not a known side effect that I know of.
Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population;   This literature marketed report was received from the authors of a published article and concerns to a 14 year old female patient.      On an unknown date, the 14 year-old female presented with with chronic abdominal pain and vomiting and initial upper endoscopy revealed Helicobacter pylori negative duodenal ulcer and due to it she was treated with proton pump inhibitors (PPI) therapy and follow up upper endoscopy revealed an isolated papilloma in the proximal esophagus, which was removed by biopsy forceps; immunohistochemistry confirmed Human Papillomavirus subtype 16/18. The patient had Esophageal Squamous Papilloma.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On an unknown date, reported as "6 months follow up", the patient showed normal esophageal mucosa on upper endoscopy.  This is one of two reports from the same literature article (MARRS CASE # 1908USA009206).    Sender's Comments:  US-009507513-1908USA009206:
Sore; Chills; Hypertension; heart rate increased; A spontaneous report was received from a consumer concerning a 55 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced blood pressure increased, heart rate increased, chills, and discomfort.  The patient's medical history included hypertension. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol.  The patient received their first of two planned doses of mRNA-1273 (Lot # not provided) on 31 Dec 2020 for prophylaxis of COVID-19 infection.   On 03 Jan 2021, consumer called to report her heart rate-136, blood pressure-145/74, chills experienced on 31 Dec 2020, and sore on 01 Jan 2021.   Treatment for the event included metoprolol.   Action taken with mRNA-1273 in response to the events was not provided.   The event, blood pressure increased, heart rate increased, chills, and discomfort, were considered as unknown.  The reporter did not provide an assessment of the event, blood pressure increased, heart rate increased, chills, and discomfort.; Reporter'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.
Patient complained of chest pain 3 days after his second Pfizer COVID vaccine and was diagnosed with Myocarditis.
Almost 30 hours after shot given, patient woke up with tingle feeling in left pinky finger. Pins and needles feeling and touch sensation felt numb like wearing a glove. Hand was still functioning properly with proper grip strength. Almost 48 hours after shot given, patient said left ring finger and outer palm as well as pinky finger were feeling pins and needles. Sensation of left hand - outer palm, pinky finger and ring finger has remained numb touch sensation like wearing a glove. Grip strength still remained normal and function of hand is normal. Pins and needles sensation is constant. This sensation is still present at day 9 after shot administered. Day 9 has started sharp pained feeling sensation in left hand coming and going, not constant. Day 4 after shot, patient woke with a fever and nausea. Fever lasted three days. Nausea still present at day 9. Patient missed school due to symptoms. Hard to concentrate with nausea waves.
heart rate was high; tingling all over my body; dizzy spells; bad shivers; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Psoriasis and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MOMETASONE FUROATE for Psoriasis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers). The patient was treated with COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at a dose of 1 dosage form; VITAMIN C [ASCORBIC ACID] at a dose of 1 dosage form; CYANOCOBALAMIN (VITAMIN B COMPLEX [CYANOCOBALAMIN]) at a dose of 1 dosage form; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] at a dose of 1 dosage form; MAGNESIUM GLYCINATE at a dose of 1 dosage form; MECLIZINE [MECLOZINE] at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (heart rate was high), PARAESTHESIA (tingling all over my body), DIZZINESS (dizzy spells) and CHILLS (bad shivers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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 case was linked to MOD-2021-232185, MOD-2021-232186 (Patient Link).; 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.
Patient states felt skin was burning on eczema rash. She had a previous ruptured aneurysm in brain, and she stated she felt piercing pain in her ears for a few hours.  She also experienced back pain.  She has called her physician and is waiting for a return call. She stated she felt better today.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX. On 30th March 2019, several hours after receiving SHINGRIX the patient experienced headache and cold. On 1st April 2019, the patient experienced injection site bruising and injection site redness. The patient was treated with ADVIL. On an unknown date, the outcome of the headache, cold, injection site bruising and injection site redness were recovered/resolved. It was unknown if the reporter considered the headache, cold, injection site bruising and injection site redness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. The patient received the dose of SHINGRIX in the morning with her wife and that evening, he began to experience headache, started little cold at night. On 1st April 2019, 2 days after receiving SHINGRIX, it appeared black and blue at the injection site with redness. The dimension of injection site redness was 3 inches x 2 inches. All the symptoms were resolved at the time of reporting. The reporter did not provide the consent to follow up. The lot number was not available. This case has been linked with case US2019061251, reported for the patient's wife.
8 months after my PREVNAR 13 shot in my left arm I think the pain at the site of the injection might almost be gone. The first several months the pain was absolutely horrible and painful. It has gotten less painful (gradually) with time. I tried pain pills, ice, TENS - nothing worked.
The follow up received on 10/14/03 states pt had a booster DT injection on 6/28/03. Apparently developed local soreness later apparent lymph node enlargement, presumably adenitis in axilla accompanied by fever. Was seen in the ER (no records available) given Clindamycin for nine days and recovered uneventfully. Information received from discharge summary states lymphadenonitis. msv
Yellow spots on his upper right chest on the same side that he received the injection; Age at vaccination 14 years; This is a spontaneous report from a contactable consumer (patient's father).   A 14-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0191), first dose via intramuscular route of administration, administered in right arm on 26May2021 at 10:00 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma but controlled from an unknown date and unknown if ongoing. No known allergies were reported. The patient's concomitant medications were not reported. This report not related to study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient received COVID-19 vaccine at the age 14-year-old (off label use). The patient's father stated that on 28May2021 at 06:00 his son had a side effect from taking the vaccine. The patient broked out with; and he had yellow spots on his upper right chest on the same side that he received the injection. No treatment received for the event yellow spots on his upper right chest. The outcome of the event off label use was unknown and other event outcome was not recovered.
Pain, raised knot at injection site, redness from injection area to armpit, pain in armpit starting within 8-10 hours of injection. Fever up to 100.1 F 36 hours later, chills 36 hours later. Symptomatic treatment with ice pack, Tylenol, and Advil. Redness, pain and swelling still present 48 hours later but improving
Patient jumped while administering Prevnar 20 and needle bent; Patient received half of the dose; racing heart rate; had a vagal response; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (intervention required), outcome "unknown", described as "racing heart rate"; PRESYNCOPE (intervention required), outcome "unknown", described as "had a vagal response"; INCORRECT DOSE ADMINISTERED BY DEVICE (intervention required), outcome "unknown", described as "Patient received half of the dose"; NEEDLE ISSUE (intervention required), outcome "unknown", described as "Patient jumped while administering Prevnar 20 and needle bent". The event "racing heart rate" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: racing. Therapeutic measures were taken as a result of heart rate increased, presyncope.  Clinical course: Patient jumped while administering Prevnar 20 and needle bent. Patient received half of the dose and had a vagal response which she was treated for. 2 hours later was seen and treated in ER for racing heart rate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7 days of serious nausea and severe heartburn Unable to eat or drink until day 7  Still have heartburn on day 7
I was been feeling left shoulder pain with facial paralysis. My left face side and lips feel numb(I feel numbness and pain)  along with swelling and irritation in the left eye. I have been feeling difficulty working on computers. The symptoms have began on 18 march 2021. It has been persisting till now.
Developed fever of 104C irritability; SOB, Tachycardia; @ 1PM temp 100.4-looks ok referred to PMD;
Round, red disc on eve on vaccine admin. date. Progressed to large raised, itchy disc at site. No systemic symptoms. Patient has been using OTC BENADRYL cr. No medical attention sought.
Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at the injection site) 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 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site). On 29-Mar-2021, INJECTION SITE RASH (Rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported.  No treatment information was reported.
No adverse event. COVID-19 vaccine administration errors; dose administered past the expiration/ beyond-use date.
At the time only arm pain and phlebitis. The second dose it was stronger. I had a headache and body ache, chills and fever.