chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (some tenderness at injection site) 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. Concomitant products included CEFALEXIN (CEPHALEXIN AMEL) for UTI.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 INJECTION SITE PAIN (some tenderness at injection site). At the time of the report, INJECTION SITE PAIN (some tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   This case was linked to MOD-2021-015479 (E2B Linked Report).; Sender's Comments:  MOD-2021-015479:
Sterile abscess at site of either Hib or Varicella vaccine. Appears to resolve spontaneously.
Information has been received from a pharmacist concerning a 65 year old male patient who on 03-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663894/0129Y) SQ. The patient had been taking monoclonal antibody for a study but discontinued on 29-DEC-2008. On 05-MAR-2009 or 06-MAR-2009, 2 to 3 days after administration of ZOSTAVAX (Merck), the patient experienced injection site reactions. The patient experienced erythema, swelling, induration, pruritus, bruising at the injection site and swelling of his entire arm. The pharmacist also reported that patient reported redness and itchiness immediately after administration. The patient had sought unspecified medical attention via telephone. At the time of reporting the patient's adverse events persisted. This is one of several reports from the same source. Additional information has been requested.
BODY ACHES; FEELING COLD; FEELING HOT; BODY STIFFNESS; This spontaneous report received from a parent concerned a 23 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 07:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced feeling cold. On 25-MAR-2021, the subject experienced feeling hot. On 25-MAR-2021, the subject experienced body stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, feeling cold, feeling hot and body stiffness was not reported. This report was non-serious.
I contracted COVID-19 around 06/20/2022 with symptoms of runny nose, sore throat, headache, fatigue, lightheaded, and shortness of breath. I was given monoclonal antibodies on 06/24/2022. I was ill for 7 to 8 days before my symptoms began to improve. I was later prescribed a steroidal inhaler for lingering shortness of breathe and fatigue that I used for 10 days. I am fully recovered with no lingering symptoms.
1) moderate-high arm pain Overall "flu-like" feeling within 9 hours of the vaccine, including: 1) headache 2) fatigue and body aches 3) stomach pain 4) difficulty sleeping 5) general malaise Within 24 hours, a mild rash appeared at the injection site, about 3" diameter overall. Raised, red, did not blister. Most symptoms resolved by the 2nd day.
REDNESS AND SWELLING AROUND 4CM CIRCUMFRENCE AROUND INJECTION SITE ON LEFT DELTOID.  WARM TO TOUCH.
Tuesday noc started w/stomachache, soreness of shoulders & neck, h/a, fever 101-102;Wednesday AM T100-102 same s/s w/sleepiness all day;PM fever broke, cont w/ h/a & neck ache;Thursday returned to school;
Developed ringing in the ears about 2-3 days after the COVID vaccine.  Did not have ringing in the ears prior to getting the vaccine.
around the injection the size of a cherry had black and blue; gold color; upper arm pain; intense fatigue; swelling on the upper arm about the size of an orange; redness, like tomato red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange), VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue), VACCINATION SITE DISCOLOURATION (gold color), PAIN IN EXTREMITY (upper arm pain) and ERYTHEMA (redness, like tomato red) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 003B21A) 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 reported medical history.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange) and ERYTHEMA (redness, like tomato red). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue), VACCINATION SITE DISCOLOURATION (gold color), PAIN IN EXTREMITY (upper arm pain) and FATIGUE (intense fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange), PAIN IN EXTREMITY (upper arm pain), ERYTHEMA (redness, like tomato red) and FATIGUE (intense fatigue) outcome was unknown and VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue) and VACCINATION SITE DISCOLOURATION (gold color) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked toMOD-2021-068416 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-068416:Original Case : MOD-2021-068416
I started having a pain in my chest and I noticed a rush which was very very itchy, painful in a circle right in the middle of my chest. I though it was shingles since I had ir before, I went to the doctor and he prescribed some mediction and a cream, I still have the circle and it still itches, looks better but today I am supposed to get the second Pfizer shot.
Developed severe, acute  chest pain abruptly, 10 days after second dose of Pfizer vaccine. Pain exacerbated by deep breathing or lying on back, and on one side (can't remember which). Pain mitigated somewhat by leaning over in chair, forehead resting on desk. Severe, acute pain lasted 48-72 hours. Mild pain persisted approximately 10 days.  Due to description of symptoms, and mitigation from leaning over, tele-health doctor suggested possible pericarditis diagnosis.
Information has been received from a licensed practical nurse concerning a 4 month old female with no medical history or allergies who on 03 Jan 2007 was vaccinated with an oral dose of Rotateq (human bovine) (lot #655484/1032F). On 10 Jan 2007, one week after vaccination, the patient developed decreased bowel movements. Medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
tested positive for COVID after testing negative at end of treatment; tested positive for COVID after testing negative at end of treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), on 02Mar2021 as dose 2, single (Lot number: EN6202) and on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfur for Allergy. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for COVID after testing negative at end of treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: testing negative at end of treatment; positive, notes: tested positive for COVID after testing negative at end of treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Addition information: After being on paxlovid I relapsed with COVID symptoms again about 7-8 days after finishing treatment. Also, tested positive for COVID after testing negative at end of treatment.
22AUG94 pt was administered vax 10AM pt lt office w/o an complications, however 3PM mom called pt had a fainting episode in car; pt did not bring pt into clinic because pt paniced; mom was advised to take pt to ER; dx vasovagal react;
15:10 walking to check out window - became pale - stated couldn't see, skin diaphoretic B/P 84/48 pulse 61, emesis x 2 - B/P 79/49 (15:15) - 15:25 - skin warm & dry - B/P 99/58 - no more emesis - vision clear, up walking.
Patient received 3 injections (Hep A, Menveo, and Gardisil 9).  He fainted after receiving the last vaccination (Gardisil 9).  He states that when he stood up he felt naseous.  He said that when he got in the chair, not even a minute later, he felt like he was going to pass out.  The patient  became pale and sweatly and fainted.  He was not unconscious for maybe a minute or less.  The patient was placed on the exam table and his head lowered and legs elevated.  Color quickly returned to the patient, but we kept him and checked his BP 3 times before he exited the facility with his siblings.  He is one of triplets and his siblings received the same injections, but had no reactions.
Patient received her first dose of Moderna vaccine on 1.7.2021. At a routine anticoagulation visit 7 days later (1.14) her INR was supratherapeutic at 5.5. Patient denied any changes in medications/diet/activity. The only change was receiving her first dose of the COVID vaccine. Patient only has a history of 1 supratherpeutic INR in 2019 due to accidentally doubling warfarin dose. Patient and spouse both report that there is no chance of a duplicate dose in this case. Patient's dose adjusted and INR will be checked more frequently per protocol.
3-4 days later he had diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (3-4 days later he had diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (3-4 days later he had diarrhea). The patient was treated with ELECTROLYTES NOS for Diarrhoea, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (3-4 days later he had diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medications were reported.  Treatment medications also Included yogurt and lots of water.
Information has been received from a physician concerning an 11 year old female consumer who "about one month ago" was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included a second dose of Gardasil (MSD). Other concomitant vaccination may have included Menactra. " Soon after vaccination" the patient developed nausea, dizziness, injection site redness and injection site swelling. The patient was examined by the physician. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about 2015, the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In or about 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
positive for covid; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program.   A 43-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 17Apr2021, as 1st dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22APR2021, after receiving first dose of COVID vaccine, the patient was positive for COVID. Reporter enquired whether it was fine to received second dose or to change the appointment. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date in Apr2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
No coughing, runny nose prior to vaccination. 11/9/09 - 6:00 PM woke c/o. Upset stomach (no N&V) headache - fever 101 degrees to 102 degrees 11/9 & 11/10 - 11/11 - feeling better - no fever - 11/12 - c/o numbness/ tingling in Rt arm - low grade fever 100 degrees - photosensitivity, headache some difficulty with breathing @ times. - (has asthma - no recent problems) Seen in ER on 11/12 - Lab work & CAT Scan - normal. To be seen by FMD 11/13/09.
Currently on titrated steroid regimen for asthma; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced currently on titrated steroid regimen for asthma on 07Oct2021. Therapeutic measures were taken as a result of currently on titrated steroid regimen for asthma. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341987 Pfizer
Second vaccine was given at the wrong interval...Should have been given at 2 months after the initial and was given at 1 month after the initial dose. Patient stated no adverse reaction at this time. Pharmacy instructed to contact the patient and explain that the second dose was given at the wrong time, patient is to receive the next dose to complete the series, 2 months after the error dose. Patient will be called on or around May 6, 2018 for the final dose in the series.
Extreme fatigue, muscle aches, pain at site of injection, slight headache and brain fog
Tacchyardia, seizures, syncope, tingling, numbness, paralysis, stutter, spasms, facial spasms,
Started with tender, swollen, knot at injection site followed by hives 24-48 hours later.
Pt developed erythema, edema and pain 8cm in diameter around shot area - symptoms worsening over last 4 days.
In late March 2021 I started experiencing persistent and significant pain when exercising, specifically cycling. This continued for about a month and stopped. In late May 2021 the pain returned and lasted about a month. In late September 2021 and continued until mid november when i quit riding because the pain was too intense. In early March 2022 I started riding again and the pain was there but I have been able to ride some but at a reduced effort and for shorter time periods compared to before the pain started.
acquired idiopathic urticaria on 9/11/2021.  Still ongoing today which makes it ongoing for 5 months currently with no signs of easing.
dizzy; I am walking, and my cheeks are flushed; temperature is around; chills; pressure on top of the head; Her body was hurting a little; Not feeling well; very slight headache and a little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little) and FLUSHING (I am walking, and my cheeks are flushed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy) and MYALGIA (Her body was hurting a little). On 03-Feb-2021, the patient experienced HEAD DISCOMFORT (pressure on top of the head). On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around), CHILLS (chills) and HEAD DISCOMFORT (pressure on top of the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Information has been received from a physician concerning a 65 year old patient with high blood pressure and high cholesterol, and no known drug reactions/allergies.  On 26-FEB-2008, the patient was vaccinated with ZOSTAVAX (Oka/Merck).  The physician reported that during the week of 12-AUG-2008, the patient developed a "nice case" of shingles on his right chest.  The patient is being treated with acyclovir.  The patient sought medical attention at physician's office.  At the time of the report the patient has not recovered.  The physician considered the shingles to be an other important medical event, as it required.  Additional information has been requested.
Retinal Vein Occlusion. Eye injections to treat occlusion. Still in treatment with primary care physician and retinal doctor.
The patient received Janssen COVID vaccine on 3/6 to RIGHT deltoid. She has a past medical history significant for LEFT sided breast cancer, treated with lumpectomy and radiation ~5 yrs prior. Remains on Letrozole. 1 day post-vaccine, she developed fevers (tmax 104), chills, malaise. 2 days post-vaccine, the fevers, chills, malaise dissipated but she developed a "rash" to her LEFT breast (same site as prior malignancy). This rash became a widespread erythematous area encompassing her entire breast. Axilla excluded.  No palpable lymphadenopathy. She reports area to be tender and itching. Rash is blanchable. It is somewhat response to OTC antihistamines (Claritin/Benadryl) and OTC hydrocortisone. She has no respiratory distress, lingering fever, or other allergic reactions. She was given a prescription topical steroid (triamcinolone) and will follow up with her in a few days, if she remains stable. If not back to baseline within the week, will obtain breast MRI for further evaluation.
Left deltoid injection site swollen, itchy, hot, arm is tight. Erythema and swelling too 5.5cm below elbow. Began as swelling around injection site. Erythema 28.5cm in circumfrerence. Treated with Medrol, Zyrtec, Prednisone, and Motrin.
Bell's palsy diagnosis by PCH. Left side of her face was paralized for about 30 days. No control of left side at all.
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: en5318), in left arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301485A), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I currently have Type 2 Diabetes" (ongoing); "High Blood Pressure" (ongoing); "Cholesteryl" (ongoing). Concomitant medication(s) included: ICOSAPENT ETHYL; QUINAPRIL; JANUMET XR; FARXIGA; OZEMPIC; ATORVASTATIN; NIACIN; ASPRIN; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: Patient received other medication in 2 weeks. Patient received orally, Pfizer drug for COVID 19 Treatment started on 02Jun2022, Lot number: ga1189. Other concomitant medication in 2weeks includes : 50+ Women's vitamin, brand, daily.
passed out after vaccine was given moved to EMS room BP: 108/61 HR:77 O2 98%