chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like her throat was swolen; couldn't breathe; This case was reported by a consumer via interactive digital media and described the occurrence of throat swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, 10 hrs after receiving Bexsero, the patient experienced throat swelling and difficulty breathing. On an unknown date, the outcome of the throat swelling and difficulty breathing were unknown.   It was unknown if the reporter considered the throat swelling and difficulty breathing to be related to Bexsero.  Additional case details were reported as follows: This case was reported by the consumer for his/her daughter. The age at vaccination was not reported. The patient just got the vaccine. The patient did not have any reaction to any other ones but this one bothered her. About 10 hours later the patient felt like her throat was swollen and she couldn't breathe. The reporter still has to take patient back for a booster in a month.  The reporter going to but, was little nervous why the patient would have such a delayed reaction. The reporter did not give permission to follow up.
3-4 inch "knot" on left arm at site of injection. Area is reddened, warm to touch, per patient and patient's wife. Patient states he noticed area "about 2 days after I got the shot". Patient reports area has improved "some" since 2/21/15, however states area is "still red and swollen, about 3-4 inches". Instructed patient to use warm or cold compress on area for about 10-15 minutes at a time and take TYLENOL, if permitted by doctor, for inflammation. Advised to follow-up with MD if no improvement.
11/3/2003: Pt called to report that she came down with a fever and her right arm became swollen and painful late in the day after receiving her immunizations on 10/27/2003. By 10/29/2003 the symptoms were not improved and she saw her physician. The pt states that her physician informed her that the symptoms were due to a staph infection and put her on a course of Cephalexin. She stated that at this time she is "feeling better", and that she no longer has a fever and the swelling and discomfort in her arm are greatly reduced.
Itchy, back hurting, arm hurting , heavy breathing while walking, stuffy nose, headaches, body chills , aches in back and hip area and right arm hurting.
1235 Patient reported feeling lightheaded. Patient denies any other symptoms. BP 140/80, R 17, P 77, O2 95%. 1300 Patient denies dizziness, able to stand and ambulate with a strong even gait. Declined need for EMS services. Discharged from clinic. 1330 Called patient and she stated that she feels better and has no further concerns.
That next day, the injection site pain was with me for over a month. I couldn't move my arm; felt like someone was jabbing me. I can finally touch my arm now without feeling pain. The brain fog - it feels like - in the front of my forehead right above my eyebrows -  like there's something the size of orange that is just sitting there. It stops my thoughts and word processing. I was fine the day before the vaccine. That has not gone away. The doctor does not know what to do about the brain fog. I was having horrific full body muscle pain - especially in my legs. Like someone had put 20 lbs weight on each of my ankles. That is sort of resolved. But the fatigue - hasn't resolved. I always have a little bit of low level fatigue but this is worse - I have to have two naps a day now. Brain fog is the most troubling to me - hard to function - it's like instant Alzheimer's - my words are stuck in my mouth and I feel like I'm trying to think through a veil or fog.
A patient called & informed us that she had shoulder pain since her first injection of Moderna at the injection site. She took a picture because is swelling and she thought the immunizer had injected to high into the shoulder. She had no issues with the second injection. After following up with her doctor, she mentioned they theorized that the first dose punctured the bursa in the shoulder. She may have to undergo surgery.
Cellulitis and induration at the site of the injection. Treated with Kenalog 40mg IM and Claritin 10mg PO BID
Within 5-6 hours of receiving the vaccine, developed a rash on abdomen, mainly on the left side.; Rash consists of a few dozen small reditchy bumps; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) from an unknown date and for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) via an unspecified route of administration in the arm left on 13Mar2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 03Apr2021 at 21:30, within 5-6 hours of receiving the vaccine the patient developed a rash on abdomen, mainly on the left side. The rash consists of a few dozen small red itchy bumps. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events rash on abdomen, mainly on the left side and small red itchy bumps were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The patient started coughing and got nauseated in a few minutes after receiving the vaccine. She experienced tingling in the right arm, sore throat, hoarseness and headache. The cough and nausea stopped after about 10 minutes. Patient  was stable and left about 30 minutes after the shot was administered.
Patient described feeling of tingling in fingers that spread to cheek all on the left side starting on Friday. She reported to the ER on Friday with concerns of a stroke. All tests came back normal. Tingling lasted 5 minutes.
Pt. Type 1 DM. Developed lighheadedness, shakiness, and palpatations within 10 minutes of receiving vaccine.  blood sugar WNL.. Observed in ED x 30 additional minutes and released with interventions.
09:40 patient was in the car going home, reported nasal stuffiness and scratchy throat 10:00 returned to Vaccine Clinic; c/o above, received 50 mg oral Benadryl (VS, pulse ox and EKG wnl) 10:10 complained it was difficult to swall0w, 0.3mg Epinephrine via auto injector administered, peripheral IV started, 250 ml NS infused; ambulance called 10:20 ambulance arrived 10:29 patient transported to  Hospital  1600 called patient who was just leaving the hospital; per patient she received oral steroids, Albuterol inhaler; discharged on Benadryl, oral steroids and orders to carry an Epi Pen
HIVES ON HANDS AND FEET ONLY; This spontaneous report received from a consumer concerned an 18 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, and batch number were not reported) dose was not reported, administered on 18-JUL-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hives on hands and feet only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives on hands and feet only was not reported. This report was non-serious.
temperature; aches and pains; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains) 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 18-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 BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains). At the time of the report, BODY TEMPERATURE INCREASED (temperature) and MYALGIA (aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Hypertension.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). The patient was treated with TOPIRAMATE for Headache, at a dose of 25 mg once a day; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Migraine, at an unspecified dose and frequency and ATENOLOL, CHLORTALIDONE (TENORETIC) for Hypertension, at a dose of 100 mg once a day. At the time of the report, HEADACHE (Headaches) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable
3/25/03 - sudden abdominal pain, SOB, weakness, nausea, tingling of arms and hands.  Went to Hospital er, EKG, chest x-ray, nitroglycerine, ASA, QIcectail, O2 per nasal canal, Bloodwork and sent home 3/27/03
Dizziness, Fluttering eyes 911 called and arrived 10.30am Temp 97,pulse 60 and BP 138/82 Patient has history of TIA as confirmed by grand daughter
Big red itchy patch, approx. 6"x3" which continued to today, Oct. 3, 2014. No treatment.
Moderna COVID-19 Vaccine: Yesterday, 1 week post injection - bright red rash at injection site, warm to touch, feels like a hard bump at the site, whole upper arm hurts (my arm hurt for a few days after the injection, then was OK) I called my PCP's office.  They stated to monitor, use Tylenol, warm compress.  Seek medical visit if it gets worse. Today:  I still have a rash, warm to touch, my arm doesn't hurt as bad.  My mom thinks it might be spreading.  She works in my PCP's office and they recommended reporting  it here and monitoring.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-SEP-2017 the patient was vaccinated with VARIVAX lot # M049127 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 01-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. This is one of everal reports from the same reporter. Lot number N010107 has been verified to be a valid lot number for VARIVAX.; Sender's Comments: US-009507513-1709USA002098:
I received the 3rd booster shot of the Pfizer vaccine on Friday.  The only side effect on Saturday was some slight discomfort at the injection site on my left arm. On Sunday, the joint in my left shoulder became painful and I could not raise my left arm above my head. On Monday, the pain in the joint of my left shoulder become to subside.
Patient receive 1ml of vaccine instead of 0.5ml as first dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (Patient receive 1ml of vaccine instead of 0.5ml as first dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient receive 1ml of vaccine instead of 0.5ml as first dose). On 13-Jan-2022, ACCIDENTAL OVERDOSE (Patient receive 1ml of vaccine instead of 0.5ml as first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported.
HPI   Here for breathing complaints   1. SOA on exertion: States since she had the covid vaccine in April her breathing has gotten worse, mainly when she is is exercising but occasionally when she is resting she feels like she has to breathe faster She uses albuterol inhaler a few times a day but it doesn't seem like it is helping She used to take a daily inhaler but doesn't recall which one She was treated for RUL infiltrate in March of this year Pt had covid infection in October 2020
Information has been received from a physician concerning a 57 year old female with penicillin allergy, allergic reaction to antibiotics ("e-mycin", azithromycin, clindomycin), drug allergy to indomethacin and drug allergy to codeine who on 30-OCT-2006 was vaccinated subcutaneously with a 0.5 mL dose of Pneumovax 23 (Lot# 651319/1007P). Concomitant therapy included ATROVENT, ACCOLATE, CLARITIN, ACIPHEX, ESTRING, vitamins (unspecified), ASPIRINE, AMBIEN and FLOVENT. The physician reported that on 30-OCT-2006 the patient had fever, chills, muscle aches, localized swelling, redness and tenderness at injection site (right upper arm) approximately 4-5 hours post-injection. The patient was treated with BENADRYL and TYLENOL. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
FEVER; CONTINUOUS HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: J2041H21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced continuous headache. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from continuous headache. This report was non-serious.
HALF HOUR AFTER SHOT IN LEFT AREM MOUTH TASTED LIKE METAL THEN ANOTHER HALF HOUR MY LEFT CHEEK, TONGUE, TEETH, JAW, NECK WENT NUMB, I CAN FEEL IT NUMB AROUND MY LEFT EYE TO. ITS LIKE BELLS PALSY WHEN I TRY TO SMILE LEFT SIDE OF LIPS GO DOWN ANSLEFT SIDE OF LIPS ARE NUMB AND THELEFT SIDE OF FACE IS SWALLEN AND JAW IS TIGHT.CHEEK FEELS THICK, TINGALING IN ARM DOWN LEFT ARE TO PINKY FINGER. SORE ARM WHERE SHOT IS. TIGHTNESS IN SHOULDER. CALLED NURSE SAID TO WATCH IT STILL THE SAME AFTER ALL NIGIHT, STILL NUMB ANS SWALLEN BUT CAN EAT BREATH AND TALK.
LEFT DELTOID has constant burning, pain and weakness.  I am unable to hold my arm at a raised position for more than a minute and it just aches.  It started back in Feb 2021 the day after I got my second vac.  I have not seeked medical help.  I did not feel this was important at the time.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    This case contains information for patient 04 out of 25. No concomitant medication information was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No adverse events were reported for any of the patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received which included Patient age, initials, gender and new references were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
When I woke up after two days of 1st dose of Covid19(moderna)01/08/2021, Right wrist was tight and hurting., and it lasted pain range of 10 after three days, after cold compress and Ibuprofen, constantly wearing wrist brace to ease he pain, I have to see my primary care. They prescribed Prednisone(series) and Meloxicam after the series and as needed.  It went away while I am taking the prescriptions. Then it has continuous pain range 5 and I have to continuously wear my wrist brace even while working. Then after second dose Covid 19(Moderna)02/05/2021, first thing the next day, pain went up to range 10 again and up to now, I have  to take Ibuprofen from time to time, warm and heat compress to alleviate pain and wearing wrist brace everyday.
Diagnosed with COVID-19; Diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 51; unspecified unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 04Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Last Monday (Mar2021; pending clarification), the patient was diagnosed with COVID-19. The patient was surprised that Pfizer didn't have additional information and asked if the company was doing any trials on people like her as she was sure there are more people than just her. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Patient is fully vaccinated and boosted on 11/14/2021.  COVID + on 12/31/2021 at visit to the ed.  Chief complaint: rectal bleeding and abdominal pain.  67-year-old male, history of MS presents to the ED complaining of lower abdominal pain, bloody stool that started today. Has had multiple bloody bowel movements. Crampy abdominal pain. Denies any nausea or vomiting. Does complain of sore throat and nasal congestion, mild URI symptoms. Denies any blood thinner medication or antiplatelet agents. No rectal pain. Has never had this happen before.  Also positive for congestion and sore throat. BP (!) 164/106  | Pulse 110  | Temp 100.1 °F (37.8 °C) (Oral)  | Resp 22  | Ht 180.3 cm (5' 11")  | Wt 86.2 kg (190 lb)  | SpO2 95%  | BMI 26.50 kg/m² CT scan showing multiple incidental findings including prostate enlargement, possible compression fractures. This was discussed at length with the patient, concern for possible metastatic disease. Possible prostate cancer.  Labs normal. Discharged from ED.
This was for booster shot. Mouth & tongue completely numb as if I went to the dentist.  This just happened haven?t been able to set up dr appt yet
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 15-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of Flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
rhabdomyolysis following receipt of BNT162b2-V; myocarditis; This is a literature report.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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 (First dose), for COVID-19 immunization. The following information was reported: RHABDOMYOLYSIS (medically significant, life threatening), outcome "unknown", described as "rhabdomyolysis following receipt of BNT162b2-V"; MYOCARDITIS medically significant, life threatening), outcome "unknown".; Sender's Comments: Based on the nature of the events, a causal relation between the reported event myocarditis, Rhabdomyolysis and the administration of the vaccine BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200056097 Same drug/event and different patient.;
Pt noticed red raised rash on trunk and arm. Pt evaluated by physician diagnosed with post vaccine urticaria.  Advised to take OTC Benadryl and f/u with PCP/ER for worsening s/s. Pt provided with telephone number for the vaccine healthcare center network.