chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised red rash about 4 inches in diameter at the injection site on my upper right arm of 7 days before. No rash had occurred before 3/5/2021 since the vaccination. This lasted about 3 days before fading out almost completely by 4 days (3/9/2021. No pain or itching.
Upon receiving the vaccine he stood up quickly from the chair and passed out immediately after. He fell back and his mom caught him and lowered him to the ground. He woke up quickly and said he felt nauseated. He drank a little water and cold rag. He sat there for a few minutes then got up and appeared to be alright and left with his family.
This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient got her first shot 8 weeks ago) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient got her first shot 8 weeks ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient got her first shot 8 weeks ago) outcome was unknown. Not Provided. 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. No concomitant medication reported. No treatment was provided. Reporter did not allow further contact.
Left arm injected, and I have been experiencing burning of the left side of my face. The burning is not present on the right side of my face.
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot# M025192, lot# M027884, lot# M036612, lot# M046133 (expiration dates were not reported) and lot# N000237 with expiration date of 25-OCT-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004408: US-009507513-1708USA004409: US-009507513-1708USA004393: US-009507513-1708USA004392: US-009507513-1708USA004394: US-009507513-1708USA003935:
Injection was administered at around 11:30 AM,. Immediately after the injection the patient started to faint and showed some hand movements. The pharmacist and technician helped the patient to the floor, where the patient continued to faint and had more hand and leg movements. after a short period the patient started responding to questions and wanted to sit up. Once the patient moved from the floor the pharmacist noted a wet spot under where she was laying down and concluded that patient may have voided her bladder. The patient was given some water to sip and asked for her sister to be brought into the pharmacy. The patients caregiver gave her orange juice and the pharmacist called EMS and waited for paramedics. Upon arrival the paramedics evaluated the patient and the patient opted to leave for her home with her sister.
Initial report received from a nurse on 07 December 2006. A 66 year old, female patient experienced a sore arm, nodule at the injection site and began flu-like signs and symptoms (non-specific) on the evening after she received an injection of Fluzone (lot number U2165DA, route not reported) in the left deltoid on 09 October 2006. She had 1 previous dose of Fluzone in the past and she did not have any illness at the time of vaccination. At the time of the report, she had pain and nodule at the injection site was still persisting; she was unable to sleep on her left arm. She was not recovered. Follow-up information received on 22 January 2007 from a health care professional. The patient was 46-years-old (not 66 as documented in the above narrative). Fluzone No Preservative 2006-2007 had been administered intramuscularly in the left deltoid. The patient had experienced pain at the injection site and entire arm which is worse in the morning and at the end of the day. The patient never had a nodule at the site or flu-like symptoms. She had physical therapy four times "since this report" and has experienced a little relief with "iontophoresis and Advil." At the time of this report. the patient continued to have intermittent pain.
REBOUND COVID-19; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: low body temperature, and allergy. 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 14-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 53 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 2022, the patient experienced rebound covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rebound covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
info was recv from a MD concerning a pt who recv varicella vax on 18dec95; in July 1996, pt was dx w/ neuroblastoma. in nov96 pt presented to MD w/ chickenpox, w/ approx 15-20 lesions noted on the first day.
Tongue swelling - occurred hours after receiving vaccination on 4/9. Swelling subside after 1-2 hours  Throat closing sensation - symptoms started on 4/11. Treatment - Benadryl, Claritin, Motrin, honey, warm water, gargle salt water. Swelling occurred on 4/11 and 4/14-15; still experiencing the symptoms as of today - 4/16.  Tongue itching - occurred hours after receiving vaccination on 4/9. Still experiencing symptoms today - 4/16
I had some fatigue the day after the vaccine, no mayor reactions. On July 8th2022, I woke up with sore throat and I had 100.8 fever, headache, extremely fatigue. I was in bed the entire day. I had a home test and congestion. Home test for COVID-19 was positive, the PCR also positive. I had a virtual visit with the doctor that recommend, he prescribed medication for 5 days, I felt fine that. When I had another test, I tested Negative (7/16).
Admitted for hypertensive urgency, COVID + 1/3/22-1/6/22. Treated baricitinib 1 mg daily, remdesivir 200 gm first dose only the stopped  due to low eGFR, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product 4 times, having received vaccine on 01/06/2021, 02/03/2021, 111/01/2021, and 04/28/2022. They tested positive for COVID-19  via antigen test on 09/30/2022 at the facility at which they were a resident. I see no indication they were admitted to hospital for this illness. They died on 10/01/2022. COVID-19 is in Part II of the death certificate.
Cold sore developed on my upper left lip.     I do not have herpes.   I have not engaged in sexual activities since my husband died in 2009.   I correlate this cold sore with the vaccination that I received on 3/15/21.    I am treating this sore with topical analgesic cream.  I still have the sore and it is now 3/26/21.
The next morning my eyes were sensitive to light and then I became more exhausted by the hour. Full body Aches set in, foggy head, headache. By around two I began running a light fever. By about 3 pm I felt overall horrible. By four-five I became incredibly nauseated and began vomiting about an hour later. I kept vomiting throughout the night until it was only acidic bile left. During this time I was burning up if I had even a sheet on my skin, but freezing if I didn?t. I was sweating late into the night.  Vomiting stopped around 3 am.   The next two days I managed rice, bananas and teaspoons of water but was always nauseated. Fever was gone, but headache and exhaustion remained.  Daily nausea finally began to wane and was replaced by heartburn and gross feeling in my throat for about two days. About a week and half after the shot I finally regained my energy and had no stomach issues. Two weeks after injection today- The injection site still is bruised and burns/itches from time to time lightly.
Patient's right upper arm with erythema, I does not appear infected but a localized reaction is present. He received his HPV and MCV4 vaccines in the location yesterday; recommended ice 10 minutes hourly as able and Tylenol prn. This likely will take 3-5 days to improve. Re-evaluation recommended if he develops fever, increased redness or other symptoms.
Complained of abdominal pain -rt upper quadrant after getting vaccine. After several months of CT scans, ultrasound, Hida scan and endoscopy - found gallbladder sluggish. Surgical consult.
contracting covid infection after receiving 3 doses of Pfizer vaccine; contracting covid infection after receiving 3 doses of Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracting covid infection after receiving 3 doses of Pfizer vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 DAYS AGO (07/17/2018) PARENTS NOTICED ERYTHEMATOUS, HARDENED KNOT ON RIGHT THIGH AT SITE OF INJECTION. NOT WARM TO TOUCH BUT DOES APPEAR TENDER TO TOUCH. AREA OF INDURATION AT VACCINATION SITE ONLY ON RIGHT THIGH. LOW GRADE TEMP ONCE 3 DAYS AGO HIGHEST 100.4. PT HAS BEEN MORE FUSSY LATELY & DECREASED APPETITE.
Injection site became very swollen bright red & very hot & inflamed. Face became red & hot. Throat & tongue felt swollen. 11/10/11 & 11/11 emergency room.
Local skin rxn vs cellulitis at injection site 1-2 days post vaccine.  Placed on Keflex x10 days.
Case previously recorded as MA2009-5224. Initial case report received from a physician via agency, on 19 NOV 2009. A patient 1-year-old male was vaccinated inadvertently with S-OIV FLUVIRIN (batch no. 102124P1) once i.m on 13 NOV 2009. No adverse event was reported. Agency reference no.:NA09-008308.
pt states developed itching and a 4x3 hot, red, hard swollen spot around the injection area.  pt states the spot in now pink and itching has subsided since taking a Benadryl per PCP instructions.
chest pain; racing heart; muscle ache; really shaking up; bad lower back pain; headache; nausea; diarrhea; she feels weak; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up) and BACK PAIN (bad lower back pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, Muscle ache and Back pain, at an unspecified dose and frequency and CELASTRUS PANICULATUS, CENTELLA ASIATICA, VALERIANA JATAMANSI (SLEEP TEA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), PALPITATIONS (racing heart), MYALGIA (muscle ache), NERVOUSNESS (really shaking up), BACK PAIN (bad lower back pain), HEADACHE (headache), NAUSEA (nausea), DIARRHOEA (diarrhea) and ASTHENIA (she feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided
Case number PHEH2014US025071, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 71 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
About 1 hr after receiving flu shot, breaking out around neck & low back - itching & hives - took BENADRYL 25 mg x 2 - hives spread over about 50% of body - got better after BENADRYL - was gone next morning.
Started tightness in my chest, short of breath, and rapid heartbeat.  Saw my Dr a few days later and had an EKG. Still experienced same symptoms.  NP ordered halter monitor on 3/4 which I wore for 48hrs.  Results showed I was in AFIB NP rx'd Elaquis.  Saw Dr. on 4/25 and rx'd Metaprolol.  Going for an angiogram in June.  Tested positive for Covid on 5/27
This is a spontaneous report from a contactable other health professional. A 5-month-old male patient received the first dose of PREVNAR13 0.5ml single dose via an unspecified route of administration on 05SEP2014. Relevant medical history and concomitant medications were not reported. The patient experienced hives on 05SEP2014, 8 hours after having received PREVNAR13. The hives had lasted up to a month, but resolved on an unspecified date. The reporter believed that the hives were due to PREVNAR13. A physician wanted to test the patient to see if it was a true allergic reaction to PREVNAR13 and the reporter wanted to know if there was any way that they could obtain samples of PREVNAR13 to use for testing purposes.  Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.
Been sick with flu like symptoms for 2 weeks without fever. So tired don't want to get out of bed sometimes. Uncontrollable coughing all night. Weakness after little activity.
Headache and sore throat and stiff neck. And I went to the doctor for these symptoms on the 17th of March because that is when I really started feeling bad for the symptoms. I'm feeling fine now. I still feel a little neck stiffness but almost gone.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route of administration, lot # and expiry date was not reported) for prophylaxis. On October 2018 (reported as 12 hours later), the patient had intense pain and swelling from injection site which radiated to back of patient. The patient went to the emergency room and received arm sling to wear. At the time of report, the patient did not recover from the events. The reporter's causality assessment between the events and the suspect therapy was not reported.
patient reported feeling tingling sensation down her vaccine arm and slightly cool to the touch on lower arm, upper arm began feeling warm. patient reported no other feelings or symptoms, no allergic reaction. advised patient to move arm to see if feeling would subside. she did, then relaxed fora  while and feeling began to lessen. she stayed with me long enough for the feeling to subside. she said she felt fine and left, after i told her i would report her symptom just in case.
Moderna COVID-19 Vaccine EUA. Severe headache, muscle aches, nausea, vomiting, fatigue, soreness at site of injection. Symptoms beginning ca. 12 hr after injection. Vomited 4x between 2:30 a.m. and 11 a.m.  Symptoms somewhat improved by 2:30 p.m on 01/09/2021, 24 hr after injection: headache reduced, able to consume liquids, but still fatigued.
Pt recvd 3 doses of Hep B vax 27FEB90, 27MAR90, & 27AUG90 & 27SEP90 screened & found to be pos (having antibodies); checked again 20OCT91 & was neg showing low titers;
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R002084; expiration date: 02-OCT-2019 or lot # N024717; expiration date: 06-APR-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006261: US-009507513-1809USA006262: US-009507513-1809USA006263.
From telephone contact with the reporting nurse it was stated that a 5 year old patient (1 of 2) received an IPOl, a Tripedia and a MMR (manufacturer not specified) vaccination on 05/25/01. The patient developed a large local reaction, exact site not specified. Further information requested.
diagnosed with transverse myelitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for blood pressure abnormal. Vaccination history included: BNT162b2 (Dose: 1, vaccination date: 29Jan2021, LOT- EN5318 or RN5318- Hard to read on vaccine card), administration date: 29Jan2021, when the patient was 68-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, 05Mar2021 , LOT- EN6202, right dose), administration date: 05Mar2021, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "diagnoses with transverse myelitis", "temperature changes", "Muscle weakness", "gait is fumbled, balance issues", "gait is fumbled, balance issues", "pain in left arm after doses", "skin on thighs hurts to the touch", "near his ribs is tingling and prickling", "near his ribs is tingling and prickling"; Hepa vaccine . The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset Apr2022, outcome "not recovered", described as "diagnosed with transverse myelitis". The event "diagnosed with transverse myelitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Unknown results; Magnetic resonance imaging: (Apr2022) that there are two areas in the spinal cord, notes: show the myelin is missing causing misfires. diagnosed with transverse myelitis in Apr2022. /which showed the missing myelin sheath in the spinal cord. Therapeutic measures were taken as a result of myelitis transverse.  Clinical course: Caller is calling on behalf of her husband, Caller states the patient's MRI showed that there are two areas in the spinal cord that show the myelin is missing causing misfires. diagnosed with transverse myelitis in Apr2022. is losing muscle mass and strength. Neurologist did a scan on 04Apr2022, which showed the missing myelin sheath in the spinal cord. Neurologist put him on IV steroids for a week straight in Apr2022, exact dates unknown. Caller states this did not work. Product information Unknown for Steroids. Exact name of product unknown. Also, patient was given 900mg of Gabapentin to help him sleep, states he was on this for 2 months and it didn't work either- 300mg by mouth for two days, then one by mouth twice for 2 days and then by mouth TID (three times a day). The patient had visited multiple doctors. The adverse event dose not resulted to visit Emergency Room. The patient was not hospitalized. HEPA Vaccine was taken. The patient received Steroids and Gabapentin for treatment of the filed event. States neither of these medications worked for the patient. Caller does not have any specific details of either the steroid treatment or the Gabapentin to provide.
31-year-old male. Records review and patient history reveals SM presented to the Primary care on 23 Oct 2009 with 2-week history of polyuria and polydipsia. SM history also reveals increased fatigue which may have been noted as early as Sept. SM's primary reason of seeking evaluation was a sudden, significant weight loss of about 20 pounds over previous 2-weeks. After initial lab results from Primary care showed elevated glucose, patient was contacted by phone and instructed to go to the ER. His glucose level was 361; his UA was positive for glucose and ketones; he was given a dose of Insulin in the ER. He was prescribed Metformin which he only took for 2 days. On 26 Oct 2009, SM's fasting glucose was 277. He received instruction on SBGM and insulin, and was started on bedtime LANTUS with NOVOLOG before meals. He was seen by an Endocrinologist on 29 Oct 2009 and has continued periodic follow-up with Endocrinologist, as well as local PCM. He has received diabetes self management instruction and continues to control his diabetes with intensive insulin therapy. SM's initial HbgA1c on 29 Oct 2009 was 11.1 (4-6) and his GAD-65 Ab was >30.0 (< 1.0), IA-2 antibodies (Pancreatic Islet Cell Antibody 512) were 7.8 (<0.8), his C-peptide was 0.6 (.8-3.1) and his insulin level was 3.7 (2.6-24.9). SM denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was treated with Prednisone 50 mg x 5 days, starting on 5 Oct 2009 for acute low back pain. SM has noted tingling in his feet and visual blurriness related to alterations in his blood glucose levels. Prior to diagnosis, SM had been very active with sports (bike riding, completion of triathlon). His BMI was normal (~25) prior to diagnosis. Of note, he completed an insurance physical in August which was completely normal. SM has family history of diabetes (PGM with T1DM, MGM with T2DM).
Fever to 102. Localized swelling, erythema and pruritus in the left deltoid area measuring 8.75 x 7.75cm.