chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A red area at the site of injection about 4 inches across; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) 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) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across). At the time of the report, VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across) 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.   No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) 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) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across). At the time of the report, VACCINATION SITE ERYTHEMA (A red area at the site of injection about 4 inches across) 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.   No relevant concomitant medications were reported.  No treatment information was provided.
Slept from 2 pm that day till 7AM next morning very unusual. Restless sleep: very jerky when waking, could not hold head steady. Did eat 3 times in time frame above. Would not open eyes temp 99.6 with Tylenol. Boys first vaccination.
Bleeding at the injection site (at the time of the injection),few drops of blood; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. 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 VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding at the injection site (at the time of the injection),few drops of blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Upon internal review on 27-Sep-2022, Non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Had influenza symptoms (fever, cough) and positive nasopharyngeal swab for influenza about 2 months after influenza vaccine.
Left upper arm erythematous, warm to touch (+) swelling. No SOB. Symptoms started on 10/5/11. Treatment - ice BID & TYLENOL 325 mg 2 tablets PO BID PRN.
3rd dose of initial Pfizer Covid-19 vaccine was given 6.5 weeks after 2nd dose instead of 8 weeks. No adverse events occurred with the early administration of this 3rd dose.
Tested COVID-19 positive on 09/19/2022; body aches; chills and low grade fever; I had a telehealth visit and was prescribed a course of PAXLOVID. After about two weeks I started feeling much better but then developed a producing cough and labored breathing I was prescribed Z PAK for 5 days followed with prednisone for 12 days. I also took albuterol as needed.
He is on oxygen and a CPAP; Double pneumonia; Cough; Wheezing; Sore throat; stuffed up; almost couldn't breath; COPD; Has all RSV symptoms except for fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: HYPOXIA (medically significant), outcome "unknown", described as "He is on oxygen and a CPAP"; PNEUMONIA (medically significant), outcome "unknown", described as "Double pneumonia"; COUGH (non-serious), outcome "unknown"; WHEEZING (non-serious), outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffed up"; DYSPNOEA (non-serious), outcome "unknown", described as "almost couldn't breath"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "Has all RSV symptoms except for fever"; HEADACHE (non-serious), outcome "unknown". The event "has all rsv symptoms except for fever" required emergency room visit. The patient underwent the following laboratory tests and procedures: Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Negative, notes: he tested negative for COVID-19 with self testing and testing at pharmacies. He was tested 4 or 5 times.  Clinical course: Patient doesn't know if he is calling about a Pfizer product but he tested negative for COVID-19 with self-testing and testing at pharmacies. He was tested 4 or 5 times. He has symptoms that could be RSV. He has everything except the fever. Has a cough, wheezing, sore throat, headache, is stuffed up,. He is on oxygen and a CPAP. Is 75 years old and worried about his symptoms. The only almost couldn't breath place that tests for RSV is (Withheld) Urgent Care. Doesn't know what Pfizer could do about RSV or RSV testing. Clarified he doesn't know what RSV stands for but knows RSV is a lung disease. He also has COPD. Clarified he is not calling about a specific Pfizer product related to RSV he is calling about research that Pfizer completed regarding COPD and COVID-19, even though what he may have is not COVID-19 but may be RSV. The CDC is putting a warning out about RSV and testing for RSV. He will be tested for RSV but doesn't know if his insurance will cover it or not. He has all the RSV symptoms except the fever. He had double pneumonia and almost died. He has used Pfizer products for COVID-19. Clarified he did have the Pfizer COVID-19 Shot brand.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dyspnea on exertion, orthopnea, SOB - diagnosed with possible myocarditis, myositis and pneumonitis along with diaphragm weakness potentially related to immune checkpoint inhibitor toxicity
injection painful, with both pushes of they syringe.  Unlike any injection I've experienced.  Painful injection , but pain began about 6pm.  Continued painful and restricted mobility of arm. (Had to use left arm to lift or move right arm., hand, no strength in hand?   Pain so intense at 5am left for ER 9-10.  Treated as post immunization reaction.  Given strong ibuprofen.  Went to Primary Dr. 7/30 -- non stop pain, at a  6-7, increased motion of arm.  Primary treated as tendonitis, scripts for diclofenac gel, gabapentin. Instructed to complete Vaers form and advise pharmacy
Very sore throat, headache, body and muscle aches, congestion. Fatigue after a couple days - that subsided but lasted the longest - 2 weeks I would say. Then we tested positive again. Second time I had a little congestion, a minor headache. Nothing serious.
Fever 100.2, congestion, bronchitis,diarrhea,vomiting,chills, hot flashes, itching. Dissiness,weakness,
Numbness of the left side of head, face, lips, neck, shoulder down to elbow.
body aches, cough, chills, fever with recent travel onset 5/8/22
Initial and follow up information was received from a pharmacist concerning to a 69 year old female patient with rheumatoid arthritis. No allergies reported. On 25-SEP-2017 (also reported as "a couple of days ago"), the patient was vaccinated with a dose of ZOSTAVAX (Lot No. M037655, exp. date 29-NOV-2017) subcutaneous for prophylaxis. Secondary suspect included sterile diluent (manufacturer unknown) (Lot number and expiration date not reported). Concomitant therapies included prednisone (manufacturer unknown) and PLAQUENIL. On 01-OCT-2017, the patient returned to the pharmacy describing "pain in her ear, radiating to her scalp and head". The patient made an appointment to be examined by an unspecified physician. On 02-OCT-2017, the physician diagnosed the patient with shingles. No laboratory tests were performed. The patient did not received treatment. At the time of the report, the patient had not recovered from shingles. No death nor life threatening were reported. The relationship between shingles and therapy with ZOSTAVAX was not reported.
Reports approximately 5 hours after immunization developed HA, body aches to joints, nausea with vomiting. Noticed redness and warmth to site of injection. 10/28 fever, vomiting, diarrhea and body aches, redness to Injection site about size of dollar bill. Sunday symptoms started to resolve vomiting ceased 1030 am. Monday morning no further fever, Injection site with small nodule, nor redness or warmth.
Father indicates that the girl has red dots on her face and it itches. The patient is taken to the emergency room for treatment.
HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient was clingy with the parents, not sleeping (in a daze) and had fever of 103.
Started with fever and general malaise the day post vaccination. Hives spread out over trunk that have worsened with time appearing one week post vaccination. Improved with benadryl but again worsened once medication stopped so patient just started Medrol dose pack.
One hour after the injection I developed a severe tremor. For two days I was so tired I could barely walk. Then I became extremely nauseous and started vomiting to the point that I could barely breathe. I was incapable of keeping fluids down for over two days.  I began taking Zofran and that enabled me to drink water again.  Two weeks later I am still having a difficult time eating solid food.  I have no energy or appetite.
About 2 months after the vaccine, patient developed a large lump under his right arm. On 01/24/2023, patient was diagnosed with Mantle Cell Lymphoma.  Pet Scan is scheduled for 01/27/2023. Chemotherapy will begin shortly thereafter.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL was administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 21-FEB-2013 (lot # and expiration date were not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
Stroke - right arm and leg weakness, confusion and diagnosed with left pontine lacunar infarct by CT scan 3/28/21. Needed 30 days of hospital and rehab care Had residual post stroke weakness and had a fall 5/2021 with femur fracture needing surgery
Information has been received from a health professional concerning a 32 month old white male with no known medical history who on 4/1/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 643821/0865M). There was no concomitant medication. There was no illness at the time of vaccination. On 8/31/04, the patient experienced 10-12 lesions on his trunk and a few behind the knee crease. He was afebrile. Unspecified medical attention was sought and he was treated with diphenhydramine hydrochloride. There was no product quality complaint involved. Follow up information indicated that on 8/31/04, the patient developed a rash which lasted two to three days and the patient recovered. No further information is available.
My husband had the shot and 2 days after I started my period again after it had just ended 3 days before his shot and it lasted for a full month.  I also had night sweats, chills, body aches, tired all the time, as well as insomnia.  This lasted for a full month.  I tried to report to my doctor, but they were in denial that this could be vaccine shedding.  A co-workers husband who also works at the SY and got the the J&J shot suffered the same affects as I did.
This spontaneous report as received from a other health professional refers to a 15 year old female patient. The patient's medical history included myalgia. On 2017 the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal conj vaccine (unspecified). On an unknown date the patient experienced myalgia. The outcome of myalgia is unknown. Additional information is not expected.
Patient usually has migrane but they have increased since she received the vaccine. Patient is still experiencing increasing migraines and headaches since then. She contacted her doctor and he suggested to report it to vaers. Patient has been taking Advil and  Butalbital as needed.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II (dose was not reported, subcutaneously, HSA; lot # H014977, expiration date 09-AUG-2014). The MMR II was supported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to a 17 months old patient who on 25-JUL-2012, was vaccinated with a dose of VAQTA (route and lot number not reported). The licensed practical nurse reported that she was administering VAQTA and the vaccine leaked out between the needle and the syringe when she was administering the product. The nurse clarified that this was not the prefilled syringe, the dose came from a single dose vial. No adverse symptoms were reported. Additional information has been requested.
Patient was administered 0.2 mL of Pediatric Pfizer COVID vaccine (orange cap) prior to dilution. Patient left office in stable condition. Provider talked to patient's father on the same day and he reported that patient is doing fine . As advised, father will continue to monitor patient's condition and temperature as needed.
mother came in with son and filled out paper work and claimed son was 12. He was 11 and 364 days. her son  turned 12 the next day
Around April 19, 2021 started feeling stomach sick--flank pain on my right side, pain on the upper center of my stomach and went around to my back and that continued for a week. I then I went to see my NP. I had ultrasound on my stomach- normal, blood test. She wrote a referral to have an upper and lower GI-test 06/15/2021- with Dr. Dr. ordered a Hida scan - 07/26/2021- then the next day the results were that my gall bladder was not functioning normal- Bilary dyskinesia. On 08/30/2021- I had surgery to have my gall bladder removed and I was out of work for 2 weeks. I do not think it is associated with the vaccine.
About 5 min after receiving IM Pfizer COVID injection, patient developed flush feeling, dizziness, and sore throat. Taken to ED for evaluation. Monitored for approximately 1 hour with resolution of symptoms.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 15-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Fever, chills, muscle aches, headache, upset stomach, sore throat, shortness of breath, extreme fatigue, odd taste in mouth.
Diarrhea; Fever; Pain at Injecttion site (Right); A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection (right), diarrhea, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) pain at injection (right). On 24 Feb 2021, the patient experienced the event(s) diarrhea, fever.  Treatment details included History Allergy, Caller took Imodium.  Action taken with mRNA-1273 in response to the events was not reported.  On 24 Feb 2021 the outcome of event(s), pain at injection (right) was resolved. The outcome of event(s), diarrhea, fever was unknown.
Patient states that she experienced a bad headache the evening she received the vaccination. The next day the injection site was swollen and red and painful. She has had a half-dollar sized bruise for 2 weeks. It is no longer swollen or painful. She saw her doctor and they informed her "the bruise may last for months and the vaccination administrator may have hit a nerve or blood vessel. Patient is a former nurse and states she "has never seen anything like this before".
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions or medical history were reported. The nurse reporter that, on an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (HPV4) (lot number, expiration date and frequency were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several r4eports from the same source. Additional information has been requested.