chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a Consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red, painful, and itchy rash. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the event  red, painful, and itchy rash. Treatment details included Antibiotics, Prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event red, painful, and itchy rash was unknown..
This is a spontaneous report from a contactable consumer (reporter's son). A male patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on as single dose of for COVID-19 immunization. Patient medical history not reported. Patient concomitant medications include IBUPROFEN (ADVIL 12 HOUR). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number  expiration date not reported) via an unspecified route of administration on (at age on unspecified date as single for COVID-19 immunization. Reporter reported that her son got the second dose of the COVID vaccine and after the vaccine he had worse side effects on unspecified date. Caller reports he had fever and chills. Caller states she gave him advil and he was able to sleep and 4 hours after the Advil he woke up vomiting. She reports he had a lot of vomit about 20 times, almost 20 times. In the morning he started wheezing, he had a stomach ache and sharp pains in his stomach and was very nauseous. He had a lot of pain in his stomach. Caller states that the pediatrician, was no help to her. She was very worried, today he woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Her son is better now but she does not know if he has Myocarditis now because the boy in the news had the same side effects as her son and had vomiting and stomach ache. Caller enquired she just needs to know what she needs to do. Is this a normal side effect. The Outcome of event stomach ache and vomiting recovered in 2021, outcome of other events was unknown.
On the 19th around 2pm, I started to feel achy and tired. I took Tylenol and started deinking a lot of fluids. I also restricted my activities. At about 3/4pm I decided to take my temperature and it was at about 100 deg. It did not last long. My temp returned to normal by 8/7pm. I still felt achy and tired. When I got the shot, it didn't hurt but the next day it began feeling sore. It lasted about 2-3 days. I've had an autoimmune disease. When I experience rashes or things similar, I credit it to my autoimmune disease. My PCP also suggests that back in March I might have had COVID. I was exposed to individuals and within 5 days, I became extremely sick.
Pt exam 2/25/2021 found swelling to left hand from wrist to fingers with discomfort in left arm which began 2/13/2021. No erythema noted.  No clubbing, cyanosis.  Treatment - Patient advised not to get 2nd vaccine.
At 1030on 5/5/21 the patient developed right-sided facial droop, and right arm and leg weakness. These were accompanied by headache and confusion (unable to state year of birth/age). No intracranial bleed was noted on head CT and NIHSS was 5. Glucose WNL and BP 146/72. Patient received alteplase to treat suspected ischemic stroke. Patient received ondansetron pre-hospital for nausea, and received Norco and a fluid bolus. Patient is being admitted to ICU for monitoring after alteplase administration.
This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, 2 patients were vaccinated with VAQTA (lot#L003011 (non-valid), expiry: 15-NOV-2017, lot#L014068, expiry: 12-NOV-2017, dosing details and route of administration were not reported). The vaccines were exposed to a temperature of 34.6 F for 1 hour. There was no previous temperature excursion. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
chills; severe headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (severe headaches) and PYREXIA (fever) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (severe headaches) and PYREXIA (fever). On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills), HEADACHE (severe headaches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
During the night after the BOOSTRIX TDAP vaccine, I had sever pain in the shoulder and upper arm region where the shot was administered.  On 03 Feb, I returned to pharmacy and explained the problem and it was stated by the Pharmacist that the shot was administered too high on the arm. Pharmacy recommended a homeopathic ointment to ease the pain.  Today I have been unable to sleep due to the pain and the pain persists to date 04 February 2017.
Information has been received from a pharmacist who stated another pharmacy called her to tell her a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (name and manufacturer of the specific vaccine was not provided) had a seizure. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was considered to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter.
Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago; Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: I have Gerd and take famotidine; "Hiatal hernia" (unspecified if ongoing), notes: I have hiatal hernia. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: Tested positive for COVID 19 2 days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I received the Moderna booster (after initially getting Johnson & Johnson vaccination) on Monday, April 18. The next day, on Tuesday, April 19, I started being achey and fatigued with a headache, as expected after this vaccine. However, I also developed a left earache (unilateral). It has now been more than 4 weeks, and I still have the earache. It is a constant dull ache, with occasional exacerbation and stabbing sensation. It hurts deep inside the ear.
Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are focused vertically from chin
During the night after I was vaccinated, I had pretty intense pain in my sternum.  The pain was there for about 2 days.  Then 3 days after vaccination I developed a urinary tract infection.  This is the first time I ever had one in my life.  I am not sure if these two things are related to the vaccine or not.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.
Pt came for check up. Needed PPD & #2 Varicella vaccine. PE normal. PPD was placed on rt forearm & 2 min later the Varicella vac. on the left deltoid. One-2 secs later pt fainted few secs later pt started talking.
Less than 5 minutes after administering vaccine, patient stated to feel hot/sweaty and nauseous then proceed to vomit. Patient denied difficulty breathing and was given ice packs and stated to feel immediately better, but was told to stay an additional 20 minutes after the 15 minute post-vaccine adminstration period and then left the pharmacy area after that. Followed up with patient's mother 5/6/22 and she states patient has continued to have vomiting and diarrhea since vaccine administration, but has not been taken to follow up with a physician.
Within minutes of getting vaccine complained of headache and dizziness. Watched in clinic for an extra half an hour, was stable no other complaints, thought he was feeling better so sent home. Parent and parent returned to UC on 1/19 reporting that headache continued for several day and was intermittent after that. But still happening most days. Better with Tylenol of ibuprofen, but dad was using sparingly.  Had follow up in pediatrics on 2/2. Dad reports headaches are improving  in frequency and severity But patient still complains 2-3 times a week. Mostly seems to complain during school or homework so dad is not sure if he is having pain or if it is behavioral. Is concerned as this is not a symptom he had previous to vaccine and the symptoms are so prolonged.
Rec'd 1st dose Hep B at 4:00 pm on May 11th. At 5:30 pm began to itch and soon after broke out in rash on arms and legs. Phoned her physician advised to take Benadryl. On May 12th some urticaria continued and rash continued. May 15th follow up still rash primary upper arm and lower leg.
Case number PHEH2015US026927 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and  when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
At 11:50, patient presented with Itching throat/cough started less than 5 minutes after injection. Patient had a normal HR and oxygen sat.  At 11:58, patient was given 50 mg of diphenhydramine that was administered IM, 10 mg cetirizine by mouth, and 20 mg pepcid by mouth. A red rash appeared on the right forearm 5 inches in length. After 20 minutes, symptoms were reduced and patient returned to work.  Recommended she stay on the floor for an hour with light duty and to be watched by coworkers and to call for a ride home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 08Jan2021 as dose 2, single (Lot number: EJ1686), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Apr2022 as dose 4 (booster), single (Lot number: O84S21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Strongly positive by antigen test; (24Jun2022) Negative, notes: Tested negative on 24Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Chest pressure/chest pain, palpitations, hot flashes.  EMT called for 2nd unit to transport patient to hospital.
Feeling fatigued; Achy from head to shoulders/whole body aches; Headache; fever up to 96 F; Shoulder pain; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F.   The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Patient was feeling fatigued and achy from head to shoulders, and not feeling generally well. On 04 Jan 2021 after taking the vaccine, the patient experienced, achy from head to shoulders, shoulder pain, headache, and fever up to 96°F.  She took Tylenol which helped her fever briefly.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, fatigue, achy from head to shoulders, shoulder pain, headache, and fever up to 96F, was considered not recovered/resolved.; Reporter'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.
04/08/2021 at 1440 immediately after injection patient experienced dizziness, was clammy to touch, pale in color. Patient verbalized not feeling well. Blood pressure 160/82, pulse 70 bpm.  Pt became sweaty and laid down, continued with "wave of dizziness," so decided to alternate between standing and sitting. At 1500, symptoms continued. blood pressure 180/100 pulse 70 bpm, drinking water c/o some shakiness. 1510 blood pressure 164/84 still c/o waves of dizziness, clammy. No respiratory distress. 1520 blood pressure 180/100 pulse 85 bpm 97% O2. No longer feels clammy, states that he "feels normal other than lightheaded and dizzy. Seems to subside then comes back again." Examined skin: pt had slight erythema on upper chest, blanches when pressed. No itching sensation.  1530 blood pressure 182/102, pulse 85 bpm, 97% O2. "I feel dizzy when you take my blood pressure." When asked about his breathing pt states "breathing feels fine." 1540 no itching. Erythema appears more red and more spread out on chest. "just don't feel right" Still c/o waves of dizziness and states he feels like felt when he took bactrim approximately 12 years ago- slow onset- pt experienced rash and just overall "not feeling right." 1545 blood pressure 172/102 pulse 92 bpm 97% O2. Erythema appears better, not as spread out across chest, more condensed. "Dizziness still comes in waves." 1607 blood pressure 204/102, pulse 90bpm, 97% O2- clammy to touch. After discussing with patient and patients spouse, agree that patient needs to be seen by either PCP, Dr. or go to ER. At the time pt did not wish to go to ER. Wife proceeded to call Dr.'s office to see about getting him in. Pt then started to feel worse and like he needed to go to ER. offered to call for an ambulance, pt refused as his wife could take him and would probably be quicker. staff offered diphenhydramine and pt declined, stating he would wait until he got to ER for treatment. Pt appeared very anxious and nervous. transported him via wheelchair to his vehicle at 1620, his wife then drove him to ER. 04/09/2021 at 0828  I left a voicemail with pt for follow up.  0830 I called to get follow up on pt. I spoke with the nurse that treated the patient. Pt did indeed come to ER and was treated for a reaction. He was given a dose of benadryl and solumedrol. Pt verbalized feeling like he was having a severe anxiety attack and that his adrenaline was really high. Nurse stated that she agreed with him. Pt was later discharged that evening. No epinephrine use reported.
Swelling and pain of left supraclavicular lymph node (Virchow node).; Swelling and pain of left supraclavicular lymph node (Virchow node).; Swelling and pain of left supraclavicular lymph node (Virchow node).; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in arm left on 23May2021 13:00 (Batch/Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced known allergies amoxicillin. Concomitant therapy included some vitamins. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications that the patient received within 2 weeks of vaccination in two weeks reported as some vitamins, nothing new. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced swelling and pain of left supraclavicular lymph node (Virchow node) on 01May2021 10:00. Event resulted in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The treatment was unknown. The outcome of event was not recovered. The reporting patient classified the event as non-serious.
My son had Pfizer vaccine for his first and second shots as he was only 16 years old at the time of shots in April and May 2021.  Yesterday, 01/05/2022, he was given by the reported facility a Moderna booster shot while he is only 17 years and 2 months old.  I was not with my son but it was my husband accompanying him for his booster shot yesterday. Isn't it that the only authorized booster shot for 16-17 years old is Pfizer?  I spoke with one of the CDC supervisors yesterday and I was advised to do submit this report so that if the facility who gave the booster shot to my son is making a mistake, they should be reported.  As of this time, my son has not complained of any adverse symptom.  Thank you.
Patient reported approximated 2 hrs after receiving flu shot shortness of breath, increased warmness and itchy throat. Later that evening symptoms worsened accompanied by facial swelling and dysphagia and drooling. She went to the ER for evaluation.
Redness and swelling at injection sight, severe fatigue and somnolence days following vaccination.
This is a 35-year-old female, G2, P1 Ab0, 23 weeks pregnant, who presents to the emergency department for chest pain.  Patient reports receiving her second Madura COVID-19 vaccine yesterday at around noon.  She states that later that evening, she reports onset of fatigue, and pleuritic chest discomfort.  She reports increasing in discomfort into this afternoon, with shortness of breath.  She also reports body aches, and bilateral lower extremity calf pain.  No fevers, or chills.  No nausea, or vomiting.  Patient is currently being followed by doctor of OB/GYN, with whom she had a conversation with this morning.  Doctor already recommended she come in for evaluation.  Otherwise patient denies any vaginal bleeding, discharge.  No urinary symptoms.  No prior history of a cardiac or pulmonary disease.  No lightheadedness, dizziness, or syncope.  No prior history of DVTs, pulmonary embolisms.
About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little.  14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100%   Discharged back to work at 16:15.
JE was administered first without issue. Then almost immediately after injection with COVID,  patient reported a shooting pain that blossomed down her arm and radiated to finger tips causing some numbness. As I sat with her for 15 minutes, it began to subside. By the time I left, just a bit of numbness in fingers remained. Needle most likely hit a nerve. Counseled patient to keep moving and that I would check in on her later this afternoon. Upon calling her a few hours later, she reports pain and numbness mostly gone, just may be a bit of residual numbness in pinky finger. She will let me know if it does not subside or worsens.
I was exposed to COVID-19 at a high school graduation. The next day after returning from the graduation I had congestion, no fever but felt off so I tested and it was positive. I called the telehealth and the told me to quarantine. The next day I had fatigue and a cough that lasted for a couple days. I tested negative on May 25, 2022, I called the telehealth who then cleared me to go back to work.
This spontaneous report as received from a 61 year old female patient regarding herself. The pertinent medical history was none. It was unspecified if the patient had drug allergies or reactions. On an unknown date in 2007, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expire date was unknown). Concomitant therapies included TETANUS AND DIPHTHERIA TOXOIDS ABSORBED and also administered on the same day. On an unknown date in 2007, the patient experienced warm itchy bumpy sensation after receiving PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were reported as recovered on an unknown date in 2007. The patient sought medical attention. Additional information is not expected.
local redness, pain swelling; systemic malaise, myalgias, h/a, nausea, vomiting, chills