chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of about 100-101/fever of 101.3/He still has the fever and he just took it and it's now 100.9; slight headache; chills during the night but not now; a stuff neck; This is a spontaneous report from the Medical Team. A contactable consumer (patient) reported that a 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular ("in the muscle") in the right arm, on 20Jan2021 14:30 at a SINGLE DOSE for covid-19 immunization. The patient's relevant medical history was not reported.  There were no concomitant medications.  Patient received first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 for covid-19 immunization. The patient experienced 'Fever of about 100-101, chills during the night but not now and a stuff neck'. The patient later reported that he got some chills that evening when he got the second dose of vaccine (20Jan2021). Woke up this morning (21Jan2021) with a fever of 101.3 and slight headache. Patient wanted to know if he could take Tylenol, Ibuprofen, or Aspirin, if it's okay. He wanted to clarify that chills started later that evening (second dose vaccination) but it was not bothering him now. He still has the fever and he just took it and it's now 100.9. Patient was recovering from the events "a stuff neck" and "chills during the night but not now". Whereas he had not recovered from " Fever of about 100-101/fever of 101.3/He still has the fever and he just took it and it's now 100.9" and  headache.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Pt had 3rd DPT in MAY91 & w/in 48 hrs exp sz;
This patient reported incorrect birth date on vaccination screening questionnaire while making appointment online. After receiving the vaccine we found out that her birth date is younger than what's reported on the form. She is approximately 16 years and 8 month at time of vaccination and ended up receiving Moderna vaccine which only has EUA for people of 18 years of age.
Patient first became ill 10/09/09 reporting a fever (101 F) and diarrhea. Patient became fatigued and achy. Patient developed a non-pruritic rash above the knees and distal that resolved spontaneously after about a week. Most notably she was extremely sore down the back of her legs. 10/12/09 the patient presented to Dr. Patient reported that she was instructed to continue Advil and APAP. Leg pain continued to worsen throughout the week. The patient began to notice some weakness and numbness starting at her feet and moving up to thighs and mid abdomen. Pt denied neck stiffness. Patient presented to ER and was admitted 10/18/09. Primary diagnosis was Guillain Barre Syndrome likely related to influenza vaccine, recent diarrhea illness or both. IVIG was infused for 5 days per hospital protocol. 10/25/09 the patient's strength was a little better. Patient passed physical therapy with stairs. Back and leg pain continued and was treated with Vicodin and Neurontin. 11/5/2009 MR and DC summary for 10/19-10/25/2009. DC DX GBS  Patient with c/o's fever,diarrhea, weakness, numbness/tingling of lower extremities. PE: noted decreased sensation, reduced/absent reflexes, decreased strength in LE's. Tx: initially IV ABX and Antivirals, then IV IGG.
Fever, headache, body aches, racing heart rate, shortness off breath, fatigue
2 days after receiving the second dose I received shortness of breath and was heavy cheated.  I ended up at the hospital. I am now on a daily use inhaler to help my breathing during normal activity. I did not have asthma prior to the vaccine.
brought to hospital with suspected GI bleed; was found to be positive for COVID as well; acute on chronic hypoxemic respiratory failure (6L Hi-flow O2 supplementation); cough; experienced pulmonary code blue; CPR x 20mins without return of circulation; family contacted and decided to make pt DNR; pt died in the hospital
Patient received Hep B vaccine and MMR vaccine on Monday, May 21, 2007. By the next day, she began to feel "bad" and have fever. By Friday, May 25, 2007, she found a rash on her legs and bruises/hematomas all over her body. She went an emergency department where she was admitted to hospital x 4 days. She was treated with transfusions and steroids and discharged with a diagnosis of "immune thrombocytopenic purpura" by pt. report. Patient came to our office on 6-05 when she looked well, but some bruising remained. 9/21/07-records received for DOS 5/25-5/28/07. DC DX: Immune thrombocytopenia probably secondary to measles, mumps, rubella vaccination. C/O bruising and multiple rashes over bilateral extremities. PE: Petechial rashes on lower extremities, bruises with ecchymosis over bilateral hip area and elbows.
Post vax on 10/06/2001 the patient developed a fever, sore throat, and swollen glands. On 10/11/2001 the patient developed a petichael rash on her face and neck.
pt recv vax;devel sl amount of itching at inject site prior to inject then devel flu like sx of mild fever & gen aching;
bad reaction" to "a vaccine" that resulted in her being admitted to the hospital with encephalitis; 7 months pregnant; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient was 7 months pregnant  and experienced a bad reaction to vaccine that resulted in her being admitted to the hospital with encephalitis. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt reported one sided swelling of the face under her eye/over her cheek and states that it is very itchy.  Pt states that sx began following receipt of 2nd zoster recombinant series.
Little weak; Headache; Little bit dizzy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on 16Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that she was allergic to ibuprofen. On an unknown date, the patient after getting the vaccine, had a headache, she was feeling a little bit dizzy but not too bad and a little weak. She wanted to confirm if she could take Tylenol or Ibuprofen to get relief.  The unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient passed away on 4/30/21. Wife reports that on 4/29/21, she found him in the garage in a "pool of blood, face down" after a fall. Upon finding him on  4/29/21, she took him to the emergency room where he had a CT scan. Patient was diagnosed with a "concussion" and sent back home, and was instructed to follow-up with his primary care provider on 4/30/21. On 4/30/21, patient was "sleepy all day." On his way out of the house around 3:30, he suddenly put his hand on his wife and proceeded to collapse. The wife also fell, and by the time she gathered herself and went to check on her husband, he had passed away. An ambulance came to the house; CPR was performed for 40 minutes but "they could not get him back." He was not transported to a medical center. An autopsy was not done, but the coroner informed patient's wife that he likely died from a "clot, maybe a PE." Wife wonders how this could be, since he was on Plavix for 5 years. Wife does not feel that the COVID vaccine is to blame, but thought she should report the issue just in case. This writer is assisting wife of patient to fill out electronic report.
patient fainted after the vaccination while sitting in the chair just outside the pharmacy. patient soon became responsive and was assessed. No allergic reaction was present, and it was deemed vasovagal syncope.
Pt states at time of injection his hand jumped. He states that he woke up today with his arm and hand tingly like pins and needles.
This spontaneous report as received from a consumer refers to a male acquaintance patient that was in his 70's. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date (within the last 5 years), the patient was vaccinated with ZOSTAVAX (dose, lot number and route were not reported). Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX, patient developed shingles. It was unspecified if the patient sought medical attention. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Approximately 3 weeks after receiving an MMR vaccination in his left arm, the client reported discomfort which progressed to pain, redness and swelling. "Hot". Lasted approximately 3 days and then went away. Spoke to a clinic but was not seen or evaluated.
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of ROTATEQ (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
patient reports: swelling of area, headaches, asthma issues, extreme fatigue, hot and itchy at imz location   Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. Patient symptoms have gradually improved to date.
Patient called 12/21/15.  States she started having right arm soreness and progressive weakness after flu vaccine.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-Mar-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        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 concomitant medications reported by reporter.  Patient was 38 1/2 weeks pregnant.
Patient exhibited signs and symptoms of syncope. Felt dizzy, clammy skin, nauseous. Had him lie down for 15 minutes with legs elevated and used an ice pack on the neck to help improve blood flow. Patient recovered.
24 yo G2P1001 at 34w5/7 with EDD 7/9/21 received TDAP vaccination and Janssen COVID vaccination on 6/2/21.  Presented to hospital 6/4/21 complaining of squeezing chest pain.  Elevation of troponins.  CT chest negative for pulmonary embolism or other pathology.  Maternal echocardiogram negative for cardiomyopathy or structural heart disease.  Leading diagnosis myocarditis with patient treated with IV steroids and hospital observation.  Discharged home safely 24 hours following admission.
Vaccine vial potentially stored in fridge for longer than recommended period of time (may have been up to 28 days No adverse reactions, no illness
I started experiencing chills, and a fever even with Tylenol .  About an hour later I felt really nauseous and then started throwing up. I threw up 4 times and then continued to dry heave for another hour. My temperature hit 102. I then started experiencing extreme pain in my right kidney area. I ended up trying to take Benadryl and then  threw that right up. I  then ended up going to the ER and receiving  Zofran, Fluids, Tylenol, Torodol and Morphine.   I got discharged with "an adverse reaction to the covid-19 vaccine and unknown pain" When I was discharged I had a fever of 100 and on the drive home I was in intense pain. It subsided but I am still not feeling well, I feel very groggy and light headed in addition to the pain.
6cm ulcerated lesion to left shoulder. Lesion biopsied, sent to pathology. Pt was in contact with friend who had been vaccinated.
Heart attack; Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19-year-old male patient received BNT162b2 (BNT162B2), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; MYOCARDITIS (medically significant), outcome "unknown".  Clinical Course: The caller stated that another friends 19-year-old son had a heart attack after the vaccine and now had myocarditis for the rest of his life.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever, chills, aches lasted until 04/25/2021, then went away. reporting this because of tinnitus that started 04/25/2021.  I had tinnitus before, but it went to a level 10 that day,  subsided to level 7 where it remains as of 5/6/2021
No additional AE reported.; An office manager reported that VARIVAX had a temperature excursion on 10-OCT-2020 and was administered.; This spontaneous report as received from  an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On 14-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S038700, which has been verified to be valid, expiration date reported as "30-NOV-2021", but upon internal validation established as 01-DEC-2021), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided). No additional adverse event (AE) were reported.  Additionally, it was reported that the suspect vaccine was exposed to a temperature between minus 14 degrees Celcius (C) to minus 10 degrees C for a time frame of 1 hour and 15 minutes; and minues 9 degrees C to 8 degrees C (minus 9.3 degrees C) for 32 minutes for a time frame of 1 hour and 47 miinutes, as recorded by digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA007367: US-009507513-2010USA007667:
redness to arm from shoulder to elbow. red, warm to touch, swollen and itchy.
pt recvd vax 27APR93 & on 3MAY93 pt devel a rash & a high fever which resulted in a convuls; pt presented to ER & was adm to hosp; spinal tap, BC & CBC were neg; infectious disease MD was consulted & gave dx of react to the vax;
12-23-2020 severe chills, nausea, and severe body aches did not check temp. 12-24-2020 she still feels off, but not as bad. Temp is normal
Patient developed a copper taste in her mouth, scratchy throat, cough, and shortness of breath 15 minutes after vaccine administration.  She developed a headache on the way home which became severe by the next day with double vision.
Rash, urticaria, pruritus and unilateral raised red bumps on chest and back.
Last period was March 14th; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included none and received concomitant medication (not specified). The patient received unspecified allergy and anxiety medications within two weeks of vaccination. The patient's last menstrual period was 14Mar2021. 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 an unknown date in Apr2021, the patient experienced delayed period since it was reported that her last period was on 14Mar2021. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products. The clinical outcome of the event delayed period was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2 hours after (3:00pm) pain in the arm, very tired have to go to sleep in the afternoon. Late at night pain in the joints ( ankles, elbows, wrist). Next day joint pain was gone, tiredness was gone, but left arm was hurting for 3 days.
Rec'd flu & pneumonia vaccine approx. 2:30pm 11/5/10. 11:30pm - awoke with inability to lift (L) arm & achy body pains. 2:30am - achy all over, dizzy, blacked out x 2. Felt faint. By morning, sx. had subsided. Mon 11/8/10 - seen by MD - asymptomatic, no Tx.
Tingling/numbness in both arms immediately following injection, fever, body aches for more than 24 hours.
This spontaneous report as received from a pharmacist refers to a 76 years old female patient with no drug reactions and allergies. On 14-MAY-2015, the patient was vaccinated with the dose of ZOSTAVAX lot # L002424, expiration date 23-APR-2016 (dose and route of administration were not reported). No information on patient's concomitant medication was provided. In May 2015, after receiving ZOSTAVAX the patient experienced redness, soreness and a small hardened area around injection site, about size little bigger than half dollar coin. The patient sought medical attention via speaking to the pharmacist. No treatment was given for the adverse events and none lab diagnostics tests were performed. The outcome of adverse events was reported as recovering/resolving. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Mother states evening of 04/10(7 days after receiving immunizations) child had onset of redness on left uper arm at site of MMR injeciton. Area size of quarter and warm to touch. Child has no fever, swelling .
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) on 18-OCT-2010, dose 2 of GARDASIL (Lot # not reported) on 28-DEC-2011 and dose 3 of GARDASIL (Lot # not reported) on 28-FEB-2012. No adverse effect was reported. Additional information has been requested.
Narrative: On PCP visit 1/29/2020, patient reported new dx with Guillian Barrre' syndrome; symptoms did not progress to the need for ventilator before intervention. He thought he had a sinus issue 2-3 days before, the day of admission he could not walk, L facial droop. Spinal tap + for GB, 5 bags IGG resolved many symptoms. Patient treated at hospital.
First dose administered 3 day after BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was 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 EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 3 day after BUD) had resolved.        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.
Glucose levels are elevated as compared to normal after receiving the in 2nd dose of the vaccine. Additional insulin is required to keep Glucose levels at steady level, which is still above desired target range
Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
This case was reported by a physician via call center representative and described the occurrence of herpes simplex in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The patient reported to a physician about an outbreak of herpes simplex experienced approximately 1 week following vaccination with SHINGRIX. The physician did not have details of lot number/expiry or any specific patient details.
pt anxious has flushed feeling; face red; has previous anxiety observed for 15 minutes; pt says he has ipipen and will go to er if symptoms worsen or still present in24 hrs. insisted on leaving.