chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia / shortness of breath; atrial fibrillation; whooping cough; acute bronchitis; upper respiratory tract infection; other cardiac complications; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 17-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with pneumonia, acute bronchitis, an upper respiratory tract infection, whooping cough, shortness of breath, atrial fibrillation and other cardiac complications. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX) (reported as caused by zoster vaccine live (ZOSTAVAX)).  The events of pneumonia/shortness of breath, acute bronchitis, upper respiratory tract infection, whooping cough, atrial fibrillation, and other cardiac complications were considered to be disabling. Upon internal review, the events of pneumonia, atrial fibrillation, and whooping cough were determined to be medically significant.
Within 1-2 minutes: left hand felt numb and my body became very warm. Within 5-10 minutes: a huge headache. Within 30 to 45 minutes: Blood Pressure fluctuated, headache became worse, and chills started to occur. Within  1 hour to 1.5 hours: the headache became a huge migraine and my head felt like a bowling ball (I was still at work at this time.)  Eventually, I could not lift my head off the desk. About 2 hours to 2.5 hours later, I felt so bad that I could not continue to work and head to leave work and go home. Upon arrival at home, the chills, aches, pains, migraine, some fever, eyes could barely stay open, and diarrhea started. About 7 hours later, a full blown Lupus flareup seemed to have started and/or it seemed to feel like a full blown case of the flu (if that makes any sense at all.) By the time I wrote this, all the symptoms have remained the same. I have had chicken soup, Gatorade, and bananas and treating this like the flu. I have continued to take my medication except for the Prednisone because I was told not to take the prednisone at the time that I was given the COVID19 shot at 9am this morning. I have stayed at home since I arrived at home around 1:30 or so...
Information has been received from a registered pharmacist concerning a 75 year old male family member who in October 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On the same day the pt was also vaccinated with a dose of influenza virus vaccine. Shortly after the injection, the pt complained of injection site sensitivity and says that the site is still sensitive. No medical attention was sought and no treatment was required. No diagnostic studies were performed. On 13AUG2003 it was reported that the pt had not recovered. No product quality complaint was involved. Additional information has been requested.
SHINGRIX 2nd vaccination. Headache for approximately 3 days, muscle soreness in back of neck.
Breakthrough case admission after 2 vaccines Moderna 2/28/21 Lot# 012L20A;  Moderna 11/21/21 Lot# 012H21B
For about 1 week after receiving this vaccination, I was running a fever of about 101F, had diarrhea really bad, whole body muscle aches, and nausea. Since some other people I know had the same problems as I did, I just let it run it's course and did not go see a doctor about these side effects.
Pain at site of vaccination 10/10 Rx Naproxen 500 mg and TYLENOL #3.
Intussusception requiring surgical correction at facility in another city due to patients age. (hospital)
Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride home pt declined and said he did not feel the need. he hais he feel better and pt discharged
p/5mins post inject c/o burning in inject site, ice applied; a few minutes later c/o dizziness, was responding but c/o feeling bad; walked to car & got in, was not able to get out @ hosp;
shivering, low grade fever, muscle aches arms back, legs, headache, low energy began in early morning after vaccine. Slept extra during the day and took Tylenol and Ibuprofen
Came to emergency room with generalized weakness, shortness of breath and poor appetite. Patient was admitted with acute hypoxemic respiratory failure due to COVID-19 pneumonia.  Patient was treated with supplemental oxygen, zinc, vitamin-C, mucolytic, antitussive and empiric antibiotics. Patient also had acute metabolic encephalopathy due to COVID-19 and elevated troponin that was presumed from demand ischemia and type 2 MI. Patient was discharged to skilled nursing facility in a stable medical condition.
APPROX 5 DAYS AFTER RECEIVING THE JANSSEN VACCINE PATIENT DEVELOPED RIGHT FOOT,LEG, AND THIGH PAIN, SHE HAD DISCOMFORT IN THE DISTAL LOWER RIGHT LEG. SHE CONTACTED PCP ON 11/19/21 AND CAME IN FOR AN OFFICE VISIT THE SAME DAY. LABS WERE DRAWN FOR A D DIMER AND THE RESULTS WERE 0.56 (H). DUPLEX SCAN WAS ORDER ON RIGHT LOWER EXTREMITY  ON 11/22/21. IMPRESSION WAS POITIVE FIR INFRAPOPLITEAL DVT OF POSTERIOR TIBIAL VEINFROM PROXIMAL TO MIDCALF. PATIENT WAS TREATED WITH XERALTO 15 MG BID FOR 3 WEEKS AND THEN 20 MG QD FOR 9 WEEKS. RETURNED TO OFFICE 11/30/21. SHE NO LONGER HAS SIGNIFICANT DISCOMFORT ON THE RIGHT LOWER LEG
exceeded the time frame between doses,Missed the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (exceeded the time frame between doses,Missed the second dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (exceeded the time frame between doses,Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (exceeded the time frame between doses,Missed the second dose) outcome was unknown. Not Provided      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.   Concomitant medications were not provided.  Treatment information was not provided.
She had a fever and ran a fever for 5 days. She also had congestion with a cough. She didn't have an appetite with a headache that would come at go.
after vaccines given pt appears to be fine 5 to 10 minutes after when had left office and waited for elevator, fainted and was brought back into office by m/c
Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Employee reports 1/7 one hour later his arm started hurting. Then throughout the day the pain got worse and he took Tylenol and ibuprofen. Onset of fatigue and body aches last night. 1/8 0300 woke up with nausea and started throwing up. This afternoon he still has headache, body aches and arm pain. He continues to experience vomiting. Temp to 99.1 He's drinking ginger tea and                          water and can keep that down. He's staying hydrated. 1/11 employee reports all symptoms have resolved. He felt better around 7:30-8:00 Saturday night.
Information has been received from a 75 year old female consumer with an allergic reaction to some medication in the past, but she doesn't remember the name of the medication and no pertinent medical history who on 06-MAR-2008 was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 08-MAR-2008 the patient experienced headache and pain all over her body after getting zoster vaccine live (Oka/Merck). Unspecified medical attention was sought, there were no lab studies involved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a physician concern this 75 year old female consumer with polymyalgia rheumatica, neuropathy peripheral, hypothyroidism, hyperlipidemia and osteoporosis who on 06-MAR-2008 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658839/1411U) at 11:00 am. There was no illness at the time of vaccination. Concomitant therapy included levothyroxine Na, alendronate sodium (+) cholecalciferol (MSD), ibuprofen, calcium (unspecified) and vitamins (unspecified). Subsequently, on 06-MAR-2008 the patient complained of aches, nausea, headache and "I burn all over." At the time of the report the patient's status was unknown. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the physician indicated that the patient complained of one and a half week of chills, fever, sweats, headache and all over body ache. At the time of the report the patient recovered on or about 17-MAR-2008. It was reported that the patient stated "she is doing well". Additional information is not expected.
Patient went to ER several hours after receiving flu shot. Patient treated for collapsed lung. ER aware of shot but said collapsed lung was due to COPD exacerbation. Patient treated at hospital. Patient did not agree.
Our son (13) began to complain of stomach pains the evening of Feb. 2, 2011.  He had a very difficult night the night of 2/1-2/2/11.  On Wed., Feb. 2, he was diagnosed with acute appendicitis at 4pm and had surgery at 9pm at Hospital.  The surgery was laporoscopic and successful.  The appendix had not ruptured.  However, when his breathing tube was removed (late Wed. night, Feb. 2, 2011), his larynx spasmed, collapsed, blocked the airway, causing pressure to build up and fluid to be pushed into his lungs.  He was released from the hospital on Friday, Feb. 4, 2011 and is now recovering at home.
Headache; Fatigue; Tinnitus; Sick; This is a spontaneous report from a contactable consumer or other Non-HCP.  A 55-years-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04May2021 at 10:30, administered in right arm (age at the time of vaccination was 55-years-old) as a DOSE 2 , SINGLE dose for COVID-19 immunization. The patient had Augmentin allergy. The patient had no other medical history. The patient's concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 at 10:00, administered in right arm (age at the time of vaccination was 55-years-old) as a DOSE 1 , SINGLE dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since or post the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced Headache, Fatigue, Tinnitus and Sick. The adverse event treatment was visited my primary, then eye doctor, CT Scan. The clinical outcome of the event Fatigue was recovered on an unspecified date in 2021, while the clinical outcome of the events Headache, Tinnitus and Sick was not recovered  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician concerning a 62 year old female who "at age 51" (1996) reportedly received her first or only dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient had never received a second dose of varicella virus vaccine live (Oka/Merck). In 2007, she had a negative titer for varicella virus. There was no reported adverse event. Medical attention sought and current patient status was not reported. A product quality complaint was not reported. The physician does not wish to be contacted about this issue.
103 fever 2 days after the vaccine.  Then became afebrile. Then found deceased on 4-26-2021
on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; This is a spontaneous report from a contactable consumer or other non-hcp. A male (for reporter sons wife's grandfather) patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization; she took the vaccine and is having side effects of burning on top of her ear lobes and also after a week it started cracking and itching very bad. Agent relays that the daughter in law and father-in-law and grandfather are having the same side effect. Agent relays that the caller wanted to report it and wanted to know if this was new or if this is normal. It was stated it was the Pfizer vaccine. Caller states the 1st time this happened it was about 10 days after the 1st vaccine and it was the weirdest thing, the top of her, she believes, right ear at first it was itching and burning and then started to crack and that lasted 5 days. States she applied Neosporin and Vaseline on it and didn't think much of it. She stated that after the 2nd shot about 1 week in, on the other ear, she had burning, it was bright red and heat and the same thing with cracking. Caller states she thought it was sunburn, but she wears a hat, and her ears are covered. On an unspecified date the patient experienced on the other ear, she had burning, it was bright red and heat and the same thing with cracking. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt stated that she developed a large lump about the size of a baseball on her arm and complained of itching.  Upon return to the clinic on 12/6/00, pt had a red circle at injection site about 50 mm in diameter.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 4:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.66 for dose administered on 27-Feb-2021 and 61.74 for dose administered on 27-Mar-2021. No concomitant medications were reported. Batch number 019B21A administered on 27-Mar-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A administered on 27-Feb-2021, underwent temperature excursion on 27-Feb-2021 with temperature range from 33 to 35 degrees Fahrenheit from 09:00 AM to 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Approximately 5 - 10 minutes after receiving vaccine we were leaving and my son fell into the door frame and then in to me. I lowered him to the floor. He complained of feeling dizzy, nauseated, not being able to see, hard to breathe, and was sweating - although complaining of freezing. His skin was clammy to touch and warm. He never lost consciousness. Clinic staff checked his pulse and put a cool cloth on his head & neck. They told me he "passed out" due to anxiety - although he was NEVER anxious about the vaccine & never passed out completely. After 10 more minutes, I was told to take him home & let him rest. The next day, his left arm from shoulder to elbow was very swollen, dark red, itching, & tender to touch. I gave him benadryl every 6 hours & reported this to his physician. The physician said it sounded like an allergic reaction & continue with benadryl unless he has difficulty breathing & if that occurs, to take him to the ER. The arm remained swollen, red, tender, & itching for 2 more days. Benadryl was given during this time. Time of events were from 06/11/08 until 06/15/08.
Developed peripheral neuropathy after 2nd dose and it got worse after boosters.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastrooesophageal reflux disease" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; IRON; PREVACID. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (disability) with onset 15Apr2021, outcome "not recovered", described as "Developed peripheral neuropathy after 2nd dose and it got worse after boosters.". The events "developed peripheral neuropathy after 2nd dose and it got worse after boosters." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of neuropathy peripheral.  Additional information: Patient Developed peripheral neuropathy after 2nd dose. Patient did not have any prior vaccination also patient tested for covid post vaccination.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore) in a 6-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore). At the time of the report, RHEUMATOID ARTHRITIS (feels like Rheumatoid Arthritis) and NECK PAIN (my neck is sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported only reason that patient was taking the Covid-19 vaccine was that being forced to by the company. Patient had seen several Doctors. Patient said that was in the late fifties. No treatment medication details were provided. Patient experienced swollen joints in my hands and thumbs. Both of my knees are painful. My neck is sore. Feels like Rheumatoid Arthritis. Patient had Rheumatoid Arthritis RA. No concomitant medication details were provided. Company's comment: This case concerns a female patient of unknown age, with a history of Rheumatoid arthritis, who experienced the unexpected AESI of Rheumatoid arthritis. The event occurred at an unknown date after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The medical history, of Rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non-Significant Follow up. On 16-Nov-2021: Non Significant Follow up. On 16-Nov-2021: Non Significant follow-up appended, snapshot document was attached; Sender's Comments: This case concerns a female patient of unknown age, with a history of Rheumatoid arthritis, who experienced the unexpected AESI of Rheumatoid arthritis. The event occurred at an unknown date after the first dose of mRNA-1273 vaccine. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The medical history, of Rheumatoid arthritis remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.