chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received a DTaP vaccine on 6/19/2017 and within 24 hours my arm had developed a golf ball sized know that is very painful and warm to the touch. I also have a severe headache and 100.9 fever. I am type 1 diabetic and the last 36 hours, my blood sugars have been above 350.
Pt started with high pitched cry and was inconsolable 30 min post vax. It lasted for about 3 hrs. He was taken to MD's office and was given Benadryl and Infant Tylenol. Pt experienced high pitch cry (3 hrs) after first DTAP.
blotches on skin all over body, not raised crying for 12hr;wouldn't eat for 8hr;blotches began to resolved 5PM;14APR96 but not completely until 16APR;
This spontaneous case was received from a health care professional on an unpublished manuscript and refers to a 62-year-old male patient. The patient's concurrent conditions included end-stage liver disease and diabetes mellitus type 2 without retinopathy. Information on patient's medical history and concomitant medications were not reported. It was also reported that the patient did not have other immune-related disorders or frequent infections. On an unknown date (also reported as 7 months ago), the patient was vaccinated with ZOSTAVAX for prophylaxis (dosing details, lot # and expiration date were not reported). On an unknown date, the patient presented with two day history of floaters and blurred vision in the left eye. The patient's vision acuity was 20/60 (units not reported) and intraocular pressure was 16 mmHg. On an unknown date (7 months after vaccination), the patient underwent an unspecified examination which showed inflammation in anterior chamber and vitreous, multiple white retinal lesions and necrosis on presentation in the left eye. Late phase fluorescein angiogram showed late leakage and staining inferonasally corresponding to the area of CMV retinitis in the left eye and a normal appearing angiogram of the right eye. The patient was initially treated with oral valganciclovir and topical difluprednate for presumed cytomegalovirus (CMV) retinitis. On an unknown date, the patient also underwent unspecified blood tests for infectious and inflammatory etiologies which were negative apart from a borderline acute retinal necrosis (ARN). On an unknown date, subsequent polymerase chain reaction (PCR) test of his aqueous humor was positive for varicella zoster vaccine (VZV). The patient was treated with valacyclovir 1 gram 3 times per day which replaced valganciclovir. It was reported that after 10 weeks, his visual acuity improved to 20/50 (units not reported), vitritis resolved and retinal lesions became inactive. The treatment with valacyclovir was decreased to 1 gram daily and topical steroids were tapered. On an unknown date, the patient died from complications of his cirrhosis 6 months following his initial diagnosis of ARN (Hepatic cirrhosis). The patient had recovered from necrotizing retinitis was recovered. The outcome of varicella zoster virus infection was unknown. The causality assessment of the events was not provided. The reporters stated that the patient experienced milder disease and longer latency periods. The longer latency periods might be associated with wild-type virus in ARN due to VZV as well as systemic disease. The reporter stated that immunocompetence might play a role in ARN after VZV vaccination and the patient might have been relatively immune compromised due to end stage liver disease and diabetes. Upon internal review, necrotizing retinitis and hepatic cirrhosis were determined to be medically significant. This is one of the two reports received from the same source. Reported Cause(s) of Death: The patient died from complications of his cirrhosis.
Body aches, fever, fatigue, redness and swelling at injection site, tightness in the neck and shoulders predominantly on the same side as the injection.
At 3:55pm patient complained of tingling in her right arm and hand with her finger tips feeling cold. At 4 pm she complained that her right arm felt weak and heavy , she was able to push with her right arm. She denies SOB or difficulty breathing. she declined to have an ambulance called and stated she would not go the the hospital. she stated she wanted to go outside and get fresh air, she stated the she felt better and was escorted outside by this writer and a police officer. She called her husband who came to pick her up. She got into his truck on her own and denied feeling any weakness in her arm.
No additional AE reported.; dose of MMR-11 expired on 11/20/2021 and was administered on 2/23/2022.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-FEB-2022 , the patient was vaccinated with measles(+)mumps and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA (recombinant Human albumin))(M-M-R II), dose of 0.5 milliliter, lot # S037497, expiration date 20-NOV-2021 (dose number and exact route of administration was not reported) for prophylaxis (Expired product administered). It was reported that the product had no temperature excursions through date of administration. No additional adverse events were reported (No adverse event).
Head felt funny 2 hours after vaccination. At 2am woke up with chills, temperature climbed to 101.3 by 7am, and onset of headache at 10am.
Information has been received from a registered nurse concerning a 15 month old African-American male patient with no known allergies or medical history and no known illnesses who on 19-May2000 was vaccinated subcutaneously with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second genration) (lot 633752/1709J).  Concurrent vaccinations that same day included a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 7390-AA) given intramuscularly, a fourth dose of haemophilus b conjugate vaccine ( lot #468-488) given intramuscularly, and a third dose of poliovirus vaccine (IPOL) (lot # R0618) given subcutaneously.  On 26 May 2000 the patient developed a fever of 104F.  It was stated that no obvious rash was noted.  The patient sought unspecified medical attention.  It was reported that an additional patient (WAES # 00070995) had a similar experience following exposure to measles virus vacciine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second genration).
Severe itching and burning skin on back, chest, arms and fingers but not at injection site.  A patch of legion with small bumps in it, bumps that looks like chicken pox that bubbled and oozed.  They were red and itchy
Headache, full, flu-like body ache: muscles and joints, nausea and lack of appetite, fever.  I took Advil and Tylenol.  Was sick from the night of the injection on April 5 until about noon on April 7.  Was unable to work (from home) on April 6.
This spontaneous report as received from a Registered Nurse refers to a  46 year old female patient with penicillin allergy (patient got hives) and RELAFEN allergy (she has an anaphylactic reaction on an unspecified date). Patient has no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H018796, expiration date 24-OCT-2014) 0.5 ml, once, subcutaneous for company requirement. There were no concomitant medications reported. The Registered Nurse reported that patient experienced cellulitis at the injection site and myalgia on 12-JUN-2013, after receiving a dose of VARIVAX (Merck). Registered Nurse reported that patient was seeing on 13-JUN-2013, by an unspecified physician in the office who prescribed BACTRIM and MOTRIN. The Registered Nurse also stated that two other patients (MARRS cases 1306USA006664 and 1306USA009130), experienced adverse reactions after receiving doses of VARIVAX (Merck) from this lot. Nurse was requesting a lot check for this VARIVAX (Merck). Laboratory tests were not performed. At the time of the report, the outcome of cellulitis at the injection site and myalgia was reported as not recovered/not resolved. This is one of several reports from the same source. Additional information has been requested.
pt experienced lightheadedness after vaccine and fainted shortly after. She said she has fainted in the past from other procedures due to anxiety about the procedure.
Sick; she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she; Big red spot on injection site; Swollen lymph node under left arm pit; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit), VACCINATION SITE ERYTHEMA (Big red spot on injection site) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced COUGH (Coughing). On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under left arm pit). On 23-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red spot on injection site). On an unknown date, the patient experienced ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of 500mg 3 times a day for 1 week; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) outcome was unknown and VACCINATION SITE ERYTHEMA (Big red spot on injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 11-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events methyl prednisone.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Difficulty breathing, wheezing, bilateral pneumonia on x-ray; treated with oral steroids, albuterol and antibiotics; developed hives on 3/21/12.
Chills, Dizziness, High Blood Pressure, "Numb," Falling, Nausea, Vomitted x 1, Sore Arm, Body Aches.
Pt given ZOSTAVAX vaccine on 3-18-14. Pt developed herpes zoster rash on forehead on 3-21-14.
Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint pain, fatigue, mild cough, temperature elevated but not high, about 99 degrees.  Symptoms varied over about 24 hours then subsided.  Injection was Friday morning, Friday night not much sleep due to symptoms, all day Saturday in bed, slept well Saturday night, and Sunday fatigue and achiness only.
LARGE MASS DEVELOPED AND HAS SOLIDIFIED.  STILL EXISTS 6 MONTHS LATER.
sore injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 12:30 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "well controlled seizure disorder" (unspecified if ongoing); "well controlled HTN" (unspecified if ongoing); "IBS" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "local skin reaction of redness", start date: 29Sep2020 (unspecified if ongoing); "swelling", start date: 29Sep2020 (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: UNITHROID, stop date: 25Feb2021 14:00; PHENYTOIN; TOPROL; METAMUCIL [PLANTAGO OVATA]; LORAZEPAM. Past drug history included: Erythromycin, reaction(s): "known allergies"; Epinephrine, reaction(s): "Known allergies". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "sore injection site". The event "sore injection site" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
The patient's mother states the patient had a fever of 103F and a rash on the day of vaccinations. The patient was seen in the ER and was diagnosed with a reaction to the vaccination. The mother states you could feel the rash.
VACCINE WAS GIVEN BY THE WRONG ROUTE, SUBCUTANEOUS, TO THE LEFT ARM.  PATIENT WITH PAIN, REDNESS, AND  ERYTHEMA AT INJECTION SITE. TREAT WITH IBUPROFEN AND SUPPORTIVE CARE.
an atrial fibrillation episode; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (an atrial fibrillation episode) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included DILTIAZEM, ETRETINATE (TEGISON), APIXABAN (ELIQUIS), CALCITONIN, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and CHOLESTYRAMINE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ATRIAL FIBRILLATION (an atrial fibrillation episode). At the time of the report, ATRIAL FIBRILLATION (an atrial fibrillation episode) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-jun-2021 - Contact detail updated; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Information has been received from a certified medical assistant concerning an adult (age and gender not reported) patient who in approximately in October 2005 ("over the last month"), was vaccinated intramuscularly with a 0.5 mL dose pneumococcal 23 v polysaccharide vaccine (Lot # 649695/0512P). Subsequently, on an unspecified date, the patient developed an injection site reaction to include soreness, warmth, erythema and swelling. the patient was treated with antibiotics and on an unspecified date recovered fully. The patient experience was considered to be an other important medical events (OMIC) by the reporter. additional information has been requested.
Patient fainted about a minute after the vaccine was administered. Also presented with signs of elevated temperature. Patient recovered from faint and said she did not eat anything all day. Also, lightheadedness.
Received second Pfizer Covid-19 vaccine on Thursday 5/13 without acute adverse events. The following day he developed substernal non radiating pleuritic chest pain that kept him awake all night. The following morning pain progressively worsened so he went to the emergency room.
Patient came in to get the Moderna vaccine and after receiving it he started to experience an episode of syncope and started to violently shake for 1-3 seconds after regaining consciousness. Patient was aware of where he was and knew why he was in the pharmacy. We monitored the patient for 25 minutes and he was fine. Patient came home and called back to the pharmacy stating that he was okay.
Patient developed fever around 2:00am next morning, migraine the following day around 2:00pm and woke up 10/21 around 7:00am with swollen armpits/lymph nodes on left side of body/arm.
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered.  He requested water and as I was giving it to him he started to pass out.  He was conscious but slightly convulsing.  He appeared to have a minor seizure for approximately 5-10 seconds.  He was transferred to a wheelchair and sent into our recovery room.  As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak.  He rested laying down but was not feeling better.  He could not tolerate any water or juice.
bad side effect after second vaccine/nausea; felt tired/zombie-like; massive headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Apr2021 12:00 (Lot number: EW0169) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial autonomic seizure", start date: 01Mar2015 (ongoing), notes: Illness/AE: Partial autoimmune seizure, Onset date:01Mar2015, Stop date: ongoing; "Hypothyroidism", start date: 01Jan2005 (ongoing), notes: Illness/AE: Hypothyroidism, Onset date:01Jan2005, Stop date: ongoing. Concomitant medication(s) included: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE] taken for autonomic seizure, start date: 2015 (ongoing); LAMICTAL XR taken for autonomic seizure, start date: 2015 (ongoing); LEVOTHYROXIN taken for hypothyroidism, start date: 2005 (ongoing); PRENATAL + DHA taken for pregnancy, start date: Aug2021 (ongoing); B6 taken for pregnancy, start date: Oct2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date / Time, Date: 30Mar2021, Time (24hr): 12:00 PM CST(approx), Site and Route of injection, Anatomical Site of injection: Rt arm, intramuscular, Batch/Lot number: lot ER8734), administration date: 30Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Apr2021, outcome "unknown", described as "bad side effect after second vaccine/nausea"; FATIGUE (non-serious) with onset 22Apr2021, outcome "unknown", described as "felt tired/zombie-like"; HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (May2021), described as "massive headaches". Therapeutic measures were taken as a result of headache. Additional information: Family history was reported as follows: The patient's mother had High Blood pressure and kidney problems. The patient's sister had diabetic type 1 at the age 7 (1991). The patient stated that her father had heart attack in 2017 due to high BP and cholesterol. Her grandmother (Mother's Side) had breast cancer and died at age 41 and grandfather had Congestive heart failure and died at age of 81. Her other grandfather from father's side had heart attack and stroke and died in Oct2001. Her uncle died due to heart attack in Jun2021. Her aunt died in 2020 due to heart attack and overweight/obese. The patient reported that she was not pregnant at the time of first and second vaccine. Had bad side effect after second vaccine/nausea (hung over toiled 4 hours after shot, over toilet for approx. 2 hours) felt tired/zombie like, massive headaches which she took migraine medicine (maxalt). Headaches lasted 2 weeks. Symptoms started within hours after vaccine. Patient was pregnant from 15Sep2021 and due date was 22Jun2022. No follow-up attempts are possible. No further information is expected.
Patient was administered his first dose of the pfizer covid vaccine on 1/5/22 at around 5:20pm. About a minute or two after receiving the vaccine, patient's mom was about to receive her pfizer booster vaccine and patient was standing outside our booth and suddenly fainted and hit his head on the floor. Patient's mom and technician immediately went to the patient's aid. Tech notified myself and another technician and we got management to pharmacy who immediately called 911. Patient was awake by then, but was still out of it and mom held his head in her lap. He responding with yes and no to mom and I didn't want to move him to check his blood pressure, but mom said he felt warm so I provided an ice pack to place behind his head on the injury. Right before the paramedics arrived around 5:30pm, patient was much more alert and having a conversation with his mom. Paramedics arrived around 5:34pm and took his blood pressure and told the mom either she can take him to the ER or they can. Management told me that the patient eventually walked outside with the assistance of the paramedics/his mom. Mom was called 1/6/22 to see how he was doing. She said he felt fine. She ended up not taking him to the ER. She called primary prescriber who told her to monitor him and he has been fine thus far
Chills, sweat, headache, and body ache the evening after the vaccination was received.
my whole left side went completely numb and had burning sensation from my head to my toes.  was very server for about 6 hours. Still have tingling definitely not like it was in some areas on the left side 5 days later.
Pt. states after receiving the J&J Janssen 07/08/2021 started experiencing shortness of breath and arm pain. Urgent Care visit 07/11/2021 diagnosed with Bronchitis and prescribed Inhaler (Albuterol). Another visit planned for 07/15/2021 still experiencing shortness of breath.
This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and less than a year after receiving Shingles vaccine, the patient experienced shingles and drug dose administration interval too long. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. After receiving first shingles shot, the patient was told that he/she did not need a second shot and so none was scheduled and later that year, he/she got shingles, and shortly later, his/her second shot, which led to drug dose administration interval too long. The reporter asked to get a third shot or, might be two more shots.
Case number PHEH2013US024169 is an initial spontaneous report received from a health care professional on 07 NOV 2013. This report refers to multiple patients. Past medical history and concomitant medication were not reported. These patients were vaccinated with FLUCELVAX (batch number: 006021A and expiry date: JUN 2014) on unknown dates, which was out of recommended temperature range with the maximum temperature of 10.9 C for 2 days. No adverse event was reported following this administration error.