chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old male subject who was vaccinated with HEPATITIS B (manufacturer unspecified), Influenza virus vaccine. This case corresponds to case 4 in the literature article. The subject's medical history included feeding related apneic episode diagnosed as gastroesophageal reflux, atrial flutter treated with cardioversion, an episode of several febrile seizure, oxygen therapy, pneumonia which required oxygen therapy (10 days in the neonatal intensive care), prematurity (born at 35 weeks) and ventricular septal defect that resolved without treatment. His mother was diagnosed with Munchausen by proxy related to misinformation regarding his feeding, atypical spells and inability to wean from nasal oxygen. On an unspecified date, the subject received an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided). He had received all of his vaccinations. At an unspecified time after vaccination with Hepatitis B vaccine and Influenza vaccine, at 6 months-old, the subject demonstrated gross motor delay and poor oral feeding requiring supplements via a nasal gastric tube. He had poor head control, inability to sit, axial hypotonia, failure to thrive, weakness in neck and deep tendon reflexes decreased. This case was assessed as medically serious by GSK. EEG and MRI evaluations were unremarkable for premature birth. Serum CK, plasma acylcarnitines, amino acids, urine organic acids, karyotype, sweat chloride test, swallow study, small bowel follow-through, polysomnogram and abdominal ultrasound were normal. At 8-months-old, his right vastus lateralis was biopsied. Muscle biopsy was with stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. Electron transport chain function of the muscle was tested and was normal. At the age of 13-months-old, he was starting to walk and say a few words with normal progression of milestones. No radiological evidence of central nervous system dysfunction or parental consanguinity. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with Hepatitis B vaccine and Influenza vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
My skin around my eyes swelled about 45 mins after vaccine. I had a prickly itchy sensation on my back, the back of my neck & under my right arm pit. My throat felt itchy. I took benadryl & the swelling around my eyes went down considerably within a few hours. The itchiness persisted until my 2nd dose of benadryl. When I woke up this morning, I was fine.
the patient received a double dose of Varicella; They thought they had given MMR II and not MMR with Varicella (ProQuad); Both ProQuad and Varicella were administered; This spontaneous report was received from a nurse referring to 2 year old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 27-OCT-2020, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the left arm and varicella virus vaccine live (oka/merck) (manufacturer unknown) subcutaneously in the right arm, both for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). They thought they had given Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and not measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) since they didn't realize this last one contained varicella. The patient received a double dose of varicella. No treatment for receiving a double dose of varicella was given at the time of reporting. The patient also received other unknown vaccines on 27-OCT-2020.; Sender's Comments:  US-009507513-2010USA011527:
Pt experienced faintness and dizziness within 15 minute observation time after vaccination. Pt denied c/o difficulty breathing, swelling of tongue or throat, or other symptoms. No localized swelling or redness.  Pulse was 92 and blood pressure initially was 152/98. Pt seated and elevated feet. Provided with 2 bottles of water and monitored for 45 minutes. Dizziness resolved after 15 minutes. Blood pressure lowered to 138/98. Patient called girlfriend for ride home. Pt was complaining of back and chest pain during the event, which patient claimed was normal for him since surgery.
Felt sick 24 hours after my first and second vaccine but it didn?t last too long. Now around 2 weeks later after my second vaccine I am experiencing flu like symptoms abs thinking it?s from the vaccine
shaking, profuse sweating, seizures.-pt did not seek medical treatment but stated she briefly lost consciousness with her family.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site swelling and injection site discoloration were not recovered/not resolved and the outcome of the cutaneous hypersensitivity was unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. In September 2018, about 12 days before the date of reporting, the patient was vaccinated with the 1st dose of SHINGRIX. The patient stated that the injection site was very tender and he had used cold and warm compresses on the area and was unable to sleep on it. In September 2018, 11 days after vaccination with SHINGRIX, the patient experienced injection site discoloration and skin hypersensitivity. This case was linked with case US2018173511 (wife case), reported by the same reporter.
The next day I got swollen lymph nodes under both my arms..  My lymph nodes became fairly large multiple grapes size.  The subsided but still continue to have constant pain under my arm pit,  underneath my breast tissue on muscle and also on the underside of my upper arm. This pain is low grade and constant.
Crying and sore arm for long time on and off into the next day. Sensitive and tearful for 6 hours since then acting "more retarded"/"slow to understand"/"not listening", not focus, started on next day and continues to now. Screaming on and off, easily distracted, unlike before. Takes a lot of focus to dress and brush teeth. Strange behavior like licking hands, mood swings either mean spirited/easily angered or sweet. Trouble processing info, inattentive (bumping into walls), dropping things more.
After 24 hours the baby developed hives and they continued breaking out for another 24 hours plus. She was not exposed to any new foods during the period.  She is not allergic to eggs.
Moderna 1/21/21, 2/24/21. Positive on 8/10/22
syncope after 1st dose COVID-19 vaccine laid pt down 1108: BP88/56, HR64, SpO2 97% 1109: BP94/62, HR72, SpO2 98% 1111:  HR78, SpO2 97% 1112: BP90/74, HR68, SpO2 97% 1116: BP102/78, HR80, SpO2 96% 1120: BP104/76, HR74, SpO2 96%
pt recv vax 9AUG96 on 14AUG96 a red macular rash appeared on trunk;NOS noted;
The following day would not get out of bed.  It was clear by @ 6pm he was in shock - called ambulances; hospitalize 3-4 days
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
This spontaneous report as received from a physician and a health professional refers to a 19 (also reported 16) years old "transplant candidate" male patient with allergy to shell fish and allergy to iodine and a long history of IgA nephropathy. The patient's medical history included spinal stenosis, sciatica, herniated disc L spine x2, renal failure, hypertension (HTN), hypercholesterol and tethered spine. On 25-JUL-2012 the patient was vaccinated on left arm with a 0.5 ml dose of VARIVAX (Merck) (lot # 671027/1067AA). Concomitant medications included aluminum hydroxide, heparin sodium, hydrocortisone sodium succinate, levalbuterol hydrochloride, pantoprazole, propofol, sulfamethoxazole, BACTRIM TABLETS AND SUSPENSION, VIROPTIC, acyclovir sodium, epoetin alfa, fentanyl, piperacillin sodium, ZOSYN, sodium chloride, acetaminophen, hydromorphone hydrochloride, ibuprofen, XOPENEX and Lorazepam. The physician reported that on an unknown date the patient developed bilateral pneumonia (hospitalization, disability and life threatening) and zoster type rash all over his trunk, back and face (hospitalization, disability and life threatening) after vaccination. The patient was in the hospital in serious condition. It was reported that the patient was definitely immunocompromised (i.e. on prednisone and CELLCEP) at the time of vaccination approximately 3 weeks ago. The patient was in the process of being worked up for a kidney transplant. The patient was currently hospitalized with varicella, bilateral pneumonia and bilateral pneumothoraxes he was intubated and on a ventilator. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A sputum sample was collected on 24-AUG-2012. The sample was taken from endotracheal aspirate. The types of adverse experience included rash and back pain. The patient had no recent exposure to chickenpox. At the time of reporting, the outcome of bilateral pneumonia and zoster type rash all over his trunk, back and face was reported as not recovered; the outcome of varicella, bilateral pneumothoraxes, he was on a ventilator, he was intubated, and back pain was unknown. Bilateral pneumonia and zoster type rash all over his trunk, back and face were considered as disabling and life threatening by the reporter. Additional information has been requested.
Developed gouty arthritis in the months following anthrax vaccination. Has been suffering gouty arthritis acute flares multiple times per year since the vaccination.
pt exp maculopapular rash on arm & chest & itching on 28APR92 p/1st dose of Engerix-B; pt seen in ER;
RASH ROUGHLY THE SIZE OF A BASEBALL, RAISED RING AROUND THE EDGE, VERY ITCHING SLIGHTLY WARM TO TOUCH.  STILL PRESENT AT 10 DAYS POST VACCINE
This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 7 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were received as follows: The reporter stated that, 2 patients experienced soreness one week out after the vaccination with BEXSERO. The reporter stated that, very little information was known about the event was known and all other information including as batch number of vaccine, age of patient, date of vaccination, initials of patients and expiry date of vaccine were unknown. This case has been linked with the case US2016GSK015455 for the 2nd patient reported by the same reporter.
PATIENT RECEIVED FIRST VACCINATION ON 05/28/2021 AND SECOND DOSE ON 06/18/2021. THIS WAS ONLY 21 LAG DAYS BETWEEN VACCINATIONS.
haze in left eye; pain behind left eye, and pain above left eye; Headache/pain in left temporal area; told symptoms consistent with encephalitis; Within 30-36 hours after second dose, she had stiffness of neck; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ENCEPHALITIS (told symptoms consistent with encephalitis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-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 ENCEPHALITIS (told symptoms consistent with encephalitis) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck) and HEADACHE (Headache/pain in left temporal area). On an unknown date, the patient experienced VISION BLURRED (haze in left eye) and EYE PAIN (pain behind left eye, and pain above left eye). At the time of the report, ENCEPHALITIS (told symptoms consistent with encephalitis), MUSCULOSKELETAL STIFFNESS (Within 30-36 hours after second dose, she had stiffness of neck), VISION BLURRED (haze in left eye), EYE PAIN (pain behind left eye, and pain above left eye) and HEADACHE (Headache/pain in left temporal area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Magnetic resonance imaging: for most part appears normal (normal) for most part appears normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications included trigger point injections. The patient was evaluated in the ER for symptoms of stiffness of neck and headache and was told the symptoms are consistent with encephalitis, however, the diagnosis had not been confirmed.  She was also evaluated by her primary doctor on 22Mar2021, an ophthalmologist on 15Mar2021, 19Mar2021 and 03May2021, a retinal specialist on 03May2021 and is scheduled to see a neuro-ophthalmologist on 03Jun2021.  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.   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.
Information has been received from a medical assistant concerning a 15 year old female who on 11-FEB-2008 was vaccinated IM with the first dose of GARDASIL (Lot # 657622/0388U). Concomitant therapy included MENACTRA. Each day since the vaccinations the patient developed new symptoms such as eye pain/pressure in both eyeballs, chest pain like heart attack, headache, neck pain, both arms tingling and crackling with pain, both legs tingling, ribs on both sides ache, sides hurting, fainting frequently (7 times in one day). Patient then would hit her head when she fainted. Patient trying to get in with a neurologist. Medical attention was sought in the emergency room several times. At the time of reporting the patient had not recovered. No product quality complaint was involved. Additional information has been requested.  6/10/08 Reviewed PCP medical records which consisted of various ER records. 1/15/08 -- Seen in ER for chest pain.  Only records provided are labs which reveal mild anemia. 3/6/08 -- Seen in different ER for chest discomfort, pain in right calf, trouble breathing.  Had been seen earlier in day at clinic for same & received Toradol injection. DX w/chest wall pain & tx w/motrin.   3/11/08 Seen in 3rd ER for syncopal episodes x 2 days, epigastric pain, HA x 2-3 wks, & intermittent chest pain x 2 mos.  States chest pain started after hit w/paint ball 6 wks prior.  Admittted to family stress & frequent parental arguments.  Patient is home schooled entire life.   3/13/08 Seen in 4th ER myalgias, syncope & chest pain x 3 mo  3/14/08 Seen in 5th ER for passing out x 1 week w/eyes rolling back & wakes w/HA or chest pain.  Dx w/benign syncopal episode 3/16/08 Returned to ER #5 w/chest pain, epigastric pain, syncope & leg pains x 6-8 wks.  MSW eval done.  Referred for outpatient neuro consult.
by following day patient had soreness and a slight rash on upper arm. by second day patient stated upper arm was swollen and very rashy.
breakthrough bleeding for 5 days; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 03Apr2021 at 06:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (unspecified), she did not have a menstrual cycle in 7 years because she had an intrauterine device in place. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications include ongoing levonorgestrel (MIRENA) intrauterine delivery system. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown) on 13Mar2021 at 18:30 (at the age of 49-years-old) in the left arm for COVID-19 immunization. There were no other vaccinations within 4 weeks of the vaccine. On 06Apr2021 at 05:00, the patient experienced breakthrough bleeding for 5 days. The patient was not treated for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of breakthrough bleeding was resolved on an unspecified date.   Information on the lot/batch number has been requested.
A little sick to my stomach; Rash on her back, abdomen area, under both arms (spreading lower); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her back, abdomen area, under both arms (spreading lower)) and NAUSEA (A little sick to my stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced RASH (Rash on her back, abdomen area, under both arms (spreading lower)). On an unknown date, the patient experienced NAUSEA (A little sick to my stomach). At the time of the report, RASH (Rash on her back, abdomen area, under both arms (spreading lower)) and NAUSEA (A little sick to my stomach) 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.   Patient states she put on her lower back at first some Comet that she usually puts on her lips.Concomitant medication was not provided.; 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.