chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 19 year old female, with no known medical history or allergies, who on 09/14/2004 was vaccinated with a second dose of varicella virus vaccine live.  Concomitant therapy included norelgestromin (Ortho Evra).  Five days later, on 09/19/2004, the patient started to break out on her arms and legs with few spots on her chest.  Unspecified medical attention was sought and hydroxyzine hydrochloride was ordered.  The first dose of varicella virus vaccine live was given at 14 years old and the patient experienced no adverse symptoms at that time.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report was received from a nurse via company representative, referring to a 11-year-old male patient. The patient's concurrent conditions and medical history was not reported. Concomitant medications included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and meningococcal vaccine (unspecified) (manufacturer unknown). Approximately on 14-APR-2019 (reported as "about 10 days ago"), the patient was vaccinated with the first dose GARDASIL 9 in the right arm (route, lot# and expiration date not reported) for the prevention of human papilloma virus. On that day, after GARDASIL 9 was administered, the patient fainted (syncope). It was reported that the patient sought medical attention and no treatment was given for the event. On an unspecified day in April 2019, the patient recovered from syncope. The causal relationship between GARDASIL 9 and syncope was not reported. Upon internal review, the event of faint was considered to be medically significant.
Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sickness
Tdap vaccine given in LUE, then GARDASIL vaccine given in RUE. Pt walked to chair from table, then had fainting/stiffening episode x approximately 1 minute. Pale, clammy but responsive when I ran in.
Patient (pt) is a 26 year old male who received both typhoid and flu vaccine on 23-10-03. He felt fine the first wk and then at the end of October he had a knot in his throat, bad taste in his mouth and throat pain. Went to the doctor and was given amoxicillin for Strept- throat. States that the amoxicillin helped his throat. One week after the amoxicillin he started to notice a problem with blurred vision, dizziness and problems with balance. States it was constant and not associated with activity. Because of the dizziness and problems with his balance he was having problems playing basketball. Also had a headache. Described as constant, "hurting bad" and located in the frontal area of his head. Never had headaches like this before. He returned to the medic and was given meclizine for the dizziness. He tried it for 1 wk without any improvement so he returned to clinic. The clinic arranged for him to go for a MRI and further evaluation. MRI  revealed a cerebellar lesion vs. demyelinating disease. He was then given steroids and pt noted improvement in dizziness and stated that his blurred vision cleared. States headaches went away when his vision improved. Pt arrived at hospital on Dec 23 and stated he was taken off his steroids. While at home on Jan 2, 2004 he had a seizure witnessed by his cousin. Pt reported that his cousin said that he started shaking and fell to the floor. Pt did bite his lip. No incontinence noted and pt has no recall of event.  Pt was transported where he was admitted for evaluation. Pt states he has no prior history of seizures.  Hospital records indicated that when he was admitted he had mental status changes with combative behavior and a fever of 102.8. Intubation was required to complete medical workup. Initially started on Rocephin, Vancomycin and Acyclovir for empiric treatment of meningitis. Because blood and CSF were negative, the antibiotics were discontinued. Pt was discharged on January 7, 2004 with a normal gait, strength and appropriate mental status. Follow up as out patient with repeat MRI and Cerebral Spinal Fluid Analysis. March 18, 2004: Pt states he is doing well and feels there is an improvement in his condition. Only problem now is that he has occasional spasms on his right side of his body lasting 5-10 seconds. Spasms do not interfere with activity and he is not falling. He also complains of brief periods of dizziness during spasms. He is now hoping to resume some form of physical activity. Nurse follow up on 05/18/04: Cerebellar lesion, nystagmus, ataxia.
Pt was administered 2 vaccines that were not ordered by the physician.  No adverse symtoms have been reported.
Patient broke out in hives, had some shortness of breath, wheezing. Patient given steroid, BENADRYL and Neb.
Fatigue and Swelling in face which spread to entire body and I took 5mg loratadine initially because I was at work. Headache which was intermittent throughout vaccine day and 4/12/2021 thru 4/14/2021. I took 800mg ibuprofen and 25mg diphenhydramine at 8pm 4/12/2021.  Fever presented at 6:30pm on 4/12/2021.  At 6:45p,m chills and shivering. I turned heater to 81 degrees . At 9;58pm my fever was 100.8 degrees F. I took 1075mg Aspirin at some point during the evening of 4/12/2021. During the day  of 4/12/2021 I had joint pain and pain that progressed throughout my body.  I had intense back pain from below my shoulder blades to below my waist during the day of 4/12/2021 and got progressively worse as the day progressed.  Swelling slowly getting better still a little swelling on 4/14/2021.  Muscle aches, Pain, still remain on 4/14/2021 but are less.  Fatigue is still intense on 4/14/2021. Diphenhydramine 25mg and Aspirin 1075mg have been taken intermittently from 4/12/2021 to 4/14/2021. One dose of Meclizine 12.5mg because of dizziness on 4/13/2021.
Patient was diagnosed by primary care and specialist w/rotator cuff tendonitis - was told to ice, rest and take anti-inflammatory.
Limited range of motion in left shoulder. Pain on exertion esp when abducting or pushing down. Pain in shoulder at night-wakes me up. Audible sound heard upon use of left shoulder.
Headache Myalgia, Fever & Nausea Vomiting Narrative:
9-23-10 (L) arm sore - bright red arm from shoulder to elbow sore. Fever on 9-23-10. Dev. cough with wheezing 9-23-10. Had some itching took BENADRYL 9-23-10. Saw Dr 9-25-10 gave her Benzonate ate 100 mg cap tid x 10 days. Dev. hive that night. Has seen Dr again since then and feel that hives was from Benzonate ate 100mg tab.
This case was reported by a nurse via sales rep and described the occurrence of migraine in a 16-year-old female patient who received MENVEO (batch number M15036, expiry date July 2016). Concomitant products included Tdap vaccine. On 22nd June 2016, the patient received the 1st dose of MENVEO .5 ml. On 22nd June 2016, less than a day after receiving MENVEO, the patient experienced migraine (serious criteria other: as per reporter) and fever. The action taken with MENVEO was unknown. On an unknown date, the outcome of the migraine and fever were not recovered/not resolved. The reporter considered the migraine and fever to be possibly related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. The field representative stated that the nurse reported that the patient experienced severe migraine with fever of 101 degree F after receiving MENVEO injection. The patient had TB test at the same time as the MENVEO vaccination. The patient required visit to the emergency room. The patient's initials and the manufacturer of the concomitant vaccine were unknown.
That afternoon, post vax, pt ran a low-grade fever and was treated with Tylenol. On 7/27/01, the pt had 2-3 bowel movements which consisted of a green pasty texture with loose stool. On 7/28/01, he had 2-3 bowel movements which were the same and also on 7/29/01. He was anxious while trying to nurse. It would take a couple of times to latch on and then finally nurse. At 16:00, parents noticed purple and red spots and small bruises on his legs (from mid-thigh down to ankles on both legs). Mother remembered reading article on meningitis and knew petechia/purpura were symptoms of a severe form of meningitis. Immediately, she call his pediatrician and he called back, immediately. Upon hearing of marks on the infant's legs, the doctor told mother to immediately take pt to ER. As soon as we arrived, the pt was taken into back room, weighed and temperature taken. He was seen by 2 doctors. He is catheterized for a urine sample and he is given an IV line in his right hand. Several tubes of blood are taken for CBC and other blood clotting test. They dx'd him with petechia and purpura and possible HSP. They told the mother to follow-up with his pediatrician because the infant may have taken a reaction to one of the vaccines, given 6 days prior. He was released to go home. Mother takes pt for follow-up visit and he still has petechia and purpura on his legs and he is also still experiencing several green, pasty textured loose stools today. The doctor reviews all test results from the hospital and determines that the infant appears to have taken an adverse reaction to the pneumococcal conjugate vaccine. She advises mother to watch for fever, vomiting, more petechia/purpura spreading, crankiness, unwillingness to nurse, etc. Advised to contact her immediately if any of these symptoms occur. On 7/31/01, the pt had 2 green, pasty textured loose bowel movements today. He still appears anxious when attempting to nurse but finally latches on and nurses and still has petechia and purpura on legs. On 8/1/01, he had 3 green, pasty textured bowel movements today; still anxious when attempting to nurse and still has petechia and purpura on his legs. On 8/2/01, the pt had 1 green, pasty textured bowel movement and still appears anxious when attempting to nurse and still has petechia and purpura on legs. On 8/3/01, he had normal bowel movements and nursed normally today. On 8/6/01, the petechia and purpura are almost completely gone and on 8/8/01 he is eating and sleeping normally. His stools are normal and the petechia and purpura are now gone from his legs.
No additional AEs; M-M-R II was reconstituted with the incorrect diluent and administered; This spontaneous report was received from a healthcare business professional (office manager), referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.     On 16-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (1 time dose, lot # S035356, expiration date 05-NOV-2021; strength and route were unknown) for prophylaxis. Caller confirmed that the diluent (suspect, strength, dose, frequency, route, lot# and expiration date were unknown) that was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  was the diluent used to reconstitute meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO) vaccine (product preparation issue). No additional adverse events. The reporter inquired if the patient needs to be revaccinated after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered using the incorrect diluent.
Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme inflammatory response; A spontaneous report  was received from a consumer and  physician concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight.  The patient's medical history was not reported by the reporter. Concomitant medication was not reported.  On 22 Jan 2021, 15 minutes prior to the onset of the event, the patient received first of the two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, 15 minutes after the vaccination, patient had a severe allergic reaction. Patient had extreme inflammatory response, heart attack, neurological issues was unable to think straight, urinator catheter placed in on sight as fluid build and kept coming out, pulled out 1500ml. Patient was hospitalized 22 Jan 2021 through 24 Jan 2021. Laboratory information at the time of event was not provided.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight was unknown.; Reporter'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.
15mins post vaccination, pt c/o nausea and lightheadedness.  Vitals: BP 118/86, HR 93, RR 16, O2 SAT 100%.  Pt given crackers and apple juice.  Pt stable and released from vaccination site.
After the vaccine was given, patient sat and talked to the pharmacist for a few minutes, then walked off to do some grocery shopping. About 10 minutes later, as the patient was exiting the store she fainted. Her pulse was fine, breathing was fine, she would open her eyes and make eye contact every now and then but would not speak. After a few minutes we were able to get her seated in a wheelchair. The EMS was called, they looked her over and let her leave after just a couple minutes. She was driven home by family.
Fever, joint aches and fatigue  for about 24 hours I just stayed in bed and drank water.
This spontaneous report as received from a register nurse, refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB, (strength, dosage, route, and lot# were not reported). None symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presented to ER 4/27/04 at 11:00PM with temp 104.1 Rectal and actively seizing. Diagnosed with febrile seizure. No other illness noted. Treated with Motrin, Tylenol, and rocephin. Discharged at 3:00AM 4/28/04 in improved condition.
SLIGHTLY HOT TO TOUCH AT INJECTION SITE; DELTOID MUSCLE TONE LOSS; SWELLING BELOW INJECTION SITE; PAIN AT THE INJECTION SITE, PAIN IN BELLY OF LEFT DELTOID, LEFT DELTOID PAIN AT THE TIME OF INJECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vascular necrosis of the hip, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection. On an unspecified date, the subject experienced slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection, slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. This report was non-serious.
Large swelling of injection site Fever, sore throat, runny nose - treated with tylenol but no resolution as of today.
Site: Pain at Injection Site-Medium, Additional Details: Patient said both arms hurt now. second dose on 10/23/21 was moderna lot 939901, rx 1543991, opposite arm as the first one.
10:days after first vaccine eyes were swollen.  Saw eye doctor, he did not know direct cause.  Exactly 1 week after 2 nd vaccine eyes were significantly more swollen.  Primarily, upper lid and under eye   Right eye on both occasions was significantly worse but both I pacted
?Moderna COVID-19 Vaccine EUA? sore muscles (All over, not just injection site), chills, fever, upset stomach
Syncope following immunization. Pt did not call, called EMT, checked out by EMT, patient refused to go to hospital. Patient was able to walk out to car and answer all questions.
her arm, hand and face to go numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (her arm, hand and face to go numb) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BOSENTAN (TRACLEER [BOSENTAN]) and TADALAFIL (ADCIRCA) for an unknown indication.   On 29-Jun-2018, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) .6 mg/dl every six hours. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (her arm, hand and face to go numb) (seriousness criterion hospitalization). At the time of the report, HYPOAESTHESIA (her arm, hand and face to go numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information of the events are not reported. Reporter assessed the events are not related to IH Treprostinil and TD-300/A device but most likely related to  post vaccination with COVID vaccine.  Company comment:Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Head tilted to side; arms jerked; eyes rolled; Mom historian; episode lasted several seconds.
Feeling very very tired, feeling kind of washed out, tired, he felt like laying down, going to sleep and not waking up; Difficulty in walking; Chills; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling very very tired, feeling kind of washed out, tired, he felt like laying down, going to sleep and not waking up), GAIT DISTURBANCE (Difficulty in walking), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z6A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Muscle disorder NOS.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SOMNOLENCE (Feeling very very tired, feeling kind of washed out, tired, he felt like laying down, going to sleep and not waking up), GAIT DISTURBANCE (Difficulty in walking), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Feeling very very tired, feeling kind of washed out, tired, he felt like laying down, going to sleep and not waking up), GAIT DISTURBANCE (Difficulty in walking), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Not fever, he measured his temperature just in case.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
chicken pox; was supposed to get his 2nd dose in july; This spontaneous report as received from a nurse via a company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date in May (year not specified), the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, lot # and expiry date was not reported) for prophylaxis. On an unknown date (after vaccination), the patient experienced chicken pox (varicella). It was reported that the patient was supposed to get his second dose in July (year not specified), since he had chicken box, he was never given second dose (inappropriate schedule of product administration). The outcome of varicella was unknown. The relatedness between the event and the suspect therapy was not provided.
30 minutes post-vaccine.  disorientation, swollen lips/tongue, swollen face, metallic taste in mouth.  subsided after a double dose of benadryl.
pt cried const p/recvd vax @ 9AM; seen by MD 4PM & said everything OK; pt cont to cry, refused bottles throughout noc & next day; Friday early PM devel resp problems & taken to MD;
Extremely sore arm - I had to hold it as though in a sling  for 2 days as letting the arm hang naturally was too painful. Vasovago occurred during the night during which I was nauseous, fainted and vomited. The injection itself was very painful (only the second one, not the first). I felt as though the doctor punched my arm. I still have a slight pain in my muscle several weeks later.
pt recv vax; acute asthma attack 30 mins p/ vax; tx w/ proventil inhaler then cont tx w/ serevent inhaler
MISSED THE FINAL DOSE; This spontaneous case report was received from a pharmacist on 07-Mar-2019. It described a male consumer who "missed the final dose". The consumer was receiving Vivotif for travel.  It was reported that the consumer missed his final dose of Vivotif.  The action taken with Vivotif with respect to the event "missed the final dose" was not applicable.  The clinical outcome of the event "missed the final dose" was unknown.  Company's Comment: The causality of the event "missed the final dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the final dose" was considered as not applicable.
back pain has been getting worse; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included back pain. The patient's concomitant medications were not reported. The patient back pain had been getting worse on 20Dec2020. The outcome of event was unknown.   Information on the lot/batch number has been requested.
pt recv vax & devel a febrile response temp greater than 102;it also reported that other unspecified vaccines were given;
NauseaVomiting Narrative:  Experienced nausea that lasted for 2-3 hours the morning following injection
approx. 2 hours after I received the injection,  I developed hives to my face, chest and back