chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute demyelinating encephalomyelitis.  12/07/2009 ED, hospital records, neurology consult received. Service dates 11/27/09 to 11/30/09. Assessment: Suggestive of Multiple Sclerosis. Patient c/o feeling off balance and tilting towards the left side when standing or sitting. Numbness and weakness. Weakness left side. Dragging (L) foot/leg. Decreased hand coordination. Work related stress. Flat affect. Small burn left wrist. Difficulty tandem walking. MRI demonstrated (R) frontal ring-enhancing lesions and left cerebellar non-enhancing lesion.  12/10/09 DC summary/ hospital records received for  DOS 11/27/09-11/30/09.  Dx: demyelinating disease, suggestive of tumefaction MS. Left-sided weakness had resolved by the time of discharge and plan to continue steroid therapy as outpatient.
No additional AE reported.; Caller reported expired MMR II was administered.; This spontaneous report was received from a nurse and refers to a 2-year-old male patient.  The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 20-SEP-2022, the patient was vaccinated with an expired  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #T029549, expiration date: 10-SEP-2022, administered for prophylaxis (strength, vaccination scheme and route of administration were not provided) (Expired vaccine used). No additional adverse event were reported.; Sender's Comments:  US-009507513-2210USA001482:
headaches; tenderness in left arm; weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "anemia" (ongoing), notes: she has anemia before it was bad and now improved.; "fall", start date: 2021 (unspecified if ongoing), notes: had a fall 2 months ago, still have bruises now; "bruises", start date: 2021 (ongoing), notes: had a fall 2 months ago, still have bruises now; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "hematoma/small blood clot" (not ongoing), notes: she had hematoma/small blood clot in the dented area of right lower leg (right leg is her bad leg) as a result of injury from the fall, this has resolved, md aware; "Rheumatoid Arthritis" (ongoing), notes: Diagnosis or Reason for Use: Rheumatoid Arthritis. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 immunization; Bnt162b2 (Second Dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "headaches"; TENDERNESS (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "tenderness in left arm"; ASTHENIA (non-serious) with onset 10Sep2021, outcome "recovered" (11Sep2021), described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 11/03/00, this patient's mother noticed a bulging anterior fontanelle. On 11/04/00, he went to the family doctor, who referred him to another doctor. On 11/19/00, the infant had a CT Scan of the head which was Nml. and head circumference remained stable. Bulging still continues.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneously (site of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
Fever, muscle ache, fatigue, headache  Treatment: Ibuprofen and acetaminophen
RESTLESS NIGHT; MUSCLES FELT SLIGHTLY TIGHT; ALL NIGHT HAD A FEVER; MUSCLES FELT SLIGHTLY SORE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced restless night, muscles felt slightly tight, all night had a fever, muscles felt slightly sore, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 units unspecified, 100 units not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all night had a fever, and the outcome of muscles felt slightly sore, headache, restless night and muscles felt slightly tight was not reported. This report was non-serious.
Does shingles vaccine cause leg cramps?; This case was reported by a consumer via call center representative and described the occurrence of leg cramps in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced leg cramps. On an unknown date, the outcome of the leg cramps was unknown.   It was unknown if the reporter considered the leg cramps to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group was not reported but was selected as adult as per vaccine indication. The patient asked that does Shingles vaccine cause leg cramps. It was unknown if reporter consented to follow-up.
Autistic; regressed in development; several treatments. Note: Pediatric office said that lot number was not reported on IPV and DPT given on 4/9/01.
Following vaccination, flu-like symptoms, with myalgia, arthralgia, cough, cold, fever of 101.4 and weakness. These treated with supportive care and symptoms lasted 48 hours and then slowly improved. After 72 hours symptoms completely resolved.
Patient described feeling strange and remained at facility for observation for 30 minutes. 2 Benadryl administered. She went back to work at a high school. When still feeling unwell, went to see school nurse. Felt faint, syncope, numbness of right cheek, tachycardia.  Ambulance called and patient was taken to ED. Later that night had flu like symptoms at home.
Woke up with dry heaves vomiting  . Fever of 102 for 24 hours.    Rapid heartbeat that was too high to register on home device,  chills , body aches ,  fatigue .    Heartbeat settled down around 1100 p.m.   Next day low grade fever of 100 and chills continue.  Fatigue lasted for several days.   Better now but occasionally get unusually tired but then I am 61 now.
I had severe acid reflux and heart pain and searing shoulder pain near my neck for two months. The neck pain has mostly gone away as well as the reflux and mostly the heart pain. My period last have been spot on regular bleeding for 5-7 days like clockwork every 28-30 days  for years and immediately after the second shot I have almost had zero period. I had a day of bleeding in March, then nothing, a day of bleeding in April, then  very minor spotting for two weeks now.  It?s most definitely related to the shot and not peri menopause since I was so regular up until that second shot.
8 days after vaccination w/Proquad and Havrix,had brief (< 1 minute) generalized seizure.  No fever.
COVID-19; HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19, and heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and heart issues was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263898.
Information has been received from a pharmacist who was also the pharmacy manager referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient inadvertently received expired dose of PNEUMOVAX23 (lot # K019933 with expiration date 20-APR-2016, dose and route unknown). Concomitant therapy was not provided. NO adverse effects reported. Additional information has been requested.
8 hours of receiving the vaccine my temperature begin to increase by 8PM it was 99 degrees Fahrenheit my body could not take liquid or food continued diarrhea. The temperature continued all the night and the diarrehea I only took a pair of aspirin the next day the same no thirst or hunger and reluctance with body, muscular and bone pain. Around 4PM all symptoms began to gradually lessen, by night I had thirst and hunger. The next day I was almost normal with only reluctance and heavy legs. This was all I experience after the vaccination.
Right arm redness, swelling and 3 cm area of induration on Day 8 of vaccine
Joint/Muscular pain and fatigue throughout entire body, hypersensitivity in right leg above knee, fleeting sharp pains in joints,muscles, and extremities
Had not had herpes simplex, oral, break out in years. After the shingles vaccine had herpes blister for 4+ months! I know it isn't exactly the same, but viral load?
chills; pretty sick; fever/on and off fever.; felt terrible; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported) as 2ND DOSE SINGLE for COVID-19 immunisation. The patient's medical history eight stents. The patient's concomitant medications were not reported. The historical vaccine included BNT162B2 first dose on an unspecified date for COVID-19 immunisation. It was reported that the patient got the 1st COVID shot and after his 1st shot he was fine. After his 2nd, he had it on 14May2021 because he was a veteran, he was fine. On Friday, Saturday and Sunday he was fine. On Monday (unspecified date) he had chills and was pretty sick to this day, 8 day later he has had an on and off fever. The patient went to the emergency room and they kept him for 4 hours, he had blood test but, of course they didn't give him a COVID test at that time. They said blood was fine, it just had to run its course. This past Saturday (unknown date), they (patient and the reporter) went and took a COVID test and they found out they were both negative and he still has the chills. He felt terrible. He mentioned that he was compromised, he had problems, he had eight stents. It was added that he was compromised due to 8 stents. She asked if this was antibodies. The patient took a blood test and did "intravenous" (unspecified).  Fever of 103 then it "goes normal. Then 98.1. She stated two people in their family have died. They queried how long this will last, the fever on and off, high low, high low, and if it was normal. The reporter thought it may be three days, that he would have it. This was the 8th day that he had a temperature that goes up and down. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My husband received his 1st shot on Friday,  01/25/21 and had a stroke on Sunday, 01/27/21. He received his 2nd shot on 02/26/21 and had a stroke on 02/28/21. He had another stroke on Wednesday, 03/10/21. He was admitted  both times.
patient came to mass vaccination clinic, was given vaccine as part of mass vaccination before discovering was 14 years old.  Had no symptoms or adverse effects after vaccination
ARM PAIN; BODY ACHES; BONE PAIN (LEGS AND HIPS); RINGING IN EARS; CHILLS; JOINT PAIN (LEGS, BUTTOCKS AND  SHOULDER); FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included antibiotic allergy, seasonal allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or illicit use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 09:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced arm pain. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced bone pain (legs and hips). On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced joint pain (legs, buttocks and shoulder). On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and joint pain (legs, buttocks and shoulder), was recovering from fever, chills, and nausea, had not recovered from ringing in ears, headache, and arm pain, and the outcome of bone pain (legs and hips) was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
p/vax mom report pt lips, ears swelling;taken to MD then welts, red blotches on face, trunk;tx in ER;
1 of 3 pts (immunized from same lot; 2 pts from same vial) upon nursing home admission who recvd tetanus toxoid & reimmunized 4 wks later (nursing home policy) exp inj site react; pt's rxn was hot to touch, swelling down arm, 6-7cm;
left eye keeps twitching; No immediate vision changes until later in the day when left eye gets tired; This is a spontaneous report from a contactable nurse (patient) reported that a 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 24Dec2020 07:45 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient's medical history and concomitant medications were not reported. Patient is not pregnant. On 26Dec2020 (also reported as 'approximately 2 days after the first vaccination'), the patient's left eye keeps twitching. No pain. May intensify and becomes obvious. No immediate vision changes until later in the day when left eye gets tired. No treatment received for the reported events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Muscle soreness, not just at the site of the vaccine. Back aches especially. Nausea. It lasted throughout the day but passed witin 24 hours.
Symptoms started on the 6th of October 2021 the same evening as the second dose of Pfizer BioNTech.  Started with congestion and coughing.  I awoke in the middle of the night with a fever and headache.  That morning still had congestion and coughing with SOB.  Seemed like I had asthma but have never been diagnosed nor had any trouble prior to the vaccine.  The congestion would come and go but the cough and SOB continued.  It's been over three weeks and I still have SOB with coughing mainly at night.  Went the urgent care the first time on Monday 10/25/21 to see if I had an upper respiratory viral infection.  The doctor ran all the normal tests the first visit other than a viral panel.  Everything came back normal so I was prescribed prednisone and albuterol and told to come back if symptoms worsened.  Tuesday 10/26/21 I had the normal SOB and coughing present but nothing worse than before .  Wednesday 10/27/21 I had awoken with same symptoms but around 10 am began to have the worst chills of my life.  I was shaking so bad that I bit my tongue several times.  I was freezing so I decided to take a warm bath which helped with the chills after five minutes.  An hour after the chills I had a temperature of 102 and went back to the urgent care.  The same tests were ran and all came back normal.  A viral panel was also done and came back negative for all common viruses including the COVID 19 virus. The doctor said I had symptoms of an upper respiratory viral infection but no virus was present.  It just seems like too much of a coincidence that I was healthy prior to the second dose of the vaccine and that same evening ended up getting sick.
positive skin tests using the Fluzone Quadrivalent vaccine; local reaction; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who experienced positive skin tests using the fluzone quadrivalent vaccine and local reaction while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious positive skin tests using the fluzone quadrivalent vaccine (skin test positive) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date the patient developed a non-serious local reaction (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (positive skin tests using the Fluzone Quadrivalent vaccine, local reaction).  At time of reporting, the outcome was Unknown for the event positive skin tests using the fluzone quadrivalent vaccine and was Unknown for the event local reaction.
On 06/02 my husband tested positive and I was still negative. I went in to get a PCR I was still negative Friday. And on Saturday I woke up with bad symptoms and my doctor called in PAXLOVID.
Around 1:00 am on 8/28, I felt a pounding headache and experienced some coughing as well. I woke up a couple hours later and I kept taking Motrin every 6 hours (for the headache) and I also had a very bad cough. I still went food shopping and did normal activities. On Monday, I felt poorly but I went back to work. I am careful with masks and everything. Then my husband was sick a couple of days before and we didn't think that was COVID either. He called me on Monday - and told me that he had the results Monday morning that he tested positive for COVID. So I left off school and went back to my son's school and picked him at 09:00 and I called my teenagers and told him that I was going to go get tested. Teenagers were still not at school yet. I went and got tested - at 10:30 am (all of the rest of us) and we were all COVID positive. I went home and as the day progressed, I started to feel worse - I started to have pain in my joints. I had a low grade fever and I was still coughing very badly and still had a headache. I ended up in bed for 9 days. They told me I could come back on the 10th day - but I didn't because I was having a fever that was only controlled by the Tylenol round the clock. The fever got less and less and I was suppose to be 48 hours fever free and I just wasn't. I finally went to the doctor because I was worried. I went to doctor September 15th or the 16th. But on the 13th, I went for a COVID test to the same testing site - I tested negative at that time but was still running a fever. Doctor told me to give her a call if I was still having a fever still in a few days;. I was feeling better - the fever was coming maybe about twice a day at that time is all - about 02:00 am maybe and then at 09:00 am. The doctor told me to try to go back to work the following Monday, the 20th. I did go back to work on the 20th. My husband had given me three different kinds of cough medicine to take and I had been taking Vit D etc. The symptoms I experienced right after the second dose - pain in my arm from the shot; had a fever; I had pain in my joints; I got the vaccine on Monday of our spring break so I didn't have to work and I went to bed that day and the next morning and I asked my husband for Motrin because I was shivering and burning up - at 05:00 but didn't take the Motrin - fell asleep and then at 09:00 am I took Motrin. I could function then when I took Motrin around the clock. Those symptoms lasted for about three days.
1/7/21 @ 10:00pm  Emesis 1/8/21 Nausea through out the day 1/8/21 @ mid-morning, Diarrhea, Nausea 1/8/21 @ early evening, Diarrhea, Nausea 1/9/21 Nausea 1/11/21 @ 10:10 pm, Nausea and dizziness
flu like symptoms; aches; fever; tired; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever and tiredness. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the pain, fever and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter did not have any specific details regarding any patients. The nurse reported that, lot of patients complained of flu like symptoms for up to 24 hours, after Shingrix administration. The reporter mentioned low grade fever, aches and feeling tired. The nurse stated that, she only reports events when they were not listed in the package insert. The reporter consented to follow up. This case has been linked with case US2018086784, reported by same reporter.