chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 20NOV93 & approx 16 days later devel swelling, heat & pain in knees, ankles & wrists; pt was seen by MD who prescribed anti-inflammatory drugs which resulted in dec swelling & pain; hands still numb; dx carple tunnel synd;
Patient died 1 week after vaccination.  According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination.
Pt started with myalglas and fever on 12/09/08 along with facial pain. Seen by doctor on 12/10/08 and Rx'd Amoxicillin. Re-evaluated by another doctor 12/15/08 for worsening myalglas, headache with photophobia. Sent to ER for eval the same day. Re-eval by Doctor 12-16-08 and scheduled for RUQ abd US and brain CT. MRI brain ordered  for 12/19/08.
11/18/02 Employee received flu shot and had an adverse reaction 1 hour later. She returned to the flu clinic "complained of swelling, intense aching of left arm where flu shot was administered. Employee sent to occupational health services and seen by RN who sent employee to ER for further treatment. No SOB or respiratory problems were present. Area was ? free of redness or firmness. Sent home after treated without further problems.
Area where vaccine given is red, swollen and warm to touch. Redness and swelling has continued to spread and get bigger since receiving the vaccine. No c/o fever or SOA. Pt has put some ice on the area but no other treatments at this time.
Patient noted vaccine burned a bit more at time of injection on 2/28/13 compared to first dose administered 12/28/12. Subsequent to that the burning generalized up and down arm and onto right shoulder. Also has had a dull headache since then. Notes pain & difficulty reaching behind her. She is having difficulty drawing & lifting things with right arm. (At time of visit on 3/5/13 at 8:50am). Dx: Dysesthesia (favor early RSD). Treatment: GRALISE tablet 600mg starter pack.
A non-serious, spontaneous report of child under indicated age received FLUMIST was received from a health professional concerning an 11-month-old male. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
This initial spontaneous report was received from a registered nurse referring to unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered improperly stored PEDVAXHIB injection (lot # L006545 with expiration date 16-NOV-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Joint pain right knee, radiating to hip and ankle. Began after first dose, still persisting. Pain both when bending and also when straight, aching pain.
Diarrhea, H/A, weakness, flank pain, genital itching.
Pt began screaming 30 min p/DTP; screaming lasted approx 6 hrs; rx w/APAP only mom called MD x 2;
moaning X 24 hrs and fever > 104 X 24 hrs for 24 hrs /p injection.
Pt had flu shot. About 1 week later (11/08/03) pt noticed excessive tearing left eye, assymmetrical facial weakness, change in sense of taste when chewing.  Pt was seen by MD on 11/10/03. MD noted peripheral weakness of CNVII, weakness left upper eyelid, facial asymmetry. A neurologist was consulted and diagnosed Bells'Palsy prescribed Acyclovir 500mg 5 times a day for 10 days and Prednisone taper.  On 11/11, pt noticed blurred vision, headache, blackspot in left visual field.  On 11/19/2003 pt reported vertigo x2 and dizziness. Medical record states ptosis. msv
Fever, sore arm, head ache 8:00 pm. - by 8:00 am 12/28/2013 arm very sore no fever.  5:00 pm 12/28/2013 fever of 101 arm swollen with redness took ibuprofen and flu medication. By 8:00 am 12/29/2013 fever 101.1 called nurse and let fever run the rest of the day with no medication.
Right leg thigh red and swollen over entire lateral thigh from knee to hip.  Treatment per Dr. > ice and watch for further developments 3-30-09 I spoke with patients father this morning at 0945.  He stated that patients leg is much improved.  The swelling and redness have resolved and she only has a small bruising at the injection site.
delay in side effects; injection arm irritated; injection arm itchy; injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red). At the time of the report, SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter. Treatment included Benadryl was noted.
Pt devel severe hives & high fever following Cholera & TYphoid vax, disappeared p/ 2 days of DPH;
Irregular menstrual cycle, heavy period. First time my period has been irregular in my adult life.
2 weeks after my 3rd Moderna shot I started to experience heaviness in my left leg. During that time I also developed rashes on both arms, on my chest in the shape of a V and kneecaps. I also was experience fatigue that k have never experienced before. The muscle weakness moved over to both legs after a couple more weeks. Within 1.5 months or sore I had muscle weakness all over my body. I was not able to lift my legs or arm and was completely dependent on family for help. I was unable to care for myself and confined to a wheelchair.
Breakthrough case of COVID - sx onset 05/24/2022 - positive test date 05/24/2022 I woke up with a really sore throat, later in the day I had a fever of 102, chills, headache, body aches.05/25/2022.  I woke up with a fever of 104, Tylenol helped bring it down a little bit. I emailed my doctor 2 times and she never got back to  me, I waited until later 05/25/2022 so I went through my insurance company and got an e-visit with a provider who prescribed Paxlovid. I started to feel fine on Saturday.  The Paxlovid gave me the moist horrible taste in my mouth for the entire five days I was taking it. Currently I feel fine, at 100% . Since I have had 3 antigen tests showing negative (Sunday, Monday & Tuesday).
Patient received B12 shot the same day. By 1pm felt lips numb and tingly, was not feeling good. Site of injection, red, tender, swollen. Called doctor, pt asked to go back to the doctor office. Nurse observed and sent her back home. By 3P face was numb so went to ER. Felt very dizzy, heart pounding, systolic BP was high around 158. Then felt itchy, heart palpitations, whole body numb and tingly, felt nauseous, then went into shaking. Nurse put IV for blood tests but did not get IV started until 1 hour later which exacerbated GI pain issues. Given phenergan and DILAUDID to help with nausea and pain a bit. Admitted to the hospital because legs were still numb and tingly. By 9PM Friday, dry heaving, potassium was very low, had a charley horse on leg. Given oral BENADRYL and phenergan. By 1PM on Saturday felt a bit better still a little tingly and numb, had bowel movement and they stopped IV fluids since was able to drink ginger ale. Patient who is a nurse was very upset with care at hospital so she left even if she was not feeling well completely. Today still feels lips and face a little tingly and numb.
I am experiencing a lot of joint pain in my hands...my fingers...arthritis-type symptoms...ever since the 2nd dose...I also broke out in different-looking rashes all over my body several days after receiving the shot...blisters on palm of left hand...intensley itching radh on left hand and up left inner arm.. rash soread to my face,under my breasts. ..this rash looked like sandpaper.  Big,round rash on inner thigh...lyme test was negative.. the rashes FINALLY subsided after about a month...then the joint pain set in.. I am afraid...no booster for me!
Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and diarrhea were occurring. Those symptoms now resolved but myalgias persist.
Patient complained of feeling light headed and nauseated at 17:20.  VITALS 17:22: Temp 97.8, HR 82, RR20, BP 98/60,   Patient was able to speak clearly and appropriately. Last food consumed 2 hours previously with peanut butter crackers. Patient given orange juice .  VITALS rechecked 17:28: BP 116/78, patient reported improvement of complaints with hydration and juice.  Patient left site at 17:35 with symptoms resolved.
Looks like hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Looks like hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Looks like hives). At the time of the report, URTICARIA (Looks like hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Developed facial shingles 2 days later  Bells palsy 2 weeks later
Rash believed to be hives. Extensive and covering the entire body. Benadryl and Allegra ineffective.
Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second time I had severe chills around 1:45 pm in the afternoon. And My right arm has soreness.
Patient developed Bell's Palsy 14 days after vaccination. Another 10 days after that, she developed symptoms of right leg weakness that have progressed to bilateral lower extremity weakness plus sensory symptoms that meet criteria for Guillain Barre Syndrome.
Patient reported today having severe flu like sx (fever, chills, sweats) for 3-4 days. Also, had swelling, redness and pain to injection site. Today, during administration of 2nd dose patient had small hematoma remaining on left deltoid. 2nd dose administered onset of edema within 3-4 minutes of administration. No additional adverse sx presented.
weakness, stomach digestive trouble for over 1 week, soreness, dizziness, restlessness, trouble tracking/thinking
I would say the first thing I noticed I was lethargic and we were coming back and I just didn't feel myself.  I don't know if there was any symptom in particular and on Wednesday I woke up and felt like I was beginning a cold with a runny nose and headache and didn't think much about it and was still doing my normal activities and as the day wore on I was tired and on Thursday my symptoms were more pronounced and my head felt like a melon and I took a home covid test and it was positive and I called the physician and he said treat it like a cold and the symptoms lasted about a week and I had a lingering cough after about 6 days and it is a weakness of mine and anytime I get a upper respiratory I have a lingering cough, for the first 4 days I just laid around and took my cold medication and drank fluids.  I stayed fairly isolated for 10 days to 2 weeks.
The same day as her vaccine (8/4), she began to develop shortness of breath which progressively worsened over the weekend. Diagnosed on 8/9 with bilateral pulmonary emboli.
GARDASIL vaccine administered in (L) deltoid. Patient had syncope episode with seizure like activity and loss of urine.
severe lower abdominal discomfort; very tender; hurts to press on; watery stools; bloating; fatigue; pulse ox of 94; This is a spontaneous report received from a contactable consumer. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, after administration, there was severe lower abdominal discomfort, very tender, hurts to press on, watery stools, bloating, fatigue, and a pulse ox of 94 in Jan2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: was all better and now 10 days after my first Paxlovid dose, and 1 day after testing negative for Covid on 2 rapid tests, I developed a new nasal pressure and congestion; Positive, notes: 3 days after those negative tests, I just tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient had received other medication in 2 weeks. Patient had received Paxlovid on 22Apr2022 for treatment of COVID-19 and stop on 27Apr2022. She was all better and now 10 days after her first Paxlovid dose, and 1 day after testing negative for Covid on 2 rapid tests, she developed a new nasal pressure and congestion. 3 days after those negative tests, she just tested positive for Covid again. Seems to be a recurrence since I haven't been out of my house much at all in the last 2 days since leaving isolation. Other medication in 2 weeks product was Xeljanz. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The day after I received the 2nd dose, I started to feel chills that went through my body. It was so cold that I could not get warm. I was wearing extra clothing and blankets and I was still shaking. I checked my temperature, and it was 102.8. I took some Tylenol and made some warm water with lemon and took a nap. I woke up two hours later and I was soaking wet. I started to have a bad headache. I changed my clothes and took one more Tylenol and I laid back down in my bed. My temperature was 102. I woke up around 10 at night and my clothes were soaked. My temperature at the time was 102.2. I took some Pedialyte and felt better. I woke up in the morning and again my clothes were soaked. The following morning, I woke up and I felt a little better, but I was feeling extremely tired and my arm where I received the vaccine was getting red and tender. I didn't have the chills anymore, but I felt very tired for the whole week. The top of my arm was very red, itchy, and swollen. It took a while to go away, but every day was a little better with the swelling in my arm. I never thought to check under my arm, but then I noticed that I had a bump under my armpit. The bump under my arm is enlarged and painful if I touch it. It is sending a sharp pain down to the side of my breast and around my shoulder blade. I have an appointment with the doctor on 07/06/2021 to find out what this is.
Patient was given 0.25mcg Moderna Bivalent Booster but was to be given 0.5mcg. Wrong dosage given.
The Janssen Vaccine was administered to a minor. No reactions at the time of Vaccine, or day following.
I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago.  I was paralyzed from the waist down, hospitalized, and had a very slow recovery.   This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.)  Little was known at that time.    I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected.  Currently the muscles going down the back of my lower leg and around the ankle are affected.   Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI.  I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing.  My breathing was erratic for a few days and I felt nauseous for 2 weeks.  I have not had the second covid shot.
Moderna COVID- 19 Vaccine EUA: soon after vaccination patient reported feeling warm and naseated. Symptoms resolved within one day.  Six days after vaccination patient developed an itchy rash on the face that is warm to the touch, stomach cramping, dizziness, and chest discomfort. Physical exam remarkable only for rash: patient presented alert and oriented, well-appearing. Patient prescribed hydrocortisone cream.
Information has been received from a consumer concerning his 31 year old son with no past medical history of allergies who in 6/99 and 5/00 was vaccinated with the 1st and 2nd doses of pneumococcal vaccine 23 polyvalent. The day after the 2nd dose of the vaccine, the pt experienced very serious adverse experiences described as back pain, pain around the pelvic girdle, burning all over the body (especially in the buttocks and legs), severe headaches and difficulty with defecation and urination. In addition, he had not been able to work in 2 years and was confined to his bed nearly all of the time. He consulted several doctors and had been admitted to a hospital in the past but he received conflicting views about whether this can be related to the double vaccination. It was reported that the pt was hospitalized several times but was usually discharged because they cannot determine the cause of his illnesses. Additional information has been requested. Additional info from the consumer noted that he has spoken with multiple doctors and no one can help his son. Follow up info from a pharmacist noted that the pt did not have pneumococcal vaccine 23 polyvalent vaccine prescription filled at this pharmacy. The pt had obtained the vaccine before he became a customer at this pharmacy. Additional info has been requested.
pt woke up from NAP w/high pitch cry; mom called & MD heard crying & it was high pitched which confirmed mom's concern;
afib; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criteria hospitalization and medically significant). On 22-Jul-2021, the patient experienced CHEST PAIN (Chest pain). The patient was hospitalized from 20-May-2021 to 20-May-2021 due to ATRIAL FIBRILLATION. On 20-May-2021, ATRIAL FIBRILLATION (afib) had resolved. On 22-Jul-2021, CHEST PAIN (Chest pain) had resolved.            Patient  Never had any heart issues until after vaccine,Now on prescribed meds and awaiting treatment and testing by cardiologist. he is not claiming his heart issue was caused by vaccine, but thought it should be reported for records.  Company Comment  Very limited information regarding this events has been provided at this time. 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. Further information has been requested.   This case was linked to MOD-2021-259218 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.
PATIENT HAS AN ITCHY, SORE, RASHY ARM. SHE NOTICED IT THIS MORNING. SHE WILL APPLY ICE FOR 10-15 MINS AT A TIME AS NEEDED AND WILL APPPLY CORTISONE 1% IF NEEDED FOR THE ITCHING.