chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED to Hosp-Admission Current   9/9/2021 - present (6 days) Hospital  Patient presents with  ? Fever ? Flank Pain   Patient is an 72 y.o.  gentleman with history of BPH, hypertension who came with history of fever and right flank pain for the last 2 days.  Patient also states he has some mild headache.  Denied cough, shortness of breath, sore throat, nausea, vomiting, diarrhea.  Patient was taking Tylenol and ibuprofen but he stopped it because he was afraid he cannot damage his liver and kidney.  Patient states he seen his little Bronkaid pro infection from the school.  Patient got his two dose of COVID-19 vaccine in February ( Moderna ).     Review of Systems  Constitutional: Positive for fever.  HENT: Negative.   Eyes: Negative.   Respiratory: Negative.  Negative for cough and shortness of breath.   Cardiovascular: Negative.   Gastrointestinal: Positive for nausea.  Genitourinary: Negative.   Musculoskeletal: Negative.   Skin: Negative.   Neurological: Positive for weakness.  Hematological: Negative.   Psychiatric/Behavioral: Negative.
Complained her back hurt and her legs hurt.  Gave Motrin then a few weeks later noticed strange activity.  In December noticed she was holding her breath during this strange activity.  Contacted doctor and they ordered eeg and mri eeg showed activity.  Referred to neurologist.
dinitrophenyl high levels noted in her blood; Initial information received on 07-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 71 years old female patient who reported dinitrophenyl high levels noted in her blood while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 30-Sep-2021, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  once (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left arm for immunization.  On an unknown date the patient developed a non-serious event " dinitrophenyl high levels noted in her blood "(blood test abnormal) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported"calling to find out if FLUZONE HIGH DOSE QUADRIVALENT has dinitrophenyl in the vaccine or in the making of the vaccine. Caller stated she had lab work done and the lab technician advised the patient that she had high levels noted in her blood."   Relevant laboratory test results included: Laboratory test - On an unknown date:  [dinitrophenyl high levels noted in her blood]  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (dinitrophenyl high levels noted in her blood).  At time of reporting, the outcome was Unknown for the event dinitrophenyl high levels noted in her blood.
After booster dose of the COVID19 mRNA vaccine this October 8th, she developed tinnitus and hearing loss.  This was an insidious in onset, however, her ENT physician attributes it to the vaccination because of proximity in time. She does not have exact date of onset but occurred after vaccine in month of October.  Her symptoms persist
REDNESS AND SWELLING THAT SPREAD DOWN AND ACROSS ARM- PT WENT TO URGENT CARE FOR TREATMENT - RECIEVED ANTIBIOTICS AND STERIOD
Information has been received from a physician concerning a patient (age and sex not reported) who on an unspecified date was vaccinated with Pneumovax 23 (lot 3 not reported). Subsequently, the patient experienced inflammed rash. The outcome of the rash was not reported. No further information is available.
Swelling and erythema on left arm was noted 15 hours after vaccination (DTaP and IPV). Pt complained of slight pain and itchiness on injection area. Mother claimed she had a low grade fever but temperature was not taken. Motrin was given every 8 hrs. Swelling subsided after 4 days.
Swollen and painful upper arm (continuing today 9/10) difficulty raising arm. Muscle aches "flu-like" experience, with sleepless night (9/8). Continued muscle aches, diminishing on 9/9.
After vaccine had dizziness at 15 min, itchy throat at 20 min - no treatment at site, did not improve with Benadryl - developed soreness, fatigue in evening, insomnia due to R with sometimes left facial tingling, sometimes with wrists, back, feet - no SOB/weakness/double vision/speech issues - now at day 21 milder but continuing  with now L>R facial tingling
NERVE TINGLING IN LEFT THIGH; LEFT LEG PAIN CENTRED IN KNEE; GENERAL WEAKNESS; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low thyroid, penicillin allergy, sulfa drugs allergy, and allergy to mango, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 42A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced nerve tingling in left thigh. On 11-APR-2021, the subject experienced left leg pain centred in knee. On 11-APR-2021, the subject experienced general weakness. On 10-MAY-2021, treatment medications included: meloxicam. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chest tightness, and had not recovered from left leg pain centred in knee, nerve tingling in left thigh, and general weakness. This report was non-serious.
Fever, chills, aches, sore arm (36 hours), fatigue, headache. Most side effects started 12 hours after shot. Fever and chills lasted most of the night. Aches, fatigue, and headache lasted 24 hours.
02/20 Approx. 4:30pm: very sharp but steady pain in liver that subsided in about 5 minutes. 02/20 Approx. 5:30pm: cramp type pain in spleen area that subsided in approx. 15 minutes. 02/20 Approx. 6:00pm: arm pain & swelling at injection site that slowly increased over time. 02/21: Arm pain increased - very painful, swelling, limited ability to move arm without pain. 02/22: At the time of this submission, the arm pain & swelling is not as bad - it's minor now.
Low fever, red spot about the size of a nickel that's raised and hot at injection site, arm pain that's keeps waking me up the last two nights.  Arm is still hot on 11/06/2015.  Asthmatic cough has kicked in & seemed to be timed with the low fever.
On 3/21/19 my 12 yr old son received his 2nd HPV vaccine. On 3/25/19 he was hospitalized with loss of reflexes to lower extremities, dizziness, headache, lethargic - had spinal tap done - released on 3/26/19. On 3/27/19 he hospitalized again and had to have 2 MRIs performed - on this day he lost reflexes in lower extremities and arms, along with dizziness, lethargic and headache. Was finally released on 3/30/19 from the hospital.
Can send you photos if needed - had swelling & redness of the (L) arm that involved 2/3 of the upper extremity - pain & itching at the site. No reaction on right. Started 11/13 and progressed to 11/15 started on prednisone.
Patient called the pharmacy approximately 7 hours after vaccine administration to report itchiness at injection site. When questioned, she said the area did feel warm to the touch and described the area as slightly "swollen". She did not report any breathing issues or swelling of the tongue. I suggested she take a Benadryl tablet (diphenhydramine) , which she confirmed she had available at home. I instructed her if the reaction changed or got more severe to see medical attention immediately. I also informed her that I would be reporting this as an adverse reaction and incident report.  Patient had received a Fluzone High Dose vaccination on 9/13/19 and a Prevnar 13 vaccination on 9/8/2018 with no reactions to either injection.
Vasovagal sysmptoms as follows: dizzness, weekness, and tingling on arms and hands approximately 5 mins after arriving in the observaton room.  I have observed pt to be oriented to person, time, and place. She was able to call her husband and speak to him as well as communicate with clear speech to the health care team though english is her second language. Initial VS were taken at 1109 BP was low at 79/44, HR 72, 100% on RA. Pt was taken back to the treatment area at this time.  Treatment/intervention Upon transfer to the treatment area VS were monitored every 5 min, pt was given water and offered crackers.  She accepted and drank approximately 240 ml of water, but refused the crackers.  VS were as follows: 1115 BP 102/67, HR 90, 100% on RA - BP back to normal, and symptoms improving. 1120 BP 105/77, HR 77, 100% on RA 1125 BP 100/58, HR 70, 100% on RA 1130 BP 98/63, HR 85, 100 % on RA 1135 BP 108/63, HR 67 100% on RA At this time pt was feeling better, her husband was present and I accompanied her outside. She ambulated without difficulty and was steady on her feet.  She stated that initial symptoms continued to occur in waves but with much less intensity and frequency. She discharged home at 1150.
Developed swelling and redness with itching next day of vaccinations. Seen on 6th day, now red erythema on Left arm 8x5 cm and induration 4.5x3cm at the vaccination site. Advised to apply ice, Ibuprofen 3 times daily and CLARITIN daily x 1 week.
Pink/red tinged mucousy discharge in stool 1 week after rotavirus vaccine given. Increased fussiness.
Several months after I got the shot, I woke up with palpitations, very rapid heartbeat (150) and it lasted for 15 minutes. I went to the doctor the next day, and he referred me to my cardiologist, he put me in a monitor, I will have an echocardiogram next week. He believes that is supraventricular tachycardia.
Information has been received from a healthcare worker referring to a female patient of unknown age. Information regarding concurrent conditions and medical history was not provided. The patient was vaccinated with her first dose of GARDASIL on 31-AUG-2011 and second dose of GARDASIL on 14-SEP-2015, (dose, lot #, route and application site were not reported). No adverse effects reported. Additional information has been requested.
A nurse reported pt received vaccine on 10/30/2000, subsequently he developed nausea, chills, sleepiness, achiness, dark colored urine and was unable to get warm. Also developed reaction at injection site, reaction characterized by 3" by 4" area of redness, swelling, inflammation and warmth.
Pt was given a bivalent 5 thru 11 yrs  booster that had not been diluted...
Fatigue, frontal headache, joint pain in bilateral wrists and elbows, chills, one time episode of dizziness and nausea (lasted about 30 seconds - was already in standing position for 10 minutes when it occurred), increase temperature Tmax = 38.1 C. headache, chills, joint pain, fever lasted about 2.5 days.
On day three after received Varivax vaccine, pt started to have muscle ache from shoulder region down to his left arm, he also had lots of spasm to his left shoulder blade. He went to his PCP for evaluation since OTC NSAIDs didn't help him with his discomfort. He also reported some muscle atrophy and fatigue experience with the same arm. He was treated with Flexeril by his PCP. His symptoms' went away about 4 weeks after he received his vaccination.
Patient reports getting shingles within 3 days of vaccine. Severe pain, fever, rash.
Hep B and IPV given 1 - 3 -14 - (L) leg. (L) thigh and leg swelling/limping went to ER 1 - 5 -14 dx acute lymphadenitis.
Fever to 102.8 24 hrs after MMR, hib. Thus far fever has lasted 2 days no other site of infection found.
Angioedema; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; swelling face, eyes, lips and throat; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration on 17Mar2021 06:00 PM as single dose in right arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included idiopathic angioedema and no chronic health conditions. Patient had allergies to medications, food, or other products included Zithromax - anaphylactic, several other antibiotic - rash, hornet and wasp sting allergies. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 at 10:00 AM, the patient experienced angioedema - swelling face, eyes, lips and throat which occurred 16 hours after injection. Event resolved with use of Benadryl. Prior history of angioedema. Since symptoms resolved with Benadryl, I did not seek further medical care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events were recovered in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The pt had severe headaches and vertigo after MMR vaccine. He ultimately developed obstructive hydrocephalus requiring ventriculo peritoneal shunt.  MR received for a 3 day admit for c/o progressive problems which began several weeks after MMR vax.  Pt. initially c/o flu-like symptoms-nausea and vomiting.  He developed tinnitis, and unsteady gait, agitation, headaches, and inability to concentrate.  Additional c/o on Review of Systems include: fever, chills, night sweats, weight loss, headaches, ear pain spinning sensation, post-nasal drip, voice changes, cough, change in sexual function, difficulty breathing at night, snoring murmer, nausea, urinary frequency, neck pain and popping, appetitie changes, nervousness, numbness, and weakness. PE: WNL except 1+ reflexes, plantar responses are flexor, and walks with a wide based gait at least one foot apart. Patient had a VP shunt placed during hospital stay. Discharge DX: Hydrocephalus, Sinusitis, Allergies, Pneumonia, Osteoarthritis, Headaches.
Two days after vaccine I experienced a chronic headache for over two weeks which I have been treating with Tylenol (six per day) Today is the first day where symptoms seemed to have eased
side effects started showing up about five hours after time of injection and some are still present currently. These side effects include injection site pain, tiredness, headache, joint pain, muscle pain, and chills. The side effects that are still present are injection site pain and joint pain.
At 1:30 am (10 hours after injection) I woke up with chills and fever. I took two ibuprofen and went back to bed. Felt feverish after getting up later that morning and the rest of the day. Fever was 100.6, then broke around 8 o'clock on the evening of 9 June.
Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.
Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 30-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of many reports received from the same source. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 48-year-old male patient who received Rabies Vaccine. Co-suspect products included Rabies Vaccine and Rabies Vaccine. On 5th April 2010, the patient received Rabies Vaccine. On 12th April 2010, the patient received Rabies Vaccine. On 29th April 2010, the patient received Rabies Vaccine. On 29th April 2010, not applicable after receiving Rabies Vaccine and Rabies Vaccine, not applicable after receiving Rabies Vaccine and Rabies Vaccine and unknown after receiving Rabies Vaccine, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were provided as follows: The age at vaccination was not reported. Back in 2010 the patient received an unknown rabies vaccine for what reporting registered nurse believed was pre-exposure. The dates were 5th April, 12th April and 29th April. The patient had blood titers drawn, and the patient's titers were reportedly low. Reporting registered nurse did not have titer level information.
Moderate injection site pain; tiredness; moderate headache; muscle pain; chills; joint pain; nausea; feeling unwell; woke up in the middle of the night with chest pain; insomnia; This is a spontaneous report from a contactable other hcp (patient). A 21-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: VAC0022679), via intramuscular, administered in Arm Left on 08Feb2021 15:00 (at the age of 21-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021, the patient experienced moderate injection site pain, tiredness, moderate headache, muscle pain, chills, joint pain, nausea, feeling unwell, woke up in the middle of the night with chest pain, insomnia. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an other health professional and refers to a 13 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-JAN-2017, the patient was vaccinated with with an expired dose of VARIVAX lot # L002870, expiry date 27-JAN-2017 (exact dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent to contact the physician.
Tingling feeling in the left arm; Burning feeling in the left arm; Bubble bruise at the injection site; Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 55-year-old male patient who received HAB (Twinrix adult) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   On 15th September 2019, the patient received the 3rd dose of Twinrix adult (intramuscular) .5 ml. On 15th September 2019, less than a day after receiving Twinrix adult, the patient experienced injection site bruising and injection site pain. On 29th September 2019, the patient experienced tingling of extremity and burning sensation. On 29th September 2019, the outcome of the injection site bruising and injection site pain were recovered/resolved. On an unknown date, the outcome of the tingling of extremity and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site pain, tingling of extremity and burning sensation to be related to Twinrix adult.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient developed a sore arm and bubble bruise at the injection site that lasted for two weeks. 14 days after vaccination, the patient then developed a tingling burning feeling in the left arm that still persists at the time of reporting. The reporter did not consent to follow up. As per sales data sheet reported batch number was changed from H4A3 to H4A37.
just a sore arm; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient. A 75-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C", start date: 1983 (unspecified if ongoing), notes:  was in a car accident and they didn't screen the blood for Hepatitis C; "Encephalopathy" (unspecified if ongoing), notes: too much ammonia that goes into the brain/ended up in hospital; "She was in a car accident" (unspecified if ongoing); "cirrhosis liver" (unspecified if ongoing). Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020; ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovered", described as "just a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter assessed the case as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same reporter/patient/drug, different events/timeline/dose;