chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Freezing cold; Everything hurt; He was moaning/whimpering; His entire body was very hot; His face flushed; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the parent.   A 12 year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 09Dec2021 at 15:30 (Lot number: FE3590)at the age of 12 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Attention deficit-hyperactivity disorder" (unspecified if ongoing), notes: ADHD and medication for that. Concomitant medications included: METHYLPHENIDATE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FK5127, Anatomical location: Right arm, Administration Time: 12:00), administration date: 04Nov2021, when the patient was 11 years old, for COVID-19 immunisation.  The following information was reported: FEELING COLD (non-serious) with onset 10Dec2021 at 00:30, outcome "not recovered", described as "Freezing cold"; PAIN (non-serious) with onset 10Dec2021 at 00:30, outcome "not recovered", described as "Everything hurt"; MOANING (non-serious) with onset 10Dec2021 at 00:30, outcome "not recovered", described as "He was moaning/whimpering"; FEELING HOT (non-serious) with onset 10Dec2021 at 00:30, outcome "not recovered", described as "His entire body was very hot"; FLUSHING (non-serious) with onset 10Dec2021 at 00:30, outcome "not recovered", described as "His face flushed". Therapeutic measures were taken as a result of feeling cold, pain, moaning, feeling hot and flushing.   Additional Information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Around 00:30, the patient came into the parent's bedroom claiming to be freezing cold and by 12:30 symptoms had not improved. He had taken three baths to warm up, been given Tylenol, had not eaten anything yet that morning (reported as this morning) and was sleeping (reported as now sleeping). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included Tylenol for feeling cold, pain, moaning, feeling hot and flushing.
Pt presented 2 days after the immunization, with inflammation, erythema, and pruritic rash localized to area around injection site. Mother reports that rash was hot to the touch and has been itching. Pt's PCP evaluated the reaction and recommended to ice the area as well as using hydrocortisone cream for itchiness. We will follow up via phone call in 3 days. We counseled parent to seek immediate medical attention if symptoms worsen or change in anyway. All questions were answered and parent expressed understanding.
expired 26Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.  The physician received notice from lab director that a vial with lot number 036A21A expired 26Aug2021. Since 27Aug2021, has provided 1-2 vaccines per day. She states there was a total of 9 doses administered to 9 different patients. The physician states that the information for the 9 patients are not available.
Information has been received from a physician concerning a patient on 25-JUN-2007 was vaccinated with ZOSTAVAX. Subsequently the patient was given ZOSTAVAX (lot # 656395/0290U) rather than VARIVAX. No adverse symptoms were reported. Additional information has been requested.
Swelling from R thigh to the R ankle in the 24hr following the vaccine.  Leg was swollen and he seemed to have pain and less mobility. The swelling resolved and he is able to move leg with no pain.
Allergy; Swelling; This is a spontaneous report received from contactable reporter (Other HCP).  A 67-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy"; SWELLING (non-serious), outcome "unknown", described as "Swelling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Six weeks after the second dose I was driving on a long trip. When I got out of the car, I felt really dizzy. I was dizzy for days and it was not improved. It was intermittent during the day and came on with movement. It was like feeling fuzzy headed. Sometimes it happened during the night. I went to the Emergency room and all testing was negative. I was given some nausea medicine. I still have some Vertigo after three weeks. It is a little better because I avoid those movement that make it worse.
Flu like symptoms starting the day after immunization and lasted for a day and a half. Weakness of arm. Injection site red and swollen. Redness and swelling still present today, 8/9/18. Patient tried cold packs, seemed to make pain worse. Patient saw PCP today, 8/9/18, and was given prednisone 4 day course.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The certified medical assistant reported that the patients were administered doses of ROTATEQ that were improperly stored, orally (dose and lot number not provided) (dates unspecified). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Fully vaccinated, not booster.  Asymptomatic COVID breakthrough infection with inpatient hospital stay.
Fainted for a brief moment when see needles. 11:15am Patient reported feeling better.
Presented to hospital on 1/25 after being found down for possiblly few days after fall at home. Treated for acute cystitis, rhabdomyolosis, atrial fib with RVR and then aeaiting palcement at rehab facility when tested positive for COVID. Developed increasing O2 requirements and started on dexamethasone with remdesevir. O2 reuqirements continued to increase. Patinet requested DNR status, refusing mechanical ventilation.
rash on my back that is very sensitive, also, top of my scalp is very sensitive (no rash)
Pain from shoulder down to wrist and up the side of neck on arm where vaccine was received. Burning pain under arm. Swelling under arm and above collarbone and redness on skin in that area. Onset was day after vaccine and improved slowly over next few days. Resolved completely four days later.
This spontaneous report was received from a Registere Nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date over the last 15 months 48 doses of improperly stored (Oka/Merck) VARIVAX from unspecified lots were given to an unspecified number of patients. These 48 doses were exposed to 7C for an unspecified length of time before administration to those unspecified patients. There was no known adverse effects. This is one of the two reports from the same source. Additional informattion has been requested.
Pt started having feeling of "flutter feeling on her heart," 5 mins after vaccination. 2 episodes of flutter like feeling, 1st one lasted 15-20 mins. after 5 minutes resolved then started having the flutter feeling on her heart again.  Patient did not have chest pain, sob, dizziness, swelling of lips/tongue, throat. HR was elevated to 114 initially and 2nd episode with 119 bpm. otherwise, rest of vital sign stable.   Action: vital signs and observation Called clinician of the day Dr. and recommended sending patient to Emergency Department for higher level of care.   Paramedics came and patient went to Emergency Department.
Within a few hours of receiving TDAP.  Pt c/o hourly diarrhea X 10 or 12.  Denies fever, bloody stools, rash, nor v, or other sx.  Stomach was "sensitive" the next day but essentially well.
Severe menstrual cramping, like being in labor, but I?m not pregnant and my last period was 2 weeks ago so I wouldn?t expect any mild PMS symptoms for 2 more weeks. Also a strong vaginal aching, like on a very heavy period day, plus the standard chills, nausea, heart racing/fever.
Constant tinnitus in the right ear since 28 hours after the 2nd vaccine. Around the 3rd week of ti nits, started having jaw/tooth pain.
a few days later she was really tired for a couple of days; Slept more than she usually does; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Mar2021 02:00 (Lot number: EN6199) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Arthritis" (ongoing); "Colitis" (unspecified if ongoing); "benign tremor in her left hand" (ongoing); "Hot flashes" (unspecified if ongoing); "high blood pressure" (ongoing). Concomitant medication(s) included: LIALDA; XELJANZ taken for arthritis; PROTRADON taken for tremor; ATORVASTATIN taken for hypertension; ASPIRINE. Vaccination history included: Bnt162b2 (1st dose, I had no reaction to the first two shots), for COVID-19 immunization, reaction(s): "I had no reaction to the first two shots". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a few days later she was really tired for a couple of days"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Slept more than she usually does".  Additional information: The patient told that  she wanted to get the Pfizer Covid 19 vaccine booster shot but because she was on Xeljanz, her doctor said she would have to stop Xeljanz a week before and a week after. The patient got her first two shots of the Pfizer Covid 19 vaccine a few months ago and wanted to get the booster shot. The patient had no reaction to the first two shots until a few days later; she was just really tired for a couple of days and slept more than she usually do. The patient did not want to give up Xeljanz, which she took for arthritis, because she was scared  hands and fingers would swell and hurt and knuckles would get real big again. The first day, she took Xeljanz, it made all that go away. Her hands did not hurt and was able to do yarn work with Xeljanz. One day the caller went to bed at about 4:00 in the afternoon and slept all night long. The caller never felt anything else other than that. The caller got the Prolia shot a couple of weeks ago for bone density and that shot hurt.  No follow-up attempts are possible. No further information is expected.
Hallucination; Decreased appetite; Head discomfort; Hyperhidrosis; Insomnia; Toothache; Tremor; Chills; Fatigue; Nausea; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 45-year-old female 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.     Concurrent medical conditions included Drug allergy (allergy to sulfa drug). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and TOPIRAMATE (TOPAMAX) for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HALLUCINATION (Hallucination), DECREASED APPETITE (Decreased appetite), HEAD DISCOMFORT (Head discomfort), HYPERHIDROSIS (Hyperhidrosis), INSOMNIA (Insomnia), TOOTHACHE (Toothache), TREMOR (Tremor), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment product information was provided  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
occurrence of GBS; This case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows:                                       The age at vaccination was not reported. The patient received Shingrix vaccine and experienced guillain barre syndrome. The reporter consented to follow up.
A non-serious report was received by a pharmaceutical company representative concerning a 34-year-old female. The patient had a history of sinusitis and had been under treatment since 12-Nov-2007. No drug history was reported for this patient. The patient received FLUMIST late on 14-Nov-2007. Within hours she experienced increased sinus, teeth, jaw, eye pain and headache. The teeth, jaw and eye were the most uncomfortable. Outcome for the reported adverse events was not reported. The patient did not experience a rechallenge while receiving the suspect product. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Rash left leg, Benadryl 1 tsp 4 times a day.
patient seen 12/8/21 with increasing size of redness, warmth, pain L deltoid area, approximately 10 x15cm. Due to continuing to increase in size after 48 hours after injections, treated with antibiotics for possible cellulitis/infection.
This morning I started menstruating. I haven't had a period in a couple years and thought I was in menopause.
Day 1 chills  Day 2 4am morning Dizziness and Vomiting --- contiues and still she feels dizzy. She was admitted on day 13 to ER  for observation.
After the shot my arm had a red, hard lump that lasted about 3 days and went away. Then about a week later the injection site began itching and turned red. The next day it was swollen and red and still itched. This lasted for about 4-5 days. No other symptoms.
Information has been received from a physician concerning a 58 year old female with a history of urinary tract infections who on 7/20/02 at 9:30AM was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant medication included estrogen therapy. The patient also had a Mantoux test (lot # C0942AB). The patient was reportedly not ill at the time of vaccination. After receiving the vaccination, the patient developed extensive urticaria and hives followed by polyarthralgias in the knees, ankles, wrists, and fingers. It was reported on 8/19/02, that the patient's rash has essentially subsided and the patient continues to have polyarthritis or at least polyarthralgias with a little bit of swelling in her knees and certainly some stiffness. It was reported that during the acute phase of this progression, the patient's serum iron was depressed which the reporter stated it might have been a viral reaction, viral anathem, such as Parvo virus 19 or something followed by a polyarthritis. The reporter also stated that the polyarthralgias will subside. Labs were performed on 8/15/02 including a blood count, erythrocyte sedimentation rate, serum C-reactive protein test, RA factor, serum antinuclear antibodies test, and serum antistreptolysin O antigen test. The results were reported as: CBC w/ diff = WBC 6.7x10*3/CUMM, RBC 4.15x10*6/CUMM, hemoglobin 13.1 grams/DL, hematocrit 39.6%, MCV 95fL, MCH 31.5pg, MCHC 33.0 G?DL, RDW 11.9%, platelet count 287x10*3, MPV 9.3 FL, neutrophils 58%, lymphocytes 35%, monocytes 6%, eosinophils 1%, basophils 0%. Absolute counts: neutrophils 3886 cells/cumm, lymphocytes 2345 cells/cumm, monocytes 402 cells/cumm, eosinophils 67 cells/cumm, basophils 0 cells/cumm, ESR - Westergren 6 MM/HR, ANA 0.3 EIA units. Rheumatoid factor = negative. Streptococcal AB, OT = < 50IU/ML. Small amounts of Group B beta strep, 10,000 colonies or less, were isolated in the patient's urine just before this started and as not considered significant in view of her history of UTI's but the physician planned to repeat the urine and culture. The patient's uterine ultrasound showed a thin endometrial stripe and was otherwise completely normal which made her unopposed estrogen therapy reassuring and the patient's dose of estrogen was reduced. It was reported on 8/19/02, that the patient was started on celecoxib 200mg once a day and the physician plans to follow up with the patient in a couple of weeks. The reporter also stated that of course, this whole reaction occurred right after a pneumococcal vaccine in which case, of course, it should subside. Additional information has been requested.
Pt was at 2nd dose scheduling & had syncopal episode. Assisted fall to the floor by mother. EMS C-spine negative; VS stable (BP 126/78; HR 87; RR 18). Pt felt better after juice & water.
Injection site soreness (arm pain); headache; chest tightness; tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05May2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), drospirenone (MANUFACTURER UNKNOWN), ethinylestradiol (MANUFACTURER UNKNOWN) and levetiracetam (LEV); all for unknown indication and from an unknown start date. The patient had no known allergies to food, medications or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 12:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021, the patient experienced injection site soreness (arm pain), headache, chest tightness and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site soreness (arm pain), headache, chest tightness and tiredness were recovering at the time of the report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Severe ongoing arm pain; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 4CN59, expiry date unknown) for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. The patient was treated with non-drug therapy (Physiotherapy). On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comment: The reporter reported that the patient experienced severe ongoing left arm pain after her 2nd Shingrix vaccination.  The patient was referred to physical therapy to regain normal use of her arm. The reporter was consented to follow up.
Large welt, redness, hot, fever, fatigue, headache starting 10 hrs after vaccine and lasting for 10 hrs.
Fever chills and fatigue from evening of 2/11/15 until 2/13/15.
Next day arm red sore, upper arm red + hot- went to doctor- started on antibiotics + steroid cream- went to doctor again 2 days later.  X-Rays done  conts on Z-PACK- Doctor feels cellulitis nicked a nerve- Now still has difficulty moving arm.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for Covid-19 immunization.  Medical history included ongoing kidney disease. Concomitant medications were not reported. The patient stated he had the first dose of the vaccine on 05Apr2021 and was supposed to go for the second dose on 26Apr2021, but on 19Apr2021, Monday, he tested positive for Covid-19 after first dose of vaccine. He asked if he should still go to his appointment on 26Apr2021 to get his second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on 19Apr2021. Outcome of the events was unknown.   Information on the batch/lot number has been requested.
This spontaneous report as received from a nurse refers to a patient (date of birth, age and gender unspecified). The nurse reported that the patient received third dose of GARDASIL 0.5ml intramuscular, (lot and exp date unspecified) in less than 12 week interval between doses. No adverse effects reported. First dose administered 17-NOV-2009, second dose administered on 23-MAR-2010 and third dose administered 26-MAY-2010. Patient's outcomes was unknown. This is one of two reports from the same reporter. MARRS: 1308USA002622. Additional information has been requested.
Tinnitus - ringing in both ears.  24/7.  Mild-moderate.  I can feel pressure within the ear but ears are not plugged.  Mild headaches.  Aerobic type exercise/elevated heart rate cause tinnitus to get worse (louder more frequencies heard)  temporarily along with worsened headache/(earache only sometimes) both dissipate within 10-30 minutes.