chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given at 4 pm. Fine until 3 am - fever, headache, malaise, dizziness, vomiting, weakness. Dizzy, pale, orthostatic in office. Some improvement with ibuprofen and ZOFRAN. Sent home with instructions to go to ER if worsening/persistent symptoms.
INfluenza vaccine and Human Papilloma VIrus vaccines  given November  10 about 11:45 AM. Patient woke up with numbness on right side of face on November  11.  Presented to Emergency Room on November 12 with Bells Palsy of  right side of face. Unable  to move right side of face.  Unable to close right eye.  Previously healthy, no symptoms on day of vaccine administration.  Received MR from pediatrician revealing a healthy 12 year old in for well-child exam. 24 hours after Flu and Gardasil vax. child developed numbness, pain, and inability to move the right side of face. Assessment:  Facial Nerve Palsy-unclear etiology. Child was sent by car to Minneapolis Children's ER to be evaluated. ER report received:  DX: Bell's Palsy
Uncontrollable crying immediately. Within a few hours his thigh turned very red with hard spot. His thigh is still red. No known fever.
Patient woke up around 2 am the morning following the vaccine (approx. 12 hours after vaccination) with fever, chills, and sweating. Patient also states his arm is excessively sore and he cannot raise his arm. Patient feels awful, and says this reaction is much worse than after his first vaccination with SHINGRIX. Patient is feeling slightly better on the second day following vaccination, but still not feeling great. Patient is aware these are possible side effects to vaccination, but feels it is more excessive than usual.
This spontaneous report as received from a pharmacist via field employee refers to a female patient of unknown age. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial, lot# H018091, strength, formulation, dose/frequency, route and duration were unspecified). Pharmacist reported that the patient developed shingles after receiving ZOSTAVAX (unspecified date in 2013). Patient had sought medical attention by going to an emergency room. The outcome of shingles was reported as recovered/resolved(unspecified date in 2013). Additional information has been requested.
Information has been received from a pharmacist concerning a 67 year old male with coronary artery disease, cardiac failure congestive, cholesterol high, cardiac defibrillator, hypertension and allergy to propoxyphene, and lisinopril (WAES# 0802USA04233) and a history of coronary artery bypass, low back pain and upper respiratory tract infection who on 07-FEB-2007 was vaccinated with a 0.65 cc dose of Zostavax (Oka/Merck) (658867/1413U) subcutaneously in the "deltoid upper region left arm".  Concomitant therapy included thiamine, nitroglycerin, TYLENOL WITH CODEINE, aspirin, COMBIVENT, WELLBUTRIN, digoxin, furosemide, isosorbide, metoprolol, omeprazole, simvastatin (MSD) and spironolactone.  On 08-FEB-2008 the patient experienced horrible pain in left arm.  The patient stated that he had a heart attack in the past and never experienced pain like the one he experienced with Zostavax (Oka/Merck).  The patient had pain go from the left shoulder to wrist and lasted 10 minutes.  The patient called the clinic.  The patient recovered on 08-FEB-2008.  There was no product quality complaint.  Additional information has been requested.
Patient claims she had neurological side effects (i.e. memory loss) the day after vaccination. Also experienced diarrhea and GI side effects.
grand mal sz lasting 10min;given APAP/advil & observed in hosp x 24hr;
Achy all over approx 24 hrs after injection. Progressed to tingling fingertips, toes, lips 10/5/09. Progressively sever. Sx's - short of breath, severe fatigue, weakness - impaired ambulation needs walker - has pronation and foot drop. Severe muscle pain - takes MOTRIN and NEURONTIN.   10/28/09:  Primary Care Records received for date of service 10/8/09  Dx: Not made Assessment:  Presents with numbness in both feet and hands and around lips, diffuse muscular aching, absent reflexes in lower extremities, difficulty walking on toes and possible weakness in LE's.  Gait is normal.  BP 150/100-antihypertensive therapy started.     12/21/09 Medical records received for date 10/9/09 and 10/20/09. DX: west nile virus vs GBS. Consultation for c/o malaise, muscle aches, tingling. Pt states notices onset of sx after vax beginning in feet and hands tingling, which has spread to torso, perioral area. Now w/ aching in back and legs. Assessment: slight weakness in biceps/triceps bilat. 10/20/09 OV DX: (+)west nile titer.
Swollen and painful lymph nodes in right supraclavicular region; no other lymphadenopathy
Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III,  and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).
Right arm swelled from elbow to above shoulder 2 to 3 times normal.  Was hot, red, itchy and painful lasting 7 days.  Was given claritin daily for one week to help with itching.  Cold packs applied for several days.  Onset was several hours after injection.
The pt developed fever of 100-102 deg. F for about 6 days. Non-stop crying. Rash and swelling at injection site also noted.
No additional AE; PROQUAD vaccine that had undergone temperature excursion; This spontaneous report as received from a registered nurse, referring to a currently 4 years old male patient. Information regarding the patient's pertinent medical history, concurrent condition and drug reactions or allergies was not provided.    In 2021 (reported as undergone temperature excursion before calling MNSC), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # U002539 with expiration date: 24-JUL-2022, dose, strength and route were not reported) for prophylaxis. No additional AE.     Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) experienced the temperature excursion under 13.8 degrees Fahrenheit (F) for 1 hour and 48 minutes (product storage error). The previous temperature excursions was not reported.  This is one of five reports from the same reporter.; Sender's Comments:  US-009507513-2110USA001533: US-009507513-2110USA001521: US-009507513-2110USA001664: US-009507513-2110USA001341:
I had a high fever, bad body aches, my joints hurt. I stayed in bed for 2 days and I was extremely tired.
Received Dtap 1-11-06. On 1-13-06 abscess had occurred at injection site. Went to doctor 1-14-06. Dr said it was from Dtap. No antibiotics given since "it was already healing." 3 days later area well healed.
Headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown day in 2016, the patients were vaccinated with an improperly stored doses of PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosage regiment and route unknown. Concomitant medications were not reported. No adverse events were reported. The vaccine was subjected to temperature excursion of 45.9 degrees Fahrenheit for 4.5 hours on 11-JUL-2016. It was reported there were no previous temperature excursions. Product quality complaint (PQC) was not filed. This reports is one of several reports received from the same reporter. Additional information has been requested.
Fever - 100 degrees, started Friday night, broke Sunday morning Fatigue - extreme for Friday & Saturday Headache - Friday through Sunday Muscle aches- Friday through Sunday
about 30 minutes later tingley on left side of face. next morning arm felt sore. went to work stomach hurt. didnt eat. left work early had chills and could not get warm. when i got home had diarea. had diarea for three days. Bad headache. went to bed and could not sleep. Finally fell asleep. really weak for a couple of days. also legs were very painful. I have pain in my legs some times. but this was really intense,put hot and cold to help. really tired wanted to sleep.
Diarrhea, dehydration, headache, fatigue, minor body aches.  Treated with Naproxen Sodium, water, and rest.  Dehydration is under control, no effect on other symptoms.  Injection site swelling at approx. 1.5"
No adverse event; adult received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adult received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adult received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adult received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (adult received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medication were reported. The pharmacist stated they accidentally gave the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11. No treatment information was provided by the reporter.
10 days after administration pt noticed itchiness and small bruise at injection site.  Bruise began to get larger and on day 12 patient has large area of swelling (10 inches in diameter) that is warm to touch.  Small bruise at center of swelling.  Pt denies fever, chills, body aches. Pt instructed to call PCP for evaluation
I had a shingles vaccine booster yesterday. Today I have a fever of 100 degrees, a headache, and severe body aches and pains.
W/in 10 minutes of receiving vaccine of reported SOB Felt like she couldn't get enough air - removed mask - still SOB - took BP 110/72 @ 1045am- pt waited to make sure she was sure she was having a RxN before taking Benadryl. Took 50mg Benadryl @1115 D/C 1145 Feeling Normal
Patient stated he was not feeling well and went to UIC ED and diganosed with a PE. He was sent home with a prescription for Xarelto.  Patient received the COVID 19 MRNA Moderna Vaccine
can feel pain a Little; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. The patient was treated with calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and still felt little pain but no rash. The patient stated that he/she used a lot of calaming lotion it helped. The follow-up would not possible as no contact details were available.; Sender's Comments: still can feel pain a Little but no rash
Patient received multiple immunizations on 9-17-08 including DTaP, MMR, Varicella, IPV.  The last 2 were given in the left thigh.  Today we received a phone call from the child's mother stating the injection site on the left thigh was red with a raised area in the center.  The area of induration was no larger than the center of the bandaid that covered the site.  She also was reported with of fever of 101.7 F (O).
She's having back pains; headache; This is a spontaneous report from a program. A contactable female consumer reported that:  This is a spontaneous report from a contactable consumer, the patient via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. Medical history was not provided.  Concomitant medications were not provided. On an unspecified date the patient experienced back pain and headache. The patient mentioned that the pains she is experiencing are unrelated to the vaccine.The clinical outcomes of back pain and headache were unknown.; Sender's Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The case will be reassessed if additional information becomes available.
Eyes Swollen almost shut; weak; dead arm; Itchy rash all over the body; chills; soreness in arm; tingling in arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash all over the body), EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak), CHILLS (chills) and LIMB DISCOMFORT (soreness in arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and PARAESTHESIA (tingling in arm). On 19-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash all over the body). On an unknown date, the patient experienced EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak) and HYPOAESTHESIA (dead arm). At the time of the report, RASH PRURITIC (Itchy rash all over the body), AMBLYOPIA (weak), CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and HYPOAESTHESIA (dead arm) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Adverse events were updated.
Mouth ulcers appeared on may 7 2021 and have continued may 25 2021
No adverse reaction to the vaccine itself, but patient presented with COVID & hemorrhagic stroke to the ED on 6/29/23.  Patient was transferred the same day to a local Medical Center where she expired on 7/9/23. Tests/labs conducted on 6/29/23: CBC, CMP, urinalysis, blood cultures, head & neck CT, EKG, chest x-ray (unremarkable). EKG: rate 86, sinus, left axis, normal int4rvasl, t wave inversion in lead III, V4, V5, V6, no acute ST elevation. T wave cahgnes in v4-v6 new when compared to 10/12/16 CT head: small acute left thalamic hemorrhage, chronic left thalamic lacunar infarct, age appropriate supratentorial and infratentorial atrophy, moderate chronic white matter microvascular ischemic disease  CT neck:  1.   No acute extracranial vascular abnormality identified.  2.   Nonspecific fluid distension of the midthoracic esophagus (reflux? distal  obstruction?)  Labs indicate a white count of 6.4, H&H 11.1 and 34 and platelets are 128.  Patient has no previous labs within the last year for comparison.  Patient also has a CMP with anion gap of 6.  Urinalysis without any acute evidence of infection.  Patient did have blood cultures obtained.
After receiving injection 14-15 minutes after I started to get chest tightness. I took two puffs of inhaler and walked to triage room to be monitored for another twenty minutes. I took two more puffs of inhaler and chest tightness went away a few minutes after.  No other reactions occurred and was cleared to leave after twenty minutes.
PATIENT DEVELOPED CHILLS OVERNIGHT AND REDNESS AND SORENESS/PAIN AROUND INJECTION SITE. TOOK TYLENOL TO HELP WITH CHILLS.
Patient is very scared of needles.  Took her about 5 minutes to calm down and actually take the shot.  When she left the vaccine room she walked approximately 15 feet down an isle.  We heard someone call for help.  Patients mother said her daughter started to "go down".  Patient stayed on the floor for a few minutes and then was moved to a chair.  After sitting for about 15 minutes they left the store.
pt recvd vax & 6 wks following vax pt exp unspecified react & was hospitalized; It was stated that the vax contributed to hospitalization; No further details were provided;
Headaches nauseau decreased appeitite  muscle aches chills sweats dizziness confusion  body aches muscle and joint pain vertigo had to go to physical therapy to fix vertigo issue  eyes had to be readjusted  took about 3 months have continued to have terrible headaches have been to several neurologist and placed on several meds  and I am now on several new meds and have had  several injections  and occipital nerve block still having the headaches continue to have severe muscle and joint pain was diagnosed with fibromyalgia  I have went to chiropractor and physical therapy which did not help much.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 21Oct2023 to 25Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352197 same patient, different drug/event (Paxlovid Case);
Around 7:00 AM this morning this patient noticed the area around the injection site was swollen with a red, raised area the size of a quarter. She took Aceteminophen 1500 mg at this time. At 1:00 PM this afternoon the swollen are was larger with an induration measuring 51 mm across. The patient was referred to her doctor.
Information has been received from a physician concerning an approximately 7 year old female with no past medical history and no allergies who on 08/05/1996 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 01/24/2002 the pt presented to the physician's office with a case of chickenpox. It was reported that there were a fair amount of lesions with typical chickenpox presentation. The pt was prescribed Benadryl. Additional info has been requested.
Generalized rash beginning in the shoulder/neck region advancing  to both arms in 36 hours and to torso 72 hours and middle back. Other generalized regions on the front of legs near midline. Treated at 72hrs topically with hydrocortisone cream. Responded well at 96 hrs burning ichy rash subsided. Lasting rough patches and scarring from areas that were scratched.  Two co-workers have reported similar experiences  recently. "Covid Arm Generalized Rash)
Why does a magnet stick to my injection sight?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?). At the time of the report, VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on May 11, 2021, single dose, for COVID-19 immunization. Medical history not reported. Concomitant medications reported as none. On an unspecified date in 2021, patient experienced cold-like symptoms, phlegm, coughing, felt sick and had back pain from her persistent coughing. Patient confirmed receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine May 11, 2021 and felt sick on the following Friday. She explained she's experienced cold-like symptoms, phlegm and coughing. She added she has back pain from her persistent coughing. She asked what medication can she take to relive her symptoms. And if Tylenol or cough medicines could be used to treat her symptoms post-vaccination. Verbatim and Event Description: Patient took 1st dose of COVID-19 vaccine May 11, 2021 and then that Friday she felt like she had a cold with a cough and phlegm. She wonders what she can take that will not decrease the efficacy of the vaccine. The outcome of all the events: unknown. No follow-up attempts completed. Information about batch/lot number cannot be obtained, despite being requested.