chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Twenty four hours post vax, pt ran a temperature of 103 and was taken to the ER. Pt had runny nose and cold, and mother was told that fever was probably from shots.
(R) arm pain, redness, swelling radiating to shoulder, shoulder blade pain, fever, sweats, leg cramps, rib pain.
Got flu shot. Left area with aide - supervisor was asked to come; man had fallen. Bleeding  from mouth. Knocked out 2 upper front teeth. PHN helped nurse clean his face. Teeth put in milk. Man to go to dentist.
Not feeling well post second dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well post second dose of Moderna COVID-19 Vaccine) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well post second dose of Moderna COVID-19 Vaccine). At the time of the report, MALAISE (Not feeling well post second dose of Moderna COVID-19 Vaccine) outcome was unknown.            no concomitant medications were provided by the reporter
Fever of 102.7, followed by vomiting on 9/26, disturbed sleep, loss of appetite, irritability, inconsolable crying for several days.
Headache; Nausea; swelling at Injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, nausea, injection site swelling and injection site erythema. On an unknown date, the outcome of the headache, nausea, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the headache, nausea, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced some swelling and a large, size not specified, redness at the injection site and experienced nausea and headache, which had resolved. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020118902.
Information has been received from a pharmacist concerning a retired male physician who on an unspecified date, was vaccinated with a single dose of Zostavax (Oka/Merck).  On an unspecified date, the patient developed a small localized rash on his torso which was very painful.  It was reported that it developed into a large growth or abscess at the base of his spine which required surgery to have it removed.  It was not specified if the patient was hospitalized as an in-patient for the surgery.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
to ED from behavioral health unit where he had fever and tested + for COVID, + cough, SOB, chest pain, pneumonia, elevated D-dimer; TX: doxycycline, decadron, zinc, singulair, vit c, Vit D, lovenox, O2; d/c'd home on room air
My arm is red; It is itchy at time; My arm is swollen; My arm is hot; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time). At the time of the report, PERIPHERAL SWELLING (My arm is swollen), VACCINATION SITE WARMTH (My arm is hot), VACCINATION SITE ERYTHEMA (My arm is red) and VACCINATION SITE PRURITUS (It is itchy at time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided   Reporter did not allow further contact
This is very mild. She came to ED for acute conjunctivitis left eye only with tearing. It began 2 hours after the vaccine. There is minimal erythema and tearing of the left eye. Will treat with topical antibiotic. I think its likely she has a coincidental concurrent viral conjunctivitis and this is not related to the vaccine, but timing is compelling for VAE. She has no other viral symptoms and she was perfectly well at time of vaccine administration.
Fainted; unconscious for 1-2 minutes; Felt dizzy; sweating; shaking; brain feels foggy; didn't sleep well; left arm started hurting from shoulder to elbow; A spontaneous report was received from a consumer who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of left arm started hurting from shoulder to elbow, didn't sleep well, felt dizzy, fainted, unconscious for 1-2 minutes, sweating, shaking, and brain feels foggy.   The patient's medical history included asthma, hypoglycemia allergy to penicillin and tuberculin (TB) test. No concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On the same day, the patient experienced left arm started hurting from shoulder to elbow.  On 14 Jan 2021, the patient reported that she didn't sleep well, felt dizzy, and fainted. The patient was unconscious for 1-2 minutes before the ambulance arrived. It was noted that the patient's vitals were normal, so she declined to go to the hospital. The patient also experienced sweating, shaking, and brain feels foggy like she has a hangover. The patient stated that the Moderna vaccine gave her the same reaction except with penicillin and TB test she went unconscious immediately. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainted and unconscious for 1-2 minutes, was considered resolved on 14 Jan 2021.  The outcome for the events, felt dizzy and brain feels foggy, was not resolved.  The outcome for the events, left arm started hurting from shoulder to elbow, sweating, shaking and didn't sleep well, was unknown.; Reporter's Comments: This spontaneous report refers to a 51-year-old female patient with medical history of asthma who experienced unexpected serious events of fainted and loss of consciousness (1-2 minutes), and non-serious events of dizziness, sweating, shaking, brain feels foggy, didn't sleep well and  left arm started hurting from shoulder to elbow) the next day after administration of the first dose of mRNA-1273, lot # : 012L20A, Exp date-unknown. Based on temporal information provided and with no other etiological factors, a causal association cannot be excluded. The event of left arm started hurting from shoulder to elbow is consistent with the known safety profile of the study medication.
Patient described having headache, numbness on forehead and burning on back of her neck stretching down left trap muscle. Sensation and numbness have diminished gradually but she says it is still present as of a week.
Patient was given the wrong vaccine, Meningococcal was ordered and HIB (meningococcal protein conjugate) was given
Facial edema, initially treated with amoxicillin at Dentist for suspect tooth infection on 9/11/20, left side swelling improved and right side facial swelling when patient awoke on 9/12/20, right sided edema improving 8 hours after awakening. Started on fexofenadine OTC for reaction
This spontaneous report was received from a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection in arm (route of administration, dose, lot number and expiration date were not reported) for prophylaxis. Concomitant vaccinations included an unspecified influenza virus vaccine. On an unknown date, the patient experienced staphylococcal infection which she described as "horrible". The patient stated she did not think she would survive the infection. She was rushed to an Urgent Care where she was treated with cephalexin to which she had an unspecified reaction and was still "raspy" at the time of the report. It was not specified if the patient was also admitted to a hospital. The patient wanted to be compensated for pain and suffering. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the PNEUMOVAX 23 was not reported. Upon internal review, the event of Staphylococcus infection was considered to be medically significant.
Visible, painful vein from injection site to left breast. Started menstruation over a week early. Aches and pains from head to toes including finger tips and toes. Weak.
Symptom was a large 3-4 inch pink skin splotch and whelt (slightly defined swelling) at the injection site on the upper arm near shoulder. The whelt went away after one day but the pink splotch did not.  The unusual thing not experienced with the regular dose was that this pink discoloration migrated gradually down my arm close the elbow crook inner arm for four days then dissipated in color until  only traces remain after 5 days. I only had mild fatigue and some nausea. My arm and shoulder to the elbow was remarkably sore for five days.
3 minutes after injection of vaccines, patient had a vagal reaction that lasted about 10 seconds.  No injuries to patient.  Patient then stated he felt nauseated.  Placed patient in chair.  Gave water and crackers.  Had ancillary staff contact Pediatric NP, Clinic Supervisor and ADN.  BP stable.  Waited 20 minutes.  Patient's mother asked to contact Pediatrician or go to Emergency room as needed.  Patient blood pressure taken.  BP at 84/62 prior to leaving clinic.
Full dose not administered at time of vaccination. Patient moved arm while immunizer was depressing the plunger and needle came out of arm and some of the dose squirted out.  Recommended to caregiver than another dose be administered ASAP. Caregiver did not want to repeat dose at this time.
Monday morning at 3:30 I began throwing up and did so off and on until around 10am. I ran a fever of 100.4 for about 24 hours. My body ached, my head ached and all I could do was sleep. I alternated Tylenol and Advil Monday and Tuesday.  Today I am still tired but all other symptoms have ceased.
Patient signed for TDAP - RN gave adult Hepatitis B instead of TDAP.
weight gain; 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 WEIGHT INCREASED (weight gain) 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 WEIGHT INCREASED (weight gain). At the time of the report, WEIGHT INCREASED (weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight increased: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications were provided.
6 year old female received the 1st dose of the Pfizer COVID-19 vaccine at facility on 04/17/2021 @ 10:30. The same day, 04/17/2021, pt started experiencing pain in the arm at the injection site and fatigue. The pain in the arm resolved in 2 days, fatigue is still occurring. 04/20/2021 pt started experiencing dizziness, vertigo, nasal congestion, ears feel clogged, diarrhea, and paliptations, which are still occurring. Pt went to a hospital on 04/27/2021 and 04/30/2021 and had CAT scan of lungs and head. CAT scans were normal and kidney function was discovered to be low. Pt saw ENT, who stated the ear is swollen and prescribed Promethazine and Vancycovir. Pt is asthmatic and has a UTI. Pt takes Sulfamethoxazole-Trimethoprim, Metronidazole, Meclizine, Promethazine, Valacyclovir, and vitamins. Pt denies any allergies. Pt was advised to consult with ENT in regards to symptoms. SPI was consulted and Dr. was notified.
Around the time I received the 2nd dose on the date above, I started experiencing a buzzing sound in my right ear. Initially I thought this was due to wax build-up and did not associate it with the vaccine. I did not report it in my daily and weekly check-in reports. I treated the ear with an OTC wax remover with no effect. Then I went to my primary care practice. They found no excessive wax build-up and referred me to Dr. He found no obvious source of the problem and sent me for an MRI. It showed no problems. I recently read that this condition may be associated with the COVID vaccine which is why I am reporting it now.
Became dizzy.  Monitored vitals, no treatment needed, 30 minutes later patient improved.  Left without problems.
I did not complain about the flu shot, but I'm still having pains in my elbows joints, do u know how long it will take.....I keep soaking with warm water & rubbing the area.
pt recv vax OCT96 & devel unspecified cold sxs & t101;pt recovered;
Information has been received from a pharmacist and an assistant director of nursing concerning a male nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1415U), and developed severe adverse reactions including redness and swelling at the injection site.  Unspecified medical attention was sought.  The director of nursing reported that the patient was improving.  No additional information was provided.  This is one of several reports received from the same source.  Additional information has been requested.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Pfizer vaccine was administered outside of Facility- reported by patient  I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/16/2021 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/16/2021 ATRIAL FIBRILLATION, UNSPECIFIED
s/p 2nd covid vaccination Pfizer on 10/19/2021. On 10/22/2021 concern for site reaction/cellulitis, pt started of Bactrim DS for cellulitis. Forgot to take bactrim ds since 10/29, however on 10/31 am awoke with diffuse erythematous maculopapular pruritic rash everywhere except the left deltoid area previously affected by local erythema thought to be cellulits. 10/3.1/2021 treated with benadryl and pepcid with strict ER care and allergist referral, pt declines steroids due to reported prednisone allergy.
Received intramuscular injection in right arm at approximate 9:30am.  Remained seated for 15 minutes per instructions from clinic personnel.  Finished a conversation at left the facility after approximately 9:55am. While driving back to office (appx 5 minute drive total), experienced clammy skin, sweating at 3 minutes into drive.  I considered pulling over, though I knew I should be around people where I could be monitored, so continued on. Experienced elevated temperature, blurriness of vision and my vision began to turn bright and white.  As I pulled into the parking lot, I thought I may be passing out.  I got out of the vehicle, sat down on the nearest bench and asked two individuals who where outside to stay with me, and I explained my symptoms to them.  I remained seated for approximately 10 minutes, and when I felt the symptoms subside, went into my office and am now filing this report.
This case was considered medically important (OMIC). Information regarding Dryvax was received from a healthcare professional regarding a 28 year old male pt who experienced chest pain and first degree heart block. At 28 years of age, the pt received a dose either on 7/27/03 or 7/29/03. The pt received Anthrax vaccine "several days" prior to immunization with Dryvax. Approximately 3.5 weeks post-immunization, the pt experienced chest pain and first degree heart block (atrioventricular block first degree). No additional info was available at the time of this report.  Follow up on 10/01/2003: "This case was considered medically important.  Follow up information provided a change in patient age and primary provider name.  Information regarding Dryvax (smallpox vaccine, dried calf lymph type injection) was received from a healthcare professional regarding a 29-year-old male patient who experienced chest pain and first degree heart block.  At 29 years of age, the patient received a dose either of 07/27/2003 or 07/29/2003.  MEDICAL HISTORY:  Relevant medical history was not provided.  PRODUCT DETAILS:  Indication for Dryvax was immunization. Product was administered either on 07/27/2003 or 07/29/2003.  Dose regimen was 1 dose.   CONCOMITANT THERAPY:  The patient received Anthrax vaccine (manufacturer unknown) "several days" prior to immunization with Dryvax.  EVENT DETAILS:  Approximately 3.5 weeks post-immunization, the patient experienced chest pain (chest pain) and first degree heart block (atrioventricular block first degree).  TEST RESULTS:  Blood immunoglobulin M (results: Positive for Lyme disease) and blood immunoglobulin G (results: Positive for Lyme disease) were donw on an unspecified date.  No additional information was available at the time of this report."
Information has been received from a physician concerning a 12 year old female who on 23AUG1995 was vaccinated with a dose of varicella virus vaccine live. On approximately 19MAR2003 the patient developed a breakthrough case of chickenpox. It was reported that the patient presented to the doctor's office on 19MAR2003 with "scattered fluidy bumps". Unspecified medical attention was sought.  Additional information has been requested.
Had several strokes; Memory loss; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had several strokes) in a 43-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.    Co-suspect product included non-company product ATOGEPANT for Migraine.    The patient's past medical history included Migraine. Concomitant products included ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) for Migraine.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ATOGEPANT (unknown route) at an unspecified dose. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Had several strokes) (seriousness criterion medically significant), AMNESIA (Memory loss) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Had several strokes) and AMNESIA (Memory loss) outcome was unknown and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  The start date of Qulipta (atogepant) was unknown, it was confirmed the patient did start samples, therapy was ongoing.  Company comment: This case concerns a 43-year-old, female patient with a history of migraine, who experienced the unexpected serious AESI event of CEREBROVASCULAR ACCIDENT (Had several strokes). The event occurred at an unknown date. The patient received two doses of mRNA-1273 vaccine, at an unknown date. The rechallenge was not applicable since it is unknown when the event occurred in relation to vaccination. The medical history of migraine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to important medical event and medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up received contains email attachment which is non significant.; Sender's Comments: This case concerns a 43-year-old, female patient with a history of migraine, who experienced the unexpected serious AESI event of CEREBROVASCULAR ACCIDENT (Had several strokes). The event occurred at an unknown date. The patient received two doses of mRNA-1273 vaccine, at an unknown date. The rechallenge was not applicable since it is unknown when the event occurred in relation to vaccination. The medical history of migraine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to important medical event and medical judgement.
patient tested + for covid on    4-24-22 patient passed away on   6-23-22
racing heartbeat, dizzy/lightheaded feeling, slight tingling in arms and hands, slight tightening of throat.
Narrative: Patient contacted telephone triage nurse today requesting to speak with PCP clinic. States he received the second dose of the moderna covid vaccine on 4/8/ 2021, now has a rash at injection site he is concerned about. Patient describes as, "Looks like welts all over the area- one is as large as the palm of my hand." No pain, area is red, "just very itchy."
24hrs post vax pt devel hives on lt thigh & spread to thorax & other extremities; Good response to DPH; Resolved over 72hrs; No sequelae;
Next day started small rash if tiny blisters on buttocks legs lower stomach, spots are sz of quarter, continued for 3 days, no new spots on the 18 the but rash is still their, very painful and itchy, dr proscribed valtrex because it looks like shingles.
Narrative:  Patient with complex medical history. Presented to ED via ambulance as caregiver noted increased cough, shortness of breath, chills and could not get pulse ox reading. Patient has chronic cough but was worse on day of ED visit. Found to be COVID-19 positive in ED. He was hypotensive (received fluids and norepinephrine), was converted to BiPAP and admitted to ICU. Patient received 5 days of remdesivir and 6 days of dexamethasone. Oxygen requirements improved and he was weaned to home levels of oxygen (2-2.5 L). Norepinephrine rapidly weaned off. He resumed home midodrine. Unexpectedly, patient found to have positive blood cultures for 4 consecutive days. He was found to have 1.6 cm vegetation on R atrial lead of AICD. Patient transferred to different hospital for management of infectious endocarditis with persistent bacteremia.
VACCINE GIVEN OUTSIDE OF LICENSED AGE RANGE. NO ADVERSE EFFECTS REPORTED.