chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough, shortness of breath, hypoxia.    Date of admission: 4/2323 80 y/o married female with multiple co-morbidities including hypogammaglobulinemia on Gamunex infusions, COPD/advanced bronchiectasis (on chronic steroids but no home O2), OSA on CPAP, CAD with stent, atrial flutter on chronic anticoagulation, and T2DM presents with 3 day hx of cough and increased dyspnea as well as family reported confusion.  Exam notable for agitation, fever, confusion, tachycardia.  Significant ED lab/imaging findings: POS COVID testing, leukocytosis, and new left basilar opacities on single view CXR.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On an unknown date in or around December 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered disabling.
Rec'd 2nd vaccine of 2 on 5/5.  Was fine that day.  Woke up 5/6 with severe congestion, chills, nausea, motion sickness, sore & stiff muscles in legs and lower back, very bad taste and smells  to all foods (not a metallic taste, all foods just tasted really bad and smelled bad like they were rancid).  Took 1 sudafed for congestion and drank one 20oz bottle of Gatorade G Zero Lemon Lime all day.  Tried to eat foods but could not due to the taste.  Could not keep eyes open all day and very fatigued.  On 5/7 congestion was gone but still all foods tasted and smelled terrible and had motion sickness all day.  On 5/8 my taste buds and sense of smell started coming back but still nauseated with all movements and cold all day.  On 5/9 taste buds are okay now and smells are back to normal but still have motion sickness and chills.  Congested again too.  Finally able to eat light foods.  Lacking energy to do anything though.
No additional AE; this was an adult patient; This spontaneous report was received from a medical assistant and refers to an adult, postpartum and delivered 6 weeks ago, patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W028561, expiration date: 06-MAR-2024, (strength, exact dose, dose number, and route of administration were not provided) for prophylaxis; and sterile diluent, solution for injection/infusion, lot# W018605, expiration date: 25-OCT-2024, (strength, dose, route of administration, and indication were not provided) (product administered to patient of inappropriate age). No additional AE details available (no adverse event).
On June 7, 2004 my son developed a small cluster of tiny red bumps on his right buttock. After a few days the bumps developed tiny white pustules and spread in a line around his buttock toward his right hip. On 6/10/2004 I took him to his pediatrician and had him examined and was informed he had shingles. I was asked if he came into contact with anyone who had shingles or chickenpox and told his doctor that he did not. I was prescribed Bactroban Cream and Zovirax to be topically applied. He had a low grade fever of about 101 and was tired, irritable and demonstrated a loss of appetite. Since he did not come into contact with anyone who had shingles or chickenpox, I inquired if the varicella innoculation could have made him susceptable to shingles. I was told no. My son has never had the chickenpox so I was at a loss to explain how he could develop shingles without ever presenting with chickenpox first. He is not in any daycare or structured classrom setting and only associates with close family members with whom any shingles or chickenpox infection would have been known.
Approximately 10:10am RN called to assist client who was witnessed by co-worker to sit on couch in hallway then head fell back - upon RN arrival patient's eyes rolled back and not responsive to voice, shallow breathing. Thready pulse, lifted to floor to open airway, then responsive.
Student had TDAP vaccine was instructed to wait 10-15 minutes and sit on a chair. Stud. was standing fainted about 5 min. after the taking the shot. Hit his head on a metal part of a trash can, sustained approx 1 inch cut on his forehead. Student was out for a few seconds and was asking what happened when he gained consciousness. Ice applied to forehead. BP- 100/80, at 2:15p, 2:25p - BP normal, PR - 88, oriented to time, place and person. Student said he didn't eat lunch because he did not like the food for lunch in the school cafeteria. Orange and crackers given. Sch. nurse called mother and told her what happened, student awake and alert. Instructed mother to come pick student up and have him checked by a doctor. Emphasized the importance of being checked by the doctor today 3:00p mother here to pick student up. Student awake, alert and oriented. Vital signs stable. Reminded mother to take patient to the doctor to be checked.
** Based on the specifics of my symptoms, I strongly suspected my reaction is related to a previous, undiagnosed head/skull trauma sustained at the point of pain **  Splitting migraine headache. Sudden bouts of severe, piercing pain traveling from the right back of my head (behind and below the ear, near nape of neck) forward/through to front of head, behind the eyes.    Onset in late evening around midnight- lasted approx. 4 hours, caused extreme distress and incapacitated. Typical migraine symptoms like extreme sensitivity to bright light and loud noise stimulus.  Hydrated and took NSAIDs.  Abated in the early morning ~ 4 AM, was able to rest and sleep afterward.
pt recv vax DEC96 & JAN97 pt exp chickenpox;9 other pt were reported as well (WAES 97030174, 97030176-97030181 & 97030183-97030184);
I had vaccination on 10/14/2022. On 03/30/2023 I started to have an achy body with low grade fever. On 03/31/2023 I tested COVID-19 Positive at home. I called the clinic and I was prescribed Lagevrio mucous relief over the counter medication and a steroid. I was prescribed an inhaler but I didn't have it filled.  I am still fatigued and have congestion on 04/17/2023. I am sleeping better and feeling better each day.
Took Naproxen at 1:30 p.m. day after 2nd vaccine.  Had taken Naproxen prior to getting vaccinated without side effects.  This time had severe allergic event after taking Naproxen 20 or so minutes later.   Had to call 911 an ambulance administered Benadryl an steroids' to help with skin reaction and closed larynx
Pt started 10/18/09 developing dry, nonproductive cough, fevers to 103, generalized body aches and joint pains.  10/28/09:  Medical records received for dates 10/20/09 to 10/22/09. Final DX:  Viral Syndrome with fever.  Assessment: Scratchy throat progressed to dry, nonproductive cough, sore throat, fevers to 103 and generalized body aches and joint pains, specifically worse in the hips and knees.  Also has some HA which gets worse with coughing.    11/17/09 Hospital records received for dates 10/20/09 to 10/22/09. DX: viral syndrome with fever. SX: fever, cough, chills, sore throat, body aches. ID consult DX viral syndrome.   ICD9 codes: 780.6, 079.99, 462, V58.66
rash behind right ear/ painful rash on neck and temporal area of head; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2019, the patient received Shingrix. On 21st June 2019, 39 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient noticed a rash behind his right ear.  At the time of reporting, the patient had a painful rash over the right side of his neck and the temporal area of his head.  The rash looked like shingles. Emergency visit was required.
pt recv vax & devel granuloma @ inj site;pt was advised to apply warm packs, move the legs a lot & massage;the granuloma lasted for one to four weeks;
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.  This case contains information for the 12th of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: Master case
developed shingles about 4 weeks after my first covid shot. shingles lasted about 8 weeks and then I proceeded to get my second covid shot on 5/26/21
At bedtime pt states her arm was red, swollen to almost double the size of her other arm and painful.  There was a large bump on her bicep about 6 inches away from this site of administration in the deltoid.  This is also where the redness developed.  She states the swelling went down to about the elbow.  I examined her arm and did not visualize any bumps.  The skin on her bicep and inner arm was slightly red in color.  The arm did not appear to be swollen at this time.
INCREASED SORENESS; FLUSHED SKIN; LOWER BACK IN EXTREME PAIN; LEGS IN EXTREME PAIN; HEADACHE/ SKULL WAS IN A LOT OF PAIN/ PAIN AROUND TEMPLES; CHILLS IN MY EXTREMITIES; FEEL WARMER; FEVER; VOMITING; PAIN AROUND EYES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced increased soreness. On 10-MAR-2021, the subject experienced flushed skin. On 10-MAR-2021, the subject experienced lower back in extreme pain. On 10-MAR-2021, the subject experienced legs in extreme pain. On 10-MAR-2021, the subject experienced headache/ skull was in a lot of pain/ pain around temples. On 10-MAR-2021, the subject experienced chills in my extremities. On 10-MAR-2021, the subject experienced feel warmer. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced pain around eyes. Laboratory data included: Body temperature (NR: not provided) 100, 104.5, 102.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased soreness, flushed skin, legs in extreme pain, chills in my extremities, feel warmer, fever, vomiting, and pain around eyes on 11-MAR-2021, and was recovering from lower back in extreme pain, and headache/ skull was in a lot of pain/ pain around temples. This report was non-serious.
pt recv vax 20JUN97 & JUL97 pt exp a varicella-like gen rash & itching;the rash consisted of central, raised vesicular appearing lesions w/approx 10 swells total;
No other AE reported.; the vaccines were given less than 30 days between live vaccines/ V ARIV AX was invalid because it was given to soon.; This spontaneous report as received from a patient's mother and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 26-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  Her doctor said, that the vaccines were given less than 30 days between live vaccines and that the dose of varicella virus vaccine live (oka/merck) (VARIVAX) was invalid because it was given to soon. On 26-OCT-2020, the patient experienced inappropriate schedule of product administration. The action taken with the suspect therapies, the outcome of the events and causality assessment was not provided.
Information has been received from a 73 year old female consumer with no known allergies or pertinent medical history who on 06-MAY-2008 was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. It was reported that the night of vaccination the patient woke up with vomiting, diarrhea and a headache. Medical attention was not sought, and there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician (follow-up) and a 73 year old female consumer with no known allergies or pertinent medical history who on 06-MAY-2008 at 08:53 am was vaccinatedSQ with zoster vaccine live (Oka/Merck) (Lot #458844/0204X). There was no concomitant medication. There was no illness at the time of vaccination. It was reported that the night of vaccination at 22:00 pm the patient woke up with vomiting, diarrhea and a headache. Medical attention was not sought, and there were no lab studies performed. On approximately 10/11-MAY-2008 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
NOT FEELING WELL; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included omeprazole. On 16-DEC-2021, the patient had not been feeling well (dose number in series 2). She was taking Prilosec (omeprazole) and patient's husband asked if there was a problem taking it with Motrin (ibuprofen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Ovarian cyst.  Cramp like lower abdominal pains have continued most days since the onset in March.
10-20-2023 1200, Employee reported of having severe headaches and fatigue 2 days following Covid-19 Comirnaty (PFR) 2023-2024 vaccine.  Experienced also fever and chills.
Symptoms started around 6:00 P.M. Had intense left calf pain, left knee pain and went up into left thigh. Also had nausea and headache. Pain was so bad thought she had a blood clot, went to ER. Dr. ordered venous doppler was negative, told muscle strain and gave FLEXERIL, told to take Naproxen for pain. That night her husband noted her left arm was very red, hot to touch and swollen 2" x 3" area. Patient was still nauseated the following day and ongoing left knee pain, and arm red and swollen.
Aches and fever all day 4/17/19 from 2nd dose of SHINGRIX. Patient was recovering without continuation of symptoms on 4/18/19.
Patient tested positive for COVID 19  on 5/1/2021 he was asymptomatic.
Small pin-point or slightly larger pustules that appear to contain a clear fluid in patches on abdomen, chest, and back, and on inner aspect of knees and on thighs.  Randomly scattered on other parts of body also.  The bumps have white/clear heads and the skin between the bumps, where they are clustered, is pink.  They do not seem to be bothersome to the patient.
Moderna COVID-19 Vaccine EUA No teatment.  rash on arm that injection was giving in.
feeling fatigue today; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling fatigue today) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2021 and COVID-19 in April 2021. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Balance disorder.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced FATIGUE (feeling fatigue today). At the time of the report, FATIGUE (feeling fatigue today) outcome was unknown.            No concomitant medications were reported.  Patient received 1st dose of Moderna with Lot number: 042L20A on 15Jan2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 3  Patient received 2nd dose of Moderna on 24Apr2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 4  Patient received 1st booster  dose of Moderna on 08Nov2021 in Deltoid (Shoulder) IM in the Vaccination Location: Contact 5  with Lot number: 071F21A  Patient received 2nd booster  dose of Moderna on 057F22A in Deltoid (Shoulder) IM in the Vaccination Location: Contact 6  with Lot number: 057F22A  No treatment details were reported   This case was linked to MOD-2022-658052, MOD-2022-658049 (Patient Link).
Caller wanted to report side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller wanted to report side effects) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller wanted to report side effects). At the time of the report, IMMUNISATION REACTION (Caller wanted to report side effects) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication were reported. No treatment details were reported.