chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On or about 09-JUL-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, dose, frequency, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related condition.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The event caused the patient hospitalization. The outcome of event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
rapid test positive for COVID-19; 101-102°F fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19), PYREXIA (101-102°F fever) and CHILLS (chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-2021 and COVID-19 since 15-Jan-2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (101-102°F fever) and CHILLS (chills). On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Jan-2021, PYREXIA (101-102°F fever) and CHILLS (chills) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (rapid test positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       He took Tylenol and Advil for the symptoms. He takes blood pressure medicines as a chronic treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of Pyrexia and chills, a causal relationship cannot be excluded. Based on the current available information SARS-CoV-2 test positive is unlikely related to vaccine per recent agreements, the event is assessed as unlikely related to mRNA-1273.
On day 4 post-vaccine, sudden onset of anxiety, chest heaviness, dizziness, confusion, headache, nausea, sweats. Evaluated in ER. No treatment.
feeling really sick; flu-like symptoms; diarrhea; felt warm a few times; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Gout, Allergy and Enlarged prostate. Concomitant products included LORATADINE for Allergy, LOSARTAN and METOPROLOL for Blood pressure high, TAMSULOSIN for Enlarged prostate, ALOPURINOL for Gout, PANTOPRAZOLE, FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Mar-2021, the patient experienced MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times) and VOMITING (vomiting). At the time of the report, MALAISE (feeling really sick), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIARRHOEA (diarrhea), FEELING HOT (felt warm a few times), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Patient is experiencing pain in his left arm and shoulder. He is also complaining of tingling sensation going down the arm. He is going to call and talk to his doctor as a follow up.
Severe leg pain, legs felt very heavy and was extremely hard to lift them. I was unable to walk by myself the pain was so awful and my legs just felt that heavy! It?s hard to explain the pain almost like a severe ache and throbbing when laying down or sitting but sharp pain when standing or moving. Today day 4 pain is Lessing but still ache, was able to walk on my own on day 3 after the vaccine.
Headache, Myalgia, MILD INJECTION SITE SORENESS, MUSCLE PAIN, AND HEADACHE DAY FOLLOWING INJECTION Narrative:  Other Relevant History:
My period got very heavy and irregular. Right before I got the booster, I did get my period and it lasted for 7 weeks until my gynecologist had me go to the ER in which they gave me a shot of naproxen to slow down/stop the bleeding. 4 days later, it did stop but my periods are still not ?normal?. My dr put me on birth control to try to mediate that but I still am bleeding heavier and instead of having a 7 day period, I?m having my period for about 2 weeks
I started having chills and a fever, I also had aches and pains and pain at the injection site on 3/13/21 starting around 11am. Today I woke up on 3/14/21 and my arm is much more sore and has a hard big lesion around it. I also have a bad headache and aches and pains throughout my body.
Red spot the size of half dollar around where injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 9APR96-pt was potentially exposed to varicella on 7APR96 from a visiting relative who brother had a full-blown case of chickenpox;22AUG96 pt exp gen rash (between 15-20 lesions) & minor temp;
pt called 5NOV92 to report 1-2 days of migratory, swollen, stiff wrist, ankles, knees; later seen by MD who felt vax reaction; tx Pred & Naproxen
p/vax pt devel low grade temp, rash on face;1-2cm plain erythematous lesions on forehead, cheeks;h/a;9/17//99 neck pain w/flexion;more vesicular lesions;9/18.99 moderate neck pain w/flexion;about 30 vesicular lesions scattered;
Fever between 99.8 and 100.3; Chills. I'm not seeking treatment other than OTC fever reducer.
wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning  before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002  (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck)  (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318)  on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.
The patient had fever lasting 2 days and left arm pain lasting 4-5 days after the first dose.  After the second dose, he also had a fever the first day, developed severe pain in the right arm with swelling and sensation of heat which did not respond to ibuprofen; radiation of pain down to his hand and into his upper chest, all of which persisted for several days, requiring a visit to the emergency department on 2/12/21, where a workup including CBC, chem, CK as well as an x-ray of his shoulder and venous doppler study were negative. His pain and swelling have persisted for over a month although they are starting to gradually improve.
brief minor nosebleed several hours after shot; sore arm for several days; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 11Mar2021 at 16:15 (at the age of 69-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included diabetes, high blood pressure, asthma and had nosebleeds when taking Naproxen; depression worsened on anti-depressives. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 20:00, the patient experienced brief minor nosebleed several hours after shot; sore arm for several days. Patient did not received treatment for events.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 11-JUL-2014, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 21 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Includes no new information.
C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,76. O2 Sat 98%. TEl./EKG SR.
Pt got the first shot, the flu shot in the left deltoid and was fine after that shot. He requested that the updated covid shot, Comirnaty, be given in the same arm. After giving the shot in the same arm, at least 1 inch apart from other shot, pt stated he was getting dizzy while sitting there. Immediately after, he passed out in the chair and his body started to freeze/tense up. I hesitate to call it a seizure but he was unresponsive for a good 20 to 30 seconds. I held him in place so that he wouldn't fall or hit his head. I tried to bring him around by calling his name. He didn't respond so I called to my tech to call 911. By the time the tech picked up the phone, patient was responding to me and I explained what happened as he was confused. He stated he was very nauseous and dizzy. I asked him easy questions to keep him talking and to gauge his responses. There was no slurring of speech and no abnormal movements after he came back. He refused the 911 call. I asked him if there was anyone he could call to come sit with him and monitor him for a while after he left. He called his fiance to come and pick him up. He did admit that about 10 years ago he had a similar reaction to getting a shot for an MRI. He stated that he had passed out and seized on the nurse that was helping him then. I told him not to get 2 shots at once anymore and to report the dizziness and fainting on his VAR in the future as he did not with us. He did end up vomiting a bit in our garbage can before he left. He also admitted that he did eat breakfast this morning. I did suggest that he follow up with his MD due to this incident.
Fever, malaise, runny nose...ongoing still on 01/31/2016 at 0130 am. Treating with Advil and Tylenol.
Patient experienced swollen, red arm to elbow up to base of her neck. As day went on, she experienced a swollen, tight, hot red arm to elbow up to base of neck.
Injection sight red and swollen from 24 hours after vaccination until time of report. Lymph nodes in left arm pit sore and swollen.
Rash appeared on right arm, opposite from immunization) above and below elbow.  There was surface skin discomfort and discomfort.  Got worse.  No fever. On 6/3 saw physican who diagnosed shingles.
got COVID twice; got COVID twice; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID twice".  Clinical information: Adverse Event(S)/Product Complaint Details: Age/Date of Birth: 10-17 years. Doctor reports he caught COVID disease twice, has received COVID vaccine and I don't have a booster, cause I got two shots and got COVID twice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, cold sweat that evening. Non vesicular rash in AM on (R) arm (varicella) swelled, itchy, hot, arm numb. Rash on (L) arm (MMR) (R) arm influenza. Then appeared after Tx with corticosteroids and antihistamines.
Patient received Pfizer monovalent vaccine when he was supposed to receive Pfizer bivalent vaccine. It is unknown at this time if it will be recommended for the patient to receive an additional booster in two months for bivalent coverage
BOWEL MOVEMENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-APR-2021, the subject experienced bowel movement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bowel movement was not reported. This report was non-serious.
Staph infection; had a lack of effect; HPV; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a female patient of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies was not provided.  On an unknown date (reported also as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced human papillomavirus (HPV) (papilloma viral infection), so it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had a lack of effect (vaccination failure). It was mentioned that the patient experienced a "staph" infection (staphylococcal infection), on an unknown date, after the shot, as well.   Information about treatment for the events, if any laboratory diagnostics were performed, or if the patient sought medical attention was not provided.  At the time of report, the patient had not recovered from the papilloma viral infection. The outcome of vaccination failure and staphylococcal infection was not provided.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and papilloma viral infection, and vaccination failure was considered related by the reporter. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and staphylococcal infection was not provided.  Upon internal review, staphylococcal infection was determined to be a medically significant event.  This was one case of two from the same reporter.; Sender's Comments:  US-009507513-2105USA007264:
Chills, was shaking. high temp 103 over the night, then 101, 99.  Sore arm.
Sneezing, congestion, cough, sore throat, DTAP 5, Hep A, IPV, and MMR4-6 y/o shots due. T/C taken and Fluids given
A Little after a week from getting the first shot I developed a large circular rash that was hot and itchy and very sore. I was seen at urgent care and put on antibiotics for suspected cellulitis. However the doctors could not rule out that it was not some kind of injection site delayed reaction.
This spontaneous report was received from a registered nurse referring to an unspecified number patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M026876 with an expiration date on 26-JUL-2017) (dose, route and . No adverse events were reported and frequency were not reported). No adverse events were reported and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.