chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vision loss; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 27-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, route, dose, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a clinic for long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequent to vaccination), the patient was treated for vision loss and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was considered to be medically significant.
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 24-Jan-2022 at 12:26 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. Last menstrual period and estimated date of delivery were not provided. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details provided.   This case was linked to MOD-2022-473097 (Patient Link).
racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Got vaccine on March 1, 2021.  On March 6, 2021 developed atrial Flutter with tachycardia. Pulse 127 blood pressure 138/95,  Weakness,  slight SOB.
CHRONIC RESPIRATORY FAILURE 10/8/2021 AORTIC VALVE STENOSIS CHRONIC RESPIRATORY FAILURE 10/8/2021 ANEMIA CHRONIC RESPIRATORY FAILURE 10/8/2021 FACTOR V LEIDEN MUTATION, HETEROZYGOUS
On the day of the vaccine, 1/7 no reaction.  The typical slight sore arm on injection site but nothing odd. On the morning of 1/8 I woke up with noted chills and headache.  I checked my temp and noticed 100.4* oral temp.  I also had back pain, muscle pain, headaches, continued fever (improved with motrin) and chills. My left arm from my shoulder to my wrist was with noted pain/aches, improved with motrin. On the morning of 1/9 I felt much better, did not take any motrin/tylenol and without any fever/chills.  Noted improvement of muscle aches in general and arm felt  the same as 1/7 (much better!).  Noted lymph swelling of my axillary lymph nodes with aching pain.  This has not gone away at current but improved with x1 dose of motrin.
Has medical issues; This is a spontaneous report from a contactable consumer (Patient wife). A male patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had medical issues (as reported). Patient stated that she has her husband's Covid card in her purse. No further details provided by the reporter. The outcome of the event was unknown.
Hurts to breathe; Tired; Headache; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 17Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and environmental allergy since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL) and loratadine (CLARITIN). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Apr2021, the patient experienced tiredness, headache, joint aches and it hurt to breathe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired, headache, joint aches and hurts to breathe were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
When I received my second dose of the Pfizer vaccine 12/6/21 I was 6w1d pregnant. I started spotting blood 12/20/21 and miscarried 12/22/21 at 8w3d pregnant.  I have never experienced a miscarriage before and successfully delivered a baby 5/2/20 with no complications. I have No medical conditions that would cause me to miscarriage.
started being itchy all over and itching like crazy; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (started being itchy all over and itching like crazy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia, Anxiety, Acid reflux (esophageal) and Allergy to antibiotic (Patient is allergic to Antibiotics.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (started being itchy all over and itching like crazy). On 13-Feb-2021, PRURITUS (started being itchy all over and itching like crazy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication provided. No concomitant medication provided.
Information has been received from a physician concerning a 4 year old patient who on 6/14/04 was vaccinated with MMR (lot # 646122/0610N). On 7/9/04 the patient presented to the reporting physician's office with parotiditis and possibly some encephalitis and headache. The physician based the suspicion of encephalitis on the fact that the child was not acting normal and was uncharacteristically combative. The reporting physician did not plan any treatment at that time. No product quality complaint involved. Upon internal review, the report of possibly some encephalitis due to the patient's not acting normal and uncharacteristically combative were considered to be an other important medical event (OMIC).  No product quality complaint involved. Follow up information reported that the pt on 03Jul04 developed a cough and congestoin. On 07Jul04 the pt complained of mouth hurting. On 08Jul04 the pt was described as combative and had unusual behaviors. On 09Jul04 the pt developed left parotid swelling. Subsequently, the pt recovered by 14Jul04. There were no relevant diagnostic tests or laboratory data. This report no longer meets the criteria for submission because the adverse events aggression and abnormal behavior are not serious.  No further information is expected.
pt recv vax;21nov95 exp chicken pox type of rash w/ over 100 lesions on trunk,back,head & perianal area;to md;2 lesions noted to be fluid filled;mom denied exposure to chicken pox prior to vax;
"Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented with leg edema found to be in CHF, diuresed. On admission she was also found to be anemic, reported melena. Transfused and treated empirically with PPI - GI said she was too high risk for endoscopy. Stools became brown and hgb stabilized. Tolerated resumption of anticoagulation. Risk > benefit regarding endoscopy I agree. Loaded with venofer. During stay developed respiratory insufficiency fever and leukocytosis treated with zosyn -- > levaquin for HOSPITAL ACQUIRED PNEUMONIA. On discharge tested positive for covid but no longer needing oxygen."
I received my first dose of the vaccine on 6Mar2021, and 5-6 days later I caught COVID; headache; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced "i received my first dose of the vaccine on 6mar2021, and 5-6 days later i caught covid" on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , I had a bad headache for 2 days, it was the worse 2 days of life on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included Sars-Cov-2 test: unknown results on unknown date. Therapeutic measures were taken as a result of "headache, i had a bad headache for 2 days, it was the worse 2 days of life".  Caller stated "I received my first dose of the vaccine on 06Mar2021, and 5-6 days later I caught COVID I went to the hospital and they only gave me a shot for my headache and then i went home, I had a bad headache for 2 days, it was the worse 2 days of life. At the hospital they only told me to take Tylenol or Motrin at home. I didn't have the lost of tasted or the shortness of breath. On 15Apr2021 I was scheduled to get 2nd dose. How long should I wait to get the 2nd dose"? Caller stated "Keep up the good work!".  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
head congestion; cough at night; chills; extreme fatigue; fever at night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the right arm on 10Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication that was taken within 2 weeks of vaccination included amphetamine (ADDERRALL) and Multiple vitamins for unknown indication. On 13Mar2021, the patient had experienced extreme fatigue, head congestion, chills, cough at night and fever at night. The patient received over the counter remedies as a part of treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme fatigue, head congestion, chills, cough at night and fever at night was resolving at the time of report. No follow-up attempts are possible. No further information is expected.
Redness at the site of injection spreading to almost the hole arm  from deltoid muscle almost to the elbow. Very itchy and hot to touch. Redness developed 3 after the injection. Benadryl 25mg every 4 hours was recommended as well as doctor's visit.  Patient came in the next day. After taking Benadryl redness and itchiness significantly improved.  Continuation of Benadryl was suggested and visiting MD if symptoms worsened.
2x2 cm. indurated - non-tender lump (R) deltoid. No erythema.
Tinnitus in left ear that was loud enough to make sleep difficult.  The Tinnitus subsided after about 3 hours of sleep, but hearing is now impaired in the left ear.
Fever over 102, dizziness, headache, malaise, muscle and joint aches, fatigue, beginning within 12 hours of the vaccine administration, lasting nearly 48 hours.
3 inch diameter rash.  It never showed up until 2 full weeks after the shot.  Located where the shot was given
Onset: 1/26/21 Redness, swelling to (L) upper arm radiating down (L) arm, warm to touch, itching ordered: Triamcinolone 0.1% lotion, hydroxyzine 25mg QID, for 5 day Xyzal 5mg BID for 7 days
I have had diarhea since 2/6-2/8/21, congestion, coughing, sneezing and a headache from 2/8-to present day. I haven't taken anything except Excedrin as the symptoms have not been too bad.
Arm pain, headaches, Numbness in hands, loss of use of arm at times, pain from neck to hand. Trouble sleeping due to pain.
This case was reported by a physician and described a male subject of unspecified age who did not respond to immunization to Hepatitis B vaccine (Manufacturer unspecified) for prophylaxis. On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown). About three to four years later, on an unspecified date on or before 14 November 2006, a hepatitis B surface antibody titer was zero.
Hi I am a medicine Intern. I am reporting my own symptoms which are suggestive of multiple sclerosis like condition, symptoms being Vertigo, Tinnitus, bilateral Paresthesis and weakness in all 4 limbs, within 10 days of receiving 1st dose of Hep B vaccine. The symptoms initially lasted for 3-4 months then resolved and are now back again for 2-3 months and going on. I have had 3 MRI's of brain, Lumbar-Puncture and various blood tests all are normal till now. I have done some reading and there are many similar reported cases, please look into this matter. Thanks.
11 mo rec'd 1st dose of HIBTITER 5FEB91- following morning was seen in office w/fever of 105. Sp Tap showed H. Influenzae.
Itching redness around the armpits and groin at 6:00pm now 10/22/2013 9:22 AM the itching and redness is all over his body.
pt recv vax & devel cellulitis @ the inj site characterized by a golfball size area of swelling;also devel a fever which persisted for 4 or 5 days;pt was treated w/an antibiotic & recovered;
PATIENT EXPERIENCED INCREASE A FIB  AFTER VACCINE; PATIENT HAD A FIB PREVIOUSLY
Pt developed fever, sore throat, tachycardia and rash the following day. Diagnosed with fifth disease.
Diffuse red splotch, similar in appearance to a birthmark.  No bump, heat, pain or drainage.  No other symptoms/reactions.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 15-NOV-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot# K009810, expiry date: 10-OCT-2015, anatomical location unknown) that underwent an unsupported temperature excursion. No adverse experience reported. The outcome of the events was unknown. Additional information has been requested.
SWOLLEN LYMPH NODES IN ARMPIT AND NECK; This spontaneous report received from a patient via a company representative concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced swollen lymph nodes in armpit and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in armpit and neck. This report was non-serious.
Left leg swollen from knee down; Harder for her to move; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move). The patient was treated with PARACETAMOL (TYLENOL) from March 2021 to March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient experienced swelling on her left leg which moved to the back of the knee. It was soft and not painful to touch. The patient reported having difficulty moving the knees and legs.   The patient was treated with Tylenol and generic ointment.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received is non-significant. Reporter contact details updated.
COVID arm; Left arm was red in the area of injection only; A little swollen in the area of injection only; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE ERYTHEMA (Left arm was red in the area of injection only) and VACCINATION SITE SWELLING (A little swollen in the area of injection only) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE ERYTHEMA (Left arm was red in the area of injection only) and VACCINATION SITE SWELLING (A little swollen in the area of injection only). On 31-Mar-2021, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE ERYTHEMA (Left arm was red in the area of injection only) and VACCINATION SITE SWELLING (A little swollen in the area of injection only) had resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-406101 (Patient Link).
This spontaneous report as received from a nurse via a company representative refers to a female patient, currently 17 year old. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 06-JAN-2015 the patient was vaccinated with GARDASIL (dose and frequency were not reported) (lot # K006191, expiry date: February 2017) intramuscularly for prophylaxis. The patient experienced memory loss, fatigue, tremors and immune problems on unspecified date. The patient reported that, memory loss was continuing. The outcome of tremor, immune system disorder, fatigue and amnesia was reported as not recovered/not resolved. The relationship between the events and GARDASIL was not reported. No product quality complaint was involved.
patient reported pain at injection site radiating up shoulder and down the arm, redness and swelling, and itching on the arm
Knot on her neck; Felt sleepy; Nauseous; This spontaneous case was reported by a health care professional and describes the occurrence of NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous). At the time of the report, NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Fever 102 for 24 hr. Irritable, decreased appetite, vom for 24 hours, tired, inconsolable.