chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Medical assistant referring to 3 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date in AUG-2016 (reported as 02-AUG-206 or 03-AUG-2016) the patients were vaccinated with improperly stored PROQUAD. Concentration, dose and route of administration were not reported (lot # M06104, expiry date 01-AUG-2017. It was reported that the temperature excursion was for 9 hours at 9 degrees F, according to the data logger. There was no previous temperature excursions. No symptoms were reported. Additional information has been requested.
She had a poor response to a full course of PCV7 with PPSV23 booster (9 of 23 > 1.3).; Literature Article.  Information has been received from the authors in a published literature article entitled as stated above concerning a 15-year-old female patient with history of developmental delay, multiple congenital defects, and lymphedema who was referred to the immunology clinic for evaluation of recurrent ear infections that began at 3 months of age requiring tympanostomy tube placement at 18 months. Her physical exam was notable for abnormal facies, scoliosis, strabismus, abnormal thumbs, and unilateral lymphedema. Her laboratory evaluation revealed macrothrombocytopenia, mild leukopenia with low T-cells and markedly low B-cells by flowcytometry, and notably low IgA (11.7, RR 69 - 309) and IgG (423, RR 613 - 1295) (units not reported). Whole exome sequencing identified a heterozygous mutation in Cell Division Cycle 42 consistent with Takenouchi-Kosaki Syndrome (TKS).  On an unspecified date, the patient was vaccinated with the full course of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (lot#, expiration date, strength, dose, route of administration and anatomical location were unknown) as booster.   Subsequently it was noted that she had a poor response pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (9 of 23 > 1.3) (Vaccine response impaired).   At reporting time, the outcome of the event was unknown. The causality assessment between the Vaccine response impaired and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) was related.
Head ache and nausea. Head ache has continued  till present day, not relieved with any OTC med.
Left arm pain/Tenderness; Swelling of the lymph nodes in the left armpit; swelling; Redness; Fatigue; headache; muscle pain; joint pain; chills; nausea first and booster doses; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Left arm pain/Tenderness), LYMPHADENOPATHY (Swelling of the lymph nodes in the left armpit), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness) and FATIGUE (Fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (migraine medicine as needed) and Asthma (asthma inhaler - not used in over a year). Concomitant products included ALBUTEROL for Asthma, RIZATRIPTAN for Migraine.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain/Tenderness), LYMPHADENOPATHY (Swelling of the lymph nodes in the left armpit), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea first and booster doses) and PYREXIA (fever). At the time of the report, VACCINATION SITE PAIN (Left arm pain/Tenderness), LYMPHADENOPATHY (Swelling of the lymph nodes in the left armpit), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (Redness), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea first and booster doses) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took migraine medication more often than inhaler due to using the computer for work. .  No treatment medication was provided   This case was linked to MOD-2021-405022, MOD-2021-405042 (Patient Link).
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 25-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-215; exact dose and route of administration were not reported. There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1200 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
One week after my second Pfizer vaccination (received on 4/7/21) I had a mammogram.  It showed no evidence of disease.  Less than 3 months later (found on 7/01/21) I had a 2.4 cm grade 3 triple negative tumor visualized by MRI (07/08/21) and again by mammogram (07/21/21) and diagnosed by biopsy (07/21/21).  I have had chemotherapy, surgery, radiation, and am continuing immunotherapy at the time of this filing.
Vomiting, nausea, severe pain in lower back (specifically left side) pain in left side of stomach, dizziness, pain when taking deep breaths, loss of appetite
On day 1, first shot, arm tenderness, evening chills and slight fever.  Day 2, bright red area, approx. 3 inch diameter, appeared over injection site.  Muscle aches, arm tenderness, and fatigue lasted 3 days.  On day 9, today, bright red area, approx. 3 inch diameter, and arm tenderness, reappeared over injection site.
I was very tired and my arm was a little bit sore and I ran a 99  temperature that just made me miserable. I sat around and didn't do anything because I didn't have any energy. It lasted 3 days until 02/29/2021. I did not see my Doctor for this.
Patient began to have hives and required epinephrine and then 3.5 hours later required the same treatment and admission for further monitoring.
"Eco" in the right ear; high blood pressure 15/9; Pain in the arm; fever 101 F; Lightheaded feeling in the right side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side). At the time of the report, HYPOACUSIS ("Eco" in the right ear), HYPERTENSION (high blood pressure 15/9), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (fever 101 F) and DIZZINESS (Lightheaded feeling in the right side) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.
IRREGULAR MENSTRUAL CYCLE & MORE SEVERE PMS:  My period came 1 week later than it should have and bleeding was inconsistent with previous cycles. It was spotty and very light over a much longer time frame. Usually, my regular cycle lasts 5 days, and this cycle began 5/27 and lasted for 8 days. My next period (June) came early starting 6/21 and has been much heavier than usual already. Pre-menstrual symptoms of heavy cramping, constipation, and fever started a week prior, reaching as high as 102.8F. and was on and off for two days. Nausea and cramping was severe for 2-3 days before 6/21 at the start of this June menstrual cycle. I have no been ill for any reason prior to receiving my second Moderna dose and when I met with the doctor on Monday 6/14 to discuss my symptoms, I was told to "keep an eye on it" with no specific diagnosis or recommendation.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 29th August 2018, the patient received the 1st dose of SHINGRIX. On 29th August 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: At 16:00 O' clock, the patient received SHINGRIX vaccine in right arm. The patient experienced redness at the injection site either the night of or the next day following vaccination with SHINGRIX vaccine. The patient could not recall the exact onset time. The events was resolving after a few days but then a larger red spot appeared before the reporting day. It was red above, below and on the sides of the injection site. The patient had denied permission to contact their physician.   This case was linked with cases US2018GSK165658 and US2018162299 (husband's case), reported by the same reporter.
Patient states 4 days after vaccine, lost feeling in arms. Been having muscle problems since. On HUMIRA and leflunomide.
Onset of fever on 8-6-11 up to 102 degrees. Playful when afebrile. Seen in doctor's office on 8/8. Presented later to ER where resp. arrest occurred during evaluation. CPR and defibrillation with aggressive IV inotropes unsuccessful. (intermittent fever present 8/6-8/8).
The next morning after the vaccine the patient was eating some eggs and they tasted like metal. The next day everything tasted bitter. Its like her tounge has something on the tip of it.
Adverse effects started approximately 12:00am the night of the second vaccine.  The AE's included cough, temperature of 101.2F, total body aches and required best rest for approximately 36 hours.  This was followed by the development of a chronic, persistent and deep cough. Previous to receiving the vaccine I was being treated for diverticulitis in January of 2021 and it was noticed that I had slightly elevated eosinophils (~1000).  After the second vaccine dose the cough continued to worsen and get deeper and more persistent.  At  the end of March I was referred to a pulmonogist and it was found my absolute eosinophil count was 130000 and I was sent to ER for treatment. After admission, I was referred  to the Cancer center for further outpatient treatment. During my outpatient treatment  (March 24- April 30) I slowly developed paraplegia to the state where in could no longer walk  After numerous tests including bone marrow biopsy, thoracic and abdominal CT scans, 3 brain MRI's several parasite tests  no specific cause of the high eosinophils was determined.  Additionally, multiple organs were effected including infractions in the brain, high tropinin levels (pericarditis/myocarditis?) requiring echo cardiogram , TEE, and angiogram, as well as bowel resection resulting in  an ostomy (May 1, 2021). All together, I required major surgery for a life threatening condition, spent 7 days in ICU, 7 days in the hospital surgical unit, 20 days in a rehab facility, and an additional 3 weeks in a nursing and rehab unit.  I am still recovering and receiving home care and rehab.  As there was no discoverable cause of the hyper-eosiniphilia, it is my strong belief that the Moderna Covid vaccine (2nd dose) was a  significant contributing factor, an accelerant and/or the root cause of the hyper-eosiniphilia and the subsequent events unfolding.  It seems highly probable that the vaccine is the cause and further investigation should be conducted.
Unusual blood clots during period. Sought care from OBGYN, As it goes I had a full hysterectomy on June 10th. Ultrasound, biopsy, blood work, urine samples, 4 separate physical exams. Two days later on June 12th Pupils was not equal and non-reactive, blurry vision, dull headache, tingle in left hand. MRI, CAT, new blood work, team of doctors determined it was a TIA mini stroke. Follow-up with Dr. to discuss this new health turn. Went over history, findings, ongoing care. Few months passed and was feeling ok but in Oct 8th oxy level down to 83%. MRI w/ contrast and series blood test were ordered. I was given eliquis for pulmonary embolism.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 11-JUL-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot# unspecified, expiry: 20-MAR-2013), 0.65 ml, subcutaneously. No adverse effect was reported. Additional information has been requested.
Case number PHEH2013US009217 is an initial combined report received from a nurse on 18 APR 2013 with a follow up information received from quality assurance department (QA reference number: 224311) on 22 APR 2013. This report refers to a male patient whose age was not reported. It was reported that during administration of an intramuscular dose of MENVEO (batch number: A12025, expiry date: DEC 2014) to him on 18 APR 2013, some of the vaccine splashed back on to the vaccine administrator's face because the syringe had a slip tip and needle popped off. The reporter stated that the patient received the majority of the vaccine. No adverse reactions were reported. The quality assurance department registered a complaint with reference number 224311. No further information was provided.
Extreme weakness in arms and legs? difficulty walking due to the weakness? an episode of unable to stand on legs .. forced to fall to floor due to weakness? unable to get up to walk .. arms very weak Called for help to get off floor?.Legs unable to hold body wait.. no walking for 3 hours then strength back some able to walk very cautiously
Initial case was received on 16 September 2010 from a healthcare professional. A nurse informed the reporter about a patient who reported that during administration of ADACEL (lot number not reported), if any vaccine leaks and gets on her skin, she experiences "numbness of the area." The reporter requested not to be contacted, since she has no further information regarding the patient or situation. Documents held by sender. None.
first start with sore arm and neck-then started hurting in chest- now have blisters on lip and throwing up
sneezing; coughing; congestion; fever; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm (triceps muscle) on 30Dec2020 10:30 at single dose for covid-19 immunization. Medical history included seasonal allergy from 1995 and ongoing, seasonal asthma from 1995 and ongoing. The patient had no concomitant medications. The patient experienced fever on 31Dec2020, congestion on 02Jan2021, sneezing and coughing on an unspecified date. Time the vaccination was given around 10:30 a.m, but she known she was okay to leave by 10:45 a.m. No additional administered vaccines. The adverse event was not required a visit to emergency room or physician office. Prior Vaccinations (within 4 weeks) was none. Relevant tests were none. Certified nursing assistant works in hospital where she cares for Covid patients. She received the vaccine on 30Dec2020 and by the next day, she had fever and congestion. The fever has gone away but she was still congested and was sneezing and coughing at home. The caller stated she was a CNA calling on behalf of herself in regard to the Pfizer COVID vaccination. She stated she received the vaccine on 30Dec2020. She had like a fever and everything over the weekend- starting Thursday night, Friday and then part of Saturday. She also had this congestion ever since she got the shot. The caller confirmed she received her first COVID vaccine on 30Dec2020. Late Thursday night, 31Dec2020, she woke up and had a fever. She had her husband check her temperature. She confirmed she recovered completely from the fever. She hadn't a fever since Saturday (02Jan2021), probably around 8pm. She didn't have a fever at all on Sunday. The congestion really didn't start until Saturday morning, 02Jan2021. She stated the congestion was still persisting at this point. Caller stated, " it honestly feels like a sinus infection" The caller was able to provide the Lot number off of her patient card. Caller made the comment the card also had the date she had to go back for her second vaccine. The patient underwent lab tests and procedures which included body temperature: recovered completely from the fever. The outcome of events for fever was resolved on 02Jan2021, for congestion was not resolved, for other events was unknown.
2 weeks after the vaccination, 04/06/2021, tremendous knee pain. I am usually active in walking, terrible knee pain. I had psoriasis  years ago, and it flared up about the same time, Psoriasis flared up on my left elbow and left forearm.  I saw my PCP in May/June, I did not attribute the knee pain or the psoriasis to the vaccine.  The psoriasis was spreading to my arm. My PCP  did not link that to the vaccine and I did not either. She worked me up for different types of arthritis,  insect bites, Lyme disease rheumatoid arthritis, and those all came back negative.  The psoriasis continue to spread on my left forearm, to a point I had never seen before, I could not control it with steroid cream so I went to see my dermatologist.  07/12/2021, I went to see my dermatologist, she diagnosed it as Atypical psoriasis because it had been dormant for several years. She prescribed me a Stronger prescription for steroid cream,  Triamcinolone.   No, I have not recovered from the AEs. It's not as bad. But I am not considering the 3rd vaccine. j When I went to the dermatologist NP, in July, she asked me anything specifically happen to you in March. when I told her I had 2 vaccines in March. She said she had a lot of psoriasis and eczema patients that had flare ups after the vaccine.
COVID-19 treatment; COVID-19 treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 17:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: ENG201), in right arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 12Oct2021 as dose 3 (booster), single (Lot number: 31045B4) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Lipitor, reaction(s): "Known allergies: Lipitor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2022, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive, notes: Positive test for covid on 21Oct22; (28Oct2022) Negative, notes: Tested negative for covid on 28Oct22; (30Oct2022) Positive, notes: Tested positive for covid on 30Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
BROUGHT BY EMS FROM THE FACILITY FOR LOW O2 SATURATION. COVID POSITIVE. PER EMS PT O2 SAT WAS 99% ON 4L. PT NORMALLY ON 2L. PREVIOUS HX OF COPD. PT A&OX2
Sore throat, fever, h/a, & cough, laryngitis; 2DEC91 fully recovered;
Mom states that patient b/c very pale for approx. 3 hours after vaccinations.  Fell asleep & slept soundly without any s/s of distress noted.  Mom stated he screamed when he was first moved from his car seat & had color in face with screaming.  He was given Motrin for discomfort after vaccinations, noted to help with pain without any further screaming noted.  Mother states that his color returned to normal without any further s/s of adverse rxn after 3 hrs.  Mother will talk with doctor prior to completing the remainder of the vaccinations.
pt reported that dr has diagnosed her with cellulitis at the injection site and prescribed her antibiotics. upon examiniation, pt arms looks red and inflamed much like typical covid arm
This spontaneous report as received from a registered nurse in a doctor office refers to a 69 years old female patient. On 04-FEB-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as H018441, exp. date 28-FEB-2014). On 05-FEB-2013 the patient came to the office with redness and swelling at the site of injection. It was unknown if medical treatment was prescribed. The outcome of the events was reported as recovering. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Patient had a seizure of semiology of blank stare with blue lips and non-responsive. After it resolved, she could not remember anything and was sleepy for approximately one hour. No jerking movements or incontinence reported.
This spontaneous report as received from a pharmacist via a company representative refers to an 81 year old male patient. No information regarding the patient's medical history was provided. On 04-APR-2013 the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose was not provided. Batch/Lot no. was not provided. No concomitant medication was reported. 2 to 3 days after vaccination the patient was presented with a bad case of shingles, reported as the worst shingles the doctor had ever seen. On an unknown date the patient was hospitalized due to paralysis of his gastrointestinal (GI) tract. The patient received treatment (unspecified). The reporter considered these events to be events of significant disability or incapacity. It was reported that the patient recovered (date unknown) or was recovering from the events. No causality assessment was provided. Additional information has been requested.
Information has been received from a physician concerning a 6 yr old male who on 02Jun00 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that on 02Nov05, the pt developed 20-30 varicella lesions. The pt was noted to be afebrile. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the pt was recovering. Additional information has been requested.