chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I went for my appointment, I got two vaccines that day, the flu shot on the right arm, no major issues with that, just typical muscle ache, she gave me the booster in my left arm, but because there is a tattoo on my left arm the nurse decided not to shoot through the tattoo she elected to shoot at top of the shoulder. I went home and about three hours later, the left arm was in pain, it was a stabbing pain in the joint, not like a regular pain, and that was on a Friday evening, I took ADVIL and TYLENOL and nothing worked. I went to urgent care on Monday and they had never seen anything like it, they gave me a shot of TORADOL, and that settled it down for a day and was instructed to go see my Primary care Dr. if it got worse and I did that on Oct 5, and she prescribed the pill version of the TORADOL called ketorolac and told me to take that for 10 days and in the mean time she referred me to an orthopedic surgeon and scheduled an MRI for me to take. The MRI was done on 10/18/2022 and I went to see the Orthopedic Surgeon on the 10/21/2022 which revealed that I had a torn rotator cuff and severe inflammation of the muscle. He gave me a shot of CORTIZONE and then set me up for physical therapy and it has helped a bit. I still wake up at night and I am very sore, and I can't really raise my had that high and I can't hold any weight in that arm at all.
I got hives all over my body, burring in her stomach and a low grade headache.
Nearly immediately after this dose, I started feeling the electromagnetic charge of my body. I felt like I was a foot wider on all sides. I also felt like I was floating.  I also had tinnitus in my right that was so significant that my ear drum throbbed at points.    After months of chiropractic care, all symptoms have subsided except for the tinnitus. I've now had constant tinnitus in both ears 24 hours a day every day for over a year.
Hospitalized 01/27/2022-02/07/2022 for left upper lobe pneumonia; COVID-19 positive; leukocytosis. Treated with baricitinib, Remdesivir, dexamethasone, zinc 50mg daily, vitamin D3 50mcg daily and vitamin C 1,000mg daily.
Information has been received from a physician concerning a 17 year old female patient with Gilbert's syndrome (benign syndrome with normal variance) and no known drug allergies who received GARDASIL series (first dose on 10-Sep-2007, lot # 658554/0928U; second dose on 26-Nov-2007, lot # 659439/1267U; third dose on 29-Apr-2008, lot # 659964/1978U). There was no concomitant medication. In approximately February 2011 ("about 1 1/2 months before diagnosis date of 31-MAR-2011"), the patient experienced weakness, trembling and pain in her legs. So she went to the emergency department at a hospital. The symptoms had been processing to her arms. Blood tests were ordered at the emergency department but the results were not available for him to review. Lab work performed (unknown which tests were done) was normal according to the patient's mother. It was believed that no cerebrospinal fluid (CSF) analysis was performed. ON 31-MAR-2011 the patient was diagnosed with Guillain-Barre syndrome by the reporting physician. The physician referred the patient to a neurologist on 31-MAR-2011 who confirmed his diagnosis of Guillain-Barre syndrome. At the time of reporting, the patient had not recovered from Guillain-Barre syndrome. Follow up information has been received from the neurologist who reported that no vaccine was given to the student patient at his office. The patient was seen in office for neurological evaluation secondary to lower extremity weakness and was diagnosed with idiopathic cryptogenic neuromuscular disorder. There was no history of vaccine exposure given at that time related/unrelated. No evidence vaccine. Electromyography (EMG) and nerve conduction velocity (NCV) were performed and both were normal. On 13-APR-2011, the patient recovered from the adverse event. Guillain-Barre syndrome was not life threatening, but was disabling in the fact that the patient needed assistance with walking. Additional information has been requested.
About 5 minutes after receiving vaccination patient noticed her left arm  was very cold and then it went numb from the base of her left ear to her hand.  Tested strength in both hands and it was equal.  After 20 minutes the patient stated that the numbness was going away but the coldness was still present in the left arm.
Patient returned to the site of vaccination 4 hours after being vaccinated with bilateral forearm hives and erythema.  This area was mildly pruritic.  Treated with Diphenhydramine 25mg and VS were normal.  She was observed and left without incident in the care of her mother.
This spontaneous prospective pregnancy report was received from a medical assistant, refers to 27 year old female patient. Patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant therapies included amoxicillin. On 20-SEP-2016, pregnant (6 months of gestation) patient was vaccinated with one dose of VARIVAX, subcutaneously, (lot#/exp date unknown). On 20-SEP-2016, the patient came into the office with an upper respiratory infection and she was erroneously vaccinated. No adverse symptoms reported. The LMP and EDD was not known. No treatment was given for the adverse events. Lab diagnostics studies performed was reported as none. The outcome of the events was unknown. Patient sought medical attention by visiting physician's office. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
102 fever; aches,pain; chills; headache; very very cold; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache) and FEELING COLD (very very cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Two knee replacements). Concurrent medical conditions included Osteoarthritis. Concomitant products included MELOXICAM for Osteoarthritis.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of Extra strength and DOXYCYCLINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-1 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative. On an unknown date, X-ray limb: not measured not measured.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient put herself on doxycycline treatment for one week, All Those events lasted for a day and a half.   This case was linked to MOD-2021-023532, MOD-2022-468649 (Patient Link).
Large red rash at injection site that spread to size of orange. Itchy and hot to the touch.
Noted itchy, painful discrete lesions (3) on left lower abdomen, left upper hip and left buttocks:  raised erythematous base about 1-1.5 cm diameter with vesicular (1-2mm) centers, one with several small vesicles about 36 hours after vaccine. Had developed fever of 100.3 degrees F. Ten hours post vaccination along with malaise, joint aches and soreness at injection site left arm.
THREE blood clots in lower leg. Being treated with Eliquis blood thinner. Long term treatment needed, and multiple specialist visits  to diminish the blood clots.
Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Rash (about 50 papules) on back abdomen and groin area. To do Benadryl and Calamine lotion.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 15-MAY-2008, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a health department.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 01-DEC-2015, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
This case was reported by a consumer and described the occurrence of swollen axillary lymph nodes in a 54-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date in November 2010 the subject received 1st dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced swollen axillary lymph nodes. At the time of reporting the swollen axillary lymph nodes was resolved. The consumer reported another case, see A0948278A.
Left ear sudden hearing loss; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Apr2021 13:30 (Batch/Lot Number: Er8734) as a single dose for COVID-19 immunisation. Medical history included asthma. Allergies were unknown. The patient's concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 12:00 PM. The patient experienced left ear sudden hearing loss on 14Apr2021 20:00. Event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included high dose steroids. The patient underwent PCR COVID Nasal swab test: negative on 14Apr2021. Outcome of event was recovering.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event left ear sudden hearing loss cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received concerning a male who on 03-APR-2008 was vaccinated with ROTATEQ vaccine live (human-bovine) (Lot # reported as 660289/1888U). Concomitant therapy included PREVNAR vaccine (CRM197) and diphtheria toxoid (+) hepatitis B virus vaccine  rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX). The patient received the first dose of ROTATEQ vaccine live (human-bovine) (Lot # reported a 0301X) was received on 08-JUL-2008 also out of recommended age. The patient has problems with reflux, bronchiolitis and ear infection but they are not believed to be related to ROTATEQ vaccine live (human-bovine) since they started before the patient received the vaccine. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
cellulitis; pain in armpit; had a pain at injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis), AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site). On 13-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (cellulitis). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis) outcome was unknown and AXILLARY PAIN (pain in armpit) and VACCINATION SITE PAIN (had a pain at injection site) had not resolved.        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.   The concomitant medications reported was meds for high blood pressure. The treatment reported was patient was prescribed antibiotics - Bactrim  for cellulitis.  on 13-Jan-2021, the symptoms returned, patient was having redness and warmth to the touch in the injection site. Also, patient's arm was swollen and hot.; 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.
Within a day or so, woke up in the middle of the noc screaming - face was red - mother couldn't help her stop crying, unconsoleable and fever. Ever since that incident child experienced more seizure activity than normal. Prior to vac. only infantile spasms.
Cough had nothing to do with COVID-19 vaccination on October 2022. Persistent cough began approximately 01DEC2022. Patient has been seen by a clinic physician and pulmonologist. A working diagnosis was asthmatic reaction successfully treated with cortical steroids cough has resolved.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate: manufacturercountry: devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Prior history of cervical surgery w/insertion of rods and screws (2019).  Post surgery developed scapula dyskinesis on the left side.  No current treatment for condition which has not been painful for the last two years.  Also have had left shoulder issues separate from the cervical repairs which was last treated over a year ago with a cortisone injection.  No problems following the first Moderna injection.  However, about an hour after the second shot today I developed a sharp pain in the left scapula area  and left shoulder that felt as if I had been stabbed.  The pain resolved after sitting immobile on a recliner for about a half hour.  It is now over six hours later and the pain seems to have resolved leaving me with just some discomfort in the area of the left scapula.  I have remained sedentary for the rest of the day.
Ringing in ears, tinnitus. Shortly after injection 15 -20 minutes after. Still present and intensifying.
Skin shows multiple macular-papular lesions and a few vesicular lesions. The lesions are now pretty well generalized. Impression: varicella. Pt doesn't appear ill, toxic or in distrexx.
Pt received vaccine in LD and with 30 seconds fainted. Pt was pale and began to perspire. He was responsive within 1 minute. We had him lie down and proceeded to check BP 3x, all of which were WNL.
Patient had received first dose of Pfizer Covid-19 vaccine one month prior to filler injection and second dose two weeks prior to filler injection; pain; redness; This is a spontaneous report from a non-contactable other hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included hyaluronic acid (JUVEDERM ULTRA) taken for an unspecified indication, start and stop date were not reported. The patient experienced patient had received first dose of Pfizer covid-19 vaccine one month prior to filler injection and second dose two weeks prior to filler injection on an unspecified date, pain on an unspecified date, redness on an unspecified date. The outcome of the events inappropriate schedule of product administration, pain, erythema was unknown.  No follow-up attempts are needed. No further information is expected.
PHARMACY TECHNICIAN FORGOT TO DILUTE THE PFIZER VACC COVID-10 5-11 Y BEFORE ADMINISTERATION. .NO KNOWN ADVERSE REACTION.
onset of itching, redness, swelling, pain, hot at injection site at day 7 after vaccination.
Initial report received from a health care professional in the USA on 19/Jun/2006. A 57-year-old male patient developed fevers, malaise and diarrhea after receiving the injection of YF-VAX on 08/Jun/2006. The lot number, route and site of administration were not reported. The reporter refused to provide any further information.
Rash onset in the evening of 3/12/02 which involved to the appearance of chickenpox covering face, trunk and extremities. Had a dense cluster of blisters approx. 2" in diameter over left deltoid region. Denies fever or other symptoms. Given Zovirax oral suspension.
evening of 3 Apr 21 woke up from sleep with sense that I could not breath; something wrong.  i drove to local ER where I was admitted to ICU fo2 days, with numerous blood clots in both lungs and one on my right upper leg.  I was not in any vehicle accident nor suffered any fall or injury prior to this diagnosis. I was in complete shock.  No family history of blood clots.
Information has been received from a consumer concerning her now 6 year old son with penicillin allergy, egg allergy and certain food allergy and a history of zinc deficiency who in approximately 2004, "when he was between 12 or 24 months old", was vaccinated with a dose of PEDVAXHIB. The mother reported that she was unsure the manufacturer of the vaccine. In approximately 2004, "after receiving the vaccine", the patient developed allergies and rashes. The mother also reported that the patient developed eczema on an unspecified date. "After a few years", the patient had recovered. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested.
Site: Swelling at Injection Site-Mild, Systemic: bleeding down arm/pt concerned of non OSHA compliance(lack of glove use to wipe dry blood off of arm)-Mild, Additional Details: pt's vaccine site started bleeding after needle was removed. immunizer cleaned the blood that was dripping down her arm off with a glove on and made sure she stopped bleeding, but took blood covered glove off and finished wiping off the dry blood with an alcohol swab. Patient called and told pharmacist her concerns about the incident.
Pt woke this A.M. fussy and temp of 102.8 rectally, then temp went down to 101.0 rectally after giving juice. Pt without any other problems per mom.
1.  10/20/2023 9:18 pm -- Checked into ER with chest pain and spiking high blood pressure (180/75).  Blood tests showed that there were no heard or kidney issues.  Chest x-ray was normal.  Was released from ER after blood pressure subsided some and chest pain lessened.  The following day, I noticed a mild f3ever that broke in the evening as which my blood pressure returned to normal (130 / 60 ) and I felt much better.  2.  10/24/2023 --  I awoke early and felt very dopy.  I fell and was unable to get myself up after which my wife managed to get me up and into the ER again.  Blood tests indicated liver issues and a number of other blood results that were out of normal range.  I was diagnosed with acute hepatitis.  Scans of the abdomen and head were normal.
Within 5 minutes of receiving the shot in the individual's Left arm she complained of paresthesias without paralysis in left neck and left  face area
Pt recvd vax 155PM APAP given; pt ate supper then vomited w/mild sz directly thereafter approx 7PM; 30 mins later vomited, screamed & had violent sz lasting 5-10" in ER t103.8; brief rash;