chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day felt sluggish; Woke up 2 hrs later to sweating; Diarrhea; Stomach aches 5 hours later; then intense and uncontrollable shaking and shivers; then intense and uncontrollable shaking and shivers; The patient received the third/boster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Nov2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The medical history included immunization. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. The concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date in Oct2021 for immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, both as a single dose for COVID-19 immunisation and experienced no adverse reactions. On 07Nov2021 at 15:30, 5 hours later, the patient experienced stomach aches, then intense and uncontrollable shaking and shivers and at 17:30 woke up 2 hours later to sweating and diarrhea. 08Nov2021, next day, he felt sluggish and continued the diarrhea. The patient felt better on 09Nov2021, but stomach aches and diarrhea had continued. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since, the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense and uncontrollable shaking and shivers, sweating and felt sluggish were resolving, while the clinical outcome of the events stomach aches and diarrhea were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache.  Treated with ibuprofen . Nausea.     Limited food.
Jerk motion of arm his shoulder blew out; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Slight fever that was resolved by acetaminophen.  Redness and swelling around injection site and arm pain.
patient presented with lightheadness and pressure in ears approximately 10 minutes after administration of vaccine.
PAIN AND MUSCLE SORENESS IN THE ARM FOR 2 DAYS AFTER THE VACCINE. THE PATIENT HAS NO PAIN OR DISCOMFORT NOW AND DID NOT GO TO THE DOCTOR.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch#  unknown) for COVID-19 immunization. No medical history reported. On Jan 22, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising). At the time of the report, pain in extremity (very sore arm), feeling hot (heat emanating) and contusion (bruising) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information 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 events, a causal relationship cannot be excluded. Further information requested.
Seriousness criteria other medically significant (OMIC). Initial report received from a consumer on 6/22/06. A 58 year old male pt reported that he received the yellow fever vaccine. lot number 5792 in the right arm on 3/27/1965 while in the military. The pt reported he also received tetanus, smallpox, typhus and polio vaccination on 3/17/65. Trade name, manufacturer and lot numbers were not reported. Per reporter, who is the pt, in April 2002 he had blood tests and tested positive for Hep C. In 2003 he had a liver biopsy. Recovery status reported as not recovered. Follow up information received on 10/30/06. Per the reporter, the pt has chronic Hep C and a liver biopsy on 4/3/03 showed liver fibrosis, necrosis and steatosis. Other diagnostic and treatments were not provided. Per this new information, and due to medical evaluation of the case, this case was upgraded to serious.
Hives on and around injection site. Started to appear two days after injection and then worsened.
Severely lethargic,  muscle and joint pain, low-grade fever migraine type headache, runny nose,  body aches  swelling itching and redness and pain of injection site swelling to size of handball , and swelling of lymph nodes under arm and then neck, most sx lasting three days.until now
Pt called the day after getting the PNEUMOVAX c/o injection site, swollen size of her fist and pink. She was feeling lightheaded. Pt offered appt. for same day and did take this. Pt instructed to take ADVIL, rest and increase fluids put cool compress on site pt. later in day canceled appt. Stating she wanted to wait 2 days after pt felt there was some improvement, 4 days later pt feels she is better.
Flares; Pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Flares) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Flares) and PAIN (Pain). At the time of the report, ERYTHEMA (Flares) and PAIN (Pain) outcome was unknown. Not Provided      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.
Hospitalization: ADMITTED 9/6/22 DISCHARGED 9/10/22. Presentation to the ED: Congestion, fever, cough, shortness of breath, palpitations. COVID-19 + date: 9/6/22. Treatment: Remdesivir & Dexamethasone.  Discharge to: HOME.
Patient received Shingrix in left deltoid area on 11/2/2020. That night, patient developed a rash. It started in acromioclavicular joint area and then she noticed some rash on the left side of the neck, biceps and axillary areas. There was no pain but some minimal burning. She denied any discharge, fevers, chills. No similar rashes in the past. Patient denied taking any new medications, supplements, traveling or sick contacts.  Skin exam showed erythematosus macular rash about 1-1/2 inch by half inch in size on the left side of the neck just below occipital area. Patient also had multiple raised lesions in the anterior part of deltoid upper biceps and axillary area.
.05ml given to 6 month infant instructed mother and grandmother of the vaccine error. Clent sat in facility for 20min to ensure no complications. Incident occured at 11:30am on 11/02/2009
Tinnitus.   Mild tinnitus started after first vaccine.   Much worse after second vaccine. Has not stopped after 10 days.  Physician said to use nasal steroid which made it even worse after 2 days so i discontinued.  Now just taking Claritin D and waiting to see if it goes away on it's own.. Physician also mentioned oral steroids but am I afraid those will make it worse like the nasal steroid did.
Information has been received from a nurse concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (lot# 667866/1437Z) (exp. 25-FEB-2013). Concomitant vaccine included ADACEL. On 16-MAR-2011 the patient fainted after receiving her first dose of GARDASIL. She fell and injured her nose which resulted in a nosebleed. She was kept in the office for 30 minutes after she woke up and taken to an emergency room to treat her nose. Oxygen, smelling salt and ice were given as treatment for the adverse events. There was no lab diagnostics studies performed. At the time of the report, the patient's status was recovered. Additional information has been received from a physician and medical records regarding a 17 year old female with no known allergies. On 16-MAR-11, the patient was vaccinated with GARDASIL (lot# 1437Z) (expiration 25-FEB-13) injection intramuscularly in her deltoid at 4:00 pm. The patient had no known illnesses at time of vaccination. The patient had an ADACEL (lot# C3249AA) (expiration 04-NOV-11) injection intramuscularly in her deltoid at 4:00 pm. The patient had received one previous dose of ADACEL on 07-DEC-07. The patient had a FLUZONE (lot# U3774EA) (expiration 30-JUN-11) injection intramuscularly in her deltoid at 4:00 pm. It was reported that she had intranasal FLUMIST previously in 2004 and 2010. On 16-JUN-11, the patient experienced a syncope episode immediately after injections. The patient got off the exam table and fell. She injured her nose (redness, swelling) and suffered head trauma. The patient was referred to the emergency room for further work-up. An x-ray revealed that the patient had suffered a mildly displaced anterior nasal bridge fracture. The patient underwent a computed axial tomography exam of the brain for indications of fall, head trauma and loss of consciousness, which revealed no acute intracranial abnormality. The patient remained in the doctor's office after the incident for 30 minutes. The patient's vitals were checked and ice was applied to her nose. It was unknown if the patient recovered. Additional information has been requested. All available medical records will be provided upon request.
Following administration of H1N1 flumist patient had tightness and lump high in back of throat. Patient also reported brief transient dizzy spell.No loss of consciousness or SOB. No treatment required, was observed for approx. 45 minutes total, all symptoms resolved within 10-15 minutes.
pt recv vax 31OCT95 & noticed a white wheal w/surrounding redness @ inj site on 1NOV95;pt was evaluated by MD but no medical tx was initiated;pt is recovering;
Sore arm starting immediately after shot and lasting more than 3 days. Acne breakout on face starting the day after the shot.
Blurred vision, severe headache, numb tongue that deviated to left, cranial nerve 7, 9, 12 involvement. Pain behind right ear into jaw and eye and down into neck and shoulder.
01/13/22 presents to EC ED for "suicidal ideation". PMHx of "heart palpitations, gluten sensitivity, depression, and suicide attempts"
Dizziness while sitting, leaned forward, head between knees, cool compress to neck and forehead, drank water resolved.  At 3:10, after leaving Health Unit, nausea and vomiting small amount of food, sat, observed for 15 minutes, NAD, symptoms resolved, home with parents.
Patient woke up with fever( temperature unknown) , nausea when waking up she proceeded to do daily activities,   felt light headed which caused her to faint.
SICK FOR 3 MONTHS; SPOTS ALL OVER BODY AND PACK, SPOTS STARTED AT THE INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick for 3 months, and spots all over body and pack, spots started at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 3 months, and the outcome of spots all over body and pack, spots started at the injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20230108457. This case, involving the same patient is linked to 20230109456.
Red, swollen arm, started evening of injection. Spread to elbow 2 days after.
8/24/04: Arm puffy, red. 8/25/04 shoulder to elbow and around arm, red, swollen, hard spot where shots given, arm is stiff.
RASH TO RIGHT ARM AND UPPER BACK. GRANDMOTHER ADVISED TO GIVE HIM ORAL BENADRYL AND ORAL IBUPROFEN FOR ANY PAIN. ADVISED TO GO TO NEAREST ER IF ANY SIGNS OF ANAPHYLACTIC REACTION.
High fever up to 102, chills, and elevated heart rate. Also soreness at injection site
A report has been received from a Health Professional concerning an 8 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown. It was reported that the patient was given 2 doses of the FLUMIST on the same day. FLUMIST (INTRANASAL) was continued. The patient recovered from the event of TWO DOSES ON THE SAME DAY on an unspecified date. The report was considered to be non-serious.
This spontaneous report as received from a pharmacist via company representative refers to a 50 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose were not reported) subcutaneous. No concomitant medications were reported. On an unknown date the patient experienced redness at injection site. The patient sought medical attention, she went to see the pharmacist. The outcome of redness at injection site was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
After I received the 2nd vaccine I started my menstrual cycle 2 days after on 3/14 and then continued to have menstrual bleeding every 10-12 days for approx 2 months which was when I seeked medical attention.  my cycle was always regular and approx 28 days. During these shorter cycles I experienced heavier than normal bleeding and signs that I was not ovulating . I ended up needed a 12 day course of oral progesterone to reset my cycle
From initial information received on 04May05 from a health care professional regarding an adverse event occurring, it was reported that a female pt (age and date of birth not reported) inadvertently received a 0.1 millimeter dose of Tet Tox ADS USP, lot number unk, admin ID in the left forearm on 29Apr05 instead of Tuberculin PPD. An unspecified amount of time later, the pt developed large local redness with warmth over most of her forearm. She was seen in the ER on 01May05 and was diagnosed with cellulitis. The pt was seen for a re-check visit the following day. At that time, the symptoms were less severe. The pt has not recovered from these events.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers to 54 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
This spontaneous report was received from office manager refers to 28 year old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with GARDASIL 9 (dose, units, route and frequency not reported) (lot # N019103 and expiration date: not reported) at the age of 28 years. No adverse effects reported. No product quality complaint involved.
Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysacchride vaccine. On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine. Fourteen hours later the pt developed a fever of 103 to 104 deg, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site. He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone. His white blood cell count was 16,000 and later rose to 22,000. The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at." Additional info has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polyssaccharide vaccine and developed a swollen arm and redness from his shoulder to his wrist (WAES0312USA00217).  Follow up on 12/16/03: "Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N).  On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine (manufacturer unknown).  Fourteen hours later the pt developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site.  He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone.  His white blood cell count was 16,000 and later rose to 22,000.  The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at".  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additonal information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N) and developed a swollen arm and redness from his shoulder to his wrist (WAES 0312USA00217).
5MAY91 t102 po, 6MAY91 t102 po, sore throat, swollen glands, h/a, stuffy nose, nausea, difficult swollowing; no rash;
I received the injection around 2:30 I felt fine. It did not hurt going in. I stopped by a restaurant to get some take out and must of started feeling disorientated and completely forgot I had this folder with the VSAFE information. I started feeling chills all over my body, I kept taking my temperature it was 95.7, I started having a headache top of my head, the temporal, the back of my neck. They were all over the place. I went to bed and I couldn't sleep. It was like my brain was going crazy, it wasn't like an anxious feeling. I finally feel asleep around 4am and kept waking up remembering fragments of valid dreams. The dreams were fragment with such dread and anxiety in them.  It was like a huge wave of depression and anxiety. By about 9am I was fully awake, but my body hurt, my muscles ached I felt fatigued. The chills and headaches were through. I was still having weird racing thoughts. About 10pm it all went away and I slept fine and woke up the next morning and I was fine. My arm is still sore at the injection site but all the other symptoms went away.    Saturday morning I was talking with a friend on the phone, and she reminded me of the folder I received the folder. I completely forgot about this folder. I found this folder later that day and then I tried to access VSAFE. It made me realize how disorientated I was.
I experienced soreness and pain at the  injection site.  I also felt very tired/fatigue with severe neck,  shoulder pain with a minor headache.
improperly stored vaccine in use; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.    The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. On 18-DEC-2019, the patient was vaccinated with the improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S004399, expiry date: 06-NOV-2020) (strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis.      It was reported that the vaccine was exposed to a temperature of 9.4 Celsius (C) for a time frame of 25 minutes (product storage error). There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Sore throat; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.