chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Iritis; Scarring in the back of eye; Floaters in both eyes; eyes red inside; eyes swollen outside; This spontaneous case was reported by a consumer and describes the occurrence of IRITIS (Iritis), CONJUNCTIVAL SCAR (Scarring in the back of eye), VITREOUS FLOATERS (Floaters in both eyes), OCULAR HYPERAEMIA (eyes red inside) and EYE SWELLING (eyes swollen outside) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced IRITIS (Iritis), CONJUNCTIVAL SCAR (Scarring in the back of eye), VITREOUS FLOATERS (Floaters in both eyes), OCULAR HYPERAEMIA (eyes red inside) and EYE SWELLING (eyes swollen outside). The patient was treated with PREDNISONE at an unspecified dose and frequency and ATROPINE at an unspecified dose and frequency. At the time of the report, IRITIS (Iritis), CONJUNCTIVAL SCAR (Scarring in the back of eye), VITREOUS FLOATERS (Floaters in both eyes), OCULAR HYPERAEMIA (eyes red inside) and EYE SWELLING (eyes swollen outside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
The next day had shooting pain soreness, one week later sick with vomiting, headache and body twitches Still having leg pain and abd pain.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 18 years old, male patient with no pertinent medical history reported. On 04-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 11-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Tumor in left thigh. This then spread to lungs and brain. From diagnosis in brain was dead in 5 weeks.
2hours after receiving injection developed a uticarial rash on upper body.  Treated with zyrtec 10mg and 25mg of benadryl.  Resolved after 30 minutes of receiving benadryl.
Patients wife states the evening of his vaccine he experienced  a fever, chills, nausea and body aches...she reported this the next day...follow up call to check on  patient-wife stated he was feeling much better-fever free and not further complaints
Swelling in left side of face (eyes, nose, left cheek area); itching of eye at beginning of reaction significant pain. Treatment: KEFLEX, acyclovir, ibuprofen, ice pack, fexofenadine. Outcome: after 3 days the symptoms went away - don't know if it was from the medications or just on their own.
Within a couple of hours after receiving the vaccine I started getting tired quickly. I lost the ability to form sentences. I started to get shaky and pale. My heart was starting to palpitate, and I was getting dizzy. I couldn't stand up. I had a hard time breathing, and I couldn't even form a sentence. It was also difficult to talk or breathe. Those symptoms lasted a couple of hours. I felt nauseas, but I didn't throw up at all. The next day I was okay. I just felt groggy. The symptoms I had felt similar to the issues I have with my POTS disease.
:12/23/2021:Patient is a 80-year-old male with a past medical history of myasthenia gravis who is Covid positive and presents with shortness of breath.  Patient states that the onset of his symptoms was 1 week ago.  He tested positive for Covid 4 days ago on Monday. Experiencing myalgias, lethargy, shortness of breath, cough, fever, rhinorrhea, sore throat and ear pain.  He states that he was also experiencing loss of smell and taste.  The patient denies any nausea, diarrhea, abdominal pain. 12/23/2021: Chest xray-Mild bilateral mid and lower lung airspace disease suggesting pneumonia.
On evening of 10/8 patient states right arm sore/hurting, no bruising, no redness, 10/9/12 upon awakening 6:30am on 10/9 patient notice bruising approx 1 in around injection site-she states bruising worsening as day progressed-not red but arm felt warm. On 10/10/12 upon awakening patient states bruise larger about 2 in, redness on arm below injection site, feels warm to touch, some redness on R arm. No fever on any day per pt. Upon examining pt arm on 10/10/12 4:10pm bruise approx 1-2 in, redness below shot on arm, pt states warm to touch. Told pt to ice site, Tylenol pain/fever, and for patient to call MD stat for eval. Benadryl if allergic reaction. Pt called MD not in office 10/10/12 pt says she will call MD 10/11/12. She will notify us of outcome.
Bruise; Diarrhea; Where they gave me my shot in my arm is super sore; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Where they gave me my shot in my arm is super sore) and FATIGUE (Fatigue) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruise), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Where they gave me my shot in my arm is super sore) and FATIGUE (Fatigue). At the time of the report, CONTUSION (Bruise), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Where they gave me my shot in my arm is super sore) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information about concomitants was provided. No information about treatment medication was provided.
Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Hospitalized (11.15.21);  COVID-19 positive (11.15.21);  fully vaccinated  Admission Date: 11/15/2021 Discharge Date: Nov 19, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID [U07.1] COVID-19 [U07.1] HOSPITAL COURSE: 81-year-old female with past medical history of hypertension, hypothyroidism, asthma, seasonal allergies on chronic prednisone who presented to emergency room on 11/15 with slurred speech and confusion.  There was initial concern for stroke.  CT head was negative for acute abnormalities.  CT angiogram head and neck did show tubular 3 mm aneurysm protruding from the carotid arteries.  Other notable tests were positive COVID PCR, positive UA, hypokalemia, hypomagnesemia, elevated D-dimer and inflammatory markers.  Chest x-ray was clear.  Blood cultures were obtained which remained negative.  Patient was started on Rocephin. Patient was admitted for further assessment and management.  Neurology were on consult.  MRI of the brain did not show evidence of acute ischemic infarction, although there was comment on mild chronic small-vessel ischemic changes, chronic bilateral basal ganglia lacunar infarctions, age-appropriate brain atrophy.  Neurology recommended aspirin and statin as well as optimizing cardiovascular risk profile, they also recommended zio patch on discharge and outpatient neurosurgery follow-up for small aneurysms.  Patient's confusion improved by the following day.  Based on her history, she did qualify for monoclonal antibody for COVID and received this on 11/17.  Patient's respiratory status was monitored closely and did not require oxygen.  Initially physical therapy recommended subacute rehabilitation, however this changed to home with PT/OT/RN services after she recovered from her infectious symptoms.  She was discharged home with home care on 11/19/2021.
pt recv vax 4DEC98 & pt was hosp on 8FEB99 dx pneumonia;no cult were performed & causative organism was not identified;pt died on 9FEB99 this is 1 of 5 resident, out of 54 vaccinated, who devel pneumonia p/vax lot# 456689 or 456690;
A female patient with rabies exposure experienced a rash, facial swelling, dizziness and temporary hearing loss while receiving RabAvert. The patient had received RabAvert 1ml, scheduled to be administered on days 0,3,7,14 and 28. Past medical history indicated no known hypersensitivity to eggs.   The patient was bitten by a raccoon and the status of the rabies in the raccoon was unknown as the animal was not retrieved. The patient received her 4th vaccination approximately 1 month prior to the report, and 12 hours later developed a generalized rash that was described as strawberry colored, with facial swelling, dizziness and temporary hearing loss in one ear. There was no associated fever. A recent rabies antibody titer was 2.01 IU. The patient was stated as having a complete recovery.
exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx; exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 37 years as dose 3 (booster), single, administration date 27Jan2021 (Lot number: EL3247) as dose 2, single and administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "exposure to covid positive roomie", start date: 25Dec2021, stop date: 25Dec2021. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "exposure to covid positive roomie 25Dec then tested + Ag on 31Dec after work mild fatigue ST mild sx". The patient underwent the following laboratory tests and procedures: home Ag: (31Dec2021) positive; (02Jan2022) positive; (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Patient received Shingrix shot that was intended for other family member instead of Covid 19(Moderna) vaccination. Administering pharmacist discovered error and administered the correct Covid 19(Moderna) shot into patient's other arm.
Patient stated she got a severe headache after vaccination. Onsite EMS was called and vitals taken BP 190/94 HR 72  99% O2 room air. Patient went home.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2021-395985 (Patient Link).
red big bite; changed to a medium red color but then went back to a dark color; Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple; Redness at the site; This spontaneous case was reported by a consumer and describes the occurrence of BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color), RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple) and VACCINATION SITE ERYTHEMA (Redness at the site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the site). On an unknown date, the patient experienced BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color) and RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple). At the time of the report, BITE (red big bite), ERYTHEMA (changed to a medium red color but then went back to a dark color), RASH (Rash on her lower leg, one red big bite on her back, two red bites, looks like bug bites, dark and rashy, almost dark purple) and VACCINATION SITE ERYTHEMA (Redness at the site) outcome was unknown. not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No specific follow-up information recorded.
After the first dose of the COVID vaccine, I woke up with severe neck pain. It was on the right side of my neck (opposite of my vaccine site). It was extremely severe and woke me up from my sleep. Movement made it worse. Nothing immediately made it better. It radiated down to my right shoulder. The pain lasted for about 2 weeks. I got a massage, used a heating pad, used an at home massage device, and Tylenol and ibuprofen.
Left Facial Paresthesia/tingling in Left Ear; Numbness and tingling in Left Ear; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 14:30 (Lot number: FC3184) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: PARAESTHESIA (non-serious) with onset 11Sep2021 08:00, outcome "not recovered", described as "Left Facial Paresthesia/tingling in Left Ear"; HYPOAESTHESIA (non-serious) with onset 11Sep2021 08:00, outcome "not recovered", described as "Numbness and tingling in Left Ear". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination was Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Known allergies was none reported. The events were assessed as non-serious, did not result in death, did not result in medically significant, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, not intervention required, did not cause congenital anomaly/birth defect. Seriousness criteria-Other: No.  No follow-up attempts are possible. No further information is expected.
Bilateral tinnitus. I've had tinnitus since I was 10. I hardly noticed it previously. A couple days agter my second COVID 19 shot, I noticed large uptick to the point that it's now impacting my ability to sleep and function throughout the day.
This spontaneous report was received from a registered nurse and refers to a 15 months old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-JAN-2019, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB third dose, intramuscularly in the right vastus lateralis lot number R013572 and PROQUAD first dose, subcutaneously in the right vastus lateralis, lot number R018778. Other suspect therapies included INFANRIX fourth dose, intramuscularly, in the left vastus lateralis, lot number CX59C, HAVRIX first dose, intramuscularly, in the left vastus lateralis, lot number 3KT7B and PREVNAR 13 fourth dose, intramuscularly, in the left vastus lateralis, lot number W33490 all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved.  The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1902USA002414: US-009507513-1901USA011370: US-009507513-1902USA002413:
a reaction/vaccine symptoms; arm hurt; feeling achy; flu like symptoms; a red rash around neck, arm, back and torso; red bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, and RASH ERYTHEMATOUS in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071f21a, 022b21a, and 002c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS. The patient was treated with BENADRYL for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION, PAIN IN EXTREMITY, PAIN, INFLUENZA LIKE ILLNESS, RASH ERYTHEMATOUS, and MASS had not resolved.            Concomitant medications were not provided.  Treatment included Benadryl which didn't help and medicated shampoo (unspecified).
Patient site of injection got extremely red and the rash spread her entire upper arm from site of injection to her elbow. Contacted primacy care physician who prescribed amoxicillin and recommended benadryl. This started after receiving vaccine, got worse and the patient complained of pain.
Information has been received from a nurse practitioner concerning a female who on 20-OCT-2005 was vaccinated SQ with a 0.5 mL dose of Varivax. Recently the patient developed "full blown case" of chickenpox. The child had several hundred lesions and went to the ER. The patient's outcome was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Dizziness, Palpitations & HYPERtension Narrative:  Employee received vaccine this AM at approximately 0853 this AM, Patient was monitored for 30 minutes after receiving vaccine based on employees verbal report of having a prior reaction to the flu vaccine about 10 years ago. The employee reported having heart palpitations and it felt like "heart was beating out of chest" while on duty after the observation period was complete. The employee returned to the vaccine clinic for further evaluation and was assessed and vitals were taken. Employee was noted to have a heart rate around 105-110s and a BP of 170s/ 90s which the employee stated was "unusual". The employee was then monitored for an additional 30mins, which after 15 mins the employee stated "I'm feeling really bad" , employee reported dizziness and stated "I feel like I'm going to pass out. The employee was started on 2L 02 via face mask and transported to the ER for further evaluation. Vitals were reassessed and found to be within normal limits. Patient verbally reported feeling much better at this time.
Moderna Vaccine lot # 035C21A was affected due to out of temperature range. No adverse reactions from patients.  2 patient's affected.
Case previously recorded as MA2009-6275. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reports. Medical history: Not reported. Agency reference no. NA09-008851.
6 hrs after receiving 4th anthrax shot, neck stiffness, erythema of neck & face,tx w/benadryl, #2 blocker and solumedrol. Later, returned to ER w/shortness of breath,chest tightness, increased heart rate. Neck & face swelling, sob,given epi
After about 7 hours I payed down to get some rest. I had whole body aches, headache and whole body chillz shivering. I also felt warm to touch and had a fever. Injection arm was very sore and I felt very fatigued
At 6 AM on 5/15/03 pt had a febrile seizure lasting with temperature of 101. Examined by MD with rectal temp of 101.3. Exam - pt was found to be normal.
Patient awoke early Wednesday morning feeling very feverish and had tightness in his lungs.   He did not have a thermometer  to take his temp, but felt feverish.  His symptoms have eased some as of his call into the pharmacy around noon.
Pt. developed an injection site reaction characterized by redness, swelling and induration.  The redness and swelling extended to her left breast and back.