chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was initially received on 23-Feb-2016. The case report was received from a Health Professional and concerns a 13 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication prevention of seasonal influenza on 17-Feb-2015- 17-Feb-2016, Batch no: U50309, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s) event (s) and outcome: On 17-Feb-2016, AFLURIA PFS was previously exposed to a temperature excursion of 9.5 degree C for 2 hours (non serious, outcome: Unknown) and had been administered. No adverse effect had been reported. Action taken: discontinued. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
I have had headaches the entire time. What has frieightened me is the swelling that started immediately underneath where I received vaccine. A red inch thick red line at the bottom of the swelling. It's hot to the touch. I have a lot more pain than I feel is expected. Received a dose of antibiotics for cellulitis but they haven't helped. I'll be out of those antibiotics by Wed and then feel it's necessary to go to the ER. I'm afraid it is some sort of infection or the swelling isn't able to be released throughout my arm. Feels as if there is a rubber band tied around my lower bicep and blood flow isn't functioning properly. I hope this makes sense. I looked up covid arm but I don't think it relates much bc this reaction happened later that evening and it's been a week without any improvement.
patient slumped, syncopal episode for less than 2 seconds. Awakened stating "I feel light headed".  Site staff reported event to NP right way, at 10:30am, BP 120/80 pulse of 58, Patient's mother came to patient's side, repeat BP 120/78, pulse 58; , repeat again at 11:20 116/80, pulse 60. Mother declines EMS. Patient in good spirits, A&ox4, and left site with mother normal gait and affect.
This spontaneous prospective pregnancy report as received from a nurse on behalf of physician refers to a female patient of unknown age. The patient's medical history included irregular periods and one or two miscarriages. Patient had no drug reactions/allergies. Approximately on an unknown date in April 2013 (reported as 6 months ago), the patient was vaccinated with a first dose of GARDASIL (lot number, expiry date were not reported) 0.5 milliliter (ml) intramuscularly. On 20-JUN-2013, the patient was vaccinated with a second dose of GARDASIL (lot number, expiry date were not reported) 0.5 ml intramuscularly. The results of urine pregnancy tests on 18-OCT-2013 and 21-OCT-2013 were negative. On 21-OCT-2013, the patient was vaccinated with a third dose of GARDASIL, 0.5 ml intramuscularly. The result of "HCG" (human chorionic gonadotropin) blood test for pregnancy on 25-OCT-2013 was 19,000. Patient sought medical attention for the same. Patient stated to nurse that she was 4 to 6 weeks pregnant. Accordingly the patient became pregnant with Last menstrual period (LMP) of approximately September 2013. The pregnancy outcome was pending. Additional information has been requested.
"Up crying all noc w/t102.4; sleeping @ 815AM; (pale w/red cheeks, dec feeds, lethargic-cries intermittent;
Since Monday evening, patient t has been having fevers of 103.9-104.3. Both legs have been red and swollen, warm t touch. Parent is giving Tylenol and ibuprofen to help with fever. As soon as medication wears off, high fevers spike again.  Spoke with mom on 06/12/2019-instructed her to alternate giving Tylenol every 4 hours, and ibuprofen every 6 hours. Also instructed her to try cool compresses to the legs to help with the swelling.
Hives all over the body, started October 14th, currently on day 13. Still have hives, severity has lessened
Narrative: COVID infection following COVID vaccine series 01/08, Pfizer dose #1 01/28, Pfizer, dose #2 08/03 pt cc: no symptoms exposure: unknown 08/07 COVID swab, result: detected.
On 12/26/20 at approximately 6:40 in the morning, I awoke with very watery eyes, excessive clear mucus from the nose and excessive sneezing (approximately 20 per hour).  I took diphenhydramine & loratadine around 7:45.  The symptoms did not reduce so I took another diphenhydramine at noon and finally another at 6 pm.  The following day the symptoms were less and loratadine & 1/2 diphenhydramine was taken in the morning
One week after receiving Zostavax vaccine for shingles, I began to feel tingling along the course of nerves on my back where I had previously had shingles several years ago. The next day I broke out in blisters. I am sure it is herpes zoster as I have had it in the past. I did not seek medical attention, though.
Patient states that she has had swelling start in her knee that is bothering her.  She had normal adverse reactions to the injection site, but nothing significant.  She is not sure if this is due to Shingrix, but is unaware of what else could cause this for her.  Recommended to follow up with MD.
incorrect product storage; No AE; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On 02-DEC-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T028303, expiration date: 20-AUG-2022, 0.5 milliliter for prophylaxis (route of administration was not provided) (incorrect product storage). The varicella virus vaccine live (oka/merck)(VARIVAX) underwent temperature excursion of 25.5 degree Fahrenheit for  9 hours and 42 minutes; 23.7 degree Fahrenheit for 13 hours and 27 minutes. Previous temperature excursion was not detected. No additional adverse event was provided.
Initial unsolicited report received from a consumer on 03-Nov-2017 and additional information was received on 03-Nov-2017. This case involves 55-year-old male patient who was vaccinated with 0.5 ml single dose of FLUZONE QUADRIVALENT via intramuscular route in the left deltoid (batch number, expiry date, dose in series were not reported) on 01-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, 2 days after the vaccination, patient's left elbow started hurting and had not stopped hurting. Reportedly, patient will visit to doctor. Reporter stated he was not sure if the side effect he was experiencing was truly from Sanofi's product. Lab data and corrective treatment were not reported. The outcome of the event was not recovered at the time of reporting. List of documents held by sender: none.
Had a reaction in her right knee that put her on a cane; This is a spontaneous report from a contactable nurse (patient)  A76-year-old female nurse received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiration date: 30Jun2021) on 20Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Osteoarthritis (diagnosed about 45 years ago). Concomitant medications were not reported. The patient received first dose of BNT162B2 on 30Jan2021. On 22Feb2021 the patient experienced a reaction in her right knee that put her on a cane. The event was considered serious as medically significant. The patient informed the knee was getting considerably better, but she can still feel it.  She can now walk without too much of a problem. At the time of the reporting the patient was recovering from the event.; Sender's Comments: Based on the information provided, the event "Had a reaction in her right knee that put her on a cane" is likely to be an intercurrent event unrelated to the use of suspect product BNT162B2 in this 76-year-old female with underlying osteoarthritis. This case will be reassessed should additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Cold; Pain in arm; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix .5 ml. In June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd June 2019, the patient experienced cold. On an unknown date, the outcome of the injection site pain and cold were unknown.   It was unknown if the reporter considered the injection site pain and cold to be related to Shingrix.  Additional details were provided as follows: This case was received from the vaccine patient assistance program. The patient received Shingrix in left arm. The patient experienced pain in her left arm (injections site) after receiving 1st dose of the Shingrix vaccine. The patient also stated that she experienced a cold 3 days later.  The patient was agreed to follow up. No further information was given.
9PM temp went up & 8PM vomited when APAP given; 230AM seen in er t104.5;
Received Pfizer COVID Vaccine after receiving first dose of Moderna; Received First dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prevention.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prevention.    Concurrent medical conditions included Allergy (diagnosed allergies), Immunocompromised, Respiratory disorder NOS, Chromosomal abnormality NOS, Endocrine disorder (endocrine abnormalities (including diabetes)), Diabetes (endocrine abnormalities (including diabetes)) and Obesity.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) .3 milliliter. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna). On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received First dose of Moderna) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer COVID Vaccine after receiving first dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. In Apr-2021, the patient went to receive his first dose of Moderna vaccine and at that time, he was told that the clinic would not give the second dose because it was out of the EUA. Hence the patient received his first dose of Moderna vaccine on 03-Apr-2021. Then he went to a Pfizer clinic and informed them that he had not gotten any of the vaccine yet and he was administered the Pfizer COVID Vaccine between 10:00 - 13:00 on 10-Aug-2021. This was his second dose. The patient mentioned that he was fine and did not have any issues. Treatment information was not provided.
Patient developed a temp of 103 degrees the evening that shot was given. Temp at 1530 today 102.2 after receiving Tylenol at home at 1330 arm is red hot swollen and firm. Red area covers entire bicep area.
Lot number maybe a Number two or a Z, not sure by the writing, 01ZLZOA  or 012L2OA Next day feeling tightness in chest and lightheaded, and shortness of breath, some right side jaw pain.
Tired, nauseated,desire to sleep, under arm lymph nodes tender, could not function for 3 days. OTC Rx and rest
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19.  Patient reported no adverse reactions after the administration of vaccine. Vaccine number 1 NDC code was reported as 80777-0273-99
Received vax's 3/27/03 a.m. Mother states because very fussy with inconsolable crying. Last pus? and today. Returned to clinic 3/28/03 baby exam'd - MD indication of illness. Injection sites - no redness, swelling or pain. No fever. Advised Tylenol or Motrin and return to office or ER if condition worse.
Approx 3" knot with redness at injection site. (R) arm no painful-is a little itchy and hot to touch.
Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient only received half of his Moderna bivalent vaccine dose; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (patient only received half of his Moderna bivalent vaccine dose).    The reporter does not report any other adverse reactions.  The reporter does not had any information on the patients other Moderna Covid-19 vaccines.  Concomitant medications were not reported.  No treatment information was provided by the reporter.
10/26 Burning heat on neck, shingles came out. Called dermatologist right away and was diagnosed with shingles during the visit. Prescribed 7 day of VALTREX and 10 days of Gabapentin for pain. On 11/5 went to regular doctor when felt better to drive. Doctor confirmed the shingles. A month in and still feels tired, wiped out and exhausted. About 95% of rash is gone and also pinching.
Pt L upper arm is red, hot to the touch and feels hard @ injection site.  <- hist Dx  Skin is mildly red-not hard child not ill- playful- afebrile.
Seizure like activty, initially described as "fits" with feeding by parents.  Events occurred more frequently over the next month and began to occur at times other than feeding.  Patient was referred to a neurologist by this MD for seizure activity.  Details of the subsequent course of illness are unknown to me.
Headache; Dizziness; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced HEADACHE (Headache), DIZZINESS (Dizziness) and MYALGIA (Muscle pain). At the time of the report, HEADACHE (Headache), DIZZINESS (Dizziness) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient is a 90-year-old male with PMHx significant for HTN, HLD, DM, OSA, s/p MVR who presented to the ED via EMS for dyspnea. Per chart review, the pt was also bradycardic with a HR of 29 bpm for which he received Atropine. The pt denies chest pain, nausea, vomiting, dizziness, or HA. Upon arrival to the ED, his HR was 30 with BP 134/58. He received an 500 cc NS bolus, Zofran, calcium gluconate, glucagon with improvement in HR to 49-50 with adequate BP. Case was discussed with Dr. who accepted the pt for evaluation and recommended against pacing as the pt is not symptomatic. He was transferred to another hospital for further evaluation. He arrives on a Dopamine gtt in no acute distress and with
Booster was  November 10 2022 and died of heart failure February 8 2022.  May not be related but needs to be recorded
Truncus arteriosis S/P partial repair. On Lasix and Captopril, Being followed by GI, cardiology.  8/3/07 Received Autopsy Report which reveals COD as failure to thrive due to congenital heart disease, s/p correction of truncus arteriosus.
Pt vaccinated with DTP experienced inconsolable non-stop crying for over 3 hrs.
Starting the next morning after receiving my second dose of the Moderna vaccine I started to experience flu like symptoms of chills, body aches, headache, as well as nausea.
Fever of 102 began 5/9/pm and has gone up to 105.  Mother reports has only gone down to 99 during the past 5 days and has stayed elevated.
Sore throat by 4 am. Lethargic, slight fever (99 to 100), runny nose, and cough by 11am. Fever of 102 degrees by noon the next day on Sunday 01/13/13. Gave him water, ginger tea, orange juice, and about 2 or 3 doses total of kids liquid ibuprofen over the 2 day period. Fever was gone by Monday morning 1/14/13 with still slight cough and runny nose present.