chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N.) concerning a 6 month old patient who on 18-JUL-2008 was vaccinated with the first dose of ROTATEQ (lot # 660377/0274X), the second dose on 19-SEP-2008 (lot # 661031/0476X) and the third dose on 18-NOV-2008 (lot # 662603/1271X, dose and route not reported). On 23-FEB-2011 the patient presented with rotavirus and the lab confirmed presence of rotavirus in the child's stool. The child had diarrhea for five days, multiple daily episodes. The patient was not hospitalized and had "now" (approximately in February 2011) recovered. Follow up information was received from a registered nurse (R.N.) and medical records a thirty three month old male (14.6kg, 38") who was vaccinated with oral ROTATEQ, the first dose given on 18-JUL-2008, the second dose on 19-SEP-2008 and the third dose on 18-NOV-2008. The nurse reported that the patient had all three doses of ROTATEQ at appropriate age and intervals. On 18-FEB-2011 the patient experienced diarrhea (duration unknown). Stool specimen was collected on 23-FEB-2011 and on 24-FEB-2011 results for rotavirus EIA value was reported positive. At the time of the report the patient recovered. This is an amended report. Adverse event of inappropriate schedule of drug administered was removed and patient's age of thirty three months was updated to patient demographic screen. All available medical records will be provided upon request. Additional information has been requested.
18x25 cm tender, indurated, erythematous area (L) deltoid - (Pt. unaware he was previously vaccinated with PPV 6/5/12).
12 mo old WF received varicella vac on 08/01/02. Mom called 8/6/02 states child has rash that started on her face and spread to her neck. Mom states looks like chicken pox.
12:00 Feb 1, 2021 Covid19 part 2 vaccine received in left arm no reactions 22:30 pain starts in left arm then in right arm then down both arms, aches start in all joints even feet 23:00 shivers begin and shaking, feel freezing cold, headache begins 24:00 shivers stop, nausea begins and now burning up across neck and back, horrible body aches, cant sleep 01:00 must have fallen asleep, feeling exhausted 03:00 woke up sweating, tired, weak, nauseated  04:00 able to get up to go to the bathroom but dizzy and weak Feb 2, 2021 remained weak all day and night, no appetite, off work Feb 3, 2021 able to work 1/2 way through the day felt fine after eating one week after vaccine a silver dollar sized rash appeared on right side of face, took about a week to go away
Feels extremely tired, fatigued and lifeless; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feels extremely tired, fatigued and lifeless) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feels extremely tired, fatigued and lifeless). At the time of the report, FATIGUE (Feels extremely tired, fatigued and lifeless) outcome was unknown.            Treatment details were not provided. No relevant concomitant medications were reported.
Hotness; A lot of pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hotness) and PAIN (A lot of pain in the body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced FEELING HOT (Hotness) and PAIN (A lot of pain in the body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In May 2021, FEELING HOT (Hotness) and PAIN (A lot of pain in the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had no allergy.  Concomitant medication was not reported.  Patient was not given other vaccines prior to Moderna COVID-19.  It was reported events lasted for 2 nights.   This case was linked to MOD-2022-475434, MOD-2022-475393 (Patient Link).
patient had seziures twice; Initial information received on 09-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who had seizures twice (seizure), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiration date not reported] at an unknown site of application via unknown route for prophylactic vaccination.  On an unknown date, the patient reported of developing seizures twice (seizure) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant as per important medically event list.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for seizure.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient who had seizures twice (seizure), while being vaccinated with INFLUENZA VACCINE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Experienced a flare of her juvenile RA, which was in remission. Rheumatologist thinks GARDASIL injection given.
pt recv vax 23SEP97 4PM mom gave APAP immed p/& cont for 24hr;next evening noticed red area rt thigh called ins nurse hotline said no worry;noticed torso rash also on head;T101;rash not serious  to cont APAP;
pain & swelling @ site of inject; fever up to 101; arthralgias, myalgia, abdo cramps, swollen cervical lymph nodes; onset w/in 24 hrs; duration 6 days;
7-8 CM AREA OF REDNESS, HEAT AND SWELLING APPROX 1 INCH BELOW LOWER INJECTION SITE ON L UPPER ARM AND SECOND S/P MASTECTOMY R SIDE.  C/O MUSCLE ACHE, SORENSS @ REDDEN AREA. DEVELOPED CHILLS, BODY ACHES AND "JUST DIDN'T FEEL WELL DAY AFTER IMMUNIZATION LASTING 11/29/2005-12/01/2005. REDDEN L ARM PRESENT TO ELBOW.
After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square). At the time of the report, VACCINATION SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-649344 (Patient Link).   Reporter did not allow further contact
pt recvd vax & exp serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular diseases, & has been non-diagnostic;
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027220A) for COVID-19 vaccination.     The patient's past medical history included Alcohol abuse (1 drink/month) in October 2020 and Marijuana abuse (one time 15 years ago). Family history included Cancer (Paternal family history of cancer (patient's grandmother and uncle passed away from cancer)) since an unknown date and High cholesterol (Maternal family history of high cholesterol) since an unknown date. Concurrent medical conditions included Drug allergy (Sulfa drugs (Minor reaction)) and Spotting menstrual (Spotting, but monitored by doctor and occurred in first pregnancy as well). Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) and PARACETAMOL (TYLENOL) for Migraine.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2020, Pregnancy test: positive (Positive) Positive. On 06-Jan-2021, Blood test: inconclusive mmHg (Inconclusive) (pre-vaccine) HCG 4717 at 5 weeks. On 06-Jan-2021, Ultrasound scan: inconclusive (Inconclusive) gestational sac was slightly irregularly shaped (unofficial finding).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Caffeinated tea.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Client presented for first Moderna booster.  Previous Moderna vaccinations were 11/19/21 and 1/24/22 at Pharmacy.  Patient is not immunocompromised.  The interval between second primary vaccine and the first booster for an immunocompromised person was inadvertently used (3 months) instead of the interval for a regular first booster (5 months).  No immediate ill effects.  It is noted the patient anticipates traveling internationally in the next 6 weeks and that is why she came in for her booster vaccine before traveling.
Information has been received from the authors in a published literature article, concerning an 18-year-old healthy female experienced numbness and tingling in the right arm 3 weeks after receiving the first GARDASIL vaccine injection into the right deltoid muscle. Over the following 3 months, she developed lower back pain, neck stiffness and pain in the legs resulting in difficulty sitting in class. Diagnostic tests obtained at that time included an unremarkable nuclear magnetic resonance imaging (MRI) of the cervical and lumbar spine and elevated Antinuclear antibody (ANA) titers of 1:320 with speckled and homogeneous pattern. Despite the symptoms experienced after the first injection, she received a second GARDASIL vaccine 3 months after the first injection, which resulted in significant exacerbation of previous symptoms. Additional symptoms, such as fatigue, orthostatic intolerance, dizziness, urinary incontinence and blurry vision appeared which in conjunction with pain and numbness resulted in significant functional impairment. In fact, the patient became wheelchair bound at that point and had to take medical leave from college for a full semester. Bedside heart rate assessment revealed a supine heart rate of 88 bpm and a maximum heart rate of 128 bpm within 5 min of standing. Neurological examination demonstrated reduced temperature sensation in the hands and feet without motor weakness. MRI of the brain, cervical, thoracic and lumbar spine, electromyography and cerebrospinal fluid analysis were unrevealing. Serological tests were only remarkable for elevated ANA titers. Based on clinical presentation, the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS) and possible small fiber neuropathy; a tilt table test and further autonomic reflex screen testing were not performed. Patient outcome was recovering since it was reported that over the following 3 years, the patient's symptoms improved significantly with the use of duloxetine and doxepin for neuropathic pain, and she was able to return to college full-time. Nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 1/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystanding lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Postural orthostatic tachycardia syndrome was AND Neuropathy peripheral considered disabling. This is one of several reports from the same literature: 1007USA02012. Additional information has been requested.
12 x 12 cm erythema, 6 x 6 cm induration, 3-2 mm pustules L deltoid.
Shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 07-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 25-APR-2011, the patient presented with complaints of a painful rash and was diagnosed with shingles by her primary care physician. The patient's shingles outbreak lasted several weeks causing severe pain and suffering. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the events shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles to be disability.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA007100:
Patient reports having mild pain in upper arm 2 days following vaccination. Purple bruise with yellow border was seen on patient's upper arm when in office.
Daily nausea for about 30 minutes for about 11 days. No treatment sought. Fatigue requiring 1-1 1/2  hour nap for 7 - 8 days following shot. No treatment sought No fever present
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 168 doses were given from LOT 048B21A. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
After shot he left and went home then wife brought back immediately. Patient's tongue swollen and trouble breathing. Also had shakes. I administered an epipen 0.3mg and called 911. EMS took him to hospital where he spent 24 hours.  10/30/2009 hospital records for 9/18/2009.Dx possible allergic reaction to vaccine  patient with  c/o's rash, itiching, hives, throat swelling, chest tightness, and SOB. Tx: IV Solu Medrol, Benadryl and Pepcid.
Right MCA ischemic stroke with full left hemiparesis,  mostly resolved with tPa. Idiopathic. Negative work up for coronary artery or carotid artery or intracerebral artery disease, arrhythmias, anatomic cardiac disease.
No adverse reaction was noted at the time of the administration. No adverse reaction has been reported since the time of the administration. Patient was ordered VAQTA 0.5ml dosage. Patient was administered VAQTA 1ml dosage. No other treatment for administering the 1ml dosage was provided.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment medication was provided to the patient.
Pressure on the chest/Throbbing pressure on the chest; Raised blood pressure in the middle of the night; Heart racing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night), PALPITATIONS (Heart racing) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-1900, the patient experienced HEADACHE (Headache). On 02-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night) and PALPITATIONS (Heart racing). At the time of the report, CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night), PALPITATIONS (Heart racing) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Patient reports that 1 day after vaccination she developed a large rash on the same arm as the injection that extended from the injection site (left deltoid) down to almost the patient's elbow, about 3 inches wide
pt recv vax; lt shoulder swelled at inject site; sore; could not lift arm; arm sore from elbow; red on inner aspect of arm; warm to touch; applied ice as instructed by ER; recv IV w/ atb;
Seasonal FLUMIST given instead of H1N1 mist. (dispensed by pharmacy, packaging very similar).
Swelling (in form of a ball) in the neck area after the first dose. Inflammation in the neck area, started in the feet, hands, head, inflammation in hands and other parts of the body, hives (allergic type) larger than one inch and pain in the swollen areas after second dose.
pt recv vax 15APR96 & 17APR96 pt exp induration about the size of a golf ball, redness, warmth & tenderness all @ the inj site;
Patient developed nasal congestion, cough and fatigue 1 month after receiving COVID vaccine. Patient subsequently tested positive
5/6 Patient was admitted with abdominal discomfort, distention, shortness of breath. He underwent paracentesis, with improvement in his symptoms. He was found to be positive for covid. He was deemed a good candidate for paxlovid and discharged to home to complete course
Myalgia, Arthralgia, chills, goosebumps, temp 98.6, took tylenol 1000mg Narrative:
IMMUNIZATION GIVEN AT 6PM ON 3/29, PT WAS WARNED OF POSSIBLE RASH. PT NOTICED RASH ON 3/30/16 AND STATES THAT IT PROGRESSED THROUGHOUT THE DAY. NEW RX CALLED IN FOR ACYCLOVIR ON 4/4/16 AND PICKED UP IN THE EVENING OF 4/4/16.
Narrative:  COVID INFECTION FOLLOWING COMPLETION OF COVID VACCINE SERIES 01/25 COVID vaccine dose #1 02/16 COVID vaccine dose #2 05/15 COVID POSITIVE (tested as part of pre-op for colonoscopy), asymptomatic
This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.