chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no pertinent medical history reported and no known drug allergies who on November 2008, August 2009 and 11-DEC-2009 was vaccinated intramuscularly with the first 0.5 mL, second 0.5 mL and third 0.5 mL dose of GARDASIL (LOT# first dose 659180/1758U, second dose 659964/1978U and third dose 663453/0249Y), respectively. There was no concomitant medication. The patient was found to be pregnant since the pregnancy urine test was positive. No adverse effect was reported. The date of the last menstrual period was in October 2009, the estimated date of delivery is in July 2010. Follow-up information was received which reported that the female with no previous pregnancies or births and was pregnant, and the estimated conception date was possibly 09-NOV-2009. The date of the last menstrual period was in October 2009, the estimated date of delivery is 08-AUG-2010. The Maternal serum-alpha-fetoprotein (MSAFP) and amniocentesis was performed by obstetrician/Gynecologist (OB/GYN) and no results were reported. Follow-up information was received which provided specified dates of the first dose and second dose. It was noted the first dose of GARDASIL was received on 14-NOV-2008 and the second dose on 12-AUG-2009. Follow-up information was received which reported that the female during entire pregnancy time period was taking prenatal vitamins, daily for prenatal care and SLOW FE, daily for anemia. During pregnancy/delivering, the patient had complication of low amniotic fluid and fetal distress (had captured in NWAES # 1001USA03408B1). Obstetric labs, ultrasound and fetal stress test were performed and outcomes were unknown. On 20-JUL-2010, at LMP of 38 weeks the patient through C-section delivered a normal male infant, weight "5 pounds 1.6 ounce" and length 19.5 inches. Upon internal review, C-section was considered to be an other important medical event. The infant's experience had captured in NWAES # 1001USA03408B1. Additional information has been requested.
In a little more than 24 hrs after the injection I began to have mild Migraine, and strange feeling as if I am coming down with a cold which subsided after taking Motrin.     Then later in the evening my right leg  from knee to my foot began to feel numb with a desensitization feeling. I took a hot shower, massaged the leg, the feeling did not go away. I have began stretching moving about more, getting up and down walking. The feeling and desensitization only began after the injection, only in this one leg, and has not ceased. It was  intermittent, as  it was coming and going, it was happening in the evening, now it is happening all during the day, even as I type this note, I am experiencing this weird feeling, I am not sure what to call it, it's not total numbness, some kind of desensitization  feeling.  It's very weird and scares me. I am not sure if I should even get the second dose.  feel like a guinea pig with this vaccine.
Hives.  Advised by NP to take Benadryl and seek care at ER in 30 minutes if hives don't subside or if breathing becomes affected.
pt was admitted to hosp on 27OCT92 for pneumonia began to devel resp problems & was transferred to another hosp on 27OCT92; dx Haemophilus Influenza meningitis & died 27OCT92;
Left arm is very sore; Nauseous; Coughing; Back pain intensified; Felt bad all day; Fever; Muscles hurt; Joints hurt; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore) and FEELING ABNORMAL (Felt bad all day) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain (She usually has back pain).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy). On 09-Mar-2021, the patient experienced COUGH (Coughing), BACK PAIN (Back pain intensified), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm is very sore) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt), ARTHRALGIA (Joints hurt) and NAUSEA (Nauseous) 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.   Concomitant product use was not provided by the reporter.
pt recvd vax pt has high fever, shaking, bleeding from mouth & nose; rhinitis; OM;
Information has been received from a physician concerning a 7 yr old male who on 19Jul00 was vaccinated in the left arm with a dose of varicella virus vaccine live (lot 635981/0447K). On 03Oct04 the pt complained of soreness in his left arm. He had difficulty lifting his arm due to this soreness. On 05Oct04, he developed a rash on his left arm with a dermatomal distribution C 7-8. The rash had an erythematous base and clustered lesions. He was diagnosed with Herpes Zoster. Interventions included acyclovir (Zovirax) oral suspension. It was reported that the pt was recovering and will be seen again in two weeks. There was no product quality complaint involved. The pt's herpes zoster was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Approx 16 hrs p/vax given (dose #1), employee developed pain in all joints lasting 48 hrs; pain subsided p/this time;
8 hours after injection: Stiffness in arm and sore at injection site - duration 48 hours  24 hours after injection:  Slight fever - duration 8 hours Headache - duration 2 days 36 hours after injection: Rash on face - duration 3 days
Had COVID-19 in October 2020 and still have fatigue, always sleep, body hurts really bad brain fog, cannot remember. After the 1st dose, vomit, stomachache tired very sleep, stayed two and a half days in bed, no appetite and headache. In March saw doctor to check for fatigue. Flare ups of Fibromyalgia in March and August 2021 could walk and had shot in my neck and could not move my arms. February 12, 2021 was 2nd dose.
This spontaneous report was received from a pharmacist referring to unknown multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients received improperly stored doses of VARIVAX lot # M023382 with expiration date on 11-MAY-2018 and lot # M025864 with expiration date on 24-MAY-2018, (dose and route were not provided) for prophylaxis. It was reported that the vaccines were reconstituted with sterile diluent (MRK INJ) which was not involved in a temperature excursion. On an unspecified day, the data logger registered that during 14 hours, 30 minutes the temperature under the vaccine was stored, was -14° Celsius (°C) to -10°C (-10, 6°C), there was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1706USA009407.
Fever up to 101, both legs swollen, tight painful when touched, slight redness, pt. very fussy.
Patient stated he had chills, headache, felt fatigued but could not sleep the night of vaccination. He felt feverish, nauseous, and fatigued the day after vaccination.
This spontaneous report was received from a medical assistant refers to multiple unspecified patient of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # K010215, expiry date: 05-MAY-2017). Lot # K010215 was confirmed as an invalid lot number for the product. Medical assistant reported that the vaccine underwent temperature excursion at 47 degree Fahrenheit for 16 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Itching all over the body started about 2 hours after receiving the vaccine ( around 11:30am). At noon, I noticed I was dizzy and weak, and I couldn't stand up without holding onto something. The itching got worse as the day went on and became intense and painful around 3pm. At that time, I noticed a rash on both arms, my legs and my chest, so I took 25mg of hydroxyzine (prescribed by my doctor) which has been helpful in the past for itching and rashes. Around 7pm, I had hives on my arms and legs, and the itching was getting worse and more painful. I also had intense itching on my face, especially on/around my nose. I took another 25mg of hydroxyzine but the itching wasn't subsiding and at that point, it was so bad that I couldn't focus on anything else. At 9pm, I still had hives and itching but also noticed that I was having a hard time breathing and it felt as though my throat was closing up. This continued throughout the night, with it being at its worst between 1-3am on March 12th. I woke up and the rash was gone, but the itchiness is still present and I'm having trouble breathing. I keep choking and gasping for air.
This case was reported in a literature article and described the occurrence of anaphylaxis in an infant female subject who was vaccinated with DTAP vaccine (manufacturer unspecified0, poliomyelitis vaccine inactivated (non-GSK) and MMR vaccine (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of DTAP vaccine (unknown route, unknown lot number), unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown route, unknown lot number), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown lot number). Within minutes of vaccination with DTAP vaccine, MMR vaccine (Non-GSK) and Poliomyelitis vaccine inactivated (Non-GSK), the subject experienced anaphylaxis, decreased consciousness, hive, abdominal pain and hypotension. This case was assessed as medically serious by GSK. The subject was treated with EPINEPHRINE and diphenhydramine. At the time of reporting the events were resolved. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Patient had multiple symptoms on concern: Neuropathy, dizziness,  lymhadenopathy, tinnitus, throat tightness
No additional adverse events; Medical assistant calling for TE evaluation on VARIVAX that has been administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 21-JUL-2022, the patient was vaccinated with 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032315, expiration date: 22-SEP-2022, for prophylaxis (strength and route of administration were not provided), after a 40 minute temperature excursion between -14 and -10 Celsius degrees (-14.04 C) (product storage error). There was no previous temperature excursion and no additional adverse event reported.  This is one of several cases received from the same source.; Sender's Comments:  US-009507513-2208USA006426:
Janssen Covid vaccine was received on 3/15.  On April 14th, the female teenager began experiencing symptoms that felt like a severe cold.  Out of an abundance of caution she scheduled a Covid test on April 16th.  Despite wearing a mask and social distancing where possible, she was exposed for a very short period of time to another student who tested positive.  The female teenager received a positive test result on April 19th and continues to experience symptoms that have gotten more severe in  nature.
increased seizure activity; I  had the normal yet severe side effects of sore arm & neck; I  had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
mom stated pt started coughing approx 15 mins p/vax; cough sounded "croupy"; mom thought pt looked swollen across bridge of nose & in throat area so pt taken to MD-given DPH;
HE RECEIVED HIS FIRST DOSE (MODERNA) 2/9/2021. HE WAS LATE IN GETTING HIS 2ND DOSE SO HE CALLED THE CALL CENTER AND ASKED ABOUT IT. THEY INCORRECTLY SAID HE NEEDS TO RESTART THE SERIES. oN 4/2/21 HE GOT HIS 2ND DOSE, BUT IT WAS PFIZER. THE CALL CENTER REMINDED HIM ABOUT HIS 4/23 APPOINTMENT. HE CAME IN FOR ANOTHER DOSE WHICH AT THAT TIME IT WAS EXPLAINED TO HIM EVENTHOUGH IT WAS 2 DIFFERENT MANUFACTUERES, THE SERIES IS COMPLETE.
at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26
Entire body began itching for hours; large red welts appeared on right foot and wrist area of both hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Allergies" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 29Oct2022 at 01:30, outcome "recovering", described as "Entire body began itching for hours"; URTICARIA (non-serious) with onset 29Oct2022 at 01:30, outcome "recovering", described as "large red welts appeared on right foot and wrist area of both hands". Therapeutic measures were not taken as a result of pruritus, urticaria. Additional information: Clinical course: Entire body began itching for hours, large red welts appeared on right foot and wrist area of both hands. Itching continued for 36 hours. The patient was not tested for covid post vaccination. Stated that she was healthy.
This spontaneous report as received from a nurse refers to a 20 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Nausea; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site tenderness) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site tenderness). On 12-Jan-2021, the patient experienced NAUSEA (Nausea). On 08-Jan-2021, VACCINATION SITE PAIN (Injection site tenderness) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; 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.
-Fever 100.4 ( continuous for 5hours -2 days after vaccine was administered)  -chills -swollen lympnodes  -chest/ lung area tightness (only occurred 5-10 hours after vaccine was administered) -extreme fatigue -night sweats (only occurred 5-10 hours after vaccine was administered)  - Autoimmune symptom flare, while prior to vaccine was considered in clinical remission - sore arm (5hours - 4 days after vaccine)
Redness and swelling of right deltoid started 8/13/07 in PM shot given at 2:30 PM. Covers 3/4 of upper arm.  Denies fever and not painful to touch.  Warm to touch.  Treatment: cool compresses and IBU. RTC if get worse.
This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, Oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional information has been requested.
RIGHT ARM WITH REDDNESS, SWELLING, WARM TO TOUCH.  CHILLS AND DIFFICULTY BREATHING
Right away he was pale, legs were totally white, then started vomiting & diarrhea 30 minutes later. Then started hysterical & violent screaming for 4 hrs. Then slept for 12 hrs without waking. Swollen legs & red. Was given TYLENOL & BENADRYL.
Onset complete transverse myelitis 3/4/22.  Treated with IV steroids, plasma exchange, IVIG with significant but incomplete recovery to date.
6 days after vaccination I noticed tenderness in lymph nodes in both breasts and down sides of under arms.