chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No problem until several hours, into the night after vaccines given. Pt. woke up vomiting, lasting almost 3 hrs. until dry heaves. Better the next day. No fever but loose stools all family members had eaten same foods previous vaccines only difference. Spoke to mom at 48 hrs. child doing better. Taking fluids.
I received the MMR vaccine on 4-20-09.  I am exclusively breastfeeding a 14 week old infant.    On 4-29-09 she developed a fever of unknown origin. She became lethargic, restless, diaphoretic, and irritable. On 5-1-09 she was hospitalized. CBC, UC, blood cultures were all normal.  An LP was attempted, but unsuccessful. On 5-2-09 she developed a rash.  She was discharged on 5-3-09 without a diagnosis.  I am concerned she developed this illness via my breastmilk after I was vaccinated. 5/26/09 Received hospital medical records for 5/1-5/3/2009. FINAL DX: fever (rule out sepsis), irritability. Records reveal patient experienced fever, irritability, poor feeding, increased drowsiness, increased stools x 3 days.  LP attempted but unsuccessful.  Tx w/IV antibiotics until c/s neg then d/c antibiotics.  Markedly improved w/good feeding. D/C to home w/PCP f/u. 8/17/09 Received ICD9 codes: 0389, septicemia; 3229, meningitis NOS; 78791, diarrhea; 99591, SIRS, d/t infectious process w/o acute organ dysfunction.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Systemic: Nausea-Mild, Additional Details: Pt got Shingrix (2nd dose) in L deltoid 5/14/2022 at 1 pm. Pt was somewhat tense awaiting shot, was coached on relaxing her arm as much as possible. As soon as needle touched skin, she yelped and slightly jumped. Pt commented it was very painful, but left in pleasant mood. Pt called pharmacy ~3:45 pm complaining of severe arm pain. Confirmed it was local to injection site, no shoulder joint pain, no anaphylaxis. Pt told to monitor, ice, take ibuprofen. If pain spreads or worsens, call doctor.
We received the following literature report on 15 JUN 2009: 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710, MA2009-1712 to MA2009-1716 and MA2009-1718 to MA2009-1722). Laboratory-confirmed influenza illness was reported (date?). Request was sent on 22 JUN 2009, no follow-up information received.
Headache; muscle ache; sore arm; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-May-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 25-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache) and HEADACHE (Headache) outcome was unknown.            No Concomitants included. No Treatment mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received; Reporter's Comments: N/A; Sender's Comments: N/A
This spontaneous report as received from a nurse refers to a greater than 60 years patient. The patient's medical history included unknown chicken pox. On an unknown date the patient was vaccinated with one dose of VARIVAX (merck) (lot# unknown, route and dose unknown) instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unknown if the patient had sought medical attention. No PQC involved. The action taken and outcome unknown. Additional information has been requested.
Patient developed rash over upper torso anterior/posteriorly and bilateral arms/neck. Pt went to Immediate Care for follow up. No change 48 hours post vaccination.
Skin became very itchy with small raised bumps, lasted for 5 hours and then subsided, Mild Fatigue.
Random swelling of lip and throat with a rash. Has been on going since 2 weeks after receiving 2nd covid vaccine.
The evening post vax, the pt developed a headache, fatigue, chills, and arthralgia.
Approximately 12 hours after shot -had extreme muscle aches, full body nervous system sensitivity, could not walk or hardly move. Legs and back were particularly painful. Spent most of day crying/screaming in pain. Pain significantly subsided after 24 hrs followed by a 12 hour period of profuse sweating while nausea and dissiness lasted for a full 48 hr period.
15 days from date of receiving Varivax, developed itchy bumps and canker sore in mouth. Scattered 0.5-1cm macules with central pustule, vesicle or papule on upper back, chest dorsum L hand, temple and scalp. 3.5 cm x 7cm mild erythema mild induration at injection site.
Pt says she had fever of 101.1 F, headache, body aches. Says she "was flat on back" for 2 days
No additional AE; Healthcare business professional states that a 6-year-old male was administered GARDASIL 9 today, 11/18/2022.; This spontaneous report has been received received from a Healthcare business professional and refers to a 6-year-old male patient.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 18-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 millimeters (ml) administered for prophylaxis (lot #1775808 confirmed to be valid, expiration date reported and stablished as 20-AUG-2023; strength, and route of administration were not provided) (product administered to patient of inappropriate age ). No additional adverse event (AE) was reported.
Swollen left upper arm headache, neck ache. Left upper arm with 6X8cm area of erythema of skin, mild induration.  No focal central firmness or fluctuance.
Feeling lousy; Increased shortness of breath; Feeling nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy), DYSPNOEA (Increased shortness of breath) and NAUSEA (Feeling nausea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL and RIVAROXABAN (XARELTO) for an unknown indication.   On 01-Oct-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) 18 microgram four times per day. On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling lousy) and DYSPNOEA (Increased shortness of breath). an unknown date, the patient experienced NAUSEA (Feeling nausea). At the time of the report, FEELING ABNORMAL (Feeling lousy), DYSPNOEA (Increased shortness of breath) and NAUSEA (Feeling nausea) outcome was unknown.            no treatment medications were reported.
shingles; approximately 47-year-old pt administered zoster vaccine live (ZOSTAVAX); Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 47 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. In or about December 2012, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician at a family medical facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider at a family medical group for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was not provided. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
After leaving Clinic symptoms started within 10 minutes. Started with scratchy throat. Then tingling in my lips. Bottom lip slightly swollen.
Patient had flushing/sweating, dizziness, anxious, sweating. Low BP 84/46 -- > 116/75 -- > 121/82. Patient stated did not eat since 4/24/21 6PM. Patient stable, released from vaccination site.
Pain on R torso Narrative:  Patient experienced pain in his R torso 2 days after receiving the vaccine. He reported passing loose stools, and the pain has resolved afterwards. Patient reported diarrhea was not watery and was not bloody or tarry in color.
Information has been received concerning a pt who on 06/01/00 was vaccinated with the first dose of varicella. On 06/11/00, the pt developed several pustulant red bumps on his torso and face. On 06/15/00 the pt recovered from his experience.
Mother called this AM 0910, son told her he noticed "itchy pimples" last night. Per mom 6-8 pimple like bumps on back of leg, groin, and stomach. No fever.
Client reports red, raised and itchy area in arm where she was vaccinated with first dose Moderna COVID vaccine, onset next day and lasting one week total.  Client reports she placed warm compresses to relieve symptoms.  Client reports no reaction with second dose Moderna COVID vaccine on 4/21/21.
Got home from work in the early afternoon, after a bit of time realized that it was not, in fact, that hot that day. Waited until another member of the household could go out and buy batteries for the thermometer, took a temp at about 7 PM which read 102 F. Fever broke the next day.
Red, hot area on left inner thigh, about 2 inches from injection site. Spread significantly by day 2. Saw Dr both days.
first dose in left leg; chronic urticaria; began waking up feeling itchy like I had been bitten by bed bugs or mosquitos; would be covered from head to toe in hives and wheals at all times of the day and night; This is a spontaneous report from a contactable consumer. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP753A, Expiry date was not reported), via an unspecified route of administration Left leg on 15Mar2021 11:15, as 1st dose, single dose and the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533, expiry date was not reported), via an unspecified route Left Arm on 05Apr2021 11:15, as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included anxiety and depression from an unspecified date and unknown if ongoing. Concomitant medication reported was finasteride, 1 mg, 1x/week for unspecified indication. Patient did not have any know allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reporting adverse side effects of chronic urticaria following my first and second COVID-19 vaccination on 15Mar2021 and 05Apr2021. Following first and second COVID-19 vaccination, the patient experienced adverse side effects of chronic urticaria on 24Mar2021. The following week after first vaccine, on 24Mar2021, he began waking up feeling itchy like he had been bitten by bed bugs or mosquitos. Over the next two months, his condition only worsened where she would be covered from head to toe in hives and wheals at all times of the day and night. He visited with a dermatologist and an allergist and was prescribed numerous antihistamines and corticosteroids such as prednisone to try to control his chronic hives. After consultation with his allergist, he was prescribed Xolair/omalizumab as a last resort to controlling his chronic urticaria. Prior to his covid vaccination he had never experienced anything like chronic urticaria and his condition has only worsened since his second vaccination. Patient was treated with Antihistamines, prednisone, Xolair. The outcome of event was not recovered.   Follow-up attempts are possible. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021709306 similar report from same reporter
1st dose was taken on 10/16/2010.  Went to a party that evening, had a glass of wine, then noticed that a rash developed on my arm about 30 minutes after.  More hives devlop the next day. 2nd dose taken on 10/18/2010. Swelling of arm and hives seemed to be getting better during the week.  No alcohol until 10/22/2010.  On 10/23/2010, arms became painfully swollen, itchy with more hives developing and on other parts of my body. Fever was also present that night.  Visited doctor on 10/25/2010 - she prescribed prednisone, cephalexin and Atarax if needed.
itching and skin blisters on right leg, next day sores in the mouth and blister on lip, abdominal pain in upper right quadrant
Urticaria 24 hours post administration of Prevnar. Began Benadryl 1/2 teaspoon every four ours as needed.
Pt experienced severe nausea.  She went to the emergency room at 8am on 10/5/22.  She was treated and relesed.
Chills;  vitals, rest, monitor x 30 min, po hydration  with improvement / symptoms subside/ stable released home
2 days after dose had fever and myalgias.  2 days after 2nd dose she woke with vertigo symptoms, with confusion and disorientation that is increasing each day.  She report slight right sided difficulty, but not frank weakness or true neuro changes.
Pt recv vax on 10/14/98; 20 min later pt exp swelling of LA.
died three minutes after she got the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, (friend of patient's child), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died three minutes after she got the Pfizer Covid 19 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died three minutes after she got the Pfizer Covid 19 vaccine
Headache, fatigue, chills, fever, swollen lymph nodes, sore throat.
Patient is a 49 y/o female that presents to the ED to covid symptoms. She reports that she tested positive two days prior at her PCP office for COVID. She states that over the last several days she has had worsening symptoms and severe SOB. She reports that she she has also had extreme fatigue, nausea, diarrhea, fevers, chills, and dizziness. She reports that she is vaccinated but has not received the booster. She has a history of hypertension. She denies any other complaints including CP, Syncope, numbness, tingling, or recent trauma
C/O HAVING HEADACHE AND RASH SPORADIC ITCHING RASH ALL OVER BODY, LOW GRADE TEMPERATURE. PATIENT ALSO HAD A COUPLE EPISODES OF EMESIS PER MOM.
This spontaneous report has been received from a 64 year old female consumer, who was reporting on herself. The patient's concurrent conditions included headaches and AUGMENTIN allergy, which manifested as hives. There was no concomitant medication. On 16-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported). On the next day (17-JUL-2015) the patient experienced erythema. Each day the redness "was becoming larger" but the patient was not experiencing any pain. No treatment was given an no lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of erythema was not recovered. The relatedness between the event and (Oka/Merck) ZOSTAVAX was not reported.  Additional information has been requested.
This spontaneous report was received from a physician assistant via a company representative referring to a 2 months old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with ROTATEQ (Lot# and Expiration date not reported) 1 dose orally. The patient had also been administered a dose of PREVNAR 13, PENTACEL and an unspecified hepatitis B vaccine (manufacturer unknown) (dose, lot#, expiration date and route not reported) at the same visit. The physician assistant reported that on an unknown date the patient presented with a full body rash including the face within 8 hours of receipt of the ROTATEQ. The adverse event was treated with BENADRYL, and the rash resolved within 24 hours. Reporter's causality was not provided. Additional information has been requested.
Patient was administered Moderna's bivalent booster on 9/14/2023. The FDA pulled the authorization for this vaccine on 9/11/2023
01/21/22 Covid symptoms started. I was having pain everywhere, flu-like pain. I started getting a bad headache and then just within 4 hours I was running fever in bed of 101.2-102 for a couple of days, and then it was a low grade fever for a couple of days. Upper respiratory started and I was all stopped up in the head and coughing and had chest tightness. Then, I started hurting in my back area like I had pneumonia, and I am prone to pneumonia and know what to expect. It went on that way for 7-8 days but it took a week after the positive Covid test that I felt better, but it was a couple of months before the symptoms were totally gone. I tested positive on 01/28/22 at the pharmacy Drive -thru.
stomach pain; cold sweat; fever; This is a spontaneous report from a contactable consumer. A 71-year- old male consumer (patient) received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9809) via unspecified route of administration on 24Feb2021 04:45 PM as single dose in right arm for COVID-19 immunization. No medical history reported. Concomitant medications reported was lisinopril (ZESTRIL), simvastatin and acetylsalicylic acid (BABY ASPIRIN). Patient has not received any other vaccine in four weeks. No covid prior vaccination and post vaccination was reported. No known allergies were reported. Patient previously took BNT162B2 first dose on 03Feb2021 on 04:45 PM in right arm. After 2nd dose, 8 days later, developed stomach pain and cold sweat that lasted the night. The next morning had fever of 102. Next day 101.8. To say 101.2 and now 99.6. No treatment was received as response to the event. Outcome of the event was fever recovering and for other events its not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 7 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. No product quality complaint was involved. This is the one of several reports from the same source. Additional information is expected.
RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/19/21. WENT TO ER ON 02/25/21 COMPLAINING OF PALPITATIONS X3 DAYS. DIAGNOSED WITH PALPITATIONS AND HYPOMAGNESEMIA. DISCHARGED AND INSTRUCTED TO FOLLOW UP WITH PCP.
05/24 cough and stepped throat  05/25 severe cough and dry flems 05/26 severe cough, dry flems, 104 fever. COVID QUICK TEST NEGATIVE 05/27 mild cough mild head ache no fever 05/28 mild cough, no fever. PCR TEST POSITIVE FOR COVID-19
Patient received vaccine at 1249 then proceeded to develop urticaria and welts to LE. By the following morning the rash involved the trunk, legs, neck, and face.
muscle pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain in legs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In July 2021, the patient experienced MYALGIA (muscle pain in legs). In July 2021, MYALGIA (muscle pain in legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken with co-suspect UPADACITINIB (RINVOQ) was reported as drug withdrwan with respect to the event. Patient could not determine if it was from the vaccine or the Rinvoq. Patient stopped taking Rinvoq in Jul 2021 for about a month. She started back the Rinvoq on 31 Aug 2021 and would see if it came back or not. Primary reporter contact for lot number information was not available for the first regimen of Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event(s) of muscle pain in legs with RINVOQ(UPADACITINIB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Live follow-up received additional causality of co-suspect drug was updated to reasonable possibility from not provided and co-suspect drug stop date of second regimen was added.
painful firm, warm raised lump at site a few hours after vaccine.  Pt called on call provider. No SOB ,no hives, no chest pain no wheezing.
Otherwise healthy 13yr female who presented on 8/22/21 with progressive vulvar swelling and ulceration. She states that on 8/20/21, she noticed three or four "red/purple bumps" on her right labia majora. These were painful, and gradually progressed to a "sore" at the base of her right labia, near the introitus. Her vulva continued to swell, and an additional area of ulceration formed on her left labia majora. She reported painful urination, and described that her skin burns when urine touches it. She was febrile on presentation at 100.5 F. Patient denied any form of sexual activity, and ended her most recent menstrual period two days prior to the initiation of her symptoms. Of note, she had her second COVID-19 vaccine on 8/18/21 and had chills and night sweats one night after but attributed this to the vaccine. Found to have Lipshutz ulcer.
Pt developed chicken pox and low grade fever at age 10 years, Had Varivax at age 15 months. Disease uncomplicated.