chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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 05-Feb-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). In February 2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
About 5:30pm on Thursday same day as vaccine started having is tense cramping in abdominal area, similar to a period cramp. Since I have PCOS I felt it was weird but thought maybe it was a muscle reaction to vaccine. Got worse throughout the night but was bearable. Then came what felt like UTI like symptoms which was very bizarre since I had nothing that could have caused that. Decided to wait it out and see if it would go away. By Sunday (3 days later) pain was still uncomfortable but I could manage as I have 3 kids. Around 3:30pm Sunday 4/18 the pain was in my right abdominal and lower back it took. My breath away. Finally decided I needed medical help and learned I was passing a kidney stone which has never happened before. I drink 80-90 floz of water a day, exercise regularly, and eat a very healthy diet of veggies, protein, and minimal carbs. Nothing I was experiencing made sense and all I could be told was, ?Guess your unlucky.?
patient went limp and was poorly responsive to stimulation. breathing was shallow. EMS was activated and patient was admitted to the hospital.  6/15/07 Received hospital medical records which reveal patient admitted for 23 hour observation from 4/2-4/3/07 after becoming fussy,pale & limp on afternoon of vax.  All studies were WNL & D/C to home on apnea monitor FINAL DX: apparent life threatening event.
This case was reported by a pharmacist and described the occurrence of pain all over body in a 74-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline).  No adverse events following previous vaccinations.  On 20 November 2007 at 09:45 the subject received 1st dose of Fluarix (.5 ml, left arm).  In December 2007, approximately 2 weeks after vaccination with Fluarix, the subject experienced pain all over body.  The subject has not required any treatment, but plans to see his physician regarding the all over body pain.  At the time of reporting the event was unresolved.  The pharmacist considered the event was possibly related to vaccination with Fluarix.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Other medication were received in 2 weeks. Antiviral details included Product: COVID 19 Treatment. Brand was Paxlovid. Indication was for Treatment of COVID-19. Vaccine was received and vaccine brand was Pfizer / BioNTech. Vaccine lot unknown reason was not available/provided to reporter at the time of report completion. On day 5 of paxlovid 07Jun, patient tested negative for Covid Started having a severe cold on 14Jun with constant sneezing, severe headache and overall tired, patient tested positive for Covid on 15Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
48 hours post ?, developed limp and itching/erythema. 75% of thigh indurated and warm. On rx for cellulitis.
arm is still very sore 9 days after my shot; arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now). At the time of the report, PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 47 year old female pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix "in 1998, early 1999," and on 6/19/99 "according to the client." This represents an inappropriate schedule of drug administration in that the LYMErix administrations deviate from the recommended 0, 1 and 12 month schedule. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, flu-like symptoms, fatigue, rashes, tingling in her hands, arms, feet and toes, headaches, neck pain, and finger pain." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Site of  vaccine injection started turning red. Itchiness began within twenty minutes of receiving shot. Itchiness was bad enough to put an histamine cream on it. Next morning the arm was swelling and the injection spot swollen more. The redness was worse and the area now hot. I had a slight temperature for a day, The temp went away, chills followed and I was ice cold. Day two after shot the chills left. The spot of injection was getting redder, swelling more and itchy. I am on day three and my arm is swollen, red and itchy.
Information has been received from a physician concerning three patients who on an unspecified date, were vaccinated with a dose of VARIVAX (Merck) (Lot number not reported).  The patients developed an injection site reaction.  There was no product quality complaint.  (Also refer to WAES #0808USA02461).  Follow-up information has been received from a Licensed Practical Nurse, concerning an 10 years old female patient who was vaccinated with a dose of VARIVAX (Merck) (Lot #660402/0271X).  The patient experienced red and swollen upper arm from injection site.  Further information is expected.
Pt recv vax on 2/2/99; 15 min post vax pt exp dizziness & lip tingling
Hives spread across arm, Shortness of breath increased. Some confusion and fatigue occurred around 10PM.  Went to ER and received Benadryl and Prednisone for presumed allergic reaction.
Woke with headache, stomach cramps, nausea, fatigue, sore muscles, and twitching. Took cold shower, advil, and drank water.  Still feeling off but slightly better at 7pm on 5/12/2021.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 04Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 33130BQ) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Cardiac" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "obese" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound to Covid positive antigen and PCR after completing antiviral meds; Positive, notes: Rebound to Covid positive antigen and PCR after completing antiviral meds. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medical history: Diabetic, HTN, Cardiac, High Cholesterol, obese. Product: COVID 19 Treatment, start date: 06Jul2022, stop date: 10Jul2022. Other medication in 2weeks product: Too numerous to list Meds for Diabetes HTN high Cholesterol. Adverse event: Rebound to Covid positive antigen and PCR after completing antiviral meds. Adverse event start date: 14Jul2022, start time: 07:00 PM and outcome recovering. Treatment ae: No and known allergies: Yes.
covid vaccine breakthrough case  dose 1  3/23/21  ER2613 dose 2  4/13/21  EW0150
gotten the flu shot last three years and two of the three patient got the flu; patient was so sick in March and ended up going to the ER; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case involved a patient who gotten the flu shot last three years and two of the three years patient got the flu and patient was so sick in march and ended up going to the emergency room, after receiving INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received three doses of suspect INFLUENZA VACCINE produced by unknown manufacturer from last three years (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient gotten the flu shot last three years and two of the three years patient got the flu (influenza) and the patient was so sick in march and ended up going to the emergency room (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the both reported event.  There would be no information available on batch number for this case.
Area to left thigh injection site is red and hard. Area may have been warm to touch but unable to tell as ice was applied upon reaction.
3 vaccines given (see below). Immediately after, pt experienced throat tightness, shortness of breath, reddening of face, fear. EPIPEN given (per order of MD) for anaphylactic reaction.
Developed fever, congestion, rhinorrhea and cough the next day after vaccines. Wheezing and more labored respiration started 3 days later, and seen in the urgent care and ED the next day ( 4 days after vaccines). the patient was given an albuterol neb, and diagnosed with bronchopneumonia. The patient was treated outpatient with Azithromycin. Mom concerned that episode may be vaccine related and asked for to be reported.
Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth.  Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.
pt recv vax 10JUL97 & inj site became itchy shortly thereafter;6 hr later site was red, swollen & raised in a 10cm circle;pt exp a fever & next 24hr which lasted approx 36hr;hot to touch;area still remained discolored;
threw up blood; lungs hurt; sore arm; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATEMESIS (threw up blood), PULMONARY PAIN (lungs hurt), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 001B2HA) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and HEADACHE (headache). On 24-May-2021, the patient experienced HAEMATEMESIS (threw up blood) and PULMONARY PAIN (lungs hurt). At the time of the report, HAEMATEMESIS (threw up blood), PULMONARY PAIN (lungs hurt), VACCINATION SITE PAIN (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment details were provided. Up to that time the patient had not sought for medical care.   Patient received the first dose of the Moderna Covid-19 vaccine on 20 APR 2021 nd had no side effects. Patient received the second dose on 18 MAY 2021 and had a sore arm and headache and threwup blood and his lungs hurt. Lot number reported for the second dose is 001B2HA. Patient is not on any medications  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.; 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.
The patient was admitted to the hospital by the Vascular surgery service for right groin infection with wound dehiscence, and cellulitis. He will be treated with incision, drainage and antibiotics. He has a positive COVID-19 CR today as an incidental finding.  The patient had COVID-19 in December 2020 ? positive test 12/22/20. He subsequently tested negative and returned to his nursing facility. The patient was vaccinated 1/26/21 and 2/16/21. The patient did not require any COVID-19 treatments. The patient had to stay in the hospital longer than needed because he could not be discharged back to nursing home.
Noticed a few blisters on back about 3-4 days later. No more blisters 4 days later per patient.
Information was received from a licensed practical nurse regarding a patient of unknown age and gender, who on 02-DEC-2014, was vaccinated with a dose of MMR II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
could not breathe; throat began to close; hiccupping; almost vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could not breathe), THROAT TIGHTNESS (throat began to close), HICCUPS (hiccupping) and NAUSEA (almost vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (could not breathe), THROAT TIGHTNESS (throat began to close), HICCUPS (hiccupping) and NAUSEA (almost vomiting). At the time of the report, DYSPNOEA (could not breathe), THROAT TIGHTNESS (throat began to close), HICCUPS (hiccupping) and NAUSEA (almost vomiting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No Treatment for the event was provided.   No relevant Concomitant medications were reported.
That night I went to bed, my left armpit swells up and is sore. I had really bad night sweats. The next day, my armpit was sore for three or four days. It randomly happens that the pain will come back and be swollen and sore and goes away for a few months. The night before I seen my doctor, I was having breast pain and swelling in that armpit.  My doctor did a mammogram and said it was a normal side effect. It's just the left armpit and not the other side.
I had a fever, joint pain in my knees, elbows and wrists. I was also very fatigued and generally didn't feel good.
Sore throat leading to Sinus infection into bronchitis Oral Thrush Shingles
Head cold Like stuffy nose; Runny nose; Sneezing; Head cold Like stuffy nose; Could taste the chemicals from the vaccine in ''my'' mouth; Headache; Tiredness; Arm ache; Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM), for unknown indication on an unknown date and experienced drug allergy. On 15Apr2021 at 15:00, the patient experienced taste the chemicals from the vaccine in her mouth. On the 1st day Thursday (15Apr2021 at 15:00), she got headache, tiredness, arm ache, body aches, chills. The 2nd day Friday (16Apr2021), she woke up with a head cold like stuffy nose, runny nose and sneezing all day along with the 1st day symptoms. On Saturday (17Apr2021), she still had a headache and body ache. On Sunday (18Apr2021), she still had a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events taste chemical, body ache, tiredness, arm ache, chills, head cold like stuffy nose, runny nose and sneezing was recovered with sequelae on an unknown date in Apr2021, while that of headache was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt called the pharmacy at around 8pm on 11/17,  complaining her arm was very swelling and couldn't move her arm. She noticed her arm was very painful and small degree of swell after 3 to 4 hours after received her vaccination from the pharmacy. Pt used ibuprofen and ice pack, the swelling had gone down and pain gradually vanished.
Information has been received from a physician concerning a 16 year old female patient who on 16-DEC-2011, was vaccinated with the first 0.5 ml dose of GARDASIL (Lot number: 671463/1359AA, Expiration date: 23-JUN-2014, route not reported). Concomitant therapy included MENACTRA and an unspecified flu vaccine (manufacturer unknown). It was reported that while on GARDASIL, the patient passed out and hit her head. On 16-DEC-2012, the patient was taken and admitted to the emergency room of an unspecified hospital for an unspecified length of time. On an unspecified date the patient recovered. No further information is available.
Pt recvd vax 29SEP92 & had an inc area of erythema, sl raised, & blanching w/pressure; each day area becomes larger; as of 5OCT 3x6 cm; however, it is not tender; 13OCT reporter described event as maculo-papular rash;
Localized shot reaction to DTaP #5 (2/26).  Seen 2/27 by doctor.
Much delayed second moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a physician concerning a 10 week old male with no pertinent medical history or drug allergies who on 19-FEB-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq (lot# 659771/1599U).  There was no concurrent medication.  On 23-FEB-2008 the patient had to go to the ER for excessive diarrhea.  A stool sample was taken which tested positive for rotavirus.  Therapy with Rotateq was discontinued.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Initial misuse report received from a healthcare professional on 05 August 2013. A patient (No information was provided regarding the patient) was administered an expired dose of MENACTRA. No adverse event was reported. List of documents held by sender: none.