chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An hour after the vaccine I was a little bit dizzy but it went away pretty quickly. A week later I went to the emergency room with racing heart palpitations was told I did not have myocarditis. I did not have a positive PCR test but I did have a nucleocapsid test and it was positive for COVID, I have insomnia, trouble breathing, heart palpitations, chest pains. Currently on medications for those.
diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months; stomach cramps; minor nausea; chills within 24 to 30 hours of vaccine; felt very weak within 24 to 30 hours of vaccine; low grade fever within 24 to 30 hours of vaccine; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea) and CHILLS (chills within 24 to 30 hours of vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LOPERAMIDE for an unknown indication.    Concurrent medical conditions included Irritable bowel syndrome and Arthritis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LOPERAMIDE (unknown route) 2 mg. On 20-Feb-2020, the patient experienced PYREXIA (low grade fever within 24 to 30 hours of vaccine). On 20-Feb-2021, the patient experienced ASTHENIA (felt very weak within 24 to 30 hours of vaccine) and CHILLS (chills within 24 to 30 hours of vaccine). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps) and NAUSEA (minor nausea). At the time of the report, ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea), CHILLS (chills within 24 to 30 hours of vaccine) and PYREXIA (low grade fever within 24 to 30 hours of vaccine) was resolving.        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.   No concomitant medication was reported by the reporter.    This case was linked to MOD-2021-333465 (Patient Link).
pain over right eye; Armpit pain accompanied by injection site soreness; Armpit pain accompanied by injection site soreness; pain in left side armpit lymph node; tired; headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain; headache around back of head accompanied by flashing; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 27Feb2021 08:15 (Batch/Lot number: unknown) at the age of 38 years, as dose 1, single for COVID-19 immunisation. Relevant medical history included: "obese/ overweight" (unspecified if ongoing), notes: BMI: 32; "High cholesterol" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Oral allergy syndrome" (unspecified if ongoing); "severe tree pollen allergy" (unspecified if ongoing); "tree nuts allergy/ wheat sensitive" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; VITAMIN D; BIOTIN. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "pain in left side armpit lymph node"; FATIGUE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "tired"; HEADACHE (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing, slightly electric pains on top back left quadrant of head/ right forehead pain"; PHOTOPSIA (non-serious) with onset 27Feb2021 14:30, outcome "recovering", described as "headache around back of head accompanied by flashing"; EYE PAIN (non-serious) with onset 28Feb2021 08:15, outcome "recovering", described as "pain over right eye"; AXILLARY PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 28Feb2021 08:15, outcome "recovering" and all described as "Armpit pain accompanied by injection site soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, fatigue, headache, photopsia, eye pain, axillary pain, vaccination site pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was also concomitantly taking unspecified multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First night  (2/12 - 2/13):  chills and tremendous thirst, vomiting 2/13 : vomiting subsides throughout the day, body aches, headache 2/13 night: shortness of breath for about 6 hours; p02 = 84.   Breathing better next morning and p02 back to 96; no more vomiting
Information has been received from a health professional concerning a 71 year old female with a history of herpes simplex II, irritable bowel syndrome and gastroesophageal reflux disease who on 09-FEB-2007 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX(Merck) (lot # 656606/0033U. There was no illness at the time of vaccination. On 12-FEB-2007 the patient developed an outbreak of genital herpes. The patient self-treated with acyclovir starting 12-FEB-2007 and then contacted the office by phone on 13-FEB-2007. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  Additional informatio indicated that on 12-FEB-2007 the patient developed a headache and herpez simplex II outbreak. The patient tool VALTREX and subsequentlt recovered.  No further information is expecetd.
swollen lymph nodes in his left arm pit; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration in Arm Left on 01Jun2021 (3 days ago) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient noticed swollen lymph nodes in his left arm pit. He did receive the injection in his left shoulder. He would like to know if that was a normal side effect from the vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
SEEN IN OUR OFFICE FOR 4 YEAR OLD WELL CHILD VISIT.  RECEIVED 4 YEAR OLD BOOSTERS: Dtap, MMR, IPV, AND Varivax ON 6/17/09.  WOKE UP ON 6/19/09 WITH SWOLLEN LEFT UPPER ARM.  DIAGNOSED WITH LEFT UPPER CELLULITIS TREATED WITH AUGMENTIN.
pt recv vax & exp rt shoulder & upper arm numbness, loss of balance & weakness in legs on 11NOV96, 10 days p/vax pt went to MD & dx w/GBS;pt hosp on 11NOV96;
Headache, Diarrhea, Nausea Vomiting,  fatigue  Narrative:
Hospitalization: 8/26/22 ADMITTED; 8/30/22 DISCHARGED. Presentation to the ED: fever, shortness of breath, COPD, cough for the past couple days, 89% ON ROOM AIR. COVID-19 + date: 8/26/22. Treatment: remdesivir; dexamethasone. Discharge to: HOME.
Seizure like activity throughout body. Headache and neausea    given steriods after ER visit on 10/3/20
No adverse event; Patients already received a previous bivalent booster on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In September 2022, the patient experienced EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022).  No concomitant medication was reported. No treatment medication was reported. HCP stated 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022.
Ten hrs after 2nd Hep A, PT's eyes started itching and he developed sclera edema. Stated he was light headed, skin felt "funny", rather cold to touch. He took Benadryl and went to a friend's house to be observed. After he slept he felt fine.
Pt after discussion with treating allergist elected to complete dose 1 of Pfizer COVID-19 vaccination. Per pt report she had premedicated with Benadryl 100mg po prior to immunization and brought along her prescribed epi-pen. After reciept of vaccination, she proceed to recovery area where she was dictated to 30 minutes of observation, approximately 7 minutes after inoculation began having symptoms consistent with upper airway swelling and self-administered epi-pen and called for medical assistance. EMS was then called and upon arrival found her in stable condition and transported the patient to emergency room at Hospital.
3OCT98 9AM pt recv vax & 5PM noticed red, warm area @ site;5OCT98 area had become bruised;pt was febrile & saw MD;rx med;
Feeling of being very cold, unable to get warm. Pronounced shaking. Lasted about an hour. Also unable to sleep until very late into the morning.
Headache, muscle pain, shivering, sweating, tiredness, lethargy. Confined to bed 14 hours, all symptoms did not resolve for 3 days. No fever or other symptoms.
Pt recvd vax 420PM & by 730PM exp rash around inject site & across shoulders, t101;930PM rash spread over most of body t103; Taken to ER & observed;
15 y/o pregnant female at OB Intake given Moderna Booster dose. Previous covid vaccines had been Pfizer Purple Cap.  Pt is approx 8.6 weeks pregnant with history of nausea and vomiting.
Left arm developed swelling and had pus drainage on 2/23 and 2/24, No fever. She was happy and normal at office visit on 2/25/12 she was placed on antibiotic and had I & D done at site. She returned on 2/27/13. No drainage or fever noted.
Fever of 102, 2 hours later infant threw up, fever has been ranging from 99-104 with fever reducers.
RN rpt pt recv 1dose varivax 5/8/98 &  3rd dose of recombivax HB & 5/16/98 area was ``sore @  site'' pt exp local site react on lt leg which was ``size of a lemon'', also feverish, raised, red, swollen & sore to touch. pt treated w/ATB
presented to ED with tight closing of the throat and trouble breathing within minutes of the second dose.  She was given epinephrine and Benadryl at the site of vaccination.  Symptoms resolved, only lingering symptom was heart racing. Had throat swelling after initial dose that required benadryl to resolve.
Moderna 4/14/21, 5/12/21, 12/8/21. Positive on 2/1/22
Mother phoned 01/13/04 had 3 day history of rash, 20 lesions some blistered, some red, 1 scab.  Afebrile, developed rash 01/10/04.
Initial misuse report received from a healthcare professional on 02 May 2013. It was reported that a diluent was found left over in the box so a child may have received ACTHIB reconstituted with sterile water instead of ACTHIB Diluent. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
29Aug96 pt recv 1 dose vax. 19Jan98 pt devel 8 varicella-like lesions & low grade fever 100.8 Visited MD. 3 other pts reported adverse exp following vax. (WAES98020281,98021661,98021662
Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who was vaccinated with 0.5 ml second dose of expired vaccine MENACTRA (lot U5836BA and Exp. Date 18-Mar-2019) via intramuscular route in the right arm on 22-Mar-2019. The patient's medical history was not reported and concomitant medications included Hepatitis A Vaccine for Immunisation. It was an actual medication error case due to expired vaccine used. No specific symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient had rash and hives due to the vaccine being administered on her extremities and trunk. Currently experiences sometimes an irritating cough.
Joint pain and weakness, muscle pain 8/6/21 presented to emergency department with right sided weakness, confusion and slurred speech Received TpA for CVA
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea was not reported. This report was non-serious.
LARGE HEMATOME SEVEN INCHES IN DIAMETER, MILDLY BRUISED, NO LYMPHADENOPATHY, NO CONSTITUTIONAL SYMPTOMS AT THE ANTHRAX IJECTION SITE INTO THE RIGHT ARM.
Telephone call on 1/31/02 at 09:25, the pt complained of swollen eyes; eyelids shut today and yesterday AM on awakening. Does not have a thermometer but states that her boyfriend told her that she has felt warm on the last 2 nights. She complained of increased fatigue on Tuesday AM. She got menses that night. She was very tired and stayed out of work on 1/30/02. She states that she has taken Benadryl due to what she things is a possible allergic reaction. The pt was instructed to call her MD and to see if MD feels it is necessary for the pt to be seen. On 2/1/02, telephone call to home of pt and left message for pt to call. On 2/4/02, telephone call to pt at work and pt states that her MD thought that there was a reaction to one of the vaccines she had received on 1/28/02. The pt was started on Allegra that day. She states that she did experience a scratchy throat and itching of her nose and also complained of a rash on her chest. The pt states that all her symptoms had greatly subsided by 2/1/02. The pt is well at this time.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 6th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50
Information has been received from a health professional concerning a 25 year old female patient with a history of genital wart and cervical dysplasia and no known allergies who on 07-JAN-2010 was vaccinated IM with the third dose of GARDASIL (lot number 663452/0671Y, expiration 18-SEP-2011). Concomitant therapy included vitamins (unspecified) and ALDARA cream. A note on the patient's chart form from 11-JAN-2010 stated that she had been feeling lightheaded for 2 days (since 09-JAN-2010). The patient then continued to feel lightheaded, felt like she would "black out" and experienced palpitations. The patient saw her primary care physician and a Halter monitor was normal. The patient would see a cardiologist. The patient was seen in office on 06-MAY-2010 and stated that she had the same reactions after the first dose but no reaction after the second dose. The first two dosed were given at another location, dates of administration and lot numbers not available. The patient stated she was starting to feel better. Additional information has been requested.
Myalgia, Fever, SORENESS AT INJECTION SITE/CHILLS Narrative:
Worsening stuffy nose; Tiredness; Experienced coughing/Dry cough; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration to her right arm on 03Jun2021 15:00 (Batch/Lot number: EW0181, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. Age at vaccination was 12-year-old. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 via an unspecified route of administration to her right arm on 23May2021 (at the age of 12-years) (Batch/Lot number: EW0182) as single dose for Covid-19 immunization and no reaction was reported on previous exposure to vaccine. Mother called on behalf of her daughter who took the second dose of the Pfizer COVID 19 vaccine last 13Jun2021 and experienced coughing on the same day when she took the vaccine. Tiredness on the next day but it already went away. Worsening stuffy nose and cough was persisting. Asking if these were normal side effects of the vaccine or her daughter needs to see a doctor. Potential duplicate AE Report E transmit. No zip code provided. First dose was given last 30May2021. Patient would turn 13-year. Stuffy nose and persisting cough were not listed as side effects of the vaccine. Side effect dry cough on 13Jun2021, tiredness on 14Jun2021 and stuffy nose on 15Jun2021. Stuffy nose was reported as worsened. Her daughter had her second dose on Sunday. Her daughter was almost 13-year-old. After the vaccine she started coughing. The next day she was tired. Now she was coughing with a stuffy nose. She stated that her daughter had no fever. Referred to HCP. Caller stated it was a dry cough that started the evening of the vaccine. States it was persisting. Regarding stuffy nose, caller stated it started yesterday and was worse today. Tired, states it was only an issue for the patient the day after the vaccine. Reporter seriousness for events was unspecified. Caller denied any medications, medical conditions, labs, testing or treatments for the patient relevant to the events. Outcome of the event tired was recovered on 14Jun2021, whereas other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt had a generalized convulsion while at work.  Movement was noted in all 4 extremities.  Pt initially unresponsive to first responders, then agitated once awake.
Pain in arm at point of injection starting that night, with pins and needles down arm into fingers. And still persist daily two months after the hepatitis b vaccine.
no adverse event; patient received improperly stored vaccine; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # U022983 exp date 22-JUL-2023) (dose and route not reported). The temperature of excursion was 49.3°F for a time frame of 3 hour 11 minutes. There was no previous temperature excursion.