chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client had a syncopal episode 5 minutes after receiving vaccine. Client was sitting in the observation area when she slumped in her chair next to her parent. Nurse went to client. Client awoke immediately. Client allowed to lie on floor with feel elevated on a chair for 5 minutes. BP was 120/72. Client was brought to a sitting position and allowed to sip water and eat a sugary snack. After 5 minutes in this position, BP measurement was again 120/72. Client was assisted into a chair and stayed in the observation area with a volunteer for an additional 30 minutes. Client was awake, alert, oriented and pain free at 12:10 and allowed to leave with parent.
I had most of the side effects listed, but the one that is still bothering me til this day is that my heart feels like its racing, beating fast and sometimes feels likes its pounding, very uncomfortable.
From info received at manufacturer on 11/15/02, it was reported that a 4 y.o. male was administered Daptacel, Fluzone SV '02-'03 USP, IPOL, and MMR on 11/12/02. The child was seen in the ER later that night w/a fever of 104 deg F, and swelling and redness in both legs at the inject sites. He was diagnosed w/cellulitis. It was not reported whether the PT recovered.  Follow up on 12/03/2003: "From correspondence received on 04/14/2003 from the reporter, no further information was provided.  No further information is anticipated, this case is closed."  Follow up on 01/22/04: "No further information was provided. No further information is anticipated, this case is closed."
Pt came in for second Moderna shot and reported localized Right arm reaction after her first Moderna shot. She indicated there had been tenderness, site pain, swelling, and proximal redness; no other s/s were reported per the pt. It was recommended by the provider that the pt wait thirty minutes post second shot in order to be cautious; the shot was given in the Left arm and no reaction was noted during the observation period in clinic. The pt was recommend to seek medical care immediately if she had any concerning s/s after leaving the clinic.
Initial report was received from a health care professional on 19 August 2011. A female patient (date of birth not reported) with no reported past medical history had received a "TDAP vaccine" (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the day of vaccination, experienced a seizure. The patient was taken to the ER (emergency room). No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. On 16-FEB-2015 the patient was inadvertently administered with a dose of ZOSTAVAX (lot# unknown) which expired on 17-JAN-2015, subcutaneously. No adverse effect was reported. Additional information has been requested.
Severe joint pain for 48 hours, chills for 48 hours, Fatigue 48 hrs, stomach spasms - 72 hours, headache on going, Itchy skin  on going.
less dosage of the Moderna Bivalent Vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (less dosage of the Moderna Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced UNDERDOSE (less dosage of the Moderna Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (less dosage of the Moderna Bivalent Vaccine) 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 UNDERDOSE (less dosage of the Moderna Bivalent Vaccine).    No concomitant drug information was provided.  Reporter confirmed that it was not related to any on-going clinical trial. No treatment drug information was provided.
Headache; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ENS318; Expiration Date: 30May2021), via an unspecified route of administration in right arm on 29Jan2021 (at the age of 50 years old) as dose 1, single for covid-19 immunisation. Medical history included she has allergies and asthma, she has had it since when she was 5 years old, COVID-19 virus test positive from Nov2020 to an unknown date. There were no concomitant medications. She stated she received her 1st dose at the end of Jan2021 and has been having difficulty obtaining appointment for 2nd dose and was worried about that. She has not received her second dose yet. Also the patient has been experienced headaches on an unspecified date and patient said she "does not typically get headaches wanting to know if there was any relation with the vaccine. She stated she has been having a slight headache that she doesn't know if that was from the shot, she has it every other day. Therapeutic measures were taken as a result of headache with tylenol, no further details provided about this product. Reporter considered events as non-serious. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
-Local reaction "lump", soreness, redness/rash -Blood pressure 170/90, unusually elevated -Weak, light headed -Blood sugar less than 100 -Chills, couldn't get warm
facial paralysis on right side; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 33-year-old male patient (reporter's son) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on Mar2021, four hours after the vaccine was received, the patient experienced facial paralysis on the right side. The patient went to the hospital and the side effects subsided. The outcome of the event was unknown.   Information about Lot/Batch number is requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for a pregnant female of unknown age. The consumer will continue to be contacted for further monitoring of AEs during the pregnancy.
death; This is a spontaneous report from a contactable consumer. A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 16-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jul2021 at the age of 16-year-old for covid-19 immunization. The patient experienced death on 13Oct2021.  The patient died on 13Oct2021.  The lot number for vaccine (BNT162B2), was not provided and will be requested during follow-up; Reported Cause(s) of Death: death
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had administered diet coke. The patient experienced adverse reaction when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out), (gastrointestinal) complaints, and vomiting. The action taken with covid-19 vaccine was not applicable. The outcome of the vomiting, funny taste in mouth, (gastrointestinal) upset, sick ever since, like a weird gas pain, burping (seventy percent burp out) and (gastrointestinal) complaints was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211630.
Patient within 1 min after flu shut fell to floor and had a seizure. seizure may have lasted 1 min. she awoke after
Very bad stomach pain the next day. Extreme vomiting, diarrhea, sweating. At hospital heart rate was low, no fever, confusion, mental symptoms, memory loss. Symptoms lasted for 8-10 hours. May not be related?
Vaginal bleeding (32yr postmenopausal), Ovarian cyst. (4/9/2021).
No adverse event; My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.) and NO ADVERSE EVENT (No adverse event) in a 0-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, 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 16-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) & said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs.) had resolved 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 WRONG PRODUCT ADMINISTERED (My husband had a Moderna Booster last week Friday (16Dec2022). Then Pharmacy called him yesterday (22Dec2022) &amp; said that he got the wrong dose, that he got the pediatric dose for 6yr to 11yrs).    No concomitant medications were reported.  No treatment medications were reported.
an infant was given the second dose of Fluzone Quad early at 3 weeks instead of 4 weeks, 10 days early, no adverse event; Initial information was received on 09-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a seven month old patient (gender was not reported) who was vaccinated with the second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT, on an unknown date in the third week instead of 4 weeks after the first dose (10 days before). Lot number and other dosing details were not reported.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event was reported at the time of reporting.  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 and Module VI of the 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.  Information on the batch number was requested.
About 5 minutes after receiving shot, patient said he was feeling weak and dizzy, began acting lethargic, reported nausea.
Swelling, SOB, chest tightness same evening of receiving the vaccine worst the next morning. Took ALLERGAN and applied cortisone. Recovered.
cough still like covid mucous in bronchial tubes; cough still like covid mucous in bronchial tubes; Tired than ususal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Drug allergy (allergy to oxysporein drugs in antibiotic), Anaphylaxis (Full blown anaphylaxis on tablet) since June 2012, Autoimmune thyroid disorder since 15-Jun-2014, Arthritis and Hypertension. Concomitant products included HYDROXYCHLOROQUINE from 04-Sep-2019 to an unknown date and DULOXETINE from 19-Jun-2019 to an unknown date for Arthritis, LISINOPRIL for Blood pressure management, LIOTHYRONINE for Hypothyroidism, LEVOTHYROXINE for Thyroid activity decreased, PARACETAMOL (TYLENOL) and VIT D [VITAMIN D NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal). The patient was treated with IPRATROPIUM BROMIDE at a dose of nasal solution. At the time of the report, COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test:. On an unknown date, Sinoscopy: normal (normal) right sinus examined with scope- looked ok.         This case was linked to MOD-2021-053063 (Patient Link).
on 22NOV92 father of pt, exp weakness of extremities & progressed to total paralysis of arms & legs;
Diarrhea for 10 hours x 8 episodes  Nausea impacting appetite  Severe fatigue and muscle abs body aches.   Also symptoms appeared around 8pm and continued on until next day
At the site of injection and surrounding areas the arm became very red, inflamed and swollen. Pt began taking benadryl afterwards that helped some. The site and surrounding areas are still very red. Pt states it feels better today than yesterday.
Feb. 13, 2021 could not lift left arm for 2 days, left upper arm spasms/twitching continued. March 2-6, 2021 left leg lower spasms on back side. March 10 left leg aches, limp. March 13  rash noticed on 3 areas on back of left leg rash bumps white itch. March 15 upper left arm twitches, left leg Achilles tight, rash red, left foot pulsating. Symptoms ongoing for 2 1/2 months including fatigue, then random symptoms. Some of Treatment: rash ointment, bloodwork, chiropractor visits, GABAnol supplement
Nineteen days after receiving the smallpox vaccination he began to experience substernal chest pain rated 6/10 in intensity. He reportedly had a normal EKG and an elevated Troponin level.
Two circular erythematous patches with a diameter less than 1 cm appearing 8/17/2021 Muscle intermittent lumbar muscular spasms beginning 8/9/2021
The patient had no adverse side effects at time of call.; Pharmacist called asking for recommendations after it was discovered that two live vaccines were administered less than 28 days apart. Pharmacist states that a 19 year old patient needed VARIVAX and MMR-II for school purposes.; a 19 year old patient needed MMR-II; This spontaneous report was received from pharmacist and refers to a 19-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter subcutaneously, lot #T035400, expiration date: 16-OCT-2022 for prophylaxis. On 25-AUG-2022, less than 28 days from another live vaccine, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter subcutaneously, albumin status of recombinant human albumin (rHA) lot #U006486, expiration date: 26-FEB-2023 for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age). The patient had no adverse side effects at time of call.
shortness of breath.  wheezing,  facial and tongue swelling.  Epinephrine given x1
Tested positive for Covid; after Covid vaccines; Tested positive for Covid; after Covid vaccines; Pfizer Covid vaccine: states one vaccine, #4 of a total of 5 Covid vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 58 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "Pfizer Covid vaccine: states one vaccine, #4 of a total of 5 Covid vaccines"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Nov2022, outcome "not recovered" and all described as "Tested positive for Covid; after Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: still testing positive for Covid several days later; (03Nov2022) Positive; Weight: (03Nov2022) 115 lbs, notes: Weight: thinks about 115 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
chills; headache; fatigue; blotching redness on her arm; little bit of itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH MACULAR (blotching redness on her arm) and PRURITUS (little bit of itching). On 03-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN 03-Mar-2021 for Chills, Headache, Fatigue and Temperature elevation, at a dose of 200 mg, 1 tablet. At the time of the report, RASH MACULAR (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient reported that on 03-Mar-2021, she experienced little bit of temperature (body temperature not reported). She confirmed that following treatment with ibuprofen, she felt completely fine. Patient wanted to due diligence by reporting this to Moderna. No further details were reported.
headache, body aches, "flu-like symptoms"Patients symptoms relieved with taking tylenol.
TASTE METALIC; SLURRED SPEECH; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, unknown route, and batch number: 043AZ1A) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced taste metalic. On 03-MAY-2021, the subject experienced slurred speech. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from taste metalic, and slurred speech. This report was non-serious.
15JUL91 8PM fever-almost 105 ax, vomiting; 19JUL91 still t104 ax, vomiting, some listlessness, appetite dec lasted until 2JUL91; taking APAP;