chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; chills; body aches and sore arm; 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), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live,full-term birth) on 28-Feb-2018.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 13-Feb-2021, the patient experienced CHILLS (chills). 13-Feb-2021, the patient experienced MYALGIA (body aches and sore arm). On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and MYALGIA (body aches and sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glucose tolerance test: normal normal (normal) normal. On an unknown date, Ultrasound foetal: normal normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-016183 (Patient Link).
Felt light headed and fell to my knees and laid on the ground for a couple of minutes and then was brought to a cot to lay on. Nurse checked vitals and within normal limits.  Nurse monitored for 45 minutes.  He was able to take fluids and eat.
Approximately 20 minutes after receiving the vaccine, the employee developed dizziness and felt faint followed by acute arm pain, nausea, vomiting X several episodes, and a fine macular papular rash over arms trunk, neck, and scalp. The employee reports she took ALEVE that morning and later took her own BENADRYL after going home. Today 10/9/17 she is no longer vomiting but still has a rash and headache. She did not report to work today.
two weeks later I got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: This case was reported by patient. The age at vaccination was not reported. The patient had vaccination first came out to taken Flu shot and asked to patient had shingle shot or not. The patient had taken Shingles shot and two weeks later got the shingles.
administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The booster dose was given on 11-Nov-2021 between 09:00 AM to 11:00 AM. The pharmacist reported there were no reported adverse reaction.   This case was linked to MOD-2021-390578 (Patient Link).
Puffy eyes and burning face.  Face pain.  My face felt almost chemical burned.  I research moisturizing cream and bought Neutrogena Hydro Boost with Hyaluronic Acid.  This made my face feel worse.  I have discontinued use and take ibuprofen and an antihistamine.  The pain and swelling is better but not yet 100%
A 15-year-old male who came in for his Pfizer 12 year old+ COVID-19 vaccination. Client received a Pfizer pediatric (5 to 11-year-old) dose. Client's parents notified of the error.
Developed severe pain at injection site with influenza vaccination, later itching & now with (L) shoulder, deltoid, arm pain persisting = 5 weeks later.
Pt. states that after receiving the 2nd dose of Shingrix 10/18/2021, started experiencing symptoms 10/19/2021 of fatigue chills, headache, body aches,  and ear pain (sinus canal). No noted Primary visit/communications.
disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.
Immediately after both doses of Moderna I had heart palpitations, low blood pressure, lightheadedness, sweating. However, about 12 hours after I had the second shot of Moderna, all of my joints and limbs swelled and became extremely painful. Since that very day I have been battling extreme inflammatory arthritis and seeking medical help from both my primary care doctor as well as a Rheumatologist. After an entire year of this I am now on Humira and Methotrexate (chemo) medications as well as a 24hr pain patch. I can't work, drive, or barely take care of myself. This is HORRIBLE and given the immediate onset of symptoms right after my second dose of Moderna, it is the cause of the pain and suffering I have been in for the last year!
Painful, red, swelling to right upper arm.  Patient visited urgent care clinic on 11/11/16 and is still seeking treatment.
16-year-old received vaccine; A spontaneous report was received from a  nurse concerning a 16-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was congenital disorder. Concomitant history was not provided by the reporter.   On 09 Mar 2021, The patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left deltoid  for prophylaxis of COVID-19 infection .  On 09 Mar 2021, a 16-year-old, received the Moderna COVID-19 vaccine.   The treatment history was not provided.  The Action taken with the first dose of mRNA-1273 in response to the event was not applicable.  The outcome of event, 16-year-old received vaccine/inappropriate age of vaccine administration, was considered resolved on 09 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 030A21A) with no associated AEs reported.
Right leg: upper site- red hive 1.5" long hot swollen. Right eyelid: red swollen hives.
Large local area of erythema with associated warmth and tenderness.  The area is firm to pressure.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202) via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced fatigue. He said that the fatigue is mild. Outcome of the event was unknown.
low oxygen; cough; sneezing; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (low oxygen), COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (low oxygen). At the time of the report, OXYGEN SATURATION DECREASED (low oxygen), COUGH (cough), SNEEZING (sneezing) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-109930 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109930:husband
Patient hospitalized for Malignant neoplasm of left ovary, Admission for chemotherapy within 6 weeks of receiving covid vaccination.
Patient has injection site reaction. Area is red, swollen, hot to the touch approximately 3 inches in diameter Patient also reports sores on her tongue that appeared on same day
AFTER VACCINE WAS GIVEN, ADMINISTERING NURSE REALIZED THE DOSE HAD EXPIRED ON 29 APRIL 2023.
I had a very fast sore throat with sinus congestion. My cough was mild. I took Dayquil and Nyquil for my symptoms. I had no idea it was COVID-19. On the 5th day I tested myself for COVID-19 on February 01, 2023, and it was positive. I did a telemedicine appointment and she advised me to treat the symptoms like before, but I could have Paxlovid. I did not take the anti-virals though. The only other symptoms I had was complete exhaustion where I was unable to function for 4 days. No other symptoms returned. It took about 15 days to completely recovered.
Arm  extremely sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient just got his/her first shot a week ago and his/her arm was extremely sore, but nowhere as bad as having shingles, from what the patient read. Additional supportive information: The follow-up could not be possible as no contact details were available.
expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAV (Havrix) (batch number N39BM, expiry date 31st January 2022) for prophylaxis.   On 2nd February 2022, the patient received Havrix. On 2nd February 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Severe muscles spasms that were epileptic in scope; severe, very severe, headache; This is a spontaneous report from a contactable other health care professional (Patient). A 76-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Feb2021 09:45 as a single dose for covid-19 immunisation. Medical history included ongoing glaucoma from an unknown date and unknown if ongoing. Concomitant medication included sertraline taken for an unspecified indication, start and stop date were not reported and eye drops for glaucoma. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9263 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:45 (at the age of 76-year-old) as single dose for covid-19 immunisation. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 22Feb2021 01:00 the patient experienced Severe muscles spasms that were epileptic in scope. And severe, very severe, headache Took place 12 hrs after shot. spasms lasted 24 hours, with after effects another 12. Headache lasted 48 hours. The patient did not receive treatment for the events. The outcome of the events was recovered on unspecified date of 2021.  Follow-up attempts completed. No further information expected; Sender's Comments: As there is limited information in the case provided, the causal association between the events Epilepsy and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Healthy child no previous illnesses. About 30 hours after vaccine was noted to have episodic upward both eye gaze movements that increased in frequency. No tonic/clonic movements of extremities. Had 1 episode where head became limp. Seen in ER and hospitalized. Video EEG negative, seen by Neurology diagnosed motor tic. 3 weeks post episode, eye movements almost all resolved.
FIRST DAY - SMALL AMOUNT OF SWELLING AND NO FEVER.  MORE SWELLING ON SECOND DAY. 5/11/07 LARGE AMOUNT OF SWELLING AND 07.7 AXILLARY TEMP.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.  It was reported that the patient received GARDASIL 120, intramuscularly on 31-JUL-2013 and on 23-JUN-2014. No known adverse effects. Additional information has been requested.
Approx 15mins after having the shot administered I sat in my car and felt the medication coming on by it clouding my vision then causing me to faint (and by description from my fiancé) I had what appeared to be a mild seizure. I was out for a minute or two and when I was conscious again my vision was blurry and I felt very drunk for the next 45mins - hour. I also felt like I could taste the chemicals from the vaccine when I became conscious again.  The drunk/vertigo feeling subsided slowly over time but I was given a Benadryl from the pharmacist so I?m not sure when the dizziness stopped but I definitely could not drive home. My fainting was not due to any anxiety due to having a shot or anything, I was perfectly fine for approx 10-15 mins after the vaccine then I felt a cold feeling coming on from my right shoulder then up my neck then I got foggy and dizzy and passed out
Rapid heart rate up to 163 bpm. 2.5 hours, unable to reduce. Required emergency pharmaceutical intervention.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration in right arm on 09Mar2021 at 15:15 (at the age of 75-years-old) at unknown, single dose for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia (CLL) and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine and fluticasone propionate. The facility where the most recent COVID-19 vaccine was administered was reported as other. On 14May2021 at 09:00, the patient experienced rapid heart rate up to 163 bpm which has not reduced in 2.5 hours. The event required emergency pharmaceutical intervention with intravenous (IV) dialtiazem, diltiazem 120 mg, and ELIQUIS 5 mg 2x, doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included heart rate: rapid heart rate up to 163 bpm and nasal swab for COVID-19: pending result, both on 14May2021. The outcome of the event was not recovered. The event was reported as non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-APR-2011, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Strong increasing fever over a period of several hours beginning around 9 hours after dose. Fatigue, dizziness. Chills.
Mother reports after last immunizations infant having elevated temp., 101 to 102 degrees, high pitched cry, with periods of inconsolable crying after visiting with ARNP was told to give acetaminophen alternating with ibuprofen.
Started having severe pain in shoulder/joint, radiating down arm and up neck.  Continued through the night and next 8 days when I went to occupational health.  Was put on Prednisone for a suspected subacromial bursitis.  Three days of treatment and I still have pain, waking up with severe burning in shoulder even with prednisone, Motrin, ice.  Following up with occupational health in another ten days.
p/vax pt exp temp 101, eyes rolled back, lethargic, vomiting @ grandma house;pt mom went to pick pt up & eyes rolled back again (?sz);
Initial case report received from executive director on 19 Nov 2009. A elderly patient was vaccinated IM with INFLUENZA virus vaccine (batch no. unspecified) on an unknown date. They experienced aspiration pneumonia and hypoglycaemia. The patient's outcome was unknown. Company assessment: On a case level, the case was considered unexpected. Serious criterion: Hospitalized Causality: Possible (Temporal relationship plausible or reasonable) Expectedness assessment according to EU SPC/US SPC: Aspiration pneumonia and hypoglycaemia are unexpected after vaccination with INFLUENZA virus vaccine. No change in benefit-risk ratio. No measures required.
Severe stomach pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pain) 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 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Reporter did not allow further contact