chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first does of Moderna on March 23, 2021. I had no reaction in the first 15 minutes.   My husband and I left the site and stopped to do some shopping about 5 miles down the road from the site.  I was driving.  When I got out of the car, I immediately noticed that I was unsteady, I thought I was just being clumsy until I walked around my car to help my husband ( I am his caretaker) out of the car but I was collapsing and needed to steady myself against the car and get my way back to the car because of intense dizziness.  When I got back into the car, I asked him if he could make it to the restaurant and get me some water.  He did and I drank a bottle of water.  At this time I felt like I was going to have the runs and throw up at the same time so I drove through the parking lot and used the bathroom at the restaurant.   I was a little dizzy but it was not as intense as when I first got out of the car.  I was able to walk to the bathroom and back out without any difficulty.  I did have the runs but the feeling of throwing up passed.  We got back into the car and waited until I felt safe to drive.  After another 15 minutes I drove home.  During the drive I felt sick again and had to stop in a parking lot and throw up.  After throwing up, I felt fine and drove the rest of the way home.  I was able to make it into the condo with no problem and take a shower.  I felt steady and no longer sick.  I went to bed for a couple hours and then got up and ate some food which I kept down. During the rest of the day, I took it easy.  Today I feel fine.  No headache.  I will write if I  have any other problems.  I am wondering if anyone else has had a similar experience.?  Should I take the second dose?
Very sore arm beginning 2 or 3 hours after injection, lasted 24+ hours. Headache beginning three hours after injection and continuing for 24 hours; only slightly relieved by TYLENOL. Fever and chills at 12 hours after injection and continuing for several hours. Achy, flu-like feeling at 12 hours continuing for 12 hours. Felt much better at 24 hours except for headache. Following first dose (7/2/18), only experienced sore arm and headache. Side effects much worse with second dose.
Shortness of breath Chest pains Leg pains Heart Attack Timeline of Adverse Events: March 5, 2023: Went to the Emergency Room due to chest pain, discovered my right artery blockage and was having a heart attack. Had an emergency procedure to add stents to open passage way.  March 6, 2023: Had a second procedure to add another stent to the right artery.  (Hospitalized for one week) April 20, 2023: Had third procedure to add stent in the cx left artery done by Dr.
DX: Pericarditis S/S: Lethargy/fatigue, Dyspnea on exertion, dyspnea with lying down or orthopnea, edema, anorexia or poor feeding, tachypnea, acute chest pain or pressure Clinician description:3-4 weeks of progressive shortness of breath and dyspnea on exertion.  Typically sleeps propped up on 3 pillows, no new orthopnea or nocturnal dyspnea.  History of sleep apnea but intolerant of CPAP S/S onsetn: 03/26/2021
Administered 0.5mL dose instead of 0.3 mL dose.  On 8/9/2021 patient was contacted and was experiencing small amount of pain in the arm the vaccine was administered in.  No other reaction.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021 at 11:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 09-Sep-2021 at 11:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Sep-2021 at 11:50 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medication was reported.
Within 5 minutes of administration experienced metallic taste. followed by limp and facial tingle and burn. Did not progress for the 15 min watch time. stopped at store and started having tongue and soft palate swelling and burning.  Had taken zrtec in am for seasonal allergies . Went home and took 50 mg of benadryl . No hives, itching on face and neck only ( mild). Reaction did not progress.
40 minute afebrile seizure about 11 hrs after receiving vaccines.  11/30/2007 MR received ER visit 11/10/2007 with DX:  Likely Febrile Seizure.  Infant developed fever on the pm of vax.  Pt was witnessed to fall, become unresponsive, foam at the mouth, and vomit.  Pt had L sided shaking of L arm and leg lasting ~40 minutes.   PE (+) for coarse lung sounds with bilateral rhonchi, otherwise WNL. Pt d/cd home to F/U as outpatient.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on unspecified date in early 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021 (1-2 days prior reporting), the patient had Covid-19 test and found to be positive and had suspected clinical vaccination failure.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210815333-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Fever, seizure, T max 102, generalized tonic seizure. Records indicate cough & cold symptoms.
Patient was dizzy, lightheaded and shaky. Store staff got her a chair and she was seating by the check out. They provided her water to drink. No complaints of trouble breathing. Upon questioning had not eaten since breakfast. Blood pressure was measured at 160/103 on Left arm, seated. Patient had intended to buy a lunch. We had her sit, eat, and drink water. After eating was able to get up and was assisted to car just in case by store staff.
Chills, fever up to 102, severe body aches, severe headache, vomiting, nausea, dizziness, stomachaches
Patient was given a Fluzone on 2/3/2023, but she had already received a flu shot for the 2022-2023 season on 10/7/2022. No adverse reaction or symptoms. Patient was made aware of error immediately after Fluzone was given on 2/3/2023.  Provider notified her and provider did not have any recommendations or concerns
No additional adverse event; VAQTA was administered after a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 29-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, syringe, 0.5 milliliter (valid lot #U002749, expiration date: 04-MAY-2022), administered for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion (product storage error). The temperature, timeframe and if there was a previous temperature excursion was unknown by the reporter. No additional adverse effect reported.
Intense itching without rash occurring 7 days after injection.  Patient had mild erythema around injection site immediately after injection, which resolved.
Patient presented to the clinic with left arm pain and itching at the injection site. Patient stated that she has observed increased itching and limited range of motion since the injection, reporting that she was unable to lift her arm to a 180 degree angle due to stiffness and soreness. During this time period, I anticipated an allergic reaction/inflammation. The patient was given a medrol dosage pack and 2.5 milligrams of hydrocortisone to administer to the injection site.
Frequent hot flashes and sweating (significant enough to disrupt sleep). I'm four years post-menopause. Until the second vaccination, I hadn't experienced hot flashes in a year.
swollen ankle with no pain; dry mouth; pain in the knee; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen ankle with no pain), DRY MOUTH (dry mouth), ARTHRALGIA (pain in the knee) and VACCINATION SITE PAIN (soreness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Back surgery. Previously administered products included for Product used for unknown indication: Johnson&Johnson Vaccine on 09-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson&Johnson Vaccine. Concurrent medical conditions included Atrial fibrillation, Blood pressure high, Back disorder, Pancreatitis and Allergy to antibiotic (erythromycin allergy). Concomitant products included CARVEDILOL (COREG), PANCREATIN (CREON), FAMOTIDINE (PEPCID [FAMOTIDINE]), OLANZAPINE (ZYPREXA) and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swollen ankle with no pain), DRY MOUTH (dry mouth), ARTHRALGIA (pain in the knee) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swollen ankle with no pain), DRY MOUTH (dry mouth), ARTHRALGIA (pain in the knee) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
* Pain/soreness in injection site from the day of vaccination, persisting three days later (current, though lessening) * Large red blotch around vaccine site; noticed 24 hours after injection, persisting to three days later (current), tender to the touch * Itchiness at injection site 48 hours post-injection * Mild achiness in back the day after injection (12 hours after lasting til 30 hours after), with pain in chest reminiscent of bad heartburn
Administered vaccine just below left deltoid in the bicep brachii region (information provided by her MD after examination) instead of deltoid muscle. Redness and inflammation occurred the same day with swelling around the injection site. The patient called the pharmacy and was instructed to apply cold compress to the zone after noticing the redness and swelling in the days after the injection. Patient also took advil for the swelling. Patient reported that she was unable to sleep on her left side from pain resulting from the adverse event. The patient saw a MD May 18th because of how tired she was feeling and blood was drawn on May 22 for routine blood work.
Headache, Arthralgia, Fever, joint pain, fever, HA, cough Narrative: Took OTC Dayquil for above sx
Day of the vaccine I felt fine. Started to have a warm and painful touch to the existing varicose vein in the left leg.  Morning of 12/08 I went to the gym (normal) but took it easy--slight limp due to left ankle/foot feeling kind of numb/slight pain. By 11:00 a very strong feeling of pain in my left foot. Limping. Did not trust to put a lot of pressure on it. Had to be careful walking. By 5 pm severe pain when walking and at rest. Pain 8 or 9 out of 10. Close to fainting from pain while walking. Laid down about 6pm. Intense waves of pain until about 3am. Then the pain disappeared. Ankle still feels numb and slight tingle (12/11).
Daughter called pharmacy to indicate patient experienced an approximate 4 x 4" slightly raised "bubble" on inside of left arm in the approximate location of the vaccines. Area was red, warm, and with associated pain. Redness has improved throughout the morning and is now more pinkish. Reported pain is approximately the same as first experienced. Potentially some transient associated nausea but appears to have subsided. No fever reported, no other symptoms reported. Patient was concerned with the swelling on the inside of the arm. Patient was advised to avoid ice and to ensure movement of the arm to allow the vaccine to dissipate out of the muscle. Ibuprofen or TYLENOL was recommend for the pain. Patient was advised to call the pharmacy if symptoms change or worsen. Informed patient all symptoms appear to be reported, most common reactions per major compendia. Daughter requested that I report anyway.
Initial consumer report received on 10 May 2010: This patient received MENVEO vaccine (batch no. not reported) intramuscularly on 07 May 2010. After 3 hours of vaccination, the patient became very dizzy to the point that the room began to spin and that she had to hold on to the wall to ambulate. Although she felt very to passing out but she never did. The severe symptoms lasted approximately 5 hours. The dizziness lingered to a lesser degree over the weekend. The symptoms were completely resolved on 10 May 2010. Follow up report received from a consumer on 07 May 2010: The report was initially reported to Novartis on 07 May 2010 and not on 10 May 2010. Post vaccination, after one and half hours the patient became very dizzy to the point that the room began to spin and that she had to hold on to the wall to ambulate, she felt very close to passing out. The outcome of the events were reported as ongoing.  Following an internal review on 28 May 2010 for the data received on 07 May 2010: it was found that the events "hold on to the wall to ambulate" and "vertigo" were coded separate and now merged together as single event.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), on 06Apr2021 as dose 2, single (Lot number: ER8737), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2590) and on 06May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Congenital Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.
Red and Swollen Entire Left Arm; Red Injection Site; Swollen Injection Site; Reaction Spread to the entire Left Arm; Enlarged Lymph Node in the Left Armpit.; Red and Swollen Entire Left Arm; A spontaneous report was received from a healthcare professional concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event(s) red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red injection site, swollen injection site, reaction spread to the entire left arm, enlarged lymph node in the left armpit, red and swollen entire left arm was unknown.
My son received his Hep B vaccination at 2 days old, before being released from the hospital.  At 5 days old, he began having seizures that grew in frequency and severity over several hours resulting in a week-long hospital stay.  Many tests were run, he was put on anti-seizure medication and finally released after a week.  03/26/2007  MR received for a 6 day hospitalization for new onset seizures beginning at 6 days of age. The infant had jerking in his left arm, head was turned to the right and eyes staring straight ahead.  This was witnessed in the office by the MD, which also included eye blinking.   PE: WNL. Infant treated with Acyclovir, antibiotics, and Phenobarb. Final DX: Benign seizure disorder of Newborn.
Employee was seen by clinic for pain, stiffness, and decreased movement in left arm, Medications and Home PT  ordered. Employee placed on light duty. Follow up on 05/31/23.
clinic experienced a temperature excursion with Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C. On 05May2023 a dose of Menveo was administered to a 16 year old female patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 05-MAY-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: clinic experienced a temperature excursion with Menveo vaccines on 04May2023 that lasted 45 minutes and reached a low temperature of -0.8C. On 05May2023 a dose of Menveo was administered to a 16 year old female patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 11-May-2023 The pharmacist reported that a clinic experienced a temperature excursion with Menveo vaccines one day prior to the reporting date that lasted 45 minutes and reached a low temperature of minus 0.8 Celsius. The reporter did not know which lot number was administered. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Menveo after temperature excursion, which led to incorrect storage of drug.
Redness, pain, swelling at injection site approximately 6cm x 10cm in size.
still with Bell's Palsy symptoms; shingles / still with / active shingles; Suspected vacination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In July 2021, between 7 and 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the bell's palsy and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received both Shingrix doses and developed shingles 3 weeks before the date of reporting and she was still with Bell's Palsy symptoms and active shingles. Less than 9 months after receiving Shingrix, the patient experienced Bell's Palsy symptoms.  Patient was planning to travel on November 2021. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.  The reporter consented to follow up by fax.
About 3 days after receiving the first dose of the Moderna Vaccine, I started feeling pain under my left armpit and my lymph nodes were swollen. That symptom subsided in 3 more days. Then, almost a week after the vaccine (6 days after), I started feeling an itch at the site where I received the vaccine. It continued itching during the evening and then at night I noticed a large red patch on that same area. The following morning my arm was slightly painful.
6 days following the vaccine (1/22), extreme itching and redness around the injection site. Next day, it got (1/23) it got redder and itchier. It looked like there were 2 giant hives on my my arm (bigger than a nickel). Took 1 Benedryl (25mg), which didn't help. Hardly slept due to itching, and soreness to the touch. I can't wear a blouse with a sleeve. Today (Sunday 1/24), the redness came together into 1 big red blotch, measuring  2"x3.5". Hot to the touch, and very sensitive. I feel pain into my shoulder blade area and where my arm meets my body in the front. Also, pain going towards my elbow. Ice / cold packs make it feel better. I will call for Dr. appointment tomorrow (Monday morning).
4 months after 2nd vaccination I started having cardiac events. They began with a sharp pain in my chest when I was hiking, then after that I was having dizziness at work, then at times my heart would hurt. I still have the soreness in my heart after all these months, even after my cardiologist ruled out any problems with my heart. I was put on metoprolol. I am very worried about what is going on and it effects my daily life.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. Treatment include Heating pad.
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot # unknown, strength, dosage and route unknown for unknown indication). The nurse reported that the patient was administered a dose of (Oka/Merck) VARIVAX that was improperly stored. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Extra doses given (3ml instead of 0.3ml); reported to Center, representative of which is writing this report