chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightheadedness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and ASTHENIA (weakness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031120A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis (worsening, now on Prolia (every 6 mos. injections)) in 2014, Acute pancreatitis in 2009, High cholesterol in 2014 and Asthma (Lifelong). Concurrent medical conditions included Seasonal allergy (Lifelong) and Iodine allergy (Lifelong). Concomitant products included ATORVASTATIN for High cholesterol.   On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Lightheadedness) and ASTHENIA (weakness). The patient was treated with Manual therapy (ECGs, OJ and fruit cup) for Dizziness and Manual therapy (ECGs, OJ and fruit cup) for Asthenia. At the time of the report, DIZZINESS (Lightheadedness) and ASTHENIA (weakness) was resolving. Not Provided          This case was linked to MOD-2021-020930.
Rapid heartbeat; Shortness of breath; Pain at injection site; Chills; Fatigue; Fever; A spontaneous report was received from a consumer concerning a 25 years-old, female patient who experienced rapid heartbeat/MedDRA PT: tachycardia, shortness of breath/MedDRA PT: dyspnoea, pain at injection site/MedDRA PT: vaccination site pain, chills/MedDRA PT: chills, fatigue/MedDRA PT: fatigue, and fever/MedDRA PT: pyrexia.  The patient's medical history included anemia and low immune system. Concomitant product use was not provided by the reporter.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 025A202A) intramuscularly (injection site not provided) for prophylaxis of COVID-19 infection.  On 23 Jan 2021, after receiving vaccination, the patient experienced pain at injection site, chills, fever, fatigue and shortness of breath. On 24 Jan 2021, the patient experienced rapid heartbeat. The patient was hospitalized and during hospitalization, heart rate was noted as 125 bpm which reduced down to 110 bpm. The patient was discharged on 25 Jan 2021. Following hospitalization, patient had ongoing fever and was advised to contact hospital for direction regarding readmission.   Treatment included self-administered Tylenol, six times daily.  Action taken with mRNA-1273 in response to the events was unknown.  The events chills and shortness of breath were considered resolved on 24 Jan 2021. The events pain at injection site, fatigue, and rapid heartbeat were considered resolved on an unknown date. The event fever was considered not resolved.; Reporter's Comments: This case concerns a 25-year-old female who experienced serious expected events of tachycardia and dyspnea along with nonserious expected events of fever, chills, fatigue and vaccination site pain.  The events occurred 1 day after the first dose of mRNA-1273. Treatment included Tylenol. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe dizziness Breathing became closed off Sick  Cold Weak  Severe zinging running down both arms and legs 45 min. After shot.
After vaccine I experience periorbital tenderness and periorbital swelling throughout the day. This morning I woke up with left side facial swelling and periorbital swelling with no visual disturbance. Follow with occupational health who administer the vaccine and was told it was not the vaccine and to follow up with a variance report to see the following up step. No further test was done at occupational health and told to follow up with PCP if it got worse.
sever lower, middle & right side, stomach pain. Went to ER and diagnosed with appendicitis. removed my appendix.
Unsure of onset date/time, pt reports she developed a rash around vaccine site shortly after receiving vaccine on 09/15/14.  Rash still present at in-office visit today 09/29/14.
The injection site started feeling sore around 11 PM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Oct2021 17:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunisation; Bnt162b2 (Dose:2), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Oct2021 23:00, outcome "unknown", described as "The injection site started feeling sore around 11 PM".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Potential adverse event to fetus: vaccines administered before patient knew she was pregnant. Was approximately 6 weeks of gestation on 3/27. Tdap and MENACTRA were administered at the office and Typhoid/Yellow Fever at pharmacy.
2nd dose one year after the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 07th October 2020).   On 6th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The route of administration of Shingrix was reported as injection. The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. The patient inquired if she needed to get another dose since the 2nd dose was late.  The reporter did not consent to follow-up. The patient declined to give consent to contact her for follow up and did not want to give any contact information and full demographic information.  The patient did not provide healthcare professional contact information.
patient received the wrong vaccine. she is 12 years old and received the pediatric pfizer (5-11 years of age) no symptoms. Patient's parents aware of situation. Medical Director aware of situation. Patient will receive correct pfizer vaccine in 21 days from 1 st dose .
No adverse event occurred. Advised by CDC phone contact to report that she had received additional vaccine at another facility.
Client contacted the Health Agency 9/25/21 regarding a vaccine reaction from receiving a 3rd dose of Moderna vaccine at Health Center 9/24/21. Contact information for the client was forwarded to the Epidemiology and Immunization Branch. Client was called by a Immunization Public Health Nurse 9/27/21. The client explained that after his first two doses of Moderna received 1/21/21 and 2/18/21, that he did not have vaccine reactions, however did have a sore arm and fatigue a few hours after receiving his 3rd dose of Moderna 9/24/21, which he did not experience after the first 2 doses. The client explained that his sore arm and fatigue has since resolved the following day (9/25/21) after his vaccination, and he did not experience any other reactions. The client also mentioned 9/27/21, that he did follow up with his primary care provider to inform them of the sore arm and fatigue experienced after the 3rd Moderna dose.
IPOL 0.1mL was given to the patient instead of Tubersol with no reported adverse event; IPOL was administered intradermally with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA043808.  This case involves a 30 years old male patient and poliomyelitis vaccine (inactivated) (IPOL) 0.1ml was given to the patient instead of tubersol and ipol was administered intradermally with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 06-Feb-2023, the patient received an unknown dose of suspect poliomyelitis vaccine (inactivated) (ipol) suspension for injection(batch/lot number: W1A191M and expiry date: 16-Feb-2025; unknown strength; 0.1 mL 1X) via intradermal route (incorrect route of product administration) in the left forearm for immunization instead of tubersol (wrong product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events.  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 the guidelines. 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.; Sender's Comments:  01479461: 01479487:
Information has been received from a health professional concerning a female who on an unknown date was vaccinated with an unspecified dose of GARDASIL, 0.5 mL.  Lot # was not provided.  Subsequently, the patient developed severe pain and possible cellulitis at the injection site after the GARDASIL injection.  The patient sought unspecified medical attention.  At the time of reporting the patient had recovered on an unspecified date.  Additional information has been requested.
Patient c/o of fast heart rate and dizziness. No signs of pallor, diaphoresis. No c/o of SOB or chest tightness.  Treatment: Assessed heart rate of 108 BPM. Informed patient to take slow, deep breaths, remain seated and drink water.  After 10 mins, patient feels much better and had no more complaint of dizziness. Heart rate assessed and it's WDL. Reminded pt. to just rest at home, avoid any extraneous activities and call PCP if any chest tightness or shortness of breath occurs.
Pt given TDAP vaccine 3/18/14. Reports 3/19/2014 while at work had chills, swelling to (L) deltoid and numbness to LE. Sent to ER. Reports blood work done. IV fluids given.
Patient vaccinated with second dose 14 days after first dose. Guest was educated about appropriate interval and expected side effects. Guest expressed verbal understanding. Guest stated he was told by his first dose clinic correct interval was 14 days and also he saw online that 14 days was ideal dose interval.
5-7 days after vaccine patient has erythema and warmth approximately 3cm width band around upper left arm just below location of PREVNAR 13 administration. Treat w/BENADRYL and cool compress.
After receiving the first dose, experienced severe arm pain, shoulder pain, and hand numbness. Acute pain and numbness has worn off, but there is still moderate pain when using the arm. About a week post-dose, began spotting. Was not due to have menstrual period for 2-3 weeks according to birth control pill pack, and normally does not have any menstrual symptoms (no period) at all. Bleeding has increased daily, and is now fairly heavy. Accompanied by cramps.
Shingles on right bicep , shoulder area and neck. Lasted about a week before blisters scabbed over
ADMINISTER FIRST DOSE OF PFIZER 0.3ML TO PATIENT'S LEFT ARM. PATIENT WAS FINE FOR THE FIRST COUPLE MINUTES. AFTER A FEW MINUTES PATIENT FAINTED IN THE CHAIR AND WOKE UP. HE HAD A SEZIURE FOR A COUPLE MINUTES AND THEN VOMITTED. WE CALLED 911 RIGHT AWAY AND EMS SHOWED UP. ALL HIS VITALS WERE NORMAL AND EMS SENT HIM HOME.
Fever, chills, fatigue, headache, muscle soreness, pain at vaccine site.
First Vaccine- broke out in a rash on mostly left arm, some of the torso and legs.  Rash was very itchy.  Took Benadryl which didn't help the itch. Second Vaccine- Body aches, chills and fever starting 2 hours after injection.  Symptoms lasted 2.5 days.  1000 mg of Acetaminophen(Tylenol) taken every 4 hours. Day 4 and 5-terrible "thunder clap" headache- Tylenol taken but did not help so switched to Ibuprofen(Advil). Periodic headaches in the following days.
Initial report was received on 05 May 2011 from a health care professional. A 45 year-old female patient with no known allergies and no reported illnesses at the time of vaccination had received on 26 April 2011 ADACEL, lot number C3517AA (route and site of administration not reported). On 04 May 2011, the patient reported she started experiencing a stiff neck which kept her from sleeping through the night and she was unable to move her head due to the soreness of her neck. Treatments, laboratory data or relevant diagnostic tests were reported. She had no other vaccinations within four weeks of the suspect vaccine. The patient last Td vaccine was in 2007. The patient's outcome was not reported. Documents held by sender: none.
Patient experienced redness and pain at the site, as well as headache that lasted about a week. She also reports tinnitus in her right ear. After 2 weeks, there is still a raised bump at the injection site and tinnitus.
pain; paralyzed from the waist down; issues with her mobility and balance; issues with her mobility and balance; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   The patient reported that she was totally paralyzed and she believed it was due to the zoster vaccine live (ZOSTAVAX) she took on an unknown date in February 2017 (reported as 29-FEB-2017) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). She explained she started to have issues with her mobility (Mobility decreased ) and balance (Balance disorder) 5-10 days after the vaccine was given. She went to go visit her cousin in another city and on 27- OCT-2017, she started to have even harder time maintaining her balance. Her cousin took her to the hospital on 29-OCT-2017 and she was completely paralyzed from the waist down (paraplegia), she stated they did some tests (unspecified) and gave her medicine. At the time of reporting, the patient had not recovered from mobility decreased, balance disorder and paraplegia. The patient anted compensation for all the pain she endured.   Upon internal review, the event paraplegia was determined to be medically significant.
broke out after first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported for his/her son in law. Age at vaccination was not reported. The patient now all broke out after first shot for shingles. The follow-up would not be possible as no contact details were available.
Anaphylaxis - 50mgs benadryl , received 2 shots epinephrine, received succinate and methylPrednisolone
Right thigh and knee became red and swollen (2x normal size) lasted for 3 days, no fever.
Cellulitis (warm, red rash) requiring treatment with Keflex. Patient was seen at her doctors office 4/21/16.
This spontaneous report as received from a physician refers to a patient of unknown age. On 01-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J001180, expiration date: 18-AUG-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001193; 1403USA001195) from the same reporter. Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 05-JUL-2011, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 06-DEC-2016, the patient was treated by a physician at a primary care office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Follow up occurred on 10/12/00, for right upper extremity vax reaction. Over the last 24 hours they have been cool packing the area about every two hours while she is awake. She was started on some Keflex (250 QID for seven days). The areas were marked yesterday for the parameters of the erythematous area. Allergies are to Penicillin and Micronase. She is hemodynamically stable. There is no fever. Physical exam shows a slightly warm, much smaller erythematous area on the right upper extremity. Elbow range of motion is full. So is shoulder range of motion. There is no lymphadenopathy. She has no complaints. and there has been no shortness of breath or wheezing. Her lungs are clear. Assessment: 1) Resolving reaction to pneumovax. 2) early cellulitis. Plan: 1) To maintain the current treatment regimen as ordered yesterday unless new symptoms develop or she worsens in any way. 2) Then return to the ER or clinic as needed for follow-up. Keflex Order: Cellulitis secondary to Pneumococcal vax.
high itching over her whole body, itching all over even her head and hair, up and down her spine, everything; This is a spontaneous report from a contactable consumer (patient's husband). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on 13Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced high itching over her whole body, itching all over even her head and hair, up and down her spine, everything in Jan2021. Outcome of the event was unknown.   Information about Lot/Batch has been requested.
There has been a pretty extreme direct soreness in a spot on the backside of my right arm by my armpit crease that hasn't gone away for two weeks now. It hurts to the touch and also hurts when I stretch my arm.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient admitted for syncope.  Had acute kidney injury.  This was likely secondary to volume depletion.  Patient had an abnormal UA so was started on rocephin.  This was transitioned to Keflex on discharge.  MIC pending.  Patient improved and was discharged back to the ECF.  COVID test was positive on discharge.  Was not tested on admission.  Was likely positive on admission as well.  SNF agreed to take him back as they have others with it at their facility.  Patient had no respiratory issues from it.  No need for remdesivir or decadron.  Patient has right lower extremity wounds from a fasciotomy early this year.  Healing well.  Wound care saw and adjusted orders a little"
On October 1st I lost my equilibrium. I suffer from vertigo, so I thought I was going to get a dizzy spell. I went to sleep to try to sleep it off but when I woke up, I was still bumping into walls. I went to the emergency room, and they did different test to see why I was off balance and throwing up. They didn't find anything until they did an MRI and there were lesions in my brain, the lesions meant that I possibly had Multiple sclerosis, but they weren't sure. I then was seen by a Neurologist requested a spinal tap to see if there were proteins and on this past Monday I was diagnosed with Multiple sclerosis. I was given 5 IV steroids over the course of 5 five days. I was also given some anti-nausea medications.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on 22-MAY-2015, the patient was vaccinated with improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
01/21/2021 First dose, I experienced a sore arm for about 24 hours and a slight headache. 02/18/2021 shaking, low fever, I attempted to lay down but I was shaking so bad and it caused a bad headache, fever spiked to 102.0 by 11PM. The shakes lasted about an hour and a half. General body aches for 24 hours. The next day around 1PM I felt a lot better.  Later that night fever spiked again. I was using cold compresses and Tylenol and I went to sleep, next morning it was gone. On 02/22/2021 When I went to work, I felt a heart flutter. Saw dr. She was going to do EKG, but fever was raised again. Was sent home. The feeling in my chest lasted about 5 days and it only happened with extra activity, when I rested it wasn't too bad.
Welt and swelling at site of vaccination, exhaustion, body aches, headache lasting 2-3 days after vaccination.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Treatment medication information was not provided. Concomitant medication information was not provided. Reporter did not allow further contact.
Initially had stroke-like symptoms on left side, now resolved. Continues to have extreme weakness and SOA with any exertion.
24 hours after injections left arm became swollen, hot, red. Fever to 100