chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sensation prior to having cramps in the legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (sensation prior to having cramps in the legs) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (sensation prior to having cramps in the legs). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (sensation prior to having cramps in the legs) outcome was unknown. Tylenol to treat the symptoms      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided
Moderna Vaccine- Rx#1217288.  Booster shot.  Swollen Left Upper Arm, Severe Itching and Redness that started 12+ hours after vaccine and lasted for 3 days.
Grade 3 flu symptoms with beginning malaise & light body aches, followed with shivers and chills, and sick feeling, nearly like having the flu, deepening body aches all night through next morning, followed with more chills the next day and difficulty walking or moving about. This followed that evening by fever and body aches, headache and difficulty moving about. I have never had an adverse reaction before to a yearly flu shot, or to the original shingles vaccine called ZOSTAVAX.  I almost felt I should visit the emergency room, but I did not.
approx 1 hr p/vax pt c/o pins & needles feeling in rt arm & hand; mom reported hand & arm was purple in color; saw MD next day; prescribed Advil tabs & heat application;
Upon completion of last injection (TWINRIX) patient stated he felt nauseated and he was about to faint. Patient began jerking upper extremities and then became limp. Skin pale and clammy. Last approx 20 sec.-1 min and regained stability. Approx 3 min later began jerking again as well as vomiting. Patient assisted to floor, turned on side. Shortly regained stability. EMT escorted to ED.
throwing up; chills; sick; This is a spontaneous report from a contactable consumer.. A 40-year-old female patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2, lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization and the patient experienced tired for like a day or day and a half and got up and was fine and felt a little fever and chills.  It was reported that with 2nd dose patient was sick for 3 days, throwing up and chills and it was bad. The outcome of the event sick  was recovered; while the other events was unknown.  Information on Lot/Batch information has been requested.
GAVE HIM THE COVID 19 SHOT AT 12.40 PM AND ASKED THE PATIENT TO WAIT FOR 15 MINUITES AT THE DESIGNATED WAITING AREA. PT WAS WITH HIS SPOUSE AFTER FEW MINUTES THE SPOUSE SOUITED AT ME THAT THE PT IS PASSING OUT. I IMMEDIATELY RAN OUT AND PATIENT WAS ON THE FLOOR AND HE SAID HE IS NOT DOING WELL FEELING TINGLING AND HE WAS SWEATING. HE WAS ABLE TO BREATH AND TALK . WE CALLED 911 AND I GAVE HIM EPIPEN 0.3MG ONE SHOT AT 12.45 PM. I WAS STILL MONITERING THE PT AND AT 12.50 PM EMS PERSONAL CAME AND TOOK OVER FROM ME. EMS PERSONAL CHECKED HIS VITALS AND THEY SATISFIED THAT HE WAS DOING GOOD AND LET HIM GO HOME. I CALLED THE PATIENT AROUND 2.30 PM TO  ENQUIRE ABOUT HIS HEALTH AND THE PT SAID HE IS DOING FINE AND HE SAID THAT HE PASSED OUT IN THE PAST MANY TIMES  AFTER A BLOOD DRAWN OR SHOT. AS A PHARMACIST I FEEL HE DID NOT HAVE ALLERGIC REACTION FROM THE VACCINE ITSELF.  ANXIETY IS THE CAUSE OF ENTIRE SITUATION
Hidradenitis Suppurativa. It started on my left arm pit with 2 bumps. Got very infected and had drained at urgent care thinking it was just ingrown hairs. Then 2 weeks later, I got 5 more on the same arm pit. I got one on my right arm pit now and one on my groin. I have taken Doxycycline HYC 100mg 3 different times for infections. I am waiting to see dermatologist September 23 for treatment options. I have never had this before until about 2 wks after vaccine shot.
Pt got 15 mth old vaccines yesterday. This morning, child presented to office with BILATERAL eye edema and fever. Some rash noted. Referral made to Allergy specialist.
Low grade fever, redness/mild erythema without induration on upper anterior and external rotation on right arm. Developed pneumonia; put on Levaquin.
After receiving MMR shot on 5/22/02 patient stopped speaking and went into his own world.  Diagnosed with Autism 11/02. The hospital discharge summary received on 2/4/03 states seizure. The medical record received on 2/12/04 states sensory deficit and colitis. 60-day follow up on 04/14/04: "Pt has not recovered from adverse events.  My son developed autism and there is no cure for that!" Per annual report- My son has Autism caused by the themirosal in his infant vaccines.  Compounded by injecting him with 3 live viruses (MMR) at one time.
Zostavax vaccine was administered too close to the deltoid resulting in supraspinatous tendonitis and adhesive capsilitis.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in). At the time of the report, VACCINATION SITE ERYTHEMA (1st dose-big red blotches on her right arm where the injection went in) and VACCINATION SITE RASH (1st dose-big red blotches on her right arm where the injection went in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-403034, MOD-2021-403065 (Patient Link).
On 11/1/01, the pt had immediate pain at the injection site with a headache and a fever of 104F. 6 hours, post vax, she had chills, continued headache, vomiting, ear pain, neck pain and felt faint. On 11/07/01, she saw a doctor and was hospitalized.
I had shortness of breath, cough, chills and fever, along with body aches.  I was coughing a white milky sputum. There was no indication of lung infection. Extreme fatigue.
shoulder pain requiring visit to orthapedic specialist. cannot lift arm. injection entered bursa sac.
Breakthrough admission after three vaccines  Moderna 3/1/21 Lot# 010A21A;  Moderna 3/30/21 Lot# 032M20A;  Moderna 11/4/21 Lot# 076C21A
Difficult to breathe; Sore throat; Congestion; super congested and found it difficult to breathe; She was cold; Tingling in her fingers; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 08Jan2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the vaccine on Friday (08Jan2021) at 3:00 PM and an hour or two later, she was cold and had tingling in her fingers. Everything got better. On Saturday (09Jan2021), the patient had sore throat and congestion. On Sunday (10Jan2021), the patient was super congested and found it difficult to breathe. That could have been because of congestion. Today (11Jan2021), the patient was still congested. The patient is not sure if that is a vaccine side effect or if she should get tested for coronavirus. The main thing is the congestion. All the other has resolved. The patient worked in the hospital and was not sure if she should get tested. The patient had not recovered from "Congestion; super congested and found it difficult to breathe". The patient recovered from the other events in Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. It was reported that the unspecified number of patients received (Oka/Merck) VARIVAX (injection, 0.5 ml once, subcutaneous, dose unspecified in series, lot# was unspecified) that underwent multiple temperature excursions. Nurse stated (Oka/Merck) VARIVAX was exposed to a maximum of SF for cumulative 194 hours. Nurse stated excursions and (Oka/Merck) VARIVAX administrations occurred between 19-NOV-2013 and 28-FEB-2014. Nurse stated she currently had no patient data. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Rash, redness, itchiness and slight swelling around injection site. Raised area warm to the touch.
Spiked temp of 104.8 on the evening that he received his vaccines. Continued to have fevers and his highest temp was 105.3 on 7/9/14 at 5:30 AM. Was evaluated in our office on 7/8/14 and 7/9/14.
9 x 9 cm erythematous reaction occurred about 24 hrs after DTAP/IPV given. Quite warm to palpation.
2 yr 5 month old pt was given expired Hep B vaccine. Called pt's mother and left her voice mail to contact clinic.
This spontaneous report as received from a registered nurse refers to a 18 year old patient. Medical history was not provided. On 09-DEC-2013 the patient was vaccinated with VARIVAX (Merck) subcutaneous. Concomitant medication was not provided. On an unspecified date after injection, the patient experienced induration at injection site, redness and swelling. Treatment information was not provided. The outcome of the injection site reactions was not provided. There were three patients with injection site reactions reported: one other patient experienced the most severe reaction. Case was linked to case 1401USA002343 and 1401USA001254 (same reporter). Additional information is not expected.
I started feeling a lot of sinus pressure and the back of my neck started hurting. I had the chills and had a temperature at the same time. I was very achy and I lost my sense of smell. I went to Urgent Care on Wednesday and was told I had tested positive for Covid. I also had shortness of breath.
69 year old patient/administered Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Additional patient notes included No history of Meningococcal vaccine..   On 10th August 2021, the patient received Menveo. On 10th August 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The registered nurse reported that a 69 year old patient was administered Menveo, which led to inappropriate age at vaccine administration. The patient was HIV positive and had no history of a Meningococcal vaccine.  The reporter did not consent to follow up.
Local reaction with marked erythema, warmth, and pain at injection site within 12hrs of administration. Size of affected area 12cm X 10 cm Treated with Benadryl + pain meds.
PT RECEIVED VACCINATION 5 DAYS EARLY, DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR SIDE EFFECTS. ADULT SISTER MADE AWARE.
Pt devel a lump @ inject site, w/marked tenderness & warmth p/receiving Td; 1 wk later, pt exp severe itching, which was noted to continue occasionally as of 21FEB91; No tx was used for this rxn;
Initial report received from a healthcare professional on 10-OCT-2013. 4 employees received 0.25 ml dose instead of 0.5 ml dose of patients were treated with expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient states she  developed "a painful "stitch" in my side on 3/28, then developed a shingles rash on 4/1.  I went to the doctor's office on 4/2 where I was given an antivial medication for my shingles to use for 7 days and a steroid cream".
bad Headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad Headache) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history not reported.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced HEADACHE (bad Headache) and DIZZINESS (dizziness). At the time of the report, HEADACHE (bad Headache) and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-068476 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068476:Dose 2
Patient received immunizations and approx 15 min later she developed swollen eyes, hives, red rash which spread over arms, legs, back feet, itchy throat received BENADRYL oral, albuterol neb, rash slow to improve admitted to hospital/Sats 96-100% HR 170's decreased to 130's after tx.
2 days p/vax pt devel inj site pain w/inability to move shoulder;pt  seen by MD & treated w/pred;10NOV there was no improvement in sx;reporter stated that the pt was injected just under acromian process, & inj may have been intra-articular
On 2/17/22 patient recieved vaccine that expired on 2/12/22.
pt had shot & walked back to school & face was flushed upon arrival (5mins), mouth & throat was itchy & numb, edema around lips, eyes swollen, & intense burning in chest, blurry vision
Rash began 3 days after dose and spread from the left upper arm (where she got the shot) and involves her upper chest, neck, scalp and face.  Edema and erythema involving left upper arm, both ears, scalp line, posterior neck, and anterior chest. Notable edema of both ears, white scale along posterior scalp line, mild erythema of bilateral upper eyelids. Rash is vesicular with some open blisters at the left posterior neck.
One hour after his 2, 4, and 6 month vaccines he had inconsolable screaming for 4-6 hours. Arching of back and stuffing in his body. He ran a slight fever and had lumps on his legs for a few days.
hives; itching; swelling around the eyes; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 04Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 06Apr2021, two days after receiving the first dose patient experienced hives, itching, and swelling around the eyes. Patient was given Zyrtec and went to emergency room where she was given intravenous Solumedrol and intravenous Pepcid as a corrective treatment for the reported events. Outcome of the events were unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
The patient did not remember receiving 2 previous doses of this vaccine. He requested the dose / vaccine and came back a day later stating that his wife told him he had already completed the series.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients whose demographics were unknown. The medical history of patients and concurrent conditions were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored VARIVAX (lot # K010437, expiry date: 22-JUL-2016; lot # L026411, expiry date 15-FEB-2017) dose number, dose and route unknown. Concomitant medications were not reported. No adverse symptoms were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
C/O SOB and tachycardia shortly after receiving flu vaccine - went to ER - HR 120, BP 163/94. R 20 - placed on O2 - denied SOB, chest pain, labs drawn with EKLT. Accucheck 96 during MD eval HR increase 150, c/o weak, dizzy - 0920. HR 80's. referred to cardiologist  Echo (normal).
CHILLS; SWEATING; ACHINESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included alcohol use, and concurrent conditions included asthma, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and patient had no drug abuse or illicit drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 16-MAR-2021 16:00 at right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levofloxacin for asthma, and montelukast sodium for asthma. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced sweating. On 16-MAR-2021, the subject experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, sweating, and achiness. This report was non-serious.
After receiving the pfizer covid vaccine,  within hours felt flushed....lightheaded...,  slight headache with minutes of receiving vaccine.  Felt as if I was running fever, no fever. The following day...neck pain with chest discomfort...assuming acid reflux or something...discomfort continues for few days, took my blood pressure,  extremely high...I have never seen my blood pressure high like this...waited for another day...ended up going to the ER for neck pain,  chest discomfort,  symptoms of what is said to be heart attack,  didn't get worked up as much at ER...blood still extremely high...dr. says nothing...but follow up with Dr. I have proof of my blood pressure,  never been dx with hypertension....I regret that I decided to get vaccinated...I will not return for second required dose..next week...after what I'm experiencing...I'm going to share with others within my community....I am scared.
first dose of Shingrix on Jan 2019 / second dose yesterday (April 26th, 2021); This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2019).   On 26th April 2021, the patient received the 2nd dose of Shingrix. On 26th April 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 age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No further information available. The patient did not consent to follow up.
The arm that received the injection is severely sore. It still hurts to lift it above my head, dress, or lift things.
Some pain right from the arm where there shot was administered coming right up to the area of collar bone on right/ There seems to be some sort of crumb forming around collar bone and very painful; There seems to be some sort of crumb forming around collar bone; Some pain right from the arm where there shot was administered; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old, male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO198) via an unspecified route of administration in the right arm on 03Aug2021 at 13:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as not available. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO186) via an unspecified route of administration in the right arm on 13Jul2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 05Aug2021 at 04:30, the patient experienced some pain right from the arm where the shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and was very painful. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events some pain right from the arm where there shot was administered and came right up to the area of collar bone on right, there seemed to be some sort of crumb forming around collar bone and very painful were not recovered at the time of this report.