chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 21-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine) had resolved.            Patient received the first dose of Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine. Patient received the first dose of the Pfizer on march 22nd.  No concomitant medications was provided.  No treatment medications was provided.
Fever of 101, chills, severe headache, nausea. Started at 5 am following day, still ongoing at 1 pm (24 hours after injection)
Pain in bicep when left arm is raised. No discomfort when arm is at rest (down).
12/24/04, client had temp 102 or higher and had seizure. Brought to ER. Motrin given and observed and discharged. 12/25/04, 05:00 AM, another seizure. Called doctor and was instructed to give Motrin and Tylenol alternately. 01/19/05, seizure again. No temp, no illness. Started on Phenobarbital 1/20/05. EEG normal. Has an MRI scheduled, then Neurologist appt on 5/4/05. Has a family history of seizures (mom's nephew, mom's sister and mom's cousin. All "grew out of them"). Spoke with mom on 5/10/05 and pt had MRI on 4/25/05 and results were "normal". Now weaning off Phenobarbital, last dose will be 5/29/05. So far, no seizure activity. Stated that pt didn't get fever with last set of immunizations but did get light rash which lasted x 3 days.
This spontaneous report as received from a registered nurse refers to a currently 1 year old patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 07-AUG-2014 the patient was vaccinated with (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous in the left thigh, lot number K006770, expiration date 07-NOV-2015, for prevention (dose number were unspecified). On an unknown date in August 2014, the patient experienced injection site reactions and swelling after an injection (Oka-Merck) PROQUAD. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between (Oka-Merck) PROQUAD and the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Health care worker reported that he had an adverse effect of the second dose of Moderna vaccine. He described normal side effects in the first two days following the second dose: fatigue, nausea, headache. Then noticed redness and a cluster of vesicles on the right upper forehead on 4/22/21. Diagnosed with Shingles and treated with antiviral medication.
Fever 102, pain, joint pain, fatigue, stiff neck, malaise, chills, over all severe flu-like
Information has been received from a certified medical assistant concerning a 71 year old male with gout, hypertension, hypercholesteremia, and diverticulitis who on 23Mar04 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included bisoprolol fumarate/HCTZ (Ziac) 5 mg once daily, allopurinol, 300mg once daily, meloxicam (Mobic) 15mg once daily, sildenafil citrate (Viagra) 100mg prn, hydrochlorothiazide (+) Valsartan (Diovan HCT 160) 12.5 mg once daily atorvastatin calcium (Lipitor) 10mg once daily and colchicine 0.6 once daily. On 24Mar04 the pt developed a fever. On 25Mar04 the pt came in to the office with a red, itchy area on the upper trunk, right arm and right  side, and swelling. His temperature was 98.9 the client was treated with a steroid injection. It was reported that the pt had not recovered. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a local site reaction. Additional information has been requested.
Arthrus reaction, started as a red bump in the morning and progressed to a large, raised, red and warm area surrounding and involving the injection site.
getting COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (getting COVID) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (getting COVID). At the time of the report, COVID-19 (getting COVID) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   It was reported that on 10-Jan-2021, the patient had the bam infusion done. Reportedly, the patient's second dose was scheduled on 28-Jan-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI-TCR (reporter provided email address)
Case previously recorded as MA2009-4321. Initial case report received from a health case professionall via agency, on 11 NOV 2009. A male patient was vaccinated with 0.5 mL once of FLUVIRIN (batch no. 102125P1) i.m on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
Patient received Moderna vaccine. Around 5 minutes later, she began to feel lightheaded. Blood pressure was checked and was bnormal. Patient started to feel better after about 5 minutes. She was evaluated by EMT.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that, on an unknown date, the patient may have received a dose of ZOSTAVAX (lot number, dose and route unspecified) that had expired on April 2012. This occurred with another unspecified pharmacist and the pharmacist was not sure if the patient did receive ZOSTAVAX or not. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information is not expected.
No adverse effects reported; The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes; This spontaneous report was received from a receptionist referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medications were no reported.  On 25-JUL-2019, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot# R021370 and expiration date 07-NOV-2020) (dose, frequency and route not reported) for prophylaxis. The vaccine was inappropriately stored at 25 degrees Fahrenheit for 3 hours and 49 minutes (product storage error). It was reported that a digital data logger was involved, but no previous temperature excursion information was provided. No adverse effects were reported.  This is one of two cases received by the same reporter.; Sender's Comments:  US-009507513-1907USA016750: US-009507513-1907USA016750:
Information has been received from a physician concerning a 60 year old female patient who on 22-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) 0.65ml, intramuscularly. On 22-MAY-2009 she experienced soreness and was treated with ice packs. At the time on the report on 22-MAY-2009 the patient had not recovered. The patient sought unspecified medical attention. There were no laboratories diagnostics studies performed. Additional information has been requested.
Perniosis 3rd toe, right foot first noticed four days after vaccination, still present on day 8 after onset.
admitted to hospital with heart problems, Ventricular Contractions TWICE in one day; large red rash on right arm from elbow to top of arm; worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go; felt fatigued; sick with 100 degrees F temperature and 99 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (sick with 100 degrees F temperature and 99 degrees F). On 01-Apr-2021, the patient experienced CONDITION AGGRAVATED (worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go) and FATIGUE (felt fatigued). On 02-Apr-2021, the patient experienced CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day) (seriousness criterion hospitalization). On 03-Apr-2021, the patient experienced ERYTHEMA (large red rash on right arm from elbow to top of arm). On 31-Mar-2021, PYREXIA (sick with 100 degrees F temperature and 99 degrees F) had resolved. On 08-Apr-2021, CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day), CONDITION AGGRAVATED (worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go), ERYTHEMA (large red rash on right arm from elbow to top of arm) and FATIGUE (felt fatigued) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID-19 POSITIVE Narrative: Employee received J&J vaccine on 3/11/21. COVID-19 positive on 3/15/21. Admitted to local hospital on 3/29/21 with COVID-19 pneumonia. Developed a pulmonary embolism during hospitalization- now on apixaban.  Other Relevant History:
Rash on torso, arms, &legs (not itchy), observed at 5:50am on 2/7/21, and is still present. A congested cough began at 8:00am on 2/7/21, and is still present. Note:  On 2/5/21 at 3:00pm, chills, fever, body aches, diarrhea, and fatigue began, and lasted 5 hours.
Vial punctured 24 hours or even 48 hours prior to being adminstered; A spontaneous report was received from a nurse who was also a 31-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced the event, vial punctured 24 or even 48 hours prior to being administered.  The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 vaccine (Lot 039K20A) intramuscularly for prophylaxis of COVID-19 infection on 06 Jan 2021. The patient noted that the vial was punctured for 24-48 hours before the vaccine content was administered to her.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, vial punctured 24 or even 48 hours prior to being administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 31-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 039K20A), reporting Out of specification product use without any associated adverse events.
Extreme muscle soreness and Weakness in legs (thigh muscles, Calves, hips, knees, feet and bottom of Feet) that is still on-going that started Day after 1st shot and progressed Greatly after second shot; Menstruated in April and May even though past menopause for more than 2 years; Headaches; swollen glands in neck and armpits; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (at the age of 49-years-old) as dose 2, single for covid-19 immunization. Medical history included blood pressure, allergic to Latex, allergic to shellfish, allergic to sulfa drugs. The patient had received BNT162B2 dose 1 (Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 16Mar2021 as dose 1, single for covid-19 immunization and had experienced Menstruated in April and May even though past menopause for more than 2 years, extreme muscle soreness, weakness in legs (thigh muscles, calves, hips, knees, feet and bottom of feet), Headaches and swollen glands in neck and armpits. The patient received no other vaccine in four weeks. Concomitant medication included metoprolol succinate (TOPROL XL); olmesartan medoxomil (BENICAR); escitalopram oxalate (LEXAPRO).  On an unspecified date, the patient experienced extreme muscle soreness, weakness in legs, progressed greatly after second shot (condition worsened), menstruated in april and may even though past menopause for more than 2 years, headaches, swollen glands in neck and armpits. Treatment was given for the events with Tylenol and was asked to rest. Extreme muscle soreness and Weakness in legs (thigh muscles, Calves, hips, knees, feet and bottom of Feet) that was still on-going that started Day after 1st shot and progressed greatly after second shot. Patient was not covid prior vaccination. Patient did not test for covid post vaccination. Outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected.
It was reported post vaccine's pt developed a local reaction of redness and swelling at the injection site, the thigh was warm and swollen.
Right arm cellulitis at injection site with fever and swelling. KEFLEX 500 mg BID X 10.
Hospitalized for 4 days with DVT and PE. Shortness of breath, coughing, leg swelling, numbness, pain and multiple occluded clots from lower leg to groin.
c/o pain, heat & swelling rt arm; diaphorectic most of the time; rt upper arm rest, hard, round, swelling @ site of inject; around tender to touch; abscess;
8cm X 11cm red area at injection site, 5 days after reaction. Both DTAP and IPV given at the same sight (right deltoid).
Pt. after Vaccination pt. report feeling faint and weak. Appear pale. Pt. slump down in chair.  Placed supine on floor feet elevated. Pt regain consciousness. EMS arrived .Pt refuse transport stated starting to feeling better. Pt Stay seated on floor until 1300.  Drank water and was able to get walk. Pt. left ambulatory accompanied by spouse and aunt.
Generalized tonic-clonic seizure activity lasting approximately 15 seconds with return to normal activity afterwards. No specific treatment given.
pt recvd 1st dose of HEP B vax w/no noted problem; pt recvd 2nd dose of vax 18AUG92 w/in an hr following vax pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
Patient hospitalized for scheduled repeat c-section at 39w0d gestation. "with apgars 8/8 at 1 and 5 minutes respectively. Birth weight 7lb 11.5oz. Her delivery was uncomplicated. Postoperatively, she recovered without issues and by POD#2 she was ready to be discharged to home. "
Patient reported that she received her second dose of the Moderna COVID-19 vaccine on 05/16/2021. Patient stated that one week later on 05/23/2021 she went to an ER due to chest pain and SOB. Patient stated that she was diagnosed with DVT and a Pulmonary Embolism following imaging studies and was transferred to another hospital for medical treatment. Patient stated that she underwent catheterization to remove the blood clots from her lungs, and is now on Eliquis and continuous oxygen.
On October 20th, 2021, Patient presented to the pharmacy for the 1st Dose of the FDA Approved Pfizer-BioNTech COVID-19 Vaccine. Prior to administration that patient said that he was afraid of injections but during administration the patient stated that he did not feel the needle being administered for the vaccination. After administration, the patient said he was dizzy and that he needed a bottle of water, after retrieving the bottle of water the patient woke up from fainting and stated that he fainted and was not able to hear during the time that I went to retrieve the bottle of water. The other pharmacist and technicians kept watch on him for 15 minutes and he felt okay afterwards and left the pharmacy in a healthy state.
Patient describes feeling cold when sitting in observation but nothing else. Went to car. Patient began vomiting multiple times on drive home while shaking. Several hours later patient with a headache. The next day she reported feeling exhausted and today reports feeling well.
Left calf and ankle swollen after 2nd dose on 5/2, d-dimer blood test 0.54, ultrasound found a Baker's cyst.  No treatment yet and left calf is still swollen after 4 weeks.
Received Vaccine on Friday January 15th 2021 at approximately 0715am after my Isolation and having had no symptoms for over a week.  Received injection, was observed by our Physician staff for approximately 35 minutes with no adverse reactions noted at that time.  Approximately 30 hours later on Saturday my left arm began to hurt and a very very strong fatigue came over me and I took a 2 and a half hour nap on the couch.  I was still extremely fatigued upon waking, but my arm continued to hurt more and more up to the point it wasn't usable for anything heavy and/or strenuous at all, hurting just to use it for getting up from the couch.  I was assisted to get me things like water, food and stuff.  The arm pain began to radiate towards my left shoulder and eventually throughout the day the pain was spreading from my shoulder to include my left upper thorax and left rib cage.  By Sunday, what had begun as left arm pain had now become stronger an approximate 5/10 pain.  It started to present as atypical chest pain having the pain now fully encapsulated within my left upper chest.  Felt what appeared to feel like intercostal pain and a general ache all throughout.  By Monday the pain was still all throughout and assessed the situation from a cardiac standpoint and found that the pain was mostly positional and I wasn't exhibiting any cardiac symptoms such as shortness of breath, no sub-sternal pain, no jaw pain, no back pain.  It hurt more as I would take a deep breath and began to move my left arm around and bringing it up from my side and did a stretch with my crooked elbow of my left arm I raised it to the ceiling and moved my thorax to my right side and found that this would make it hurt more, so I did some twisting of my thorax and abdomen and found that the pain would increase from movement, it was then that I began to think that it might be Pleuritic pain.  Tuesday the 19th and Wednesday the 20th I had to call in Sick because I developed a severe muscle ache below my left calf between my calf and left ankle, as if it was in constant spasm and it affected my walking, like a Charley Horse feeling and wondered if it were the same kind of feeling that I had in my chest and I found it quite odd that all my symptoms were on the left side which is the same side I received the vaccine because my right side didn't have any muscle aches.  The overall chest pain began to subside over the next couple of days, but the pleuritic pain that I described never decreased in intensity or pain level.  I saw my Personal Dr yesterday January 21st 2021 at approximately 5:15pm as he was walking out of his office and we discussed my symptoms and believing that my symptoms seemed to indicate some kind of tentative diagnosis of a pleurisy issue as he had agreed that there didn't seem to be any cardiac involvement and am scheduled to see him again tomorrow Saturday January 23rd at 4pm  As I write this the pain continues as before with no seeming end point and is not diminishing.  I had phoned and talked yesterday afternoon and felt it best to check with my primary physician because he hadn't had any reports such as mine.
Patient reported to observation Nurse practitioner she was feeling extremely nauseated. Patient dry heaving patient stated she felt tensed and nervous prior and during receiving the vaccine. Patient did mention nausea was normal for her whenever she became anxious.   Patient did state prior to the appointment she had ate a heavy breakfast and had not been drinking sufficient water. Patient was keep for an additional 15 minutes for a total of 30 minutes patient verbalized feeling better. Denied feeling nauseated, or any other allergic reaction symptoms patient was informed to call 911 or go to nearest emergency room if symptoms returned.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  On 01-Apr-2022  vial was initially stored in the refrigerator  and thawed on the day of use. Patients administered the vaccines on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022,01-Apr-2022 and 04-Apr-2022. Vial did not undergo any temperature excursion issue.  No treatment medication reported by reporter.
Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die