chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/21/2021 11:22am HCP #2 Triage for COVID 19 SEVERE post Vaccine Reaction VAERS reportable Contact #: Your concerns: Dept: Have you missed work? #shifts: today Did you seek emergency care? yes Date and Time of Vaccine: 1/20/2021 @ Age at time of vaccination, ____24____ years Sex: m Was the vaccine received at facility? yes Site of vaccine (LD or RD): LD Type of Vaccine Pfizer ( X) Moderna ( ) Other _______________ 1st or 2nd dose: 2nd When did your symptoms start? 1/20/2021 Please note reported symptoms yes or no, these symptoms are considered mild to moderate and are NOT VAERS reportable Injection site pain yes Tiredness yes Headache yes Muscle Pain yes Chills yes Joint Pain yes Fever (note temp if known) no Injection Site Swelling no Injection Site Redness no Nausea no Feeling Unwell yes Swollen Lymph Nodes (lymphadenopathy) no Other: Patient reports THE FOLLOWING SEVERE post vaccine ADVERSE reactions (reportable): Difficulty breathing no Swelling of your face and throat swelling of the lower lip A fast heartbeat relates heart rate greater than 110 A bad rash all over your body no Dizziness and weakness If COVID-19 symptoms persist and/or worsen beyond 48 hours consider COVID-19 testing Treatment/Advise: Plan: Consulted with HCP, patient sent to urgent care clinic for further evaluation. If patient was vaccinated at another facility, they need to contact that facility , it is an expectation that the facility that gave the vaccine complete the VAERS report. Patient verbalizes understanding and agreement with plan. VAERS report is completed electronically if vaccine given at facility. Signed by HCP on 1/21/2021 at 11:22am
Pt. seen in office 08/21/15 for 4 yr WCE; Rec'd 5 yr immunizations (for pre-k). Redness and warmth to (Lt) arm began 08/222/15. Increased s/s on 08/23/15. Non-tender; afebrile on exam for s/s on 08/24/15. Tx with MOTRIN-prn; warm/cold compresses and KEFLEX for (?) cellulitis.
Patient presented to clinic 1 day after pneumovax injection, left deltoid area. Grossly swollen, pain, hot, and red. Patient evaluated by provider.
Had vaccine shot on Saturday 12/19/20. Slight tingling/numbness in cheek and upper jaw for 45 minutes on Sunday 12/20/20.
THIS PERSON WAS GIVEN H1N1 FLU MIST AT CLINIC STAFFED BY PHYSICIAN ASSISTANT STUDENTS.
urticaria (hives) 3hr p/vax;PE WNL x/diffuse urticaria on belly sides & face per MD;
One week after Moderna covid vaccine #1, my injection sight got very swollen and itchy for about 3 days. I also had a mild headache and nausea during this time.
Information has been received from a physician concerning a female with a history of ventricular septal defect and cardiac valve disease who on 02-DEC-2007 was vaccinated IM with the second dose of Gardasil.  Concomitant therapy included ZOLOFT.  On 03-DEC-2007 the patient experienced dizziness.  Subsequently, the patient recovered from her dizziness.  The reporter felt that dizziness was not related to therapy with Gardasil.  No further information was provided.  Additional information has been requested.
hot flashes; difficulty breathing; swelling of throat; fast heartbeat; dizziness; weakness; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2, COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 13:45 (Batch/Lot Number: EN6204) as single dose for covid-19 immunization.  Patient was not received any other vaccine in four weeks, Vitamin B12 received in two weeks. Concomitant medication included cyanocobalamin (VITAMIN B12). Patient was not pregnant. The patient experienced difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus, hot flashes, could not focus on 31Mar2021 13:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included allergies to shellfish (though allergy test says otherwise, wool, poison ivy, jewelry not identified why, heart rate fast on 31Mar2021. There was no covid prior vaccination, no covid tested post vaccination. Therapeutic measures were taken as a result of hot flashes, difficulty breathing, swelling of throat, fast heartbeat, dizziness, weakness, tinnitus. The events outcome were resolved with sequel.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
COVID-19; COVID-19; Dose Number: 1 Batch/Lot No: GH9694; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:00 as dose 1, single (Lot number: GH9694) at the age of 45 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Dose Number: 1 Batch/Lot No: GH9694". The patient underwent the following laboratory tests and procedures: Body temperature: low grade fever, notes: low grade fever; SARS-CoV-2 test: Negative, notes: Tested negative on 2 different antigen test; Negative, notes: Tested negative on 2 different antigen test; Positive, notes: Two days later tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as treatment for covid-19. Tested negative on 2 different antigen test. Two days later tested positive along with low grade fever, headache and runny nose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness, swelling - approx. 10cm with redness increasing toward       with pain and fever. Received vaccine on Friday and had increased redness, swelling and fever over weekend was seen in employee health. 6/22 and sent to clinic.
Side effect observed April 29, 2021, suspected Left superclavicular lymphadenopathy.  Tele-health tentatively diagnosed as superclavicular lymphadenopathy without seeing / touching mass In person examination ruled out superclavicular lymphadenopathy and scheduled a surgical consult
Patient was spotting 2 weeks before her next menstrual cycle. Never had this problem before. Periods normal. This happened 4 days after her second shot. It?s going on 3 days spotting already
Burning began at injection site before IM injection was completed. Post-injection, burning and pain started in my left shoulder and progressed through my deltoid toward my elbow. Burning and pain continued for 6 days, the pain and weakness have persisted in my left arm. I have a very sore spot on my upper forearm, adjacent to my elbow. It is approaching 12 days post-injection, yet the pain and weakness in my left arm continue and are not improving.
Awoke the morning after receiving the 2nd dose of the Pfizer COVID vaccine with low-grade fever, slight headache which worsened throughout the day, chills, and body aches.
Periorbital swelling, bilaterally - noted day after vaccinations received. Spontaneously resolved. No other symptoms.
Soon after the injection she went limp, blood pressure dropped and she remained semi-conscious.  We called the emergency medical team.  They did a full eval and released her to her mother to take her home.
Mother notice orange copus amounts of drainage coming from right ear. Left ear is dry with ear wax. No appitite. Not thirsty. Slight fever of 100.1 F. Fatigue. Child reports unable to hear as well from right ear. Throw up clear liquid. She was brought to clinic. She was advised to contact the Health Department to report event. The clinic was shocked by the amount of drainage coming from the right ear. They referred to ENT which is scheduled on 12/3/2021. The drainage was so severe that the clinic couldn't see the ear drum. The clinic is thinking possible diagnosis of ear infection with possible proferation of eardrum. Left ear was diagnosed with ear infection. She got Amoxcillin 400 mg/5mL take 10mL by mouth twice daily x 5 days.
At Hepatitis A Outreach, box of pediatric Hepatitis A vaccine in cooler instead of adult formulation. Used vial of pediatric for adult client.
Swelling, Mild tenderness, redness, 8"4 effected area.
contracted COVID-19 after first vaccination; got very sick; had not had second dose as of time of the call; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (contracted COVID-19 after first vaccination), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19 after first vaccination), ILLNESS (got very sick) and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call). At the time of the report, COVID-19 (contracted COVID-19 after first vaccination) and ILLNESS (got very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had not had second dose as of time of the call) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.
Full body rashes or hives; My arm started feeling a bit itchy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 08May2021 at 09:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. Allergies to medications, food or other products were reported as not that the patient knows of. The patient previously received first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 11May2021 at 03:00, the patient experienced full body rashes or hives. The patient was not sure which one they were. This was about 3 to 4 days after the shot. The patient's arm started feeling a bit itchy when he went to sleep that night and the next day these bumps were spreading all over. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event full body rashes or hives, started feeling a bit itchy was not resolved at the time of this report.  No follow-up attempts are needed; No further information is expected.
Patient was due only for a Dtap vaccine but was given a Pediarix vaccine instead. Patient did not have an adverse reaction to the vaccine but was given the incorrect vaccine. The patient was not due for a Hep B or IPV vaccine at the time.
Grad Intern, administered vaccination to patient at around 11:10 am. Patient was fine after and sat in the waiting area. 5 minutes later, technician noticed patient slumped backwards in her chair, unresponsive to calls and then flags for Grad Intern and pharmacist. They rush out to waiting area, grabbing an EpiPen along the way, and had the store manager  call 911. Upon examination, patient was unresponsive and her eyes were rolled back with possible trouble breathing. Patient was also observed to be shaking briefly and sweating profusely. EpiPen was administered to the right thigh and patient became responsive 10-15 seconds after administration. Patient's Aunt  was contacted. Patients blood pressure was taken and was 85/57 with pulse 59. EMS arrived  about 15 minutes later and evaluated and took her to the hospital.
General dizziness that appeared this morning after the second shot. Felt like flu symptoms. Temperature below 37.3. It started to dissappear at 14:00
During the early morning hours of Friday, February 19, approximately 12 hours after the vaccination, I awakened to a 102 degree temperature, chills, nausea (triggering dry heaves), strange dreams, and very weak legs.  Over the course of the day I alternated taking Ibuprofen (200mg) and Acetaminophen (500mg) every two hours for eight hours to drive down the temperature.  I also pushed water, and took naps.  I continued this treatment throughout the day of Feb. 19, and once on Saturday, Feb. 20.  I experienced a deep degree of lethargy beginning these days and continuing for several days later.  I did not "feel like my old self" until Friday, Feb. 2, eight days following the vaccination.
1st dose of vaccine, August 4, had bleeding on the site of administration resulting to hematoma on the left arm that lasted for 3 weeks. Experienced flu like symptoms dry cough, nasal congestion and headache, body ache and fatigued. 2nd dose of vaccine August 25, soreness on the left arm, flu like symptoms body aches and fatigued, headache, pain all over my body. I took acetaminophen day 1 after vaccine as I really dont feel well. , on day 2 (friday) I woke up with redness patch on my left arm, sored left arm, body pain, muscle/body aches, fatigue, low grade fever, headache, pain all over my body. I took tramadol 1 tablet and 2 tabs of ibuprofen just to ease the pain that helped a little bit for the entire day, at night I took naproxen before i sleep. Today, day 3, redness patch on my left arm seemed to be bigger and wider.  warm to feel and put some ice pack just to relieve the soreness. hydrating myself and took some acetaminophen this morning.
my voice suddenly drops and I sound like a man; fingers hurting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting). At the time of the report, DYSPHONIA (my voice suddenly drops and I sound like a man) and PAIN IN EXTREMITY (fingers hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Got 1st dose, forgot the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date 1st dose received).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: The patient received the first dose of shingrix and forgot to receive second dose.  The reporter stated that he/she forgot the 2nd dose. It had been a year. The reporter also asked what was the recommendation, restart the 2 injection series or just give the 2nd dose. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Mother noticed raised, red spot on the child's right deltoid,at the Prevnar injection site, on Monday morning 10/11/04. The area became black and blue over the next few days. Today, 11 days post injection, there is an erythematous and edematous area at the site with a hard lump beneath it. Mother reports she massaged the area after she noticed the swelling and redness. The child never showed any signs of discomfort in the area, however was a little more irritable.
Pre term labor. Due date 10-21-21. All labs came back normal. No explanation for sudden onset.
This spontaneous report as received from a registered nurse refers to a 4 month old patient (gender not reported). On 07-AUG-2013 the patient was vaccinated with ROTATEQ (lot # 1844AA, expiry date 01-JUN-2013) dose 2, oral. Dose was not reported. The first dose was given on 06-JUN-2013. On 07-AUG-2013 the patient received an expired dose of ROTATEQ (expiry date 01-JUN-2013). No adverse effect was reported. Additional information has been requested.
Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain; Sudden head rush; This is a spontaneous report from a two contactable Other Health Professional (one of which patient) received via Medical Information Team.  A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), via an unspecified route of administration in arm left on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine at 10 mg and rosuvastatin calcium at 20 mg, both from an unknown date and ongoing.  The patient experienced headaches, dizziness, loose stool, upper back pain where the lungs are/upper back pain, all on 02Jan2021. The patient also experienced loose bowels on 03Jan2021 and sudden head rush on 30Dec2020.  The patient underwent lab tests and procedures which included COVID-19 test which resulted negative on 06Jan2021.  The patient outcome of headache, dizziness, loose bowels was recovering, the outcome of loose stools was unknown, the outcome of back pain and sudden head rush was recovered.
SEVERE HEADACHE, SHARP PAIN IN ABDOMEN, MUSCLE ACHES, JOINT PAIN, NAUSEA, VOMITING, CONSTANT LOOSE BOWEL MOVEMENTS, CHEST PAIN, BURNING AND PAINFUL URINATION, ELEVATED THYROID LEVELS, AND GALL BLADDER DYSFUNCTION
This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient's current conditions or medical history were not reported. On an unspecified date in 2011, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). 17-MAR-2014, also reported as today, the patient reported a case of shingles. At the time of the report outcome for shingles was unknown. The patient went to the pharmacist for medical attention. Additional information has been requested.
Mother states that one day post vax, the child broke out in whelps the size of quarters and in certain areas these were raw. She took him to see an MD and he suspected an allergic reaction to immunizations.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 years old male patient who experienced fever, pain, large area of erythema, induration and tenderness, while he received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 15-Oct-2018, the patient received a dose of suspect QUADRECEL VACCINE lot C5497AA via unknown route. On an unknown date, the patient developed a non-serious fever (pyrexia) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious pain following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious large area of erythema (erythema) following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious induration following the administration of QUADRACEL VACCINE. On an unknown date, the patient developed a non-serious tenderness following the administration of QUADRACEL VACCINE. It was also reported that on 18-Oct-2018 patient came back with a reaction on his arm at injection site. Developed large area of erythema, duration and tenderness of the right deltoid with defined lines. On 20-Oct-2018 following up for reevaluation. (Other relevant tests included No lab data.) Final diagnosis was tenderness, induration, and large area of erythema, pain and fever. The patient was treated with KEFLEX. The patient outcome is reported as Unknown for fever, as Unknown for pain, as Unknown for large area of erythema, as Unknown for induration and as Unknown for tenderness. List of documents held by sender: none.