chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; received their first dose of the Pfizer covid vaccine on 24JUL2021 but both of them tested positive after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (husband) that a male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/lot number: Not Provided, Expiry Date: Not Provided), via an unspecified route of administration on 24Jul2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, received their first dose of the Pfizer covid vaccine on 24Jul2021 but both of them tested positive after the first dose. This report related to a study or programme. Reason for no lot number: of Pfizer covid vaccine: Other: Support agent disconnected prior to completion of transfer. No voice contact made between this safety agent and the Caller. Full details not obtained.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Fever of 101.9, rapid heartbeat, labored breathing, nausea, strange behavior - out of it, saying things that didn't make sense.
sore arm, brain fog. pt came in on day 2 10/08/2019 and said it is getting better but not completely normal. she hopes it goes away by day 3
Warm to the touch; Itchiness at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
No verbal Warning toward injection PAIN..!   Immediate severe headache....  Awakened 12 hours after injection with Chills and mild fever...  Severe pain at injection point...   Overall body aches, ringing in the ears....
Left arm - itchy, burning, welts immediately. Same day - Rash to elbow and bump where injection site.
Exhaustion; Very tired; Full body ache; I developed shingles; Received the third dose of Moderna covid-19 vaccine; Lightheadedness; Brain fog; Felt off; Sore arm at the injection site; not stored at the proper temperature; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A, 031A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bicuspid aortic valve since 07-May-1985.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (not stored at the proper temperature) and INJECTION SITE PAIN (Sore arm at the injection site). On 13-Apr-2021, the patient experienced DIZZINESS (Lightheadedness) and CONFUSIONAL STATE (Brain fog). 13-Apr-2021, the patient experienced FEELING ABNORMAL (Felt off). On 21-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine). On 23-Apr-2021, the patient experienced HERPES ZOSTER (I developed shingles). On an unknown date, the patient experienced FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache). On 13-Apr-2021, INJECTION SITE PAIN (Sore arm at the injection site) had resolved. On 14-Apr-2021, DIZZINESS (Lightheadedness), CONFUSIONAL STATE (Brain fog) and FEELING ABNORMAL (Felt off) had resolved. At the time of the report, PRODUCT STORAGE ERROR (not stored at the proper temperature), EXTRA DOSE ADMINISTERED (Received the third dose of Moderna covid-19 vaccine), HERPES ZOSTER (I developed shingles), FATIGUE (Exhaustion), FATIGUE (Very tired) and MYALGIA (Full body ache) outcome was unknown.            No concomitant product was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Date of 3rd dose was updated, New events were added in the follow up outcome of the events are updated On 21-Jul-2021: Follow-up received and updated batch no and patient demography.
Went in for routine CT scan in December for my lungs and while reviewing it the radiologist found a cyst on my thyroid. In February they did an ultrasound and a biopsy is scheduled in the future. This is the 3rd cyst after I began receiving the COVID-19 vaccines. The first was in my scrotum in the summer of 2021 and the other on my kidney in the Spring of 2022
PT EXPERIENCED NAUSEA, HA, FATIGUE 1 DAY POST VACCINE. REPORTS HE FELT BETTER 2 DAYS POST VACCINE AND WENT FOR A REGULAR WORK-OUT WITHOUT COMPLICATIONS. PT WOKE-UP 3 DAYS POST VACCINE WITH CHEST PX, SOB, FATIGUE. HE CALLED 911 AND WAS BROUGHT TO HOSPITAL VIA AMBULANCE. PT HAD UNREMARKABLE EKG INITIALLY, LABS DRAWN. INITIAL TROPONIN 4.7, EKG REPEATED WITH SOME MINIMAL ST ELEVATION, 324MG ASA GIVEN. COORDINATING TRANSPORT TO ANOTHER HOSPITAL WITH CARDIOLOGY SERVICES, TROPONIN REPEATED AND FOUND TO BE 10.8 WITH GLOBAL ST ELEVATIONS ON EKG. PT TRANSPORTED TO HOSPITAL FOR PRESUMED PERICARDITIS. AWAITING UPDATES ON PT CONDITION TOMORROW.
Severe headache, nausea, body aches, fatigue, diarrhea began 3/26 and still have diarrhea, fatigue and headache
Sudden onset of dizziness and nausea, feeling weak and faint. Lasted approximately 15 minutes. Then had chills for additional 10 minutes. Then felt basically normal again.
Systemic Grade 3 reactions of injection site pain-heat-swelling, systemic body pain (skin, muscle, joint), fever for 36 hours 100.6, chills, fatigue, nausea, lasting for 3 days overall. Unable to function or work. My reactions were more severe in comparison to 10 colleagues vaccinated at the same time. Resolved by day 4, except left arm pain, which lasted 4 weeks.
Patient lost consciousness (twice) while sitting in the lobby and hit her head on the blood pressure machine.  Small laceration and minor swelling was seen at the time.  911 was called and paramedics took the patient out of the building after checking her BP and blood glucose.  Unknown if patient went to the hospital afterwards.
CLIENT RECEIVED HER MENACTRA AND VAQTA IN HER LEFT DELTOID THEN PASSED OUT.  CLIENT CAME TO THEN PASSED OUT AGAIN.  LOWERED CLIENT TO FLOOR AND ELEVATED LEGS WITH HELP OF FATHER, and RNs.  HER VITAL SIGNS STABILIZED, SHE WAS ALERT AND ORIENTED X 3 AND WAS ABLE TO SIP WATER AND COLA.  ONCE STABLE, ASSISTED CLIENT TO HER FATHER'S VEHICLE.  CLIENT STATED THAT SHE HAD JUST COMPLETED A RUNNING AND WEIGHT-LIFTING WORKOUT AND HAD ONLY EATEN 3 GRAPES FOR BREAKFAST.
patient with a history of recuuring shingles was administered a dose of zostavax; between the age of 35 and 40 years old; This spontaneous report was received from a registered nurse regarding a patient of unknown age (between the age 35 and 40 years old) and unknown gender. The patient's historical conditions included herpes zoster. The patient's concurrent conditions and concomitant therapies were not reported. On 09-MAR-2020 (reported as today at the time of call), the patient was vaccinated with Zoster Vaccine Live(ZOSTAVAX) (strength, dose, anatomical location, route, lot and expiry dates were not reported for re-occurrence of shingles (product use in unapproved indication and inappropriate schedule of product administration).
soreness at injection site; Swelling at Injection Site; Red Area; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), PARACETAMOL (TYLENOL), PRAVASTATIN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and GLUCOSAMINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area). At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include antiprosol, Adroitin, Propetigil and Arthritis Tylenol.
Sore arm; Every single bone where she has arthritis started to ache; Feels terrible; Felt like stabbing pains on body; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body) and HEADACHE (Terrible headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles (Had worse reactions now compared to shingles vaccine in past.). Past adverse reactions to the above products included Adverse reaction with Shingles. Concurrent medical conditions included Arthritis, High cholesterol, Migraine, Allergic rhinitis, Penicillin allergy and Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Feb-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) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), BONE PAIN (Every single bone where she has arthritis started to ache), FEELING ABNORMAL (Feels terrible), MYALGIA (Felt like stabbing pains on body), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.   The vaccine facility staff asked the patient to take 4 baby aspirin.   Action taken with mRNA-1273 in response to the events was not applicable.
Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapezius muscles. The pain was much worse in the evening/night and was sometimes absent during the day. Also on day 14 post vaccine (1/7/2021) I developed a cold sore for the first time in my life.
On the day of vaccine administration, patient had small red area and knot that went away overnight.  On the evening of 01/12/2021, she noticed the same area was itchy and had a knot around the area of previous injection.  The area is warm to the touch and visibily swollen from shoulder to elbow.  Left forearm has some slight swelling also as compared to the right.  No other symptoms at this time.  She was evaluated by nursing leadership and pharmacy personnel and advised to alternate tylenol and ibuprofen, use cold compress, and elevate arm when able to help with swelling and inflammation.
Pain, redness and swelling in arm that spread to elbow and axilla over 4-5 days. Fever of 103.0 for 2 days after injection. After 7-10 days developed skin peeling at site that looked like sunburn.
Experienced  severe joint pain in Left Shoulder,  Right Shoulder, Left and right Hips, Stiffness in fingers.   Symptoms have persisted for 3 weeks.
Patient developed edema and itching around injection site within 12 hours; area about 10cmx6cm. No rupture symptoms.
Right arm weakness, right hand numbness, leg weakness, fatigue, blurred speech, small eschemic stroke right side
This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 17-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot number H011331, expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 336 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302uSA001216, 1302USA000400, 1302USA001215). Additional information has been requested.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 08:10am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/27/2022. No adverse side effects or event as result of dose.
12 yo male with hx of broken bones (broke both arms twice 2012, 2021) here for sick visit. Pt had his immunization on Tuesday.  Had a reaction from injection.   He experience swollen arms Like 1 1/2 inches big and now its 3 inches big already   Gave benadryl helping some. Eating well. No GI sxs vaccine adverse reaction noted re; meningococcal vaccine treat symptoms indications to RTC discussed  Start prednisoLONE 15 mg/5 mL oral solution 5 mL 2 times a day for 5 days Start triamcinolone acetonide 0.1 % topical cream 1 application 2 times a day for 14 days
HYPOTENSION 5/3/2023 DM 2 W HYPERGLYCEMIA HYPOTENSION 5/3/2023 COMMUNITY ACQUIRED PNEUMONIA HYPOTENSION 5/3/2023 DM 2 W HYPERGLYCEMIA
Little appetite; Extremely weak; Hot and cold flashes; Chills; Fever greater than 100 F; Injected arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills) and PYREXIA (Fever greater than 100 F) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore). At the time of the report, DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Body temperature: 100 (High) Fever greater than 100 F.         Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Symptoms:: Rash developed at first on the left eye lid and then spread over to stomach and lower abdomen , groin and thighs and hand area. A few hours later to the neck area and also on the back side. Itching all over the body at various places Treatment at ER: diphenhydrAMINE (BENADRYL) , Famotidine (PEPCID) and methylPREDNISolone Sod Succ (PF) ( SOLU-Medrol PF) and Sodium Chloride 0.9 %   all given Intravenously Diagnosis: URTICARIA (HIVES)
Diagnosis: HSP  Henoch-Schonlein purpura; Symptoms started August 9 with extreme abdominal pain that persisted for 2 days.  He was taken to the Emergency room on August 11th by suggestion from the nurse at our pediatrician's office.  An abdominal CT scan was done and revealed no cause other than inflammation.  We went home without answers and luckily abdominal pain subsided August 13th.  During that time, patient could barely eat anything due to extreme pain.  August 14th patient was finally feeling well when he began to display a rash on his lower legs that looked like hives at first and then flattened out.  Throughout the day the rash spread up his legs to the bottom of his belly and to his upper arms.  The rash was accompanied by extreme pain in his legs, especially his knees and ankles.  We brought patient to the walk in clinic on August 15th where they advised we go to the emergency room.  At the emergency room the doctor ran blood tests that confirmed a diagnosis of HSP( Henoch-Schonlein purpura).  The emergency room was very traumatic on both occasions, as patient is very afraid of having his blood drawn, which caused a stress response.  We have to continue to monitor patient's kidney function and he continues to have rash flair ups.
runny nose; annoying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 (Lot number: EW0187) at the age of 73 years as dose 1, single and administered in arm left, administration date 15Jun2021 (Lot number: EW0181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "runny nose"; IRRITABILITY (non-serious) with onset 2021, outcome "unknown", described as "annoying". Therapeutic measures were not taken as a result of rhinorrhoea, irritability.  Additional Information: Is report related to a study or programme was reported as yes. she was having runny nose since she got the first and second dose of Pfizer BioNTech COVID-19 vaccine. Patient had runny nose, that was just running down, literally running down her nose, it was very frustrating with that runny nose, patient feel like she had a cold which she dont so that was very annoying. Treatment: Consumer stated, "No, she haven't done anything, its just that she was going to tissues, like tissue are going out of file, she meant its just like you would think she had cold or something, its just she was sitting here right now talking to you and its just running down, literally running down my nose." Other medical conditions: Consumer stated, "I have like a high blood pressure and being treated for seeing a pain management specialist, its comes from age you know."  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included Pravastatin, PEPCID and TOPROL. On 11th May 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day 1 hr after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site itching. The patient was treated with Anti-Itch Cream. In May 2018, the outcome of the injection site pain, injection site swelling and injection site itching were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site erythema, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On 12th May 2018, 25 hours after receiving SHINGRIX, the patient experienced redness, swelling, itching, stinging and soreness at the injection site. After several days, the patient visited her healthcare professional's office and saw not her regular doctor, but his partner. The partner advised her to put warm compresses on the site and prescribed an anti-itch cream, which did alleviate the itching and stinging. He advised the patient that her regular physician should call in a prescription of cortisone to take before receiving the 2nd dose. The day before reporting, the patient saw her regular physician for a routine follow-up appointment. While there the patient discussed the reaction with him. The swelling, itching, stinging and soreness had resolved after about 1 week, but the redness, while fading, was still very noticeable. The physician advised that the patient should not get the 2nd dose because cortisone might interfere with the effectiveness of the vaccine, and she might have a more severe reaction with the 2nd dose.
Patient turned 12 , one day before and received the 5-11 pediatric vaccine.  This was corrected however, on the second dose as she received the 12+ Pfizer adult.