chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 9:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 9:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.47 for dose administered on 12-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 27-Mar-2021 with temperature 34 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 12-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: patient experienced hearing loss for 24 hours- hearing has now returned-Severe
Information has been received from a registered nurse concerning a 22 year old male with no known allergies or pertinent medical history who on 17-JUL-2007 was vaccinated intramuscularly with 1 ml second dose of RECOMBIVAX HB (Lot# 652715/0108U). There was no concomitant medication. Subsequently 21-JUL-2007 the patient developed a fever of 102 degrees Fahrenheit, swelling of the glands of his neck, fever blisters on his lips, and back pain. The nurse noted that the patient's brother was experiencing the same symptoms, but had not been vaccinated. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was available. There was no product quality complaint involved. There was no product quality complaint involved. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 2/25/21 Lot# EN6202;  Pfizer 3/18/21 Lot# ER2613;  Pfizer 10/31/21 Lot# FF8841
Hives. Rash. Pressure and pain in chest, shoulders and upper back. Slight difficulty in breathing.
Heart Arrhythmia  , shortness of breath, Fatigue, skipped Hear beat
Two weeks ago his son had a cold. It was not Covid. He was tested and was negative for Covid.; This is a spontaneous case received from a contactable consumer (patient's father) via. A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on 23May2021 09:00 (age at vaccination 14-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was none. Concomitant medication was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE does not require a visit to emergency room/physician office. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE following prior vaccinations was none. It was stated that two weeks ago his son had a cold. It was not COVID. The patient underwent lab test which included COVID test and was negative. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Information has been received on 15-FEB-2019 from a lawyer regarding a case in litigation concerning a 61 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  On or about 01-MAR-2017, the patient was administered the ZOSTAVAX (lot# and route unknown) vaccine by a healthcare provider. On or about 27-MAR-2017 the patient was treated by two physicians for shingles and opthalmicus OD as a result of vaccination with ZOSTAVAX. The outcome of the events was unknown. Upon internal review herpes zoster opthalmicus was considered medically significant. Additional information has been requested.
I went to ER with extreme chest pain and difficulty in breathing.  I was diagnosed with pericarditis.
Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; Hep B-Pedi/Adol administered on 29-JAN-2007, 12-FEB-2007, 17-JUL-2007 and 26-OCT-2007; This spontaneous report has been received from a healthcare professional, via medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2207USA007680), concerning 14-day-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.      On 29-JAN-2007, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).         On 12-FEB-2007, she received the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration) and on 17-JUL-2007, the third dose of inappropriate schedule of product administration was administered (inappropriate schedule of product administration).  On 26-OCT-2007, the patient received a 4th dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (extra dose administered).; Sender's Comments:  US-009507513-2207USA007680:
Donor had a hot flash and started sweating. Donor placed on bed and feet elevated. Head towered. Juice given. Cold towels applied. Felt better within 5 minutes.
BURNING SENSATION FROM THE INJECTION SITE TO THE NECK REGION. SWELLING OF THE NECK LYMPH  NODES, SIZE OF A NICKEL. ANXIETY AND TIGHTNESS IN THE NECK AREA AROUND THE SWELLING.
Huge bruise on the right side of my abdomen just above the hip bone. Large bruise with lots of blood in the center of it.
This spontaneous report as received from a healthcare worker (office administrator) refers to an unspecified number of patients of unknown age and gender. On an unknown date, multiple unspecified patients were administered liquid PEDVAXHIB (dose, route, lot # and expiration date were not provided) that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because there is no contact permission.
This spontaneous prospective pregnancy report was received from a physician and refers to a 37 year old female patient The patient's medical history and concomitant medications were not reported.  On 05-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). On 12-APR-2017, the patient discovered she was pregnant. The patient became pregnant with last menstrual period (LMP) of 13-MAR-2017 and estimated date of delivery (EDD) of 18-DEC-2017. No adverse effects were reported. Additional information has been requested.
A non-serious spontaneous report of inadvertently given H1N1 to 63-year-old female, was received from a registered nurse concerning a 63-year-old female. Neither medical history nor concomitant medications was reported for this patient. On 04-Nov-2009, the patient received H1N1, Intranasal vaccine for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 05-Nov-2009: Reporter's address, responsible physician details and administrator address received.
Swelling and pain in right axillary lymph node. Started 1 week after vaccine
A non-serious spontaneous report of administration of full dose (0.2ml) in one nostril was received from a registered nurse/health professional concerning a 15-year-old male. Neither medical history nor concomitant medications was reported for this patient. The patient received H1N1, Intranasal on 10-Nov-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Started having SOB, cough and scratchy throat. She then transported to the ER and treated. Given benadryl 25mg IM.
Left arm 14/2 cm, Right 7 cm with 7 X 7.5 CM. Red warm itchy reaction.
This is a spontaneous report from a contactable consumer (mother of patient). A 53-year-old male patient received on 02May2017 11:00 PREVNAR 13 at 0.5 ml single dose intramuscular in the left arm for prevention in the physician office. Medical history included triglycerides and cholesterol high diagnosed several years ago, back pain, heart disease, Crohn's disease, costochondritis, vitamin d deficiency, acid reflux (esophageal), thyroidectomy all from an unknown date and ongoing. The patient also had thyroid cancer in Jul2011 and a quadruple bypass in Jul2014. In 2005 the patient had a pneumococcal vaccine (manufacturer unknown) for immunization. On 30Apr2017 the patient got an unspecified allergy shot . No adverse effect occurred with prior vaccinations. Concomitant medications included ANTARA for triglycerides, AZULFIDINE EN for Crohn's disease, COLESTID for Crohn's disease, LIPITOR for high cholesterol, levothyroxine sodium since he had no thyroid, metoprolol tartrate for high blood pressure, nortriptyline for hand tremors, pantoprazole for acid reflux esophageal, ranitidine for acid reflux esophageal, tizanidine for costochondritis, vitamin D3 for vitamin D deficiency, tramadol hydrochloride for back pain, PLAVIX for blood thinner for heart stent, all ongoing since an unknown date. On 02May2017 about a half an hour after receiving vaccination, the patient his arms and back broke out and had red flat blotches that extended down to his wrist (not itching). The patient called the physician who suggested to take BENADRYL or ZYRTEC, but the patient did not take the recommended medications due to Crohn's disease. Physician suggested also to take him up the ER if the red blotches made him uncomfortable. Outcome was not recovered.
Approx 4-6 hrs after administration, patient developed redness, swelling, tenderness at site of administration. Also developed low grade fever. Symptoms worsened over 2 days and pt sought medical care.
Information has been received from a 66 year old female patient with no known medical history or allergies who on 28-AUG-2007 was vaccinated with Zostavax (Oka/Merck), 0.65 ml.  Concomitant therapy included thyroid and water pill medication (therapy unspecified).  On 28-AUG-2007 the patient experienced a mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy.  The patient's mild sore throat, mild headache, and a red patch on her arm at the injection site which was swollen, hot and itchy persisted.  The patient sought unspecified medical attention.  No further information is available.
itching at injection site after a week of first vaccine; rash at the injection site after a week of first vaccine; Skin rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 27-Jan-2021, the patient experienced PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash). At the time of the report, PRURITUS (itching at injection site after a week of first vaccine), INJECTION SITE RASH (rash at the injection site after a week of first vaccine) and RASH (Skin rash) outcome was unknown.        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.   concomitant medication information is not provided.
Approximately one month post vax pt was presented to physician with pimple like lesions and was diagnosed with chickenpox. Pt was treated with Benadryl and Amoxicillin. The lesions continued for a few days and faded away. Then about ten days later the pt broke out with nine more pimple like and itchy lesions on arm. Subsequently the pt recovered.
According to my wife, 10 minutes post shot I had what appeared to be a mild seizure and lost consciousness for 1-2 minutes. Prior to that happening, I told her I felt light headed. She notified personnel while we were in the 15 min wait holding area and when I regained consciousness two EMTs were checking me out. They took my vitals, asked me questions and had me get out of the car and walk around. I was monitored for several minutes. It was recommended I visit a hospital or urgent care if I continued to feel unwell. My wife & I left the vaccine site and decided on the way home to go to the hospital just to ensure everything was all right. We went back home for about 30-60 minutes. During this time my heart rate continued to remain elevated and it felt like I had adrenaline coursing through my system. I attributed the feeling to recovering from passing out, but it did not dissipate.  Upon arrival to the ER I began having trouble trying to breathe and chest pain. During the triage EKG it was discovered I was experiencing atrial fibrillation. I was given treatment, fluids and monitored for several hours before being released. Estimated time from receiving shot to being diagnosed with afib was approximately 2.5-3 hours.
Beginning on 10/16, patient developed fever and fatigue.  this resolved over several days, fever was gone by 10/19. On 10/20, develoed blurred vision, short term memory loss (could not remember driving to work, lightheadedness and tingling in hands and feet.  was evaluated in the ER. Over the course of next few days, developed pain and parasthesias in both legs and arms, myalgias, neck pain, back pain.  Was admitted to the hospital on 10/27 for suspected transverse myelitis. workup essentiall unremarkable, but symptoms persisted. continued with headache, weakness in arms and legs, balance difficulties.  As of November 2021Requiring a cane to ambulate, extreme fatigue, persistent tachycardia. She has been evaluated by neurology and cardiology, work-up  still ongoing.  she subsequently developed herpes zoster in early February 2022.  Patient's symptoms have persistent without improvement, continues to be disabled from employement
Same night of inject 4JAN91 temp to 103 also had vomiting, both arms swollen; 5JAN91 temp 102 to 103; 6JAN91 temp 101 Did not take to MD, antipyretic given 7JAN91 child was okay.
Fever for 5 days, personality changes, blank staring for minutes, temperament changes (happy for a minute then crying), can?t walk straight and keeps falling down, lethargy,
Pt. received one dose of Flucelvac 0.5ml in the AM on 11/13/22 around 9am., This client then came back to the mass vaccine clinic and got another dose (2) by a different immunizer. Received two doses of same flu shot within hours.
I noticed a large rash, approximately 2.5 inches in diameter on the inside of elbow, with raised bumps, very red. Does NOT hurt.
Initial report received on 17Jul06 from a health care professional. A healthy 13 yr old male pt with a history of ADHD and weight problems had received an IM dose of Adacel, lot number C2457AA, in the left arm, and an IM dose of Menactra, lot number U2082AA, in the right arm on 27Jun06 in the morning. The subject was taking Ritalin LA 20mg every other day at the time of the vaccination. On the evening of 04Jul06, seven days post immunization, the pt developed flu-like symptoms and the following day experienced seizure like activity. The pt was taken to the ER at a nearby hospital and was subsequently air lifted to another hospital. Treatment and diagnostic tests/laboratory data performed were not reported. At the time of this report, the pt had not recovered and was still hospitalized. 8/3/06 Received medical records which revealed patient had been admitted 7/6/06 & d/c 7/27/06 w/ diagnosis of status epilepticus & meningoencephalitis.  Presented with headaches & vomiting followed by seizures.  Had persistent HTN during admission. Neuro & nephro followed. Developed mild pancytopenia possibly due to bone marrow suppression from viral infection. Patient then readmitted to hospital on 7/31/06 for new symptoms of severe headache & left sided weakness.
Splitting headache that felt like a migraine. Started at 1:45 PM and lasted until 5 AM.  Vomiting started at 5:30 PM along with chills that lasted until 6 AM.
This spontaneous report as received from a healthcare worker refers to patients of unknown age and gender. On an unknown date, unspecified number of improperly stored GARDASIL (injection, 120 Y) doses had been administered to patients (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
03/13/2022  I developed spontaneous hives. I went away and then came back on 4/15/2022, 4/17/2022 and 4/18/2022. I had hives on different parts of my body for 4 days. The allergist said there were 2 possibilities, one from the Vaccine, Hashimoto Thyroiditis or the combination of the two. I was placed on Claritin. I am currently not experiencing this condition. I have to be hive free for a month before I can receive my next COVID vaccine.
CHEST TIGHTNESS ,ATRIAL FLUTTER, BODYACHE, CHILLS LOW GRADE FEVER  & FATIGUE
Woke up about 10 am not sure exact time could not breathe could not turn over in bed due to shortness of breath. Could not get to bathroom due to shorness of breath, urinated in floor.  Facial swelling,  intense itching all over body.  Upper abdominal pain. Confused dizzy and disoriented. Unable to get medical attention because too short of breath to get to front door. Passed out for 24 hours. Unable to drive vehicle for 4 days due to dizziness, skin color turned yellowish.  symptoms resolved after 9 days when I took liver detox supplement from health food store.
My daughter experienced a tonic-clonic seizure 10 days after her second dose of flu vaccine. Then another seizure 1 month later. 2/2/06 Reviewed medical records and confirmed diagnosis of new-onset seizure. The date of ER visit was 11/04/04.  Child was finishing up Ceftin for sinusitis. PMH states child has 'mild cerebral palsy'.  2/2/06 Per telephone f/u the provider indicated that the dates for the two 2004 Fluzone vaccines were 10/8/04 and 11/12/2004.   1/1/10 - follow up - no seizures for 2 yr (since 1 mo. after vaccine)
16 x 17 cm area of erythema with vesicles, fever 103, myalgia, HA x 5 d
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Unable to move her arm
Terrific headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrific headache) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrific headache) and PYREXIA (low grade fever). At the time of the report, HEADACHE (Terrific headache) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medication were reported  No treatment medication were reported   This case was linked to MOD-2021-389429 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Had to pull over and take a nap for 20 minutes), MALAISE (Did not feel well), PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel), FATIGUE (Super tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose) in a 5-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication. Previously administered products included for COVID-19 vaccination: Pfizer (2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced SOMNOLENCE (Had to pull over and take a nap for 20 minutes) and FATIGUE (Super tired). 01-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose). On 04-Dec-2021, the patient experienced MALAISE (Did not feel well) and PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel). On 01-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose) had resolved. At the time of the report, SOMNOLENCE (Had to pull over and take a nap for 20 minutes), MALAISE (Did not feel well) and FATIGUE (Super tired) outcome was unknown and PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel) had resolved. No concomitant medications were provided. No treatment medications were reported. The patient was involved in their 40's. Patient's arm hurt all the way down to the wrist for 2 days.