chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot; Booster dose after Janssen vaccine; booster; muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side; could not walk on her right calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211239219.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FH8028) at the age of 71 years as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 10Mar2021 (Lot number: 180522) as dose 1, single for immunisation. Relevant medical history included: "Cigarette Smoker" (not ongoing), notes: as a teenager, stopped cigarette smoking at 18-years-old.; "Non-Alcohol User" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergic to Cipro"; Benadryl, reaction(s): "Allergic to Benadryl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster dose after Janssen vaccine"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; THROMBOSIS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Blood clot"; MUSCLE STRAIN (medically significant) with onset Nov2021, outcome "unknown", described as "muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side"; GAIT INABILITY (non-serious) with onset Nov2021, outcome "unknown", described as "could not walk on her right calf". The patient underwent the following laboratory tests and procedures: blood test: (27Nov2021) blood clot, notes: Classification: UNK. Therapeutic measures were taken as a result of thrombosis. Clinical course details: First week after the Pfizer vaccine, the patient was fine. In Nov2021 (second week), on an unspecified date, the patient experienced odd things like muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side. She woke up and could not walk on her right calf. 10 days after taking the Pfizer shot, on 27Nov2021, the patient was diagnosed with a blood clot. Treatment medications (dates unspecified) included Xarelto (rivaroxaban) for blood clot prescribed by the doctor.  Additional information: Other pre-existing medical conditions included no drug abuse or illicit drug usage. This report was serious (other medically important condition). This event (s) is considered unassessable. The event (s) has a compatible/ suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). No follow-up attempts are possible. No further information is expected.
Approximately 4 hours after injection.  All over body ached.  Fever, Loss of appetite, Wanted to just sleep.  No treatment.  Went home from work, didn't work the next day and only 1/2 day after that.
Cerebral infarction 163.9. I was admitted to the hospital on April 4th,  15 days after taking the Janssen shot. My initial symptoms included tingling, numbness, and inability to walk.  The doctors confirmed during MRI that I had had a stroke.  I was in the hospital for four days, and released to PT/OT three times a week for the next 4 weeks to regain full use of the right side.  I  am also unable to work during this time.
Sore throat, dizziness, nausea, chills, sweats, muscle aches, felt like a cotton ball was in my left ear.
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 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 2:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 2:04 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, 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 82.47 for dose administered on 03-Mar-2021 and 82.55 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 Degrees Fahrenheit at 1 pm. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 8AM to 9AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-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).
I received the vaccine on Wednesday morning around 930.  That evening around 7, I started having some heart flutters along with the fatigue/muscle weakness. Thursday morning I had the sore arm and the fatigue/muscle weakness continued, but nothing cardiac. Friday morning around 8 am I started having chest pain and lots of flutters again. I spoke with a friend that works in the ER and she said they were seeing this a lot and that it usually resolved on its own. It is now a week later and I still have a few episodes of flutters each day, no chest pain with it, and about 4 pm experience extreme muscle weakness/fatigue. The sore arm was very mild and only for a couple days.
given shingles vaccine at same time as COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031321A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Additional information included second dose date, batch and lot number for both doses and an updated narrative
patient received 1st Covid 19 vaccine, seated in observation and began to feel like he was going to pass out, and dizzy, He was diaphoretic. VS taken . BP- 140/75, P- 92, O2- 100%, T- 99.1, water offered and patient is drinking, He is arousable, alert and oriented X4, BP rechecked @ 1002, BP sitting- 124/79, P- 79, O2 100%, standing BP at 1004 111/79. P-78. He reports that he has a history of passing out with medical procedures, he reports no further issues with dizziness and diaphoresis , he was monitor for 40 minutes.
sore at injection site, treatment resistant headache (over 36 hours so far), joint and muscle fatigue
Pt had influenza vaccine on 11/8/09 @ 1600. Intramuscular injection into left deltoid. 0.5ml of NOVARTIS, exp. date. Site reaction noticed as minimal @2015 and target reaction noticed @0005 on 11/9/09. Pt refused any medication interventions and offered cold compress.
The patient reported that her arm was very swollen (more than expected). She also reported that her fingertips and palms of her hands were red, and that the skin had started peeling. She said it was itchy and painful, and generally very uncomfortable. The skin peeling started on her fingertips in the evening (on the day the vaccine was administered), and spread to her palms the next morning.  This was her second dose, and she did not have any problems with the first.
A mother reported that her 19 month old daughter received an injection of Prevnar on 6/21/00. The infant had received DTAP and IPV (Aventis Pasteur SA) vaccines on 6/16/00. On 6/22/00, the infant became cranky. The vaccine provider confirmed this report on 8/7/00.
24 hrs after vaccinating 3" x 4" red, raised, hot, hard area appeared at KINRIX site. Site was also itchy and patient ran a fever of 100.9 degrees F. Mother gave TYLENOL & administered topical cortisone cream to area. 48 hrs after vaccination site remains  the same. Mother taking child to pediatrician.
redness over a 3X3 inch area below the injection site; This case was reported by a nurse via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for him/her self. The age at vaccination was not reported. The patient received first dose of Shingrix and experienced a localized reaction. The reaction was unexpected and the redness remained for several day over a 3X3 inch below the injection site. The reporter asked dermatologist and She stated it had happened to most people. Consent to follow up was not granted as contact details not available.
Pt was inadvertently given 1 mL dose of influenza vaccine instead of correct 0.5 mL dose. Pt reported chills and rigors on the night of the injection which resolved by morning. Pt reported no skin reaction.
The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023; No adverse event; Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 10-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered dose of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Mar-2023 and was administered on 10-May-2023).    No concomitant medications were provided. The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 02-Mar-2023. The vial did not undergo any temperature excursions. No Adverse events were reported.  No treatment medication was provided. This case is for patient number 4.
Two days after administration of the vaccine the patient came into the pharmacy with a rash on her upper arm below the site of administration. The rash was approximately 2 inches in diameter. She had reported swelling as well but that had subsided. The patient was advised to take Benadryl and use hydrocortisone cream.
Patient states approximately 15 minutes following first dose of Pfizer, she experienced hives on her inner forearms bilaterally. Patient denies itching, shortness of breath, and dizziness. Hives resolved on their own after 50 minutes. Patient did not seek medical care.
After receiving the vaccine, the pt developed prominent musculoskeletal symptoms and neurological findings of fasciculation and muscle spasm.  The most recent information received on 12/5/99 reports the condition of th pt as unknown.
24 hours, post vax 1st Anthrax, pt developed painful, erythematous area at site of injection, not raised but indurated. No fevers.
Slight tickle; Sick; Felt weak; Arm swollen to size of baseball at injection site; Redness in arm; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Slight tickle), ILLNESS (Sick), ASTHENIA (Felt weak), VACCINATION SITE SWELLING (Arm swollen to size of baseball at injection site) and VACCINATION SITE ERYTHEMA (Redness in arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Macular edema in 2019, Pain back, Neck pain, Eczema in 2018, Sleep apnea, Gallbladder disorder (Low functioning gallbladder) in 2019, Spleen enlarged and Hernia in 2006. Concurrent medical conditions included Hypothyroidism since 1972, Blood pressure high since 1993, Asthma, Ulcerative colitis since 1975, Liver fatty since 2006, Liver enlargement since 2019, High cholesterol since 2005, Allergy (Erythromycin: Hives Tramodol: Sore swollen throat, flu like symtoms Methocarbam: Flu symtoms Thimerosal: red itchy eyes from contact solution Apap/Codeine: increased rectal bleeding, constipation Doxycycline: HYC stomach pain, rectal bleeding MRI Dye: Dizziness, light headed, extreme vertigo, nausea, weakness Latex redness, rash Lialda: rash/palpatations Fluorometholone: swollen throat and swollen tongue CT Dye: difficulty breathing, wheezing, throat tickles metal: rash aspartame: palpatations MSG: palpatations), Allergy to nuts (Pecans swollen lips Walnuts burning tongue cashews sore throat, stuffy nose) and Fruit allergy (coconut wheezing, difficllty breathing Pineapple wheezing, difficulty breathing). Concomitant products included AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, MESALAMINE and MESALAMINE for Ulcerative colitis, ENALAPRIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, LOVASTATIN, CYANOCOBALAMIN (B12 1000 SR), VITAMIN D NOS and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for an unknown indication.   On 26-Mar-2021 at 4:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 4:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DISCOMFORT (Slight tickle), ILLNESS (Sick), ASTHENIA (Felt weak) and VACCINATION SITE SWELLING (Arm swollen to size of baseball at injection site). 23-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in arm). On 05-May-2021, VACCINATION SITE ERYTHEMA (Redness in arm) had resolved. At the time of the report, DISCOMFORT (Slight tickle) outcome was unknown, ILLNESS (Sick) and ASTHENIA (Felt weak) had resolved and VACCINATION SITE SWELLING (Arm swollen to size of baseball at injection site) was resolving.            No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-071039 (Patient Link).
dizziness, pounding h/a, fatigue, orthostatic hypotension (2 hrs), local swelling @ inject site lasted for 5 days;
Patient reported stroke-like symptoms as he was driving to work: started "feeling funny" with dizziness; progressed to feeling weakness in left side of face with facial drooping; tingling in left hand progressed to numbness and weakness in left arm and leg; difficultly coordinating motor movement in right arm; difficulty/ diminished speech "tongue felt fat."  Symptoms resolved within appx 1+ hour from onset.  Per patient, he was given an injection at the hospital (unsure for what?) and was discharged with a prescription for chlorthalidone 25mg daily, blood pressure was elevated.
My afib  started again Sunday morning following booster. Had been in normal sinus rhythm for 7 weeks following a cardiac ablation. I am wondering if the booster had anything to do with going back into atrial fibrillation. Experiencing shortness of breath, fatigue, all over muscle ache/fatigue.
pt recv vax 31JUL95 & 10AUG95 pt devel a rash, fever to 101 & mild chills, moderate to severe myalgias, & arthralgias, especially in both hands & neck/back;fever resolved p/2 days & the arthralgias lasted up to 2wk;
This spontaneous report was received from a pharmacist and refers a currently 63-year-old female patient with diabetes. The patient's medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, for prophylaxis (lot#, expiration date, exact dose and route of administration were not reported). Concomitant therapies included metformin. On an unknown date, after vaccination with ZOSTAVAX, the patient developed shingles. According to the reporter, the patient went to see a pharmacist, when seeking a medical attention. The outcome of shingles was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported.
Client reported the morning after receiving the COVID vaccine Pfizer, he woke up with chest tightness. The client stated the symptoms lasted about 3 hours. The client did not take any medication for the symptoms. The client denied dizziness or shortness of breath. The client did not follow up with his primary care doctor or an allergist.  The client denied any chronic conditions or medications. The client has no known allergies. The client reports a history of chest tightness after smoking. The client stated he last smoked the day before receiving the COVID vaccine Pfizer.
c/o laryngitis, frequent soft stool, body aches, joint pain & alternating between hot & cold sensation from 24hrs p/vax;
Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of ROTATEQ at 16 weeks of age. There were no adverse effects reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Approx seven minutes after injection of TDaP pt began pale, dizzy and fainted. Pt assisted to floor, legs elevated, color returned quickly. After sitting 1-2 minutes again pale in color and returned to pt room table. pt continued pale color was lying down. Ate crackers drank water felt better, went home 11:30. Checked on child at 1:55pm doing well.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L039092, expiry date 06-OCT-2017, lot # L043622, expiry date 03-NOV-2017, lot # M004326, expiry date 25-JAN-2018 (dose, route and site of administration were not reported). There were no known adverse effects. The vaccines experienced temperature excursion of -5.2 degrees Celsius for 50 hours 17 minutes. This is one of several reports received from the same source. Follow up information has been received from the registered nurse on 07-SEP-2016. Patients' identifiers and dates of vaccination were unavailable at the time of the call. The nurse reported that there was no patient who had reported issues following GARDASIL 9 administration. This report refers to a patient of unknown age and gender. On 24-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # K008333 or M011116. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot# L035511, K022993 or L029618 (dose was not reported). Additional information has been requested.