chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was 40.22 years.  Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively , 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35 2 PM: 35, 3 PM: 34,  4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
impotent; Drug effect decreased; Psoriasis flare-up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4469214-00.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), on 15May2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at 2x/week (unk, 2x/week (citrate free)), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "not recovered", described as "impotent"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare-up". The action taken for adalimumab was dosage not changed.  Clinical Course: It was reported that, on unknown dates, the patient experienced Covid vaccine made patient impotent, plaque psoriasis flares came back and Humira worked in the beginning but not working now. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter considered "impotent" related to BNT162b2. The reporter's assessment of the causal relationship of "drug effect decreased" and "psoriasis flare-up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter considered the event "impotent' and "Psoriasis flare-up" was probable related to the suspect Humira. The reporter's assessment of the causal relationship of "drug effect decreased" with the suspect Humira was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Son had received first 2 vaccines. 5 minutes later received a Tdap, within two minutes he became pale, sweating, began to vomit and he later stated he saw black spots and heard ringing in his ears. He was also escorted to a chair. Given cold compresses and a soda. Lasted 5-10 minutes.
Three times in my life, after I receive the flu shot, 1985, 1994 and 2006, 2 weeks after I receive the flu shot, I come down with flu like symptoms, that are intermittent for 6-8 months, cough, fatigue, fever, aches, that result is many days of lost hospital work. Doctors do not believe this was caused by the flu shot. It has taken me an entire life time to figure out the name for this which is "vaccine induced immune dysfunction".  Dr. agrees that this condition exists.  Conventional medical doctors do not. I cannot receive the mandatory flu vaccine at my hospital due to the potential loss of work days, in a very strict attendance policy system.
He had fatigue and some body aches beginning on the day after the second dose. Then today he reported start of chills and more body aches. Counseled him to take some tylenol or advil to alleviate those symptoms and get some rest at home.
After 1st dose, I had 10 days of severe diarrhea. It started within the 24 hours after receiving the 1st dose.   On Feb 2/19/21, I received the 2nd dose and within 48 hours I had vertigo and sink rash on my elbows, knees and buttocks. Now 11 months later I still have rash and vertigo.
Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M70A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, CETIRIZINE, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], PAROXETINE, ATORVASTATIN and VITAMIN D3 for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included Vitamin D3 was noted. Treatment included Creams, including Coaltar were provided by the reporter.
About 13 hours post vaccination fatigue set in.  Shortly after that came extreme body aches, fever, chills, nausea, headaches and light headedness.  These symptoms lasted for 48 hours post vaccination.  At about 40 hours post vaccination, chest pain started.  I am currently at 51 hours post vaccination and finally the aches, fever and chills went away.  Lightheadedness and fatigue remain.
4th dose received a full dose; 4th dose administered less than 6 months after 3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-422792 (Patient Link).
Severe chills, took 2 200 mg. ADVILS and symptoms subsided in 30 minutes. Injection site arm with pain and redness which lasted 4-5 days.
Pain/Swelling at injection site and in gland of armpit; Pain/Swelling at injection site and in gland of armpit; severe headache; migraine; Severe nausea; Muscle spasms in legs; Fever of 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2023 as dose 2, single (Lot number: FP7136) at the age of 48 years, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 24Mar2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Ancef, reaction(s): "Drug allergy: Ancef". Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: FP7136, Location of injection: Arm Left), administration date: 02Mar2023, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Fever of 103"; MUSCLE SPASMS (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Muscle spasms in legs"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 25Mar2023, outcome "not recovered" and all described as "Pain/Swelling at injection site and in gland of armpit"; NAUSEA (non-serious) with onset 25Mar2023, outcome "not recovered", described as "Severe nausea"; MIGRAINE (non-serious) with onset 25Mar2023, outcome "not recovered"; HEADACHE (non-serious) with onset 25Mar2023, outcome "not recovered", described as "severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, headache, migraine, nausea, muscle spasms, pyrexia.  Additional information: Patient did not received other vaccine in four weeks. Patient did not had covid prior vaccination. Patient had received other medications in two weeks.
redness and a rash around the trunk area.; rash around the trunk area; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   On 6th November 2020, the patient received Shingrix (intramuscular). On 7th November 2020, 1 days after receiving Shingrix, the patient experienced erythema and rash. On an unknown date, the outcome of the erythema and rash were recovering/resolving.   It was unknown if the reporter considered the erythema and rash to be related to Shingrix.  Aditional details were provided as follows: The reporter stated that after Shingrix vacciaton, the patient had redness and a rash around the trunk area. The reporter stated redness and a rash around the trunk area were still ongoing currently but had gotten better. The reporter did not consent to follow up. This was 1 of 2 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020183487:same reporter
This spontaneous report as received from a company representative refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient who received ZOSTAVAX 2 weeks after vaccination developed lesions on both her arm and wrist. No treatment was given for adverse event. No laboratory studies were performed. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Information has been received from a licensed practical nurse through the pregnancy registry for GARDASIL concerning a 17 year old female with penicillin allergy who on 11-OCT-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot # 655620/0171U).  There was no concomitant medication.  On 19-NOV-2007, the patient had a blood work drawn in the office for a pregnancy test which was positive (LMP approximately 22-OCT-2007).  It was reported that the patient was 3 to 4 weeks pregnant.  The patient sought unspecified medical attention in the office.  Follow-up information received indicated that on 25-JUN-2008 the patient vaginally delivered a "normal" infant.  Upon a skeletal joint exam in the hospital the baby was found to have pes adductus (club feet).  The baby's club feet were considered a congenital anomaly.  No further information is available.
2 days p/recv vax pt exp swelling at inject site; constipation; dark yellow urine;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, drug reactions or allergies and concomitant therapies provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (albumin status, exact dose, dose number, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered doses of PROQUAD experienced a temperature excursion between 15 and 46 Fahrenheit degrees for 1 hour. Digital data logger was used to capture the temperature excursion. Previous temperature excursions occurred on, but no details were provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008478: US-009507513-1709USA008479: US-009507513-1709USA004743.
Patient received Pediatric Pfizer 0.3ml dose diluted with 1.8ml of Sodium Chloride.
Right arm redness, swelling, and pain; 8 cm red, raised patch on right deltoid.
He had COVID; He had COVID; This is a spontaneous report from a contactable consumer (parent). A 29-year-old (also reported as 30) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient had no medical history and concomitant medications. No treatment was received. The patient received two Pfizer vaccine doses about ten months ago then he had COVID. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
pt recv vax & several hr p/vax pt devel a fever of 105 & 8cm area of redness @ each inj site;tx w/Motrin & recovered;
This is not a adverse reaction. I am reporting an error. Patient received moderna for her first covid 19 vaccine and was mistakenly given pfizer for 2nd dose.
I have had more anxiety than usual. ALmost a resurgence of anxiety I had as a child.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient experienced swelling, redness, induration around the area where flu shot was given. I recommended patient to ice the location and apply hydrocortisone cream. If the red area spread or became worse or if patient was still concerned I recommended her to visit her doctor or immediate care center to have it checked out. Patient received an antibiotic due to reaction on 10/20/18.
Patient called to report swelling of right arm thirty six hours post injection. Patient stated hurt in muscle and "itched like crazy". She also reported vaginal itching. Patient called her health care provider who recommended hot and cold compresses to arm. Patient applied cortisone cream for itching. Swelling resolved two to three days later. Itching lasted longer. Follow up 1/26/2009. All symptoms resolved.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 05-APR-2005, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 F. Data logger was involved. However, no side effects were noted. Gardasil 9 was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
My right hand is swollen and my wrist hurts; My right hand is swollen and my wrist hurts; This is a spontaneous report from two contactable consumers (patient and patient's wife). These consumers reported similar events for two patients. This is the first of two reports.  An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 20Feb2021 10:00 (Batch/Lot Number: EN6200) (at the age of 85-years-old) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported.  On 21Feb2021, the patient experienced his right hand was swollen and his wrist hurts. The patient had this swollen, he never had any swelling in his body and he had this swollen hand and it was the opposite arm, it was the right and he had the shot in the left arm.Therapeutic measures were taken as a result of the events which included hand wrapped with ice pack. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
left side of body slow; left arm shaking; Brain locking; heart is beating fast and hard; BP was 200+/97; can't get out of bed; right arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and HYPERTENSION (BP was 200+/97) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard), HYPERTENSION (BP was 200+/97), FATIGUE (can't get out of bed) and VACCINATION SITE PAIN (right arm pain). On 04-Mar-2021, HYPERTENSION (BP was 200+/97) and VACCINATION SITE PAIN (right arm pain) outcome was unknown. At the time of the report, BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and FATIGUE (can't get out of bed) had not 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.   Treatment information not provided.
nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (product=COVID 19,, lot number=EP6955, dose number=1,, vaccine location=Left arm), administration date: 17Mar2021, when the patient was 34 years old, for Covid-19 immunisation, reaction(s): "small episode of sciatica", "nerve pain in left leg, similar to sciatic nerve pain".  The following information was reported: NEURALGIA (non-serious), outcome "recovering", described as "nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return". The event "nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not take other vaccine in four weeks. Patient had COVID prior vaccination. Patient had COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was supposed to get second shot of SHINGRIX on the day of reporting but the patient had side effects with the first one. The patient asked should she get the second one.
Swollen lymph nodes and pain under right arm presented six days after initial vaccine.  Swollen lymph nodes and pain under left arm (less severe, most pain in in right) Fluid retention throughout body.