chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 27-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 27-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received full dose.   They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  No treatment information was provided.
the expiration was overlooked and administered----- 1st shot of the initial series for moderna, expiration was 11/27/22 and was sdministered 12-14-22
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 22nd February 2023, the patient received Havrix. On 22nd February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's Comment: The reporter consented to follow up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
mom reported by telephone today that pt had 2 seizures evening of vax 1 hr apart; called MD said give APAP & ice packs;
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 10-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R001658 with expiration date 17-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
C/o soreness in left arm, most pain in axillary region, did get MENACTRA and HPV #1 in left arm at wcc on Tuesday, no bruising or swelling this arm, no redness around injection site noted. Not feeling well. Initial injection site sore, then c/o chest hurting on that day, didn't want to go to school, then c/o underarm hurting; not red but sore; not using L arm; high tolerance to pain; has takes some ibuprofen the last 2 nights 10 ml both nights.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever 101.2ºF) and myalgia (muscle pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002F21A) for COVID-19 immunization. No medical history reported. On Aug 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 7, 2021, patient experienced pyrexia (fever 101.2ºF) and myalgia (muscle pain). At the time of the report, pyrexia (fever 101.2ºF) and myalgia (muscle pain) outcome unknown. Diagnostic results: On Sep 7, 2021: Body temperature 101.2°F (high). The patient's concomitant medications included multivitamins. No treatment medications provided.
Rashes; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This was 1st of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was reporting that he had a delayed reaction to the COVID vaccine. He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162064 Same reporter/ product/ event, different patient
Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies).   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.   This case was linked to MOD-2021-035954 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.
Injection site red, swollen approximately 5 minutes for reaction to take place. L.S. CTA. Alert. Called ED with report sent client to hospital for observation. Injection sites-shots given in areas affected, MMR, Varivax.
Soreness, where shot was given.  Itchy Eyes, Cough, Every bone in body hurt. Felt like I had been in a car wreck.  Headache.
Heavy menstrual bleeding; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0151) via an unspecified route of administration in the left arm on 20Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovary syndrome (PCOS). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control pill from an unknown date and unknown if ongoing. On 22Apr2021, the patient experienced heavy menstrual bleeding and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown if any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy menstrual bleeding and fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Right away I experienced dizziness; nausea - they gave me Benadryl shot. After that, it looked like it affected all my muscles and nerves - especially my lower back. From hips to toes I was in extreme pain. I thought it would go away but it didn't. The second day I went to ER and they didn't know what to do. They checked my reflexes. My right leg was responding okay but the left leg didn't move. Still my left leg is numb. They did send me home with the vaccine. I haven't had the second vaccine because I still feel the shortness of breath. Walking a little bit is like losing my breath. I have a headache, nausea and stomach was upset with diarrhea for two months and especially the first week. My lower back was most affected area. I couldn't work. My left side was numb and painful. I was dragging myself with my right leg. Since my vaccine my memory is really really bad.  I went to the doctor after three weeks and they sent me to same ER   - I think on Feb 5 - because they didn't know what to do at Doctor's office. My left side was numb.  They gave me more medicine after the second ER visit - I will have to call back with the names of the meds.
Information has been received from a physician concerning an "over 80-year-old female who "a few months ago," approximately January 2008, was vaccinated with a first dose of of Zostavax (Oka/Merck). No lot number was provided. On 19-FEB-2008 the patient "developed shingles". A "shingles-type rash was located on her forehead, above her eye, and also near her hairline on one side." Unspecified medical attention was sought. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Dose administered after temperature excursion; Temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). On 23-Jul-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The medical assistant stated that she had 2 vials that were in freezer and gone temperature excursion due to a power outage. The fridge and freezer are not in the same unit per the caller health care professional (HCP). Initially the caller said fridge had a temperature excursion but not the freezer as the alarms never went off for the freezer.   No concomitant medication and treatment medication were provided.
two or three unspecified patients and one patient received improperly stored doses of VARIVAX; no adverse effect; This spontaneous report as received from a physician refers to a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R011805, expiry date 23-APR-2020, R029517, 14-OCT-2020) for prophylaxis which was reconstituted with properly stored sterile diluent(lot# and expiry date unknown). No adverse effects were reported. Temperature range was 6 degree Fahrenheit to 14 degree Fahrenheit (minus 14 degree centigrade to minus 10 degree centigrade)(minus 14 to 11 centigrade). Time frame of 24 minutes. There was no previous excursion. Data logger was yes.  This is one of the two reports received by the same reporter.; Sender's Comments:  US-009507513-1905USA003086:
Pt experienced lethargy, dizzines on day of vaccine administration then fever of 102, then generalized body aches, Right axillary tenderness, continued lethargy for 4 days
Swelling of eyelids, burning,  hives on eyes face arms and legs.  Fatigue joint aches. Started the morning after.  My eyes lids  are still swollen and burning but body hives have subsided. Fatigue and joint pain continue
SORE TENDER PAINFUL TESTICLES; HEADACHE; SORENESS IN ARM AT INJECTION SITE; This spontaneous report received from a consumer concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced soreness in arm at injection site. On 13-APR-2021, the subject experienced sore tender painful testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and soreness in arm at injection site on APR-2021, and had not recovered from sore tender painful testicles. This report was non-serious.
Ongoing hospitalization. Found by EMS unresponsive in hotel room when quarantining in hotel for COVID. Stated he was trying to kill himself. Intentional overdose. Altered mental status, intoxicated.
Sore throat, ear ache, facial parallels, right side of face dropping, sensitive to sound in right ear , sensitive to light. Corneal abrasions, unable to close right eye lid. Went to Emergency Room  and have been diagnosed with Bell's Palsy.
Started to develop rash of flat red bumps on bottom of right foot and on torso under breasts about 1 month after 2nd dose. Began treating with Cortisone Cream late February after 1st Dermatology visit. These progressed in size and eventually rose up on the palms of my hands, between fingers, under arm area, inner thighs and inside of my mouth.  The rash on hands and feet non responsive to treatment.  Began systemic treatment with steroid injections at my most recent (4th) doctor visit regarding this rash on 05/04/22.
Patient was given a .2ml dose of the orange cap age 5-11 undiluted. No treatment at this time. Explained to patient that an extra dose was given and if they had trouble to please contact us.
having a cold with sneezing a lot and blowing her nose; had a very intense irritation on the face; having a cold with sneezing a lot and blowing her nose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021 patient had a very intense irritation on the face. She mentioned that the feeling was similar to having poison ivy on it. She also had cold with sneezing a lot and blowing nose. It was reported that she has not experienced this before. She was asking if she should consult her doctor and her 2nd dose has been scheduled on 23Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.