chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic skin condition in the legs; chronic skin condition on the injection arm has cleared after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Chronic skin condition in the legs) and THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder NOS (Chronic skin condition). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (Chronic skin condition in the legs) and THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine). In 2021, THERAPEUTIC RESPONSE UNEXPECTED (chronic skin condition on the injection arm has cleared after the vaccine) had resolved. At the time of the report, SKIN DISORDER (Chronic skin condition in the legs) had not resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up document received on 27-Sep-2021 added patient demographic details, current condition, Dose 1 and Dose 2 details
injection site pain; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain on an unspecified date. The outcome of event was unknown. This was a known side effect and it would have been reported if the pain persisted.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information was available.  No concomitant medication reported. No treatment medication reported.  This case pertains to the 20th of the total 40 patients.
It has been 63 days since the first dose (patient has not received second dose); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second dose)) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 63 days since the first dose (patient has not received second dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up document received on 21-JUL-2021 contains non significant follow up.
1/9/22 Pt presented to ED w/ symptoms for a week. Patient is a 47 y.o. male of MD with history of recent DVT, PE on Eliquis presented with shortness of breath, nonproductive cough and fatigue in context of COVID-19 pneumonia.   Acute respiratory failure with hypoxia Covid-19 Virus Infection Date of onset of symptoms: Approximate 1 week PTA Symptoms present on admission: Fever fatigue, mental cloudiness, shortness of breath, hypoxia Date of covid positive test: 1/9/2022 Vaccination status: vaccinated (Johnson & Johnson in June 2021) Imaging: CXR with no infiltrate or effusion noted, slight bilateral perihilar bronchitis Oxygen requirements on admission: 2 L NC Medical therapy: steroids Patient work of breathing normal.  He reports only becoming short of breath when going up and down a flight of stairs.  No shortness of breath with activities of daily living.  While ambulating here, SPO2 dropped to 89%.  He will be sent home with supplemental O2.  If his breathing were to worsen, or his oxygen requirement were to increase he is counseled to return to the ER.  Patient will be given referral for advanced home services (AHS) telemedicine visits.  Patient was weaned off O2 at home on 1/12/22   Chronic kidney disease stage II Baseline SCR 1.3, presenting SCR 1.4   Recent history of venous thromboembolism Patient is self prescribing reduced dose of Eliquis.  He should be on 5 mg twice daily
could feel I was about to faint any second/lightheaded; felt a wave of uneasiness come over me; felt confused & scared,everything sounded far away; felt confused & scared,everything sounded far away; my heart was beating rapidly & was sweating; my heart was beating rapidly & was sweating; began to feel terrified; got cold & clammy; got cold & clammy; face was pale; I was too weak; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 14:45 (Batch/Lot Number: FC3182) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history was none. Patient did not experienced COVID prior vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin (CLARITON) and women's daily vitamins (VITAMINS NOS), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Tetanus Vaccine for immunization and experienced allergic to the Tetanus Vaccine. Patient got her vaccine and was feeling completely fine at first. While patient wait the"15 minutes," all of a sudden, she felt a wave of uneasiness come over her. It felt like slow motion and patient felt as if something just hit her body into shock. SHE felt confused & scared, everything sounded far away and she was too weak to yell for help. She was lightheaded and knew something was wrong. Her heart was beating rapidly and was sweating. She could feel she was about to faint any second and was fighting it as hard as she could not to faint b.c. She began to feel terrified. Her husband ran to her and then ran yelled to pharm for help. He said her body felt like lava when he reached to her and her body was covered in sweat. Patient then got cold and clammy. Her face was pale. The events onset on 17Aug2021 at 14:45. The events resulted in doctor or other healthcare professional office/clinic visit. The pharmacist gave her treatment which included cold rags, water, laid down. Outcome of the events was resolved in Aug2021. Patient did not test COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
This spontaneous case, initially received from other health professional on 24-Oct-2018, concerns a 51-year-old, adult female patient. It was reported that due to power outage, there was a first temperature excursion with the FLUCELVAX QIVc and the maximum temperature reached to 56.3F for approximately 2 hours and 52 minutes. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252227, expiry date: 31-May-2019 and anatomical location: right deltoid] which underwent temperature excursion. It was reported that, the patient did not experience any adverse effects after vaccination. The reporter assessed this case as non-serious. Follow-up received from other health professional on 22-Nov-2018: The reporter confirmed that, the patient didn't experience any additional adverse reactions after administration of the vaccine. The anatomical location was updated from unknown to right deltoid. The narrative was amended accordingly.
Allergic reaction including vomiting, puffy face and eyes.  Pt was seen in ER two days after vaccination.  Pt was given IVF, steroid, and zofran in the ER.
It was reported by the pt that she received a Fluzone SV '01-'02 vaccination in her left deltoid on 11/7/01. A week later, on 11/15/01, she broke out in generalized hives, bad enough to go to the ER on 11/16/01. She was given a Depro-Medrol injection and has been on Prednisone, 4 courses since. She gets eye swelling, skin peeling on her ears, itchiness and ear infections on and off. The itchy rash appears on her neck, back, chest, under her arms and tail bone area. Her physician has reported this to the Health Dept. She states this involved 5 other pts. This was considered to be an "Other Important Medical Event".
12 mos old boy who developed red urticarial type rash within 12 hours of receiving PCV #3, Hep A #1 (havrix) and MMR/Varicella (proquad).  he went to the er where the rash went away within a few hours of receiving oral benedryl.  he finished 5 days of prednisilone. Information was received froma physician concerning a 12 month old hispanic male, with no known medical history of allergies, who was vaccinated on 12-APR-2007 with a 0.5 ml. SC first dose in the "right" of MMR II (+) VARIVAX ( lot # 656309/1393P). Concominant vaccinations administered that day included a fourth dose of PNEUMOVAX 23 ( lot number B066668 also reported B08557141) subcutaneously and a first dose in the left deltoid of hepatitis A virus vaccine inactivated (havrix) (lot number AHAVE143HA). There was no illness at the time of vaccination. It was reported that within 24 hours the patient developed urticaria. The patient was treated with BENARDRYL. The symptoms have since resolved. It was reported that the patient's medical status is recovering. No product quality was involved. Additional information was received from the doctro who reported that on 12-APR-2007, a red rash developed within 12-24 hours. The patient went to the emergency department and received oral BENADRYL and the rash got better. He was started on oral BENADRYL and prednisone and the rash resolved within a few hours. There was no reoccurance. The patient recovered on 13-APR-2007. No further information is expected.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient's parent on 5/9. Patient will plan on getting revaccinated.
Blood clot in his left lung and right lung; Blood clots in his right groin; Terrible pain on the left side of his upper body,It hurts so much; A spontaneous report was received from a consumer concerning a 78 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible pain on the left side of his upper body, it hurt so much, blood clot in his left and right lung and blood clots in right groin.  The patient's medical history was reported by the reporter as high blood pressure, prediabetes and hepatitis C due to a bad blood transfusion (treated with Mavyret). Concomitant medication was not reported.  On 11 Feb 2021, three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route at left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, 3 days after vaccination, patient had a terrible pain on the left side of his upper body and was hospitalized, the tests revealed blood clot in his left and right lung as well as in right groin, which was treated by Eliquis. Patient was observed overnight and discharged with a follow up in 3-6 months.   Action taken with mRNA-1273 in response to the events was unknown.  The reporting physician assessed the events as not related to the product, but did not recommend second of vaccine.  The outcome of events was unknown.; Reporter's Comments: Based on reporter's causality and history of diabetes and Hepatitis C infection, the event is assessed as unlikely related to mRNA-1273.
unable to work since vaccinated; severe allergy reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) at 1st dose, single for covid-19 immunisation. Medical history included COVID in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021, the patient experienced severe allergy reaction since first dose of Pfizer vaccine. Unable to take 2nd dose advised. The patient continued to have severe medical problems which her medical doctors were unclear. She felt like she was poisoned on top of underline ailments since 911 and going through 912 since vaccine. Patient stated that she needs medical advice, unable to work since vaccinated, worse than the covid she had in Jan2021. The patient stated "Help, feel like I'm dying slowly". Outcome of the events was unknown  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Adverse event began on Monday, 4/5/21 , with headache & pressure/tension, mild nausea and dizziness, fatigue; some joint pain in right arm. Symptoms improved and felt better Tues - had a dry needling session. 4/7/21 Wed afternoon all symptoms returned (except joint pain), in addition to low grade fever, heat/warmth in head/neck region & some disorientation, decreased apprt. I have had moments of higher than normal BP (when headache, fever, pressure and pain and particularly worse). I visited my PCP on Thursday 4/8/21. They felt I was having a strong anti inflammatory response to the vaccine, but they ran two COVID tests to be safe d/t protocol (I had low grade fever and headache). My symptoms have continued to this day (Sunday 4/11/21) with minimal improvement. Under advisement of my PCP, I am resting and have taken 220mg Naproxen sodium (2xs) and 500 mg Acetaminophen (multiple times).
pt awoke crying then started frothing @ the mouth turned blue & went limp & pale;paramedics called because abn breathing cont;pt was unresponsive for 15min;
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: sores in the mouth-Mild, Additional Details: pt devoloped sores in her mouth hours afyer recieving the vaccine
At time of vaccination, 20 weeks gestation.  No immediate reaction noted.  Redness, tenderness developed within 24 hours and subsided within 72 hours.  No other signs.  However, starting December 26  (day 10 post vaccination), hives appeared on my elbows, abdomen, eyes, neck and breasts.  Intense itching also started at the same time, and whenever itched, red welts appeared.  Itching was throughout the body, from feet to head, and along all extremities.  Visit to obstetrician on the 27th, and 50 mg diphenhydramine started q6 hours, which would control 80% of symptoms but did not resolve all hives or pruritis.  Completed liver bloodwork to exclude cholestasis of pregnancy on December 28th.  Saw dermatologist on the 29th for persistent signs despite use of diphenhydramine and was changed to 10 mg certirizine q24 hours, which resolved 90-95% of the pruritis, 100% of hives/urticaria, but dermatographia persists even after 12 days of continuous therapy and pruritis returns when dosing interval id complete.  There is no known topical or oral exposure to allergen to cause signs, and there are no signs in other members of the household.
diarrhea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. He was calling about the Covid 19 vaccine. He was asking how long he should have diarrhea. This was his first Covid 19 vaccine and his paperwork says he can have diarrhea, but he just wants to know how long the diarrhea will last. It was been going on since Friday, 18Jun2021. He received his first Covid 19 vaccine on Friday 18Jun2021. Caller stated he had been having diarrhea since 18Jun2021. Caller stated he knew this can be a side effect of the Pfizer Covid-19 vaccine, but he would like to know how long this side effect may last. Caller was asking if he should continue drinking a lot of water. The outcome of the event was not recovered.  Information related to batch/Lot no. was requested.
patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 20221216) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15-Nov-2022 and first dose was administered on 16-Dec-2022).    This case contains information of 14th patient out of 14 patients as described by the reporter.  No concomitant medication was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15-Nov-2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquired the patients need to be re-vaccinated.   Reportedly, vial size included was 2.5mL and date the vial was initially stored in the refrigerator on 15-Nov-2022 and the dates vaccine were administered on 16-Dec-2022, 28-Dec-2022, 4-Jan-2023, 7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023 and the vial did not undergo any temperature excursions.   Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: Master case
AFTER THE VACCINE WAS GIVEN, PT IS EXPERIENCING CONSTANT PAIN IN HER RIGHT ARM.
This spontaneous report as received from a pharmacist via field representative refers to a female patient on her late 70's. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date unspecified), per instructed in the prescribing information, subcutaneous. On an unknown date the patient experienced redness at the injection site, after receiving ZOSTAVAX. The outcome of redness at the injection site was reported as recovered/resolved on an unknown date. No treatment was given. Additional information has been requested.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients were vaccinated with ZOSTAVAX (lot# not provide). No other co-suspects were reported. No concomitant medications were reported. The physician stated that since September 2009 to November 2011, there had been an unknown number of patients who received ZOSTAVAX stored between -3C to 1C. Physician was still doing research to determine length of time ZOSTAVAX were stored this way before given to patients. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. Additional information is not expected.