chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity, start date: 31Dec2021; MUCINEX, start date: 08May2022, stop date: 09Jun2022; VITAMIN C, start date: 31Dec2021; ZINC, start date: 31Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (May2022) Negative, notes: I tested negative on day 7, 2 days after the dose of Plavoxid ended; (May2022) Positive, notes: On day 13, I took another test as symptoms were persisting and I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
HIVES, FACE AND NECK, ITCHING-TREATED AT HOME WITH BENADRYL AND ZANTAC LASTED APPROX 2-3 DAYS
Generalized varicella-like rash 2 weeks (14 days) after Varivax vaccine: Dermatology confirmation, symptomatic case/ onto pruritic/ out of about x 5 day till lesions crusted/ dried.
MATHER TOOK CHILD TO HEALTH DEPARTMENT; SHE HAD A TEMP. 100.1 RD WAS HARD AND VERY RED. TODAY TEMP WAS 98.6 DID NOT LOOK AS RED.
Information was received on 19-JUL-2016 from a registered nurse. The nurse reported that a patient received an improperly stored dose of (Oka/Merck) VARIVAX (lot # L019124, expiry 27-MAY-2017) (dose and injection site not reported) on 24-JUN-2014. The temperature of the vaccine was 21.6 F for 204 hours and 30 minutes. There were no adverse effects reported. Additional information had been requested.
Previously had two doses of Janssen.  One on 3/16/2021, next on 12/14/2021. Received Pfizer Bivalent booster on 9/16/2022 in the afternoon.  Began with a headache 9/17/2022. Progressed into injection site swelling with an itchy rash that spread across chest.  Also had swelling in left neck lymph node.
Diarrhea 7 times on 02/12/2019, three nosebleeds from 02/12/2019-02/13/2019, extreme aggression on 2/13/2019, and fever of 101.2 on 2/14/2019.
48 hours s/p vaccine pt. reports swelling, redness and warmth at site of immunization. Hives on other body area.
swollen neck; Itchy arm; Itchy neck; Rash; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), PRURITUS (Itchy arm), PRURITUS (Itchy neck), RASH (Rash) and VACCINATION SITE SWELLING (swollen arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING (swollen neck), PRURITUS (Itchy arm), PRURITUS (Itchy neck), RASH (Rash) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, SWELLING (swollen neck), PRURITUS (Itchy arm), PRURITUS (Itchy neck), RASH (Rash) and VACCINATION SITE SWELLING (swollen arm) was resolving.            Concomitant medication not provided.  Treatment not provided.
expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
Initial unsolicited report received from a pharmacist on 21-Oct-2015. This case involves a 48 years old female patient who was vaccinated with a first dose of MENACTRA in the right deltoid (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details and route of administration was not reported) on 20-Oct-2015. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. It was reported that the patient decided to take the vaccine due to a death in the area from meningitis. On 20-Oct-2015, immediately after vaccination. the patient experienced tingling in her right arm. Later that day it progressed with shoulder, neck and upper back pain on that side. On 21-Oct-2015, (day of reporting), she was worse. Her face felt numb and she had a horse voice. Patient stated that she would seek medical care in the future. No laboratory investigations were done and corrective treatment was not reported. The patient required ER/doctor visit. The outcome of the events was reported as unknown. List of documents held by sender: none.
Myalgia & HYPOglycemia  Narrative: Patient reports she feels like her joints are on fire and hard to get out  of bed this am She states her blood sugar dropped to 40 at 1:30am, she then  corrected her blood sugar and at 5:30amher blood sugar was up to 67, then about  10:20 her blood sugar was up to 101. She states she is on a insulin pump. She  states she has spoke with the employee health provider. She states she has been  alternating Tylenol and Ibuprofen. She is at home today and states her joints are  bothering her. She is awaiting a call back from her Endocrinologist.
Patient states on 4/26/16 she felt"achy" all over. On 4/27/16 she noticed some redness on her Rt. arm. Denies swelling or pain in arm. Yesterday(5/1/16) it began "itching" and she noticed increased redness. There is an approximate 6" area of redness on upper Rt. arm. No swelling or drainage noted. She is able to move her arm without difficulty or discomfort.
Cough; Throat itchiness; Tongue tingling; Anxiety; This is a spontaneous report from a non-contactable other HCP reporting for a patient. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0167) as a single dose (at the age of 39-years-old) for COVID-19 immunisation.  The patient medical history included recent visit to the ED on 02May2021 for tongue swelling, the patient took Benadryl prior to her arrival to the ED at that time, symptoms had resolved for her then.   The patient's concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on an unknown date (Lot number: ER8731) for COVID-19 immunisation. On 07May2021 the patient experienced cough, throat itchiness, tongue tingling and anxiety. The clinical course is as follows: The patient received the second dose of bnt162b2 on 07May2021. During her 30 minute waiting period after the injection, the patient began to experience cough, throat itchiness, tongue tingling.  She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. The patient was transported to ED by POV. The Differential Diagnosis was reported as: Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash). The patient had stable and improving symptoms. The reporter stated: Certainly anxiety may be a factor playing into this but recommended that she seek emergency care for observation and follow up with her primary care along with allergist to look into her two reactions that she has had this week. Therapeutic measures were taken as a result of the event and included unspecified treatments. The clinical outcome of the events cough, throat itchiness, tongue tingling and anxiety were unknown.  No follow-up attempts are possible. No further information is expected.
Hives both itchy and burning, red area in neck like a sunburn and itched and burned, wrist and hands hives with itch and burn, hives on upper arms and upper inner thighs that went from small hives to big blotchy areas in minutes (Ironically, these ares did not itch)- my family Dr. could not see me for a week so went to local HCF- given claritin and hydrocortisone cream- hives would come and go- Saw my dermatologist, emergency appt., June 22- She prescribed Zyrtec and a cream specific to the neck area, Mometasone Furoate 0.1%.  Hives resolved over time. I have pictures on my cell.
Case number PHEH2015US020579 is an initial spontaneous report received from a health care professional on 14 Oct 2015. This report refers to a 76 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly on an unknown date. It was reported that on 13 Oct 2015, the patient experienced arm pain, swelling, tightness and blisters around the injection site. One of the blisters was the size of a dime and the pain on a scale of 1 to 10 was 9. The events outcome was unknown. The seriousness and causality of the events was not reported.
nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.
Numbness in the arm where injection was administered; tingling in arm where injection was administered; headache; chest pain; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the right arm on 27Mar2021 at 10:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included sertraline hydrochloride (SERTRALINE) 25 mg daily for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01April2021 at 00:00 (4 days after the vaccination), the patient experienced numbness in the arm, tingling in arm where the injection was administered, headache and chest pain. The patient did not receive any treatment for the adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event numbness in the arm, tingling in arm, headache, chest pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
The shot was given at the top of the deltoid near the joint. Both my husband and I had the same pain in the muscle on the underside of the upper arm shortly after the shot but his went after 3 days. I still have the pain which makes it difficult to dress and anything that requires lifting the bent arm up. I went to see my doctor on October 13th and she sent me for physical therapy which I am still doing. As yet it doesn't feel a lot better but I have noticed that driving isn't as painful.
I never had issues with my thyroid.  I began losing weight and feeling weak.  on November1, 2022, 2 weeks post vaccine, I saw my doctor. My doctor thought I had the flu and I did not.  Tests indicated Hypothyroidism.  I have enlarged thyroid.  My antibody levels are high.  I continue to have issues.  I suspect the booster contributed to the issue.  I called Moderna yesterday.
she came down with symptoms of covid and tested positive for covid; she came down with symptoms of covid and tested positive for covid; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. she had her 1st dose on 25Mar2021. she came down with symptoms of covid and tested positive for covid in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Acute CVA / Brain stroke caused by a small blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 18:30 (Lot number: FL3198) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0151, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 11Jan2022 09:00, outcome "not recovered", described as "Acute CVA / Brain stroke caused by a small blood clot". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "acute cva / brain stroke caused by a small blood clot" was evaluated at the emergency room visit. Therapeutic measures were taken (put on blood thinners and cholesterol medication) as a result of cerebrovascular accident. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022; No adverse event; Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022).    No concomitant medication was reported.  The patient received booster dose  The vial was thawed on 29-Jul-2022 and kept in the refrigerator.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case contains information for the 6th of 8 patients described by the reporter.
ACHES; GENERAL MALAISE; EQUIVALENT OF A HANGOVER AND DULL HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, general malaise, equivalent of a hangover and dull headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from equivalent of a hangover and dull headache, and fever, and the outcome of general malaise and aches was not reported. This report was non-serious.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
VACCINE REMAINED IN FREEZER BEYOND MANUFACTURER RECOMMENDATION. AFTER CONSULTATION WITH PFIZER AND Agency REVACCINATION WAS RECOMMENDED  TO ENSURE PROPER EFFECTIVENESS.
Severe headache, mild fever (101). Started 6-8 hours after vaccine and lasted 24 hours after vaccination.
After the second shot I had the normal side effects that went away in a day. But then on day 11, I started having flu-like symptoms - aches headaches chills and feverish. This lasted for about 3 days. I went in for a COVID test which was negative. I recovered but now I have those symptoms again. Also some shortness of breath and minor cough occasionally.  Tomorrow will be 4 weeks from when I got the shot. If I take Advil I can manage.
At approx 0700 on 1/6/2021, I had severe pain in my left axillary lymph nodes. Pain is still present.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old male patient who experienced developing a red hot golf ball sized swelling at the injection site. At 4 years of age, the patient received the first dose in May-2010. The patient also received a dose of MMR II (Merck) and a dose of VARIVAX (Merck) in May-2010. The patient experienced developing a red hot golf ball sized swelling at the injection site in May-2010. The outcome of the events is unknown. No additional information was available at the time of this report.
A non serious spontaneous report of influenza A, fatigue, fever, sore throat, and stomach ache has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance to a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included an enterovirus on the 04-Nov (year unreported). The patient received FLUMIST 0.2ml intranasally for influenza vaccine on 22-Oct-2008. On 14-Dec-2008, the patient experienced fatigue, fever, a=sore throat, stomach ache, and was positive for Influenza A on 150Dec-2008, when tested with BIONEX rapid Influenza A&B test. On 15-Dec-2008, she had a negative rapid streptococcal test and a urinalysis revealed large ketones. The patient was treated with oseltamivir phosphate and was sent home to be followed up in one week. The events resolved on an unreported date in 2008.