chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Problems with her nose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is calling in regards to the COVID vaccine. Her daughter took her second shot the Monday before last. A week later, so this past Monday (2 days ago), she went to the ENT. She clarifies her daughter was having problems with her nose, but it had nothing to do with the vaccine. So, whatever is going on with her nose, her daughter's doctor put her on 60mg of Prednisone for 5 days. She wasn't there with her daughter, but her husband was, and she is pretty sure he did tell them she had the second vaccine 2 days ago, and she wasn't done with the 2 week period. Caller is wanting to know is it okay for her daughter to be taking a steroid? Will it lessen the effect of the COVID vaccine if she is taking a steroid? Treatment received as Prednisone. Outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness at injection site; Itching at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site).   The patient was treated with ALCOHOL for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Presented to the ER on 11/29/2021 with symptoms of shortness of breath, fever, chills,  production cough, headache and severe hypoxia. He tested COVID = on 11/28/2021.  During his stay, he mechanical ventilation,  ARDS, shcock, VAP and submassive PE.  Despite maximum therapy, he expired 12/30/2022.
Hives; Lump; Redness; Itch that is driving her crazy; Dose did not go into the deltoid muscle, it went into the tissue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy), URTICARIA (Hives) and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (numerous issues with hives thought the years- giant hives-- cause in determined - treated with steroids) since 10-Jan-1990, Breast cancer (multiple surgeries due to implant rejection-- 4 surgeries) since 12-Jan-2016, Osteoporosis (Prolia stopped due to severe bone and muscle pain 10/01/2020) since 15-Feb-2005 and Leukopenia (Remains chronic---- in depth invertigation finds no direct cause) since 10-Mar-2000. Concurrent medical conditions included Immunocompromised, Allergy (allergic to several antibiotics-face and neck rash - at time on the trunk and back) since 10-Jan-1980 and Allergy (allergic to sulpha-swelling redness pain) since 15-Jan-1990. Concomitant products included DENOSUMAB (PROLIA) from 15-Feb-2005 to 01-Oct-2020 for Osteoarthritis NOS, PANTOPRAZOLE from 15-Jan-2021 to an unknown date, HYDROXOCOBALAMIN ACETATE (VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]) from 01-Jun-1995 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 06-May-2006 to an unknown date and CALCIUM from 01-Jun-2006 to an unknown date for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue). On 09-Sep-2021, the patient experienced MASS (Lump), ERYTHEMA (Redness) and PRURITUS (Itch that is driving her crazy). On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, MASS (Lump), ERYTHEMA (Redness), PRURITUS (Itch that is driving her crazy) and URTICARIA (Hives) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Dose did not go into the deltoid muscle, it went into the tissue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medication includes steroids   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received includes- Patient route of administration-Subcutaneous tissue On 16-Sep-2021: ADR Received on 16 Sep 2021,include Patient details, Medical History and concomitants mediations added
Pt vax w/ 1st + 2nd hepta B; ex n/v, arthralgia /p both.
COVID-19; COVID-19; Pfizer- 17Apr2021/ Moderna- 09Nov2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 at 13:00 as dose 1, single (Lot number: ER2613), in left arm and on 17Apr2021 at 13:00 as dose 2, single (Lot number: EW0170) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2021 at 17:00 as dose 3 (booster), single (Lot number: 034F21), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: AS7140C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative". The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021 at 17:00, outcome "unknown", described as "Pfizer- 17Apr2021/ Moderna- 09Nov2021"; COVID-19 (medically significant) with onset 2023, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with nirmatrelvir/ritonavir (PAXLOVID).  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received a third dose longer than 6 months after receiving the first dose of RECOMBIVAX HB intramuscularly (doses, anatomical location, lot# and expiration date were not provided). No adverse effects were reported. No product quality compliant (PQC) was involved. Additional information has been requested.
Received vaccine on 1/13/2021, arm tender on Friday 1/15. On Saturday, 1/16, felt slightly nauseous and tired. Continue to feel the same and went to get tested on 1/18/2021. Tested positive for Covid.
This spontaneous report received from a nurse referred to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date in DEC-2016, the patients had been administered PEDVAX HIB (lot: K025005; expiry: 21-JUL-2017 and lot: L014427; 09-MAR-2018) which were improperly stored. No adverse effects were reported. The vaccines were stored at 34F for 48 hours. The call was because of a data logger. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010417: same reporter US-009507513-1612USA010418: same reporter US-009507513-1612USA010419: same reporter US-009507513-1612USA010420: same reporter US-009507513-1612USA010421: same reporter.
pt recv vax 17OCT96 & that same day pt exp redness & erythema @ inj site & muscle achiness & pain all over body;
Noticed swelling of right arm last night (3/8/01). Father states noticeable lump about the size of a half dollar; redness and slightly smaller induration. Child feels find with increased temperature; appetite good and active. Right arm warm to touch and tender to touch. Advised cool compresses and Tylenol and father giving Motrin. To call MD if pain or swelling or no decrease in swelling.
Intense itching in hands; Red hives in hands; Allergic reaction; Urticaria in hands; Wrist was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE for Hyperlipidemia, TRIGLYCERIDES for an unknown indication.    On 05-Apr-2021 at 12:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen). At the time of the report, PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen) outcome was unknown. Not Provided      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.   No treatment information was provided.
2 WEEKS AFTER BALANCE/DIZZINESS COMPLAINTS,  3-4 WEEKS AFTER SHORTNESS OF BREATH, BLIATERAL LOWER LEG SWELLING
Pt recvd MMR vax 25JUN90; two days later pt devel fever & achiness; Pt recovered from the exp;
Lightheadedness within 30 minutes after vaccine shot. Muscle pain all over body, splitting headache turned to migraine, fever, cough 13 hours after shot. Took two pills of advil, slept, then after about 3 to 4 hours felt better. Back pain still lingers
On 29JAN90 pt devel chills, sore throat, sore cervical glands & testicles; Next day t101-102F; On 02FEB90 seen by MD devel joint stiffness & pain primarily in rt wrist; Also morbilliform rash of mild degree; 08MAR90 arthralgia & myalgia;
It was the booster vaccine covid (moderna) and patient when verifying the system patient added having allergy to penicillin. When asked if she had an allergic reaction with the first two doses, she replied with the first she had rash, itching and she was takin to the hospital. With the second dose her doctor said to taken Benadryl 50mg before the vaccine and she did and did not have an allergic reaction. She said that yesterday she took Benadryl 25mg and was in the waiting for 1/2 hour covid protocol. At 15 minutes I went to see her and she had itchiness and rash she said she took benadryl  and when I looked it was Zyrtec generic. I gave her liquid benaryl 10ml (25mg). At 15 minutes she started to cough I injected benadryl 50mg/ml only 0.5ml to comple dose of 50mg. Patient was with her husband and at 7 they left in good condition and did not want us to take her to the ambulance. I called her on 11/3/2021 at 1:41pm she said she had a good night and had good after leaving and today 11/03/2021 (a day after the vaccine) she only had a strong head pain and fever. I reminded her to take Tylenol or Panadol
Extremely sore joints and muscles. Severe headache. Fever. Chills.   Joint pain started around 3 hours after vaccine and worsened over the next 36 hours. All other symptoms were noticed around 12 hours after vaccine.
Severe soreness at injection site worsening as day went on after shot at 08:30 am.   Extreme fatigue started around 7 pm. Severe chills and body aches started at 10 pm. I have never felt so sick in my life as I felt last night. Slept all day today. Feeling about 50 percent better as of 06:30 pm.  I felt so horrible that I was not able to go to work today.
Heavy menstrual bleeding with heavy clotting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE from 03-Mar-2021 to an unknown date for Allergy, DESOGESTREL, ETHINYLESTRADIOL (ISIBLOOM) from 12-Jan-1996 to an unknown date for Birth control, ACYCLOVIR [ACICLOVIR] from 12-Jan-1996 to an unknown date for Herpes NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) from 06-Jan-2018 to an unknown date for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021 at 5:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting). On 06-May-2021, HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding with heavy clotting) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received, reporter information, height, weight, pregnant information, ethnic group, race, allergy, concomitant medications, patient had a prior history and event stop date added and event outcome updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
had covid after vaccination/covid-19 symptoms not bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after vaccination/covid-19 symptoms not bad) in a 52-year-old male patient 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 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 COVID-19 (had covid after vaccination/covid-19 symptoms not bad). At the time of the report, COVID-19 (had covid after vaccination/covid-19 symptoms not bad) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: This report concerns a 52 year old male patient with no relevant medical history who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. It was reported that the patient was fully vaccinated with 2 doses of mRNA-1273 prior to onset of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Dizzy, nauseous, fainted, emesis, severe sweating  from 6am-8:30am
Kidney Stone, Pyelonephritis. ED visits and hospital admissions. These visits were within 6 weeks of receiving the COVID vaccine.
Extreme case of ?Covid arm? with a rash and bump at my the site of injection. Elbow area and forearm are Severely sore even after an entire week. I can?t tell if it?s muscle related or bone.
Nurse reported pediatric patient received adult dose of VAQTA. See additional AE cases 02457006 and 02457033/no PQC.; This spontaneous report was received from a registered nurse concerning an unknown gender and age of child patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On 22-AUG-2023, the patient was vaccinated with 1 adult dose of hepatitis A vaccine, inactivated (VAQTA) (lot# X006701, expiry date was reported as 21-JUN-2024, but upon internal validation established as 06-APR-2024) intramuscular injection as prophylaxis (exact dose, route of administration and anatomical location not provided) (product administered to patient of inappropriate age).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA008072: US-009507513-2308USA008381:
At 3:00AM I started having a terrible headache, massive chills and felt like I had been hit by a semi. I felt a sudden onset of horrible flu like symptoms. I felt nausous and all over body aches and was dry heaving for several hours. I was in total body pain and agony. I tried to go to the bathroom at 6 AM and I couldn't even walk. I was so dizzy and weak I had to crawl to the bathroom. I spent the next 4 days after the date of vaccination in bed. I ,missed several days of work without pay. I have differences in taste and smell, they are not quite the same as I used to be.  I will NOT be getting the second dose. It really hurt my body. I did have a bad case of covid-19 in November 2020 prior to my receiving the vaccine but it was 11 months apart.
Pain left upper arm, radiating to shoulder, subjective fever, body aches, no chest pain, no wheezing.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 22-AUG-2017 or 23-AUG-2017, the patient was vaccinated with the fourth dose of GARDASIL 9 by mistake. On 22-AUG-2017 or 23-AUG-2017, the patient was extra dose administered. On an unknown date, the patient experienced no adverse event. Additional information has been requested.
diarrhea; This is a spontaneous report from a non-contactable consumer (patient) from a sponsored program. A female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on an unspecified date. Reported as: Caller got the vaccines on Jan, wanted to cancel appointment because they have Diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO MEDICAL HISTORY REPORTED).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) had resolved.       mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Patient had shingles symptoms included neuropathy pain, blisters in right quadrant and mid area and rash on arm. Treatment medications included Atorvastatin 40 mg and Aciclovir 1000 mg for 7 days.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles
No adverse reaction; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
15 min after receiving the Influenza vaccine she developed numbness to her (L) forearm, thumb and index finger.