chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body rash; This case was reported by a consumer via interactive digital media and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had a body rash from Shingrix for four days.
Redness; Pain; Tiredness; Upset stomach; This case was reported by a consumer via sales rep and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. On 28th October 2019, 3 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the patient experienced erythema, pain and fatigue. On an unknown date, the outcome of the erythema, pain, fatigue and upset stomach were unknown.   It was unknown if the reporter considered the erythema, pain, fatigue and upset stomach to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced the redness, pain, tiredness and upset stomach. The patient asked if it is common to experience the upset stomach, three days after receiving the first shot.
H1N1 vaccine given in R dlt at 9 A. Was feeling "weird" at 9:30 A tingly, numb, throat swelling up, wheezing, etc-met ambulance went to hospital given BENADRYL and EPI-sent home-returned last night about 7 PM-same symptoms.
evening after the vaccine given, started having discomfort  in the vulvar area of my body, perhaps a little itching and began spreading to entire perineal region eventually over the next day or so.  That evening I had intense discomfort in one area of the vulva but that relented after a few days. Then it became more of a sensitivity of the entire perineal area such as when I took a shower and cleaned myself in that area. Has basically gone away now.
Shingles has started within 3 days of 1st dose of vaccine, started valacyclovir & gabapentin,
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history was not reported. In June 2015, the patient was vaccinated for prophylaxis with the first dose of GARDASIL lot # 010215, expiration date 17-JAN-2016. In August 2017, the patient was vaccinated with second dose of GARDASIL lot # N019923, expiration date 28-APR-2019. On 28-JUN-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N025429, expiration date 21-JUL-2020. No adverse events were reported.
Patient's parent presented a signed consent form for the Janssen covid 19 vaccine indicating the patient was over the age of 18 which is required to receive the Janssen vaccine. After administering the vaccine to the patient, we quickly realized the patient's date of birth in the facility database was different. This patient has not yet turned 18 and therefore should not have received the Janssen vaccine.
This spontaneous report was received from a Medical Assistant, and refers to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with an improperly stored VARIVAX lot # M006729, expiration date 08-FEB-2018 (concentration, dose and administration route were not reported). The patient's concomitant medication was not provided. No adverse reactions were reported. This is one of two reports received from the same source. Additional information has been requested.
Pt received a Moderna booster 0.25ml instead of the Pfizer 0.3ml.  Pt had no reaction after vaccine was given we kept her in the clinic for 1 hour and 35 minutes.  We discharged her home with no reaction and advised/instructed to call clinic or go to ER if anything changed parent voiced understanding.
The patient fainted for less than 10 seconds after the flu shot was administered. The patient was sitting in her mom's lap and after receiving the shot, the mom noticed she wasn't responding. Her mom shook her to wake her up while the immunizer came and got me (the pharmacist). I immediately went into our vaccine room and when I walked in, the patient had woken up and was crying. I immediately called EMS. They arrived at our pharmacy within 10 minutes.  The patient's vitals were normal, and she did not have any other signs/symptoms of an adverse reaction. Upon evaluation, the paramedics gave the parent the okay to take her child home.  The parent will be following up with the pediatrician as this has not happened in the past.
14.5X12 cm redness and 5X5.5 induration at injection site, started one day after vaccine administration.
Missed period.  Has had normal cycles for past 8 years, and as soon as got the first vaccine skipped cycle.
Redness, swelling, and warm to the touch at injection site. Benadryl and ice didn't improve and warmth is increasing. Patient will be seeing an immediate care professional today.
Pt.'s arm tender to touch, slight redness approx. 5" diameter, swollen shoulder/back of arm, afebrile. Applied cold compress, MOTRIN for discomfort.
DIZZY, HEADACHE PT ATE BREAKFAST, MED CONSULT CAME, BP 190/103 (DID NOT TAKE BP MED). TRANSPORTED TO HOSPITAL
I basically contracted COVID-19 in early august and then I recovered. Then a month later, just before labor day weekend my Colitis flared up after 21 years.
At 7:30 pm developed temperature to 104 F, SOB, joint pain, severe chills, sensitivity to light and migraine.  Because SOB was severe, paramedics were called and transported to ED.  BP was 88/47.  Was given Benedryl and Prednisone in ED and placed on 5 day course of prednisone.
Rec'd vaccine while on shift at work. Had reaction nine hours later and went to the ER. C/o heart racing, back soreness, N/V, rapid breathing, oral temp 100.5 F 10/30/16 ER visit diagnosed with Tachycardia. Treating physician couldn't rule out flu shot caused.
red spot just below the injection site with 4 to 5 cm in diamete; Swollen; Itchy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red spot just below the injection site with 4 to 5 cm in diamete), SWELLING (Swollen) and PRURITUS (Itchy) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ERYTHEMA (red spot just below the injection site with 4 to 5 cm in diamete), SWELLING (Swollen) and PRURITUS (Itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 24-Jan-2021, ERYTHEMA (red spot just below the injection site with 4 to 5 cm in diamete), SWELLING (Swollen) and PRURITUS (Itchy) had resolved. 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 concomitant medications were reported.  Treatment information include Antibiotics and anti inflammatory like Ibuprofen, Benadryl.
Had some aches for about 24 hours. Slight fever 100.3  8ish hours post shot.  Noticed a bruise when I took off the bandaid 12 hours post shot. And a rash on my arm 24 hours post shot
Customer had genital herpes suppressed for years before receiving the pfizer 3rd dose by taking Acyclovir, With in a month of receiving the vaccine the herpes flared. She continued to use the acyclovir and added acyclovir 800mg for 5 days for the flares.  She said the flared seem to be lasting longer.  Current flare stated 7/20/22 and is still ongoing.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "First-degree AV block" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had taken other vaccination and medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bumps have tiny blisters in the center; bumps are itchy; bumps are very bright red; Bumps on neck, torso, legs and back; Little body ache; left arm was a little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy) and ERYTHEMA (bumps are very bright red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitamin D deficiency, Drug allergy and Digestion impaired (trouble digesting pills in stomach). Concomitant products included COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was a little sore) and PAIN (Little body ache). On 23-Feb-2021, the patient experienced BLISTER (bumps have tiny blisters in the center), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported. patient took Neuro-Immune Stabilizer topical cream as concomitant medication.
No adverse event; 7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 24-Feb-2023 at 1:02 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 24-Feb-2023 at 1:02 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients).    Concomitant medication was not provided.   It was reported that the vaccine was frozen with no known temperature excursion before being thawed. The vial was initially stored in refrigerator on 24-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to C-INT-0002940, US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712700, US-MODERNATX, INC.-MOD-2023-712708, US-MODERNATX, INC.-MOD-2023-712760, US-MODERNATX, INC.-MOD-2023-712765, US-MODERNATX, INC.-MOD-2023-712766, US-MODERNATX, INC.-MOD-2023-712708 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Non significant live follow up received: Vaccination time added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712760: US-MODERNATX, INC.-MOD-2023-712765: US-MODERNATX, INC.-MOD-2023-712766:
Patient had extreme pain and swelling in shoulder within 3 hours. The pain was bad enough all the way down the arm to where patient had to go to the ER. Patient describes the pain as shooting pains that went all the way down to her hands and could not move arm at all that evening. She also had swelling that went down to her elbow. She was given pain meds and BENADRYL at the hospital but was out of work for a week. She says the pain didn't totally alleviate until 7 days later.
Vaccinated in the AM. redness and swelling occurred in the PM before bedtime. Redness and swelling resolved on 12/24/04.
itch at the injection site; a little hard at injection site; 3in circle that was red at injection site; swelling at the inejction site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch at the injection site), VACCINATION SITE INDURATION (a little hard at injection site), VACCINATION SITE ERYTHEMA (3in circle that was red at injection site) and VACCINATION SITE SWELLING (swelling at the inejction site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itch at the injection site), VACCINATION SITE INDURATION (a little hard at injection site), VACCINATION SITE ERYTHEMA (3in circle that was red at injection site) and VACCINATION SITE SWELLING (swelling at the inejction site). At the time of the report, VACCINATION SITE PRURITUS (itch at the injection site), VACCINATION SITE INDURATION (a little hard at injection site), VACCINATION SITE ERYTHEMA (3in circle that was red at injection site) and VACCINATION SITE SWELLING (swelling at the inejction site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not take any treatment medication.  After getting the vaccine the patient underwent a colonoscopy.
Pt. presented with blisters at vaccination site.  Dressing applied after picture taken.
CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE  12/9/2022 - RECURRENCE OF SAME SYMPTOMS
Severe body aches and chills. Mild Headache. Loss of appetite. Severe Fatigue. Lasted approx 24 hrs.
Information has been received from a physician's assistant concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot # not reported). Concomitant therapy was unspecified. The  patient sought unspecified medical attention. Subsequently, the patient experienced a rash. The specifics of the rash were not reported. The outcome of the rash was not reported. Additional information has been requested.
No adverse event; 02Feb2021 First dose10Mar2021 Second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (02Feb2021 First dose10Mar2021 Second dose).    No concomitant medications were reported. It was reported that age of caller was not confirmed. No treatment medications were reported.
Pt fainted about 3 minutes after vaccine.  100 degree weather, no air conditioning inside.  Reports no lunch.
Fever (approx. equal to 101 degrees). Soreness and muscle pain bilateral arms (site vaccines were administered).
Soreness at the injection side on left arm started within an hour of receiving the vaccine on 10/20/2021. Soreness intensified on 10/21/2021. Experienced the soreness more when trying to lift or move my left arm. Symptoms lasted until 10/24/2021. On 10/21/2021, I experienced fatigue. I had low energy and was very sluggish. Symptoms lasted the entire day. On 10/21/2021, I also experienced a headache with intensity alternating between mild and moderate. The headache was particularly intense at the back of my head. Location varied over time, sometimes it would be localized at back of my head, forehead and/or temple and other times affect the entire head. Symptoms lasted until 10/24/2021.
Legal report from the US of a male pt who experienced toxic exposure to mercury coincident with Certiva. On an unspecified date, the pt was exposed to Certiva therapy. On an unspecified date, the pt experienced toxic exposure to mercury, which led to permanent neurological injuries. It was reported that the pt was exposed to mercury from continually inhaling and ingesting mercury emissions. Pertinent lab test, diagnostic procedures, medical history or concomitant medication info was not provided. The pt was a child. The event of toxic exposure to mercury was considered serious.
Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-546697, MOD-2022-546695, MOD-2022-546699 (Patient Link).
FEELING VERY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 09-APR-2021, and had not recovered from headache. This report was non-serious.
Left arm sore within 12 hours of each dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: ENS318) as dose 1, single and intramuscular, administered in arm left, administration date 23Mar2021 (Lot number: ENS318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Left arm sore within 12 hours of each dose". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient also received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Dec2021 02:00 PM, (Lot number: FF2S89) as dose 3, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. Adverse events: Left arm sore within 12 hours of each dose. Experienced Headache and exhaustion, felt nauseated, shortness of breath. The patient was not affected by covid prior vaccination and was not tested with covid post vaccination. No Known allergies. The other medical history was Asthma.  No follow-up attempts are possible. No further information is expected.
pt recvd MMR vax on 22AUG91 & 36 hrs following vax pt devel a rash & fever; also vomited once; 25AUG91 presented to ER w/tonoclonic seizure; t104.4 ax & pt was hospitalized;