chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Did not get the whole booster; They put the needle in my arm and and as they administered it, some of the product squirted out; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Did not get the whole booster), DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2023, 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 07-Jan-2023, the patient experienced UNDERDOSE (Did not get the whole booster) and DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Did not get the whole booster), DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out) 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 assessments were provided for UNDERDOSE (Did not get the whole booster) and DEVICE CONNECTION ISSUE (They put the needle in my arm and and as they administered it, some of the product squirted out).    No concomitant information was reported. It was reported that, at a pharmacy on Saturday, they put the needle in patient arm and as they administered it, some of the product squirted out. Patient did not get the whole booster. Patient did not receive an additional booster dose. No treatment information was reported.   Reporter did not allow further contact
Pt called stating he had fever 102 and RT arm was sore and very red. Advised to come to office to see Doctor. Prescribed Augmentin for possible Cellulitis, Benadryl and Tylenol. 11/17/08 pt is doing better reaction less red at this time.
Massive rash down arm; tired; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Massive rash down arm), FATIGUE (tired) and HEADACHE (slight headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027420A and 01M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No reported medical history) and Gluten sensitivity.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 4:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced RASH (Massive rash down arm), FATIGUE (tired) and HEADACHE (slight headache). On 10-Feb-2021, RASH (Massive rash down arm), FATIGUE (tired) and HEADACHE (slight headache) had resolved.            The patient did not have any acute illness at the time of vaccination and up to 1 month before. The patient had no chronic and long standing health conditions  No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Slight numbness in the left cheek (face) down into the left arm, increased anxiety, Pt vitals checked and 1 25mg of Benadryl given PO,  Pt rested approx. 2 hours before she felt comfortable to leave
Red Rash about 4 cm in diameter started 6 days after shot administered. Recommended Benadryl
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male patient who experienced ear infections. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was unspecified intramuscular. Concomitant medications were not reported. The patient received 2 of the 4 doses of the Prevnar vaccine and experienced ear infections. The patient required implantation of ear tubes. (See case HQYWYE499103MAY05 adverse event non expedited). No additional information was available at the time of this report.
extreme hair loss post vaccination; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15May2021 12:00 (at the age of 46-year-old) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient had no known allergies. She had no covid prior vaccination. The patient did not receive any other vaccine in four weeks and any other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:30 (at the age of 46-year-old) as single dose for COVID-19 immunisation. The patient had inappropriate schedule of vaccine administered on 15May2021 12:00. The patient experienced extreme hair loss post vaccination since 01Jun2021 12:00. The AE resulted in Doctor or other healthcare professional office/clinic visit. Doctors had not found any other reason or source of hair loss. No treatment received for the hair loss. The patient had not tested Covid post vaccination. Outcome of the event hair loss was not recovered.  Information about the Lot/batch number has been requested.
Breakthrough COVID infection. Pt fully vaccinated on April 4 2021. Pt tested positive for COVID on August 29 2021
Patient reports to a small blister forming on this skin away from the injection site about a week after the vaccine.  About another week later his is having more blister like reactions mainly on the left side of the body.  He describes them as non-painful, fluid filled areas similar to poison ivy.  Patient was not sure if this was related to the vaccine.  He plans to make an appointment with his dermatologist.
PATIENT EXPERIENCED PAIN AT INJECTION SITE AND ITCHING AT INJECTION SITE. FEVER >100. SYMPTOMS SUBSIDED OVER 3 DAY PERIOD. PATIENT INFORMED DR WHO TOLD HER TO TAKE ADVIL AND BENADRYL.
Red, scaly, maculopapular rash on face, neck chest, upper thigh & back; pt also had fever, h/a & arthralgias w/swelling & loss of strength in hands; In addition, eyes became swollen, red & itchy;
Patient described having welts, redness at the injection site, pain, swollen glands, dizziness  and lethargy.  Patient did not report to pharmacy unitl 10/15/2016.  Told patient to follow up with their physician since still red and hot to the touch.
pain; red skin; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a 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 pain and skin red. On an unknown date, the outcome of the pain and skin red were unknown.   It was unknown if the reporter considered the pain and skin red to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient had pain and red skin after the Shingles shot.
aches and pain in hips; very lethargic/lethargy was worse; sore throat; chills; head pain/headaches; nauseous; had no appetite; had horrible diarrhea; stomach cramps; slept 13 hours which my normal is max 8 hours/Slept 15 hours straight Sun. To Mon; This is a spontaneous report received from a contactable consumer (patient). An adult female patient of an unspecified age (reported as 63, no unit provided, pending clarification) received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in right arm, on 08Jan2021 12:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included known allergies to penicillin and mango. Concomitant medication included probiotics, colecalciferol (D3), cyanocobalamin (B12), lysine and elderberry (ELDERBERRY [SAMBUCUS NIGRA]). The patient did not receive other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. The patient received her first vaccine on 08Jan2021, Friday. On 09Jan2021 at 16:30, Saturday or next day after the vaccine, the patient got nauseous late in the afternoon and had no appetite, so she ate some Jasmine rice and Peppermint tea. Within 3 hours, she had horrible diarrhea and stomach cramps. She went to bed early and slept for 13 hours which her normal is max 8 hours. She woke up on 10Jan2021, Sunday, and was very lethargic and had sore throat, chills and head pain across the back of her head, she never had headaches. She slept for 15 hours straight from Sunday To Monday (10Jan2021-11Jan2021). She woke up with the same symptoms on 11Jan2021, Monday (same as Sunday), but lethargy was worse. She had the same diet & care on Sunday, Monday and Tuesday (10Jan2021-12Jan2021) hot tea and hot showers letting hot water beat on her head and body. The patient still had chills, sore throat, head pain and was lethargic. On 21Jan2021 (Tuesday evening by 19:30), head pain was gone, was not as lethargic & throat was not as sore. The patient only drank hot peppermint tea, 3 liters warm lemon filtered water and soup. The patient was gargling with warm salt water & took 800 mg MOTRIN daily. On 13Jan2021 (Wednesday, the patient was back at work Wednesday but started to experience aches and pain in hips and sore throat but better. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
Facial edema, rash and cough about 5-6 hours after immunizations.
c/o ache in rt arm w/in 24hr of vax;2wk p/vax devel severe pain elbow to neck w/numbness of thumb;tingling of fingers;
This spontaneous report as received from a physician via a company representative refers to two patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (lot#, dosage, route and indication unknown). On an unknown date both the patients reported blood in their stool after receiving ROTATEQ. It was unknown if the patient had sought medical attention. The outcome of the event and action taken with ROTATEQ were unknown. Additional information has been requested.
7 hours after vaccination, mild headache and weakness, gradually intensifying headache to a very bad, throbbing headache by 11 hours after vaccination, which continued through until 22 hours after vaccination. At 20 hours after vaccination, took 2 extra-strength acetaminophen which helped alleviate headache pain. Additionally, nausea and vomiting began at 17 hours after vaccination, and continued until 22 hours after vaccination. General body aches continued through 57 post-vaccination.
Had fever on 12-30-15 - 101 degrees F - mother gave MOTRIN. Went to ER - on 1-2-16 - fever and rash diagnosed as serum sickness, BENADRYL and Ibuprofen was given. 12/30/15 - Received Flu (Influenza vaccine) FLUZONE - UI1515AA Exp - 6/30/16 in her (R) thigh, intramuscular. 12/30/15 - At night got fever, mother gave MOTRIN or Ibuprofen. 12-31-15 - Fever and developed few lesions on her thigh. 1-2-16 - Fever and rash progressed. Went to ER where blood work and chest X Ray was done and sent home - allergic rash. 1-4-16 - Still with fever and swollen eyes - and BENADRYL not working, so steroids - prednisone 15mg/5ml. 5 ml PO BID x 5 days. 1-7-16 - patient was dizzy and not walking right - so was advised to go to ER - went to hospital where blood work was done and diagnosed as serum sickness and advised to continue steroids. 1-8-16 - Doctor called and she said eyes are red but no fever. So thought Kawasaki advised to take to ER (went to ER on 1-10-16) and diagnosed as Kawasaki and IVIG given on 1-11-16 and discharged on 1-12-16. Readmitted on 1-13-16 as fever and aspirin and bld wk.
Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS,  the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
Warmness at the injection site; Itchiness at the injection site; Redness at the injection site; Raised borders at the injection site; rash that is increasing; Sharp worsened pain under her arm pit; Lymph nodes under clavicle were enlarged; Couldn't raise left arm; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and AXILLARY PAIN (Sharp worsened pain under her arm pit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 06-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't raise left arm). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged). On 08-Jan-2021, the patient experienced AXILLARY PAIN (Sharp worsened pain under her arm pit). On 09-Jan-2021, the patient experienced RASH (rash that is increasing). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised borders at the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), MOBILITY DECREASED (Couldn't raise left arm), VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), AXILLARY PAIN (Sharp worsened pain under her arm pit), LYMPHADENOPATHY (Lymph nodes under clavicle were enlarged), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Raised borders at the injection site) and RASH (rash that is increasing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child became weak, her eyes rolled, and she fainted, with mild seizure-like shaking while lying on floor of doctor's office. When she came to, her face was extremely pale and she was disoriented. She kept complaining of her chest hurting hours afterwards.
random on and off nose bleeds since receiving thevaccine; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (random on and off nose bleeds since receiving thevaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concomitant products included FLECAINIDE, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), METFORMIN, RABEPRAZOLE SODIUM (ACIPHEX), TELMISARTAN, SEMAGLUTIDE (OZEMPIC), RIVAROXABAN (XARELTO) and LIRAGLUTIDE (SAXENDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (random on and off nose bleeds since receiving thevaccine). At the time of the report, EPISTAXIS (random on and off nose bleeds since receiving thevaccine) outcome was unknown.            No treatment medication reported by the reporter. Patient was on blood thinner since last 4 years. Patient stated that she never had nose bleeds in her life. patient spoke with her doctor once back in April-march 2021 and the doctor said it might be a result of dry weather. Patient was going to see the MD in 2 weeks. Vaccination facility was fire department. Patient also reported that most nose bleeds lasts 2-3 minutes. On 30-JUN-2021, it lasted about 4-5 minutes and then stopped. Then it started again, and she stopped it right away within minutes. The occurrence was every couple of weeks initially, then it started happening twice every few weeks, then 3 days in a row and not every 2-3 days. Consent provided for Safety to follow up preferably via email (not working right now) and/or Phone (Leave detailed message because she does not answer calls from random numbers).
Very sore arm for 2 days; low grade temp 2 days; period late 10 days as of today (I guarantee I am not pregnant)
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/27/2021 and 3/29/2021. PMHx HTN, CHF, COPD on O2 at home and BPPV w/prior recent admission for cardiogenic shock. Presented to ED 12/27/2021 with worsening shortness of breath, dry cough, and nasal congestion that began on 12/23/2021 w/O2 sats 77% on room air, tx'd w/HFNC, methylprednisolone and remdesivir.  Cont'd to decline, requiring maximum support on HFNC and NRB oxygen.  Code status on admission was "Do Not Intubate". Expired 1/1/2022 due to acute on chronic respiratory failure from Covid-19 PNA and interstitial lung disease.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-OCT-2013, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-APR-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccination failure; Type A Influenza; Dark mucus; Off label use; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) unknown for asthma and chronic obstructive pulmonary disease.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. In February 2020, the patient started Breo Ellipta at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after starting Breo Ellipta, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza a virus infection, mucus discharge and off label use. On an unknown date, the outcome of the vaccination failure, influenza a virus infection, mucus discharge and off label use were unknown.   It was unknown if the reporter considered the vaccination failure, influenza a virus infection and mucus discharge to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the influenza a virus infection and mucus discharge to be related to Breo Ellipta.  Additional case details were reported as follows: The patient was dentist. The age at vaccination was not reported. The patient stated that started Breo Ellipta for 14 days in February and then developed Type A Influenza. The patient did not take any more Breo Ellipta after those 14 days, but just resumed it last week before reporting date. The patient had taken about 5-6 days so far of Breo Ellipta (filled a 30 day supply) and as he was reading about it became concerned about the risk for developing COVID-19 due to any possible immunosuppression. The patient would stop taking it because he does not have asthma or COPD, the doctor was prescribing it short-term only for some chronic congestion, which led to off label use. The patient also had dark mucus. This case was considered as suspected vaccination failure, as time to onset and laboratoty test were unknown at the time of reporting. The patient consented to follow up.