chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal depression" (unspecified if ongoing); "Extremely drug sensitive, myself and family members" (unspecified if ongoing), notes: Extremely drug sensitive, myself and family members; "menopause" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTERONE; BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient passed out for abt 5sec and cameback, Her face was flushed and immediatly after turned white. She drank some water and after that she was feeliong okay. Mother reported she has fained before from the HPV vaccine. SHe didnt not want to call the ambulace. Sat for another 15 under observaction and then she was okay to go home
My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Premature beats, Anxiety and Stress. Concomitant products included CLONAZEPAM for Anxiety and Stress, BISOPROLOL FUMARATE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (My arm was sore). At the time of the report, MYALGIA (My arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-399963, MOD-2021-400041 (Patient Link).
Hospitalization: 10/4/2022 - 10/6/2022  Presentation to the ED: acute onset chest associated with SOB, nausea and vomiting that woke  him up from sleep. Patient had tested positive for COVID 2 weeks prior to arriving at the ED.  COVID-19 + date: 10/4/22. Treatment: no specific treatment for COVID.  Discharge to: Home.
11/7/09 father called health department-rec'd FLUMIST at school clinic. Following day c/o headache, low grade temp. 99?. 5 AM, 11/1 increased 102 degrees. West to Dr 11/2-tested + A-told to report to HD.
Light headache and body ache nausea after shot. Then fever started that evening and severe body aches, twitching, headache, nausea, chills
This is a possible breakthrough COVID case. The patient had right-sided weakness for two weeks prior to 4/20/21. She then developed weakness and confusion in the few days leading up to hospitalization on 4/20/21. The patient tested positive for COVID on 4/20/21. The patient was also previously COVID positive on 11/6/2020.
A company representative reported that a child received an injection of Prevnar and subsequently, developed vomiting and symptoms of an URI. The vomiting persisted for 3 days. No further information was available at the time of this report.
OT CAME IN STORE TODAY 11/26/19 AM AND STATES THAT SHE EXPERIENCED BONEACHE (ESPECIALLY ARMS AND CHILL SIDE AFFECTS ON THE DAY AND LAST APPROXIMATELY 36 HOURS). AND SHE ASKING ME TO DO A VAERS REPORT, SHE SAID SHE IS NOT SURE TO GET A 2ND DOSE OF THIS INJECTION TO COMPLETE THE SERIES WHEN ASKING.
Tendernes in arm; Fever; Chills; Exhaustion; nausea; Huge red knot on arm at least 3.5 inches around; felt terrible; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd October 2019, 6 hrs after receiving Shingrix, the patient experienced fever, chills, exhaustion, nausea, erythema and feels awful. On an unknown date, the patient experienced weakness of arms. On 8th October 2019, the outcome of the fever, chills, exhaustion, nausea, erythema and feels awful were recovered/resolved. On an unknown date, the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in an unknown arm. The patient reported that, around 9 am received dose of Shingrix vaccine. By 3 pm, the patient experienced fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms. After vaccination the patient had huge red knot on her arm at least 3.5 inches around. The reporter consented to follow up.
redness injection site; soreness at the injection site; little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (little itchy) and VACCINATION SITE PAIN (soreness at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness injection site). At the time of the report, VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        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.
pt spouse came by the clinic and states that his wife developed severe redness and swelling at injection site
Got her Shingrix more than a year ago/ does the dose today count as second; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than a year ago from the time of reporting).   On 24th May 2021, the patient received the 2nd dose of Shingrix. On 24th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got her 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked did the dose given on the day of reporting count as second or should the series be restarted.
This spontaneous report as received from a nurse via a company representative refers to a 19 year old female patient. On an unknown date the patient, was vaccinated with the first dose of GARDASIL (dose, route of administration and lot # were not reported). After administration, the patient fainted and had a seizure. The outcome of the events was not reported. Relatedness between the events and the vaccination with GARDASIL was not reported. Upon internal review seizure was determined to be medically significant. Additional information has been requested.
EXTREME JOINT PAIN AND NIGHT SWEATS. COULD NOT GET OUT OF BED FOR A FEW HOURS.
One hour post vaccine administration patient complained of feeling faint and nauseous.  Patient was sent home by ambulance was very weak and lethargic.  Vitals all within normal limits except for blood pressure and blood sugar which were both elevated.  Patient went to hospital with emergency medical services.
Pt received Pneumonia vaccine 2/18/11. Got a localized reaction with swelling and infection put on MOTRIN 800mg TID and CIPRO 500mg #20 2/21/11.
This spontaneous report was received from a Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (therapy type digital data logger)(lot # L043213, expiry date 28-AUG-2016) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 F to 35 F in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three options received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 28-JUL-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored VARIVAX (lot # N002204 with expiration date 19-JAN-2019; dose and route were unknown, for prophylaxis) which were exposed to temperature excursion of -14 to -10 degrees Celsius for 11 hours 29 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010404: US-009507513-1708USA010405: US-009507513-1708USA010406: US-009507513-1708USA010407: US-009507513-1708USA010408.
Parents describe episode of unresponsiveness following posturing & eyes rolling back; rxn not reported until 2APR91 did not understand significance;
Developed severe myalgias in right deltoid, right shoulder, right thoracic back, and radiated to left thoracic back.  Painful to do tasks at work like typing and note taking.  (Pt is right handed.)  No paresthesias.  History of similar myalgias occurring after administration of flu shot,  lasting for 3 months.  No erthyema or swellling of site.  No relief of symptoms with pain medication (tylenol).  Very sensitive to medications, did not want to take muscle relaxers or ibuprofen.  Recommended to pt to try moist heat and biofreeze topical lotion.
rash all over the body; mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm soreness) and RASH (rash all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (mild arm soreness). On 15-Jan-2021, the patient experienced RASH (rash all over the body). On 14-Jan-2021, PAIN IN EXTREMITY (mild arm soreness) outcome was unknown. At the time of the report, RASH (rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 5/28/00, the pt received his 1st dose of Lymerix. Subsequently, he experienced severe swelling and pain at the injection site, which was warm to the touch. Additionally, he experienced pain when lifting the injection site arm. The most recent information, received on 6/13/00, reports the condition of the vaccinee as ongoing.
w/in 24 hrs hive-like rash which was intermittent; no fever; no irritability; only lasted 24 hrs;
Very mild soreness in arm at site of injection started roughly 12 hours after injection. Severe headache and severe nasal congestion started roughly 28 hours are injection. Wet cough developed by 30 hours after injection. Extreme fatigue started when I woke up 44 hours after injection. Cold chills started 56 hours after injection. Symptoms began subsiding  when I woke up roughly 70 hours after injection. Muscular pain in the back shoulder area started roughly 75 hours after injection.
Small itchy bumps on lower left leg present upon waking at 7am. Progressed to anaphylaxis. Full body hives and severe swelling of arms, legs and face followed by stomach upset. Emergency room administered Benadryl, Pepcid and steroid injections. Discharged at 1:00pm with improvement but without resolution. Prescriptions for epi pen and oral prednisone were provided.
Child developed Dermatomyositis within 2 wks of receiving vaccines (MMR, DTaP, Hib.). Symptoms evolved over about 1 month. Initially crying with bending legs for diaper changes. This started about 1 week after the vaccines given. Then, not bending over to pick up objects; crying with being picked up under her arms; ongoing pain with diaper changes and with carrying on parents hip; laying around; not active.
Initially, I received the 1st does of the Moderna covid-19 mRNA vaccine on 21 January 2021. I took the 2nd dose of the Moderna covid-19 mRNA vaccine with no immediate reaction 4 weeks later on 19 Feb 2021.   However, after approximately 14 days of receiving the 2nd vaccine, I noticed that the skin on my back began to break out with raised red spots and was accompanied with continuous itching.  As the days went by, the itchy rash got worse and spread to multiple places on my upper chest area, back, upper arms and face.  The itching became more intense as each day progressed and was constant in duration.  It also interfered with my normal sleep.
Mild hives, rash on truck of body, oral Benadryl, OTC 4-6 Hours.
I got the shot and got shingles/Suspected vaccination failure; Got shingles again the following year; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. Following year after receiving Shingles vaccine, the patient got shingles again. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Flu like symptoms I had chills slight fever stomach ache! Arm has a huge knot on it and swollen red!
Information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider (unspecified healthcare professional), at a pharmacy, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2016, the patient was treated by an unspecified healthcare professional at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
PATIENT CALL AT 1:25PM TO OFFICE WITH COMPLAINTS OF HEAT, SWELLING AND PAIN AT INJECTION SITE LEFT DELTOID. UNABLE TO LIFT ARM PROPERLY. PATIENT INSTRUCTED TO COME TO OFFICE, SHE DID SO AND WAS SEEN IMMEDIATELY BY THE NURSE AND SUBSEQUENTLY BY A PROVIDER WHO PRESCRIBED ANTIBIOTICS FOR CELLULITIS DIAGNOSIS, THIS OCCURED THE DAY AFTER INJECTION.
TIA; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078B20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DICLOFENAC and FINASTERIDE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of Low dose and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided were unknown blood thinner medication.  Company comment: 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.; 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.
Swelling of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of face".  Additional information: Patient took the booster shot of Pfizer and had one of the side effects which was the swelling of face." Patient want to know that how to get rid of the swelling of face.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with Imovax Rabies developed serum sickness-like reaction 2 wks after beginning primary course w/vaccine & hyperimmuneglobulin.
pt recvd vax & 10 days later devel angioedema, w/swelling of the throat & an urticarial rash mostly on the face & legs; pt treated in ER w/DPH & Decadron;
Pt was pregnant at time of vaccine and suffered a miscarriage 2 months after. Dr stated the baby stopped growing prior to miscarriage.
Localized erythema with mild induration on left thigh. Approximately 4 x 4 in. area of erythema.
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA001032: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Fever, chills, nausea, vomiting, muscle and joint pain, fatigue first  48hrs. Total fatigue and weakness 96hrs.
Pt vaccinated with GARDASIL on 10/11/11, on 10/14/11 twelve red pruritic papules appeared on face on 10/17/11 - Today papules are flat & legs pruritic.
Next day after the vaccination I had numbness on the left side of the face, felt like it was drooping but with no visual indication of drooping. Eye, cheek and chin were affected.  I felt fine otherwise and didn't think anything more, this happened intermittently over the next two months and now along with the face numbness I am starting to feel a numb feeling in my left side by the breast and the opposite side of the back. I saw my doctor today and he told me to report this, as he didn't see any difference in the facial appearance from one side to the next.
Redness, swelling, and pain around the elbow. Diagnosed at hospital as cellulitis and treated with antibiotics.
This spontaneous report as received from a medical assistant refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 08-DEC-2015, the patient was inadvertently administered an expired dose of M-M-R II, lot# J014873, expiration date: 21-NOV-2015 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
Received INFLUENZA vaccine approx 5 pm 11-15-10. Did not awaken from sleep 11-16-10 ->EMS->pulseless electrical activity-> CPR -> Emergency Dept. Multiple attempts at resuscitation failed. Pt expired 11-16-10.
Period  was late by 3 weeks.   And came again 2 weeks later in February and lasted way longer than usual (6 days vs usual 4 days)