chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 03Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of pre diabetes, controlled" (unspecified if ongoing), notes: other medical history: History of pre diabetes, controlled. Concomitant medication(s) included: METFORMIN, start date: 01Mar2019 (ongoing). Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin", notes: known allergies: Erythromycin. Vaccination history included: moderna covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE , Anatomical location: Right arm), administration date: 01May2023, when the patient was 73-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE , Anatomical location: Left arm), administration date: 26Sep2022, when the patient was 72-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 22Apr2022, when the patient was 72-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 03Dec2021, when the patient was 71-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 30Mar2021, when the patient was 71-year-old, for covid-19 immunization; moderna covid-19 vaccine (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 02Mar2021, when the patient was 71-year-old, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with Paxlovid on 08Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Afternoon of vax t102 (even while on APAP); that night t103; next morning pt was irritable; was taken to ER, t104.2; @ that time pt was found to have an ear infection;
Ringing in ears, dizziness (mild) within one hour of injection. Persistent dizziness over next 10 days worsening to the point of ataxia and gait disturbance.  Presented to ER 2/24/2022 with subsequent Hospital admission, gait disturbance, ataxia, urinary incontinence x 1, difficulty concentrating, mild dysmetria on right side. Symptoms still present but improving as of discharge 2/27/22.   Much improved on 3/1/2022.
high fever up to 105, concurrent mild Otitis media and thrush, Nystatin  and amoxicillin fro treatment
Breakthrough case admission after 3rd vaccine Pfizer 2/18/21 Lot# EL9267 Pfizer 3/1/21 Lot# EN6199 Pfizer 9/28/21 Lot# FC3183
This spontaneous report was received from a physician through a former medical affairs director via a company representative concerning a 15 year old female patient. No concurrent conditions or medical history were reported. On 11-JUL-2014, the patient was vaccinated with the first dose and the only injection of GARDASIL (Lot No., dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On approximately 11-JUL-2014, reported as "since the GARDASIL was administered", the patient experienced intermittent shortness of breath and chest pains. On 12-JUL-2014, reported also as "the day after the GARDASIL was administered", the patient experienced a headache every day. The headache were severe on some days. No Product Quality Complaint (PQC) was involved. The outcome of dyspnoea, headache and chest pain was unknown. Additional information has been requested.
Redness, itching, and warmth at injection site, lethargy, armpit soreness; Lethargy day following vaccination then resolved; Remaining symptoms resolved on day 6 post vaccine
Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Patient is 12 years old and was given Flublok which is recommended for 18 and over. Spoke with the mom on 10/2 and she stated he had a headache afterwards, but wasn't sure if that was related to the vaccination.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Her physician told her that she is prone to pneumococcal infection. No drug reactions or allergies were reported. On 30-JUL-2014 the patient was vaccinated with expired PNEUMOVAX 23 0.5 ml, lot # J004747, expiration date 20-JUL-2014, intramuscular (strength and dose number were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of received an expired dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Made her not feel well; It has been more than 36 days since she got the first dose and has not got the second yet; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Made her not feel well) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Made her not feel well) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet). At the time of the report, MALAISE (Made her not feel well) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided
Administration error: Patient is vaccinated with second Pfizer booster before completing his four months of indication between the first booster and his second booster. We proceed to inform the patient and Dr. in charge of the vaccination clinic.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # reported as 1008574, expiry date: 22-NOV-2016) (Incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Miscarriage; This is a spontaneous report from a contactable Other HCP (Nurse), reported for herself.  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 25Feb2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 19Mar2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination and the last menstrual date was 02Sep2020. Gestational period 5 weeks and delivery date 19Nov2021. Relevant medical history included Hashimoto's thyroiditis. Past drug history included allergy to amoxicillin and omeprazole. Relevant concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 21Mar2021 (at 14:00), the patient had miscarriage. The event required physician office visit. The patient did not receive any treatment for the event. She was recovering from the event.   Information on the lot/batch number has been requested.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of Hashimoto's thyroiditis are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient called with questions regarding side effects with Enbrel and Shingrix Vaccine. Patient has noticed an increase in pain and discomfort after receiving the first series of Shingrix (6/31/19) Shortly after the shot (2-3 days) on 7/1/19 she developed a rash indicative of active shingles and wanted to know if it was related to use.
This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject's hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn't hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.
No adverse event; Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Two patients came in to get bivalent booster. The fill-in pharmacist gave them the monovalent instead.).    No concomitant medications were reported.  Reporter stated that would like to know the protocol for a patient receiving a monvalent(red top) vaccine, but they should have been given the bivalent(blue top) vaccine.  The pharmacist states he reported to VAERS, but he does not had the VAERS report number.  No treatment medications were reported.
genralized itching in inj arm reddness & swelling @ inj site 48 hrs p/vax
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-MAR-2015, at age 62, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
STERILE WATER FOR INJECTION WAS MIXED IN AS DILUENT. NO ADVERSE REACTION REPORTED YET AT TIME OF REPORT.
Approx 10 min past receiving Proquad injection, patient had red, hard area size of 50 cent peice on left upper arm.  No other symptoms observed x 20 min; upon departure from clinic, all hardened area had subsided.  Still slightly red area size of dime noted on ar. Instructed mom and grandmom if patient had any other problmes or signs of reaction to take child to hospital.
Sore shoulder, shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: Sore shoulder, shoulder pain). The outcome of the shoulder soreness was resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.     It was unknown if the company considered the shoulder soreness to be related to Shingrix.   Additional Information: GSK receipt date: 05-May-2023 This case was self reported by the patient. The patient stated that after his vaccine, his right shoulder was very sore.  The patient did not have any information concerning the vaccine itself.  The reporter did not consent to follow-up.
PATIENT STATES THAT AT TIME OF VACCINATION IT HURT AND CONTINUED TO HURT AREA THEN BECAME RED HOT TO TOUCH AND VERY SORE
member recieved the first covid vaccine dose at 9:20 am . At 9:29 am member complained of feeling dizzy and sweating. Member was still being observed . at 0929 am Overhead page for MD assistance to evaluate member. Found member sitting in chair in covid vaccine area. Member able to answer questions, member oriented times 4 , respirations even and unlabored. his eyes closed and head tilted forward , skin pale and wet . Pt c/o dizziness.First  BP reading 59/32 p42 , 02 saturation 100% on room air .  This RN rechecked BP 68/33  and pulse 32 via machine ,this RN checked radial pulse 40. At 0933 this RN gave epi auto injector to left thigh . At 0935 911 called and Dr. and this RN  assisted member to floor and elevated legs , applied O2 2l n.c. repeat BP 88/47 p-42 lying , then second lying BP 98/56 P 51 . Machine read 156. Member stated he was feeling better, less dizzy and was answering all questions and speaking in full clear sentences. Skin pale and wet. 911 arrived at 0942.
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (the patient). A patient of unspecified age, ethnicity and gender received a single dose of pneumococcal 13-val conj vac (dipht crm 197 protein) (unknown manufacturer), via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date. The outcome of the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm 197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm 197 protein) has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information received.
Was reported by the patients primary care provider that the patient experienced a stroke approximately 4 days post vaccination.
Initial report received from a consumer on 10/11/2005.It was reported from another company that a consumer informed them that her 81 year old father developed hives, angioedema of the lips, thumbs, testicles and had a severe rash on his back after receiving the injection of Fluzone, lot number U1773AA in the left deltoid on Oct 10 2005. The patient has received flu shots in the past and has never had a reaction. He does not have an allergy to eggs. Immunization was received at 14.00 hours and by 18.00 hours he was complaining of being itchy. He then broke out in hives, had angioedema of the lips, thumb and testicles. He went to the emergency department and was treated with Prednisone and Benadryl. At the time of this report the patient states he is still on the medication but the symptoms were much better. (OMIC)
08/01/02- Fever 101-102 degree F past two days -BOM, 08/03/02-rash all over the body, 08/09/02-Fever 101-102 for past 2days-rash all over body-several reds pustules on face, arms, legs, rash-macular
cellulitis; area of redness / around injection site/ egg sized area of redess; small blisters around injection site; This case was reported by a pharmacist via sales rep and described the occurrence of cellulitis in a 32-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema and injection site blisters. On an unknown date, the outcome of the cellulitis, injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the cellulitis, injection site erythema and injection site blisters to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received vaccie in clinic and next day called to report egg sized area of redness with small blisters around injection site. The patient drew a ring around the site and presented to clinic after the redness went beyond the ring. On 19th October 2020, patient was treated with cellulitis.
Reaction to the second shingles vaccine - 3 days of chills, fever, aches and nausea. Localized redness and heat (fist size) at injection site lasting one month.
anxiety issues; This spontaneous report was received from a consumer via a company representative referring to her daughter of unknown age. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On an unknown date, the patient was vaccinated with the first shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis.         On an unknown date (reported as after the administration), the patient experienced anxiety issues. The outcome of the event was unknown. The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was unknown.
Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-SEP-2014 the patient was vaccinated with the second dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
I have developed severe carpal tunnel in my right hand  as per an EMG 11/29/2021.
During 15-minute observation period, patient said he was thirsty and want to get a bottle of water. Atfer getting water, patient felt dizziness and was about to faint.  We called 911 and monitored him until EMT team came.  Patient was still conscious and said he felt dizzy, sweating due to potential low blood sugar and asked for a sip of gatorade. Then he started felling better after that and he said it happened before during his MRI and other procedure.  EMT team accessed his vital signs and symptoms inside their vehicle and finally released him home. His family took him home
Cherry color pin point papules. VS Q 4 x 24, O2 sats.
got a rash that all over my legs, thighs, arms, going up to my neck
Patient had FLULAVAL Nov 2009-20010 and PENUMOVAX 23 2.5 mcg/0.5ml in same arm and same day. Complained of arm pain and leg pain.
She became sick same evening as injection (NDC: 59267102501). Adverse effects started in middle of the night: chills, fever, stomach pain, diarrhea, loss of appetite and rash all over arms legs. Two days later some symptoms subsided but rash spread to face; swelling of eyes. She still has a rash and it's been 25 days now. There is some improvement to face but rash remains on arms and legs. All these symptoms line-up with Mult system inflammatory syndrome. The photos of the rash in other patients are the same too.
The patient had a lot of pain in the muscle and she developed 2 white rings around the injection site. The 1 white circle was around the injection site and 1 was below that forming the number "8". The patient came to the pharmacy to show me her arm on 10/06/2020. I was only able to observe 1 white circle around the injection site of about 20 cm in diameter. Not a lot of pain any more.
NauseaVomiting chills, feels hot-flushed, eyes are glossy Narrative:  Has not had to seek any medical attention, leaving work to rest and hydrate. Feels hot and is flushed but has not taken her  temperature.