chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a physician 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 including care for hospitalization (dates unknown), 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 is considered to be not recovered. Additional information has been requested.
Type of dose gave after expiration date and date 05apr2022; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer28Apr2021), administration date: 28Apr2021, when the patient was 71-year-old, for COVID-19 immunization; moderna (Dose 2, second dose Moderna 14Jul2021 lot 044D21A), administration date: 14Jul2021, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05Apr2022, outcome "unknown", described as "Type of dose gave after expiration date and date 05apr2022".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
onset of fever to 101 w/excessive somnolence & difficulty in arousing-signs began approx 72 hrs p/vax;
pt was not feeling well yesterday after his 2nd immunization.  Daughter states he did not want to eat this morning, was sleeping more than normal, and urniated on himself which is not normal.  Pt also fell down this morning and the paramedics came to check pt over.  She states they didn't tell her anything but did not take the pt to the hospital.  Daughter states she will take pt to ER.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was unknown whether patient was ever diagnosed with Covid-19.The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Info has been received from a health professional concerning a 9 year old white male, with no medical history and no allergies, who on 1/14/97 was vaccinated with a SC 1st dose of varicella virus vaccine live. Concomitant vaccine included a SC 1st dose of MMRII. There was no illness at the time of vaccination. It was reported that the pt's mother called and stated that the child started on 5/21/05, at 10:15, with 2 lesions that the mother thought were insect bites. Today the pt had about 20 lesions that itched on his back, torso, neck and head with no fever. It was noted that the mom stated she would use "calahyst", calamine, camphor (+) pramoxine hydrochloride (Aveeno) anti-itch, and avena (Aveeno Bath). It was reported that the pt recovered on 5/23/05. There were no lab or diagnostic tests performed. Additional info is not expected.
The day after the shot he felt it was hard if he pressed on the area; Felt kind of sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (The day after the shot he felt it was hard if he pressed on the area) and VACCINATION SITE PAIN (Felt kind of sore) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE INDURATION (The day after the shot he felt it was hard if he pressed on the area) and VACCINATION SITE PAIN (Felt kind of sore). On 17-Jan-2021, VACCINATION SITE INDURATION (The day after the shot he felt it was hard if he pressed on the area) and VACCINATION SITE PAIN (Felt kind of sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided
Palpitations the first night Hyperactivity the next day; trouble with concentration Brain fog for several days after 12/30/2020; brain fog still continuing; trouble concentrating; not as apt with mental tasks as previously
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
administered liquid conjugate only; administered liquid conjugate only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter reported that, a patient was administered the liquid conjugate portion of Menveo only. The reporter consented to follow up via email. Additional Supportive Information: The reporter reported that, a patient was administered the liquid conjugate portion of Menveo only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Can i get sick after the 1st covid shot; Is it normal to have a fever after the 1st covid shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot). At the time of the report, ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Severe swelling of the right arm around the injection site. Arm was red, hot, and swollen to the size of a soft ball. Also there was a small bruise in the middle of the swelling. She also ran a fever of 102-103 the night and day after injection. May have had pertussis reaction as a child. Has had TD booster w/o incident, but this is first TDAP.
Headache, nausea, body aches, extreme fatigue starting approximately 18 hours after receiving vaccine
mom reports the pt had a gradual inc in temp; during the day even w/APAP given regulate sz occurred during pt sleep, lasting 15-20mins; t105; seen in ER;
Fever, seizures, hospital admission. Phenobarb level low. Discharge summary states otitis media, viral infection. msv
Inflammation of tendons in upper arm, bursitis, pain in shoulder joint and deltoid area, came on gradually several days after the second injection.  tried at home care for a couple of months along with steady doses of advil, sought PT care July 9 for 6 weeks then referred to Orthopaedic, x-rays and MRI of neck and shoulder in September revealed inflammation of tendons, cortisone shot 9/17/21, and at home rehab plan continued
blood blisters in my mouth; swollen white tongue; swollen white tongue; difficult to eat; there is pain; This spontaneous case was reported by a consumer and describes the occurrence of ORAL BLOOD BLISTER (blood blisters in my mouth), SWOLLEN TONGUE (swollen white tongue), TONGUE DISCOLOURATION (swollen white tongue), EATING DISORDER (difficult to eat) and PAIN (there is pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ORAL BLOOD BLISTER (blood blisters in my mouth), SWOLLEN TONGUE (swollen white tongue), TONGUE DISCOLOURATION (swollen white tongue), EATING DISORDER (difficult to eat) and PAIN (there is pain).            This case was linked to MOD-2021-024310 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: NNI.; 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.
08/13/10 - "redness" size of baseball with pain, swelling ice packs, ibuprofen - will call MD. Call back with increased sx. 8/20- no answer. 8/21- Saw client and mom at fair, Mom states she tried to get Dr. appt.,  but unable. Used ice, heat, TYLENOL until sx subsided.
Patient reported feeling nausea. no other symptoms. snack and hydration provided. vital signs stable. patient reported no symptoms upon discharge.
metallic taste in mouth; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 01Mar2021, outcome "unknown", described as "metallic taste in mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a shape left chest pain that lasted for almost 2 weeks starting in the first week of June. The pain started to ease and now I feel it every now and then. I talked to my doctor this morning and he recommended I do the heart echo and report this here.
3-17-16 patient reported having soreness across chest and shortness of breath for a week after getting pneumonia shot. She was told to go to E.R. 3-18-16. Patient came to office with left chest and shoulder pain. Left arm had red area the size of a tennis ball. She didn't feel right and gets sick in stomach with pain. Was told to go to E.R. On 3-18-16 patient went to ER for pain over chest region and down into elbow. States site is itchy. No redness, sores or lesions. Discharge instructions: ice affected area, NSAIDS as directed. F/u PCP. Light R.O.M. exercises, RTC if worsening s/s.
Was recently diagnosed with a hypothyroid condition after a year from the initial date of the shot.  I have had increased fatigue, inflammation, and weight gain.  Increased stress on lung function.  Decreased energy. It will be an on-going, lifelong diagnosis.  It  was not said by the treating physician that it was caused by the vaccine, just that I developed it after the vaccine.
2ND DOSE OF ENGERIX-B GIVEN ON 2/23/90. 3-4 DAYS LATER VACCINEE HAD ONSET OF MALAISE,FATIGUE. ON 2/28/90 SHE DEVLPD NAUSEA,TEMP INCREASE,DIARRHEA. SINCE, SHE HAS BEEN EXPERIENCED FATIGUE,MILD NAUSEA. NO TREATMENT GIVEN.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 11-MAY-2015, the patient was vaccinated with a d ose of RECOMBIVAX HB (route, lot number and expiration date were not provided). Other suspect therapies also administered on 11-MAY-2015, included PEDIARIX (route, lot number and expiration date were not provided). Concomitant medication information was not provided. On 11-MAY-2015, the patient experienced overdose as received a dose of RECOMBIVAX HB and a dose of PEDIARIX. No adverse effects were reported. At the time of the report, the patient status was unknown. Additional information has been requested.
she received either GARDASIL or GARDASIL 9 about 15 years ago, she passed out.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant medications, drugs and allergies were not provided.  On an unknown date in 2007 (reported as about 15 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, lot # and expiration dates were not reported) for prophylaxis. On unspecified date in 2007, the patient experienced loss of consciousness for a few seconds., but ^^came to pretty quickly.^^The outcome of loss of consciousness was unknown. Action taken was reported as not applicable.  Upon internal review, the event of loss of consciousness was considered to be medically significant.  The causal relationship between the event and study therapies was not provided.
Chattering teeth. Shaking - full body Fever = 103 (then took Tylenol) Vomiting 5-6 times over 12 hours  Tachycardia = up to 130 beats per minute
L arm swollen, red and warm to touch up to the size of apple and firm to touch. Put on Atarax lig. 1tsp q 6 prn.
pneumonia; cough; feel sick; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced MALAISE (feel sick). On 29-Aug-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and COUGH (cough). At the time of the report, PNEUMONIA (pneumonia) and MALAISE (feel sick) outcome was unknown and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company Comment: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.
C/O redness, pain, swelling. Seen by Dr received antibiotic and antihistamine
20 month old patient presented on 3/30 for well-visit and was prescribed to HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) and Hepatitis A vaccine pediatric / adolescent 2 dose IM by MD. CMA prepared vaccines and administered Hib (PRP-OMP, PedvaxHIB) IM in patient's right thigh (LOT # U024489) and Hepatitis A, IM in patient's right thigh (LOT # 95EJ7). CMA documented "pt tolerated well". On 4/2, parent sent message noting patient had fever (102) day after injections and still in pain. RN responded noting fever post injection indicated muscle administration and immune response triggered. RN did note "we could definitely give vaccines in different part of the leg in the future (upper, lateral thigh would be prefe Additional information for Item 18:20 month old patient presented on 3/30 for well-visit and was prescribed to HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) and Hepatitis A vaccine pediatric / adolescent 2 dose IM by MD. CMA prepared vaccines and administered Hib (PRP-OMP, PedvaxHIB) IM in patient's right thigh (LOT # U024489) and Hepatitis A, IM in patient's right thigh (LOT # 95EJ7). CMA documented "pt tolerated well". On 4/2, parent sent message noting patient had fever (102) day after injections and still in pain. RN responded noting fever post injection indicated muscle administration and immune response triggered. RN did note "we could definitely give vaccines in different part of the leg in the future (upper, lateral thigh would be preferable". RN sent communication to MD noting "Vaccines look like they were given low and more central on the thighs? Maybe an inservice/refresher on giving vaccines for potentially less side effects?" Follow up on 4/4 noted patient's "still pretty swollen, very hard, bruising down". MD recommended to continue to monitor, use cool compresses, and contact provider if fever reoccurs, red streak or warmth to skin is noted. System lists the following as adverse reactions for PedvaxHIB include irritability, pain, swelling, tenderness at injection sites, and fever. Patient's symptoms are likely and not unusual reaction for vaccine administration. Possible contributing cause could be if vaccine given in suboptimal location (preferred upper, lateral thigh)--same CMA administered vaccines.  As patient was receiving only two injections, unclear why both were given in the same thigh.
Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 15 months old male patient who received a 0.5 ml fourth dose of vaccine DAPTACEL lot C5171AA, expiration date: 23-Mar-2019 via unknown route in the right thigh on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE. It was an actual medication error due to expired vaccine used. A 15 month old male patient received a three days expired dose of DAPTACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.