chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a currently 30 years old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was vaccinated with unspecified number of doses of M-M-R II injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient underwent antibody test (titers) and she had low titers for rubella. The patient's rubella titer was "0.9 and it needs to be 0.99 to be positive". On 03-FEB-2016, the patient who was 30 years old received a dose of PROQUAD (Merck) injection, lot# L033692, expiration date 28-FEB-2017 (dose and route of vaccination were not reported). No adverse effects associated with this vaccination were reported. The outcome of low titers for rubella and the causality between low titers for rubella and doses of M-M-R II were not provided. Causality between low titers for rubella and PROQUAD (Merck) was assessed as not related as the vaccine was administered after low titers for rubella onset. Additional information has been requested.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick).The outcome of the sickness was resolved (duration 7 days).   It was unknown if the reporter considered the sickness to be related to RSV vaccine.   It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and was very sick for seven days.  The patient thought that he/she was doing better now.  The patient would be afraid to recommend it but he/she guessed getting RSV would be worse. The follow up would not possible as no contact details were available.
seizures for 3 days in a row (Sat, Sun, and today, when he has not had any seizures for a few months. Had to administer emergency seizure medication (Lorazepam) as the seizures persisted past the 2  minute mark on 2 out of 3 of the days.  He has had persistent fever from day after shot (6/24/22) to the present day (6/28/22). Consistently 101.8.  Fever spiking at times to between 104.9 and 105.3 even after ibuprofen given. Has happened early in the morning, so it is unknown at point if it will continue to happen. If fever spikes high again  doctor says to go to ER.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2016, the patient was treated for vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Patient developed pruritus over body. Patient prescribed ATARAX and prednisone resulting subsequent shingle outbreak. Patient required 2 rounds of prednisone.
This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hydrocele in a male infant exposed to BOOSTRIX (batch number 9M9AA, expiry date 23rd October 2016) in utero. The mother received the product. On 16th September 2014, the mother received BOOSTRIX. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was exposed to BOOSTRIX during the third trimester of pregnancy. The infant was born via unknown delivery and weighed 2353 grams (5lbs 3oz) at birth. The infant was diagnosed with intrauterine growth retardation (serious criteria GSK medically significant). The infant experienced low birth weight. On an unknown date, the infant experienced hydrocele (serious criteria congenital anomaly), exotropia and maternal vaccine exposure. On an unknown date, the outcome of the hydrocele was recovered/resolved and the outcome of the intrauterine growth retardation, birth weight low and maternal vaccine exposure were unknown and the outcome of the exotropia was not recovered/not resolved. It was unknown if the reporter considered the hydrocele, intrauterine growth retardation, exotropia and birth weight low to be related to BOOSTRIX. Additional information was provided as follows: The mother received BOOSTRIX vaccine during her third trimester of pregnancy and her baby did not grow from that point. Less than a year after receiving the vaccination with BOOSTRIX, the patient had hydrocele which was noted between her patient's 2nd and 6th month check-up which resolved on its own and in 2015 during the infant's first year of life, several months after vaccination, exotropia was noted.
No additional AE; patient age 20 weeks received an initial dose of ROTATEQ on 9/19/2022; This spontaneous report was received from medical assistant and refers to a 20-week-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with initial dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #W004502, expiration date: 09-OCT-2023, administered orally for prophylaxis (strength was not provided) (product administered to patient of inappropriate age).  There was no adverse event reported.
Early the next morning after I notice my right arm was red, swellling and bruising from the shoulder to the elbow and developed a golf ball sized knot in my arm that was hot and very painful. It was so painful that I couldnt stand the touch.  The nurses advised if it got any worse to go to the ER but I didnt. My arm was nearly unusable because of the pain and finally the pain stopped around 1/8 .
This spontaneous report was received from a physician refers to a 6 month old male patient. Patient's medical history and drug reactions/allergies were not reported. On and unknown date, the patient was vaccinated with the third dose of ROTATEQ 1 ml, oral (lot# was not reported). On 29-JUL-2014, after receiving the third dose of ROTATEQ the patient had hives surrounding his mouth. The physician reports that the hives resolved on their own within 40 minutes. The physician also reported that the patient had no adverse effects with pervious doses of ROTATEQ. No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention calling the physician's office. The outcome of hives surrounding his mouth was reported as recovered/resolved 29-JUL-2014. Additional information has been requested.
covid/lung covid; covid/lung covid; Rheumatoid arthritis flare up; felt like allergies; sore arm;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4241673-00 (AbbVie Inc.).  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jan2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single and intramuscular, administration date 29Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid/lung covid"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; HYPERSENSITIVITY (non-serious), outcome "recovering", described as "felt like allergies"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm". The action taken for adalimumab was unknown.  Clinical course: The reporter's assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Causality for Humira (adalimumab) The reporter's causality for the event(s) of covid vaccine caused sore arm, covid/lung covid, rheumatoid arthritis flair up due to covid vaccine and felt like allergies was not provided.  Concomitant Drugs and dates of administration (Exclude those used to treat event) Concomitant Drugs Not Reported. Other Relevant History Not reported. event abate after stopping drug NA. . PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and DRUG INEFFECTIVE, COVID-19 , RHEUMATOID ARTHRITIS ,  HYPERSENSITIVITY, VACCINATION SITE PAIN cannot be completely excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
BREAST CANCER; This spontaneous report received from a consumer concerned multiple patients. It concerned two females of unspecified age. The patients' height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. The patient received injection left deltoid and unknown for other patient. No concomitant medications were reported.  On 09-JUL-2021, the patients experienced breast cancer on the same side they received the vaccine. The patients stated they were feeling like crap because they now had cancer. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021 and on unknown date, second patients mammogram showed more instances of enlarged lymph nodes. It was diagnosed by mammogram and an ultrasound, and biopsy. The diagnosis occurred about 1 week after the mammogram which was on 09-Jul-2021. On 14-Jul-2021, the one patient had biopsy done which confirmed cancer and unknown for other. On 28-Jul-2021, one patient had MRI of both breasts which showed that cancer was limited to the left breast. One patient had 16 consecutive days of radiation, and was currently taking medication which she would be on for 5 years and the other patient was also receiving radiation treatment at the same time as her who also recently had a covid-19 vaccine about 3-4 months ago. One patient also had a day surgery on 3-Aug-2021 at hospital. It was a lumpectomy and removal of 5 sentinel lymph nodes. The lymph nodes were clear but the actual lump showed cancer in it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220138438-covid-19 vaccine ad26.cov2.s-Breast cancer.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Initially soreness and metallic taste, reoccurrence of lower back pain identical to that which preceded diagnosis of CIDP, worsening of lower extremity weakness and numbness (worse on the left) which progressed rapidly in June 2022. I went from being able to walk continuously for miles to barely being able to walk 0.25 mile. Prior to that, except for an insurer caused interruption of therapy in September 2019, symptoms had been stable on IVIg since my diagnosis in 2012. I also developed new upper extremity interscapular paresthesias on the left.
Information has been received from a 67 year old female registered Nurse with chronic mucitis and an allergy to ampicillin and a history of sinus infection, calcium in breast and cholecystectomy (removed in past) who on 10/6/06 was vaccinated SC with a dose of Varicella Zoster vaccine. Concomitant therapy included Claritin, Lisinopril, Vitamins unspecified, calcium unspec vitamin D unspec, Synthroid, baby aspirin and Cortisone gel. On 10/10/06 at 16:00, the pt developed nausea, vertigo and loss of balance. She felt better lying down and closing her eyes. She felt like the room was spinning. No vomiting or diarrhea was noted. She had not taken her temp, but if she has a fever it is low grade. The pt currently has an abscess in her mouth currently which she has an appointment to be seen on 10/11/06. She reported that her blood pressure had been stable and she dose not have diabetes. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a 67 year old female Registered Nurse with "chronic mucitis", anxiety disorder and an allergy to ampicillin and a history of sinus infections, calcium in breasts and cholecystectomy (removed in past) who on 06-OCT-2006 was vaccinated SC with a first dose of VARIVAX (Merck) (lot # 652965/0622F).  Concomitant therapy included CLARITIN, lisinopril (manufacturer unknown), vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), SYNTHROID, baby aspirin and "cortizone gel".  On 10-OCT-2006 at 16:00, the patient developed nausea, vertigo and loss of balance.  She felt better lying down and closing her eyes.  She felt like the room was spinning.  No vomiting or diarrhea was noted.  She had not taken her temperature, but if she had a fever "it is low grade".  The patient currently has an abcess in her mouth currently which she has an appointment to be seen on 11-OCT-2006.  She reported that her blood pressure had been stable and she does not have diabetes.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information from the physician indicated that the patient was vaccinated at a pharmacy.  No significant problems were noted in the patient's chart.  The patient's symptoms were reported resolved on 30-OCT-2006.  The physician reported that it was unclear whether related to the vaccine.  Laboratory tests included an office visit on 30-OCT-2006 for a "blood issue".  No further information is expected.
About one minute after receiving Pfizer Tris immunization, patient slumped backwards in her chair and stiffened. Her eyes were open, but she was unresponsive to verbal talking for approximately 10 seconds. After 10 seconds she slowly relaxed and was able to respond to verbal commands. She said she felt normal at this point. She refused our offer to call emergency. We advised to stay seated for at least 15 minutes. We checked on her every few minutes and she said she felt normal every time. After 15 minutes she tried standing up and said it felt normal. She was with her grandmother during this whole time. The patient called her mother who advised her to remain at the store until she got there. When the mother arrived we explained what had happened, we said it could have been a vasovagal response. The mother said she was taking her daughter to the ER just to be safe.
Fever (100.4) Extreme Fatigue Muscle Aches (whole body) Joint pain (whole body) Weakness
Non-arousable, sleepy, slight fever for 8 hrs duration; Onset approx 12 hrs post inject; when seen in Er was stable;
Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023; No adverse event; HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Sep-2022, 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 18-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023) 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 EXPIRED PRODUCT ADMINISTERED (HCP confirms that 3 additional patients received expired dose on 18-May-2023 from the same lot number) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date and Date the vial was initially stored in the refrigerator was 14-Apr-2023).    Concomitant medication of the patient was not reported.  Vial size was reported as 2.5mL. The vial did not undergo any temperature excursions.  Treatment medication of the patient was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-725148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Upon live follow up patient details and dose information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725148:Patient 1 out of 4 patients
came down with Bells Paulsi; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: came down with Bells Paulsi) (serious criteria GSK medically significant). The outcome of the bell's palsy was not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that he/she had the Shingles shot and came down with Bells Paulsi for the rest of his/her life. The follow-up could not be possible as no contact details were available.
no other AE reported; expired VAQTA inadvertently given to a patient; This spontaneous report was received from a registered nurse and refers to a 37-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 04-DEC-2020, the patient was inadvertently vaccinated with an expired Hepatitis A vaccine, inactivated (VAQTA) lot # S025258, expiration date 05-NOV-2020 (formulation, anatomical location, exact dose and route of administration were not provided) for prophylaxis. There was no prior temperature excursion for Hepatitis A vaccine, inactivated (VAQTA). No other adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, lot # L009445, expiration date: 01-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specified cumulative time was reported. The temperatures were recorded by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Patient complained of injection site pain, swelling, redness. She also had loss of appetite, insomnia, fatigue, and difficulty moving her arm.
C/O dizziness at 3am. Awoke in bed turned to side. Noticed dizziness. Mild dizziness continued states she feels well as of 1p 12/2/03-less dizziness, stuffy nose. Pt returned to work, feels improved.
pt recv vax in 7/98 & in 8/98 pt exp chickenpox w/15 lesions which were described as red little blister w/a white center.