chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; 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; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
This Spontaneous report was received from a supervisor referring to a male patient of unknown age with medical history of non-Hodgkin's lymphoma, chemotherapy. Also, the patient's concurrent conditions included immune system disorder (reported as immune-compromised). There was no information about the patient's concomitant therapies. On 19-FEB-2018, the patient was vaccinated with ZOSTAVAX, injection, 1 dose in the left arm for prophylaxis, lot# N020939 with expiration date of 26-OCT-2018; (strength, frequency, and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). The patient reported that after he went home and read the package insert he realized that he was given ZOSTAVAX instead of SHlNGRIX. Also the patient stated that he was concerned because 10 years ago he had received chemotherapy to treat non-Hodgkin's lymphoma and his treating doctor told him not to get ZOSTAVAX. The patient signed the consent form for the ZOSTAVAX, but he assumed consent was for SHINGRIX. At the reporting time, the patient had not reported any side effects.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX Lot # N031004, expiration date 03-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (concomitant therapy). The temperature excursion was of 6 Fahrenheit degrees (F) to 14 degrees F, during 15 minutes. However, a previous temperature excursion of 6 degrees F to 14 degrees F for 15 minutes was also reported. A digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA002917.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that the office improperly stored GARDASIL. It was possible that an unspecified number of patients might have received the improperly stored GARDASIL but the nurse was not sure. No symptoms reported. Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 3/10/21 Lot# 044A21A;  Moderna 4/7/21 Lot# 04021A;  Moderna 12/4/21 Lot# 031H21A;  Moderna 10/29/22 Lot# 014H22A
Information has been received from a licensed practical nurse concerning a 69 year old male with a history of renal transplant who on 07-NOV-2007 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot #655766/0038U). On 07-NOV-2007, several hours after vaccination, the patient experienced pain and redness at the injection site and fever of 103. The patient was seen in the physician's office. At the time of the report, symptoms had improved and the patient was recovering. Additional information has been requested.
This spontaneous report has been received from a Registered Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 18-DEC-2009, the patient was vaccinated with the first dose of VAQTA, intramuscular, (Lot #, exp. date, strength and dose not provided). On 11-JUN-2010, the patient was vaccinated with the second dose of VAQTA, intramuscular, (Lot #, exp. date, strength and dose not provided); it was administered seven days too soon. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
In December of 2022 my legs felt heavy to me when I would walk.  On January 29, 2023, I had severe pain in my right calf and my ankle and calf were noticeably swollen.  I recognized this as a possible DVT.  I went to visit the doctor on January 31, 2023.  I went to the emergency department and had an ultrasound and started me on Eliquis.  I saw a vascular surgeon on March 13th and was advised to stay on this medication for one year.
had problems; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (had problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (had problems). At the time of the report, IMMUNISATION REACTION (had problems) outcome was unknown. Not Provided      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 medication was reported. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-621593:
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Hives. Started on hands and feet.. prescribed and steroid that helped until doses were gone. Hives returned on my head hands and waist line  So unbearable I get a steroid shot seems to help for notes hopefully for good will not get second shot!!!!
SYMPTOMS: CHEST TIGHTNESS, DIZZINESS, LIGHTHEADEDNESS. BP: 140/80 @ ONSET, 128/86 ABOUT 30 MINUTES LATER. TXMT: NONE, REFUSED.
feel blah; achy; 103 F fever; injection arm pain; injection arm lymph nodes swollen like a baseball; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel blah), PAIN (achy), PYREXIA (103 F fever), VACCINATION SITE PAIN (injection arm pain) and VACCINATION SITE SWELLING (injection arm lymph nodes swollen like a baseball) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel blah), PAIN (achy), PYREXIA (103 F fever), VACCINATION SITE PAIN (injection arm pain), VACCINATION SITE SWELLING (injection arm lymph nodes swollen like a baseball) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 800,400  milligram. At the time of the report, MALAISE (feel blah), PAIN (achy), PYREXIA (103 F fever), VACCINATION SITE PAIN (injection arm pain), VACCINATION SITE SWELLING (injection arm lymph nodes swollen like a baseball) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants provided.
Swelling of Right Foot / Ankle / Calf.  Swelling has subsided somewhat  over last couple of weeks - but still some swelling - - added a compression  sleeve  - to see if it helps with swelling reduction - as recommended by doctor
tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (tiredness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Diabetes since an unknown date, Non-alcoholic steatohepatitis, Abdominal distension from 30-Nov-2020 to February 2021, Post procedural hemorrhage from 30-Nov-2020 to February 2021 and Abdominal pain from 30-Nov-2020 to February 2021. Concurrent medical conditions included Drug allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-Mar-2021, the patient experienced FATIGUE (tiredness). On 17-Mar-2021, FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2020, Biopsy liver: abnormal Shows fatty liver and steatohepatitis.  Blood found in liver. On 09-Dec-2020, Computerised tomogram: abnormal Shows abdominal bleeding.     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.   Reporter did not allow further contact
Bell's Palsy; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy.  The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, post vaccination, the reporter who is the patient's son, stated the patient was diagnosed with Bell's palsy.  Treatment for the event included, hydroxypropyl methylcellulose, prednisone and valacyclovir.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, Bell's palsy, was considered unknown.; Reporter's Comments: Very limited information regarding the event of Bell's Palsy has been provided at this time.  Further information has been requested.
6 days p/MMR pt started breaking out w/red whelps & fever; By the end of the 8th day pt had purple bruises all on legs w/red rash; pt ankles had bruises & hand & feet where swelling; Next morning to MD given med;
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site reaction Narrative: Employee reports symptoms began within 2-3 hours after receiving vaccine. Reported symptoms include fever (100.3 F), chills, muscles aches, joint pain, fatigue, headaches, nausea, and minimal swelling on the injection site. Denies use of analgesics or antipyretics. Stayed home from work the following day.
EXTREME FATIGUE; DIARRHEA; NAUSEOUS; FACE AND LIPS NUMBING; TINGLING ON THE LEFT SIDE OF FACE INCLUDING THE EAR; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included meningitis, and concurrent conditions included chronic pain. The patient experienced drug allergy when treated with streptomycin, and vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced face and lips numbing. On 07-APR-2021, the subject experienced tingling on the left side of face including the ear. On 07-APR-2021, the subject experienced nauseous. On 08-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face and lips numbing, tingling on the left side of face including the ear, and nauseous on 10-APR-2021, and diarrhea on APR-2021, and had not recovered from extreme fatigue. This report was non-serious.
perimyocarditis/3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough; This is a literature report. This author reported similar events for eight patients. This is the sixth of eight reports.  A 15-year-old (also reported as 15.8-year-old) male with obesity, insulin resistance, and dyslipidemia presented to outside hospital ED with 3 days of sharp, intermittent, retrosternal pain, with associated fever (38 degree C), headache, loose bowel movement, and cough. Patient denied any trauma or recent viral illnesses. No prior history of SARS-CoV-2 infection. He had received the second dose of the BNT162b2 vaccine 2 days prior to symptom onset. On physical examination, there was diffuse reproducible chest wall tenderness. Laboratories unremarkable aside from elevated peak troponin-I of 5.1 ng/mL and Creatine Kinase Myocardial Band of 19.9 ng/mL. ECG demonstrated normal sinus rhythm, with no significant ST-segment changes. Chest X-ray was normal. TTE showed no structural abnormalities and qualitatively normal LVSF. He recovered with no medical intervention. Infectious workup was negative but limited to RPP, adenovirus plasma PCR, enterovirus plasma PCR, SARS-CoV-2 nucleocapsid IgG, blood culture, and gastrointestinal panel.   Demographic and clinical characteristics: Body mass index (kg/m2) 29.5. Past medical history (PMH) Insulin resistance dyslipidemia. History of prior COVID-19 infection No. BNT162b2 vaccine dose #2. Days between vaccine and symptom onset 2. Length of stay (hours) 37. Laboratories: White blood cell count (Ref: 5-10) 5.9; Peak troponin-I (Ref: 0.00-0.08 ng/mL) 5.10; Discharge troponin-I (Ref: 0.00-0.08 ng/mL) 1.30; CKMB (Ref:0-3.5ng/mL) 19.9; D-dimer (Ref: 0.27-0.41 mmg/mL) 0.53. COVID-19 testing: SARS-CoV-2 PCR Negative; SARS-CoV-2 nucleocapsid IgG Negative EKG findings Normal sinus rhythm. Imaging Chest radiograph (cardiopulmonary findings) Negative; Left ventricular ejection fraction on ECHO 62; Pericardial effusion present No; Cardiac MRI performed No.  DISCUSSION Herein described is the first case series from a single institution of 8 adolescent males with a diagnosis of perimyocarditis in the setting of recent BNT162b2 vaccination with no other identifiable cause.  No follow-up attempts are needed, information about batch number cannot be obtained.; Sender's Comments: A contributory role of BNT162B2 to the event perimyocarditis cannot be excluded based on the plausible temporal relationship, product safety profile and lack of reported alternative explanation at this time. This case will be reassessed if additional information becomes available.  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.,Linked Report(s) : PFIZER INC-202101133568 Same article/drug/event; different patient
Information has been received from a physician concerning a 12 month old twin male no allergies who on 02-AUG-2007 at approximately 15:00 PM was vaccinated SC on the right arm with a first dose of VARIVAX (lot # 658024/0833U). Concomitant therapy on the same day included a SC dose on the left arm of MMR II (Lot # 655414/1470F) and a fourth dose of PREVNAR (Lot # B58845A) with no previous adverse experiences related to it. There was no illness at the time of vaccination. It was reported that on 10-AUG-2007 the patient experienced a seizure, 15 minutes after his twin brother experienced a seizure. Unspecified medical attention sought. A chest x-ray was done (results not reported). At the time of report the patient had recovered. A product quality complaint was not involved. The patient's twin brother had similar experience after therapy with VARIVAX (WAES # 0708USA05300). Additional information has been received from the physician who stated that the patient had seizure 1 week after vaccination on 10-AUG-2007 at approximately 10:00 AM. The patient had febrile seizure (also reported as seizure) and at the time of report the patient had recovered. Upon internal review seizure was considered to be an other important medical event. No further information is expected.
pt started vomiting about 930PM cont through noc;talked w/MD 830AM was told to give liquids;called MD back 230PM MD gave prescription for compazine -t99.8
6 weeks of diarrhea following vaccines. Started day after Rotavirus given. Stool cultures and Rotavirus screen negative. Dietary modification and skin care until resolved.
pt recvd vax;states 2 days after vax lt thigh got red & swollen about size of 50 cents;has knot in area;not tender; swelling & redness is gone now but knot still there & has bruised look; bluish color;
Ghost nerve pain; Stinging tingling needles feeling; Shingles; suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for asthma and dupilumab (Dupixent) for drug use for unknown indication.   On an unknown date, the patient received Shingles vaccine. In 2015, the patient started Nucala (subcutaneous). On an unknown date, the patient started Dupixent. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced post herpetic neuralgia (Verbatim: Ghost nerve pain), tingling (Verbatim: Stinging tingling needles feeling), shingles (Verbatim: Shingles) and vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant). The action taken with Nucala was unknown. The action taken with Dupixent was unknown. The outcome of the post herpetic neuralgia was resolved and the outcome of the tingling was not resolved and the outcome of the shingles and vaccination failure were not reported.   It was unknown if the reporter considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the reporter considered the shingles to be related to Nucala.     It was unknown if the company considered the post herpetic neuralgia, tingling and vaccination failure to be related to Shingles vaccine and Nucala. It was unknown if the company considered the shingles to be related to Nucala.   GSK receipt date: 02-JUN-2023 This case was reported by a consumer via call center representative. Consumer stated she was taking Nucala for asthma in the spring of 2015 (she could not recall exactly when she started). She said she was going in to the Health care professional office and that they used the Nucala vial. She said that shortly after starting Nucala, she got shingles. She said that after recovering from shingles, she would on occasion still got a stinging tingling needles feeling that she described as ghost nerve pain. She said it felt as if she was about to got the shingles again but she would not got it. She said she was on Nucala until sometime in 2020 when she lost her job and she could not afford it. She said she was later put on Dupixent and that she started to got the same ghost nerve symptoms while on that. She said she was given the Shingles vaccine but it was after she got the shingles. She was trying to got patient assistance to restart Nucala. This case was considered as suspected vaccination failure since details regarding time to onset, completion of primary vaccination schedule and laboratory confirmation of shingles was not reported.  It was unknown if the reporter considered the event to be related to Dupixent . Did not consent to follow-up
Information has been received from a nurse concerning a 27 year old female with colitis ulcerative who was vaccinated with MMR II in the past (date not reported). A recent titer in 2006 showed non-immunity to mumps. Medical attention was sought. The patient's negative mumps titer persisted. Additional information has been requested.
no problems noted immed p/vax but 9 hrs laster pt became limp & cyanotic requiring rescue breathing, breathing again on own when EMT's arrived; adm to hosp w/adequate oxygenation; transferred to another hosp for observation;
This case was reported by a other health professional and described the occurrence of facial flushing in a 56-year-old male patient who received SHINGRIX (batch number 9779K, expiry date unknown) for prophylaxis. Concurrent medical conditions included hypertension, gastroesophageal reflux disease, hyperlipidemia, aortic valve disease and sleep apnea. On 22nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 15 days after receiving SHINGRIX, the patient experienced facial flushing, burning sensation in face, burning sensation scalp and tingling sensation. On an unknown date, the outcome of the facial flushing, burning sensation in face, burning sensation scalp and tingling sensation were not recovered/not resolved. The reporter considered the facial flushing, burning sensation in face, burning sensation scalp and tingling sensation to be unlikely related to SHINGRIX. Additional information was received as follows: The patient experienced facial flushing, flushing of head, flushing of neck and flushing of scalp along with burning and pickling sensation.
No additional information available or provided; GARDASIL 9 had a temperature excursion and then was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 02-NOV-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # T026323, expiration date 22-FEB-2023 (route of administration and anatomical location were not provided) for prophylaxis (incorrect product storage). The administered vaccine experienced multiple temperature excursions over approximately 9 weeks, the warmest recorded temperature was 73.1 degrees Fahrenheit (F). Previous temperature excursion was also reported as multiple, details were unknown. No additional information was available nor provided (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA002448: