chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023; No adverse event; Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, 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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-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 (Dose administered to patient on 5-Jun-2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired on 30-May-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-Jun-2023 after expiration date 30-May-2023).    This case contains information for patient 43 out of 50 patients as described by the reporter.  No concomitant medication information was reported.  It was reported that no adverse reactions had been reported by any patients.  The vial was initially stored in the refrigerator on 4-Jun-2023 and did not undergo any temperature excursion.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case (Patient 43)
Went to ER on 24Sep due to worsening of symptoms; Nowhas a incomplete Right Bundle Branch Block on EKG; had elevated D-dimer; SOB tachycardia with exertion.; SOB tachycardia with exertion.; Intermittent CP.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 14:00 (Lot number: EW0175) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Renal cell carcinoma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Cipro, reaction(s): "known allergies: Cipro". The following information was reported: DYSPNOEA (non-serious), TACHYCARDIA (non-serious) all with onset 03Sep2021 08:00, outcome "unknown" and all described as "SOB tachycardia with exertion."; CHEST PAIN (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Intermittent CP."; CONDITION AGGRAVATED (non-serious) with onset 24Sep2021, outcome "unknown", described as "Went to ER on 24Sep due to worsening of symptoms"; BUNDLE BRANCH BLOCK RIGHT (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "Nowhas a incomplete Right Bundle Branch Block on EKG"; FIBRIN D DIMER INCREASED (non-serious) with onset 03Sep2021 08:00, outcome "unknown", described as "had elevated D-dimer". The events "sob tachycardia with exertion.", "sob tachycardia with exertion.", "intermittent cp.", "went to er on 24sep due to worsening of symptoms", "nowhas a incomplete right bundle branch block on ekg" and "had elevated d-dimer" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, tachycardia, chest pain, condition aggravated, bundle branch block right, fibrin d dimer increased.  Additional information: The vaccination location was also reported as right shoulder. Patient did not take any other vaccine in four weeks and also event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient also reported not tested covid post vaccination or having covid prior to vaccination. He also did not take covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
severe muscle aches, severe headache , fever and day 3 diffuse all over body rash
This spontaneous report was received from a healthcare student regarding an 18 year old patient (gender unknown). On 15-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001697, 08-MAY-2014) 0.65 ml, subcutaneously instead of a dose of VARVIAX (Merck). The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Headache - 29APR21 5:00pm - 30APR21 3:00pm Swollen lymph nodes (most notably in neck/throat area and under arms) 30APR21 2:00 AM - 01MAY21 9:00 AM Overall  body aches/pains 30APR21 2:00AM - 01MAY21 09:00AM Fever/Chills - 30APR21 2:00AM - 01MAY21 9:00AM  All resolved; no treatment taken
Chills; Fever 102 °F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 102 °F) and NAUSEA (nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever 102 °F) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever 102 °F) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
second dose is scheduled on 23-Apr-2021 which is at 42 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled on 23-Apr-2021 which is at 42 days after the first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical history information was provided.  Concomitant products included ATORVASTATIN, ISOSORBIDE MONONITRATE, CYANOCOBALAMIN (B12-VITAMIIN) and FOLIC ACID for an unknown indication.    On 12-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled on 23-Apr-2021 which is at 42 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is scheduled on 23-Apr-2021 which is at 42 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is scheduled to receive the second dose is scheduled on 23-Apr-2021 which is at 42 days after the first dose.  Patient is undergoing chemotherapy and usually does not feel well after. No treatment medications were reported
Pain in neck and shoulders. Numbness in upper arm, thumb, index finger of right arm.
9SEP97 parents reports day p/vax pt devel fever (doesn't know how much) & gen rash on head trunk & arms;pt fussy;eating & drinking adequately;10SEP97 contacted parent per phone states rash is about gone-no fever;soreness @ inj site;
diagnosed with COVID after COVID-19 vaccine; diagnosed with COVID after COVID-19 vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EL3248, Expiration Date: 21Apr2021), on 26Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) and on 19Nov2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 43 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022 (also reported as 19Aug2022), outcome "unknown" and all described as "diagnosed with COVID after COVID-19 vaccine". Clinical course: the reporter was a Pfizer employee who received the vaccine "in Mar2021, then booster, and a second booster in Nov2021." The reporter was diagnosed with COVID on 29Aug2022.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The adverse event did not require a visit to the emergency room or physician office. There were no additional vaccines administered on the same dates of the Pfizer suspect. There were no adverse events following prior vaccinations. The reporter finally noted that her husband was sick as well. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive.
Shot was given at 2:30 pm, pt came back at 5:30 pm on 10/20/15, has shoulder pain from FLUZONE HIGH DOSE. Very insultive and irate pt.
Patient was given the H1N1 2009 monovalent vaccine prefilled without preservatives. Instead of the intranasal influenza H1N1. The IM prefilled syringe was given intranasal.
Approx 15 min after receiving vaccines pt became faint and went to knees we laid her down, checked blood pressure, gave water, she recovered in 10 - 15 minutes.
Within hours after the shot, patient stated arm swelled from injection site down to below elbow. There was no knot at injection site. Arm hurt. There was an itchy rash on arm that went to back of shoulder and across chest. Rec. patient take Benadryl & ice area. If not better in 24 hrs or if gets worse, contact MD or go to ED.  Spoke to patient 1 week later and she says she's 90% better.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 10-JAN-2013 had administered dose of GARDASIL (lot # 0131AE expiration date 26-OCT-2014) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the report from the same source. Additional information is not expected.
This spontaneous report was received from a nurse referring to pa atient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (STERILE DILUENT). The nurse reported that on an unspecified date the patient received an improperly stored dose of ZOSTAVAX lot number: N025387 (expiration date: 12-DEC-2018) for prophylaxis (strength, route, dose or units were not provided), which was reconstituted with a properly stored sterile diluent (STERILE DILUENT). The storage characteristics were the following: - Temperature: 15 °F to 46°F - Time frame: 40 minutes - Previous temperature excursion: 15 °F to 46°F for 40 minutes No adverse effects were reported.
she started itching all over her body.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "she started itching all over her body.".  Additional information: Caller said she had her Pfizer covid vaccine last Sep2021, then after 3 months, on Dec2021 she started itching all over her body. Caller would want to know if it's normal to take that long for the side effects to manifest. Also states, it turned out to be No more tomatoes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via patient support programs and described the occurrence of pericarditis in a 44-year-old female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the pericarditis was unknown and the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the pericarditis and sickness to be related to Seasonal Influenza vaccine. Additional details were provided as follows: This case was received from consumer via the vaccine patient assistance program. The age at vaccination was not reported. The patient experienced allergic reaction in the form of pericarditis and sick for about 6 weeks. The patient experienced swollen arm, severe pain and flu like symptoms after vaccination with tetanus vaccine. This case has been linked to case US2016GSK079166, reported for pharma drugs.
After patient received his vaccination it was discovered that he was only 15 years old (patient will turn 16 tomorrow 3/6/2021), this technically resulted in a medication administration error. Patient's parents were on-site and were advised of the error, there was no concern expressed by the parents. Patient was observed for 15 minutes and no reactions were noted.  Steps have been taken to avoid similar mistakes in the future. Staff at all levels have been directed to be more diligent in checking ages, signs have been developed to be posted with the ?must have been born  before" date.
Dizziness within 3 hours of shot given at approx 4:30 pm Dec 15th continues on to today Dec. 17th. Dizziness is mild.   #9 I wrote unknown as my daughter continues to be dizzy as I submit this report.
Migraine; This spontaneous case was reported by a non-health professional and describes the occurrence of MIGRAINE (Migraine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 MIGRAINE (Migraine). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-074715 (Patient Link).
pt was given vax 7JUN94 130PM pt returned to ER on 8JUN93 @ 505AM w/t105.7;
53 year old female with hypertension and recent COVID-19 vaccine (Moderna, 1st dose on 4/5/21), sent for abnormal labs to the ED and new onset dizziness. As for the dizziness, the patient describes it as: of 2-3 week duration, onset 4 days following COVID-19 vaccine (Moderna, 1st dose on 4/5/21), progressive, intermittent, reproducible with activity, some improvement at rest, of variable pain intensity; associated with taste change, dry mouth, malaise, nausea, and poor appetite. Of note, urgent care reported BUN 54 and Creatinine 2.89. On arrival to the ED, the patient's CT of head was notable for: No evidence of acute intracranial pathology
Information has been received from a physician's assistant as told her by the patient's primary care physician concerning a 14 year old female who was vaccinated with a dose (dose number unknown) of GARDASIL on an unspecified date (lot number, route and site not reported). Subsequently the patient was diagnosed with Guillain-Barre Syndrome after receiving GARDASIL. The patient sought unspecified medical attention (date not reported). The patient's outcome was not reported. No further information was provided. The reporter considered Gullain-Barre Syndrome to be an other important medical event. No further information is available.
I had a sore that started on 01/31/2023, that continued until the next day. I did not sleep well, I was congested, a slight headache. On 02/02/203, I took a home COVID-19 test that came back inconclusive, the next day I was feeling warmer the mucus was green. I took use another home COVID-19 test this one came back positive. I went to a urgent care on 02/04/2023, by then I was sneezing, coughing, very thick green mucus. They performed a PCR Rapid COVID-19 test that came back positive. I was advised that I needed to stop taking Flonase while I was on Paxlovid. I took the five-day course of Paxlovid and felt fine but once it was gone the inflammation to my sinuses came back. I am not sure if this is because I stopped the Flonase. I did have mild tiredness for two weeks after completing the Paxlovid.
Skin reaction w/cresent shaped burn like reaction one week after 2nd dose of Gardasil. Swollen below injection site, probable hematoma.
Nasal congestion, nasal swelling, fever, sore throat, coughing.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came in on 5-1-23 she went to the doctor and doctor said she has a hematoma due to site of injection being low
Narrative: She developed ~2-3in x 2-3 in well circumscribed rectangular erythematous rash over the injection site about 7 days afterwards. This was additional described as warm to touch and indurated. It Persisted for about w prior to spontaneously resolving. No therpaies were tried or complieted
Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient had shingles vaccine several years ago and had shingles 3 different times. The reporter stated vaccine does not completely prevent shingles, it just makes them not as bad the patien thought. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR077445, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077445:same reporter
Information has been received from a registered nurse concerning a 35 year old female who on 15-MAR-2007 was vaccinated IM in the right deltoid with a 0.5 mL dose of Pneumovax 23 (lot #655588/0883F). Concomitant therapy included REYATAZ. On approximately 15-MAR-2007, after receiving the vaccination, the patient developed a rash on the injection site of the right upper deltoid arm. The rash was described as two separate bands that went around the arm. It was also reported that the patient had been experiencing headaches since vaccination. The headaches were treated with ADVIL. Subsequently, the injection site rash resolved completely, although, the headaches have persisted. Additional information has been requested.
Chest tightness, trouble breathing, tunnel vision, flushing, sweating, elevated blood pressure all happened and resolved within 15 minutes. General malaise persisted about 4 hours post injection.
PATIENT REPORTS REDNESS, SWELLING, ITCHING AT INJECTION SITE BY THE LATE AFTERNOON ON DAY OF INJECTION, SITE WARM TO TOUCH, REDNESS SPREADING WHEN SHE PRESENTED 2 DAYS AFTER THE VACCINE ADMINISTRATION. SHE SOUGHT MEDICAL TREATMENT AT HER PCP THAT DAY AND WAS DIAGNOSED WITH SUSPECTED CELLULITIS AND GIVEN KEFLEX.
No additional AE; the MMRII expired on 12/9/2020 and was inadvertently administered to the patient on 12/23/2020; This spontaneous report has been received from a licensed practical nurse concerning a 1 year old of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 23-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 ml,  Lot # R035700, expiration date 09-DEC-2020 for prophylaxis (dosage regimen was not reported).   It was reported that no additional adverse events were reported (AE) and that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live did not experience any temperature excursion.
became "ill" Saturday evening after getting shot on Friday afternoon - spiked fever of 100.5 with aches, very sore R arm with redness and rash at injection site size of baseball, - felt bad on Sunday with body aches and soreness
10min following adm of MMR/DTP/OPV pt had hypotension, extreme facial pallor, vomiting, low pulse; symptomatic measures done until stabilized, saw pediatrician w/in 1hr;
GENERAL PRURITIS AT ARMS, UPPER BACK, ANTERIOR CHEST, W/ REDNESS AND SLIGHT SWELLING. AT SCALP THERE IS ITCHING ONLY. TREATMENT INCLUDES ORAL BENADRYL NIGHT OF EVENT AND DAY AFTER. ALSO TREATED WITH HYDROCORTISONE CREAM THE DAY AFTER. BOTH EFFECTIVE. SENT HOME FROM WORK. ADVISED TO CALL 911 FOR S/SX ANAPHLAXIS.