chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # K006396, expiry date: 04-MAY-2016 and lot # K008202, expiry date: 05-JUN-2016). Nurse reported that the vaccine underwent a temperature excursion in a large refrigerator at an unspecified temperature for an unknown time frame. No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Started with a low fever 6 hours after vaccination, with slight muscle ache symptoms. About 4-5 hours later it evolved into a high fever (104 at peak), muscle aches on the whole body, and ringing in my right ear. The next day the symptoms were more mild, but still present (other than ringing in ear) with a lower fever, and the day after the symptoms were gone except for tenderness at injection site.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735 and 2018SA284736 from same reporter. This case involves Adult patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). It was unknown whether patient experienced any adverse reaction after the injection. 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.
Information has been received from a health professional concerning a female, in grades 3-5, who was vaccinated with a dose of varicella virus vaccine live. Recently, since November 2005, the patient experienced a chickenpox outbreak. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sore arm near the site of injection; Muscle aches; Fatigue; This is spontaneous report from a contactable consumer, the patient.  A 64-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 18:00, the patient experienced sore arm near the site of injection, muscle aches and fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events sore arm near the site of injection, muscle aches and fatigue. The clinical outcomes of the events sore arm near the site of injection, muscle aches and fatigue were recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 16 year old female patient with no known allergies who on 01-MAR-2010 was vaccinated in the left deltoid with the first 0.5 ml dose of GARDASIL (lot number 663558/0819Y). Concomitant therapy include birth control pills (unspecified). Immediately post vaccination, the patient experienced syncope event. The patient turned pale, and was told to put her head down between her knees. Then the patient seat up rigid and her eyes were out of it. The patient was laid down on the floor and monitored. Her heart rate was 60, blood sugar 118, and her blood pressure "was very low", but unspecified. The patient was observed and fully recovered in the office. The nurse practitioner stated that the patient has had similar episodes in school where she passed out due to any blood or gory type of information or exposure. Additional information has been requested.
Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/7/23.
WHOLE BODY ACHE; JOINT PAIN; WHOLE BODY WEAKNESS/ RIGHT LOWER LEG WEAKNESS; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had four stents and was on unspecified blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: unknown) dose was not reported, dose number in series 1, 01 total, administered on 04-MAY-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced muscles aches for two months (dose number in series 1). The patient recovered from muscles aches for two months. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, dose number in series 2, 01 total, administered at right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had joint pain, whole body weakness/ right lower leg weakness, severe headache, and whole body ache (dose number in series 2). At the time of report, the patient's ache and weakness spread into the whole body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole body weakness/ right lower leg weakness, and whole body ache, and the outcome of joint pain and severe headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220241253.
I had a minor sore arm after receiving the vaccine. On 11/17/2022, I started not feeling well and thought I had a bug.  I tested for COVID-19 with an expired test, and it was negative. I tested positive for COVID-19 on 11/18/2022.  On 11/19 I felt worse, and I coughed up blood in my phlegm. I went to an urgent care center to be tested for flu which was negative, and they did a PCR test. The PCR test came back positive on 11/20/2022. As of today, I continue to cough, and I have a runny nose.
Covid toes and hands.  Severe painful rash, hives on hands, palms, fingers, toes, feet
This is a spontaneous report from a contactable nurse Practitioner via a Company representative. A 17-year-old other ethnic group male patient received TRUMENBA (Lot # R47584, Expiry Date 31Jul2018, NDC # 00005-0100-10) intramuscular at 0.5 mg, single on 24Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient went to the ER a couple of times because his hands and feet were tingling. His smile was asymmetrical so they thought it was bell's palsy but it wasn't. He had weakness in lower extremities, and then couldn't walk. He was eventually diagnosed with Guillain-Barre syndrome. He was hospitalized once, but caller was not provided with the dates. States the patient is going through rehab now. He was improving. He was walking and was even able to run now. Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
seizure; Initial information received on 12-Jul-2021 regarding an unsolicited valid serious case received from a pharmacist via call center via Regulatory Authority (Reference number- 00676744).  This case involves an female patient (unknown demographics) who experienced seizure when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, vaccination, concomitant and family history were not provided.  Past vaccination include ADACEL 10 years ago for prophylactic vaccination and did not have any side effect or seizures attack related to the vaccine for the past 10 years.  On an unknown date, the patient received a booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  It was reported that ''what to advise patient after informing her medical provider? does patient have to undergo tests through provider to rule out any adverse reaction from the vaccine due to her current seizure disorder. If Pharmacist calls in verify if asking of drug interactions between Adacel and Keppra.''  The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) 500 mg for her seizures.  The event outcome was unknown for seizure.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a unknown age old female patient who presented with seizure after vaccination with ADACEL. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
2nd dose administered too soon (15 days between doses) 1st dose administered 4/26/21
At 1pm the left arm was sore. By 7pm it was red and hard shoulder to elbow. Low grade temperature per wife. He drank ice water and passed out. Ambulance summoned. ER visit.
severe allergic reaction/very ill and having a fever; shingles type rash; This spontaneous report was received from a currently 61-year-old female patient referring to herself. The patient's pertinent medical history included low thyroid. Concomitant medication included levothyroxine sodium (reported as levothyroxine). The patient had a lot of allergies.   On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, lot# and expiration date was not provided; route reported as injection) for shingles.     On an unknown date in 2014, the patient experienced a "severe allergic reaction", felt very ill and had a fever (hypersensitivity) and shingles type rash (herpes zoster). There was no lab diagnostics/studies performed. The patient did not seek medical attention. The outcome of hypersensitivity and herpes zoster was reported as recovered on an unknown date in 2014.  The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was not provided.
4 inch area of redness and swelling at injection site, patient was reportedly more tired than usual after vaccine.
headache; Soreness in arm; low grade fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Nov2021 13:00 (Lot number: FG3527) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: SPIRONOLACTONE taken for acne, start date: 2004 (ongoing). Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Left, Time: 11:00 AM, Route of administration: Intramuscular), administration date: 24Mar2021, when the patient was 46 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Time: 11:00 AM, Route of administration: Intramuscular), administration date: 04Mar2021, when the patient was 46 years old, for COVID-19 immunisation; Fluzone quad (Manufacturer: Sanofi, Batch/Lot#: UT7316KA, Route: Intramuscular, Anatomical site of injection: Left Arm), administration date: 03Oct2021, for Immunization. The following information was reported: HEADACHE (non-serious) with onset 03Nov2021 22:00, outcome "recovered" (Nov2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021 22:00, outcome "recovered" (Nov2021), described as "Soreness in arm"; PYREXIA (non-serious) with onset 03Nov2021 12:00, outcome "recovered" (Nov2021), described as "low grade fever"; CHILLS (non-serious) with onset 03Nov2021 12:00, outcome "recovered" (Nov2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pain in extremity, pyrexia, chills.  Additional information: The patient took advil 8 am following day and the fever was gone by lunch time. Headache  was gone by dinner time, Arm soreness lasted for 2 days and Chills only lasted-4 hrs. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The vaccine which received within 4 weeks prior was of sanofi-pasteur in left arm. No hospitalization Prolonged. COVID-19 vaccine was administered in Pharmacy or Drug Store  Follow-up attempts are completed. No further information is expected.
Felt tired the day of and next two days after receiving vaccine; Got a headache the next 2 days after receiving vaccine; Pain on injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient felt tired the day of and next two days after receiving vaccine, got a headache the next 2 days after receiving vaccine and also had pain on injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt tired the day of and next two days after receiving vaccine, got a headache the next 2 days after receiving vaccine and also had pain on injection site was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
17 y/o inadvertently given first dose Moderna vaccine at 17 years 9  months of age. No adverse reactions followed. Client informed first dose was given inadvertently off-label due to age.
lip swelling; This is a spontaneous report received from regulatory authority. A non contactable health care professional reported for the patient. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications included hyaluronic acid (JUVEDERM) taken for an unspecified indication, start and stop date were not reported. The Health professional reported injecting a patient with JUVÉDERM® Ultra. A year later, the patient was injected with Juvéderm® VOLIFT with Lidocaine. Two and half years later, the patient was injected with Belotero Soft. The patient experienced lip swelling 4.5 hours after the second dose of the Pfizer vaccine on an unspecified date. The patient was treated with antihistamine and Dexamethasone. The event resolved 48 hours later. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Caller was bedridden with Moderna; When they get the shot they get sick for 3 days; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Caller was bedridden with Moderna) and ILLNESS (When they get the shot they get sick for 3 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 039B21A and 001B21A) for COVID-19 prophylaxis.     The patient's past medical history included Acid reflux (esophageal) and Hepatitis B (Hep B Carrier). Concomitant products included ENTECAVIR, FAMOTIDINE, VITAMINS NOS and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (When they get the shot they get sick for 3 days). On an unknown date, the patient experienced BEDRIDDEN (Caller was bedridden with Moderna). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Mar-2021, ILLNESS (When they get the shot they get sick for 3 days) had resolved. At the time of the report, BEDRIDDEN (Caller was bedridden with Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BEDRIDDEN (Caller was bedridden with Moderna) to be related. No further causality assessment was provided for ILLNESS (When they get the shot they get sick for 3 days).    Reported that when patient got the shot, she got sick for 3 days. She was bedridden with Moderna. She took Tylenol and weathered it at home. Patient most likely would have gotten the flu shot.
A report received from a health professional on 05Nov02 concerning a female vaccinee in her fifties who experienced an injection site reaction the morning after receiving Fluvirin on 01Nov02. On the morning of 02Nov02 the vaccinee complained of redness, itching and burning at the injection site. No medical intervention was required as the symptoms were self limiting. The symptoms resolved within a day and the pt is currently recovered. There was insufficient information to determine the reporters causality assessment. See Ref: PJP200200682, PJP200200683, PJP200200685, PJP200200686
Complains of bilateral knots behind her ear and a small red swollen spot on the left side of face by ear.
Vial initially stored in refrigerator on 18 oct 2022; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) 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. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) 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 (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022).    14 doses of the bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022 No concomitant medications were reported. Vial size was reported as 2.5ml On  18Oct2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 14th of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 14 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 14 US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675259:Patient 14 US-MODERNATX, INC.-MOD-2022-675270:
Flat erythematous - "hive like" - area distal to injection site - (2 cm lower) area is sl warm to touch - approx 6 cm X 3 cm - Otherwise no other untoward effects.