chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL 9 (lot # M017983 expiration date: 30-MAY-2018; lot # M024261 expiration date: 30-JUL-2018; lot # M034437 expiration date 03-FEB-2019; lot # M011840 expiration date: 01-FEB-2018). The vaccines were exposed to 68.7 degrees F for 5 hours, also vaccines with lot # M024261 expiration date: 30-JUL-2018 was exposed to 54.5 degrees F for 5 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010201: US-009507513-1612USA010218: US-009507513-1612USA010219: US-009507513-1612USA010220.
This spontaneous report was received from a pharmacist via a company representative and refers to a 11 year old female patient, who was also the pharmacist's daughter. No information regarding the patient's pertinent medical history, concomitant medications and drug reaction or allergies was reported. In October 2018, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. On an unknown date in 2018, the patient had a small bump in the area of injection. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and GARDASIL 9.
This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a 41-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 12-OCT-2016 to 12-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse event description: On 12-Oct-2016, the individual was given AFLURIA subcutaneously (special circumstances: incorrect route of drug administration without adverse event).
throat became constricted; anaphalactic reaction to flu vaccine; her tongue swollen; Initial information was received on 22-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).  This case involves an 84 years old female patient whose throat became constricted (throat tightness), anaphalactic reaction (anaphylactic reaction) and her tongue swollen (swollen tongue), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot U3604BA and expiration date was not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious throat became constricted (throat tightness), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  On 22-Jan-2011, the patient developed a serious anaphalactic reaction (anaphylactic reaction) and her tongue was swollen (swollen tongue), 10 years following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for these events.  It was reported that she was told to find out the ingredients of that vaccine and then her doctor would compare it to the current Covid vaccines to determine if any of the ingredients are the same.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events was unknown at the time of reporting.; Sender's Comments: This case involves an 84 years old female patient who experienced throat tightness, anaphylactic reaction and swollen tongue, after vaccination with FLUZONE HIGH DOSE. The time to onset is unclear. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
21 y/o male presented to ER on 8/25/2008 with 2 day history of sharp mid-sternal chest pain, radiating to neck and shoulders; worsened by positional changes, and deep breathing; SM reported 4-5 day prodrome of fever, malaise, and bifrontal headache. He had received primary SPV 8 days prior; SPV site progressed normally - no increase in pain or induration; no hx of cough, SOB, Immobility, leg pain or swelling, or trauma; no sick contacts or foreign travel. On 8/25/2008 SM was transferred from ER to hospital for cardiac care with diagnosis of suspected myocarditis; he was stable throughout his hospitalization without systemic symptoms (cvs, pulm, GI, neuro); he was discharged 8/27/2008.   12/12/2008 Reviewed medical records of 8/29-10/21/2008 & hospital admission 8/25-8/27/2008. FINAL DX: acute myopericarditis Records reveal patient experienced sub-sternal chest pain x 2 days.   Tx w/antiinflammatores.  Improved & d/c to outpatient cardiac f/u.  Continued to have chest tightness w/exercise but asymtomatic at rest.  Chest tightness gradually resolved completely.
Aches; Sore Throat; Was in Bed 3 days; Arm was really sore; Bad cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough). At the time of the report, PAIN (Aches), OROPHARYNGEAL PAIN (Sore Throat), BED REST (Was in Bed 3 days), PAIN IN EXTREMITY (Arm was really sore) and COUGH (Bad cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 102f (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated.
Received Moderna COVID-19 booster dose 9 December 2021. Since 23 December she has complained of recurrent episodes of localized itching and rashes described as raised, red, itchy whelts which worsens where her skin is scraped or scratched. Lesions spare her face, last less than 24 hours, occasionally affect her palms, and resolve without post-inflammatory changes. On December 27 she presented to the ER where she received oral antihistamines and oral corticosteroid; she did not continue the oral corticosteroid. She denies generalized cutaneous, laryngeal, pulmonary, GI/GU, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, heat, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 9 December, 14 days prior to onset of symptoms. She has used oral antihistamines with benefit. She denies constitutional symptoms. score today is 16 (1, 2, 1, 2, 3, 4, 1, 2). She feels that her symptoms are gradually improving
Blisters on the rash on leg; Skin rash on legs and arms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration, in right arm, on 09Mar2021 at 10:15 (at the age of 60-year-old), at dose number unknown single for COVID-19 immunization. It was reported that, the patient had no relevant past medical history. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. 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 tested for COVID-19. On 10Mar2021 at 17:00, the patient had skin rash on legs and arms, more dominant on right arm and leg. The patient also had blisters on the rash on leg. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken included treatment with steroid cream (unspecified). The clinical outcome of the events was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Resident had no issues after receiving vaccination. The next morning he was found in his room laying face down on the floor and unresponsive. CPR was started, 911 called. Unfortunately resident was pronounced dead at 7:55am.
8 days after getting vaccine, I had injection site redness, pain, and itching, along with a headache and neck pain.  The redness/itching lasted for a couple of days.  The neck pain and headache resolved after 5 days.
This spontaneous report as received from a consumer refers to a 64 year old female patient with high sensitivity to drugs (unspecified names, doses/frequencies and manufacturers). On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Other suspect therapies included PNEUMOVAX 23 (Lot # not reported) (dose and route not reported) applied on the same date. Concomitant therapy was not reported. On 24-DEC-2013 (reported as two weeks after receiving the vaccines) the patient experienced severe head and chest colds, fever blisters and loss of voice for four months. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of fever blisters, severe chest colds and severe head colds and loss of voice was reported as recovered in approximately April 2014 (reported as for four months after receiving the ZOSTAVAX and PNEUMOVAX 23). Upon internal review the loss of voice was considered an other important medical event. Additional information has been requested.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 16-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011184: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671.
Began having a low grade temp on 6/23/2013, no exact temperature data available, on 06/24/2013 around 5 or 6 pm, began to have an ache in left hip joint and left thigh muscle. Achiness became worse at bedtime and he couldn't sleep, so he took 2 ibuprofen and medication did relieve aches. Aches continue today, but he rates achiness as 1 or 2 on scale of 0-10 pain scale. Reports he also continues with low grade temperature.
Redness around injection about 2 inches in diameter, very sore, warm to touch, firm, and itchy.
The day after I received the booster Saturday November 13 I had body aches and chills all day and a golf ball size lump in my arm at the injection point that was very tender and itchy, the next day November 14 it was followed by nausea all day and a scratchy throat and still a golf ball size lump in my arm. Monday November 15 I woke up with a swollen and scratchy throat still the lump in my arm. The swelling in my throat was so bad it was hard to move my jaw to drink and eat. Tuesday November 16 the swelling had gone down in my throat  a bit and the lump in my arm had decreased but I had a really bad headache (the worst I have ever had) and tiredness. Wednesday November 17 the swelling in my throat is gone but it's still scratchy and I have a headache in my right temple and my arm at the injection point is still very tender.
Shortness of breath and increased heart rate - resting heart rate jumped from avg 54 to 65-70 on 8/13, day after first dose and now nine weeks later my rhr avg is 65. My VO2 max was consistently above average for years, since mid August it has steadily declined to below average. I was in excellent health, with an extremely healthy heart and now my heart health is rapidly declining.
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 76-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Mobile gave recipient booster dose too early. Last dose 11/9/2021. Language barrier. Consider invalid dose. Pt education given.
Grand mal seizure 23 minutes after receiving 1st dose of vaccine. Managed by parents. (Error on date. It was given on 3/21/21 not 3/20/21. Typo)
Redness and swelling at right arm site (DTaP). Hives-generalized-Benadryl both developed within 24 hours of vaccine.
2 slightly enlarged tender lymph nodes in lest axillary region. Approximately- 1-2 cm size on palpation.
No adverse events reported. Patient was given a booster shot of the Moderna Spikevax 12 years and older. Which is no longer recommended as booster shot as of August 31, 2022.
Pt LMP on 6-23-2017 and was normal. Urine preg positive on 6-28-2017, serum Hcg level 24,115. Unknown EDC, referred to OB.
pt recvd vax & w/in 24 hrs devel swelling, heat, induration of skin on upper arm lt where inject had been administered;
Period began within hours of receiving vaccine, despite never having period due to Depo Provera shot.
Pt was standing by nurses station post vaccination, and appeared to faint, falling to floor and losing consciousness. Dr was standing there and broke pt fall. She immediately regained consciousness and was helped to and exam room. Water and vital signs were monitored. She was also given crackers by her mother. After approx 25-30 min, pt recovered sufficiently and released in mother's care.
Information has been received from a physician concerning a female patient, who was vaccinated with the first dose of VARIVAX (Merck) on an unspecified date and received the second dose of VARIVAX (Merck) in 2008 (reported as recently) (0488X). After receiving the second dose, the patient developed injection site reaction the patient developed redness, swelling and tenderness at the injection site. The patient's reaction was "worse than her brother". The patient was prescribed antibiotics. Sought medical attention: office visit. Additional information has been requested. The patient's brother also had an adverse experience after vaccination with VARIVAX (Merck). (WAES # 0807USA03815).
2nd day sleepiness; Body went actually cold instead of fevers; Low appetite on 2nd day; Very mild headaches; Soreness in vaxx place/Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness). At the time of the report, SOMNOLENCE (2nd day sleepiness), FEELING COLD (Body went actually cold instead of fevers), DECREASED APPETITE (Low appetite on 2nd day), HEADACHE (Very mild headaches) and VACCINATION SITE PAIN (Soreness in vaxx place/Soreness) outcome was unknown.            No concomitant medications were reported.  It was reported that current status of third vaxx being a different one and patient had no itchiness rash and barely any swelling.  No treatment details 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.   Reporter did not allow further contact
BAD Reaction/ taken to / Emergency Room / her Heart Rate Finally slowed down; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was recovering/resolving.   It was unknown if the reporter considered the heart rate increased to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad Reaction to vaccine and was taken to the nearest emergency room. The patient's heart rate finally slowed down and she started to feel better.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. On 15-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as 0614AA), that had expired on 27-SEP-2012. Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Rash and burning feeling  broke out on left arm around inner elbow area and growing to circumnavigate the arm
Pt recvd 3 doses of Hep B vax SEP90; OCT90 & APR91; the 3rd dose was w/Engerix-B; Report indicated that pts "began their series on Recombivax-most had 2 Recombivax & poss 1 Engerix-B;
Left leg swollen twice the size of his right leg  Was given prednisone at urgent care on Sunday and benadryl today in our office
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 at 12:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (25Jul2022) Positive, notes: a positive antigen test, 5 days after completion of the dose pack. Therapeutic measures were taken as a result of drug ineffective, covid-19,drug ineffective with paxlovid started on 16Jul2022and stop date 20Jul2022  Clinical information: Return of Covid symptoms and a positive antigen test, 5 days after completion of the dose pack.Adverse event start date: 25Jul2022 ;12:00 PM. No treatment done for return of Covid symptoms.No known allergies.
Fever, NauseaVomiting, Tachycardia, stomach pain; weakness; decreased appetite Narrative:  employee states: her first vaccine was 1/16/21, 30 minutes after injection she was nauseated and experienced a fast heartbeat. Later that afternoon she vomited, passed out. She then had epigastric pain x 2 days with weakness. on day 3-4, her heartrate was 106-125 at time with a low grade fever, weak and poor appetite. She went to the doctor on day 6, which suggested a cardiac event. Day 7, she was hospitalized. She believes her cardiologist may also be reporting this event.
He was sick a couple days later, high fever and temperament were getting worse, we thought we should take him to the emergency room.