chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was very tired.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Feb2021 (Lot number: en6202) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "very mild von Wilderbrand" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "He was very tired.".  Additional information: The administration time of vaccination as reported as 14:00. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no know allergies.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Called pt. To follow. 10/8 high dose flue shot. Shoulder pain same day. Not too bad played golf. 2-3 weeks radiating down arm. 10/24  Chiropractor for arthritis already   Denies ever having issues with vaccines ever in the past.   Had x-ray end of October 10/27 - diagnosis pinched nerve in neck  Chiropractor stretching of neck exercises, Celebrex for pain which has been helping.   Pain level 7/10 hurts more at night and wakes her up at night 10/10.
diarrhea; brutal headache/ severe headache; This is a spontaneous report from a contactable consumer (patient parent). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 07Jan2021 at 34-year-old. Medical history and concomitant medication were not reported. After the first vaccine, the patient got a severe headache and diarrhea. It was reported that within a day (07Jan2021), he got a brutal headache, and the next day (08Jan2021) got diarrhea. Treatment received for diarrhea. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This case was reported by a healthcare professional via Novartis and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced diarrhea and cramp. The healthcare professional reported the subject received FLULAVAL, no FLUVIRIN and experienced "severe diarrhea and cramping similar to when she has had gluten". At the time of reporting the outcome of the diarrhea and cramp were unspecified. Follow-up information received via the reporter on 07 January 2011 indicated that she did not remember reporting an adverse event and no additional information is expected.
Pt was administered multiple manufactures of the COVID-19 vaccine. Moderna was administered on 3/11/21 and 3/25/21, while Janssen was administered on 3/24/21.
Lymph node in neck became swollen and painful. Mild fever for at least 2 days. Injection site became a red knot that hurt to touch. Injection site was swollen and turned to a large bruise. Lymph node under left arm swollen. Fatigue.
tired; Chills; body aches,minor body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (body aches,minor body aches), PYREXIA (fever) and FATIGUE (tired) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive from 22-Dec-2020 to 31-Dec-2020 and Tendonitis (in the left arm,). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and METOPROLOL SUCCINATE (TOPROL).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021 at 10:00 PM, the patient experienced CHILLS (Chills), MYALGIA (body aches,minor body aches) and PYREXIA (fever). On 11-Jan-2021, the patient experienced FATIGUE (tired). On 11-Jan-2021 at 5:00 AM, CHILLS (Chills) had resolved. On 12-Jan-2021, MYALGIA (body aches,minor body aches), PYREXIA (fever) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included paracetamol.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Coronary Artery Disease" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications, also reported as no other medications in two weeks. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid started on 30Apr2022 and stopped on 14May2022. Clinical course was reported as, Rebound of coryza, nasal congestion, sore throat, fatigue, myalgia, headache, malaise beginning about 4 days after completing Paxlovid on 18May2022. No treatment received for symptoms and patient was recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
This literature marketed report has been received from authors of a published article, referring to a previously healthy 14-year-old boy presented with a 2-day history of malaise, anorexia, and a painful, pruritic rash and a 1-day history of severe headache. Physical examination revealed more than 70 papulovesicular lesions over the lateral aspect of his left thigh in an L1 to L2 dermatomal distribution, photophobia, and meningismus without focal neurologic deficits or altered mental status. The patient had no recent varicella-zoster virus (VZV) exposure and had received 2 varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot # and expiration date unknown) at 1 and 4 years of age.  Laboratory studies revealed normal peripheral blood white blood cell (WBC) and platelet counts, liver transaminases, and C-reactive protein level. Cerebrospinal fluid (CSF) had a Gram-stain result negative for organisms, glucose of 60 mg/dL, protein of 64 mg/dL, red blood cell count of 268/cubic millimetre, and WBC count of 140/cubic millimetre with 88% lymphocytes and 10% monocytes. CSF and a scraping of a vesicular lesion resulted positive for VZV by polymerase chain reaction (PCR); virus from both specimens genotyped as vOka. VZV seroconversion was confirmed, and CSF tested negative for VZV IgG. The patient was human immunodeficiency virus (HIV) negative with normal numbers and percentages of T- and B-cell subsets. He was treated for 7 days with intravenous (IV) acyclovir. Pain resolved, and no new lesions developed after 3 days of treatment; headache, photophobia, and meningismus resolved after 5 days; neurologic examination was normal at discharge. Malaise resolved 2 weeks later. The authors considered meningitis to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).  Upon internal review, meningitis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same literature.; Sender's Comments:  US-009507513-1912USA005082:
Approximately at 3:40 pm, Pt returned with mom 20 min after hep A vaccine was administered, Dr. was alerted, as per parent once they reached the corner patient stated he felt like he was fainting but never really passed out she managed to bring him back walking to the clinic.  His vitals were at time of arrival BP: 74/48,  Bpm, 65, Blood sugar, 107mg/dl pt was alert x 3 and oriented x 3 .  Pt was discharged at 4:30.  At time of discharge vitals were stable, BP: 100/62, BPM:82  and was in no apparent distress. Pt was a discharged by Dr. No emergency room intervention needed.
Fever for two weeks, muscle pain, Hyperthyroidism, Grave disease (Thyroid Scan).
Patient was given injection from the presentation of the vaccine with a red cap and light blue label border; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border) in a 15-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Jul-2022, the patient experienced PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border). At the time of the report, PRODUCT USE ISSUE (Patient was given injection from the presentation of the vaccine with a red cap and light blue label border) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient did not experience any symptoms.   No additional doses, concomitant medications, or treatment medications had been administered.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
At 3 am the morning after the injection, I began to endure wave after wave of intense chills, which continued until 6 pm, along with intermittent abdominal cramps, severe headache, nausea, slight fever and body aches so intense it hurt to roll over in bed. I was so ill I did not eat or leave my bed all day ? except to urinate and take more Tylenol. I was leveled. I got out of bed for about an hour, between 8 and 9 pm and just went back to bed to try to sleep through the rest. I still felt like I was hit by a truck the next morning, with occasional chills and fatigue. But I was able to get out of bed and eat a bit. I basically lost two days. I?d do it again to help the planet/humanity beat COVID-19. But I thought you should know.
Client had a 52mm X 42 mm circular red swollen area on left upper arm. client applies warm compresses and uses Motrin.
Pain in place shot shoulder.going to elbow not able to raise arm or move back or rotate.towards left front chest and back of shoulder
fluttering in chest and some slight dizziness; fluttering in chest and some slight dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 08:30 as dose 2, single (Lot number: EN6203) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6196; Location of injection: Arm Left; Vaccine Administration Time: 12:00 AM), administration date: 02Mar2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), CHEST DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "fluttering in chest and some slight dizziness". The events "fluttering in chest and some slight dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient experienced a fluttering in chest and some slight dizziness over the past year or so, which patient had attributed to hunger, dehydration etc. Patient had mentioned this to doctor at yearly physical in october. Patient was to monitor and make a return visit should they become more prevalent.
13 hours after injection, symptoms began. First, sudden onset of intense fever, followed by chills. Body temperature remained volatile for about 2-3 hours, switching between extreme hot and cold in intervals of 15 minutes or so. In addition, within the first 30 minutes of the initial fever, high levels of pain occurred from base of the skull down through neck, shoulders, upper back, and upper left arm (side that received injection). This pain was similar to muscular body aches you would have with a flu infection, but much more intense. Any attempt at movement was excruciating - I could not even move my arm or adjust positions without crying outloud or whimpering. Around 14 hours post-injection, a different kind of pain appeared: this seemed like a nerve problem of sorts. There was a sensation of pins and needles throughout my entire body, not just concentrated near the injection site. It was somewhat like the sensation we have when a limb "falls asleep" and produces tingling pain, but again, the intensity of the sensation was notable. The pins-and-needles, full-body nerve pain lasted for about 2 or 3 hours. The muscular pain that was concentrated around my neck, shoulders, and injection site lasted for about 5 hours, after which the arm that had received the injection was still very stiff and sore for the next day. However, the soreness in neck, shoulders, and upper back subsided after about 5 hours. The fever and chill cycles began to slow down after about 3 hours and stabilized within about 6 hours. I didn't attempt to treat any of the side effects, partly because I was immoblized by pain and fatigue, and partly because I wasn't sure if there were more effects to follow. The reaction began about 13 hours after receiving the vaccine, and with the exception of soreness at injection site, the symptoms resolved by about 18 hours post-injection.
Respiratory arrest immediately following 4th immunization (Prevnar). Rescue breathing; hospitalized in PICU overnight. The hospital record states breath holding.
Gave patient flu shot on right arm. Patient bleed and then the area swell up. A ball swelling seemed to go down a bit. Swelling still there but pt have no other symptom.
YF-VAX was mixed with sterile water instead of saline or sodium chloride with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00736147) and transmitted to Sanofi on 23-Aug-2021.  This case involved an unknown (age and gender) patient administration of the YELLOW FEVER VACCINE [YF-VAX] was mixed with sterile water instead of saline or sodium chloride (product preparation issue)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE was mixed with sterile water instead of saline or sodium chloride (product preparation issue) (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was reported,"A call back is needed for assistance. This case was placed in proxy as there was no MIS (management information systems) available during the time of the attempted transfer. The caller would like to know if the vaccine is valid or must the patient be revaccinated. A Nurse reporting that the incorrect diluent was used during the administration of the Yf-Vax, on last week. There is no more Patient Information, Event Information, and Administering physician information due to the nurse not being in the office".  This case was an actual medication error due to wrong solution used in drug reconstitution (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on the batch number for this case.
Golf-sized swelling (lump) on left elbow; fatigue; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Golf-sized swelling (lump) on left elbow), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history was not reported.  Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included RISPERIDONE and DULOXETINE for an unknown indication.    On 02-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 JOINT SWELLING (Golf-sized swelling (lump) on left elbow), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (joint pain). The patient was treated with IBUPROFEN (ADVIL MIGRAINE) at a dose of UNK dosage form (2 pills). At the time of the report, JOINT SWELLING (Golf-sized swelling (lump) on left elbow), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medications. The patient self-medicated with Advil migraine (2 pills) and made the symptoms worse due to too much chemicals. The patient was scheduled for second dose on 30-Mar-2021. It was reported that everything was fine.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-MAY-2021 in which event outcome updated On 13-Jul-2021: Non-Significant Follow Up Appended
This spontaneous report was received from a nurse practitioner referring to a 61 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions / allergies and concomitant medications were unknown. On 09-FEB-2017, the patient was vaccinated with a dose VARIVAX (Lot # M019641, expiration date 20-APR-2018, dose and strength were unknown for prophylaxis), instead of ZOSTAVAX. On the same day, PNEUMOVAX23 (Lot #M026317, expiration date 11-JAN-2018) was also administered. The nurse practitioner confirmed this event was a result of human error. No adverse effects were reported. No further  details were reported. Additional information has been requested.
flu-like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant and treatment medications were reported.     Reporter did not allow further contact
Getting up from chair, leaving the office, fainted, momentarily. Lost balance & fell in the floor. Follow up exam was ok except for 2.5 cm superficial laceration, on rt side maxillary over the face. It only required bandaid, locally.
Information has been received from a consumer concerning 12 year old daughter with allergies and no drug allergies who on 20-JUL-2009 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included allergy medication (caller did not specify which medication). The caller stated daughter missed the second and third doses of GARDASIL. On 23-JAN-2010 the patient experienced inflammation in the vaginal area (daughter was not sexually active). The patient did not seek medical attention. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Injection site pain. General feeling unwell. Low grade fever. Tiredness. Headache. Symptoms ongoing. Planned treatment: rest and fluid replenishment.