chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     Patient had no allergy or no diseases. Patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza, Dtap-ipv and MMRV vaccine. Past adverse reactions to the above products included No adverse event with Influenza, Dtap-ipv and MMRV vaccine.   On 19-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medication details was reported. No treatment medication details was reported.
Six days post-vaccination on 6/18, client experienced numbness and tingling in lips, nose and lower extremities and a knot in back of throat.  Went to ED.  BP was 220/180.  Blood work was done and client was referred to cardiologist and neurologist.  Cardiology visit 6/22
This spontaneous report has been received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 15-JUN-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031568, expiration date 24-DEC-2017 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot # reported as L029075, expiration date 28-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 30 minutes. Digital data logger was involved. There were no previous excursions reported. Additional information has been requested.
Information has been received from a physician concerning a 14 year old female who on 02-Nov-2007 was vaccinated IM in right deltoid with a 0.5 ml of first dose of Gardasil (lot #1266U).  There was no concomitant medication.  On 02-Nov-2007 the patient experienced urticaria on her chin and cheeks.  Unknown medical attention was sought.  The patient's urticaria on her chin and cheeks persisted.  No product quality complaint was involved.  Additional information has been requested.
DISCOMFORT; SINUS HEADACHE; INJECTION SITE PAIN AND SORE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, asthma, and sarcoidosis, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site pain and sore. On 11-APR-2021, the subject experienced sinus headache. On an unspecified date, the subject experienced discomfort. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain and sore, and sinus headache, and the outcome of discomfort was not reported. This report was non-serious.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (left arm is stiff), PERIPHERAL SWELLING (left hand is swollen), PAIN IN EXTREMITY (Both arms were hurting), MYALGIA (both arms were hurting and in one of the visits was told this was just myalgia) and VACCINATION SITE PAIN (pain at the in jection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), MEMANTINE and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Both arms were hurting) and MYALGIA (both arms were hurting and in one of the visits was told this was just myalgia). On 08-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (left arm is stiff), PERIPHERAL SWELLING (left hand is swollen) and VACCINATION SITE PAIN (pain at the in jection site). The patient was treated with IBUPROFEN at a dose of UNK dosage form; MORPHINE for Pain, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form and TRAMADOL at a dose of UNK dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (left arm is stiff), PERIPHERAL SWELLING (left hand is swollen), PAIN IN EXTREMITY (Both arms were hurting), MYALGIA (both arms were hurting and in one of the visits was told this was just myalgia) and VACCINATION SITE PAIN (pain at the in jection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was noted by the reporter that the patient had visited the emergency room on three separate occasions for the aforementioned events.  With regards to treatment, it was reported that ibuprofen and morphine were the only treatments that helped from when the patient went to the emergency room.
queasiness in stomach; vertigo; Dose Number 5; Dose Number 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:15 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; FOLBIC. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER), SINGLE; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER), SINGLE; manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 15Sep2022 at 14:15, outcome "unknown" and all described as "Dose Number 5"; NAUSEA (non-serious) with onset 17Sep2022 at 03:30, outcome "recovering", described as "queasiness in stomach"; VERTIGO (non-serious) with onset 17Sep2022 at 03:30, outcome "recovering". Therapeutic measures were not taken as a result of nausea, vertigo. Additional information: After 36 hours woke up to use bathroom had severe vertigo on left side used furniture and walls for support to get into bathroom. Sat on toilet for about 5 minutes felt queasiness in stomach. Went back to bed used support but severe vertigo had subsided. Slept additional 3 hours vertigo had passed but still felt queasiness.
pt recv vax 1NOV96 & 7APR97 pt devel varicella;
Initial misuse report received from a healthcare professional on 23 September 2013. The cases were received on 21 March 2014 at agency. An expired PENTACEL was administered (exp. date 17 September 2013) on unspecified date. It was an expired vaccine used. No adverse event was reported. List of documents held by sender: none.
Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, asthma, common variable immunodeficiency (CVID), penicillin allergy and peanut allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient had received other vaccines within four weeks prior to the vaccination which included a PFIZER vaccine (unspecified) via an unspecified route of administration in the right arm on 02Apr2021 (at the age of 51-years-old) for unknown indication. On 26Apr2021 at 19:00, the patient experienced vomiting and chills. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with promethazine (PHENERGAN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting and chills was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
slight fever (99.3 F); chills and other stuff; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever (99.3 F)) and CHILLS (chills and other stuff) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (two years ago). Concomitant products included ENTRECTINIB (ROZLYTREK) for Lung cancer, APIXABAN (ELIQUIS) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (slight fever (99.3 F)) and CHILLS (chills and other stuff). At the time of the report, PYREXIA (slight fever (99.3 F)) and CHILLS (chills and other stuff) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.3 (High) increased 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Non drug treatment included radiation therapy and chemotherapy Patient was Eliquis as a use of blood thinner. Patient height was given as 5'11"
rash, soreness and swelling on left arm fever general flu symptoms for about 12 hours
My wife had a temperature of 102 and has since gone down a little bit to 101.
The first Hep B shot 5/6/11 - by 5/9/11 achy, tired, swollen throat - 5/20 I had a hard time walking around. Very tired joints hurt - 5/23 I went to the hospital - spent the night. Weakness over entire body, joints hurt. I told the doctor about the shot - with no acknowledgement. I was sent home. Still no better. Very weak, pale, exhausted all the time, headaches.
Patient received two doses of Sinovac, his last dose being on 9/23/2021.   Patient received Pfizer as a booster on 1/11/22.  The booster was suppose to be given 5 months after last dose.   Patient did not  experience any adverse reactions after receiving the vaccine.
This spontaneous report as received from a registered nurse via company representative refers to a 8 year old male patient. On an unknown dates, the patient was vaccinated with a series of RECOMBIVAX HB (thimerosal content: unspecified) (dose, frequency and route of administration: not reported) (lot #, exp date: unknown). On approximately 30-JUN-2014, the patient was negative for Hepatitis B titers. The reporter stated that an unspecified renal physician was evaluating the patient for a kidney transplant. It was not reported whether the kidney condition was congenital or it developed since the patient received RECOMBIVAX HB. The outcome of Hepatitis B titers negative and kidney condition was not reported. Relatedness between Hepatitis B titers negative and kidney condition and RECOMBIVAX HB was not specified. Upon internal review, kidney condition requiring evaluation for kidney transplant was considered to be medically significant. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In April 2016, a  healthcare provider at a family practice administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a physician at the family practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
pt had just received vaccine and found by ems crew with father at check out station.  pt was seated with head in hands with complaints of light headedness and dizziness. pt was pale. pt was brough to evaluation area. pt suffered brief vomiting event. initial vitals were bp 85/50 hr 69 spo2 100% ra rr 18. pt was believed to ave been suffering from vaso vagal event.pt apperaed to recover quickly. pt second vital set were 90/60 hr 69 spo2 100%RA RR 18. pt skin color returned to a pink color. pt began to "feel much better" pts father gave consent to all evaluation and treatment. pt was believed to be stable. pt care was released. pt father was informed to contact emergency services if any symptoms returned and/or worsened.
Fever, sore throat, cough, muscle aches, chest pain so severe I could not sleep the first night. I still have chest pain today.
Alopecia developed 3 weeks after injection. -initial immune response was very strong (102 temp for days, etc) At the beginning of week 3 a developed a strong headache. By the end of week three two patches of hair started falling out. One the size of a nickel, the other of a quarter. The patches grew to one being the size of a 50 cent piece and the other half the size of my palm. -treatment has been with steroid injection and acupuncture. At this point tiny baby hairs are growing in, but I still have two large patches of baldness.
Client presented at vaccination site on 01/19/22. The client reported she received her Janssen COVID vaccine on 06/01/21 (Lot #: 1808980). Client reported after 15 minutes observation and leaving the vaccine site, she had sore arm on the injection side lasted for two to three hours. Client reported after 30 minutes after the Janssen vaccine at home, she had shortness of breath which lasted two to three hours and went away on its own. At nighttime on 06.01.21, she reported she had headache and fever which woke her up and she took one aspirin pill and both the headache and fever lasted only three hours. Client reported she has history of childhood asthma and bronchitis. Client told she didn?t follow-up with her PCP. Client said she has no chronic illnesses or taking any medications, nor any known allergy. Client is requesting the booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#: FL3209 on 01/19/22 at 1618 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1648 unassisted and with a steady gait.
Swelling, - cellulitis at site with edema, erythema and violaceous hive, positive warm to palpation. Pt placed on Augmentin ES.
Joint pain in her knees, wrists, and fingers/knees are hurting me, my fingers are hurting me; Muscle ache; Could hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose:1, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:2, unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose:3 (booster), unknown manufacture), for COVID-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset Jan2023, outcome "unknown", described as "Could hardly walk"; ARTHRALGIA (non-serious) with onset Jan2023, outcome "unknown", described as "Joint pain in her knees, wrists, and fingers/knees are hurting me, my fingers are hurting me"; MYALGIA (non-serious) with onset Jan2023, outcome "unknown", described as "Muscle ache". Therapeutic measures were not taken as a result of arthralgia, myalgia, gait disturbance.  Additional information: The patient had no other conditions. The patient had not other products. The patient had second booster and her 4th shot. The patient said G, looked like GJ6742, not sure as Lot number. The patient stated that she got the booster on 07Jan and has had joint pain in her knees, wrists, and fingers for the past 3 days. It was hard for her to walk because her knees are so bad. For the last 2 days or 3 days, the patient have muscle ache that she could hardly walk. Her knees are hurting her, her fingers are hurting her. The patient queried if she should go to a doctor. The patient had not underwent any investigation. Treatment: patient stated, "No, she was going to the doctor's today." Prior vaccinations (within 4 weeks): Consumer stated, "No."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up sick - had fever, chills, body aches for two days, headache and fatigue for the entire week, swollen lymph nodes around day 3 and still swollen but getting better
MILD COLD LIKE SYMPTOMS, FATIGUE, CONGESTION/RUNNY NOSE Narrative:  Other Relevant History:
Patient received TDAP vaccine in left medial deltoid (into the muscle after palpation). Next day, patient reported soreness at site. Told ice and APAP. Pain still 30d after vaccine administration.
Uncontrollable shaking, teeth chattering, seizuring, debilitating headache just several hours after receiving DTaP and flu shot.
Fever, sore arm at injection site, overall body aches, mild nausea.  The symptoms came on suddenly at 5:00pm.  Fever lasted until 3am.  Body aches remained thru evening after injection.  Symptoms were completely gone after 36 hours.
Febrile seizure, fever 102.6 (R) 15-20 minute seizure, before postictal period had normal exam in ER No h/o febrile seizure in past
Hives around inject site & face immediately following DT booster rt arm; Also wheezing; no fever or hypotension;
BLOOD CLOT IN THE ARM; SEVERE REACTION; This spontaneous potential legal report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction and blood clot in the arm, and was hospitalized (date unspecified) for a while. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the arm and severe reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211145419- covid-19 vaccine ad26.cov2.s  blood clot in arm and  severe reaction. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received vaccine 04/08/2021.  Was admitted to the hospital later in the day  with cardiac arrest.  Deceased 4/9/2021
Side effects have been mild or nonexistent, Unlike the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Side effects have been mild or nonexistent, Unlike the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported that patient had Pfizer vaccine and boosters and patient did not trust products developed by J and J. CEP name was reported as Comirnaty Consumer Ad Testing.
Severe muscle ache, back pain ,  fatigue, chest pain, leg pain started after receive  first dose, the pain stop. The same thing happen after the second dose and it  continue.  My symptoms are so severe that I am disable ,  struggling to do normal daily tasks, and I am unable to work.