chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 31-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "moderate to severe symptoms 09May2022 and Covid Ag test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: Home Ag; Covid Ag test positive. It was unknown if therapeutic measures were taken as a result of Vaccination Failure, Covid-19. Additional information: facility type vaccine: Workplace clinic, If other vaccine in four weeks: Unknown, If treatment AE: Unknown, If Covid prior vaccination: Unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Case number PHEH2015US020290, is an initial spontaneous report from a nurse received on 08 Oct 2015. This report refers to a 59 years old male patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range at 47F before administration. No adverse event was reported.
brain fog  vision problems, extreme exhaustion    weight gain    all scar tissue from surgerys is swollen and painful  blown up and very visible,  ( face is distorted) tingling in hands and feet
1st and 2nd dose in 2018, never received the 3rd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (on 23rd April 2018 received 1st dose, batch number Z75Y2) and Twinrix (on 23rd May 2018 received 2nd dose, batch number LG325).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The medical assistant called to inquire and wanted to know do we need to start the vaccine series all over again or any guidance on administering the third dose. The reporter reported that patient received the first dose and the second dose of Twinrix and never received the 3rd dose.  The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.
Per mom the child had fever, congestion, hoarseness, and kept on coughing, slight trouble in swallowing but no trouble breathing. Mom gave medicine from another country which included an antihistamine.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 9:15AM. Patient has not reported to Clinic with symptoms at this time.
No additional adverse event; patient was inadvertently administered a dose of VAQTA that had been improperly stored; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 17-APR-2020, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S032056, expiration date of 09-NOV-2020; dose and route of administration were not reported) that had been improperly stored. The temperature of excursion was 47.7 Fahrenheit degrees and the time frame was 12 minutes. The vaccine underwent previous temperature excursion with the temperature of 58.3 Fahrenheit degrees for 14 hours. The call was because of a data logger. No additional adverse events were reported.
I had a sore arm for a day or two after the vaccination. On 05/18/2022, I began not feeling well with a stuffy nose, headache, body aches and congestion. On 05/20/2022, I went to an urgent care center and was tested for COVID-19, and it was positive. I took acetaminophen and cough syrup to help with my symptoms. As of today, I have COVID-19 brain fog, my diabetes is harder to control, and I have anxiety and depression.
BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned an elderly  male of unknown ethnicity. 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: 043A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  The patient stated that after vaccination he had quite few blood clots in both legs and he had tests (unspecified test) done and was diagnosed by the hospital. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in both legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211240250-Covid-19 vaccine ad26.cov2.s-Blood clots in both legs . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
flu; Initial information was received on 16-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient did not had the flu since stopped having it injected into the body each year.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Pt received TD on 8-15-14 on R deltoid, returned to clinic on 8-19-14 with induration on R deltoid approx 6 inches . Seen by medical provider. No fever, no redness - pt advised to F/U if S/S becomes worse.
sinuses have cleared up; Temperature has returned to normal; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinuses have cleared up) and BODY TEMPERATURE INCREASED (Temperature has returned to normal) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinuses have cleared up) and BODY TEMPERATURE INCREASED (Temperature has returned to normal). At the time of the report, SINUSITIS (sinuses have cleared up) and BODY TEMPERATURE INCREASED (Temperature has returned to normal) outcome was unknown. Probable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Hives began appearing on my arms, legs, torso. This is the 2nd time I have broken out in hives after a vaccination. The first time was Nov 4, 2011. I had them until March 2012. I though they cld have been brought on by vaccine. Dr couldn't prove or discount.
rash on the back of both arms without itchiness; swelling of lip; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; I also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours; fever of 100.5 that lasted for about 24 hours; This is a spontaneous report from a contactable other HCP (patient). A 21-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: EL3249) as 2nd dose, single for covid-19 immunization. Medical history included chronic migraines and seasonal allergy experience reactions to certain things such as changes in laundry detergent, lotions. The patient's concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ELY9231, expiration date unknown), via an unspecified route of administration administered in Arm Left on 05Jan2021 as 1 st single dose for covid-19 immunization and experienced swelling of my lip one hour after the vaccination, no other symptoms and it went down with Benadryl and Later that night noticed a rash on the back of both arms without itchiness or raised bumps. On 11Jan2021, patient underwent lab tests which included Nasal Swab, Covid test with negative result. There was no other vaccine within four weeks and no other medications within two weeks. The patient had Covid prior to vaccination and did not test for Covid post vaccination. On 26Jan2021, after second vaccination the patient experienced swelling of lip that went down with Benadryl and the same rash. In addition, about 10 hours after the vaccine, had a fever of 100.5 that lasted for about 24 hours and also experience extreme fatigue, headache, body aches and chills that lasted for about 24 hours. The outcome of all the event recovered in 2021.  No follow-up attempts are possible. No further information is expected.
In early July, the pt experienced a burning sensation at the bottom of both feet. He had to take his socks off quite frequently to cool his feet. In early August both heels started hurting and he started to use heel pads in his shoes. In late August his legs started hurting and he began to get shaky. In October, the pain spread to his hands. In December, 1999, in addition to having a burning sensation at the bottom of his feet, pain in his toes, heels, legs, and other joints, and fingers, he felt a slight burning sensation around his waist and in his arms.  The pt stated that before July, 1999, he used to jog, now he has a problem walking and standing on his feet for more than a few minutes.  An MD reported that the pts symptoms of burning of feet and chest and pain in left middle finger, pain in left ankle and both heels began one month after receiving the vaccine Lymerix. The pt was treated with Naprosyn and Zyrtec.  The most recent information received on 12/21/1999 reported the condition of the patient as ongoing. This report (formerly manufacturer's control number 1999033325-1), described the occurrence of joint pain in a 51 year old male patient who recevied Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. It was initially reported by a physician, with follow-up from a neurologist, and from the consumer himself. Subsequently, a legal complaint was received from an attorney. There were no known allergies. The patient has hay fever and is allergic to pollen. The patient takes Proscar for benign prostatic hypertrophy. The vaccinee received his first and second doses of Lymerix on 26-May-99, and 23-Jun-99 (deltoid), for prophylaxis of Lyme disease, respectively. In early July, the patient experienced a burning sensation at the bottom of both feet. He had to take his socks off quite frequently to cool his feet. In early August both heels started hurting and he started to use heel pads in his shoes. In late August his legs started hurting and he began to get shaky. In October, the pain spread to his hands. In December 1999, in addition to having a burning sensation at the bottom of his feet, pain in his toes, heels, legs, other joints and fingers, he felt a slight burning sensation around his waist and in his arms. The patient stated that before July 1999, he used to jog. Now he has a problem walking and standing on his feet for more than a few minutes. Physician reported that the patient's symptoms of burning of feet and chest, pain in left middle finger, pain in left ankle and both heels began one month after receiving dose 2 of Lymerix. The patient was treated with Naprosyn, Zyrtec, and cortisone injection. Neurologist report on 02-Mar-00, that the patient's burning sensation eventually progressed to his calves and then the front of his chest. He is fatigued and is generaly weak, especially his legs. Neurological exam was normal. The most recent information, received on 02-Mar-00, reported the condition of the vaccinee as improving. On 15 September 2004, an attorney alleged that the patient, now 56 years old, experienced "severe peripheral neuropathy." Time to onset, treatment, and outcome were not reported.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil. It was reported that the patient developed an upper respiratory tract infection. At this reporting time the patient's outcome is unknown. No further information is available.
Persistent vomiting, listlessness one hour post vaccines x 12 hours. Seen in ED, given ZOFRAN. Resolved.
Information has been received from a health professional concerning a 7 year old female with a history of varicella exposure at school who on 3/22/01 was vaccinated with varicella virus vaccine live. There was no illness at the time of vaccination. On 3/26/01, the pt developed a generalized rash. It was noted that the pt's sibling (WAES01033356) and the pt's mother (WAES01061148) broke out with chicken pox after being exposed to the child. Additional information has been requested.
Within 3 hours started feeling nautilus and light headed, then was violently puking and liquid diarrhea then dry heaving to the point of being incontinent while trying to catch my breathe between episodes could not keep water or bread down for the following 20 hrs when the puking and diarrhea slowed down. Now have aches in my shoulders arms and leg joints, a migraine that is going on for 3 days now, and wooshing ringing in my right ear is very audible
Painful area from Injection Site to Elbow; Itching Injection Site Red Spot; Red Spot Spread From Injection Site to the elbow; Swollen area from Injection Site to Elbow; Red spot (Rash) under the Injection Site; Diarrhea; Fatigue; Pain in the Left Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), FATIGUE (Fatigue) and VACCINATION SITE PRURITUS (Itching Injection Site Red Spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the Left Arm Injection Site). On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Painful area from Injection Site to Elbow), VACCINATION SITE PAIN (Pain in the Left Arm Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site Red Spot), RASH (Red Spot Spread From Injection Site to the elbow) and VACCINATION SITE SWELLING (Swollen area from Injection Site to Elbow) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE RASH (Red spot (Rash) under the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Donor states she had nausea, stomach pain, shortness of breath, weakness, dizziness. All symptoms lasted approx 10 min. No treatment.
Per pt, red, swollen, hard lump x 3-4 days. Hot to touch.
HA, chills, fever, N/V/D, congestion within 24 hours of vaccination
face being really red with intense pruritis on the side of her face; rash; temperature 99.4-102.5F/had a 101.5F temperature; could not get out of bed; headache; Flushing; waves of malaise; A spontaneous report was received from physician concerning a 68 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed.  No medical history was reported.  No concomitant medication was reported.  On 30-Dec-2020, prior to the onset of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route in lefty arm for prophylaxis of COVID-19 infection.  On 30-Dec-2020, the patient experienced flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and on an unknown date experienced could not get out of bed.  Laboratory details were not provided.  Treatment medication included Benadryl at a dose of 50 milligram at an unknown frequency via an unknown route and Tylenol at an unknown dose and frequency via an unknown route.  Action taken with mRNA-1273 in response to the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The outcome of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed was not provided.  The reporter did not provide the assessment of the events flushing, waves of malaise, face being really red with intense pruritis on the side of her face, rash, temperature 99.4-102.5F/had a 101.5F temperature, killer headache and could not get out of bed to study drug.; 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.
Patient presents for left breast discomfort. Patient reports that she had her COVID vaccine 01/27/21, 4 days after she developed a swollen lymph node in her left axilla, patient reports this was tender, but resolved without treatment or evaluation after 2 days. Following resolution of the lymphadenopathy patient reports having superficial pain from the axilla around anteriorly to the left breast. Patient denies deep pain, any palpable masses, changes in skin integrity or rashes. No nipple discharge noted. Patient reports the pain is made worse with light touch over the area including clothing rubbing on her skin. She denies chest pain, SOB, DOE, weakness in the upper extremities, denies Hx of shingles, neurovascular compromise, DM, Vitamin D deficiency.
her eye got more and more inflame through the day; her eye lid is swollen; her eye is red and painful; her eye is red and painful; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful), EYE PAIN (her eye is red and painful) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced VOMITING (throwing up). On an unknown date, the patient experienced EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful) and EYE PAIN (her eye is red and painful). At the time of the report, EYE INFLAMMATION (her eye got more and more inflame through the day), SWELLING OF EYELID (her eye lid is swollen), OCULAR HYPERAEMIA (her eye is red and painful), EYE PAIN (her eye is red and painful) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
vaccine reaction with swollen and redness on (L) thigh. MOTRIN were given to take evry 6 hrs for pain and swollen and cold compressions. ( (L) 4 1/2 x 3 1/4 cm)
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with Diabetes and none drug reactions. On 17-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J000444, 0.65 ml, subcutaneously) in the left arm. On 20-SEP-2013 the patient experienced redness, soreness, a lump the size and shape of an egg at her left arm injection site. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.