chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in the ears - "It's like when you are outside, and crickets are chirping"; lethargic; fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever). At the time of the report, TINNITUS (ringing in the ears - "It's like when you are outside, and crickets are chirping"), LETHARGY (lethargic) and PYREXIA (fever) outcome was unknown.             Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
I had a pt who got his 2nd Covid vaccine 7days earlier than the expected date by an error because he did not have his vaccination card with him. He got his first shot on 09/03/21 and the 2nd one on 09/17/21
Mom called. Left leg swollen thigh to knee. Warm to touch, painful to walk on it. Warm and cool compresses, Tylenol and ibuprofen as needed. Swelling better on 1/7/16 and pain resolved.
Headaches daily on an off, specifically left eye, for approximately 10 days starting on 1 day of vaccine Diarrhea approximately 14 days starting on day 1  Dizziness on and off for approximately10 days starting on day 1 Rheumatoid arthritis flare up, left shoulder 2 days, unable to move shoulder, day 7 & 8 after vaccine Small rash on left chin starting day 10 after vaccine Was seen by my primary care physician on day 11.   Was advised to restart my hyrdroxychoroquin medication 200mg 2x's daily for rheumatoid arthritis ( I had not been taking this for several months) Was given Medrol dose pack which was started on day 15 after vaccine All symptoms subsided after finishing Medrol pack.   I continue to stay on the Hydroxychloroquin 200mg 2X's daily for rheumatoid arthritis I was advised by my physician not to receive the 2nd dose Was advised to get J&J vaccine when available (I find this questionable)
Information has been received from a nurse referring to a 26 year old female patient. Information regarding concurrent conditions and medical history was not provided. On 04-MAY-2015 the patient was vaccinated with her third dose of GARDASIL, 0.5 ml, intramuscularly (lot # and application site were not reported). Concomitant therapy was not reported. Nurse reported patient had received the second dose of GARDASIL, in late August 2014. No adverse effect was reported. Additional information has been requested.
Gradual onset of headache, pressure, dizziness, visual disturbances, nausea, indigestion which have become constant and still exist. Visited the E.R. at the hospital on December 31, 2022. Was treated with Benadryl, Ativan, Toradol to break headache.  Sent home. Symptoms still persist.   Visited neurologist January 6, 2023.
Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.) outcome was unknown.            No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-577298, MOD-2022-577824 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time were 72, 47, and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second time were 16, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
chills; slight temperature; body aches; headache; dizziness; extreme fatigue; no appetite; very sleepy; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 08Feb2021 13:30 (at the age of 71-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. No chronic health conditions were reported for patient. Concomitant medications included daily calcium and vitamin pill. The patient previously took ciprofloxacin and experienced drug hypersensitivity, historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration, administered in Arm Left on on 18Jan2021 at 02:00 pm (at the age of 71-year-old) as single dose for COVID-19 immunization. On 08Feb2021 at 11:45Pm, the patient reported that he had these symptoms for the 2 days following vaccine included chills, slight temperature, body aches, headache, dizziness, extreme fatigue, no appetite and was very sleepy. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior or post to the vaccination. Patient did not receive any treatment for the events. Events were considered non-serious as reported. Patient was recovered with sequelae form all the events.  Information regarding Batch/ Lot number have been requested
I woke up around 6am (approximately 12 hours after the vaccination) and was walking to the bathroom when I collapsed on the floor and had a seizure. My fiancé sat with me and i have no recollection of the event. When I regained consciousness, i had a severe headache, blurry vision, and could not speak for about 20 minutes. These symptoms resolved over the next hour. No further symptoms after this episode. I have no history of seizures. My first two doses of moderna did not cause this reaction.
HIP PAIN; ANKLE PAIN; INJECTION SITE PAIN; NAUSEA; VOMITING; DIARRHEA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has had asthma as a child, and concurrent conditions included alphagal allergy, food allergy, alcoholic, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAR-2021 17:55 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced hip pain. On 21-MAR-2021, the subject experienced ankle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, diarrhea, hip pain, ankle pain, injection site pain, and nausea on 22-MAR-2021. This report was non-serious.
A WEEK OR SO AFTER GETTING THE J&J VACCINE I STARTED EXPIERENCING ISSUES WITH SMELL AND TASTE.  I NOTICED THIS FIRST WITH DRINKING MT DEW. IT TASTED RANCID AND METALLIC LIKE.  THEN AT DINNER EATING FOOD IT HAD A AWFUL METALLIC TASTE AND SMELL.  THIS IS STILL PRESISTING TO HAPPEN AS OF TODAY.
got a a little bit sick every time; sinus infections; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had got a a little bit sick every time and sinus infections while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 not reported via unknown route in unknown administration site.  On an unknown date the patient  got a a little bit sick every time (illness)and sinus infections (sinusitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (got a a little bit sick every time, sinus infections).  At time of reporting, the outcome was Unknown for the event got a a little bit sick every time and was Unknown for the event sinus infections.
Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of GARDASIL (lot # was not provided, dose of series was unknown.  Before getting vaccine the patient took a HPV test with negative results.  After getting vaccine, the patient got a HPV test with positive result.  At the time of this report, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient was given influenza vaccine to early. At age 2 months. Patient has had no adverse event.
Vomiting, Fever and chills upon waking at 12:30 am and swelling of face, lips and tongue upon waking at approximately 9:00 am on 10/18/11.
Around 24 hrs after getting vaccine I started to get dizzy when moving around.  The dizziness and Nausea has continued for now 9hrs since started.
6/2/04 Immunizations 10AM- Mom called at 2:50PM stated child screaming since shots. Instructed to go to ER. 6/3/04 mother stated she put child in car to go to ER child stopped crying fell asleep. Fine since, did not go to ER.
Vomiting, diarrhea. Multiple times on 5/5. Nausea all day
Pt.'s health "tanked" over a short period of time after being vaccinated.  A lifelong athlete, pt. completed a (15) mile charity swim in summer of 2021.  So, a vigorous individual's health crashed very fast.  In Feb 2022, she called off her wedding a few weeks before it was scheduled to take place.  Several weeks later, I received a call from her daughter that she died.  Pt. was a Lupus patient and 25% of persons with an autoimmune disorder that are vaccinated for Covid experience exasperation of their disease.  This is beyond a shadow of a doubt what happened to pt., but she was not warned that the vaccine may exasperate her Lupus.
no adverse event; Administered first dose 0n 15th apr and second dose on 23rd may; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may) and NO ADVERSE EVENT (no adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 005C21A) for COVID-19 prophylaxis.     The patient's past medical history included Vertigo.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Patient weight was reported as 150. Concomitant medication was not reported. No acute illnesses at the time of vaccination and up to one month before. Treatment drug was not reported.   This case was linked to MOD-2022-646794, MOD-2022-646300 (Patient Link).
Post vax, father returned to clinic with child at 16:00. Child had welts to trunk. No respiratory distress noted. No swelling to neck or tongue noted. Client and father were sent next door to ER. Father was instructed to immediately, show nurse the reaction and inform nurse of IZ's given. Father took child to ER, where they were treated and released at 18:30.
Fever; Hypotensive 1-2 hr Gatorade; Motrin; Tylenol
On 9-20-16 pt began having pustules erupt on arms and face that itch. Pt had received VARIVAX vaccine 9-16-16. Pt returned to office on 9-26-16 and symptoms reported to Dr. No treatment. Pt instructed to avoid work until 10-10-16.
Had a fever that would "come and go" left work due to the fever spent the day on the couch.  Certain smells are terrible, some foods very off putting, unable to eat normal amounts of food without feeling like I am going to be sick.  Forgot to eat for 7 hours yesterday (NEVER in my history do I forget to eat).  I feel okay now but my stomach is not feeling normal and my eating habits are not normal yet.  So symptoms have been present from Tuesday to today, being Friday...they are improving but I am nervous about getting a second dose if more people generally have more severe responses with the second dose.  I forgot to list it earlier, I am not able to take calcium supplements. Anything over 50 mg of calcium on a regular basis makes me very sick and blood labs will like thst have been switched with someone else's.
Stroke; Encephalitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder NOS (blood clotting disorder from 20 years). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that magnetic resonance imaging (MRI scan) performed months back detected encephalitis, stroke and stated as totally asymptomatic.   The patient reported to be taking Clopidogrel (Plavix) to treat the event.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events,  a causal relationship cannot be excluded.   This case was linked to MOD-2021-101992 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events,  a causal relationship cannot be excluded.
No additional adverse effect reported; Syringe broken; Poor quality device used; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 07-NOV-2019, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# and expiration date were unknown) and on 23-JUL-2020, was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Lot No. S008151, expiration date 20-NOV-2021) both intramuscularly for prophylaxis (strength, dose, route, anatomical site of administration and vaccination schedule were not provided). The reporter stated that, while she was administering the third dose, the syringe finger flange broke, but she was able to administer the full dose. No adverse effects reported.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; operatorofdevice: Registered Nurse; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or about 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider at a clinic for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown and the causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related.
Pt appeared to have a seizure: arms and legs stiffened, hands tensed, and eyes darted back and forth. Lasted 15 sec. Recurred 3 times over subsequent 15 hrs.
Irregular and heavy menstrual bleeding. This has occurred nonstop since 7/21/2021. It is. 11/18/21. All hormones and reproductive system are normal in this otherwise healthy and normal female.
have a headache; unwell; achy; I feel tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, feeling unwell, pain and tiredness. On an unknown date, the outcome of the headache, feeling unwell, pain and tiredness were unknown.   It was unknown if the reporter considered the headache, feeling unwell, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received 2nd dose of Shingrix and had tired, achy, unwell and headache. Patient had enquired to take Tylenol as treatment.
A 4 month old female received her second dose of Prevnar on 01/08/2002. She subsequently developed an injection site reaction characterized by a lump and a brown spot. No further info was available at the date of this report.
Worse depression; Insomnia; Tiredness; A spontaneous report was received from a consumer concerning, a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed worse depression, tiredness, and insomnia.  The patient's medical history included depression. Concomitant product use was not provided by the reporter.   On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011M20A) for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination patient developed worse depression, tiredness, and insomnia.   No laboratory details were provided.  Treatment information for the event was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  On an unknown date, the outcome of the events, worse depression, tiredness, and insomnia, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Patient states that she had a severe malaise following her second dose. She had joints and muscles aching, a fever of 100.8, chills and intense shivering to the point of not being able to talk. She says she's never felt this ill before. She has had slight improvement as of 12 noon the following day after injection.
12 hours after injection patient noted a red, swollen, hot area at site of injection, area grew to the size of her hand at 48 hours, reaction then started to subside. Now - 42 hours after injection, red area is the size of silver dollar. Patient never experienced systemic side effects. Took no treatments.
Pfizer-Biotech Covid-19 Vaccine.   Adverse Effects: Fever (101.1°F), Chills, Body Aches lasting 24 hours