chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site swelling and  bruising , hot to touch and tingling & swelling of tongue. Shortness of breath. Throat closing up
I fainted while on the toilet. Woke up on the bathroom floor with a smashed, bleeding nose. I also bit my tongue, split my lip and banged up my knee and hand. As a result I now have two black eyes.
pt recvd vax & devel upper-respiratory symptoms with cough & congestion; oxygen was continued;
Suspected vaccination failure/ Had both doses; after this had shingles, recently had them for 2nd time; Recently had shingles for the 2nd time on the left side; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had shingles on right side, refer case US2021AMR209401) and shingles (previously had shingles on right side). Previously administered products included Shingles vaccine (received the original shingles shot on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient has had both doses of the Shingles vaccines and recently had Shingles for the second time on the left side and it was a month after the second Covid shot. The patient looked on the internet and found that shingles frequently occurred in the individuals after any of the 3 Covid shots used. It was unknown if the reporter considered the shingles to be related to Covid vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209401:Same reporter.
Booster dose given at less than 6 months after initial series; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Approximately 12 days after receiving my booster I developed spontaneous urticaria and dermatographia. I have never been prone to hives or allergies to this degree, except for cats, and the severity of that ellergy has decreased greatly with age.  There were no outside triggers such as food or laundry detergents that could have prompted the event, and the hives have remained prevalent ever since. There is a group of over 3,000 people on Facebook who have basically the same story and symptoms that are incredibly difficult to get under control. All of us are pro-vaccine but it?s clear that our symptoms are an immune response to the vaccine rather than from external factors. I have been treating the hives with cortisone cream, antihistamines, and staying hydrated, but daily flare ups still occur. The dermatographia makes the skin so sensitive that wearing the wrong clothes or even bedsheets can cause a rash to break out. This has been incredibly disruptive to my work and daily life.
lost parent to Covid; lost parent to Covid; This is a spontaneous report from a non-contactable consumer (daughter) via sales representative. This consumer reported similar events for both parents. This is one of her parents cases. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The daughter recently lost parent to covid and not sure if this was a fresh or the vaccine side effects. The outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101440332 same drug and AE., different patient; Reported Cause(s) of Death: lost parent to Covid; lost parent to Covid
Patient called triage line complaining of headache and dizziness that started in the morning one day (8/3/10) after getting the Flu vaccine. Patient fell on 9/8/10 after complaining of headache and dizziness. Patient went to ER.
positive for covid; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for covid) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 (positive for covid). At the time of the report, COVID-19 (positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported using medications for Diabetes and Hypertension concomitantly. Patient was Asymptomatic for COVID. No treatment medications were reported.
Could barely get out of next bed; Headache; Body aches; Fatigue; Nausea; This non-serious case was reported by a consumer and described the occurrence of headache in a 70-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number M752F) for prophylaxis.   On 07-SEP-2023, the patient received RSV vaccine 1 ml. On 07-SEP-2023, 5 hrs after receiving RSV vaccine, the patient experienced headache (Verbatim: Headache), general body pain (Verbatim: Body aches), fatigue (Verbatim: Fatigue) and nausea (Verbatim: Nausea). On 08-SEP-2023, the patient experienced bedridden (Verbatim: Could barely get out of next bed).  The patient was treated with paracetamol (Tylenol). The outcome of the headache, general body pain, fatigue, nausea and bedridden were resolving.   It was unknown if the reporter considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.     It was unknown if the company considered the headache, general body pain, fatigue, nausea and bedridden to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-SEP-2023 The patient was in good health in general.  The patient had symptoms which came on suddenly 5 hours after receiving the RSV vaccine.  The patient could barely get out of bed the next day.  Now (the recent time) the patient was improving, but took Tylenol.  The patient was hoping the improvement continues.  That was the first time the patient had reacted to a vaccine headache, body aches, fatigue, nausea. The reporter consented to follow up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COTTON MOUTH; TASTE CHANGED SIGNIFICANTLY; This spontaneous report received from a patient via a company representative concerned a 42 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: celiac's disease, and ear infection, and concurrent conditions included: hoshimoto's thyroiditis, pcos (Polycystic ovarian syndrome), gluten allergy, and marijuana allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient was a nurse. the patient was taking other medications/products within 2 weeks of starting covid-19 treatment. The patient previously received with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 24-JUN-2021 at 12:00 on right arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s(Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: unknown) dose was not reported, 1 total, administered on 17-NOV-2021 at 10:00 on left arm for prophylactic vaccination. Age at time of vaccination 42 years old. Concomitant medications included amoxicillin trihydrate/clavulanate potassium, and levothyroxine sodium.  On 13-MAY-2022  patient received non-company suspect drug: 3 doses of Paxlovid over 24 hours (1st morning dose 1st evening dose, 2nd morning dose) for covid19. On 07-MAY-2022, the patient experienced taste changed significantly, suspected covid-19 infection, and cotton mouth (both events in dose number series 2). On an unspecified date, the patient experienced suspected clinical vaccination failure (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from taste changed significantly, suspected covid-19 infection, and cotton mouth, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000232585.; Sender's Comments: V0: 20220545163- covid-19 vaccine ad26. cov2. s- suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
The day after treatment patient developed a nodule under left nostril, which persisted for 3-4 weeks prior to "moving down" onto lip and ulcerating. Ulcer has persisted for two months.
At approximately 11 am, pt. received several vaccines: Polio booster, typhoid (inactivated), influenza (thimerasol-free), Ixiaro (Japanese Encephalitis - inactived) and Yellow Fever (live vaccine). Almost immediately after giving the YF vaccine, he became unconscious and began having a tonic-clonic seizure. Client was not breathing. RN performed a jaw thrust and was able to do rescue breathing for approximately 4-5 breaths until client started spontaneous respirations. Seizure activity (which had waned slightly) intensified. He was moved from the chair to the floor in a sliding motion, but sat up and started thrashing and flailing. He rolled under the table and, and this time, or prior to being lowered to the floor, hit his head on the consult table. An approximately 1 inch laceration was sustained to the upper L forehead - minimal bleeding. Seizure activity lasted approximately 1-1.5 minutes. During this time, administrative staff was calling 911 and getting assistance to the facility. When client regained consciousness, he was alert and oriented x3. Kept him on the floor until EMS personnel arrived. Called father to notify him of situation. Per EMS VS his BP was 142/78 and HR was 64. He was able to walk to EMS stretcher. After departure, father was called with event and transport details. Father contacted; we were unable to get in contact with client's mother at the time of the event. It is most likely that this event occurred as a reaction to the Yellow Fever vaccine. Client was discharged home from hospital.
This spontaneous report as received from a pharmacist via company representative refers to a 47 year old patient of unknown gender. No information on patient's pertinent medical history or drug reactions/allergies was reported. On an unknown date, the patient was vaccinated with dose of ZOSTAVAX (dose, route, lot # and expiry date were not provided). Concomitant medications were not reported. No known adverse effects were reported. Additional information has been requested.
a headache that was so bad, I thought I was going to pass out; Joint pain; Muscle pain; Ringing in my ears; I can hardly hear, like my head is in a bucket; Ringing in my ears; I can hardly hear, like my head is in a bucket; feels like ants are and bugs are crawling all over my face all the time; Back pain; muscle spasms in my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FF2588) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Gout" (unspecified if ongoing), notes: Verbatim: Gout. Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); OMEPRAZOLE taken for gastric ulcer (ongoing); ALLOPURINOL taken for gout (ongoing); PHENTERMINE taken for weight decreased (ongoing). The following information was reported: TINNITUS (non-serious), HYPOACUSIS (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "Ringing in my ears; I can hardly hear, like my head is in a bucket"; PARAESTHESIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "feels like ants are and bugs are crawling all over my face all the time"; BACK PAIN (non-serious) with onset 22Sep2021, outcome "unknown", described as "Back pain"; MUSCLE SPASMS (non-serious) with onset 22Sep2021, outcome "unknown", described as "muscle spasms in my legs"; HEADACHE (non-serious), outcome "unknown", described as "a headache that was so bad, I thought I was going to pass out"; ARTHRALGIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Joint pain"; MYALGIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Muscle pain".  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that I have very serious ringing in my ears, I can hardly hear, like my head is in a bucket. I have tingling on the left side of my things, feels like ants are and bugs are crawling all over my face all the time, seriously bad joint pain, back pain, muscle pain and muscle spasms in my legs. Patient states "One is phentermine and the other one is metoprolol the dose of the metoprolol is 50mg for high blood pressure, once a day. Phentermine is 35mg for weight loss, twice a day. This is Omeprazole 40mg, once a day for stomach ulcer prevention. Allopurinol 300mg and that is for Gout once a day." Patient had taken Tylenol 650mg, two tablets, twice a day.  No follow-up attempts are possible. No further information is expected.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 30 months old male patient who had received today 0.5 ml instead of the 0.25 ml dose im rt thigh, while he received vaccine FLUZONE QUADRIVALENT. 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 0.5 ml dose instead of 0.25 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ070AA via intramuscular route in the right thigh. It was a case of actual medication error due to overdose. The patient outcome is reported as Not Applicable for 30 month old male child today 0.5 ml instead of the 0.25 ml dose im rt thigh. 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 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.
Client reported severe headache following vaccination, 8 out of 10 on the pain scale. She was recently diagnosed with HTN and blood pressure measured 160/92. Paramedics on site transported her to the hospital via ambulance
Pt recvd vax & 6 hrs p/2nd dose exp fever, nausea & h/a;
Firm red circle (about 1.5 inch in diameter) appeared around injection site, on upper left arm, about one week after the injection.
Patient was nervous prior to vaccination.  Immediately after vaccination patient became nauseated and pale.  Was given a cold bottle of water to sip and was observed.  About 5 minutes post vaccination she fainted and collapsed off the vaccine chair into the observing pharmacists arms.  She regained consciousness gasping for air and her first communication was she was not able to breath.  The pharmacy immediately activated 911 for an ambulance, administered an Epinephrine 0.3mg Injection and contacted Care Clinic Adjacent for immediate evaluation and care for the patient.  Upon arrival moments later, (PA), from the pharmacist in getting the patient situated in a wheelchair and the proceeded to administer O2 for her.  Once transported in a room the patient awaited EMT/Ambulance arrival while receiving inhaled O2.  She refused ambulance transport but was evaluated by EMS and was confirmed stable.
Pt stated that she went home and was watching TV when she had an asthma attack (which responded well to Albuterol) and then she was very VERY tired, and slept for hours and hours extra that night/following morning. She came in to tell me about it and said she felt fine then. She states having had a flu shot every year and this year was the first time something happened- "must be really strong this year".
This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (name of drug not reported).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021).    No concomitant medication was reported. The patient took the 4th dose of Moderna COVID-19 Vaccine on 10-Oct-2022. The patient received Lipitor and potassium citrate on 03-DEC-2022. On 14-Dec-2022, the patient had experienced COVID Rebound while on Pfizer drug for COVID 19 treatment from 05-Dec-2022 to 09-Dec-2022. Device Date : 18Dec2022 No treatment medication was reported.
Fever, chills, body aches , red/swelling at injection site.  Began @24 hours after shot. and lasted about 18 hours. Took Acetaminophin which drastically reduced symptoms.
Pt. developed an injection site reaction characterized by a 4 inch area of redness, swelling and itching.
Mother states baby developed rash on her trunk and left leg with huge red welts--rash lasted 4 days. Mom states there was no fever.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------  DEMAND ISCHEMIA 12/23/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC  DEMAND ISCHEMIA 12/23/2021 HYPERVOLEMIA  DEMAND ISCHEMIA 12/23/2021 CKD STAGE 5 (GFR <15)    HTN (HYPERTENSION)
little bit of a cold; congestion; headache that is above and behind her head that comes and goes; arm hurt so bad she could not lift her coffee; possibly allergies; Sharp pains in her hand; Arm pain; A spontaneous report was received from a consumer concerning a 59 year old  female patient, who  received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in extremity cold , congestion nasal, headache and allergy  The patient's medical history, as provided by the reporter included unknown. Concomitant medications as provided by reporter included unknown  On 3 mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in right arm  for prophylaxis of COVID-19 infection.  On 4 mar 2021, prior to receiving mRNA-1273, the patient experienced arm pain and her arm hurt so bad she could not lift coffee. On 4 mar 2021, The patient had little bit of cold or possible allergies with congestion. On 4 mar 2021, the patient  started sharp pains in her hand and headache that is above and behind her head that comes and goes. Treatment for the events was included unknown  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events pain in extremity, cold, congestion nasal, headache and allergy were considered unknown
Patient received the vaccine on 8/15 from another store and he came in our pharmacy on 8/19 reporting blurry vision when he tries to focus on letters or words after 5 seconds.
staff member became diaphoretic, complains of chest pain, increased blood pressure.  Sent to and diagnosed with an allergic reaction to Moderna vaccine.
As soon as patient walked out of the consultation room, she started feeling dizzy and nauseous. Her skin was pale and vomited a little.
Headache, nausea, dizziness from about 10 minutes after receiving first dose for a few hours.