chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.
Nausea; vomiting multiple times; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on the left arm on 16Mar2021 at 16:45 (at the age of 20-years-old) for COVID-19 immunisation. Medical history included gluten allergy, depression and celiac disease. Concomitant medications (within 2 weeks of vaccination) included Sertraline (MANUFACTURER UNKNOWN) and etonogestrel (NEXPLANON). She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine neither was not diagnosed with COVID-19 prior to vaccination and since the vaccination, she had not tested positive for COVID-19. On 16Mar2021 at 23.00, she experienced nausea and almost vomiting multiple times. No therapeutic measures were taken to treat these events. The outcome of nausea and vomiting are not recovered/not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Pt reported profuse reddening in inj site area w/ pruritic & "felt ill".  Reported to Rph 10/7/09.
sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 54-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Influenza immunisation.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient had received Spikevax along with flu shot approximately 3 weeks ago and. Patient only had a bit sore arm and next day he was fine.   This case was linked to US-MODERNATX, INC.-MOD-2023-710279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710279:Wife case
Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction).The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.   It was unknown if the company considered the allergic reaction to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a patient via interactive digital media. The patient had his/her first shot of shingles a while ago.  The reporter stated that no one told him/her about the second shot of shingles vaccine.  The patient had scared that he/she had shingles but he/she did not. The reporter's doctor said that he/she had an allergic reaction to something.  It was definitely not shingles.  The reporter just got his/her second shingles shot at the time of reporting.  The reporter further stated that he/she wanted to avoid getting shingles. The follow up would not possible as no contact details were available.
Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm; hot feeling initially; A spontaneous report was received from a consumer, who was a 66-year-old, female patient who received Moderna's COVID-19 vaccine and who experienced a serious adverse event of chest discomfort requiring hospitalization (reported as:  "heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm" and in addition non-serious events of sore arm, and hot feeling. The patient's medical history included borderline type 2 diabetes and allergies to adhesive tape, bleach and chlorine.  Concomitant product use was not provided.   The patient received her first of two planned doses of mRNA-1273 (LOT 012M20A) on 05-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Initially on 05-Feb-2021, patient experienced a sore arm that was warm to the touch.  However, on 15-Feb-2021, she reported having had heart attack-like symptoms. She stated that it started as pressure between shoulder blades that initially went away and then started again on her carotid and travelled down her arm.  She thought it was from loading wood.  The patient then went to Emergency Room (ER) where she received a nitro pill which alleviated the pain.  The EKG, cardiac enzyme tests, nuclear imaging and stress test were all negative according to the patient's report.  She reported having been hospitalized for 2 days.   Treatment for the event included a nitroglycerin tablet.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, sore arm, hot feeling initially, heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship for events cannot be excluded.
received MENVEO instead of the prescribed SHINGRIX; received Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On 12th August 2022, the patient received Menveo (intramuscular). On 12th August 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comments: The office manager from a medical office reported that the patient had received Menveo instead of the prescribed Shingrix. The reporter consented to follow-up. Additional supportive information: The patient was given Menveo instead of Shingrix, which led to wrong vaccine administered. Since, Menveo was only allowed until from 2 months to 55 years of age and the patient's age was 66 years at the time of reporting, which led to inappropriate age at vaccine administration.
Patient had a painless welt: 3" x 4" from pharmaject injector & back pain the next morning and mom thinks it could be from injector. On 9/20/11, patient's mom reports lingering back pain and welt has gone down to injection site.
Meningitis; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event of meningitis.  The patient's medical history was not provided. No concomitant medications were reported.  On 03 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient experienced meningitis like symptoms. She was hospitalized for meningitis. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, meningitis was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of meningitis. The event of meningitis occurred 3 days after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
One week to the hour, I experienced a 5 hour episode of double vision.  Admitted to hospital for overnight stay, to rule out strock
First bivalent covid dose administered to patient on 3/27/23. Vial was stored in refrigerator, with Beyond Use date on 3/9/23. Dose was drawn and administered after beyond use date. There have been no reported adverse reactions.
After receiving flu vaccine above, Pt. experienced redness and swelling that Pt's parents state "looks like a water balloon" - regarding swelling in Pt's (L) thigh. 2 days later at time of this report, Pt's (L) thigh continues to be red and swollen. Pt. did not/does not have difficulty breathing or swelling.
Patient developed unsteadiness two days after the vaccine, and became progressively delirious, then obtunded and was placed on comfort care thereafter.
There was no reaction. patients mom scheduled him for a first dose vaccine for pfizer. She filled out the forms and marked no to ever receiving a covid vaccine. brought them back and went over the Q and A and asked if this was the first dose. She replied yes its his first dose. When putting in the patients info into system and the end of day I discovered that she lied to me and he was given a Pfizer dose at the pharmacy on 9/6/2021. I did report it and added Alerts to the patient chart to not give another vaccine if they come back in again.
Patient came up to nurse after her 15 minute post vaccination observation was completed. Patient stated that within one minute of receiving the vaccine, she developed a metallic taste in her mouth, had a heaviness in her chest and her heart was racing.  Patient stated everything resolved within 10 minutes except she still has a metallic taste in her mouth.  BP 122/84 and Pulse 68 and regular.  Patient stated she did not want to follow up with a medical facility.  Provider recommended that patient contact her primary care doctor.
PATIENT BEGAN TO FEEL NAUSEAS, CLAMMY, AND HAD TREMORS. LASTED FOR ABOUT 30-40 MINUTES. CHECKED VITALS - SUGAR WAS 117 AND BLOOD PRESSURE 126/84. PULSE 64.
localized swelling on injected arm. Mildly red, moderatley swollen from elbow to shoulder. Cool compresses, Motrin.
Pt received immunization & then his  mom received hers.  Pt came back to pharmacy for form  Pt was leaving and fainted Pt hit his face on merchandise  had bruise on nose cut on forehead.
Dizziness/lightheadedness after 2nd dose. Said ate small lunch. Given water, felt better. Reports numbness and tingling of left arm 5 min after receiving 1st dose, which lasted the entire evening. Patient stable, released from vaccination site.
pt recv vax 23OCT96 & 2FEB97 pt exp an inc temp & a moist cough;tx w/Proventil, Robitussin & Flumadine 3FEB97 for 2wk & was reordered on 18FEB97;this is 1 of 28 cases;
Patient received the Zostavax vaccine and 2 days later developed a large hot red bump at the injection site. Treated with ice and NSAIDs.
10 minutes after receiving the injection patient reported facial flushing with feeling of heat, nausea, headache, weird taste dry mouth, and tingling in fingers. Vital signs at 1328: HR 84 BPM, O2 95%, Respirations=16, BP 130/80 (manual in R arm). Called overseeing physician who instructed us to monitor patient for an additional 10 minutes, record another set of vitals and reports back change in s/s. At 1338 patient said all symptoms had resolved with vitals of HR 85 BPM, O2 95%, Respirations= 15, BP 128/86 (manual in R arm). Report was called to physician who allowed the patient's spouse to drive her home. Both patient and her spouse were instructed to seek emergency medical attention if symptoms returned/wrosened.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for COVID in Dec2020. The patient got the first dose of the vaccine on the day before the date of this report, started coughing on the day before the date of this report and tested positive for COVID on the date of this report.  Caller requested guidance regarding whether he should receive the second vaccine dose, specifically will it be effective.  Caller stated that he was "an ER doc" and understand that he did not get COVID from the vaccine. The patient underwent lab tests and procedures which included tested positive for COVID in Dec2020. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, there was not a reasonable possibility that the COVID-19 infection was related to vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Patient broke out in hives with localized redness to right arm (where vaccination was administered).  Patient had mild lip swelling, without difficulty breathing.  Pt stated that she was very "itchy."  Symptoms alleviated with administration of 50mg IM Benadryl at injection site (approximately 30 minutes from administration of vaccination).
confused; sick; dizziness; can't think straight; can't stay awake; forgetful; can't move; sleeping all the time; throws up; extreme fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), ILLNESS (sick), DIZZINESS (dizziness), THINKING ABNORMAL (can't think straight) and SOMNOLENCE (can't stay awake) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 26-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 CONFUSIONAL STATE (confused), ILLNESS (sick), DIZZINESS (dizziness), THINKING ABNORMAL (can't think straight), SOMNOLENCE (can't stay awake), MEMORY IMPAIRMENT (forgetful), HYPOKINESIA (can't move), SOMNOLENCE (sleeping all the time), VOMITING (throws up) and FATIGUE (extreme fatigue). At the time of the report, CONFUSIONAL STATE (confused), ILLNESS (sick), DIZZINESS (dizziness), THINKING ABNORMAL (can't think straight), SOMNOLENCE (can't stay awake), MEMORY IMPAIRMENT (forgetful), HYPOKINESIA (can't move), SOMNOLENCE (sleeping all the time), VOMITING (throws up) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided Antihistamine .
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 20-NOV-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # H015630 and expiry date: 21-FEB-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, chills Narrative:  Other Relevant History:
Pt. is suspected to have a reaction to small pox vaccine. (pericarditis).  Records received from reporter documenting an overnight hospital stay for c/o sudden onset of chest pain of 12 hours duration, 1 week following smallpox and anthrax vax.   PE: Unremarkable except for erythematous, raised bumps on anterior and sup. shoulders. Impression: 1) Atypical chest pain.  Pericarditis d/t viral(?) vs. smallpox  vaccine.  2) hyperlipidemia. Records received from VA hospital. Report as above.  Principal DX: Pericarditis.
Initial misuse report received from a healthcare professional on 21 February 2014. The cases were received on 21 March 2014. It was reported that less than 63-year-old patient had received FLUZONE HD vaccine on unspecified date. No adverse event was reported. List of documents held by sender: none.
This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. Upon receipt of follow-up information it was determined that this case was now valid because the patient identifier was received. Follow-up information has been received from nurse on 14-SEP-2018. On 14-SEP-2018, the call was placed to the physician. The call was answered by the receptionist and transferred to nurse. The nurse provided information regarding the patient's vaccinated with the above product. This report refers to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug allergies/reactions or concomitant medications. On 09-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. Sender's Comments: 1809USA010671: Original Case: 1805USA001303.
Headache, Myalgia & NauseaVomiting Narrative: Didn't go to work for two days.
Information has been received from a physician concerning a 35 year old female who on 21-MAY-2007 was vaccinated with a dose of Zostavax instead of a dose of varicella virus vaccine live. She had no ill effects from this. A product quality complaint was not involved. Additional information has been requested.
I only had a sore arm the first day (Thur). Friday I noticed hives on my thighs. Saturday I woke up and had hives on more of my legs and my hands. I had a phone visit with a doctor to get steroid cream and took some Benadryl. On Sunday is was far worse with hives across my whole body and I went to UTC. They  offered Prednisone and to speak to an allergist. Monday (today) the hives are not as swollen, so I have not started the Prednisone and I will see the allergist on Thur.
Small cloudy fluid filled rash all over body - spreading in clusters. Itchy, break-through chicken pox.
- L.O.C for 2 sec. - Paleness in face  * Treatment -> lay down with elevated legs
swollen arm & hand;could not bend fingers;also had splotchy,itchy rash p/last 2 doses;had non-bite exposure to dogs that were fighting w/a raccoon;had numerous scratches & cuts on hands & cleaned the saliva off the dogs;
Per patient, she started feeling very ill after an hour into getting the shot. She had migraine with throbbing pain and sensitivity to light, swollen face with black rings around her eyes. She coughed continuously throughout the night which made her lose sleep. She also had fever and no energy, which forced her to stay in bed for three days. She finally started feeling better 3 days after receiving the shot.
Within 30 (R) shoulder became very sore after a few hours the arm felt heavy and weak the next morning whole body ached barely wanted to move no energy both arms weak and heavy headache that has continued for last 4-5 days breast milk supply dropped in half.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 76 years old female patient who experienced muscle soreness is at the injection site and discomfort is at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ038AB, expiry date - 03-May-2019 in the left deltoid. On an unknown date patient developed a non-serious muscle soreness is at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious discomfort is at the injection site following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab test). Final diagnosis was discomfort is at the injection site and muscle soreness is at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for muscle soreness is at the injection site and as Unknown for discomfort is at the injection site.
approximately 15 minutes after vaccine I felt a headache and dizziness.  A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)
Client reported a metallic taste in her mouth, heaviness in her chest, headache, lightheadedness. On site EMS attended to client.  B/P 130/70, EKG done-normal sinus rhythm.  Client declined to be transported to the hospital.  Client monitored for 30 minutes, reported that she felt "a little better" and wanted to go home.  Client driven off site by her daughter.  Client and daughter encouraged to call 911 in case of emergency and follow up with primary doctor.  Verbalized understanding.