chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle and Joint pain for 16 days; Muscle and Joint pain for 16 days; This is a spontaneous report from a contactable other hcp, the patient. This 50-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL1284), dose number 2, via an unspecified route of administration in the right arm on 07Jan2021 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Hashimoto's disease from an unknown date and unknown if ongoing and migraines from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, intramuscularly in the left arm on 17Dec2020 at 1300 as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen (IBUPROFEN). On 08Jan2021 at 0500, the patient experienced muscle and joint pain lasting 16 days. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient also spoke with the physician and blood work was done. All results were normal. Unspecified therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included blood work (Unknown date): results were normal. The clinical outcomes of the muscle and joint pain were resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Headache, nausea, bodyaches, chills.    Tylenol At least 24 hours
Pt presented to clinic 24 hours after well child visit with complaint of blood flecks in diaper.
Redness and induration at site injection (L) Deltoid 6x7 cm. Area pruritic.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 042L20A) 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) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Within a minute of receiving 3rd Gardasil client reported feeling faint, followed by syncope episode (become unconscious) followed by rigidity and then tremors, repeated the rigidity and tremors one more time prior to being lower to the ground from the chair she was being supported in. Client then become conscious.
5 varicella lesions on trunk eval on 8SEP98, low grade fever 99.6,diarrhea, vomiting mild;
Pressing around heart 25 minutes after 1st dose; Hard to breathe after 1st dose; Tired for 2-3 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose), DYSPNOEA (Hard to breathe after 1st dose) and FATIGUE (Tired for 2-3 days after 1st dose) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose), DYSPNOEA (Hard to breathe after 1st dose) and FATIGUE (Tired for 2-3 days after 1st dose). On 20-Feb-2021, CHEST DISCOMFORT (Pressing around heart 25 minutes after 1st dose) and DYSPNOEA (Hard to breathe after 1st dose) had resolved. On 22-Feb-2021, FATIGUE (Tired for 2-3 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Severe headache nonstop, at the front and back of head, eyebrows, and around the temples
COVID-19; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient from other company (Pfizer) concerned a 75 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, high cholesterol issue, polyethylene glycol allergy, heart condition, thyroid and had 3 stents in aortic arteries. On 01-FEB-2021, patient received first dose of tozinameran (Pfizer vaccine) (dose number in series 1) (form of admin, route of admin not reported, batch number: EL9264 and expiry: Unknown) 1 total, dose was not reported, administered for prophylactic vaccination.  On an unspecified date, the patient had a bad allergic reaction (dose number in series 1). The patient went to the emergency as her tongue was swollen and she couldn't swallow (dose number in series 1). Treatment medications (dates unspecified) included: IV Benadryl, and epinephrine. As the patient couldn't take Pfizer vaccine due to allergy to PEG (Polyethylene glycol) so took Johnson and Johnson as second dose. On 25-AUG-2021, the patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination which was an off label dosing frequency (dose number in series 2). The drug was associated with Off label use. The batch number was not reported and has been requested. Age at time of vaccination 75 years old. Concomitant medications included acetylsalicylic acid, captopril, hydrochlorothiazide, levothyroxine sodium for thyroid, pantoprazole sodium sesquihydrate, pravastatin and vitamin.  On 31-DEC-2021, the patient had covid-19 and her antibodies were pretty high (dose number in series 2) and the patient was unsure if they are still high or not. Laboratory data included: Antibody test pretty very high. The patient was exposed to COVID last week but was not tested positive yet so enquired about administering Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and off label dosing frequency was not reported. This report was non-serious.
Headache began about 10 minutes after the injection and did not stop until May 7, 2022. During this time I also experienced dizziness upon changing positions and blackouts.  I have injured myself many times by blacking out and falling without any warning.  I am no longer allowed to drive, my life is greatly impacted by this.
Doctor gave shot high up on the shoulder part of her arm, near bone not the muscle of the arm, it hurt and did sting when he gave it; Pain in arm; Can't lift arm/ Cannot write; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 10:00 (Lot number: EP6955) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy: Penicillin Allergy" (unspecified if ongoing), notes: verbatim: Mentions Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Doctor gave shot high up on the shoulder part of her arm, near bone not the muscle of the arm, it hurt and did sting when he gave it"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovering", described as "Pain in arm"; MOVEMENT DISORDER (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Can't lift arm/ Cannot write".  Additional Information: Vaccination facility type was Vaccination Center. The Caller, called to advise that she had her first dose of the covid-19 vaccine yesterday, 31Mar2021 and she had been feeling a lot of pain in her arm and cannot lift it without feeling pain. She also said that the Doctor who administered the vaccine has injected the vaccine up high into the shoulder's bone part, not the muscle in the arm. Everyone told her it doesn't hurt, and she doesn't like needles; but it did hurt and did sting when he gave it. States it was high up on the shoulder part of her arm, near bone not down where the muscle of the arm is. There were no unaddressed medical questions referred or forwarded to Medical Information.     No follow-up attempts are possible. No further information is expected.
Second dose: was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Lot number: 5N6199) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy, body is severely sensitive; "she has had swollen eyes from being in a lumber store" (unspecified if ongoing); "can smell chemicals a mile away" (unspecified if ongoing); "had a rash from latex and metal" (unspecified if ongoing); "had a rash from latex and metal" (unspecified if ongoing); "had a reaction to cats" (unspecified if ongoing); "had a reaction to yellow flowers" (unspecified if ongoing); "had a reaction to Hay" (unspecified if ongoing). Concomitant medication(s) included: COZAAR; IBUPROFEN. Past drug history included: Amoxicillin, reaction(s): "gets a rash". Vaccination history included: Bnt162b2 (First Dose: Received 17Feb2021, lot EM1809 or EM7809, NDC and expiration date unknown.), administration date: 17Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "didn't feel great after the first dose"; Tetanus shot, administration date: 2020, reaction(s): "little reaction". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Second dose: was sick". The patient underwent the following laboratory tests and procedures: full blood count normal: perfectly normal; haematocrit: perfectly normal; hormone level abnormal: unknown, notes: it was really different. Additional information: The reporter stated that the event relatedness as related. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient id not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported.  Follow-up attempts are completed. No further information is expected.
I felt lightheaded and jittery about 1 hour after the injection.  At night I had chills, body aches, nausea, and fatigue.  The body aches, nausea, and fatigue continued for the entire day following the injection.  I took Tylenol and ibuprofen
mom states pt had a high pitch cry for the rest of the day following immun; ok the next day;
Headache, Arthralgia, Fever, Localized pain Narrative:  Other Relevant History:
Patient walked in to receive Covid-19 vaccine. We informed him that we have two vaccines Pfizer and Janssen, and that Janssen was for 18 and up. We asked him how old he was. He said he was 18 and wanted the Janssen vaccine.
Swollen cheeks, throat, metallic taste, pain in old scar tissue (surgery at L5-S1) within twenty/thirty minutes of injection Fever/headache/chills/sweating for four nights Hair shedding started 4-14-2021 and continues still
no additional adverse effects reported; a patient was administered an expired dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a 2-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 04-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002459, expiry date 15-MAY-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Severe chest pain and tired.  Reports that on 8/25/21 his spouse woke him up panicked because his breathing was not visible and she thought he was dead.  Reports headaches and dizziness at least 4 times a day.  Walking is noticeably slow and stiff.  Reports that at his visit to the doctor's office that no measurable abnormalities were found.
red patch 2-3inches in diameter at site of injection 10 days after injection. no pain or itchyness
Immediately after I received the injection, my upper lip started tingly. My lip started getting bigger, I took Valtrex as a blister came upon my lip. About 6pm , I started getting a mild headache. I woke up this morning and my headache  is getting worse, I have body aches, and fatigue. My arm is sore as well.
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis". The lot number for bnt162b2 was not provided and will be requested during follow up.
patient is experiencing a red raised painful bump at site of injection. He said it was hot and the size of a 1/2 dollar coin  lasted 24-36 hours that included a stinging sensation.
Fainting; Cold; Left arm was red and itching; Left arm was red and itching; Vomiting; A spontaneous report was received from a consumer concerning herself, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting/syncope, vomiting, cold/nasopharyngitis, her left arm was red and itching/ erythema and pruritis.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 25 Feb 2021, prior to onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced fainting, vomiting, developed a cold, and her left arm was red and itching. Treatment information was not reported.  Action taken with mrna-1273 in response to the events was not reported.   The outcome of events, fainting, vomiting, developed a cold, and left arm red and itching, was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
AFib heart palpitation really bad; Beats per minute: 116/way too high I almost passed away; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 04, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Aug2023, outcome "unknown", described as "AFib heart palpitation really bad"; HEART RATE INCREASED (medically significant) with onset Aug2023, outcome "unknown", described as "Beats per minute: 116/way too high I almost passed away". The patient underwent the following laboratory tests and procedures: Heart rate: (2023) 116, notes: beats per minute.  Additional information: The patient had Omicron vaccine, the last part of August, within 3 days, the patient ended up with AFib, heart palpitation really bad. The patient suffered from AFib; had all the other 4 COVID vaccines and did not have the problem. All of this happened when the patient got the Omicron and those are really bad. The patient's beats for a minute was 116 beats for a minute, that is way too high I almost passed away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Swelling at Injection Site-Severe, Additional Details: patient developed large bump on his bicep after vaccine administration. bump has since decreased in size but is presently about 2.5 inches in diameter. patient is experiencing pain but no other symptoms.
Skin sensitivity, chills, uncontrollable shaking for ~25min on first day of symptoms , fever, muscle/body aches, stomach pain
This spontaneous report as received from a nurse refers to a 10 months 24 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.
Developed hives on various body parts within 3 hours, treated with BENADRYL.
EVENING THAT VACCINE WAS GIVEN HIVES BROKE OUT ON  BACK AND NECK , RESOLVED WITH BENADRLY.
a lot of tingling/numbness in my hand on the injection side; a lot of tingling/numbness in my hand on the injection side; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the left arm on 05Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient previously took clarithromycin (BIAXIN) and experienced allergies. The patient verbalized, "I don't believe it's anything serious but I am experiencing a lot of tingling/numbness in my hand on the injection side" on 05Jan2021 11:30. Clinical outcome of the events was unknown.
In-duration 2x2cm. Paplovesicles 2-3. Right thigh.
This spontaneous report was received from a registered pharmacist and refers to a 69 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 09-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
This spontaneous report was received from a Certified medical assistant, who also was reported to be the administrator, and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, the patient received a dose of GARDASIL 9 for prophylaxis (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date, the patient had an unspecified adverse event after the administration of GARDASIL 9 (adverse event following immunisation). At the time of reporting, the status of the patient was unknown by the reporter. The relationship between GARDASIL 9 and the event was not provided. Additional information is not expected because the reporter did not consent for further follow up.
Sleepy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and HEADACHE (Headache). On 09-Mar-2021, HEADACHE (Headache) had resolved. On 10-Mar-2021, SOMNOLENCE (Sleepy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.
9/18/16 - Pt developed swelling, red, itchy and warm to touch over R deltoid to right elbow. Length 20 cm, width 15 1/2 cm. Treated with prednisone 20 mg 2 tabs daily x 5 days, triamcinolone acetonide 0.1% external cream twice daily to affected area.
9/29 @ 1930: urticaria lasting 5hrs, treated with 50mg benadryl. 10/2 @0600 urticaria, treatment at Urgent Care with solumedrol IM injection and instructed to start oral Pred 10/3. 10/3 @ 0100 urticaria treated with 50 mg of benadryl (did not have oral Pred filled yet)
earache (no finding per MD);neck & back arthralgia (s)-tx w/NSAIDS;sinus (inflammation of mucosa)-tx w/ABT