chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received moderna vaccine in january and never went back for second dosing; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
My blood sugars shot up to above 300 and we're very difficult to bring down. I also had moderate keytones in my urine which is very unusual for me. I reverted to giving additional insulin via injection to stop the blood sugars from raising.
Pt had fever of 101F; pain & swelling 6x4cm over site R deltoid when flu & Pneumovax given at same time and location.
Information has been received on 10/19/2001 from a mother concerning her 10 year old "healthy" son with no allergies who at the age of 4 was vaccinated with a dose of varicella vaccine. Therre was no concomitant medication. On 10/18/2001, the pt developed a low grade fever and scabs all over his body. The pt's mother counted  23. The mother also noted that there was an E-coli outbreak at her son's school and "all the kids are ill at present." The pt sought unspecified medical attention. Additional info has been requested.
Thick tongue, eyes itchy then matted shut, face swollen, hard to talk, achiness, nausea, vomiting, chills, coughing - difficult to clear throat. Swelling in face resolved in 2 days.  No redness, swelling or pain at site of injection. Did not seek medical treatment - no health insurance.  Did call a nurse information line & was told it is not vaccine related.
vomiting, diarrhea, dizziness  on Thursday began :  rash on upper arms and stomach  cough  fever  no energy
2nd dose on 8/14/2021 given earlier after dose 1 on 7/24/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 14th August 2021, the patient received the 2nd dose of Shingrix. On 14th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 24th July 2021, the patient received 1st dose of Shingrix with batch number 44dx9 and expiry date 28th October 2022. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. The was patient not immunocompromised. No other details of the vaccine. The reporter consented to follow up.
Ongoing adverse event: swelling, pain, redness, warmth and itching at injection site. Began within 8 hours and still present.  Other effects, which lasted approximately 24 hours: body aches, chills, headache, fever up to 101.
headache at base of head top of neck arm soreness diarrhea fatigue insomnia no appetite overall stomach ache
Per patient report. Evening after receiving vaccination arm became very sore and swollen. The following morning, reported chills and general ill feeling. By that evening left arm was red and hot and patient reports that she could see cellulitis starting. Reports that she has had cellulitis in the past as a reaction to insect bites. Seen by clinic outside of our health system and ordered to take amoxicillin that patient reported she had at home already. It initially improved but by 2/22 the symptoms returned and cellulitis spread down past the elbow. New prescription called in for cephalexin x7 days. Patient has not called or returned to indicate that symptoms have worsened or resolved.
Client stated, "I feel very sleepy."  Spouse reported hat client was lightheaded and dizzy.  Fire Rescue attended to client on site.   Released home with her spouse awake, alert and verbally responsive.
The patient presents with COVID-19 symptoms x24 hours. Pt states that his wife tested positive for COVID-19 and his entire family is currently sick. Pt complains of congestion, subjective fever, loss of taste, and loss of smell. Denies fever, cough, SOB, and HA.  The onset was 24  hours ago.  The course/duration of symptoms is constant.  Location: generalized.  Risk factors consist of COVID-19 exposure.   Associated symptoms: fever, congestion, loss of taste, and loss of smell., denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies shortness of breath, denies chills, denies headache, denies dizziness and denies back pain.
Patient received the Pfizer vaccine that expired on 4/25/21 at 1:25Pm on 4/26/2021
PT'S THROAT BEGAN TO SWELL- SHE COULD BREATH BUT NOT SWALLOW.  PT WAS GIVEN 50MG OF DIPHENHYDRAMINE.
t104, cool/cyanotic extremities transiently limp/quivering, screaming;
Pressure/pain in ear, painful throat when swallowing, tongue feels swollen, fatigue
Two days after I got the vaccination I noticed inflammation in the left part of my throat, since that day there are 13 days with inflammation of swollen glands. or lymph nodes.
Six months after vaccination patient started with anorexia.  Initially eating little,  Parents fed him with Pediasure.  Then he stopped having lunch and progressively stopped eating.  Went to the hospital .  Labs were done including liver function tests  that were abnormally high.. He was dehydrated.  He was treated at the Emergency department and sent home.  He was referred to a gastroenterologist who performed endoscopy and was reported normal.  He was also admitted for a week to a hospital for a week.   Recently started with headache and a Head CT was done.  Parents worried about persistent anorexia.  He has been treated with Pepcid
A 54 year old female patient reported that, two years ago in October 1999, she received a dose of influenza virus vaccine, manufacturer unknown (1999-2000 Formula) and developed an injection site reaction characterized by redness, swelling and "hot to the touch".  She recovered.  The reporter indicated that she has an allergy to egg whites, soy beans, multiple food allergies and multiple antibiotic allergies.  She recovered.  Follow up information received on 05/29/2002 from her physician stated that her patient has been on immunotherapy for about 15 years.  The information provided confirmed that she has a "lot of allergies" to foods, antibiotics EGG allergy and soybean allergy.  The patient still smokes cigarettes.  At times she has experienced tingling of her lips and tongue and her throat itches if she inadvertently eats foods to which she is allergic.  Medical notes mentioned that she develops local injection site reactions from the immunotherapy itself.
Pt recvd vax & 2 days p/vax pt devel cold sore on face, became tired, dizzy & had nausea; pt was treated w/Zovirax & events have subsided; pt recvd 1st dose on 23NOV92 & 2nd doses on 22DEC92;
Woke up flushed and complaining of headache. By 3:30 pm (after attending preschool) he was much more flushed looking and hot to the touch - temperature taken rectally and was 101. The site of shot was slightly red and warm to touch as well. By the following day, 9/22/2012 temperature was down to 99 degrees, but the injection site was extremely bruised, very red and swollen and hot to touch (bruise length approx 2 inches long, red and swollen part approx 7 inches diameter).
PATIENT CALLED THE PHARMACY TODAY (5-28-21) AND SPOKE TO STAFF PHARMACIST. PATIENT STATED THAT SHE WAS INSTRUCTED TO STAY IN STORE FOR 15 MINUTES AFTER THE VACCINE WAS ADMINISTERED, WHICH SHE SAID THAT SHE DID. WHILE SHE WAS DRIVING HOME SHE GOT DIZZY AND CRASHED HER CAR INTO A DITCH. SHE STATED SHE WANTED TO CALL AND TELL US WHAT HAPPENED AND THAT WE SHOULD BE TELLING PATIENTS TO HAVE "SOMEONE DRIVE THEM HOME"
Pt recvd vax 10AM 19MAY92 & @1PM rash began to appear -by 3PM rash was bright red & raised in patchy areas on neck, turnk & face; mom advised to have pt seen by MD; however mom did not take pt to MD;
Denies SOB, warm to touch, red, swollen shoulder to elbow, firmness at injection site. Antibiotics, prednisone and loratidine to treat.
SHAKING; MILD HEADACHE; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced shaking. On 2021, the subject experienced mild headache. The action taken with covid-19 vaccine  mild headache on 2021. This report was non-serious.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 15:00 (Lot number: EL9264) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications received within 2 weeks of vaccination. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Pain radiating down arm to tips of fingers (left side).  Shooting pain to tips of fingers periodically for last seven days.  This began immediately (5 minutes) after influenza vaccine.  Pain becomes worse with use or position.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
getting hives/rash one day after receiving the vaccine; getting hives/rash one day after receiving the vaccine; This spontaneous report was received from a pharmacist and refers to a currently 70-year-old male patient. His concurrent conditions included an allergies to penicillin and amoxicillin. His concomitant therapies included unspecified medications, mostly antipsychotic medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) reconstituted in sterile diluent (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for shingles prevention. On an unknown date (also reported as one day after receiving the vaccine), the patient experienced hives/rash. The outcome of the events was not reported.  The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was not provided.
breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Around 7 P.M. that night, I noticed I felt a hard knot in my right arm, about where the shot was given - halfway beween my shoulder and elbow.  The right arm was also swollen from the shoulder to the elbow and became painful as the hours went by.  There was also reddening and the skin was very warm to touch.  My face also swelled by the next day for 2 days after.  I took an Advil and applied ice to the outside of the right arm from the shoulder to the elbow intermittently for the next 2 or 3 days.  The Advil made me feel too sick and nauseous to go to the Emergency Room, but the pain decreased somewhat.  I had to spend the next 3 days resting with the ice on.  Any movement of my arm hurt so it was best to lie flat in bed.  I switched to aspirin the day after the Advil and slowly started feeling better.  After 4 days, all the adverse symptoms were gone.  I called Dr.'s office to report it.
Per patient experienced swelling to Right arm with pain. On next visit 08/11/2021 father reporter reaction.
I received the pneumococcal polysaccharide vaccine and the next day I started having fevers. The following evening I went to urgent care because I was still having fevers and redness on my arm where the injection was given, was increasing in size. The lymph nodes under my armpits where swollen as well. The doctor diagnosed me as having cellulitis from the injection and prescribed an antibiotic (sulfamethoxazole-trimethoprim).
This spontaneous report as received from a physician refers to himself, a 74 years old male with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) on 26-JUL-2012. No other co-suspects were reported. Concomitant medications included RHINOCORT, omeprazole, FLOMAX, LIPITOR, hydrochlorothiazide, lisinopril, tamoxifen citrate, metoprolol, omega-3 and vitamin D. On 26-JUL-2012 the patient developed rash and bruising after receiving a dose of ZOSTAVAX. The rash and bruising appeared on the forearm below the injection site. The area of the rash was about 1 cm to 1/2 cm. The patient did not seek for medical attention. There were no lab diagnostic studies performed. No treatment was given. At the time of this report the patient had not recovered. Additional information has been requested.
Patient received Afluria with a 25 G, 5/8 inch needle instead of a 25 G 1 inch needle on 10/8/2015. Patient came to the pharmacy today (10/11/15) to pick up her prescription and was notified today (10/11/15) about the needle length. Patient is very petitite and thin with minimal subcutaneous tissue; therefore it is likely that the flu shot was administered into the muscle. Patient stated she feels fine and feels that the flu shot went into her muscle. Patient is happy with no complaints at this time.
when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways; the stopper flew off side ways and cracked the screws/syringe where the needle would connect; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HG9498, Expiration Date: 31Jan2024) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the stopper flew off side ways and cracked the screws/syringe where the needle would connect".  The reporter considered "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways" and "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" not related to bnt162b2 omi xbb.1.5. Causality for "when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force/ the stopper flew off side ways" and "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  Additional information: A safety hazard was encountered with the Comirnaty vaccine. When removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force. In 2 cases, the stopper flew off side ways and cracked the screws/syringe where the needle would connect. The Lot# of both doses= HG9498, with expiration date of Jan24. NDC# 00089238201. Reporter was asking for advise whether there is a method of removing the stopper that will eliminate this cracking of the syringe hub.     The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348823 Same reporter/drug/AE, different patient;
After the shot I was fine for 4 days and then I started having a hard time breathing; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 11Mar2021,at 03:15 as single dose for covid-19 immunization, at the age of 82 years.  The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products were noted. No other vaccines were administered within 4 weeks and no other medications were given two weeks prior to the COVID vaccine. The patient was not pregnant.  The patient noted "after the shot I was fine for 4 days and then I started having a hard time breathing" on 15Mar2021, at 14:00. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Myocardial Infarction; The initial case was missing the following minimum criteria: Unidentifiable patients. Upon receipt of follow-up information on (07Mar2023), this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "A CASE SERIES: SARS-COV-2 MRNA VACCINE CAUSING MYOCARDIAL INFARCTION FROM NONOBSTRUCTIVE CORONARY ARTERIES (MINOCA)".  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), 2 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Angiogram: showed no angiographically significant disease, notes: in the major vessels; Echocardiogram: revealed LVEF of 55%; Ejection fraction: 55 %; Troponin I: 18.2 ng/ml.  Clinical course: Reported as, patient presented with sudden onset chest pain two days after receiving his first dose of Pfizer-BioNTech mRNA COVID vaccine. His peak troponin-I level was 18.2 ng/ml. An echocardiogram revealed LVEF of 55%, without wall motion abnormalities. Coronary angiography showed no angiographically significant disease in the major vessels.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event myocardial infarction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.