chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the booster dose of the Pfizer Covid vaccine on 03Nov2021; Soreness to her arm; States that blood ran out of her arm after the shot; She was sore; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 69-year-old female patient received bnt162b2 (COMIRNATY (mRNA), formulation: solution for injection, lot number: FD0810 and expiration date was not reported) via an unspecified route of administration, administered in right deltoid on 03Nov2021 at 15:30 (at the age of 69-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included lung neoplasm malignant from Feb2020 to an unknown date Part of her lung was removed due to lung cancer for her to be protected against covid it was critical, non-tobacco user from an unknown date and unknown if ongoing Is not a smoker, patient had tired and achy for about 24 hours and then she was fine. Patient was not ill yesterday. Concomitant medications included influenza vaccine inact split 4v taken for an unspecified indication from 13Oct2021 to 13Oct2021. The patient previously received bnt162b2 (Dose 1, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot no: ER8737) on 03Apr2021 for COVID-19 immunization and on 24Apr2021, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0175) for COVID-19 immunization. Age at vaccination was 68 years. Patient states her patient card has no expiry dates or NDC numbers written on it. On 03Nov2021 the patient experienced immunization. On an unspecified date in Nov2021the patient experienced slightly soreness to her arm and just feels concerned about this and is overwhelmed by her concern, states that blood ran out of her arm after the shot, she was sore patient never had anything like that before and just feels concerned about this and was overwhelmed by her concern. Patient explained that the shot was hurt a lot and then blood just spurted out of her arm. The patient was very very concerned this Pfizer Booster vaccine spurted out with the blood that was coming out of her arm and it did not take and she really didn't get any protection at all or that instead of being 90 percent protected she was 40 percent and she needs to know this. The patient underwent lab tests and procedures which included  on an unspecified date total lung capacity with result 80 percentage. The outcome of events were unknown.  Follow-up attempts are completed. No further information is expected.
Rash at the site of injection and down my arm. Swollen in the area and sore. Occurred two weeks after the injection
Patient developed tonic-clonic seizures which were quite severe.  Also chronic daily headaches.
Information has been received from a RN concerning an 8 year old male who on 24Mar1998 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 62447/1419E). There was no concomitant medication. On 27Apr04 the pt broke out with chickenpox with an unk number of non itchy lesions that started on his chest and then moved to his back. Unspecified medical attention was sought and no treatment or prescription drug was required. No product quality complaint was involved. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed with the additional information received on 17-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated her friend had got the Janssen COVID-19 vaccine and was hospitalized afterwards. She initially thought that the friend got it in NOV-2021 but then stated it could be in MAR-2021. She stated that it was possible the friend was hospitalized due to COVID-19 symptoms which primarily was the difficulty breathing resulted in suspected clinical vaccination failure, and suspected covid-19 infection (unspecified treatment administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with regulatory authority: 90000207703; Sender's Comments: V0- 20211239318-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. 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. 20211239318-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
"Moderna COVID-19 Vaccine EUA" The next day sore arm (injection site) x2days, fatigue, body aches, on and off headaches, nausea, mild sore throat. All symptoms x7 days since 12/31/2020.
noticed a red blotchy area around the injections area about a 4" area.  The following day, slight itching.
sore throat; a severe case of diarrhea 4 hours after the shot; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DIARRHOEA (a severe case of diarrhea 4 hours after the shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (First Booster dose) on 21-Oct-2021 and Pfizer vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Diabetes and Blood cholesterol abnormal (Cholesterol).    On 23-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (a severe case of diarrhea 4 hours after the shot). On 24-May-2022, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and DIARRHOEA (a severe case of diarrhea 4 hours after the shot) had not resolved.            Patient had no known allergies.Patient had never tested positive for COVID-19. Patient had no mentioned Acute and Chronic illnesses at the time of vaccination. Patient did not take any other vaccines 1 month prior to Moderna COVID-19 vaccine. They stated that they got Pfizer for the primary series and a for the first booster on the21Oct2021. Concomitant medications included Blood pressure medication, Diabetes medications and Cholesterol medications. No treatment details were reported. AE did not cause patient to seek medical care. Symptoms were reported as about the same.
Patient stated noticed itching at injection site on morning of 10/02/2021.  Patient noticed rash at injection site on 10/03/21 (noticed at 6am)
This spontaneous report as received from a nurse refers to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-JUN-2018, the patient was vaccinated with VAQTA injection, strength 25/0.05 (units not provided), dose 0.5 ml, once, intramuscular, lot# R009822 and expiration date reported as 12-JUN-2019 for prophylaxis. The nurse stated that the patient inadvertently received dose of pediatric VAQTA on that day. No adverse effects being reported. No further information provided.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On 31st March 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, fatigue, malaise and chills. On 2nd April 2018, the outcome of the fever, fatigue, malaise and chills were recovered/resolved. It was unknown if the reporter considered the fever, fatigue, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in right deltoid. The outcome of events was recovered and duration was 2 days. Only partial information was provided. The physician wanted to be transferred to MI.
Swelling at injection site. Worsened over a few days to encompass the entire deltoid muscle definition. Swelling was hard, hot and red.
I had vaccination on 11/23/2022. On 12/01/2021 I had shortness of breath with O2 stats dropping to 85%. I was given xrays antibiotics and steroid inhaler. I was treated as it was Pneumonia but it was Bronchitis that lingered. I started to have hives on 03/2022 and was diagnosed on 06/27/2022 with Urticaria. On 07/15/2022 blood panel showed that TSH was high. On 10/01/2022 blood panel showed TF was on low side. On 11/21/2022 blood panel showed that check levels and TPO antibodies were high. Currently testing for Hashimoto's Disease. I did have COVID-19 Positive on 09/08/2021.
severe headache along backside of head from ear to ear; Overall feeling weak, tired, and body aches; Overall feeling weak, tired, and body aches; Overall feeling weak, tired, and body aches; This is a spontaneous report from a contactable consumer (patient).  An 88-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248) via an unspecified route of administration in the right arm on 20Jan2021 10:30 AM at a single dose as COVID vaccine. Medical history included known allergies to crab, sulfur, penicilin. Concomitant medications (other medications in two weeks) included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN LOW), lisinopril. No other vaccine in four weeks. On 21Jan2021 11:00 AM, beginning about 24 hours after injection - severe headache along backside of head from ear to ear. Overall feeling weak, tired, and body aches on 11:00 AM. Lasted about 20 hours. Treatment was not received for the events. She had no COVID prior to vaccination. She has not had COVID tested post vaccination. The outcome of the events was recovered on Jan2021.
I've been sick for 7 days, with cough, stuffy nose, pain in upper left chest, achy,
Moderna COVID-19 Vaccine EUA  Symptoms began 14 hours after vaccination (~4:00 a.m.). Symptoms begin with high fever (101 - 102 degree fever). Shortly following identification of high fever a possible carpopedal spasm occurred. Hands started to curl in, were painful, and there was a loss of motor control. This also occurred in the feet. Spasm response resolved within 30 minutes to 1 hour. Fever ranging from 99 - 101 lasted another 24 hours and was treated with tylenol.
Telogen Effluvium, my hair started falling out about 3-4 months after the vaccine.
extreme fatigue, chills, headache, body aches, fever approx. 100*, reduced appetite bedridden 2.5 days - only got up for the bathroom and to make sure my children ate meals
Taken to ER by her mother because her mother noted her left thigh to be somewhat red today (6/13/03) after receiving a vaccination. Her mother relates that it was quite red at home. She now states that the redness has almost completely resolved. Minimal erythema present on left thigh. Pt discharged home.
No adverse event; Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57143C) for COVID-19 prophylaxis.     No medical history was provided by the reporter.     On 13-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml dose instead of the 0.5ml dose for his bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient's concomitant medications included high blood pressure medication and high cholesterol medication.  On 06-FEB-2021 (Lot:012M20A), the patient received first dose of Moderna vaccine of unknown dose. The patient did not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 06-MAR-2021 (Lot: 011A21A), the patient received second dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 25-OCT-2021 (Lot: 014F21A) patient received first booster dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  On 05-MAY-2022, patient received second booster dose of Moderna vaccine of unknown dose. The patient does not know which arm that he received his vaccine in. Patient had no Adverse reactions or side effects.  No treatment  medications were reported.
I hurt all over, my head is pounding, i feel like i am going to vomit and i have a fever of 102.3. I have never been this sicks or felt this terrible.
Tightness in throat; BPs 152/99 (pulse 120), 138/89 (pulse 105). O2 sats 98%, 96%. History of anxiety.
PATIENT SAID EXPERIENCED  HOT/COLD AND ACHING. SAID DID NOT CHECK FOR A FEVER. SAID LASTED UNTIL 3am. SAID THING SUBSIDED AND JUST ACHING NOW. WANTED IT DOCUMENTED. WE INFORMED HIM IT WAS THE SIDE EFFECTS.
SKIN SENSITIVITY. SECOND DAY-LEG WEAKNESS. THIRD DAY-COULDN'T MOVE NECK. FOURTH DAY COULDN'T WALK AND WAS ADMITTED TO THE HOSPITAL.
A report received from a health professional concerning a 7 month old male patient. The patient medical history and concomitant medication were not provided. The patient had received nasal influenza vaccine started on an unknown date and intramuscular SYNAGIS started on an unknown date. It was informed that the patient had a local site reaction  to influenza vaccine on 23-NOV-2015. The patient also had a SYNAGIS injection one week prior. Action taken with influenza vaccine and SYNAGIS was unknown. The outcome of the event of local site reaction to flue shot was unknown. The company physician assessed the event locate site reaction to flu shot (unspecified) to be non-serious.
Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.
On 10-04-09 I received a vaccination for flu. I was told I might have mild muscle soreness. On 10-04-09 at night I had fever and muscle soreness, second day fever w/muscle soreness since 10-07-09. I have lived w/muscle soreness that is not going away it is getting worst.
Area near vaccine injection sight became inflamed, warm to touch and itching.  Redness was about the size of palm of hand (per patient).  Patient returned to pharmacy on 6/27/16 with picture of area.  Area had cleared by late am on 6/27/16.
first and second doses 8 days apart; A spontaneous report  was received from a health care professional concerning a 42-year-old male patient who receive his first dose of Moderna Covid-19 on 27jan2021. He had an appointment for another clinic and was mistakenly given his second Moderna Covid-19 vaccination, 8 days from the first dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received his first of two planned doses of mRNA-1273 (batch number:unknown) on 27Jan 2021. The soldier had an appointment for another clinic and was mistakenly given his second Moderna Covid-19 vaccination, 8 days from the first dose. On 03 Feb 2021 the patient received his second of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The event "first and second doses 8 days apart" was considered as resolved on 03 Feb 2021.; Reporter's Comments: This case concerns a 42 year old male patient who received his two doses of Moderna Covid-19 vaccinations 8 days apart. There were no reported adverse events after the vaccines were administered in this case of inappropriate schedule of product administration
Narrative: After first dose of Zoster vaccine, patient experienced redness around injection site with no systemic symptoms reported. The patient received the second dose in the vaccine series with no issues.
12-1-08 Onset:  Severe pain all joints of both feet.  12-4-08:  Progression to all joints both hands.  12-8-08:  Worsening in hands, slight lessening in feet.
MYOCARDITIS; PERICARDITIS; This spontaneous report received from a consumer via a company representative concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. No past medical history or concurrent conditions were reported. All patients (some 3%) received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown)1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patients experienced myocarditis and pericarditis. The myocarditis were in men with a median age of 36 years old. The median age for the pericarditis cases was 59 years. The action taken with covid-19 vaccine was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849032-COVID-19 VACCINE AD26.COV2.S - myocarditis and pericarditis. These events are considered unassessable. The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a 30-year-old male subject with significant medical history of dizziness or fainting and headaches developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM200. Pericarditis is a listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Patients stated that they have carpel tunnel and that the symptoms feel very similar to that. 5 minutes after the injection the patient felt throbbing pain in waves starting in the right arm at the base of the thumb with lighter radiating pain the forearm to the elbow. No pain in shoulder. 60 minutes after the vaccination patient reports pain has lessened but still ongoing.
Information has been received from a physician concerning a 19 year old (also reported as 17 year old) female patient who on 29-OCT-1992 and on 18-AUG-1994, was vaccinated with the first and second doses of MMR II (route and lot # unknown) respectively. On 08-DEC-2009 (diagnosed on 10-DEC-2009) the patient developed mumps. The patient was afebrile and had L parotitis. It was reported a history of exposure to school of mumps. On 10-DEC-2009, a first blood work was performed with unspecified results. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
My right eye (underneath) is twitching (shaking). It's been approximately 22 hours since I first noticed it. More often, the shaking is rapid,   but sometimes, there are not as fast.