chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sore arm; Neck pain; Vaccine leaked out of syringe; Injected vaccine too high in arm, hit bone; Can't move hand; Administration Error; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extremely sore arm), NECK PAIN (Neck pain), UNDERDOSE (Vaccine leaked out of syringe), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Injected vaccine too high in arm, hit bone) and HYPOKINESIA (Can't move hand) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Administration Error). On an unknown date, the patient experienced PAIN IN EXTREMITY (Extremely sore arm), NECK PAIN (Neck pain), UNDERDOSE (Vaccine leaked out of syringe), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Injected vaccine too high in arm, hit bone) and HYPOKINESIA (Can't move hand). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 13-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Administration Error) had resolved. At the time of the report, PAIN IN EXTREMITY (Extremely sore arm), NECK PAIN (Neck pain), UNDERDOSE (Vaccine leaked out of syringe), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Injected vaccine too high in arm, hit bone) and HYPOKINESIA (Can't move hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the event was not applicable.
Runny nose; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on left arm on 18Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his Pneumonia and Shingles vaccine. The patient reported that he received the vaccine on 18Jan2021 and one hour later started to have an intermittent runny nose. He reported that before getting the vaccine he hadn't had a runny nose for years. He is asking if this is a side effect. He checked the webpage and the instructions, and he does not see a side effect of runny nose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
1 expired booster dose was administered past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Date the vial was initially stored in the refrigerator was 10-Nov-2021. As per HCP, the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
I've had headaches daily since I have had this Maderna Shot and they are continuous like a 5 pain rating daily and sometimes a 10 rating like a migrane I never get headaches prior to this . I usually get 3 head aches a year if that.  now about the third week I am having vaginal burning I got some cream from my primary doctor they did an exam gave me Estrogens Conjugated Vag. Cream. Haven't started it until I receive it in the mail
Glands are swollen; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache). At the time of the report, LYMPHADENOPATHY (Glands are swollen) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
The afternoon following administration of the vaccine he began to experience chest pains.  The chest pains continued throughout the rest of the day and throughout the night prompting him to present to the Hospital Emergency Department where he was noted to have a mildly elevated troponin and was admitted to the hospital.  His troponins returned to normal and he was discharged with an appointment for outpatient coronary angiogram.  Of note, he did have a Covid19 infection last fall several months prior to vaccination.
Diagnosis is PMR related to the booster; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 08Oct2021 as dose number unknown (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 (Primary Immunization Series Completed, Unknown Manufacturer), for Covid-19 immunisation. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant) with onset Oct2021, outcome "unknown", described as "Diagnosis is PMR related to the booster". The event "diagnosis is pmr related to the booster" required physician office visit. Clinical course: the patient received the booster shot on 08Oct2021. Within 10 days patient started developing multiple health issues which had been working with doctors to figure out the problem. It got to the point where the patient had been sent to a rheumatologist which took 6 months to get in with. Diagnosis is PMR related to the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported polymyalgia rheumatica and BNT162b2 cannot be excluded. 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 RAs, Ethics Committees, and investigators, as appropriate.
Beginning around 5 hours following the vaccine, I had the worst flareup of my fibromyalgia symptoms I have had in 7 years. Crushing pain all over body, joints and muscles. Stabbing headache similar to a migraine. Dizziness. Diarrhea for 1 day; abdominal pain for nearly two weeks. Intermittent nausea for nearly two weeks. Felt like I had a fever, although the thermometer said 99.7. The feverish feeling lasted for 3 days. The crushing pain lasted for nearly two weeks. The dizziness was intermittent for two weeks. Got a full-blown migraine headache 4 days after vaccine. Please note: I did NOT take my nightly aspirin dose for 2 days prior to vaccine so as to not affect the immune response. I restarted my nightly dose at 11 PM,  6 hours following the vaccine. Still had all the above-mentioned symptoms.
Raised, hard, red welt with a surrounding zone of redness, approximately 3" x 2", that was very itchy for about 7 days. Skin rash also developed from injection site down to the elbow that was also itchy.
12/17/21 Symptoms began 2 days ago, sore throat, headache, cough, pleuritic chest pain. No fever. No known sick contacts. 2 doses of vaccine  General: She is not in acute distress.    Appearance: She is well-developed. She is not diaphoretic.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: Tympanic membrane, ear canal and external ear normal.     Left Ear: Tympanic membrane, ear canal and external ear normal.     Nose: Rhinorrhea present.     Right Sinus: No maxillary sinus tenderness or frontal sinus tenderness.     Left Sinus: No maxillary sinus tenderness or frontal sinus tenderness.     Mouth/Throat:     Pharynx: Uvula midline.  Eyes:      Right eye: No discharge.        Left eye: No 12/17/21  General: She is not in acute distress.    Appearance: She is well-developed. She is not diaphoretic.  HENT:     Conjunctiva/sclera: Conjunctivae normal.  Neck:     Trachea: No tracheal deviation.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds. No murmur heard.   No friction rub. No gallop.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Abdominal:     General: There is no distension.     Palpations: Abdomen is soft. There is no mass.     Tenderness: There is no abdominal tenderness.  Musculoskeletal:     Cervical back: Normal range of motion and neck supple.  Lymphadenopathy:     Cervical: No cervical adenopathy.  Skin:    General: Skin is warm and dry.     Findings: No rash.  Neurological:     Mental Status: She is alert.  Psychiatric:        Behavior: Behavior normal.
I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 CHF EXACERBATION, UNSPECIFIED I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/25/2023 CHF EXACERBATION, UNSPECIFIED I82.433 ACUTE DVT OF BILAT POPLITEAL VEINS 4/13/2023 CHF EXACERBATION, UNSPECIFIED J96.10 CHRONIC RESPIRATORY FAILURE 4/25/2023 CHF EXACERBATION, UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 CHF EXACERBATION, UNSPECIFIED
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent (MERCK) lot # N021894 with expiration date 28-NOV-2019. On 30-OCT-2017, the patient was vaccinated with a dose of PROQUAD lot # N015623 with expiration date 15-NOV-2018 and a dose of VARIVAX lot # N015477 with expiration date 18-MAY-2019, both for prophylaxis (dose, route of administration were not reported for the suspect therapies). No adverse effect was reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine. The patient took other medication in 2weeks Unknown. The patient took Paxlovid for COVID 19 Treatment. The treatment start date was reported as 20Jun2022. The stop date was 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm, nausea, dizziness and stomach cramps. On an unknown date, the outcome of the pain in arm, nausea, dizziness and stomach cramps were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, nausea, dizziness and stomach cramps to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient received SHINGRIX vaccine 7 to 8 days before the date of reporting and still complained of sore arm, nausea, dizziness, and stomach cramps. No further details were provided at the time of this call.
This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
no additional AEs; Caller reports 2 patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding two patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours 15 minutes. On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 hours 45 minutes. On the same day, doses of improperly stored outside recommended storage temperature range, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 ml, lot number: W011626, expiration date 06-APR-2024; strength and route of administration were not reported) were administered to the patients (product storage error). The reporter called for evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is a non-valid case due to lack of patients' identifiers.  Follow-up information has been received from the registered nurse on 28-SEP-2022.  Patient's details were provided. It was updated that not properly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered to a 15 years old patient of unknown gender who was vaccinated subcutaneously on right deltoid.    This is one of several reports from the same reporter.
No side effects from shot #1 on 1/24.    Second shot on 2/22 = approx. 14 hours after shot I started with chills for 2 hours, then had about 18 hours of a low grade (100.3) temp., dizziness & slight headache - then had sweats when it broke, then I was fit as a fiddle.
I had a fever of 101 and body aches which resolved after 24 hours. I also had dryness inside my mouth around my lip area. My lips were also semi numb. This has persisted for 5 weeks and seems to slowly be getting better. Please note I have not had lip fillers.
The patient experienced an episode of syncope approximately 10 minutes after receiving the first dose of the Moderna vaccine. The patient lost consciousness for less than 45 seconds and was then coherent and responsive. Paramedics were called to the scene due to the brief loss of consciousness. Medics took vitals and performed EKG and cleared the patient to return home without needing to seek further medical treatment or monitoring.
Ear infection; Pyrexia/Fever; Pharyngolaryngeal Pain/ Sore throat. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from the father of a 7 year old female who experienced fever 103 deg F, sore throat and ear infection. At 7 years of age, the child received a dose on 09-Dec-2003. The child experienced fever 103 deg F/ pyrexia and sore throat/ pharyngolaryngeal pain on 12-Dec-2003. On 13-Dec-2003, the child was diagnosed with an ear infection. The child was treated with Lorabid (loracarbef). As of 18-Dec-2003, the fever had resolved and the child was "better". The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Within the first 5 minutes of his 15 min wait time after receiving the vaccine, he appeared to be having a seizure & went unconscious. EMS was called, they checked his vital signs. He declined offer to go to hospital, waited another 15 min, then drove home.
Rash, itching all over body. Small red papules all over body, with the worst being around the ankle area.
WIDE SPREAD, SEVERE JOINT (TOTAL BODY) STARTING APPROXIMATELY 18 HOURS POST IMMUNIZATIONS. JOINT PAIN NOT RELIEVED BY BY INITIAL IBUPROFEN 800 MG OR ACETAMINOPHEN 1000MG ADMINISTERED 6 HOURS LATER. PATIENT IS IN THE BED CRYING DUE TO THE PAIN. ALSO, REPORTS INCREASED TEMPERATURE (100.6 F), HEADACHE, FATIGUE, AND CHILLS. JOINT PAIN FATIGUE IS  SO THAT SHE CANNOT PICK UP SIMPLE ITEMS LIKE TELEPHONE OR DRINK.  PATIENT REPORTS PAIN SCALE OF 10 OUT 10 AS WORST PAIN EVER. SHE STATES THAT SHE DID NOT FEEL THIS BAD WITH COVID.
severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'.  The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.
This spontaneous report as received from an unspecified healthcare worker refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 20-OCT-2014, the patient was vaccinated with an expired dose of GARDASIL, injection administered intramuscularly at dose 0.5 ml (lot # 669313/0692AA (reported as: 0692AA) with expiry date: 13-AUG-2013; strength and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the healthcare worker did not grant permission to contact him or physician.
little bit tired, was wiped out; little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little bit of a sore arm) and FATIGUE (little bit tired, was wiped out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS, NICOTINAMIDE (VITAMIN B3) and Fish oil Capsule for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (little bit of a sore arm). On 25-Feb-2021, the patient experienced FATIGUE (little bit tired, was wiped out). At the time of the report, MYALGIA (little bit of a sore arm) and FATIGUE (little bit tired, was wiped out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal. On an unknown date, Magnetic resonance imaging: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to MOD-2021-253112 (Patient Link).
Severe headache, nausea, vomiting, chills, fever, shortness of breath. Transferred to a different hospital on 04/07/2021. Transferred to another hospital on 04/17/2021. Discharged on 04/19/2021 Admitted again to hospital on 04/27/2021 with same symptoms of severe headache, nausea and vomiting, shortness of breath. Discharged on 04/29/2021