chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore at injection site; sore under arm; headache; fatigue; swollen in area between collarbone and neck on side where shot was given; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in left arm on 06Apr2021 at 13:00 (at the age of 48 year-old) as single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient received other medication(unspecified) in two weeks of vaccination. The patient previously received first dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in left arm on 13Mar2021 at 12:00 (at the age of 48 year-old) as single dose for COVID-19 immunisation.  The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 06Apr2021 at 15:00, the patient experienced sore at injection site(vaccination site), sore under arm, headache, fatigue, and swollen in area between collarbone and neck on side where shot was given. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event sore at injection site, sore under arm, headache, fatigue, and swollen in area between collarbone and neck were not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Severe migraine; Freezing; Body aches; Chills; Nausous; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous). At the time of the report, MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-FEB-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Started with low grade fever, vomiting on 7/1/2006 then progressed to high grade fever and body aches. then fever worsened and he had a sore mouth, swollen glands and sores in his throat.
Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: Vomiting-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Temp of 102.8 the evening after vaccine given mother used Tylenol through the night.
Rash on both arm, both legs. Redness / itchiness and swelling of both feet. Went to urgent care and was prescribed hydrazine 25mg, famotidine 40mg,& topical ointment (triamcinolone acetonide 0.5%).
Patient's lips went numb; Felt strange; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange). At the time of the report, HYPOAESTHESIA ORAL (Patient's lips went numb) and FEELING ABNORMAL (Felt strange) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 03-Oct-2022, it was reported that a patient started treatment on an unspecified date with Moderna COVID-19 Vaccine at dose 1 for an unspecified indication. It was reported the patient's lips went numb and felt strange.   Treatment information was not provided.   Reporter did not allow further contact
Started getting a mild headache around midnight after 2nd Dose.  Following morning, SEVERE HEADACHE.  Could not get out of bed.  Took 800mg Ibuprofen and finally got a little relief. Headache moved to right side of head.  Starting to feel better on day 3 after 2nd Dose.
Severe itching, rash type blotchy. Started a week or so after second injection. Continues to worsen.  Doctor denies it is from vaccine.
Lost ability to taste food, more specifically salty/savory food. I have not left my home except to get the vaccine so the chances of having contracted covid-19 are very very low. No other symptoms.
muscle aches; muscles that move joint behind knees aches/both knees and shoulders aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle aches) and ARTHRALGIA (muscles that move joint behind knees aches/both knees and shoulders aches) was resolving.            No concomitant medications were reported.
Administration error - Patient received 5ml patient instead of .5ml of vaccination.  (Moderna)
fever, joint aches, neck pain-beginning 13NOV994; sent to clinic 14NOV94; fluids & APAP;
This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. Concomitant therapies included sterile diluent (MERCK). On an unspecified date, the patient had titers drawn which showed she had low titers for measles, mumps, and rubella. Physician did not know whether patient was ever administered M-M-R II prior to the titers being drawn. Due to the low titers, patient came into the office on 16-JAN-2019 to receive a dose of M-M-R II. Patient indicated on a pre-vaccination consent form that she may be pregnant, however, this was not noticed by the office. Then, the patient was inadvertently administered a dose of VARIVAX subcutaneous, for prophylaxis (dose, lot number and expiration date were not reported), instead of the intended dose of M-M-R II (wrong product administered). Physician reported this error occurred because VARIVAX was stored in a location where only M-M-R II was usually stored, and the provider who administered the dose simply did not notice that she had picked up a dose of VARIVAX instead of M-M-R II (product storage error); there was no confusion between the two products. Once the error was noticed, patient was called back into the office to receive the intended dose of M-M-R II on or after 16-JAN-2019; however, at that time the patient confirmed she was 31 weeks pregnant, therefore the intended dose of M-M-R II was still not administered. On an unspecified date, the patient became pregnant. The last menstrual period was 13-JUN-2018 and estimated delivery date was 20-MAR-2019. Initial exposure to VARIVAX was at 31 week(s). No adverse effect were reported following administration of VARIVAX. The pregnancy outcome was pending. The outcome of wrong product administered and product storage error was unknown.
vaccine administered that was not reconstituted; vaccine administered that was not reconstituted; This is a spontaneous report from a contactable Nurse. This Nurse reported for 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FD0809; Expiration Date: 25Sep2021), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 15:30 (at the age of 57 years old) as dose 1, 0.3 ml single for covid-19 immunization. The Patient No medical history was reported. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Sep2021, the patient experienced vaccine administered that was not reconstituted. Incident report was filled out and it was reported to everyone at their office, including the nurse manager and provider.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information in the case provided, the causal association between the events  Wrong technique in product usage process and Poor quality vaccine administered and the suspect drug cannot be excluded.
Injection site became very red, rock hard, swollen, hot and itchy (10 days after injection)
Dizzy, difficulty standing and walking, throat felt tight, breathing slowed down, trouble transferring thoughts to words
Tingling on her Left face; numbness on her left face; feels a little weird; few muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain). At the time of the report, PARAESTHESIA (Tingling on her Left face), HYPOAESTHESIA (numbness on her left face), FEELING ABNORMAL (feels a little weird) and MYALGIA (few muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Tylenol 1 tablet only for the symptoms she was experiencing.
PATIENT RECEIVED VACCINE AND WAITING IN STORE - AFTER 5 TO 10 MINUTES STATED SHE WAS GOING TO PASS OUT AND DID. 911 WAS CALLED AND EMS RESPONDED TO CHECK VIATLS, PATIENT NOT TRANSPORTED TO HOPSITAL AS VITALS WERE NORMAL
Hives on arms, wrists, armpits, feet, ankles, abdomen, low back, buttocks, legs. Re-occurring daily in evenings, ongoing still. Taking Benadryl in evenings.
Blurry vision in addition to swollen neck lymph node and swollen arm with redness and itching... The blurry vision is a new side effect from the second shot.  The other symptoms went away after a few weeks from the first shot but reappeared after the second shot.
Fever 104.3 10MAR92; Seen by MD 11MAR92; MD dx otitis & sinus infect;
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 13 year old patient of unknown gender with acne. No other information regarding the patient's pertinent medical history and drug reactions or allergies was reported. On an unspecified date in December 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 17-MAY-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L044475, expiration date 12-MAY-2017 (dose, route of administration and anatomical location were not provided). It was unknown why the patient did not complete the original GARDASIL series. Concomitant therapies included FLONASE nasal spray, DUAC topical acne cream and vitamins (unspecified). On 17-MAY-2016, the same day after getting GARDASIL 9 shot, the patient became lightheaded. It was unknown if the patient was given any treatment and had lab diagnostic studies performed. The patient recovered from the adverse event on an unspecified date in 2016. The relatedness between the adverse event and vaccinations with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Please note that lot number and site of vaccine is unknown per existing electronic health record.   Patient is a 61 y.o. male who presented to ED with complaints of intractable back pain.  He endorses associated  nausea and vomiting with PO intake. Overall he states his intake has been poor and he "has eaten only a can of soup in 3 weeks". He denies diarrhea or constipation. He denies fever, chills or known illnesses. Patient reports onset of low back pain around 3 weeks ago. He is unable to report any known injury or fall prior to onset of pain. He states that his pain has worsened with onset. He states his pain has worsened since onset. He states that any movement worsens his pain and he has been unable to ambulate. He reports "a little" numbness and tingling in his BLE. He denies BLE weakness stating that pain is what is limiting his ambulation. Patient also reports onset of lower abdominal pain around the same time. He states that his abdominal pain is constant and worse with PO intake.   Respiratory: Positive for shortness of breath (chronic). Negative for cough.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Positive for abdominal pain (Lower abdominal pain, worse with PO intake), nausea and vomiting. Negative for diarrhea.   For COVID, the patient did not require any treatment neither was he hypoxic over the course of his isolation and afterwards. He came out of isolation on 10/1/21.  Regarding the back pain, he had an MRI on 9/27/21 that was concerning for L2-L4 discitis/osteomyelitis. On 10/1/21, he underwent a sterile bone biopsy (no antibiotics prior to biopsy) with Interventional Radiology with final cultures no growth and non-diagnostic on pathology assessment. Subsequent to the bone biopsy on 10/1, he was started on broad spectrum antibiotics, largely consisting of vancomycin/cefepime for a planned total 6 week course to end 11/11, but given development of leukopenia attributed to antibiotics, he was transitioned to suppressive doxycycline therapy 3 days earlier on 11/8/21 with Infectious input.    Patient has a known history of metastatic lung cancer. On 10/7/21, he underwent a CT Head that was concerning for a new lesions in the right frontal and parietal lobes with vasogenic edema. MRI confirmed these findings, and he had craniectomy with resection of the parietal and frontal brain masses done by Neurosurgery on 10/12/21. Pathology of the brain masses consistent with metastatic non-small cell lung cancer. He subsequently underwent stereotactic radiosurgery to the resection beds with Radiation Oncology from 11/17-11/22/21.    Discharge Disposition/Condition Disposition: Nursing facility (specify) Condition: Stable (s/sx potential problems absent or manageable)
Red, mildly itchy rash around face, neck and upper chest lasting about 1 day and improved after taking benadryl
Vaccination failure; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 52 years for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "motorcycle accident injuries" (unspecified if ongoing); "Known allergies: Opiates" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Had a positive Covid test on 03Jun2022; (12Jun2022) Positive, notes: Woke up with a sore throat on 12Jun, tested, and was positive for COVID.  Follow-up attempts are completed. No further information is expected.
small 2-3mm papular lesions, (non-vesicular) no open lesions;papules were described by pt mom as itchy bumps;
huge local reaction to vax 5x6 cm area of erythema & induration;
Scab; shingles; sores; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prostate cancer (at the age of 65 years ).   On 7th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced shingles and skin ulcer. In June 2019, the patient experienced scab. On an unknown date, the outcome of the shingles, skin ulcer and scab were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin ulcer and scab to be related to Shingrix.  Additional case details were provided as follows: About 3 weeks ago from the date of reporting, the patient got shingles for the first time. On 17th June 2019, the patient visited his physician. His sores from the shingles were well scabbed over now and his physician thought he could receive the 2nd dose. The patient said that he worked out. He did not take any major medication. No heart medicine.  The patient did not consent to follow-up.
Vaccine given beyound 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Vicodin Allergy) and Drug allergy (Lexapro Allergy).   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-313106 (Patient Link).
App on phone and smart watch reported resting heart rate had increased 21 bpm on Feb 3. and elevated heart rate at rest of 162 bpm. Started to get up but felt dizzy. Took blood pressure with results  less than 100/50 and 90 bpm heart rate. Rested for few hours and heart rate began to decrease and blood pressure started to increase. I was no longer dizzy
Pt recv vax on unknown day;  post vax pt exp swollen iris & general numbness
Red and inflamed hives throughout body, including scalp. Swelling of the face. Uncontrollable itching throughout body. Skin hot to the touch.
This spontaneous report as received from a health professional via agency (manufacturer control number 58348) refers to a elderly male patient of unknown age (over 65 years old). The patient did not have any known allergies. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route not reported, lot # K005797, expiration date 21-MAR-2015, or lot# reported as K007773). Concomitant therapies were not provided. On 18-AUG-2014 the patient experienced redness, fever in the area upper arm and itching in the area. After a couple of days it went away on its own and the patient was okay. The healthcare worker stated the office already disposed one of the lot numbers that was used that was causing the issue lot # K005797. This is one of four reports received from the same reporter. Additional information has been requested.
Pt weak in legs and arms since vaccine on 6/1/15, sleeping a lot, daily frontal headaches and stomach pain occasionally.
had pain in arm 12 hours after initial shot, then several days now have noticed a red raised circular area with pinkish red rash.  still present on arm.
After getting the shot I felt light headed , nauseous, heart pounding.  I became very tired approx. 1 hr later and slept 3 hrs.  When I woke up my face was itchy and top of hands. I also had cold type symptoms such as stuffy nose, watery eyes, cough, chills, 99.8 temp. and a bad headache.  Around 3 am on 3/5/21 ,I started having stomach pain then diarrhea until around 12 am on 3/6/21. Still had headache and low grade temp of 99.3. Approx 11:30 am started feeling better. No symptoms except mild headache.
Local swelling at injection site to elbow associated with somnolence all vital signs normal occurred within one hour of injection.