chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthru; tested positive for COVID; Breakthru; tested positive for COVID; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Lot number: F5KE20) at the age of 45 years as dose 3 (booster), single, administration date 14Apr2021 (Lot number: EP6955) as dose 2, single and administration date 23Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "recovering" and all described as "Breakthru; tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a 64 year old patient. On 22-NOV-2013, the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiry date not provided). On 22-NOV-2013, the patient was supposed to received VARIVAX instead of ZOSTAVAX. No adverse effects reported. The outcome of patient received VARIVAX instead of ZOSTAVAX and no adverse effects was unknown. The action taken with VARIVAX (Merck) was not provided. Additional information has been requested.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: Patient refused medical services after pharmacy staff notified 911 about incident. Patient reported a history of fainiting after vaccine was administered.
w/in 72hrs pt devel 15x10cm purple, tender bruised area of the rt arm site of inj; med Premarin, calcium channel blocker;
sore arm; slight headache; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 as SINGLE DOSE for covid-19 immunisation  .  Medical history included high blood pressure , Allergy.     The patient's concomitant medications were not reported.  The patient experienced sore arm and slight headache on an unspecified date with outcome of recovered. The reported stated that patient has a headache because patient didn't take his blood pressure medication on 10Apr2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Patient is complaining of widespread rash across her back and waist.  She has felt dizzy, fatigue, nausea, and had an irregluar heart rate feeling (caffeine like). She had injection site pain/soreness and has had headaches and body/joint aches.
AFTER VACCINES WERE GIVEN MOM WAS TOLD TO TAKE PATIENT TO RESTROOM FOR URINE COLLECTING. MOM RETURNED WITHOUT REACHING BATHROOM STATING PATIENT WAS SHAKING. PATIENT APPEARED PALE AND LETHARGIC BUT WAS RESPONDING.
This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th November 2020, 1 days after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix in left arm. After receiving 1st dose of Shingrix, the patient experienced arm soreness, lack of mobility with injected arm, left hand numbness, and pain when injection site is pushed with a finger. The reporter consent to follow up.
Between 8-10 days after the injection the patient reported a rash starting around the injection site. The injection site itself became hard, warm to the touch, and itchy. The rash currently covers her right deltoid muscle and extend down the upper third of her tricep. She reports the rash is looking better each day.
Nausea, fainting, dizziness, chills, fever, body convulsions
Sedation, Arthralgia, Fever, chills and fatigue. pain at the injection site. Narrative:
After vaccination, patient became light headed.  Vitals obtained:  BP 89/59, pulse 69, respirations 18, pulse ox 98% on room air.  Juice, water and cookies given.  Symptoms resolved after 8 minutes at rest.  Patient aware to seek medical attention if symptoms return or new concerns.
Call center received call from pt on 9/8/21 at 8:36pm. Pt states she received first dose of moderna vaccine on 7/30/21 (Lot#088D; Left deltoid) and 2nd dose on 9/4/21 at pharmacy (outside)  and felt chest tightness since 9/5/21 and did not go away. Advised pt to go to the nearest ED to get evaluated and pt verbalized understanding.
BLOODY DIARRHEA; This spontaneous report received from a consumer via a company representative concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 6 decade old. 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, 2 days after receiving the first dose of vaccine, the patient was admitted for bloody diarrhea. The number of days of hospitalization were not reported. It was unknown if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bloody diarrhea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20230459184-Bloody diarrhea-The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Migraine headache, cough, chills, fatigue, loss of appetite and slight nausea. Redness and tenderness in area of the shot.
Pt reported swelling and itchy at injection site, feel sleepy than usual, reported rash only at injection site, reported no shortness of breath and chest pain. Pt has taken antihistamine at the morning of symptoms started next day. Reported the symptoms has getting better but not much.
Nearly immediately following the vaccines dark circle, bags and and what is now a permanent tired line appeared under my eyes and spinal pain.  These side affects have worsened and show no indication of lessening.  Two additional vacciness not listed on your site that were administered were Menomune and Typhim.
Fall - 7 AM Fall in Dining Room Community Center   1 PM Ambulance to Hospital ER 1:30 PM Tests - Blood, CT scan of head and brain, X-ray of Chest Release from hospital - 5 PM Arrive by car to home 5:30 PM  fall from car to grass  Call for Security and Nurse to get him up and into the house - vital signs taken Fall again  in the house at 6 PM Seemed to back to normal +/- 7 PM
Pt recv  2 doses of vax five weeks apart & failed to seroconvert;
Information has been received from a nurse practitioner concerning a 16 year old student pt with a latex sensitivity, who on 9/11/02 at 11:45am was vaccinated in the left arm with a first dose of hep b vaccine (642927/0196M). There was no concomitant medication. There was no illness at the time of vaccination. In approximately October 2002, the pt developed a "red rash" at the injection site, which spread from the pt's elbow to shoulder. The pt was treated with an unspecified amount of Benadryl. On approximately 10/17/02 the pt was "doing fine," and the injection site was reported to be "a little warm." Follow-up received from initial reporter indicated details are not known, and no additional info is available. Additional follow-up info from a nurse practitioner indicated that on 10/16/02 at 11:15am, also reported as 2 months after injection, the pt's left arm began to ache and swell at the site. The pt took Tylenol and did not report to the clinic. The reporter indicated that four months after injection, the pain and swelling increased from her shoulder to her elbow. The pt reported that "it looked like a rash or hives." The pt was prescribed Benadryl, Tylenol, and an ice pack with relief. The rash disappeared but returned in 2 days, and was relieved each time with Benadryl. It was reported that on 10/17/02 the pt recovered. No diagnostic tests or lab data were known.
Patient is a 81 y.o. male with a lab significant for HTN, dementia, hyperparathyroidism who was admitted to hospital with COVID and pneumonia and has been encephalopathic. Patient  Was admitted on 4/29/2022 when he was not able to get up from his chair. He was found in the same place over night by his family. He was taken to a hospital, he was found to have COVID and was treated with remdesivir. There he became less responsive  And provider noted that he was  ignoring his left side, CT head and CTA head and neck were unremarkable. Yesterday patient aspirated and developed pneumonia. He continued to be decreased responsivess and was transferred for further care.
Vaginal bleeding; vaginal cramping; had headache for first dose; Body ache; Fatigue; CHILLS; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site). On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping). At the time of the report, HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS), INJECTION SITE ERYTHEMA (Redness at injection site), VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-240235 (Patient Link).
Immediately after receiving the HPV vaccine patient became unresponsive. Nurse and patient's mother assisted patient to the floor. Patient convulsed a couple times while lying on the floor. Nurse administered ammonia inhalant under patient' nose. Skin color extremely pale and diaphoretic. No cardio/respiratory distress noted. Patient alert after two minutes of unconsciousness. Patient did not remember where he was or what happened. Safety maintained. Nurse advised parent to get patient checked out by a doctor at ER, Urgent Care, First Care, or family doctor. Patient c/o dizziness, ringing in ears, weakness, and headache after vaccine. Nurse assisted patient to the car in a wheelchair.
This spontaneous report as received from a nurse refers to a 66 year old female patient with allergy to lisinopril, aspirin, TYLENOL, non steroidal anti inflammatory drugs (NSAIDS). On 24-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 in the arm (reported as right deltoid region) (dose and route of administration was unknown) for vaccination. Concomitant therapies included doxepin hydrochloride, cetirizine hydrochloride, vitamins (unspecified), FLOVENT HFA, fluticasone, SYNTHROID, amlodipine and PREMARIN. On 24-SEP-2014 the patient experienced redness, swelling and pain in her right shoulder that spread to her back and down her right arm. The reporter stated that the patient had visited physician on 25-SEP-2014 and was noted to have redness and minor edema on the right shoulder and down her arm. It was later found that the patient also had the PNEUMOVAX 23 (0.5 ml, intramuscular, lot# J04332, expiry date: 26-SEP-2014, in the arm) on an unknown date in August 2013. The patient was treated with BENADRYL. An X-ray of the right shoulder was completed on an unspecified date and noted to be within normal limits. The outcome of the events was reported as recovered/resolved on 07-OCT-2014. The causality was unknown. No further information provided. Additional information has been requested.
Partially occluded Bilateral pulmonary embolism and occluded DVT of right leg from groin to ankle
Patient got lightheaded and then passed out after receiving the vaccine. She remained unconscious for approximately 20 seconds, regained consciousness as pharmacy was contacting 911. EMS was dispatched to the pharmacy, patient vitals were monitored, and they recommended she visit the ER for further monitoring. Patient's mother, who was present, transported the patient. Followed up with patient mother later regarding patient status; she was discharged from the ER with no further complications. Reaction was described as vasovagal response.
Approximately 48 hours following vaccination she experienced aching in the vaccinated arm and a generalized feeling of tiredness and weakness relieved by rest. Over the next few days symptoms became progressively worse and extended from the arm up into her neck and into her upper back, positionally aggravated. On 10/04/2010 she was examined and found to have vesicular lesions along the outer aspect of the right mid-upper arm and distally to include elbow and mid forearm. She has been prescribed medication to treat the shingles. She is an otherwise healthy hard working female with no known underlying acute or chronic health conditions or problems.
Developed continuous dry cough in about one hour. Fatigue. Next morning congested sounding cough fever headache. Next day or maybe two days no taste or smell
Excruciating pain in muscle and shoulder joint. Unable to move arm. Waking up at night from pain. Shoulder joint pain still persisting.
Moderate irritability initial 24 hrs; 2nd AM p/vax dad found pt limp-hyporesponsive in crib, unresponsive to irritant stimuli, refusing to feed, also diaphoretic; exam in ofc found pt pale, distant, hypotonic but more responsive to stimuli;
6 styes on her right eye; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (6 styes on her right eye) in a female 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HORDEOLUM (6 styes on her right eye). At the time of the report, HORDEOLUM (6 styes on her right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicine was not reported by the reporter  treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-067453 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067453:Case for dose 1
received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
After recieving second dose of Pfizer vaccine, patient developed pchest pain radiating to back the following day. Associated with nausea, vomiting, and chills. Chest pain was also pleuritic. Symptoms improving over the preceding days while in the hospital.
Body aches; chills; Felt like "hit by a truck"; Nausea; Fever->101; Soreness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea) and PYREXIA (Fever->101) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm). At the time of the report, PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: >101 (High) Increased temperature.         Concomitant product includes Beta Blocker. No Treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-AUG-2021 TCR form states Patient  was not well for 3 days after getting the vaccine but she is doing fine now and declined for a follow-up.She said that she is waiting to get a booster shot.
Immediately after third vaccination developed swelling, pain at injection site, large red rash around injection site.  Two days after third vaccination developed edema, swollen thyroid gland, nausea, dizziness, loss of appetite, burping, diarrhea which has not subsided
nausea, loose stools, t39.3, muscle/back discomfort w/pleuritic pain-adm IV fluids; Blood cx's; better in 24 hrs; pt has also recvd Macrodantin same day as shot; pt felt rxn poss from Macrodantin;
Pt recvd 4 doses of Engerix-B vax & converted p/the fourth dose;
After administration of vaccines. Client complained of lightheadedness. Nurse observed client to be pale, cold,clammy with buccal cyanosis client never lost consciousness.  Nurse assisted client onto exam table and applied cool compresses to head and neck area.  Client was given juice (apple) and tolerated well.  Vital signs assesed to be within normal limits.  Client recovered fully within 25 minutes.  Mother present and able to transport home.
This spontaneous report as received from a Registered Nurse refers to an unknown number of patients. It was reported that on unspecified dates, an unknown number of patients were vaccinated with MMR II (manufacturer unknown) (lot #, expiration date, dose, route of administration and indication were not provided) that had been improperly stored. No adverse effects were reported. No further information was provided. Additional information has been requested.
Infant experienced increasing events of periodic breathing, desaturation, bradycardia, and temp instability that required need for respiratory support.
right arm the first and second time/she had a sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: COVID, start date: 2020 (unspecified if ongoing); trolley horses, start date: 2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955, anatomical location: right arm), administration date: 07Mar2021, when the patient was 79-year-old, for COVID-19 Immunization, reaction(s): right arm the first and second time/she had a sore right arm. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome unknown, described as right arm the first and second time/she had a sore right arm.  Additional information: The patient had COVID in early 2020 and developed more trolley horses than usual after that. The patient received first and second dose in right arm and then wanted to remember not to do that again because she had a sore right arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152144 same patient, same event, different dose;
Developed COVID several days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (Developed COVID several days after the first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: unk (Positive) Patient received first dose of the Moderna COVID-19 vaccine and tested positive for SARS-CoV-2 infection several days later..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medication was reported.   Reporter did not allow further contact
GI upset: combination of loose stools and diarrhea 3-4 times per day