chrisvoncsefalvay/vaers-outcomes huggingface dataset:
struggle to breathe throat closure and turned blue from lack of oxygen. rushed via ambulance to hospital where i was put on O2 and given 2 rounds of Epi in transit. Has chest x-ray all clear and ruled out heart attacked and observed with fluids and o2 for 6 hours. was released  with rx for EPI pen and following up with allergist and GP
Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up revealed patient experienced little bit of arm soreness. Patient received COVID vaccine on December 31
rash or hives on whole body. Red blotchy marks. felt like pins jabbing; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; This is a spontaneous report from a contactable consumer (patient, self-reported). An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN9581 and expiry date was provided), via an unspecified route of administration, in the left arm, on 22Feb2021 at 08:30 AM (at the age of 83-years-old) as a single dose for covid-19 immunisation, at hospital. The patient had no known allergies. Medical history included cancer and finished chemo on 13Jan2021 (start date was unspecified date). The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 22Feb2021 at 13:00 on same day (as reported), the patient experienced rash or hives on whole body, red blotchy marks and felt like pins jabbing. The patient was treated with Cetirizine (ZYRTEC) 1/day, diphenhydramine (BENADRYL) 25mg at bedtime and acetaminophen (TYLENOL). The clinical outcome of the events was recovering.
10/09/09 4:00PM H1N1 Vaccine (Live, Attenuated) nasal spray administered.  10/10/09 Upon waking at 7:00AM noted coughing and sore throat. Temp. 99 range  10/11/09 Continued coughing and sore throat with hoarseness and diarrhea. Temp. 99 range.  10/12/09  Coughing, sore throat, hoarseness, diarrhea, with nasal congestion and runny nose. Temp.99 range  10/13/09  Cough has worsened and slightly productive, nasal congestion has worsened.  Temp. 99 range.  The following symptoms have subsided: sore throat and hoarseness.  A visit to her doctor today as a precautionary.  Continue to monitor symptoms.
42 year old female health care worker (physician) who experienced onset of severe unremitting generalized headache, severe head-to-toe myalgias and profound malaise with onset 24-28 hours after influenza vaccine. The pt has no medical history of note. Headache was not positional, no hypersensitivity to light, no N/V/ocular abril. No relief with Tylenol, Motrin or sleep. Onset head-toe severe myalgia - no muscles spared. Muscles not painful to touch. No dark urine or change in stool color. Pt reports even "toes" hurt him. Profound malaise - no stamina or endurance. The pt has run a marathon and the severity of malaise exceeded the weakness after marathon. Denies fever, cough, coryza, URTI, diarrhea. Triad of headache, myalgias and fatigue lasted approx 2 weeks.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient medical history and concurrent conditions therapies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) (lot # M029234, expiry date: 12-MAR-2019). On 14-FEB-2018, the patient was vaccinated with an expired dose of  M-M-R II lot # M006544, expiration date of 03-FEB-2018 for prophylaxis (dose, frequency and route of administration were not reported). No adverse effects were reported. Additionally, no product quality complaint (PQC) was involved.
Swelling of lips; Redness over arm; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm). At the time of the report, LIP SWELLING (Swelling of lips) and ERYTHEMA (Redness over arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment was provided by the reporter.
this patient is immunocompromised and presented for the 3rd COVID vaccination.  Past 2 doses were Moderna: dose 1, 1/15/2021, dose 2, 2/15/2021.  Unknown lot as they were given at the local department of health.  Received Pfizer in error for 3rd dose.
Information has been received from a healthcare worker for the pregnancy registry for HPV vaccine concerning a 22 year old female pt whit a history of abnormal pap who on 6/29/06 was vaccainted with her first dose of HPV vaccine , lot 653650/0697F. On 9/5/06 the pt was vaccinated with her second dose of HPV vaccine, lot 653650/0702F. The reporter indicated that the pt received the 2nd vaccination but did not realize she was about 6 weeks pregnant at the time. Medical attention was sought. An ultrasound and colposcopy was performed. The reporter indicated that there was no fetal pole at the time of the ultrasound and that it would be repeated. There was no adverse experience reported. Follow up information has been received from a physician concerning the female pt, whose last menstrual period was approximately 9/9/06. The estimated date of conception was 8/30/06. An ultrasound performed 9/20/06 showed 16P 5 wk 3 days. This is the pts first pregnancy. The estimated delivery date is 5/21/07. Follow up information has been received. On 11/8/06 the pt underwent an elective termination of her pregnancy at 12 week from LMP. Upon internal review, elective termination of pregnancy was considered to be an other important medical event (OMIC). Additional information is not expected.
Patient said developed a bump and rash, originially the size of a silver dollar, some itching also.
Erythema with edema at site of vaccine left leg. Rx: Keflex susp. 250 mg po BID for 10 days.
Patient reported she began having achiness, headache, and nausea the evening of the administration of the vaccine. She was cold and has gluteal achiness. Around 2 am she had a fever of about 101.3 degrees. She consulted with a family member (in the medical field) and took some medications to help with her symptoms. The symptoms have slowly subsided and today she was feeling more back to herself.
My arm/shoulder is very sore.  I can only move it just below my head and behind my back is not possible.
Developed symptoms on 7/30. Rapid home test for COVID-19 negative. Persistent cough, shortness of breath, dyspnea on exertion, and fatigue. Saw PCP on 8/2 - rapid point-of-care COVID test positive. Monoclonal antibody therapy bebtelovimab given on 8/4. Presented 8/8/2022 to emergency department for evaluation of cough and shortness of breath. Eliquis for history of COPD. Appetite has been poor. Pulse ox 89%. Placed on nasal cannula oxygen supplementation. Physical examination is notable for diffuse wheezing and albuterol HFA was ordered. She was not volume overloaded to suggest congestive failure in the setting. Albuterol is provided as was Decadron in the setting of her hypoxia with COVID. The patient was admitted to the medical service for further care.  ID consulted to assist with COVID management. Recommendations: - Continue dexamethasone 10mg for 2 more days followed by 7 days of 5mg - Check baseline COVID inflammatory labs - Outside of window for anti-viral therapy - Not seeing a need for antibiotics - Isolate for 20 days; end of isolation 8/19 - Monitor respiratory status and for signs of secondary bacterial infection Submitter does not have access to further medical records or course of hospitalization. If further information is needed, please contact HCF
Expired vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). In October 2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved. 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.   No concomitant medications were reported.  No treatment information was provided.
pt presented w/red, raised maculopapular rash on chest, face & arms;afeb @ this time;fever off & on;
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.  On 06-Dec-2021, Lot 012H21B vials were placed in refrigerator, upon receiving.  Patient received one of these expired booster vaccine.   This case was linked to MOD-2022-448109, MOD-2022-449524.
TIREDNESS; BLURRED VISION; DOUBLE VISION; HEADACHE; This spontaneous report received from a patient concerned a 58 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 not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced double vision. On 12-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 14-APR-2021, and double vision on APR-2021, and had not recovered from headache, and tiredness. This report was non-serious.
On Tuesday morning at 10:30 AM, this child had a temperature of 101. Treated her with Tylenol / Motrin alternating. Temperature 104 by 9 PM, went to the ER. The patient was diagnosed with bronchitis, otitis media, and tonsillitis.
after an hour she vomited; joint pain; fever (maybe low grade fever did not took temperature since it was not significant); chills; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (after an hour she vomited), ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatic cancer (Pancreatic cancer survivor 2019) in 2019. Concurrent medical conditions included Immune disorder (NOS), Psoriatic arthritis since 2011 and Allergy (General allergy (trees)). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM for Anxiety, ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) for Migraine, OXYCODONE, PROMETHAZINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PANCREATIN (CREON), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VOMITING (after an hour she vomited), ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills). At the time of the report, VOMITING (after an hour she vomited) had not resolved and ARTHRALGIA (joint pain), PYREXIA (fever (maybe low grade fever did not took temperature since it was not significant)) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient informed her doctor and was instructed to drink more water for now and may come tomorrow if she's still not ok and will do a lab test for that.   This case was linked to US-MODERNATX, INC.-MOD-2021-089305 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089305:
Weakness in L arm following day. Dull pain, radiates to L elbow. Sore, firm to the touch at vaccination site. Dr. recommended massaging site. Dr. also recommended on 10/06/2020 to attend PT. Zero change with PT as of current date. Dr. recommends referral to orthopedist. Dr. stated that the injection itself could be the cause of the adverse event as it was administered too low in the arm and not closer to the shoulder.
Pt was given Quadracel which is only approved for children ages 4-6 years.  No further treatment was given.  No adverse reaction was noted.
2 weeks after receiving my first dose, I woke up in the middle of the night with severe numbness and burning in both arms and hands that was unrelenting.  The led to a dx of bilateral carpel tunnel on 5/21/21.  Symptoms continued to worsen to include severe joint pain, swelling and stiffness, which led to a dx of rheumatoid arthritis on 12/1/21.
Pt developed RSV diagnosed at the doctors office June 17, 2022 via nasal swab. Pt had cough, runny nose, fever, and was lethargic.
Pt developed rash after 1 wk following vaccine shot. No pets detergents or perfumes. No exposure to being in the woods no soaps. Has macular blanchable, nonvascular rash on anterior ankles, tibial surface (L) knee, elbows, dorsum of feet. Worse at night.
Ringing of ears, headaches, tingling, ear stuffiness, hearing loss, ear pain, vestibular neuritis, trouble focusing, dizziness, nausea, difficulty concentrating.
Headache, lymph node reacted and created a big bump under the same arm that had the vaccine. Fever, very weak legs and knees. I still do not have full use of my arm, general fatigue. I went back to my doctor and was given antibiotic (cephalexin 500 mg) 4 capsules a day. Today I am starting to see some improvements.
High pulse, freezing, fever, feels like ribs are broken when I breathe, severe body aches.
PATIENT HAD SOME INFLAMMATION NEAR THE INJECTION SITE AND SORENESS AFTER THE VACCINE (MORE THAN WHEN THEY TYPICALLY RECEIVE A VACCINE).  AT THIS POINT IN TIME (ALMOST 3 MONTH LATER), THERE IS NO MORE INFLAMMATION, BUT THE PATIENT IS STILL EXPERIENCING SOME RESIDUAL ACHINESS WITHIN THE MUSCLE- STATED THAT THEY HAVE DIFFICULTY SLEEPING ON THE LEFT ARM AND HAS INTERMITTENT ACHES WITHIN THE MUSCLE.  SHE THOUGHT THAT IT WAS WORTH DISCUSSING TODAY WHEN SHE WAS IN THE PHARMACY (12/5/2020) - SHE STATED THAT SHE NEVER SOUGHT ANY MEDICAL TREATMENT FOR THE REACTION AND HAS NOT DISCUSSED THE CONCERN WITH HER PHYSICAN YET.  I RECOMMENDED THAT WE COMPLETE A VAERS REPORT AT THIS TIME, AS IT IS NOT TYPICAL TO STILL HAVE PAIN IN THE MUSCLE AFTER THE FLU VACCINE.  PATIENT STATED THAT IT FEELS ALMOST LIKE THE INJECTION MAY HAVE HIT A NERVE, BUT THAT IT IS SLOWLY IMPROVING/FEELING MUCH BETTER THAN IT DID ORIGINALLY.
Started with chills at 7 hours post vaccine, then throughout overnight developed achiness, headache and fever. Fever as high as 102.1 at one point but mostly lower grade. Symptoms continued through next day.  By 24 hours from symptom inception, only headache remained. The headache resolved approximately 12 hours later.   Also experienced injection site pain.
Information has been received from a nurse concerning a 12 month old female who on 22-DEC-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 661006/1321X). Concomitant vaccinations included MMR II and FLUMIST. It was reported that the patient came back to the physician's office on 15-JAN-2009 for an unrelated appointment and told the nurse that immediately after the vaccination, on 22-DEC-2009, the injection site was red, hot and inflamed, and then a day later, on 23-DEC-2008 the injection site was blue. Then 12 days after the vaccination, on 03-JAN-2009 the injection site turned blue a scab formed and the scab was still there on 15-JAN-2009, but there was no pain. No lab tests were performed. As of 15-JAN-2009, the patient was recovering. Follow-up information was received from the physician. On 22-DEC-2008, the patient with no medical history and an drug allergy was vaccinated with a dose of VARIVAX (Oka/Merck) into the left leg and a dose of MMR II into the right leg at 12 month old. There is no illness at time of vaccination. Per patients mother, 12 days later, on 03-JAN-2009 a scab formed at the injection site. The patient was seen on 14-JAN-2009 for an unrelated reason. The scab was still present at that appointment. No other symptoms were present. No lab tests were performed. The physician reported that the patient recovered on an unspecified date. Additional information is not expected.
headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, at the age of 55 years, on 15Feb2021 at a SINGLE DOSE for covid-19 immunization and tofacitinib citrate (XELJANZ XR), oral from 29Dec2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported having headache after taking Covid vaccine. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Pfizer vaccine was administered outside of the clinic - reported by patient   ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 6/7/2021 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 6/7/2021 ALTERED MENTAL STATUS, UNSPECIFIED
He developed shingles; This is a spontaneous report from a contactable consumer (patient, self-reported). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021, as a single dose for COVID-19 immunization. The patient reported that on 10Jul2021, he developed shingles and was seen in the emergency room, where he was diagnosed and encouraged to call you and report it. His vaccination provider said the same thing. He was in the process of recovering from shingles. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/were experiencing. Because your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider was in the best position to advise you about the appropriate action to take. Outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a 67 year old male patient with coronary artery disease, hyperlipidaemia, anxiety, depression, allergy to PERCOCET and a history of left shoulder rotator cuff in the past who on 15-DEC-2009 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 664864/1365Y) in the left arm. Concomitant therapy included CELEXA, ZOCAR, ATIVAN (as needed), CARDUAR or finasteride (the nurse wasn't sure which one). On 15-DEC-2009 the patient developed an adverse reaction including swelling, heat, redness and cellulitis of his left arm. Approximately 3 hours after vaccination the patient had chest pain, left shoulder pain and pain of his left arm. The patient went to the emergency room and was admitted from 15-DEC-2009 through 17-DEC-2009. The patient was treated with antibiotics. A myocardial infarction was ruled out. It was reported that the patient was put on aspirin and his arm was put in a sling. It was also indicated that the patient said it took a month for his arm pain to go away and for his strength in his arm to return. The results of EKG and enzymes were all negative. These events were considered to be disabling. This is one of several reports received from the same source. Additional information has been requested.
This patient had an indurated erythematous swelling on his left arm at the site of injection.
Mother reported night after administration pt woke up feeling like her throat was closing and felt like she was having trouble breathing, had fever 100.8 and redness/swelling near injection site.
Stem cell transplant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (MODERNA), (MODERNA).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2022 as dose 4 (booster), single (Lot number: 045J21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: STEM CELL TRANSPLANT (non-serious) with onset 17Jun2022, outcome "unknown".  Additional information: Call received from patient who completed primary series and 1 booster dose with Pfizer. had second booster on 23Feb2022, as was Immunocompromised and was diagnosed with Multiple Myeloma Sep2021. However, had to have a stem cell transplant on 17Jun2022, and doctor said had to have 3 months. doctor states that will need to restart COVID vaccinations, so can the Bivalent vaccines be used as primary series, since they provide better protection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.