chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative referring to a 49 years old female patient. Concurrent condition included adult celiac disease and hypothyroidism. The patient's medical history included acute asthmatic bronchitis. Information about concomitant medication not provided. On 28-FEB-2019 the patient was vaccinated with PNEUMOVAX 23 (lot # R033343 with expiration date 03-AUG-2020; strength, dose and route were not reported) in the left deltoid for prophylaxis. On 01-MAR-2019, the patient experienced redness and swelling at the injection site and all over the upper left arm. The patient went back to the to the physician's office on 01-MAR-2019, where it was noted that the redness and swelling was 6 inches by 6 inches in diameter. The physician recommended applying ice to the area and taking acetaminophen (TYLENOL), but to go to the emergency room if symptoms worsened. The patient did decide to go to the emergency room on 02-MAR-2019 due to the symptoms, where she was admitted to the hospital. The patient was diagnosed with cellulitis and sepsis. During hospitalization, patient received azithromycin as treatment. The patient recovered completely by 06-MAR-2019 and was discharged from the hospital on 06-MAR-2019. The physician was requesting a lot check and was requesting expedited response. The outcome of cellulitis and sepsis was reported as recovered. The causality assessment was not provided. Upon internal review, the events cellulitis and sepsis were determined to be medically significant.
My stomach, back, arms, and legs broke in in rash along with large hives; My stomach, back, arms, and legs broke in in rash along with large hives; This is a spontaneous report from a contactable 37-year-old female nurse reported for herself. A 37-year-old (non-pregnant) female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL0140, Expiration date: unknown), via intramuscular, administered on right arm on 08Feb2021 01:00 PM (Age at vaccination: 37 Years) as Dose 1, single for COVID-19 immunization at Living Facility. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and  had no Allergies to medications, food, or other products. The patient medical history includes Covid-19 on an unspecified date and concomitant medications include Lisinopril, buspirone hydrochloride (BUSPAR) and ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). Prior to vaccination patient was diagnosed with Covid-19 and since the vaccination the patient was tested for covid-19 with a negative result. On 08Feb2021 08:00 PM, the patient experienced stomach, back, arms, and legs broke in in rash along with large hives. The events assessed as non-serious. Lab data and other procedures include SARS-CoV-2 test (nasal swab) negative on 03Feb2021. Patient received Claritin and Benadryl as treatment options. The outcome of the events was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Seizure; Keratitis; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and KERATITIS (Keratitis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Coronary artery bypass in 2017, Leg amputation in December 2018, Leg operation (SURGERY IN LEG BLOOD VESSEL) in 2020, Gallbladder operation NOS and Carpal tunnel release. Concurrent medical conditions included Abstains from alcohol, Non-tobacco user, Sulfonamide allergy (All sulfur medicines manifest nausea), Blood pressure high, Plaque psoriasis, Neuropathy, High cholesterol and Diabetes. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, LOSARTAN for Blood pressure high, INSULIN for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, GABAPENTIN for Neuropathy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In May 2021, the patient experienced KERATITIS (Keratitis) (seriousness criterion hospitalization). On 17-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 17-May-2021 due to SEIZURE. On 17-May-2021, SEIZURE (Seizure) had resolved. At the time of the report, KERATITIS (Keratitis) was resolving.            Patient's concomitant medications also included taking unspecified vitamins. As per the patient's wife, he still had keratitis two weeks ago (as of 28-MAY-2021).  Unknown lab tests were done as well as unknown medications prescribed.  The patient was still taking unspecified antibiotics for the keratitis.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Also, the co-suspect drug humira should be considered as a confounding factor to the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Also, the co-suspect drug humira should be considered as a confounding factor to the events.
Sore Arm, Vomiting, Body aches, Slight fever, Headache, Stiff neck, Weakness, Diziness, Black Tongue. Took Tylenol, Darmine, Sips of water. Still have some of the symptoms 3 days now.
Patient presented to clinic the next day roughly 26 hours after injection with redness around injection site that was warm to the touch, pain 4/10. Patient was seen by the provider here at the clinic and was prescribed an antibiotic.
Patient reports an episode of dizziness about 2 hours after receiving the Moderna vaccine, lasting a little over an hour. He reports now that the symptoms seem to be overall improved, it is now 4.5 hours after the vaccine injection. Symptoms improved with rest, hydration, a snack and also took Sudafed as he thought it might be ear congestion initially.. Denies weakness, changes in his breathing, new swelling, confusion.  Pt declined office visit appt. Agreed to go to ED/UC  for new/worse/return of symptoms.
Patient given Pfizer comirnaty COVID vaccine on 4/18/22; beyond use date 4/12/22.
1st dose Nov2021, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Nov2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The pharmacist enquired that do he/she need to restart the series or administer the 2nd dose now. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
I started experiencing a type of anxiety feeling that rushed through me that lasted for a minute or so at least 4  - 6 times a day which started the day after my injection and had lasted for a couple of weeks.   It is not a hot flash but as I explained a type of anxiety feeling which I have never had in my entire life.  I?ve always been a healthy non sick person.  I still experience these effects a few times a week.  Actually I was very hesitant about any of these vaccines and now I am sorry I got.   I have not sought medical attention because the symptoms did subside and I will be having my once a year physical in the coming months. Have there been any other symptoms reported similar to mine?  Thank you for your time
Patient came in 10/21/19 with a full body rash on trunk and arms.  He said it started later the day of the immunization.  I told him to take Benadryl, cortisone on worse spots and aveeno baths to help control.  Dr. phone number did not work on Monday 10/21 to notify, but will try again.  Told pt may need medal dose pak.
Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    Concomitant medication was not provided.  It was reported that the vial size was 0.4 ml per vial. The vial was initially stored in refrigerator on 23-Dec-2022. The vial did not undergo any temperature excursion. Treatment information was not provided.  This case contains information for the 13th patient out of 42 pediatric patients as described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Patient is a 76 y.o. male patient of CNP with history of type 2 diabetes mellitus, hypertension, BPH, obstructive sleep apnea on CPAP nightly, atrial fibrillation on Eliquis, history of gout, history of nonobstructive coronary artery disease, HFpEF, asthma/COPD on chronic O2 at 3 L/min presented to Hospital with increasing shortness breath that has been worsening over the last several days.  He denies any fevers or chills and denies any chest pain.    Acute exacerbation of COPD/Asthma with hypoxia Acute on Chronic Respiratory Failure Chest x-ray-No significant change. Continued left hemidiaphragm elevation with adjacent atelectasis Continue Augmentin Continue IV steroids, Inhalers Wean oxygen as tolerated- baseline Oxygen 3 L     Type 2 diabetes mellitus A1C 6.1  Resume home meds    Obstructive sleep apnea Continue CPAP at home settings with supplemental oxygen at 3 L/min   Hypertension We will hold Cozaar as patient had low blood pressure on arrival.   Paroxysmal atrial fibrillation We will continue Tikosyn 500 mg every 12 hours and metoprolol 25 mg daily Cardiology following   HFpEF We will continue Demadex and spironolactone Cardiology following Echocardiogram 8/21/23- EF 76% grade I diastolic dysfunction   Covid-19 Virus Infection Date of onset of symptoms: 3-4 days ago Symptoms present on admission: cough , shortness of breath Date of covid positive test: 9/18/23 Vaccination status: vaccinated Imaging: chest x-ray- left hemidiaphragm elevation with adjacent atelectasis Oxygen requirements on admission: yes Current oxygen requirements: 3 liters Consultants following: ID consult Anticipated special isolation end date: 9/28/23    Continue IV steroids, then transition to oral steroids S/p Remdesivir
Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenched in sweat: VIOLANT headache: SEVERE all-over body aches lasting 24hours. 9am: drenching sweats, nausea, hypersensitivity, hperacusis, overwhelming fatigue, mild nausea. 4/10 : seas, flushing , shaky, lightheaded. 4/11: body tremors, sweats, chills, nausea, diarrhea,. 7pm: tinnitus: severe body aches-diazepam. 4/12: Tinnitus resolved: flushing, profuse diarrhea,: Imodium. 4/313: diarrhea. Polyuria about every 2 hours the entire 6 days, even when taking little to no fluids. No fevers-i never run a fever. When body aches subsided, severe post-op spine and associated leg pain vanished, has not returned.
I was living with my friend and I had my first baby, She got me in touch with a doctor's office near by. He signed his name M.D. I had only been to his office that one time, I think.  My son's 3 month shots appointment. It was December 27, 2000. He got all four of his injections and everything was okay. 3 days later on January 01, 2001, our neighbor friend tried to pick him up to play because it was still m orning, and she stated that he was hard. Patient had passed away. I did not see any signs. I always had these feelings of what if he had a reaction to his shots. I never went back to that doctor again. Patient was born by c-section because i was in labor then the umbilical cord started going around his neck. He was fine right after delivery. He was 3 days late. He was a good happy baby, no medical concerns. No pregnancy issues. I was told that it was SIDS.
She developed a migratory arthritis approx 2.5 weeks after 1st vaccine dose.  Has had dactylitis, involvement of wrist, knee , shoulder, hip so far.  Responds to NSAIDs and has just been started on scheduled course.  Labs otherwise negative for inflammatory arthritis. No other sx prior to onset of polyarthralgia to raise suspicion for infection.
Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 17Feb2021 15:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously had allergies to topical iodine- produces rash. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 16:00, the patient experienced sore arm and headache. No treatment was received for the events. The clinical outcome of sore arm and headache was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
pt stated had red knot on lt upper arm next AM;swelling & redness inc;phone call received from school nurse on 2FEB98;concerned about pt arm;instructed to apply warm compresses & take DPH;pt seen by MD 3FEB98 stated was local rxn;
mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Local rxn to left arm. Large amount of redness, swelling and warm to touch. Tx with Augmentin Followed up in office in 2 days.
Jt pain (R) and (L) shoulder (L) elbow and knee (R) wrist and ROM bilat arms afebrile, rest of ROS (-).
Adverse event: moderate bilateral tinnitus Treatment: masking, mindfulness-based stress reduction Outcome: habituation, decreased prominence but still perceivable currently
Information has been received from a physician's assistant concerning an 11 year old female who on 01-JUN-2007 was vaccinated with Gardasil (lot # 657736/0389U) (doses # unspecified) injection. Concomitant therapy included "T-Dap", and Menactra both also given on 01-JUN-2007. On 01-JUN-2007, approximately 20 minutes after receiving the Gardasil, the patient passed out in the reception area of the physician's office. Medical attention was sought. The patient was fasting and did not have anything to eat before receiving the vaccine. The patient was treated with oxygen and fluids at the physician's office. She was not taken to the emergency room. On 01-JUN-2007, the patient recovered. The reporting physician's assistant felt that the event was serious because the patient was given oxygen (Other Important Medical Event). Additional information has been requested.
Awoke with redness, swelling and painful left upper arm. Forgot he had pneumovax 1998 and received number 2 1999. 01/06/2005 actually 3rd dose discussed this with MD 2 days after 3rd dose given. 01/07 placed on duricef and clarines 01/08/2005 redness/swelling slightly improved. Redness left shoulder and elbow
Woke up at 1 am will chills and rigors. Didn't take her temperature but took TYLENOL. Had a mild headache and didn't sleep well. Took temperature in the morning when she got up and it was 100.0. Had a reported golf ball sized welt on her arm at the site of the injection the am of 8/17, not red or hot, bruised by the end of 8/17. Temp gone by end of day 8/17. Welt gone by 8/17.
Patient given HPV and Typhoid vaccines. Then patient turned for Hepatitis A vaccine. Immediately after the Hepatitis A vaccine, the patient fainted. He was speaking throughout but became weak. He layed down for approximately 10 mins, drank water, then got up. He used the restroom and was speaking and walking without incident. Patient was accompanied by mother.
having a heart attack; couldn't breath; lungs were filled-up with fluid; felt like a pin cushion; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included breast cancer/her breast cancer had came back in the same place from 2006, both breasts removed on 2006. Concomitant medication included palbociclib (IBRANCE) taken for breast cancer female from 24Jun2020 to 04Feb2021 then from 01Apr2021 and ongoing. The patient previously received the first dose of bnt162b2 (lot number: EL3248) on 17Jan2021 for COVID-19 immunization and experienced acute bronchitis. On 14Feb2021, the patient was taken by an ambulance and was hospitalized because she couldn't breath, they thought she was having a heart attack, her lungs were filled-up with fluid. The doctors had her on oxygen while she was in the hospital, and did heart and lung tests on her on an unspecified date in 2021. While in the hospital, the patient felt like a pin cushion on an unspecified date. The patient left the hospital on 17Feb2021. The patient was tested for COVID-19 three times on unspecified dates all with negative results. the patient was hospitalized again on 25Feb2021 to 01Mar2021 for reasons not reported. The outcome of the events she couldn't breath, thought she was having a heart attack, her lungs were filled-up with fluid was recovered on 17Feb2021, while for the event felt like a pin cushion was unknown.
Calf pain started 1/12/21, worsening over the next 6 days. Diagnosed with deep vein thrombosis (DVT) in left popliteal and left soleal vein on 1/18/21. Put on Apixaban for treatment  for 6 months. Repeat ultrasound on 4/17/21 showed resolution of popliteal DVT (scar tissue in soleal vein remains). Will remain on Apixaban until July 18 and then assess long-term risk (low dose long-term prevention versus going off medicine).
Sore, red at shot site; hoarse voice; sore, itchy, red eyes; cough; headache; fatigue.