chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Jul2022) Positive, notes: Rebound COVID 20Jul22. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200996400 same reporter, same patient, same product, different event;
3 1/2 hrs p/vax pt had abrupt onset of screaming & agitation; remained alert but gasping respiration, cyanosis; this cont for 2 1/2 hrs; temp to 101;
11/11, pt restless, irritable, awakening at night. Pt given Motrin according to wt. 11/14, pt had green rhinorrhea & temp 102.8 for 2 days. Pt developed a fine, red, raised rash on trunk. Dr tx:Cefzil & treated pt for sinus infection.
Pt vaccinated with DTP/OPV developed fever of 103; Screaming episode more than 3 hrs.
11/12/15 955A flu vaccination quadrivalent FLUZONE given. No prior rxn, allergies or concerns. On 11/13 919A pt RTC with concern for hives, external itch to (B) axilla and (B) medial thigh beginning at 11pm 11/12/15 and then resolving overnight now with (B) feet tingling - more internal that has resolved. T 98.4 122/74, HR 60 RRR, RR 105 at 98 RA exam NL lungs CTA, no lesions, NVD, hives or angioedema noted to keep PMD FU today.
This case was reported by a consumer and described the occurrence of strange symptoms in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. On 15 April 2005 the subject received the 1st dose of Engerix-B (lot AHBVB030AA). Less than one month following the 1st dose of Engerix-B, on an unspecified date on or after 15 April 2005 and on or before 15 May 2005, the subject experienced "strange symptoms." On 15 May 2005 the subject received 2nd dose of Engerix-B (lot AHBVB030AA). On 15 September 2005, the subject received the 3rd dose of Engerix-B (lot AHBVB076AA). This is sooner than the recommended interval of 6 months between the 1st and 3rd doses of Engerix-B. The subject reported that, "now that I have had all three shots, the symptoms are worse." The subject was seen at a physician's office. The subject reported that she is "losing her job because she can not get a definitive answer from a doctor and I can't work with the symptoms I have."
PATIENT DID NOT FEEL GOOD AND WAS DIZZY 30 MINUTES AFTER VACCINATION. PATIENT STARTED TO FEEL WORSE AND NEED HELP TO GET TO BED THAT EVENING.  PATIENT WOKE UP IN MIDDLE OF NIGHT AND FELL AT 2AM. AT 5AM PATIENT COLLAPSED AND WAS UNCONSCIOUS FOR 1 MINUTE. WIFE CALLED 911 FOR PATIENT TO GO TO ER.
arm goes numb; diarrhea; feels like pins and needles going from shoulder to baby finger; itchy rash; scaly rash; patient reports that she still has tingling and numbness in her right arm injection site; dry, patchy, scaly, itchy rash; fever; chills; shoulder pain; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash) and EXFOLIATIVE RASH (scaly rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) for Shoulder pain, at a dose of 1 dosage form; DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Shoulder pain, at a dose of 1 dosage form and Physical therapy for Paraesthesia. At the time of the report, HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired) outcome was unknown.            No concomitant medications were reported.  Patient was given steroid injections in her right shoulder and right elbow for the event tingling in her right arm.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: follow-up received on 21jun2021. Event - Tingling in arm treatment information was appended like physical therapy and steroid injection.
Developed a migraine and stiff neck and back aches exactly 1 week after the 2nd Covid shot. Just woke up in pain. A week later I lost vision, everything was blurry for 2 weeks any time I was walking, and could not drive. Went to 2 emergency rooms, was in the hospital for 2 days. Was in and out of work for a month. Had to use short term disability.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 19-SEP-2014 the patient was inadvertently administered with (Oka/Merck) VARIVAX (lot # H011724, expiration date: 12-JUN-2014) dose and frequency unknown, subcutaneously. This was supported. No adverse effects were reported. Outcome of the event was not reported. No produce quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
I received the vaccine at 6:30pm on 12/27.  I worked atb7pm and took lunch at 2:00am. After lunch, I immediately felt sick to my stomache and threw up. I went home after my shift and went to bed. After 5 hours, I woke up and went to the couch to lay down while kids watched TV. Next, I woke to several people in my house. I had a seizure and my son had called 911. I was taken to emergency department. I was admitted and stayed 2 nights in the hospital.
This spontaneous case, initially received on 23-Aug-2016, was reported by a health professional and concerns a female patient. Past medical history included COPD (chronic obstructive pulmonary disease), peripheral neuropathy, atrial fibrillation, abdominal aortic aneurysm and anxiety. Drug history included drug reactions/allergies to cefazolin and diphenhydramine. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced drug reactions/allergies (outcome: not reported). On an unspecified date in July 2015, the patient began therapy with KEYTRUDA injection for advanced non-small cell lung cancer 'refractory to all prior treatment' and died to progression of the disease. At the time of death on 11-Mar-2016, the patient was taking unspecified doses of the following medications: albuterol, alprazolam, DULCOLAX, SYMBICORT, DIPROLENE, vitamin B-12, COLACE, doxycycline, furosemide, gabapentin, MUCINEX, hydrocodone, DUONEB, lactobacillus, levothyroxine, magnesium chloride, metoprolol, morphine, multi-vitamin, prednisone, prochlorperazine and warfarin.
I experienced SIRVA in my left arm very soon after my Flu shot (within hours). It just got worse as time went on. Treatment consists of rehabilitative type exercises, pain medication and muscle relaxers.
ADMINISTERED VACCINE HELD IN REFRIGERATOR FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced administered vaccine held in refrigerator for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine held in refrigerator for more than 6 hours was not reported. This report was non-serious.
This case was reported by a pharmacist via a sales representative and described the occurrence of acute trouble breathing in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 November 2008 the subject received unspecified dose of FLUARIX (unknown). On 24 November 2008, less than one day after vaccination with FLUARIX, the subject experienced acute trouble breathing also described as "acute breathing". At the time of reporting the outcome of the event was unspecified.
A 78-year-old man with a medical history of atrial fibrillation presented with complaints of 5 days of severe generalized weakness and difficulty walking. He also reported difficulty in getting up from a chair and difficulty while lifting his arm. On further questioning, he also reported taking an influenza vaccine shot a few days prior to his weakness. He reported a history of similar illness with respiratory issues requiring tracheostomy after a simple upper respiratory infection when he was 10 years old. Physical exam showed significant proximal as well as distal muscle weakness in the bilateral upper and lower extremities. Sensations were preserved, and reflexes were absent. His laboratory workup including complete blood count, electrolytes, TSH, CPK, and aldolase levels were normal. MRI head was unremarkable. An electromyogram with nerve conduction study showed evidence of chronic inflammatory demyelinating polyneuropathy (CIDP). This episode was probably from activation of chronic inflammatory demyelinating polyneuropathy triggered by influenza vaccination. The episode during childhood was presumably an episode of Guillain-Barre syndrome that developed into CIDP. He was promptly started on corticosteroids. He showed gradual improvement in weakness. He was subsequently sent to a physical rehabilitation center. The patient was advised not to repeat influenza vaccination in future." Documents held by sender: none.
Child received PROQUAD at 11:06am - vomited right after shot was given. He was well and acting fine after vomiting. Around 11:50am he developed about 8 hives on and around shot site (left arm). 10 min later mom called back because hives moved to his face. No distress, breathing fine. Can eat and drink swallowing fine. Told mom to give BENADRYL 1 tsp per 22 lb. Any distress needs to go to ER.
Developed an itchy rash at the site of the injection. The rash became very red, itchy and felt tight and uncomfortable. The rash lasted for about 4 days and was completely gone by day 5.
10 minutes after receiving vaccine, had diffuse itchiness, sensation of dyspnea, diffuse erythema. Treated at ED with BENADRYL, SOLU-MEDROL, ZANTAC, d/c'd home with BENADRYL and prednisone x 3 days.
Multiuse vial was in the refrigerator, dated 12/09 as being opened. Vial was used for administration 12/12 but the vial should have been discarded. There was no adverse reaction noted to the patient.
Admission Date: 9/13/2022 Discharge Date: 9/16/2022  PRESENTING PROBLEM: COPD with acute exacerbation COVID-19   HOSPITAL COURSE:    The patent is a 66 y.o. male with past medical history of asthma, chronic obstructive pulmonary disease, home O2 6 liters/minute nasal cannula oxygen supplement, obstructive sleep apnea on BiPAP at home, chronic systolic and diastolic congestive heart failure, coronary artery disease, hypertension, and diabetes mellitus type 2.   He presents to the hospital on 9/13/2022 with difficulty breathing, diaphoresis, chills, coughing with some phlegm, increased dyspnea with exertion. On 9/13/2022, his primary care physician appointment diagnosed with COVID-19 infection.     Chest x-ray showed mild vascular congestion but normal BNP.  His troponin -18 and he has leukocytosis 13,000.  Recently the patient was on prednisone 20 mg orally daily for his asthma, but so far that was tapered down to 5 mg of prednisone daily only. Received 3 days of remdesivir. Patient was started on decadron, doxycycline for a five day course, will be discharge with 3 days to complete the course. Once the decadron course is completed patient will resume prednisone 5 mg daily as prescribed by pulmonary doctor.  Lasix 40 mg IV BID started, but was switch to home dose lasix 40 mg PO BID yesterday. Net IO Since Admission: -4,898 mL [09/16/22 1024] Weight on admission 103.8kg, 100.3 kg at discharge. Recommend echocardiogram outpatient. Patient discharged with 40 mg lasix once daily- patient reports taking daily weights at home. Discuss a heart healthy diet, sodium restriction, and limiting fluids. He will need follow up with PCP to evaluate diuretic requirements.    Patient was seen and examined. He is alert and oriented. Patient is asking to go home and feels that he is at baseline. Reports shortness of breath is at baseline. Denies chest pain, headache, n/v/d/c, abdominal pain. Patient is discharged in stable condition- all labs and imaging reviewed. No concerns at this time. All questions were answered prior to discharge.
Generalized itching, arms, legs, face, chest, back. Started April/May 2021. Continued and got progressively worse. Had been using antihistamines, lotions, and creams which I use for eczema. No relief.  Jan. 28, 2022;  Itching getting progressively worse. Saw dermatologist. Stronger topical steroid. May 25, 2022; Itching has been all consuming. Scratching until there were sores. Generally not feeling well. Given Clonazepam and Hydroxyzine. Discussed oral steroids. Oct. 23, 2022; Red raised rash also involving oral and genital mucosa. Given Prednisone x 3 weeks.
Pt received Menveo vaccine in RD and Tb skin test in left forearm, approximately 7 minutes after receiving vaccine pt became light headed and fainted, fell to floor began having seizure like activity for approximately 1-3 minutes, pt had hit head in the process of falling, pt came to was Alert and oriented, after laying on floor for approximately 10 minutes moved pt to exam room table and pt then again began feeling faint and went into seizure like activity again for approximately 30 secs then came to. EMS was called and sent to hospital where pt was evaluated.  Never had a hx of fainting with vaccines but has had hx of fainting with sight of blood.
9/19/2022 I went to the doctor after being in the hospital, not related to vaccine, for a checkup. Because my wife had tested positive for COVID, I took a test and it came back positive.  I remained asymptomatic.
No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 41 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Rash on shin and knee; Fever; chills; sore bones; headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included NAPROXEN (NAPROSYN E), ATENOLOL, LEVOTHYROXINE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERSYL PLUS [INDAPAMIDE;PERINDOPRIL ARGININE]) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced RASH (Rash on shin and knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (chills), BONE PAIN (sore bones), HEADACHE (headache), FATIGUE (Fatigue) and RASH (Rash on shin and knee) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Dark and painful urination; dark and painful urination; Pain in back of left thigh; Fatigue; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 33-years-old on 05Jul2021 10:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included depression, anxiety, post-traumatic stress disorder, scoliosis. Pregnant: No. The patient previously received first dose of bnt162b2 at age of 33 years old on 14Jun2021 for COVID-19 immunization. Concomitant medications included paracetamol (TYLENOL); ibuprofen; duloxetine hydrochloride (CYMBALTA); trazodone; hydroxyzine taken for an unspecified indication, start and stop date were not reported.  Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dark and painful urination, pain in back of left thigh, fatigue on 06Jul2021 15:30. No treatment was received for the events. Outcome of events was not recovered.  The patient was not  tested covid post vaccination.   Information on the lot/ batch number has been requested.
Leakage while administering vaccine; Leakage while administering vaccine; A spontaneous report was received from a pharmacist concerning a 31-year-old, male patient who experienced leakage while administering vaccine (underdose and device connection issue).   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 27 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that there was a leakage while administering vaccine to the patient. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, leakage while administering vaccine (underdose and device connection issue) was considered resolved.; Reporter's Comments: This report refers to a case Underdose and device connection issue for mRNA-1273, lot # 030M20A, with no associated AEs