chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away.  On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.
18 45 pm, patient stated she felt fainting. Bp 116/64, SaO2 100% RA, Glucose 84, RR 20, HR 61. Patient was in lying flat position. 18:47 pm, 911 was called. Reported patient is awake and alert x 3 and VS. Followed instruction not to have patient eat or drink. 19:01 pm, O2 97% RA, HR 73, T 97.7, BP 126/76, patient is in sitting position, remains awake and alert x 3. Patient stated she does not have any friend/family to come to pick her up and she lives in San Francisco. A fire officer arrived at 19:10 pm Patient's BP 120/81, O2 SAT 99%, HR 75, RR 18. Patient signed the document not to have further treatment or to be admitted to the Hospital. Patient stated she was doing fine and left the facility with steady gait, and fully consciousness with the Fire officer to the parking lot. The Medical Professional was called in the command center and stated we did everything properly without any further questions/issues at 19:29 pm.
8/4/08 Telephone call from patient reports she received vaccine 7/31/08.  8/1/08 & 8/2/08 swelling to L upper arm with redness.  She also reports injection site felt "hard".  She also reports itching, burning at injection site.  Patient reports improvement of symptoms 8/4/08.
Sore arm directly after injection which lasted 2 weeks, 3 hours after injection had significant shortness of breath which lasted over 24-36 hours, then during the same time period began severe joint pain which made it very difficult to walk or move for approx 4 days, fatigue for 1 week, and joint pain has lessened, although still ongoing, although not as severe as the first 4 days.
Patient stated she had trouble moving her arm after getting vaccine.  Soreness in the area.  Could not move after a while.  Has needed physical therapy.  Just told the pharmacy on 4/10/19.
he had a full blown vesicular rash/ papular rash; the patient experienced "injection site pain and itching"; the patient experienced "injection site pain and itching"; vesicular rash to his left upper extremity/he had a full blown vesicular rash; Indication: "patient has HIV"; This spontaneous report was received from a physician referring to a 50 years old male patient. The patient's medical histories included human immunodeficiency virus (HIV) and hepatitis C. The patient's drug reactions/allergies included sulfa. The patient had no concomitant medications.  On 19-NOV-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S004548, expiration date 12-AUG-2020; strength and dose details were not reported) intramuscularly for prophylaxis (reported as HIV) (product use in unapproved indication). On 23-NOV-2019, the patient experienced injection site pain and itching, vesicular rash to his left upper extremity. By 24-NOV-2019, the patient had a full blown vesicular rash/papular rash. By 01-DEC-2019, the rash was crusted over and he was healing. There was no lab diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the events was reported as still recovering. The causality assessment was not reported.
Information has been received from a physician concerning a 5 year old female with bilateral sensory-neural hearing loss and a history of neuroblastoma (May 2004; treated with chemotherapy; October 2004 thru November 2004), "rejection" (August 2004), and no known allergies, who was vaccinated with VARIVAX (Oka/Merck). On 11-OCT-2007, she developed malaise and fever with a maximum temperature of 38.7 and was hospitalized with herpes zoster. The herpes zoster dermatone was reported as the right ophthalmic branch of the trigeminal nerve with lesions on her forehead, scalp, and eyelid. Diagnostics included VARIVAX identification scrapings. The samples were collected on 18-OCT-2007 from a vesicle on her right scalp and right forehead (results not reported). Treatment included acyclovir. As of this report, it was reported that she was still recovery. A product quality complaint was not reported. No further was available. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify VZV was present and if is was present to identify if it was associated with the wild type VZV strain or with the Oka/Merck VZV strain. Follow up information indicated that the PCR results from the vesicle on her right scalp and right forehead identified the presence of WT VZV. Additional information has been requested.
Swelling, with small pustules, warm to touch. Seen in ER - Given oral antibiotics; Sub-cutaneous nodule 3x4cm.
1 day after vaccine, pt developed hives all over her entire body. Mother called ER who recommended Benadryl. She presented to PCP office for evaluation, confirmed Benadryl 25mg qid through 10/27/03.
Best use date was 4/21/2022  and actual expiration date was May 31 2022.
Pt recvd 3 doses of Engerix-B on 18JUL90, 28AUG90, & 17JAN91 & was found to be a non-responder;
Runny nose; Coughing; Sweating; Cold; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included CARVEDILOL for an unknown indication.    On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold). At the time of the report, RHINORRHOEA (Runny nose), COUGH (Coughing), HYPERHIDROSIS (Sweating) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Felt heavy arm after shot in arm, no worse after waiting 10 mins.  Client went home
Adult Td given in error; should have been Prevnar, Aventis, Lot # U1943CA 0.5 ml, IM, LL
Pt recvd Engerix-B 20FEB92 & 19MAR92; 19MAR92 pt exp 8 in area of erythema & severe pain @ inject site;
Pt. returned on day 7 with reddened swollen arm, pain axillary lymphadenpathy, fever 102, Limited rom arm.Deltoid area, warm to touch, malaise, Treated with Levaquin 500 mg 1 po qd #5
PT IS COMPLAINING OF SEVERE SHOULDER PAIN DUE TO THE VACCINE ADMINISTRATION.
This spontaneous report as received from a nurse refers to several patients of unknown age who was vaccinated with a dose of MMR II which were exposed to 51 degrees F for 9 hours. There was no adverse effected reported. It was unknown if the patients had sought medical attention. At the time of report, the patient's status was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Breakthrough case after 3 vaccines Moderna 1/21/21 Lot# 027L20A;  Moderna 6/17/21 Lot# 036C21A;  MOderna 1/16/22 Lot# 022J21A
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
PT EXPERIENCED TINGLING IN NECK AND BEHIND EAR; LATER WAS UNABLE TO SMILE AND HARD TO MOVE RIGHT SIDE OF FACE; DIAGNOSED WITH BELL'S PALSY IN ER;  RECEIVED ACYCLOVIR AND PREDNISONE FROM MD FOR TREATMENT
Left lateral thigh was swollen, red, firm to touch and painful area 9cm x 7.5cm in size.  Fever up to 102F the evening after injection 8/12/09 and the next day.  Treatment plan Motrin dose for age prn for pain and fever, Benadryl dose for size prn and cold compress to area.
Case number PHEH2014US003713, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 09-year-old female patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 009031A) intramuscularly on 15 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014 of the data received on 21 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Moderna Covid-19 Vaccine EUA  Chest pain, Racing heart, Shortness of breath, Ringing in ears, Dizziness, Dry Mouth, Stomach cramping
Information has been received through the Merck pregnancy registry from a physician concerning a 15 year old female with a history of dysmenorrhoea and bee sting who on 03-DEC-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 656372/0243U). Concomitant therapy included MENACTRA, NAPROSYN, PAMPRIN and TUMS. On 05-FEB-2007 the parents of the patient called the office to report the patient was pregnant. Her LMP was 25-DEC-2007 with an expected due date of 30-SEP-2008. The patient had 2 positive pregnancy tests via urine and blood through another office. On 15-FEB-2008, the patient experienced an elective termination of her pregnancy at 11 weeks from LMP. It is unknown if the products of conception were examined and if the fetus was normal. Physician reported that the patient was not actually exposed to GARDASIL during pregnancy since her first dose was given during LMP and the second dose after threatened abortion (TAB). The patient did not use any medication during her pregnancy. Upon internal review elective termination was considered to be an other important medical event. Additional information is not expected.
heart rate High; She Vomited; Temperature 101.3; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate High), VOMITING (She Vomited), PYREXIA (Temperature 101.3) and FATIGUE (Fatigued) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced HEART RATE INCREASED (heart rate High), VOMITING (She Vomited), PYREXIA (Temperature 101.3) and FATIGUE (Fatigued). On 30-Dec-2020, HEART RATE INCREASED (heart rate High), VOMITING (She Vomited), PYREXIA (Temperature 101.3) and FATIGUE (Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Body temperature: 101.3 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she is on immunosuppressants. Patient used acetaminophen for treatment.
malaise; lack of energy; cough; difficulty breathing; tight chest; is expectorating a green mucous and sometimes with blood; headache rarely; 100.9 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing) and CHEST DISCOMFORT (tight chest) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, ENALAPRIL, LEVOTHYROXINE, SIMVASTATIN, LINAGLIPTIN (TRADJENTA) and TAMSULOSIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and GUAIFENESIN (MUCUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt reported she noted shortness of breath approx 1 1/2 to 2 hours after receiving imm's, went to ER, treat with Benadryl 50mg PO, Ativan IM g PO, Decadron 10mg IM 16:13 to 18:04, B/P 129/92, p-92, r-22, 02Sat97 at 16:34 and 17:32, B/P 116/77, P-90, R-18 02Sat96. To note: Pt reports allergies to Penicillin, Lidocaine, Iodine, shell fish, pain meds.
red blotches around her upper right arm; arm felt warm; more achy; mild right arm ache; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm), PAIN IN EXTREMITY (mild right arm ache) and PAIN (more achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     No medical history reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (mild right arm ache). On 01-Feb-2021, the patient experienced RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm) and PAIN (more achy). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Blotchy rash, Pain and Vaccination site warmth, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm) and PAIN (more achy) outcome was unknown and PAIN IN EXTREMITY (mild right arm ache) was resolving.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Additional treatment details included ice, wet cloth.
Extreme pain in chest especially heart area - felt like a painful air bubble.  Hard heartbeat, elevated systolic blood pressure (174/85), extreme headache and lightheadedness.  Pain in upper abdomen especially the left side.  Fever 3 degrees above normal and total body aches. Very painful left arm Two days post: 11/16/2021 - Fever 2 degrees above normal, pain in chest and abdomen is less but still noticeable.  Systolic blood pressure still elevated 162/84 (which is usually 120/80 managed with medication) Body aches and pain in arm is less.
Patient under 18 years old received Moderna vaccine as first dose in COVID19 vaccine series. When pt returned four weeks later to receive second dose, this error was discovered and discussed with adult caregiver. Pt then received Pfizer as her second dose. Clinic staff noted that patient appeared to be in good health with no adverse effects resulting from Moderna administration  4 weeks earlier.
The patient experienced extreme tiredness, low grade fever, aches from neck down, and what she described as fuzzy or cloudy thinking. This lasted for 3 days. She was unable to work for 2 of those days.
11/01/01 -After flu shot, Arm swollen & sore; 11/02/01 - Left gym early, Tired, Could not run, Legs weak while playing raquetball, 11/02/01 - 12/31/01- Became progressive tired, Been taking naps (which was unusual) + calves start bothering him; About 12/15 -12/31 Pins and needles in hands and feet, By 12/24, tingling sensation in hands and feet which became very strong by 12/25/01; 12/24/01 - Tired,Legs felt heavy, Calves felt sore; 12/25/01 - Tired, Calves sore + a little swollen, Funny tingling sensation in hands & feet; 12/26/02 -Tired, Slept long in early AM, Very restless sleep, Tingling in hands and feet intensive, Calves still sore & slighty swollen, Not walking very well, Pain in calves when walking, Restless sleep at night; 12/28/01 - 11:45 AM appt with family Dr, Could hardly walk, Tingling very bad in hands and foot, Dr did physical and took x-rays, All seems normal, Dr you was baffled; 12/29/01 - Could not stand with walker, Began falling resorted to crawling, which was painful, Could not sleep on either side of body, Could not sleep - very uncomfortable all nite and morning tried to get up kept falling; 12/30/01 - Could not stand alone or with walker, could not crawl - all too painful, Calves very swallow, Called on-call dr, Suggest waiting until next day to see our dr or to come into emergency room, Had a very bad night; 12/31/01 - called dr's office, Wanted to have him come in office, Pt's legs and hands immobile (Paralysis) Neighbors carried him into car and took him the the emergency room, Did another physical, catscan, MRI's & other tests, Did a spinal tap that revealed Guillain-Barre syndrome; 12/31/01 - Admitted to critical care unit, There for 5 days, then moved to neurological unit, Did intravesous immunoglobulin in critical care + other tests; 01/14/02 - 12/23/02 - Moved to rehabilitation center for care & physical & occupational therapy; 12/23/02 - discharged from rehabilitation center; 03/25/02-03/26/02 Did physical & occupational therapy for 2 hours/day for 2 days a week. 60 day follow up states pt has not recovered. Ambulation is still a problem. May 2002 he recovered his fine motor skills. Continues to have difficulty using his arms . 02/23/2002 pt discharged . Awaiting a return call from MD. MD will inform of discharge details. MD treating physician while pt was in rehab. 95% improved. 04/17/2003 difficulty with fine motor coordination Annual follow up states as of 04/17/2003 Spoke to MD treating physician. MD states that the pt continues to have difficulty with his fine motor coordination, but has shown 95% improvement.
Information has been received from a female subject of unknown age reporting about herself enrolled in a study. The subject's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the subject was vaccinated with PNEUMOVAX 23 (dosage regimen was not reported). On an unknown date the subject enquired if it was normal to feel run down (depressed mood) and tired (fatigue) after getting PNEUMOVAX 23. The outcome of depressed mood and fatigue was not reported. The causality between the events depressed mood and fatigue and PNEUMOVAX 23 was not reported. Additional information has been requested.
Event: I developed shaking chills, sweats, and moderate headache beginning 10 hours after receiving my second Moderna Covid-19 vaccine dose. Temperature was not recorded. Treatment: I took acetaminophen by mouth shortly after symptom onset. I took an additional acetaminophen 6 hours later. I then took ibuprofen 3 hours after that. Outcome: Symptoms were controlled with acetaminophen and ibuprofen. Symptoms completely resolved within 24 hours of receiving the vaccine dose.