chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with hypertension and blood cholesterol increased. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date the patient experienced neuralgia and adverse event. The outcome of neuralgia was reported as not recovered/not resolved.
cold & cough;vomiting, drowsiness & rash;gen morbilliform rash;Koplik's spot on physical exam;
On 2/8/22, patient reported that he had received the first dose Moderna COVID vaccine in October 2021 at the Pharmacy. A few hours later he developed nasea/vomitting/hives/difficulty breathing and "could not stand up". He also developed migraines. Difficulty breathing continued for a week. He did not think of going to the emergency room, neither did he report the reaction to the Pharmacy. He will speak with family MD regarding getting Janssen booster shot.
11 hours after the injection I developed sever, uncontrollable shaking.  Walking was very difficult.  It was almost impossible to do anything with my hands.  The shaking lasted 1 hour.
Pt. had stem cell transplant June 2022 and needed to start his COVID vaccinations over again. No reviewed guidelines & reviewed info with patient. 1st dose of monovalent moderna given 11/1/22. 2nd dose given 12/1/2022. No adverse event for either dose.
I had severe chills and body shakes then fever and sweating. Injection sight soreness and weakness in that arm. The next day the area around the injection site went red and warm.
Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose). On 19-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2nd dose 21 days after 1st dose/ 2nd dose administered less than 26 days after 1st dose) had resolved.            Concomitant medication include  regular medications and did not provide names of the medications. No treatment information was provided   This case was linked to MOD-2022-442530 (Patient Link).
pain at the injection site; This case was reported by a pharmacist and described the occurrence of injection site pain in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. At the reporter's facility they had complaints of pain at the injection site two to three weeks following the administration of Fluarix Quadrivalent. The reporter asked has this been a common complaint this season.
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 88-year-old male patient who received SHINGRIX for prophylaxis. On 11th May 2018 12:41, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm. The patient experienced a red patch of 2 by 2 inches in size about an inch down from the area of the shot. It lasted for about total of 2 to 3 days. No further details were provided.
Heart became irregular; Bad spell; Assistole pause; Atrial flutter; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 11Mar2021 at 09:00 AM. Relevant medical history included atrial fibrillation, spinal stenosis and disk problems. Known allergies: No. Relevant concomitant drug included metoporal, flexinide, alopurinol, hydrocodone bitartrate, paracetamol (NORCO).  The patient previously received the first dose of BNT162B2 for COVID-19 immunisation on 04Feb2021 at 12:00 PM.  After 3 days following the second vaccination, patient's heart became irregular (in spite of medications) on 14Mar2021 at 12:00 PM. The patient was hospitalized after bad spell and had assistole pause, had atrial flutter, had ablation over a period of 2 months. The patient was hospitalized for one day due to the events. Treatment therapy included Medication and pacemaker on later date. The outcome of events was resolving.   Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care needed.  The patient had COVID test (Nasal Swab) on 06Apr2021 and 15May2021, both with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/ batch number has been requested.
Injection site swollen, red, hot to touch 11/21 PM whole arm stiff, swollen area tender; Chills, fever (101), shakes; nausea, vomiting, loss of appetite; extreme fatigue (slept 20 of 24 hours) 11/22 - started to improve Sun 11/23 and progressively got better.
9/12/21 PMH of Asthma, HTN, Hyperlipidemia and Type II DM who presented to ER with c/o SOB and uncontrolled sugars over 300
Headache, sore arm,  joint and muscle aches, fatigue, ill feeling for a day
Presented for shortness of breath, tested positive for COVID 2 weeks prior to arrival. Admitted for acute on chronic hypoxic respiratory failure secondary to COVID pneumonia. Tx: steroids, O2. DC home on steroids, abx, & O2.
The fatigue has only gotten worse 3 days out from 2nd shot. Also, it feels like I have been drugged & have slept  14 hrs & still extremely tired.  Also, mental confusion
This case was reported by a nurse practitioner and described the occurrence of lightheadedness in a 57 year old female pt who received hep b vaccine recombinant (Engerix B) for prophylaxis. The pt's medical history included stem cell transplant. Concurrent medications included Prednisone. On 15Dec03, at 11:30AM, the pt received the third dose of Engerix B (lot ENG5456A9). Approx 10 minutes later, on 15Dec03, the pt experienced lightheadedness, body pain, sweating and abdominal discomfort. The pt phoned her physician. The pt stated that the physician did not prescribe any type of treatment. The pt rested in bed. The events resolved on 17Dec03. The nurse practitioner considered the events to possibly be related to vaccination with Engerix B.
rash; This is a spontaneous report from a contactable nurse via Pfizer sponsored program. A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and received ongoing tofacitinib citrate tablet (XELJANZ XR, Lot number- UNKNOWN, Expiration Date- 30Jan2023) orally from 09Apr2020, at a dose and frequency of 11 mg, 1x/day for an unspecified indication. Patient medical history included knee surgery. The concomitant medications were not reported. On an unspecified date it was reported after having knee surgery and being off Xeljanz for 3 weeks she had the COVID vaccine and 2 weeks later the patient broke out in a rash after she restarted the Xeljanz. Medical Doctor (MD) was aware. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain at site given x 30 days. Bursitis. Recovery 3-4 weeks with provider recommendations.
Patient reporting feeling hot and had flushing to the face, neck, and arms. Patient denied shortness of breath and chest pain. Patient was evaluated, vitals obtained, and IM Benadryl administered. Ambulance was called for further evaluation and transported to the hospital.
Bronchitis; flu; lost taste; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Pt recvd 3 doses of Hep B vax & was found to be a nonresponder; The first 2 doses were Engerix-B; 3rd dose was Recombivax;
Pain and discomfort at injection site within minutes of shot. Hot, swollen, stiff. Took Tylenol.  11 PM severe chills. Arms and legs ice cold. Couldn?t get warm.  Began running fever 102.6 around 12 pm. Fever continued high all night, with severe headache and arm/muscle pain. Continued to take Tylenol.  Temperature dropped to 100.4 at 10:30 AM.
Fever as high as 105, seizures, high pitched screaming, vomiting, diarrhea, hitting himself in head, scratching at his face/skin, pulling his hair out by the handfuls, will not let anyone touch him.
Day 1-fussiness. Day 2- injection site red and hives on leg. Day 2 & 3 & 4 vomiting and diarrhea (vomiting minimal). She also had hives w/ previous polio vaccine.
Since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 11Feb2021 08:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: diagnosed almost 12 years ago; "aortic valve replaced", start date: Apr2019 (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder, start date: Jun2021 (ongoing). The following information was reported: ONYCHOMADESIS (non-serious) with onset 2021, outcome "unknown", described as "Since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes".  Additional information: Patient received both doses of the covid-19 vaccine and she said that the same time she started a new heart medication but she doesn't think that the heart medication is the problem but since having the vaccine she has lost 3 nails on her hand and 1 nail on one of her toes."if one were to have a reaction to the Covid 19 vaccine how soon after the vaccine would you get a reaction. states she had her 1st in Jan2021 and the 2nd in Feb2021 and since then she has lost 1 toenail and 3 fingernails. she lost her toenail probably in the spring on her foot and it had to have taken weeks to get to that point and it could have been a week after the vaccine. states then her hand started about 3 weeks after that and she lost 2 nails on her right hand and just lost 1 on her left hand. She is asking should she take the booster. If she had a reaction to Covid if she should take the 3rd. States what comes 1st the chicken or the egg. States she will take the 3rd and see if she has a reaction. States if she does have the 3rd and loses 3 more nails she has 4 left.   She thought it was Entresto caused the event she was put on and the doctor said no it probably was the Covid vaccine if anything and is doing research. States she takes 24-28mg 2 a day and thinks she started taking it in Jun2021 and is still taking it. Patient  reported Entresto is a Novartis product and she already talked to them and it has no side effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother noticed on the date of onset that child sounded plugged and nasal when she talked and began coughing and didn't sleep well that night.  The following day she noticed child was warm and had a temp of 102.8 she medicated with Tylenol and gave her a luke-warm bath.  On 8/11/2010 Mother states child seems to have recovered, no fever, no cough.
Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pains and muscle pain in her arms and legs, feeling fatigued and could barely stand. She reported these on 4/19/21. I advised her to contact her PCP to get evaluated for the signs/symptoms that she is experiencing to rule out anything severe. She did not seem to understand and asked to speak with the manufacturer. She said that she would contact the manufacturer and walked away.  When I attempted to contact her again today on 4/20/21, the phone number she provided to us has been disconnected and we have no means of reaching her at this point in time. I am hoping she heeded my advice and contacted her PCP to get evaluated.
Immediately after the 1st injection employee had tachycardia, hypertension, nausea, dizziness, hot flash, ringing in the ears, sweating.  Was monitored for 30 minutes and symptoms resolved.  Approximately 10 hours after 2nd vaccine employee had nausea, vomiting, fever, body aches and cramps, chills, headache.  Approximately 18 hours post 2nd vaccine, Lymph nodes in neck began to swell and throat was scratchy and having difficulty swallowing.
Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild
He had COVID and he is also had, like being fully vaccinated and now he has both boosters; He had COVID and he is also had, like being fully vaccinated and now he has both boosters; He is running a 101.5 after the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 29Jul2022 at 16:00 as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "His COVID was in 2020", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Jul2022, outcome "unknown", described as "He is running a 101.5 after the shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He have had COVID and he is also had, like being fully vaccinated and now he has both boosters". The patient underwent the following laboratory tests and procedures: Body temperature: 101.5.  Clinical course: Reporter reported that, she and her husband had the COVID-19 booster shots and her husband tested positive for COVID (Later reporter clarified that husband does not have active COVID right now). So, she would like to know, if they need to isolate because (Incomplete sentence). Reporter stated, "No. He did not test for COVID, no. Both took the vaccine yesterday at 4 pm. Reported said, patient was just doing well. He had COVID and he also had, like being fully vaccinated and now he has both boosters. His COVID was in 2020. So, no he did not have active COVID right now. Reporter question was, patient is running a 101.5 after the shot. I just have slight headaches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assistance of a walker device. lasted 3 days - Same side effect as after 1st dose.
Tested positive for Covid 19; This is a spontaneous report from a non-contactable consumer received via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient was tested positive for covid 19. It was reported that she tested positive for Covid 19 one week after first dose and she is due for the second dose of the vaccine next week. The patient underwent lab tests and procedures which included sars-cov-2 test with positive results on an unknown date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Dizziness, Headache, Diaphoresis, light headed Narrative: Checked blood sugar 144, BP 138/90, HR 88, pulse ox 98, temp 97.3, provided water and crackers
Febrile illness associated with papular rash (1 vesicle that crusted) 10 days after receiving MMRV vaccine
Patient is a 76-year-old male with history of CAD, atrial fibrillation on Coumadin, CHF, cardiomyopathy, hypertension, hyperlipidemia, previous MI and COPD presenting to the emergency department via EMS for generalized weakness and falls.  Patient states he has felt weak over the past few days, today he states he stood up and his legs felt weak and gave out and he fell landing on his right side.  He denies hitting his head or losing consciousness.  He states he laid on the floor for maybe 5 to 10 minutes, and then was able to get up and ambulate, however he continued to feel weak, so he called 911.  Patient denies chest pain, shortness of breath, abdominal pain, neck pain or back pain. Associated Symptoms: bruise easily, fall, weakness
This is a spontaneous report from a contactable consumer. This same consumer reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date and MENACTRA (lot number and expiration date unknown) both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu-like symptoms, fever and rash on the arm all on an unspecified date. The outcome of the event was unknown. The following information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018495286 same product and events, different patient.
Case number PHEH2015US025082, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 64-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. No adverse event was reported following this administration error.
Patient reports feeling dizzy/lightheaded after receiving vaccine. Patient needed to lay down and was transferred to Med tent. Pt was observed in med tent and released home.
Edema, pain at injection site that extended to (L) axilla. TX=BENADRYL and NSAIDS and ice.
Severe injection site reaction with inflammation and severe pain. Immunized 10/8/2007. Methylprednisone 4 mg dose pack 10/18/2007. Subacromial cortisteroid injection given on 10/28/2007.
Symptoms:  8 weeks post vaccination  First four days itching all over body.  Fifth  day pins and needles all over body.  Sixth day less pins and needles and muscle pain in legs, shoulders, back, and arms. Toward the evening itching again. Some burning sensations. I?m also very tired from lack of sleep.  ?????- Every time I almost fall asleep I wake up with my heart pounding. Like being scared awake.
Chest pain, pain in arms, fever, chills, nausea and diarrhea, stiffness in jaw that ceased after waking up.
Splenic Infarct - symptoms began after the second dose which I received 04/12/2021. I began bloating and having upper left side pain under my ribs starting 04/18/2021. I saw the nurse practitioner in Dr.'s office numerous times to complainant be examined. After insisting on a ct scan, it was discovered I had an of my spleen. I was admitted to the local Hospital on May 5, 2021 and discharged on May 7, 2021. I have been under the care of a hematologist since. My spleen has reduced in volume and there is scarring. I still have intermittent pain in my upper left quadrant. Despite numerous blood tests, genetic tests, scans, and x-rays, there has never been an explanation for my infarct. I have also developed an arrythmia and am under the care of a cardiologist as well as an electro-physiologist. I don't know when the arrythmia developed but it was sometime after the second dose and my time in the hospital.
PATIENT STATES HE HAS HAD SHORTNESS OF BREATH, AND NO ENERGY.  PATIENT ALSO STATES HE FEELS WEAK.
Shooting sharp pain in arm down into hand and fingers when injected. Within 4 hours other sx began and rapidly worsened. Pain, redness, heat and swelling in arm down to elbow, headache, overall muscle pain, fatigue, low grade fever, queasy, weak, unable eat. Then lower back from spine wrapping around right side to belly button severe pain, second only to childbirth. Wanted to lie down, but was afraid because I was alone. Also pain into L shoulder when tried and unable to raise L arm. Back pain, neck pain, cold hands and feet, overall limp feeling. Afraid I had another problem like gall bladder, kidney, or appendix as I had no idea I might get theses sx from Shingrix. Had only been warned about local issues. Pain continued for several days and only gradually dissipated over next week or so.