chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was not able to go into work today.; 12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so; over night she got really sick.; She could not sleep all night; body aches that were terrible; she had a really high fever of 105F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night) and MYALGIA (body aches that were terrible) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (same side effects as the booster). Past adverse reactions to the above products included Adverse event with JANSSEN COVID-19 VACCINE.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.) and FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so) had not resolved and ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Body temperature: 105 (High) high fever of 105F.         No concomitant medications  was provided.  No treatment medications was provided.
I spoke with my cardiologist and my primary about my uncontrolled blood pressure. So we could take measures to help with that. They both said unlikely from vaccine. I just know the my blood pressure was under control until my first shot of the vaccine
Painful arm within a few hours of dose. Wrist, arm  and hand stiff and painful for three days. Right side of neck swollen and hard within three hours of injection. Bad headache especially right side Continuing and current  problems since injection; 1.  Swollen stiff neck and face ( all over)  2. Exhaustion 3. Stiffness and aching  in right arm and hand 4. Throat irritation and discomfort, bouts of sweating and chills, chest discomfort
Patient presented for Pfizer vaccination at a mass vaccination clinic by our hospital.  Patient stated would be first Pfizer vaccine.  On 3/18/2021,  when charting the vaccination, it was discovered patient had received both doses. 1st dose on 1/18/21 and 2nd dose on 2/7/21.   Unable to contact patient to see if any adverse effects occured.
Dizziness, a sense of feeling "disconnected" or a floating sensation, extreme fatigue/could not stay awake
Information has been received from a physician concerning a 26 month old Caucasian female with no past medical history and no known drug allergies who on 30 MAY 2000 was vaccinated with the first dose of varicella virus vaccine live (lot #634491/0441K) in the left arm. Concomitant vaccination that same day included the first dose of streptococcus pneumoniae vaccine (PREVNAR) in the left thigh. It was also noted that on 12 APR 2000 the patient received a dose of hepatitis B vaccine (recombinant) (Engerix-B) (Lot #2808A2). There was no other concomitant  medication or illness at the time of vaccination. On 28 JUL 2001 at approx. 10:30, the patient developed a itchy erythematous rash with vesicular lesions located on the lower lumbar area on the left side, dermatone distrubtion. The vesicular rash was cultured and found to be varicella zoster virus. The patient was afebrile, experienced pain of 3-4 on a scale of 0-10 and experienced itching. On 02 AUG 2001 herpes zoster was noted and a specimen was obtained from a vesicle to be sent for VZV testing. The patient did not have a history of chicken pox or recent exposure to chicken pox or herpes zoster. It was also reported that patient did not have any in utero exposure since the mother was not susceptable. Follow up information on 08 AUG 2001 reported that the child has crusted over at this point. It was noted that the patient has not had an adverse event following previous vaccinations. Subsequently, the patient recovered.
No additional AE reported; Patient was administered an expired dose of MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 23-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S020961, expiration date 07-JUL-2021 (0.5 milliliter, indication was not reported) (expired product administered). The suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no previous temperature excursions. No additional adverse event was reported.
This study report as received from a consumer, as part of a marketing research study refers to a currently 52 year old female patient enrolled in a study. The patient's concurrent conditions, relevant medical history and concomitant medications were not reported. The reporter stated that a friend of a friend's daughter (the patient) was vaccinated on an unknown date with GARDASIL (dose, frequency, route and lot number unspecified). Within few months of vaccination, the patient began to have muscular problems and she was no longer able to be the athlete she once was (impaired quality of life). Action taken with GARDASIL was not applicable. The outcome of the events was not reported. The causality of the events muscle disorder and impaired quality of life with GARDASIL was not reported. Additional information is not expected since the reporter was not willing to be contacted.
Around February 18 pain started over R low back just above illiac crest.  By February 25th paresthesia from right side of lower spine around to below navel in a 2 inch band.  From about February 23th intermittent severe pain in same area. March 2nd a rash of small red bumps developed. I had a consult with a physician  at my primary care facility. She confirmed a diagnosis of Shingles and prescribed 7 days of Valtrex.  She also recommended I postponed my second vaccine which was scheduled for March 2nd.  March 9th rash was healing and pain was less severe. March 11th I had my second Moderna COVID vaccine. Mild to moderate pain persisted till around March 26th.
patient received expired dose of ACT-HIB vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00559739) and transmitted to Sanofi on 13-Apr-2021.   This case involves a 1-year-4-month-3 week male patient who received vaccine 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent (single dose vials, frequency: once, strength: standard, batch number: U6573AA,expiry date: 22-Mar-2021 via intramuscular route in left thigh) (expired product administered) on 24-Mar-2021 for prophylactic vaccination.   The patient's medical history, past medical treatment, concomitant medication and family history were not provided.   No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021.   At the time of reporting, No specific adverse event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Significant back pain.; This is a spontaneous report from a non-contactable consumer.  An adult female consumer of an unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization.  Medical history included Covid-19 prior vaccination. Concomitant medications were not reported.  The patient experienced significant back pain on 17Apr2021. It is unknown if a treatment was given. The outcome of the event was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
That night,  I broke out in small hives (similar to white heads) and a red rash  all over my chest, front/top of my shoulders, a little under my breasts and followed JUST down my spine. Additionally, my knees turned red and were very warm to touch and flared the dose 1 reaction on my toes (previous report filed)- none of it hurt or itched but it was present primarily at night from around 5/6pm and would have mostly cleared by 6/7am.
RN to J&J vaccine about 3-5 min after delivery. Assuming Vasovagal response. His brother reports that patient was sitting there and his eyes rolled back in his head and he fell off his chair and hit his head/right eye. Employee got out there and he was a bit combative and saying "whats going on, whats going on". I asked him to sit down and employee called 911. We put pressure on his eye area to stop the bleeding. He was sweating, shakey, pale, and nauseous. Paramedics arrived quickly and eventually took him away on a strecher. Update: mom came back a couple of hours later to thank us and let us know that he is home and resting. He did get 3 stiches by his eye and the reason they took him via strecher was because his blood pressure was staying so low while they were here.
Initial misuse report received from a nurse on 06 November 2013. The patient had received ACTHIB. It was reported that diluent sprayed into the patient's eye. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Within 12 hours after my first booster shot, I had extreme abdominal pain in the middle of the night. I went to the emergency department on April 1, 2021. They found a gallstone. I had it removed in January of 2022.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 10:00 as dose 1, single (Lot number: EM9809), in left arm, on 23Feb2021 at 09:00 as dose 2, single (Lot number: EL9266), in left arm and on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial flutter" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS, start date: Jan2019. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: still tested positive on day one after completing the paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient Anti-viral treatment for COVID 19 Treatment included Paxlovid (Lot number: GA6764) started on 11May2022 continued till 16May2022. The patient still tested positive on day one after completing the paxlovid. Severe body aches especially back and right shoulder blade. The patient had known allergy with cephalosporin. AE treatment included Tylenol.  No follow-up attempts are possible. No further information is expected.
The following day after vaccine, pt. developed large amount of swelling. erythema and pain at site. Now this is subsiding.
received a Typhim VI shot on 30-Oct-2019, Typhim VI expired on 19-Oct-2019 with no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received TYPHOID VI POLYSACCHARIDE VACCINE (lot number unknown, expiry date: 19-Oct-2019) via unknown route on 30-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired product administered. It was reported that an individual was given an expired Typhim VI vaccine on 30-Oct-2019, Typhim VI expired on 19-Oct-2019.  At the time of reporting, the patient had no adverse event.  Additional information regarding the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Throbbing pain in right arm around injection site since the day after vaccination, unable to carry out daily tasks with right arm. Ibuprofen relieves pain for a short duration.
Information has been received from a physician concerning a 11 year old male patient, with no known allergies and no chronic medications, who on 4/15/97 was vaccinated with a second dose of MMR (second generation) (lot # 645264/0099N). The first dose was given on 4/15/03 at another practice. On 7/29/03, 2 minutes after administration of the vaccine, the patient experienced what appeared to be a tonic clonic seizure. The seizure was observed by the nurse and the mother. When the physician walked in the patient was diaphoretic, but no longer seizing. It was noted that the patient had no personal history of seizures and was in good health. Subsequently, the patient recovered. Upon internal review, tonic clonic seizure was considered to be an important medical event (OMIC). It was noted that the patient's sister had a similar experience.  Follow up on 08/15/2003: "Follow up information from a nurse indicated that the patient had jerking of his hands, his eyes rolled back into his head and it appeared to be a tonic-clonic seizure.  The patient did not require any treatment and recovered quickly according to the nurse.  Upon internal review, tonic-clonic seizure was considered to be an important medical event. (OMIC).  It was noted that the patient's sister had a similar experience (WAES # 0307USA03533)."
pt exp back pain, tingling & numbness, burning sensations in soles;strength weakened; gait unsteady; absent reflexes, dysesthesia, GBS; dx mid thoracic disc; aching, BP160/95; facial cellulitis
Left hip was red and hot, measured 3 1/2 in x 5 1/2 in after receiving all shots.
Received booster COVID Moderna shot on 12/21/2021 and in January 2022 I started having scalp issues. Itchy, flaky, some pain. Went to Derm in January 2022 and they said could be dermatitis.  Scalp did not heal and also started to get red itchy, flaky, scaly spots on my body. Went back to derm in March for a biopsy- Psoriasis. Have never had it. Noone in my family has it. I have done nothing at all that would affect my immune system except for the COVID vaccine.  I am full of psoriasis and have lost half my hair.
Narrative:  85yo male Pt found deceased in his home on 12/14/2021 by son. Pt had h/o CAD apparently CABG x3 ? almost 4 decades ago, heart failure ,Avascular necrosis of hip Essential hypertension Right carotid artery stenosis Cardiac arrhythmia OA - Osteoarthritis of knee Osteopenia Hypogonadism Lumbago Polycythemia IMPOTENCE, ORGANIC ORIGN Coronary heart disease HYPERLIPIDEMIA Hypothyroid Postsurgical aortocoronary bypass status Unilateral or unspecified inguinal hernia,  without mention of obstruction. Pt had received covid vaccines on 2/26/21 & 3/26/21. This death is likely not related to  the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Reports no latex allergy; reports area is red and war; swelling is receding and is not as mad as day before; suggested APAP 325 and diphenhydramine 25 and to go to ER if gets any worse.
8 hours after my second shot i started  heavy menstrual bleeding  and passing cloths, fever, chills, body aches lasted about 36 hours. after that i experienced headaches and nausea which lasted 2 days accompanied with heavy menstrual bleeding and cloths. I am feeling better now but still heavy bleeding with cloths.  I have been taking Advil.
itching, rash, hives all over his body; itching, rash, hives all over his body; This spontaneous case was reported by a physician and describes the occurrence of RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergy: penicillin.  Concurrent medical conditions included Penicillin allergy.    On 21-Oct-2022, 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 RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency and RUXOLITINIB PHOSPHATE (OPZELURA) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itching, rash, hives all over his body) and URTICARIA (itching, rash, hives all over his body) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The physician reported itching, rash, hives all over his body. He did not connect the symptoms to the booster shot until he read an article. It had been at least since holiday. The physician reported using triamcinolone (topical steroid) cream and opzelura cream. He needed a solution. He had been to a dermatologist and allergist, but they could not figure it out.
Pt reports nosebleed, HA and hives after Janssen COVID vaccine when presenting for booster on 12/17.  Unknown time course of reaction.  Pt redirected to Pfizer booster.  No reaction noted after Pfizer booster.
abortion or miscarriage ache: joints ache:joints and muscles aches:whole body acid reflux blood:high cholesterol blood pressure: spikes and drops agitation alopecia alpha intrusion amblyopia bursitis mood:anxiety heart:arrhythmia cold and flu like symptoms concentration:loss of  concentration:trouble coordination:problmes balance:dizzy upon standing balance:falling balance:problems blood pressure:varies blood pressure:high depression disorder of hepatobiliary system and pancreas dry mouth edema:injection site hearing:ringing in ears energy:low energy:declining hypertension hyperventilation inflam inject site neurological:unable to perform multiple tasks simultaneously neurological:depression neurological:confusion sleep:insomnia mood:anxious neck rigid libido decrease pain: legs, lower back, right shoulder, hips and leg, right hip and chest, back, knees and hips, lower back, throughout his body, at injection site, bone and joint, muscle and joint, joint, near live and where gall bladder was, arthritic, neck, pelvic, back, chest, in feel like electrical shocks, charlie horse skin:itching, dry and flaky skin sleep:insomnia sleep:unable to sleep flat without medication somnolence weight gain testicular failure
Patient came in for a flu vaccine and the updated covid booster for ages 5-11. The patient was given the correct flu vaccine. For the covid vaccine she was  given 0.2ml of the covid booster for ages 12 and up instead of the one for ages 5-11.  The pharmacist on duty at the time of the incident did check with Pfizer to see what actions needed to be taken. Pfizer informed us that the patient should be monitored for a possibility of increased adverse reactions. The pharmacist checked with the patient's mother the next day and she just reported a sore arm with no other adverse reactions.
SEVERE ABDOMINAL PAIN, BLOOD CLOT IN RIGHT LEG, CONFUSION (CURRENTLY STILL IN THE HOSPTIAL FOR THESE ISSUES)
It has been described online as "Covid Arm."  I began to feel a burning in my upper arm.  I had expected some soreness in my arm.  I actually ran a fever the next day that went over 102, but it quickly resolved.  However, the spot on my arm was quite large, hot, red, and painful.  It has lasted, while gradually getting better, up to the time I am writing this.  The arm is still quite pink, and the redness has migrated around to the inside of my arm somewhat.  It is better now, though, and I am not concerned.  However, I would have chose Pfizer if I had known that this would happen.  My husband got Pfizer and didn't have any trouble at all.
Rash, vomiting, horrible no stop crying for 3 weeks, did not want to eat, sleep pattern was off, aggressive.
This spontaneous report as received from a pharmacist refers to a 71 years old female patient with no pertinent medical history and with drug allergy to penicillin. The patient was subcutaneously vaccinated with a single dose of ZOSTAVAX (lot number reported as H013022, expiry date: 09-OCT-2013) into the left arm on 06-NOV-2012. No other co-suspects were reported. There were no concomitant medications. On 07-NOV-2012 the patient developed a large, red, raised, itchy, hard area at the injection site. The patient had sought medical attention via coming to pharmacy. No treatment was prescribed. No lab test was done. The outcome of developed a large, red, raised, itchy, hard area at the injection site was reported as recovering/resolving. Additional information is not expected.