chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shivering, Fever, Headache, Muscle Pain, Tiredness - Shivering and Fever lasted 1.5 days, tiredness lasted 3 days.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # M038856, expiry date 14-SEP-2018 for prophylaxis. No adverse event was reported. The vaccines were stored at a temperature range of -14°C to-10°C for 483 hours and in the range of -9°C to 8°C for 28 hours. Digital data logger was not involved. There was no previous temperature excursion. No product quality complaint was involved. No additional information was available. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010627.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with improperly stored doses of PROQUAD (Merck) dose and route of administration were not reported (lot # K020753, expiry date 30-APR-2016). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt devel swelling & redness along c/malaise; came in to have site inspected; was noted a hard; red; warm induration to lt arm 3''x2.5''; sore to touch;
Initial information received regarding an unsolicited valid non-serious case received from a nurse on 01-Aug-2018. This case involves a 61 years old male patient who accidentally received an 0.5 ml expired dose of TENIVAC (Lot number: U5411AA, expiry date: 30-Jun-2018) via intramuscular route in the deltoid on 12-Jul-2018. It was case of an actual medication error due to expired vaccine used. No AE has been observed. 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. Documents held by sender: none
tinnitus constant, severe has not ceased as of 14May2021; This is a spontaneous report from a Non-contactable consumer (patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) at the age of 25-year-old, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced tinnitus constant, severe has not ceased as of 14May2021 (serious as disability, medically significant). Event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown on 2021. Treatment received for the adverse event included steroid (did not resolve tinnitus), MRIs. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Quarter size lesion, indurated. Warm, swollen. Placed on Augmentin.
Admitted with "wobbly" gait and incidental finding of COVID + PCR and Antigen, was not treated.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT FAINTED FOLLOWING A COVID SHOT AND WAS GIVEN AN EPIPEN WHILE CALLING 911 FOR ADDITIONAL HELP.
Within 30 minutes turned pale, started sweating, waves of severe nausea (lasted 36 hours), vomiting (lasted 4 hours), painful stomach cramps (lasted 3 days), bloated stomach (lasted 3 days), severe headache (1 day), frequent bowel movements/diarrhea (3 days), low grade fever (36 hours), feeling ill (3 days). Lost three days work and still recovering after 5 days. Fortunately, my asthma did not act up and there were no respiratory distress experienced.
MILD FEVER; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative 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 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced mild fever. On MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and slight headache was not reported. This report was non-serious.
devel inc fever & lethargy (acute onset) myalgia, h/a, local rxn, T38.6, leukocytosis (WBC 30);required to hosp;started on ATB, in case of actual sepsis;
Patient received the second dose of his COVID vaccine a week early. No adverse reaction during the 15minute wait time.
I first started feeling very cold around 5:00 PM that day. Once I went home I went to sleep around 10:30 and work up at 2:30 AM with vomiting and 8/10 epigastric pain that radiated to my back. I went to the hospital. They gave me morphine and Zofran but within 5 minutes of the first dose of morphine, my pain returned even more intense and I still vomited 20 minutes after the Zofran. So they pushed another Morphine and Zofran. Zofran helped at this point but the Morphine did not. At this point they gave my three different oral liquids to help calm down my epigastric region, including mylanta, lidocaine and a third medication. I went home and slept the rest of the day but Wednesday night I got diarrhea and spike a fever of 102.7 around 8PM. Now it's thursday morning and I still have a 2/10 epigastric pain, physically exhausted and had a fever this morning as well.
the glands in her neck and under her arms have started to bother me; I felt achy; chills; headache; fever; soreness in my arm like the flu shot; fatigued; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A, 023M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) soreness in my arm like the flu shot, fatigued. On 19 Feb 2021, the patient experienced the event(s) i felt achy, chills, headache, fever. On an unknown date, the patient experienced the event(s) the glands in her neck and under her arms have started to bother me.  Treatment details included Tylenol, Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness in my arm like the flu shot, fatigued, i felt achy, chills, headache, fever, the glands in her neck and under her arms have started to bother me was unknown.
The patient experienced no symptoms; patient was administered a dose of PNEUMOVAX 23 5 months after he was admonistered a dose of PREVENAR 13; This spontaneous report as received from a pharmacist refers to a 65-year-old patient of unknown gender. The patient was immunocompetent. No information on patient's other pertinent medical history, drug reactions or allergies and concomitant medications was provided.   On 16-JAN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S013490, expiration date 06-MAR-2021, dose and anatomical location were not reported) intramuscularly for prophylaxis, 5 months after he was administered a dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (dose, route of administration and anatomical location were not reported).
Pregnacy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, IBUPROFEN, BUTALBITAL, LORATADINE (LORATADIN), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN B12 NOS, CYCLOBENZAPRINE and PANTOPRAZOLE for an unknown indication.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Aug-2021. On 05-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy). On 05-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Date of last menstrual period was probably at the end of Jan 2021.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received updated regarding the Last menstrual period.
the patient found out she was pregnant after receiving one dose of GARDASIL 9; no adverse effects; This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. Patient's medical history drug allergies and concomitant medications were unknown. On 02-APR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule was not reported, lot # R004689, route: intramuscular) for prophylaxis. It was reported that, the patient found out she was pregnant after receiving one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (maternal exposure before pregnancy) and no adverse events were reported. Last menstrual period (LMP) was on 17-MAR-2019 with an estimated date of delivery (EDD) on 22-DEC-2019. The patient did not seek medical attention. Pregnancy Outcome was outcome pending. The outcome of maternal exposure before pregnancy was unknown. Product quality complaint was not involved.  Lot No. R004689 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 29-NOV-2020.
Transient numbness and loss of muscle function in left and right arms. Developed while doing computer work.  Not constant and still able to perform most tasks. As of 10/9/12 it has resolved.
fever of 102.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 102.). At the time of the report, PYREXIA (fever of 102.) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
PATIENT WAS ADMINISTERED ADULT COVID VACCINE DOSE IN ERROR INSTEAD OF APPROPRIATE PEDIATRIC COVID VACCINE DOSE.
awoke crying from sleep (no unusual);crying during diaper change (also not unusual);then stopped crying mom noted pt appeared ghost white, unresponsive to verbal stimulation, eyes open on & off but no focused;
within a month after receiving my covid vaccine I experienced a stroke. I had my vaccine on 04/30/2021 and on 6/10/2021 i was admitted to the local hospital because of a stroke
34yr old female with shellfish allergy (reaction: anaphylaxis), exercise induced asthma, previous issues with injections/blood draws (reaction: dizziness) and other comorbidities presented for COVID-19 J&J vaccine on 4/7/21.  CMA administered the JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1318.  Within 2 minutes of administration, patient became lightheaded and shortly after passed out.  Patient had one convulsion (arching back, tense limbs) lasting 5-6 seconds.  Once relaxed, patient was arousable.  Patient denied hives, shortness of breath, throat swelling, or chest pain.  At 1325, BP 48/31, MAP 76, HR 79.  Patient assisted to Trendelenburg position and remained lying for 20m. Patient developed chills and tremors during this time stating she was cold.  At unknown time later, patient endorsed feeling better and was lifted to sitting position and allowed to sit for another 10minutes.  At 1346, final BP 105/58, HR 73.  Patient endorsed feeling back at baseline.  Provider released patient and patient discharged.  Of note, provider notes patient with vasovagal syncope and convulsions after receiving J&J COVID vaccine. Patient has history of vasovagal reactions.
adverse effects happened about 20 minutes after the vaccine. patient experienced severe dizziness (described having squared visions), tremor on all extremities, muscle weakness (caused him to collapse), headache (back of the head)
Several days after recieving my Moderna vaccine, I began to feel itchiness in my feet. Within a few hours, the itchiness spread to my hands (both the tops of my hands and my palms). The itchiness spread to my wrists as well. By the morning of April 17th, I had swollen, red hives on my hands, wrists and feet. The itching was coupled with a burning feeling. Benadryl and Calamine lotion did not help. As the day continued, the hives spread to my ankles, knees and elbows. In the morning on Monday, April 19th I felt stiff (didn't know this was part of my reaction until my doctor asked me if I felt like my joints were stiff--I was too itchy to feel concerned about it), the bottoms of my feet were painful, and I could barely touch anything with my hands without it hurting. As the day continued, I became so uncomfortable between the itchiness and burning I decided to see my doctor.
local swelling/erythema/pruritus/warmth Treated with IM steroid, OTC NSAIDS Last evaluation (10/23/20) above signs had decreased about 70%
Fever of 103 F, papular rash over my entire body, headache, this lasted until 02/10/12 when I realized I was having a post typhoid immunization reaction and started Cipro.  My fevers came down within 48 hours.
Bloody nose; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 17Mar2021 at 15:45 (at the age of 68 years) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, peripheral artery disease, diabetic neuropathy and gastroesophageal reflux disease (GERD) and also had allergies to tetracycline and ACE-inhibitors. The concomitant medications included insulin (MANUFACTURER UNKNOWN), vitamins, herbal remedies and blood thinners for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 05:00, the patient experienced bloody nose. No therapeutic measures were taken as the result of the event. The clinical outcome of the event bloody nose was not recovered at the time of report.   Information about lot number cannot be obtained. No further information is expected.
no additional AE details; Nurse states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 07-DEC-2020, the patient was vaccinated with a dose of incorrectly storage hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot reported as T014835 with expiration date 17-JUL-2021 (dose, route and anatomical location were no reported) for prophylaxis. No additional adverse event was reported.  Lot number T014835 is an invalid lot number for hepatitis b vaccine (recombinant).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for eyes for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details,lot# and expiry were not reported). The patient wanted to know how long the side effects last from ZOSTAVAX. She did not elaborate on what side effects she experienced. The outcome of the event was unknown. The reporter did not provided the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information  has been requested.
2nd shot minor until two weeks later began with discomfort with upper arm in area where shot was given then he started experience should and across to right arm began to get weakness and turning head to side to side weakness for three or four weeks and it interfered with daily activities Dr. on 04/6/2021 and results of blood test 04/27/2021  visit low about of Iron and referred to Dr. 05/04/2021 results of the blood test say referred to Dr. 05/11/2021 , June 13, 2021 blood iron infusion by two Dr's 06/7/2021 07/22/2021 following after the iron transfusion. 04/27/2021 prescribed preganazon  feeling good.  Middle of June reduce pregnazone winged him off for two weeks and symptoms returned and  preganazon 2.5 mg at in evening.
POTENTIAL ADMINISTRATION ERROR - EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 63 year old male. 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 and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced potential administration error - expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration error - expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955936, 20210955892, 20210955498 and 20210955712.
I think its like a cramp like a shock and pain and like it go through my knee; I think its like a cramp like a shock and pain and like it go through my knee; A cramp like a pain; There is anything is go out of here in my leg and pain in like in my thigh area,; Both my knees thats what I felt, each day it got worse/I notice the next day is like kind of pain going to my knee.; It stop me for walking its not good; Both my knees thats what I felt, each day it got worse/but its what I see every day its being worse; It is looking abnormal for me; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217), via an unspecified route of administration on 07Jun2021 as dose number unknown, single for covid-19 immunization (at the age of 58-year-old). Medical history included blood pressure measurement -Verbatim: Blood pressure. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); amlodipine (AMLODIPINE); pravastatin (PRAVASTATIN). On 08Jun2021, the patient experienced that she think its like a cramp like a shock and pain and like it go through her knee, a cramp like a pain, there is anything go out of here in her leg and pain in like in her thigh area, both her knees thats what she felt, each day it got worse/She notice the next day is like kind of pain going to her knee, it stop her for walking its not good but its what she see every day its being worse. It is looking abnormal for her. She had never feel anything like this. Treatment: Consumer stated, the day she went, she did not receive any treatment for this probably, going to use this, can noticeable today at work. The outcome of all events were not resolved.
Vasovagal Syncope w/  orthostatic hypotension for ~5 hours following.
Saw lights emitting from blanket; Pain when she moved her arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Saw lights emitting from blanket), VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 Vaccination.     The patient's past medical history included Cataracts (Cataract surgery 5 years ago), Corneal implant (Partial cornea implants 5 years ago) and Eye laser surgery (2 years ago).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills). On 13-Jan-2021, the patient experienced PHOTOPSIA (Saw lights emitting from blanket). At the time of the report, PHOTOPSIA (Saw lights emitting from blanket), VACCINATION SITE PAIN (Pain when she moved her arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.