chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Imovax and was 10 days late in getting her second dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist  via Agency (Reference number- 00650123) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 29-year-old female patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] and was 10 days late in getting her second dose.  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Jun-2021, the patient received a dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   It was case of actual medication error due to inappropriate schedule of product administration [Latency: on the same day].   It was reported that, was it okay that the patient was 10 days late or if they need to restart the series. Patient visit to clinic on 01-Jun-2021.  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment for the event.  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 the 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.  There will be no information available on the batch number for this case.
Immediately following I had a sore arm at the injection site.; Immediately following I had a very slight rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Immediately following I had a sore arm at the injection site.) and VACCINATION SITE RASH (Immediately following I had a very slight rash at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (Immediately following I had a sore arm at the injection site.) and VACCINATION SITE RASH (Immediately following I had a very slight rash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLOBETASOL (topical) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. On 17-Mar-2021, MYALGIA (Immediately following I had a sore arm at the injection site.) and VACCINATION SITE RASH (Immediately following I had a very slight rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to MOD-2021-211541 (Patient Link).
for covid 19 5-12. Pt had an itch on ankle 1 hour leaving our pharmacy. pt visited ER day after for severe rash and hives, and received benedryl. Rash worsened affected the face and causing swelling that affected the pts ability to open their eyes. Pt went to urgent care for steroids. Pt is now improving and following up care with a allergist. reported to us today by patient.
Patient given vaccine that was out over 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that was out over 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that was out over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine that was out over 12 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received in 2016). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising. The patient was treated with dermatologicals nos (Lotion (Nos)). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema,pimples, skin scaly, pruritus, skin irritation and injection site bruising were unknown. The reporter considered the injection site pain, injection site erythema, pimples, skin scaly, pruritus, skin irritation and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported soreness at site the on the day of the injection and then 48 hours later redness, bruising at the site, tiny pimple like bumps, rough over his arm and forearm. The patient was using lotion and ice and the issue resolved toward the end of the week, but this past Wednesday the same issue returned to the left upper arm and forearm of the tiny, raised bumps and itching. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pruritus. The patient stated that it was not that bad and was not as initially or worse, but was encouraged to report it to GlaxoSmithKline by the pharmacist. He preferred to receive the authorization form. This case has been linked with case US2018075823, reported by same reporter.
This spontaneous report as received from patient and a pharmacist refers to a 63 year old female patient with diabetes, thyroid, heart disease, and pre-existing hearing loss condition. The consumer reported that she has had reactions to many other drugs (dates unspecified) such as BENADRYL makes her aggressive, sulfa drugs and all antibiotics give her rash, CIPRO gave her C.diff, Lynexa gives her TIA, NOVOCAINE causes heart problems, all Opiates cause anaphylaxis, latex causes ulceration and possibly anaphylaxis if inserted in throat, Nickel causes ulcerations well. The patient's concomitant medications were reported as many (unspecified drugs). The patient stated that she has had Herpes 1 for most of her life, and treats it with VALTREX and LYSINE. The patient's medical history included ear drum reconstruction (1982) and cold symptoms (unspecified) in January 2014. On 27-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J006832 exp 01-SEP-2014, dose 1, 0.65 ml (1 shot), subcutaneous. On FEB-2014 the patient experienced worsening of hearing from pre-existing hearing loss (disability and medically significant) and cannot hear in one ear (medically significant). On 28-FEB-2014 the patient developed Herpes Zoster (the day after she received ZOSTAVAX). The patient did not receive any treatment for the event, but self medicated with LYSINE. She described the situation as being a bright red blister from the bottom of her spine to her hip. The patient reported that now she couldn't hear in one ear (start date unspecified). The pharmacist reported that the patient had pre-existing hearing loss condition and her ear drum was replaced in 1982. Pharmacist stated that patient did not experience hearing loss but rather worsening of hearing from pre-existing hearing loss. Pharmacist also stated that the patient had suffered from cold symptoms (unspecified) in January 2014 for about a month prior to receiving ZOSTAVAX, but on the day of vaccination, the patient told pharmacist that she felt fine and did not mention cold symptoms. The date therapy started was reported as 26-FEB-2014, but according to pharmacy report, patient received ZOSTAVAX, on 27-FEB-2014. The outcome of the events worsening of hearing from pre-existing hearing loss, cannot hear in one ear and herpes zoster is unknown. The reporter's causality assessments were not provided. Additional information has been requested.
over 2wk period, became pale, was fussy, dec appetite;7/16/99 pt was hosp, transferred to ER T103 & fussiness, had fast heart beat, wheezing, rash, fever lasted 4 days;pt still has cramping stomach;
headache; terribly tired and exhausted; weak; off balance; dizziness; chills; shakes; left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included headache.   On 14th August 2020, the patient received the 2nd dose of Shingrix. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity. On 15th August 2020, the patient experienced tremor, dizziness and chills. On 16th August 2020, the patient experienced headache, fatigue, weakness and balance disorder. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the tremor, headache, dizziness, chills, fatigue, weakness and balance disorder were unknown.   It was unknown if the reporter considered the pain in extremity, tremor, headache, dizziness, chills, fatigue, weakness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced left arm was sore and then it went away that day. The following night, he experienced shakes, chills, and dizziness. He went to bed and these symptoms continued on and off into the next day and then calmed down.  He then experienced a headache that was much worse than the usual headache he has had for the last 40 years (which he typically experiences 24 hours per day). The headache was much worse now and he feels somewhat weak and terribly tired and exhausted.  The reporter consent to follow up. This case has been linked with case US2020167501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167501:
Pt with a history of multiple myeloma received injections of Pnu-Imune 23, Act-HIB (Aventis Pasteur SA) and Menomune-a/c/y/w 135 (Aventis Pasteur Inc) vaccines on 9-FEB-2000. Later that day he experienced "stroke-like symptoms" and was brought to emergency room. After extensive testing it was determined he had an embolic stroke and the reporter did not feel it was related to the vaccines.
Revaccinee developed a very pruritic papular rash limited to chest, neck, and upper back. Also, complained of generalized pruritis to entire body. Approximately 30 (3mm) papules to chest. No fever, nor complaints of malaise, muscle aches, etc.. Started on Benadryl 50mg Q4hrs. Rash and pruritis resolving as of 03-10-2003.
seizure; 14 pound weight gain; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (seizure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, APIXABAN (ELIQUIS), EPOPROSTENOL SODIUM (FLOLAN) and SILDENAFIL CITRATE for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced WEIGHT INCREASED (14 pound weight gain). The patient was hospitalized from 23-Mar-2021 to 25-Mar-2021 due to SEIZURE. At the time of the report, SEIZURE (seizure) and WEIGHT INCREASED (14 pound weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Weight: abnormal (abnormal) gained 14 pounds in 1-2 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that it was not sure if the patient was getting her diuretic in the hospital.
Information has been received from a registered nurse concerning a child who on 30-NOV-2010 was vaccinated orally with first dose of ROTATEQ and the second dose was then administered on 20-OCT-2011 at public health clinic/hospital. No adverse effects were reported. Follow up information has been received from a healthcare worker from the office reporting that the patient did not have any adverse symptoms. Follow up information has been received from a registered nurse reporting that the 12 months old male patient did not seek any medical information. No further information is available.
patient experienced aches, chills, and nightsweat lasting a day starting a few hours following receipt of influenza immunization.
Pt recvd DPT 14JUN91 & on 15JUN91 began w/fever like sx 23JUN91 whoop like cough, cyanosis, vomiting hospitalized 3JUL91, 13JUL91; As of 23JUL91 mom states pt has occasional cough;
I had swelling and soreness at the injection site that evening I had flu like symptoms cold and achy needing to drink warm fluids this lasted for two days.
Awoke two days after with severely swollen, stiff, and painful knees.  Practically impossible to bend.  Other minor unusual sore spots, base of left index finger, we're tolerable,  but I am having trouble standing, sitting, and walking because of the extreme state of my knees!  No history of arthritis, but every appearance of sudden onset!
Pt has experienced pain in arm since injection on 10.4.19 (date today upon report of issue from patient is 10/23/19)- reports pain upon raising shoulder that sometimes feels like shooting pain. Cannot take NSAIDS due to low kidney function, but has reported using heating pad to try and relieve pain.
Patient was mistakenly administered a Prevnar 13 vaccine instead of Pneumovax 23.  Nothing adverse occurred, just a medication error and vaccince given to a patient not age appropriate and for an approved reason.
Got a Pfizer covid vaccine and flu vaccine at pharmacy. Face swelled up and got Shingles! Loss of movement and numbness in fingertips and arm. Had to go to emergency room. Now have lifetime shingles! I am only 38
getting cramps in my abdomen; blood in my urine; blood flow/ still getting dark (gross) spotting; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 59-year-old female patient (Non Pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:15 PM as single dose for covid-19 immunisation. Medical history included Graves Disease and seasonal allergy. Concomitant medications received within 2 weeks of vaccination included levothyroxine, liothyronine and seasonal allergy, etc. Allergies to medications, food, or other products: penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Late night on Saturday 27Mar2021 23:45, the patient started getting cramps in abdomen, then she noticed blood in urine. Cramps subsided after Advil but work up the next morning with a blood flow. It's been 5 years since her last menstrual period, with very little spotting in those 5 years. It's been a week since the cramping and she was still getting dark (gross) spotting. This was very unusual for her body. Not sure if she should take the 2nd Pfizer shot. No treatment was received for the adverse event (except cramps in abdomen). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of cramps in abdomen was resolved with sequel. The outcome of others was unknown.   No follow-up attempts are needed. No further information is expected.
Upper arm pain and decreased range of motion remaining at 5 weeks post shot.  Unable to do typical activities of daily living as pain is restrictive and severe.
Patient was given flublok instead of fluzone quad for age range. No adverse effects were reported.
will be given Novocaine for her dental crown; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported is to receive her second dose on 10Mar2021. That same day, she needs to go to her dentist and will be given Novocaine for her dental crown. The patient experienced will be given novocaine for her dental crown on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After each shot, had significant improvement of less pain for 24-48 hours; After each shot, had significant improvement of less pain for 24-48 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, after each shot, the patient had significant improvement of less pain for 24-48 hours (unexpected therapeutic benefit). The clinical outcome of the event after each shot, had significant improvement of less pain for 24-48 hours was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient sitting in observation room, received first Moderna vaccine at 1010 am. Stated to observation staff that he is feeling dizzy and trouble reading.. Patient stated that he did not eat and that he did not take any medication. VS at 1105am BP 124/66, HR 100 and O2sat 96%. 1108 BP 123/67, HR 98, O2sat 98. VS@ 1111am BP 100/79, HR 94, O2sat 97% encouraged to drink and eat some crackers..VS @1114 BP 109/68,HR 104,O2sat 99%. VS @ 1117 BP 124/62, HR 105, O2sat 99%.Patient continued sitting and stated some head pressure on the top , not sure if HA, but no dizziness. 1125 Patient went to restroom and stated improprovement ,decrease in HA/pressure. VSS BP 124/64, HR 96 and O2sat 97% Patient felt 1145 am.comfortable going home at 1145.
Intense muscle/body aches to the point I can barely move. Started late evening the day after the vaccine. Continued overnight and remains this morning two days after vaccination.
Twelve days after the first vaccination, I had extreme joint pain and headaches that I could not remedy.  On day thirteen, I noticed that I was unable to hear very well out of my left ear.  the other symptoms went away after a week, but the hearing loss did not.  I saw my primary care physician after a few weeks of it not clearing up.  He prescribed allergy medications, then he gave me a steriod pack.  Neither made my hearing improved.  He sent me to see an ENT out of precaution.
Patient developed rash around injection shot and then it spread across chest and neck.  Patient stated rash was not itchy but it "felt funny."  Patient took Benadryl and the rash went away within 24 hours.
Lightheadedness within 15 minutes that remained intermittent and low. Nausea within 15 minutes that was transient.  9 hours after injection  body aches hear through pelvis. Excessive yawning and stretching. Headaches.  Right side worse than left.  Jaw pain especially right side
Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 22-MAY-2012 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-JUN-2016 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was treated with acyclovir, prednisone, LYRICA, and ZOFRAN. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful 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, pain, suffering and other damages. Additional information has been requested.
On day two through five have experienced extreme lower abdominal pain and frequent diarrhea.    I do not have an appendix, gallbladder, have had a total hysterectomy and no history of IBS.
Information has been received from a nurse practitioner concerning a 67 year old female with no pre-existing allergies, birth defects, medical conditions, who on 09-OCT-2007 was vaccinated SC with a first dose of ZOSTAVAX (Lot # 658209/1085U). On 10-OCT-2007 the patient called the office stating that she woke up with red puffy eyes. The patient was scheduled to be seen in the office. There were no lab diagnostic studies performed. There was no illness at the time of vaccination. There was no adverse events following prior vaccinations. No medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. This is a consolidation of two reports concerning the same patient. Additional information has been requested.
P/vaxs mom reported pt cried nonstop x 4 hrs w/high pitched cry-called MD & was instructed to cont giving APAP & come in day to be seen.("if problem persisted")-Not seen anywhere.
Information has been received from a RN concerning a 12 y/o female no medical history who on 25May1995 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live. There was no known illness at the time of vaccination. On 09Jun2003 the pt developed a fever. The RN reported that on 10Jun2003, the pt broke out in a rash, had approximately 50-75 lesions and experienced intense itching. The pt was treated with hydroxyzine HC1 (ATARAX) for the intense itching. As of 11Jul2003, the pt had no other problems related to varicella virus vaccine live. At the time of this report, the outcomes were unknown. Additional information has been requested.