chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GOT VERY SICK; CHILLS; FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 69.85 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got very sick, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got very sick, fever and chills was not reported. This report was non-serious. This case, involving the same patient is linked to 20221201975.
Period cramping; PMS; Period heavier than normal; Period started two weeks early; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration on an unspecified date (at the age of 26-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6955), via an unspecified route of administration on an unspecified date (at the age of 26-years-old) as a single dose for COVID-19 immunisation.  Medical history was reported as not applicable. The patient did not receive any other vaccines within 04 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication with 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that patients period started two weeks early, 12 hours after the patient received the vaccine. The patient had very consistent periods and it came out of nowhere. It included the cramping, pre-menstrual syndrome (PMS) and it was much heavier than normal. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the events. The clinical outcome of events period cramping, PMS, period heavier than normal and period started two weeks early was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of GARDASIL (lot#, expiration date, dose, route of administration and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme fatigue; Both injection site arms are sore; Headache; Patient received a third dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore), HEADACHE (Headache) and EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L28 and 002A21A) for COVID-19 vaccination.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) dosage was changed to 50 mcg. On an unknown date, the patient received first dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore) and HEADACHE (Headache). On 07-Aug-2021, EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Expired Menveo administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On 28th July 2022, the patient received Menveo. On 28th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comment: The patient was administered with expired dose of Menveo . The reporter gave consent for safety team follow up. Additional Supportive Information: The patient was administered with expired dose of Menveo, which led to expired vaccine used.
This spontaneous report as received from a company representative refers to a 73 year old male patient, the reporter's father. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as 6 to 7 years ago), the patient was vaccinated with ZOSTAVAX vial (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed shingles which was considered a breakthrough by the reporter. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from an office manager concerning a female who on 26-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U). On an unspecified date the patient developed cellulitis and was hospitalized. At the time of this report, it was unknown if the patient was still hospitalized or her present status. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. Follow-up information was received from the office manager via medical records which reported that on 26-NOV-2008 the 18 year old female patient was vaccinated with a dose of PNEUMOVAX 23 (lot #656439/0577U) in the left arm. On the same day, the patient also received a dose of FLUZONE (lot # U2853AB) in the left arm. Thereafter, on approximately 28-NOV-2008, the patient developed fever, headache, left arm pain and was seen in the doctor's office where they noted her to have an elevated white count of 33000. On 28-NOV-2008, the patient was sent to the hospital for further evaluation. Upon admission, the child was afebrile. The left upper arm was red, indurated and tender all around the entire injection site. The rest of the physical exam was normal. Upon admission the white count in the hospital was 25.4. During the hospital stay, there was a repeat white count the day after admission where the white count had gone down to 17000. The child continued on TORADOL and MOTRIN for pain. There was an infectious disease consult which another physician thought that it might have either been a local reaction to the vaccination of PNEUMOVAX 23 versus a cellulitis of the area. During the hospital course the child was treated with UNASYN IV. She defervesced and her redness and swelling of her arm gradually improved. She was discharged home on 02-DEC-2008 to continue P.O. AUGMENTIN XR, 1 tablet, twice a day for 1 week. It was reported that the patient had fully recovered. This is one of several reports received from the same source. Additional information is not expected.
The patient presented in the office on 11/09/2001 with 2 round lesions on his right thigh, measuring 3/4" x 3/4", which were warm and swollen. The patient was diagnosed with cellulitis and a temperature of 102F. The patient was treated with Augmentin.
Patient had a large rash begin to appear on her right thigh on April 25 2021.; This is a spontaneous report from a contactable consumer (reported for himself). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in arm left on 06Apr2021 at 14:00 (at the age of 28 years old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included attention deficit hyperactivity disorder, Other medical history: Adult ADHD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) at a dose of 60 mg, daily taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrum, minocycline, formaldehyde and experienced hypersensitivity. On 25Apr2021, the patient experienced had a large rash begin to appear on her right thigh. The adverse event resulted in doctor or other healthcare professional office and clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient scheduled second dose on 27Apr2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
BRUISE At SITE OF INJECTION - BRUISING STARTED IMMEDIATELY AT TIME OF INJECTION. BRUISE WAS 3INCH BY 2 INCH. NO ABNORMAL PAIN--BUT CONSISTENT WITH TYPICAL BRUISING.
Rash in chest / rash at the back / rash in both arms; Redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in chest / rash at the back / rash in both arms) and ERYTHEMA (Redness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Hypertension and Anxiety. Concomitant products included MIRTAZAPINE for Anxiety, SIMVASTATIN for Cholesterol, AMLODIPINE for Hypertension, GABAPENTIN for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Rash in chest / rash at the back / rash in both arms) and ERYTHEMA (Redness). At the time of the report, RASH (Rash in chest / rash at the back / rash in both arms) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.
On post-vaccination day #9, patient reported to my clinic with complaints of mild fatigue and localized itching.  He also exhibited moderate errythema/edema extending anteriorly and medially from the innoculation site and into the axillae.  Tender lympadenopathy was also discovered.  His symptoms decreased and susbequently resolved over the next 48 hours.
No Adverse event. Patient was given high dose fluzone (for 65 and over) flu vaccine, but patient is only 62 years of age
Patient developed a rash starting at ankles and spreading up over legs and torso,  also slight cough reportedly got worse, but no wheezing or shortness of breath.  Patient  was given prednisone course 60mg x 2 days, 50 mg x 2 days, 40 mg x 2 days, 30 mg x 2 days, 20 mg x 2 days, 10 mg x 2 days and will follow up
Notified by a secondary source the following information. Patient was admitted to the hospital for a stroke. The hospital discovered the patient had a stroke a week prior to vaccination. Patient pace maker had been faulty and patient INR may have been lower than therapeutic.  Unable to speak directly to patient at this time to confirm these events.  Actual progression unknown. Understood patient is improving.
I saw my PCP on 1/5/2023. On that day, my blood pressure was slightly elevated, and that was the first time I had noticed that I had possibly had blood pressure issues. After that, I began monitoring my blood pressure more carefully. During that visit, my PCP was trying to pinpoint a possible cause for the elevated blood pressure. A blood test was done, and there were indications of irregularities of the thyroid gland. He then referred me to an endocrinologist. I went to the endocrinologist on 1/10/2023. She scheduled me to undergo a thyroid ultrasound on 1/19/2023. She also put me on a thyroid medication, methimazole. On 1/19/2023, I underwent the ultrasound. The results indicated that I had nodules on my thyroid, two of which were suspicious. The endocrinologist then scheduled me to undergo a biopsy, which I did on 4/27/2023. I am currently awaiting the results of the biopsy. I saw my PCP on 4/25/2023. He did a general review of all of my blood tests and checked my blood pressure, which was perfect that day. This occurred after I had my dosages of blood pressure medications incrementally increased. The increases took place on 1/26/2023, 2/12/2023, 2/14/2023, 3/13/2023, and 3/25/2023. I was also prescribed a new medication, olmesartan medoxomil, on 3/13/2023. My PCP has scheduled me for a nuclear coronary stress test on 5/17/2023. He has also scheduled me to undergo a conservation urine test, in which I keep samples of all of my urine during a 24-hour period and then submit them for testing. This procedure is being done, because I had slightly abnormal readings for my adrenal function. Also, on 1/25/2023, I was switched over from Genvoya to Biktarvy.  On4/7/2023, I underwent another blood test, which indicated that I had abnormal adrenal function and kidney function. The doctor was not concerned about my kidney function, though, as my kidney function has been slightly abnormal for some time. Also, the elevated creatinine levels may have been the result of the HIV medication I was taking. He had mentioned that the medication was tough on kidneys, but mine were holding up pretty well.
Patient had reported itchiness and rash over their whole body after dose 1. Her doctor was informed and she was instructed to use Benadryl as needed for treatment of symptoms during her second dose.  After her second dose given on 3/26/21, while monitoring for a reaction, patient informed us of onset of itchiness on arms and in mouth., no visible rash.   I administered 50mg dose of diphenhydramine and monitored further 30 minutes.
My left shoulder hurt for about 10 days after the shot was administered. The site felt hot and my arm felt weak and heavy when I tried to lift it.  The pain subsided for a couple weeks.  Around 2nd week of December I was having trouble sleeping because my arm/shoulder hurt. Initially I thought I had slept on it wrong, because it bothered me most at night and kept me awake. It felt dull and achy. During the day it was hard to lift my arm above the height of my shoulder, especially when putting my arm into the sleeve of a jacket.  I started to ice it in the morning, and would use Advil as needed, both of which helped to relieve the pain. I kept thinking the pain would go away, but it persisted. I finally visited the Orthopedic department at Hospital on February 25, 2020 where they did xrays and gave a diagnosis of Shoulder Bursitis (triggered by the vaccine administration).
also had a flu shot in the other arm - can't find the paperwork to provide specific flu shot.  My spouse and I received the vaccines on the same day. We both had the same symptoms over the last several weeks. Symptoms include: neck muscle pain that radiates up to the head, neck muscle pain that makes it painful to turn head, light headedness upon rising, fatigue. Spouse reports balance problems upon rising at night. Symptoms  are decreasing but are worrying.
Severe joint paint and nausea starting 12 hours after booster received. Severe muscle pain from left arm, across chest, armpit area, down to left side starting 36 hours after booster received lasting greater than 24 hours. Severe muscle pain has not gotten better at this time, causing me to call in into work as I cannot move my left arm due to swelling.
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 26 year old female patient. Pertinent medical history and drug reactions/allergies were none. On 06-NOV-2013 the patient was vaccinated with GARDASIL dose 3 (dose, route, lot and expiry date unknown). The patient became pregnant with LMP of 30-JUL-2013 and EDD of 06-MAY-2014. At the time of report, patient was in 14 weeks gestation. The pregnancy outcome was outcome pending. The patient had received third dose of GARDASIL while she was pregnant. No adverse effects were reported. Lab diagnostics studies performed were routine prenatal laboratory studies. The patient went to see nurse practitioner to seek medical attention. Additional information has been requested.
pt recv vax 3MAY96 & on 13MAY96 pt devel typical measles like rash over the body & a fever greater than 104;It was noted that rash was not real itchy but pt was cranky;tx w/APAP & DPH & fluids;
Patient used fake names and received full series of all approved vaccines. It was not caught until he received his final dose of Moderna
Skin sensitivity along my back; Feels like I am sunburned; This case was reported by a consumer via interactive digital media and described the occurrence of sensitive skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced sensitive skin and sunburn. On an unknown date, the outcome of the sensitive skin and sunburn were unknown.   It was unknown if the reporter considered the sensitive skin and sunburn to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had shingles vaccination. Since that time the patient developed a skin sensitivity along back. The patient felt like he or she was sunburned. The patient was wondering if that was a side effect from the vaccination or not. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L006547, intramuscular, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a consumer refers to her mother of unknown age. About a year ago, in approximately October 2012, the consumer's mother was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). On 14-OCT-2013, the consumer's mother was vaccinated again with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). At the time of the report, the consumer's mother status was unknown. Additional information has been requested.
I received a telephone call on 10/29/13 at 0930 from nurse in jail medical.  Nurse states that patient complains of sore arm at injection sit.  Hard lump present, no erythema noted.  Flu like symptoms over the weekend with painful joints, weakness, fatigue, hot-cold symptoms but afebrile.  Symptoms present 5 days from injection.  Will see Dr. on 10/31/2013.  Able to move all extremities.
excruciating back pain starting approx 11AM 2NOV97 unable to walk Sunday or Monday-returned to work 4NOV97 but lt early for home d/t tiredness from prescribed meds;muscle pain still evident 4NOV;pt had similar rxn w/lyme disease in 1995;
Vaccine was given on 9/22/21 and vaccine had expired on 9/21/21
red and swollen on right thigh 3x5 inches by 12/26/2005.  Redness intially noted 12/24/05 about 50 cents size.
Injection site red and irritated, noted 24hrs after injection. Instructed to give TYLENOL and apply cool compresses.
Febrile seizure on 5/21/18, seen in ED at Hospital and diagnosed with L AOM and fever to 103.  On f/u on 5/22/18, L ear drum slightly red but non-bulging, continued amoxicillin but more likely that febrile seizure was MMR vaccine reaction.
Chills, fever (101 F), aches, nausea, harder and faster-than-normal heart rate, ~90 bps (normal for me is about 60 bps). Fever subsided by about 10:00 am the next day, but for the next day (10/23) I was extremely weak, tired and joints aching far more than normal for the next 24 hours.  Two days later, I am tired and shaky.
Patient tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An adult patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 30Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SARS-COV-2 TEST POSITIVE (non-serious), outcome "unknown", described as "Patient tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Oct2023) Positive, notes: Patient tested positive for Covid. Therapeutic measures were taken as a result of sars-cov-2 test positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Moderate pain at injection site, 2 days. Swollen and painful lymph nodes in armpit on side of injection, 4 days. Fatigue, 2 days. Headache (not migraine), 2 days. Chills, 1 day.
Arm so sore could not sleep. Next morning upper arm completely swollen and red. By the afternoon fluid building up, by the elbow. Arm so sore could not use. Big pocket of fluid at the elbow size of tennis ball. Dr. put on medication okay now.
In early December I began bleeding heavily, more than I have ever before. This lasted for two weeks. I was passing blood clots. I saw a doctor and was prescribed birth control pills. The bleeding diminished. Before these symptoms started I stopped taking my hyperthyroidism meds, without doctors permission. This was about a month before the bleeding started. I did the taper off method of birth control. I went back on Armour. Hemoglobin was low a few months later but I have changed food intake to increase iron absorption. In addition, I had a break through COVID-19 infection in December as well.
Fever increasing from 97 to 102 degrees, body aches, chills, nausea, diarrhea. Went from feeling totally fine to having intense side effects in a span of 20 minutes roughly 8 hours after receiving the vaccine. Side effects were intense over 12 hour span.
generalized urticarial rash which occurred about 27 hr p/vax; pt was brought to clinic had rt ear infect w/t100.4;