chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clot in the left lower leg; left ankle swelling; left foot pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the left lower leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL for Hypertension.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain). On 12-May-2021, the patient experienced THROMBOSIS (blood clot in the left lower leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the left lower leg), JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Ultrasound scan: abnormal (abnormal) Diagnosed with blood clot in the left lower leg.         Other concomitant medication include statin for cholesterol. Treatment medication for events included Xarelto. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Site: Bruising at Injection Site-Mild, Additional Details: This was  discovered on inventory  count, not  related to this patient specifically because there isn't a way to enter it any other way.  Inventory is 7 vaccine vials  and  4 diluent vials.  This patient did not receive any vaccine this date.
About 3 weeks after the 1st dose appeared a rash at the injection site. 3 months later the is still a rash. Sometimes it is slightly itchy.
Case number PHEH2013US021323, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to a 17 years old female patient. Past medical history was not reported. Concomitant vaccines included hepatitis A (other manufacturer and batch number: AHAVB703WAH06), GARDASIL (other manufacturer and batch number: J008423), Varicella virus vaccine (other manufacturer and batch number H000639) and TDap (other manufacturer and batch number: AC52B026BA) on 17 SEP 2013. She was vaccinated with MENVEO (batch number: M11081 and expiry date 30-APR-2014) at a dose of 0.5 ml in the right arm intramuscularly on 17 SEP 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursions was 0 degree Celsius for may be 10-15 minutes and on 08 SEP 2013, the temperature excursion was 0.5 degree Celsius for may be 10-15 minutes. Reporter stated that she does not know if the vaccine was frozen. No adverse event was reported following this administration error.  Follow up report frm the medical assistant received on 09 DEC 2013: Site of vaccination and concomitant vaccines were added.
Information has been received from a registered nurse referring to 4 patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 08-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M042857, expiration date 21-OCT-2018, strength, dose and route unknown) for prophylaxis, the sterile diluent (manufacturer unknown) (lot# and expiration date unknown) used to reconstitute the vaccine above was properly stored. No adverse effects were reported. The vaccines were exposure at the temperature of 12.4 Fahrenheit (6 to 14 Fahrenheit) for 15 hours and 45 minutes. There was no previous temperature excursion. A data logger was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA008578: US-009507513-1708USA007019: US-009507513-1709USA007602: US-009507513-1709USA007603: US-009507513-1709USA007604: US-009507513-1709USA007605.
Nausea/headache/fatigue, sore throat, itchy throat, cough.
It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/7/99. Reportedly, sometime post vax, the pt developed tingling in both feet with intense sensation of pinpricks on bottoms. The pt was seen by his primary physician who referred him to a Neurologist.
Right arm became bruised and swollen at the injection site depp muscle pain in the neck  and joints. Can't move neck says it feels like she has mumps.
felt like someone hit them in the arm with a baseball bat; muscle pain; fatigue; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, LIMB DISCOMFORT (felt like someone hit them in the arm with a baseball bat), MYALGIA (muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-041373, MOD-2021-041373 (Patient Link).
Pt recv vax & exp exacerbation of chronic fibrocitis which began as pain @ inj site & radiated to shoulder,upper back & neck.Pt exp "significant" pain causing insomnia.
Pin prickly feeling in different areas of her body; Headache; Funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation; Stinging feeling in sinus cavity; This is a spontaneous report from contactable consumer (patient)  A 68-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot#292673 on left deltoid (reported as left shoulder) on 25Jan2021 11:21 at SINGLE DOSE for covid-19 immunisation .  Medical history included diabetes from 11Sep2001 and ongoing , ongoing cardiac pacemaker insertion Put in about 7 years ago , ongoing blood cholesterol increased Diagnosed about 24 years ago , ongoing blood triglycerides increased.  She is allergic to statins. Concomitant medication included alirocumab (PRALUENT) 1 mL at 1ml injection every 14 days for High cholesterol (Injection on side or top of her leg. She has been taking for about 4 year).The patient experienced headache on 25Jan2021 with outcome of recovered , funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation on 25Jan2021 with outcome of unknown , stinging feeling in sinus cavity on 25Jan2021 with outcome of recovered , pin prickly feeling in different areas of her body on an unspecified date with outcome of unknown.  Clincial course reported as follows:She got the first dose of the vaccine today and while she was sitting in the observation area, she started getting a headache. It was close to noon and she just blew the headache off since she was a diabetic. She started getting a funny feeling on the top of her head and down her forehead and around her right eye, like a numbing sensation. When the feeling hit her sinus cavity, it was like a stinging. She started drinking water and she had lunch. Within an hour it started getting better and within 3 hours it was a lot better. She has a pin prickly feeling in different areas of her body but did not have the numbness sensation. She tried to report this online. She only had one virtual visit with her doctor. Treatment: declines any, she was drinking plenty of water to try and flush some it out of her system.
Information has been received from a nurse concerning a 13 year old female who on 02-AUG-2007 was vaccinated with Gardasil.  Concomitant therapy included meningococcal vaccine (unspecified) and VARIVAX.  On 02-AUG-2007 the patient fainted and hit her head and arm.  Medical attention was sought.  The patient was evaluated with an X-ray of her arm.  The patient recovered.  No other information was available.  The nurse also reported that their office had 4 other patients who had fainted after receiving a dose of Gardasil.  No details were available on those patients.  Additional information has been requested.
05/23/06 fever 103.8 - 103 starting last night Motrin given 5/22/06, Tylenol 5/23/06, 5/24/06 office call T 101.7 with Tylenol and Motrin throat erythema, RTC negative, nasal congestion.
Listlessness, nausea/diarrhea, fast pulse, these lasted about 4 days, on the 5th day my lips swelled up a bit.
Patient had developed a red, warm area from site of injection to elbow. No pain. No pruritus. Patient went to urgent care and was told that it was a histaminergic reaction and instructed to ice it and watch for worsening symptoms.
19yo male who received the vaccinia vaccine on 16Feb2018 presents to MC worsening skin lesions. On 3/11/18 the patient noticed he had ~6 erythematous papules ~0.5-1cm in diameter on his right index finger, wrist, and bicep. The lesions on his index finger and upper extremity erupted over previous breaks in his skin from grappling. The lesions where not pruritic at first, but became pruritic later that day. On 3/12, he had more lesions on his right extremity and chest. He was diagnosed with molluscum contagiosum and given hydrocortisone cream. The following day, he continued to have new lesions including one under his right eye where there was a previous grappling cut and worsening puritis. He visited the ER where he was diagnosed with MRSA and started on BACTRIM. He continued to have more lesions on his neck and left arm and made a dermatology appointment. The dermatologist was concerned for a vaccinia reaction and transferred the patient to MC. The patient states he scratches these lesions constantly, occassionally opening them up and he sees clear fluid draining from them. The patient states he is otherwise at his baseline health. Denies fever, chills, SOB, cough, abdominal pain, diarrhea. The patient states that the night before the erruptions began he had unprotected sex with a new partner. He asked both the new partner and his grappling partners if they have any skin issues and they denied. He has also been non-compliant with covering his vaccinia vaccination site. He has repeatedly manipulated it and has not had it covered throughout the day.
pt recv 3 doses of vax & lab eval 20JUL93 & 6MAY94 revealed HBsAg positive & anti-HBs negative;
approx 48hrs burning sensation, sl raised redness in area of shot, size approx of an orange;unable to sleep on that arm 1st noc;skin hot to touch x 48hrs; took ASA, DPH
I do not know that the 7-8-21 RLQ abdominal pain (ER-CT scan confirmed mesenteric lymphadenitis, no appendicitis) Pt c? no illness, viral or bacterial for >2 months at time of pain
(R) sided neck pain & stiffness - mild injection site soreness - Tx with ZANAFLEX. F/U Tx to pt reveals he has had reaction to Thimerosal in past from eye drops. Allergy list updated.
No fever. Extreme weakness - especially legs. Overall very sick feeling. Absolute dependence on walker - before could walk without help.
11/12/99:Pt. rcvd. Flu vaccine, went to ER on 11/16 complaining of weakness and numbness in right arm,shoulder, and in both legs.Symptoms persisted in legs approx. 12 hrs.11/29/99:Pt. complained of numbness in right hand.
Developed redness, swelling, itchiness of right deltoid. Given Benadryl and compresses, then started developing muscle twitching in arm, back and neck. Seen in ER. No scans of brain done, no EEG, referred to Neurology. Placed on antibiotics for possible abscess.
C/O itching that started immediately followed by redness, increased warmth. Treated in ER for cellulitis of left arm.
VZV was given in left arm (SQ) on 7-7-08.  Pt. states he noticed the area turning red the evening of 7-8-08.  He now has a 2 1/2 in x 1in area of redness at site with slight warmness to touch.  Mother is giving MOTRIN tabs 2 q 4 hours.
Vomiting, fever, chills, headache, dizziness, T 103.6F. States has had 4 MMR's. Unable to prove prior MMR's. Was hospitalized for UTI and kidney stone all at sametime. White count was 19,000. Placed on Cipro. States had reaction to last MMR, but didn't realize it was the MMR till now.
A Blood pressure reading of 180/140 was detected through routine at home monitoring.  As of early AM 02/07/2021, blood pressure is still elevated/fluctuating  with 3rd medication added (Cozaar 50mg added 02/03/2021)
Physician states that GARDASIL 9 was administered to a pregnant female who is 30 weeks pregnant; This prospective pregnancy spontaneous report has been received from a physician concerning a 27-year-old female patient. The patient's concurrent conditions included diabetes mellitus. Her medical history was not reported. There was none drug reactions/allergies reported. Concomitant medications included the following: insulin, metformin, prenatal vitamins, and acetylsalicylic acid (ASPIRINE).   On an unknown date, the patient became pregnant. Her last menstrual period was on approximately 16-JUL-2021. The estimated date of conception was not reported.   The physician stated that on 11-FEB-2022, the patient who was 30 weeks pregnant, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot #1775808, expiration date: 20-AUG-2023, administered intramuscularly for prophylaxis. The physician spoke with the patient and none laboratories were performed. At the reporting time, information regarding the pregnancy outcome and estimated date of delivery (EDD) was unknown.
Red, Bruise at vaccination point, Myalgia, Nausea, Vomiting, Fatigue, Tiredness. redness and Bruise for one week, all other issues day after only.
Pt. spouse - Reported today (3/12/21) pt. is in the hospital for "kidney failure". Pt. spouse said she was feeling nauseated on  3/4/21 and then later was in the hospital for treatment of "kidney failure".
had no energy / were not able to do anything after receiving their first dose of Shingrix; felt like plug was pulled; This case was reported by a pharmacist via call center representative and described the occurrence of loss of energy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced loss of energy and tiredness. On an unknown date, the outcome of the loss of energy and tiredness were recovered/resolved.   It was unknown if the reporter considered the loss of energy and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt like the plug was pulled, had no energy and felt like they were not able to do anything. The symptoms started the day of or the day after vaccination and lasted 3 to 7 days. The reporter consented to follow up. No further details were available. This case linked with US2020209416, US2020209434 and US2020209436, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209416:same reporter US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209436:same reporter
She recieved the first dose Covid on 2/26/21, the second dose on 3/22/21, and the third dose on 1/19/22. She presented ED of Hospital with 3 days of productive cough, body aches, and myalgia on 5/22/22. She was subsecently tested positive for COVID and admitted to manage COVID and COPD exacerbation. She was treated with steroids and Doxycycline. She is on room air during the entire hopsitalization and expected to be discharged on 5/25/22.
This non-serious spontaneous case, initially received on 22-Feb-2018, was reported by a pharmacist and concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported) that had possibly passed the 28-day expiration. Non-significant case correction received with IRD 22-Feb-2018: The seriousness criteria (non-serious) was added in the lead sentence.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication received in 2 weeks. Negative test then 4 days later positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The first few days after receiving the vaccination I had a high fever and muscle aches in my back and left knee. About 8 weeks later my hemoglobin dropped to 9.4 when it is usually at a 12 or higher. I also have heavier and longer menstrual cycles now. They used to last for about 5 days. Now they last for about 7 to 8 days. Now I also have much more blood clots than before. I usually get dizzy when I have mensural cycle. I have been prescribed Iron, vitamin D , vitamin B12, and a multivitamin.
BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
In 1 hour, patient had episode of limpness, altered mental status, irregular respirations. He was evaluated by paramedics, taken to a local ED. An EKG was done and normal. His postictal state was about 1 hour and he was observed for 2 hours.
5 minutes after Menomune, patient complained of tightness in chest, throat closing, skin flushed. Given adrenaline, Benadryl and observed 1 hour. B/P and pulse stable throughout. After 1 hour, patient stated above symptoms had cleared. Discharged with Epipen and Medrol dose pack. Follow up 9/30/03, patient denied any symptoms and stated complete recovery.
Temporary partial blindness in the left eye. Event lasted 1 minute. One quarter of the top portion of sight in my left eye was blocked by what appeared to be a dark curtain, this went away after 1 minute. Had an exam by eye doctor the same day , no eye problems were found.  Had an exam by cardiologist the following day. He prescribed a imaging order for a head scan and prescribed Clopidogrel 75 mg  and to monitor a fib for 30n days with Apple Watch.
A LOT OF NAUSEA; TOOK UNREFRIGERATED VIVOTIF; A spontaneous case report was received from a consumer on 02-Dec-2019.  Based on the information obtained from the consumer two individual case safety report PVX201912-000916 (PVX2019-2938, mother) and PVX201912-000917 (PVX2019-2939, daughter) were created and cross-linked in the database.  This case (PVX2019-2939) described an 18-year-old female consumer who had "a lot of nausea" (PT: Nausea), while receiving Vivotif for typhoid prophylaxis. She also "took unrefrigerated Vivotif" (PT: Product storage error).  Case report: The consumer took Vivotif doses, which were left unrefrigerated. It was reported that she had a lot of nausea.  Action taken with Vivotif with respect to reported event "a lot of nausea" was unknown, while with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the reported events was unknown.  Company's comment: A consumer took unrefrigerated Vivotif (Incorrect product storage) and had a lot of nausea. Considering the potential of Vivotif to cause nausea, the causality of nausea is assessed as possible with Vivotif. The causality of the event (incorrect product storage) is assessed as not related.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage) and had a lot of nausea. Considering the potential of Vivotif to cause nausea, the causality of nausea is assessed as as possible with Vivotif. The causality of the event (incorrect product storage) is assessed as not related. US-PaxVax Berna GmbH-PVX201912-000916:
At the injection site, left arm/ intra muscular, there is some  swelling. There is too some pain, level of a five out of ten: tender to touch/ contact and there is some itchiness.
Nausea vomiting cold chills fever weakness dizziness onset was 3 hrs after vaccine and the symptoms stopped 24 hrs later