chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included adverse drug reaction (had a history of reactions with many medications). On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, pain, shivering and sleepiness. On 12th July 2018, the patient experienced muscle pain, upset stomach, erythema of extremities, pain in arm and headache. In July 2018, the patient experienced diarrhea. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea to be related to SHINGRIX. Additional details reported as follows: The patient received the SHINGRIX vaccine on left arm and the patient reported that she had an intense reaction to the vaccine which included flu like symptoms, muscle pain, extreme fatigue with difficulty staying awake, a terrible headache, shivering, terrible upset stomach, diarrhea, arm pain that was killing her, bizarre redness that looked like she had a dinosaur on her arm and the redness was going in different directions. For two days, the patient did not leave her house because she felt like she had the flu. If someone touched her injection arm, she would scream. The night after she received the SHINGRIX, the patient went under the covers in her bed around 8:00 PM and she felt like she was going to die and she did not leave the house until Thursday 12th July 2018.  On 13th July 2018, the patient felt better by Friday.
Information has been received from a consumer her son, with no known drug reactions/allergies and no pertinent medical history, who on unspecified dates was vaccinated with the first and second doses of MMR II, 0.5 ml. No lot number was provided. There was no concomitant medication. The patient's mother reported that within 4 months after receiving the vaccine, the patient became autistic. The consumer stated "he did however receive the second dose". She also stated that through early intervention patient has improved, however he still was autistic. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
2nd dose of Shingrix was given on 6/16/20.  Patient noted a rash on her stomach and buttocks that began on Thursday 6/18/20. Patient did not complain of itching.  Patient called to pharmacy to report incident and was suggested to take an antihistamine and to follow up with her primary MD.  Her primary MD also recommended and antihistamine and to follow up later in the week.  The patient took both Zyrtec and Benadryl with little relief. She followed up with a Dermatologist who prescribed and prednisone taper which did give her a successful outcome.  Patient reported that the MD stated that is was not a shingles outbreak but an actual allergic reaction
2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunday evening felt feverish, chills, body aches. Felt fine Monday morning. Monday about 11 am began to feel tightness in chest, thought it was bad heartburn. Pain kept me awake Monday night, and continued into Tuesday morning. Called the doctor, was sent to urgent care. Urgent care detected elevated tritonin and had me transported to the emergency room. Elevated heart rate and rising tritonin levels had me admitted to the hospital. Given heperin and a beta-blocker, given a CT scan, and monitored over night. On Wednesday had a echocardiogram and then a heart catherter and imaging, which showed a healthy heart, no plaque, no blockages. Tritonin levels and heart rate returned to normal. Released from hospital on evening of 3/10.
pt exp urticaria - EPi given pvt MD; sent to ER-DPH;
pt became "sleepy" approx 10 minutes after receiving the vaccine. PHN noted that pt was sitting in vehicle in passenger seat with daughter as driver. pt appear lethargic but responds to verbal commands. pt weakly states she was just "sleepy". PHN asked pt if she was having any difficulty breathing or feeling any other symptoms and pt replied "no". pt's daughter was talking to her in their language has PHN was speaking. BP 148/84, pulse slow and steady @ 70/min. pt stated she wanted to lay down and PHN lowered seat back to recline and brought pt's feet up. pt did not tolerate the position change well and started gagging with dry heaves. 911 called. placed pt's feet down. pt c/o of feeling hot.
Started about 12:00 having a backache and fatigue by 4:00PM started having bad headache, dizziness, muscle aches and pains and started running fever. I felt like when you are very sick with the flu. Went to bed a woke up all night just drenched in sweat. Got up about 6:00 am and still had a bad headache and tired but by about 10:00 felt ok. So the symptoms only lasted less than 24 hours. My arm is still swollen, hot and red at the injection site.
dosing schedule needs to be re-started due to deviation from vaccination schedule; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 year old female patient who was vaccinated with first and second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot N1L47 and expiry date 23 May 2021) via unknown route in unknown administration site for prophylactic vaccination, first dose on 07 Jan 2021, second dose on 14 Jan 2021 (inappropriate schedule of product administration).  The medical history, medical treatment(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate schedule of product administration (latency unknown).  Patient presenting for 3rd dose of IMOVAX for pre exposure. Caller reporting patient was at 33 days since first dose. Caller with question on whether dosing schedule needs to be re-started due to deviation from vaccination schedule. Additional Description of event Adverse events :RN with patient presenting for 3rd dose of IMOVAX for pre-exposure. Since first dose. 1st dose: 07Jan2021 2nd dose: 14Jan2021.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After 9 months of being without a period due to menopause, had menstrual flooding out of no where that is heavy for a day or two, then goes away, then comes back. At the time of this notice, it is still ongoing and has not resolved. Heaviest period I have EVER had in my life with extreme abdominal pain/cramping that I have NEVER had before.
He reports with the other doses, he experienced fever, chills, achiness; He reports with the other doses, he experienced fever, chills, achiness; He reports with the other doses, he experienced fever, chills, achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness). At the time of the report, PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2022-531762, MOD-2022-531517 (Patient Link).
Heat and swelling at injection site, intense high pitched screaming, inconsolable crying, rash at injection site, change in breathing, lethargy, change in consciousness.
Sep 28: Patient received ZOSTAVAX right upper arm. Sep 29: Redness around injection site (12 cm) with papules (not vesicles) forming. Oct 4: Doctor visit; papules resolved, redness resolving.
Jan 2008 diagnosed Sensory Guillain Barre - Jan 08 IVIG relapse May 2008 IVIG relapse June 2008 high dose of PREDNISONE tapering down relapse Jan-Feb 2009 up PREDNISONE dose August 2009 added LEKCEPT to PREDNISONE Chronic sensory GBS/sensory CIDP.  8/27/09 Neurology consult records received DOS 1/2/08 to 7/22/09. Assessment: Guillain-Barre Syndrome. Inflammatory Polyneuropathy, Raynaud's phenomenon. Median compression neuropathy right wrist.   Patient noticed numbness and swelling in right hand, later left hand. Tingling in toes bilaterally. Alteration in sensation (Pin, vibration) in fingers and toes. Recurrent symptoms several months later. 5 day course of IV Ig. Oral and vaginal thrush. Burning and discomfort upper right quadrant. Allergy neomycin,polymyxin/hydrocort topical. Neulogical symptoms continue and get worse if prednisone dosage is reduced.
Immediately after receiving my first Covid shot, I felt nauseous and lightheaded. This lasted for the rest of the day. I woke up early the next morning with significant nasal congestion that did not stop. Over the next several days, the insides of my nasal passages became inflamed and the tissue felt raw and excoriated. Every morning after that, my nose was completely filled with congestion/mucous and would bleed. The inflammation of my nares has continued to worsen and is an ongoing adverse effect from the shot. My right nostril has become so inflamed that the opening is almost closed. I find it extremely difficult to breathe through my nose now. My nose produces a large amount of congestion every day that has never before happened in my life. I am an avid runner and love to run races, but this has significantly impeded my ability to run well. I am unable to breathe through my nose now when I run, and the congestion makes me feel increasingly out of breath. As a nurse, I was constantly pushed to get the Covid-19 vaccine when I did not want it or need it. This adverse effect continued through the time I was supposed to get my second dose. I very hesitantly received my second dose, and the congestion and inflammation only got worse. Today is March 4, 2022 and these adverse effects have not stopped. My nose continues to be very painful, and the tissue inside is inflamed and excoriated from the overproduction of mucus. This has been ongoing and constant for exactly 6 months now. This is not a transient or short-term adverse effect. It has continued to cause problems, pain, and has impeded my daily functioning at work and in my off time running. The only thing I know to do at this point is to see an ENT specialist.
Patient with no prior otologic disorders noted sudden hearing loss on left 2-3 days after vaccine.
itching red rash front of her leg under the knee; itching red rash front of her leg under the knee; burning sensation continues; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) (batch number 924T3, expiry date 3rd June 2022) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced burning sensation. On 21st November 2020, the patient experienced itchy rash and red rash. The patient was treated with hydrocortisone (Hydrocortisone Cream). On 23rd November 2020, the outcome of the itchy rash and red rash were recovered/resolved. On an unknown date, the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient received first dose on 19th November 2020 early afternoon and on saturday night, 21st November 2020 she started with a itching red rash front of her leg under the knee. At the time of reporting, the itching improved but the burning sensation was continued. The reporter consented to follow-up.
2nd for vaccination in July.  Since that time, day of the 2nd vaccine he has had intermittent ?hives".  Describes a generalized rash "under the skin" happening a few times/week, lasting minutes to hours, itchy.  History of hives as a child.  Mother reports that this is similar to his hives as a child.  Taking loratadine which has improved symptoms.  When he forgets to take loratadine notices an outbreak of the rash.  No rash today
Numbness of shoulder 5 min or less from injection, throat swollen 30 minutes later, drainage in throat, dizziness 5 min or less from injection.
Started with knees giving out.  Ended up with pain traveling throughout torso.  Diagnosed with polymyalgia.
Patient presented to a local ED on 3/25/2021 & was diagnosed with a deep vein thrombosis in the right lower extremity.  She is convinced it is related to the vaccine she received on 3/9/21 and cancelled her appt for her second vaccine.
Case number PHEH2015US020344, is an initial spontaneous report from a pharmacist received on 09 Oct 2015. This report refers to a 66 years old male patient. Medical history and concomitant medications were not reported. The patient received two doses of FLUCELVAX (batch number: 174058) intramuscular on 30 Sep 2015. No adverse event was reported.
receiving expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number BB74J, expiry date 30th June 2021) for prophylaxis.   On 8th September 2021, the patient received FluLaval Quadrivalent. On 8th September 2021, unknown after receiving FluLaval Quadrivalent, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The nurse reported that patient received an expired dose of Flulaval Quadrivalent, the vaccine expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow-up. This case had been linked with US2021191992, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191992:same reporter
Starting 6 hours after the vaccine she had fever, muscle/body aches and fatigue. symptoms lasted for 24 hours
Hives, rash intermittently for at least 4 days. Rash began (1) day after Flu vaccine given. No other symptoms!
One of five infants who experienced sterile abscess at the injection site (Deltoid) with tenderness.  Treatment included tylenol PRN>
Information has been received from a physician concerning a 19 year old female with a history of urinary tract infection who on 07-MAY-2008, was vaccinated with the third dose of GARDASIL. The dates of administration for the first and second dose was not known. There was no concomitant medication. The physician reported that on 21-MAY-2008, after the administration of all three doses of GARDASIL, the patient developed about 25 facial common flat warts and 15 warts on the back of her hands. The patient was initially examined by a dermatologist who prescribed acne cream the first visit. The dermatologist began treatment for warts after the second examination. At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. There was no product quality complaint. Additional information has been requested.
12/5/15 - onset of frequency watery stools - 10-12x/day. Stools tested several times for blood and were negative until 12/23/15 (+) hemoccult - visible blood and mucous in stool. Switched to alimentum, hypoallergenic formula 12/24 with decrease in diarrhea. No ill cultures. Possible protein intolerance after rotavirus vaccine.
I just started having regular cold symptoms and I didn't think I had COVID but my wife insisted and I went and got tested so she would stop nagging me and I had a sore throat, cough, and runny nose. I didn't have any other symptoms and I went and got tested and I was positive.
Got covid on 1.14.22. I am the only one that is vaccinated in my family and my symtoms were severe compared to everyone else in my family who never got the injection (not gonna call it a vaccine since a vaccine is supposed to prevent viral illness).  I believe i would of done much better if i never got the injections. I am reporting the ADR as an impaired immune response.  I have other relatives that got covid around the same time and had only mild sxs. None of them got the injections either.  I am a healthy 36 yo who has a healthy weight and runs and weight lifts 3x weekly.
Immediate numbness at vaccine site, followed by numbness of L side of face, diaphoresis, lightheaded, she immediately went to ER. Symptoms have persisted , now day 5 after vaccination,with L facial numbness, circumoral in Trigeminal nerve sensory nerve distribution V 2-V3, also numbness of tip of L tongue and upper L palate. She reports associated numbness of both hands and toes. Also feeling fatigue and lightheaded
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a 21 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history was not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total administrated, dose, start therapy date were not reported for prophylactic vaccination. It was unknown if patient had adverse reaction with covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total administrated, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died after second dose. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death). This case, from the same reporter is linked to 20220100127.; Sender's Comments: V0-20220100153-covid-19 vaccine ad26. cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
No additional AE details are available; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from a non health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, previous drug allergies or reactions, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022819, expiration date reported as 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided), after a non-supported temperature excursion (product storage error). No additional adverse event was reported.The temperature excursion reported was of 70 degrees Fahrenheit for 90 hours. No previous temperature excursion.
This spontaneous report as received from a physician assistant refers to a 71 years old female patient with diabetic with chronic renal failure but not on dialysis. The patient was vaccinated with 0.65 ml live ZOSTAVAX(lot# unspecified) in approximately January 2011("about two years ago"). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed a case of shingles. Acyclovir(manufacturer unknown) was given as treatment. The outcome of shingles was reported as recovering. The relatedness for shingles was unknown for live ZOSTAVAX. The patient had sought unspecified medical attention. Additional information has been requested.
Patient states immediately after receiving vaccine site becae itchy. Today presents with redness, warm t touch, with small nodule at injection site. Informed to let us aware if seeks treatment. 10/8/14 Cc seeking tx tomorrow at either an urgent care or office.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as ER2613, Expiry date was reported as 31Jul2021) via an unspecified route of administration, administered on 23Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunisation. The patient has also received the second of (bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0161, Expiry date was reported as 31Jul2021) via an unspecified route of administration, administered on 13Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that, first injection was on the 23rd of last month a little soreness in the shoulder next day (On 24Mar2021) till today it was just been feeling like an energized battery. A lot of energy. I bought this house that been vacant for 15 years and I have just been tearing walls down. Today the patient just got the second injection so far alright. I ask everyone about their experiences, and they all tell me the peeing in the be and all this negative stuff and when I tell them how it hit its blowing them away. The outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.