chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cognitive issues/has a lot of slowing in the cognitive area; had difficulty finding words she wants to say; she is forgetful, cannot think of the next word she was going to say; This spontaneous report has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.   In December 2022 (reported as last December), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dosage form (one dose), strength, lot#, expiration date, route and anatomical location were unknown) for prophylaxis at her pediatrician.  On an unknown date, the patient began experiencing cognitive issues (cognitive disorder). The patient had difficulty finding words she wanted to say (aphasia), and she was forgetful, could not think of the next word she was going to say (memory impairment), and just had a lot of slowing in the cognitive area. No additional information was provided to further clarify this statement. The patient's father asked the reporter if they were possible adverse effects from receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient did not receive any additional doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for the events was withdrawn. The outcome of the events was not reported.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all the events was not provided.
pt recv vax 4AUG95 c/o lt arm redness, warm, fever 101 5AUG; discomfort- taking meds for fever & discomfort;  to clinic c/o lt arm area swollen, "rxn to shot"; on ATB for inc blood count
Delayed reaction 9 days after injection: redness, itchy, hot at injection  site, some arm soreness similar to day of injection
MODERNA COVID VACCINE #3 GIVEN 9/11/21, LOT #020F21A; pt to ED with generalized body aches; states he ran out of pain medication 2 days prior to coming; found to be positive for COVID; not hypoxic; admitted with Atrial Fibrillation with RVR, treated with medication; pt had acute metabolic encephalopathy secondary to COVID; this resolved and pt was recovering well from COVID; pt experienced asystolic cardiac arrest and passed away in the hospital
03Jan, 06Feb, 10Jul90 pt vax;  titer test revealed pt did not gain immunity.
Diarrhea; Extremely itchy injection site; Red injection site; Swollen injection site; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, AMLODIPINE, METOPROLOL, LISINOPRIL and SPIRONOLACTONE for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN), PANCREATIN (CREON), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], RESVERATROL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MAGNESIUM and VITAMIN B NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 08-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medicines include Amlodipine, Metoprolol, Lisinopril and Spironolactone for her high blood pressure; Atorvastatin for cholesterol; a baby aspirin a day; Creon 24000 for her pancreas and many over-the-counter vitamins (B, D, B12, magnesium, C, resveratrol, CoQ10). Treatment medicine include Hydrocortisone.; 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.
Patient reports to ED 1 day after receiving Tdap vaccine with dyspnea, nausea, and flank pain. Of note, patient was recently diagnosed with an 8mm kidney stone that will required surgical removal shortly after admission. Possible that symptoms were r/t to kidney stones but unsure as the symptoms appeared shortly after vaccine administration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 10Jan2021 as dose 2, single (Lot number: EH9899), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 3302680), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "cardiac dysrrhythmia - both controlled with medications" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL, start date: 29Jun2018, stop date: 02Aug2022; ATORVASTATIN, start date: 20Jun2018, stop date: 02Aug2022; TERAZOSIN, start date: 20Jun2018, stop date: 02Aug2022; LISINOPRIL, start date: 20Jun2018, stop date: 02Aug2022; TESTOSTERONE, start date: 20Jun2018, stop date: 02Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 treatment; (unspecified date) Negative, notes: home test negative; (unspecified date) Positive, notes: Home Covid test positive; (unspecified date) Positive, notes: Covid test is positive again; (28Jul2022) Negative, notes: tested negative 28Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medications in two weeks: Brand: Paxlovid, start date: 22Jul2022, stop date: 26Jul2022, Indication: Treatment of COVID-19. Other medication in 2weeks product: Verapamil, start date=20Jun2018, stop date=02Aug2022; atorvastatin, start date=20Jun2018, stop date=02Aug2022; Terazosin, start date=20Jun2018, stop date=02Aug2022; Lisinopril, start date=20Jun2018, stop date=02Aug2022; Testosterone, start date=20Jun2018, stop date=02Aug2022. First Covid symptoms 21Jul22; home test negative. Significant cough, muscle aches, lassitude 22Jul. Home Covid test positive. Paxlovid prescribed and started on 22Jul. Took all 10 doses through 26Jul. Felt much improved and tested negative 28Jul. No symptoms at all for 3 days then, evening of 01Aug developed nasal congestion and dry coughing. This am (02Aug) have severe, frequent bouts of coughing, heavy nasal congestion, lassitude and Covid test is positive again.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2
Burning tongue; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Burning tongue) and ORAL DISCOMFORT (Tingly lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN (DIOVAN).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (Burning tongue) and ORAL DISCOMFORT (Tingly lips). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available informAation and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient came into the pharmacy Friday Morning at approximately 8:50am stating that she had recieved her flu shot and pneumonia from us within the last couple of days. She stated that she had noticed a lot of soreness in her arm Wednesday 10/7/20 night, but did not notice any redness or swelling until Thursday 10/8/20. She also stated that she had body aches on Thursday, but didn't mention having them on Friday. The area around the injection site was slightly swollen, red, and warm to the touch, and was streaking down into the axillary (armpit) area. She said that she took some extra-strength tylenol but the spreading, swelling, and pain had not gone away, and said that it was continuing to spread and get bigger. I escorted the patient to the medical clinic, where she was seen by the APRN on site. She was prescribed Cephalexin 500 mg.
Large reddened areas appeared on the trunk of the body, mostly on the front side.  Extremely itchy and uncomfortable.  Some of the reddened areas were fluid filled, these fluid filled areas grew in size over the course of the next few days.
Follow up information was received that provided patient information and lot number.  Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who experienced screaming hysterically, redness, swelling and warmth expanded form her groin to her foot. The patient received the third dose on 28-Jul-2009. The patient also received a dose of Haemophilus Influenzae B (manufacturer unknown) and a dose of Diphtheria and Tetanus Toxoids and Pertussis (manufacturer unknown) on 28-Jul-2008. On 28-Jul-2008, the patient began screaming hysterically 3-5 minutes after receiving the PREVNAR. The area around the site became red, warm and swollen about 4 inches in size. Within 20 minutes the redness, swelling and warmth expanded from her groin to  her foot. The outcome of the events is unknown. No additional information was available at the time of this report.
Tingling face; Face numbness; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via unspecified route of administration in the left arm on 23Mar2021 at 15:00(at the age of 35-years-old) as a single dose for Covid-19 immunisation. The patient had no medical history. Concomitant medication included ibuprofen (ADVIL) for unknown indication from unknown date .The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 23Mar2021, after 30 minutes of receiving the vaccine, the left side of patients face began tingling, then went numb for approximately 45 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of the tingling of face and face numbness was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
At the time I was short of breath and severely coughing and I went to the doctor and he gave me an antibiotic for 7 days. Before 7 days I went to the hospital because the cough continued and they changed the antibiotic, they did not find anything and then I went to the primary doctor and changed to a third antibiotic and I went to Urgent Care and they told me better go see a cardiologist. The Cardiologist told me that I have problems and has sent me to have an MRI. I have the appointment for February 7, 2022.
Growing red rash at site of injection, getting progressively more itchy as time goes on.  Antihistamines have helped relieve the itching.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding an 11-year-old male patient who experienced sneezing and congestion. At 11 years of age, the patient received a dose on 01-Oct-2003. Medical history: The patient's concurrent illness includes being overweight. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 01-Oct-2003. Dose regimen was 0.5 ml (intranasal). Concomitant therapy: The patient was not receiving concomitant medications. Event details: The patient developed sneezing (sneezing) and congestion (nasal congestion) on 04-Oct-2003. As of 06-Oct-2003, his symptoms persisted. The patient's brother developed sneezing and congestion following receipt of Flumist on 01-Oct-2003 at 8 years of age (See MCN HQWYE0948). No additional information was available at the date of this report.
pt recvd vax on 20JAN93 & on 2FEB93 pt devel a fine, red rash on face & lymphadenopathy;
pt recvd vax 3AUG94 & 26AUG94 PM-clammy & sweaty;no fever;27AUG t101R, irritable (scream when touched);28AUG rigid, throwing head backwards, had arched back;MD visit hosp;dx aseptic viral meningitis;neg blood & CSF cultures
This spontaneous report was received from a 53 year old female patient and refers to herself. The patient's pertinent medical history included Sjogren's syndrome (an autoimmune disorder) since approximately 2003 (reported as 12  years prior to being administered ZOSTAVAX). The patient had a history of allergic reactions to codeine (unspecified dosage, lot #, expiration date, manufacturer) with onset of hives and "throwing up and passing out briefly" on unknown dates. On an unspecified date in the middle of January 2015, the patient was vaccinated with a dose ("1 shot") of ZOSTAVAX in the unspecified arm (strength, dose, route of administration, lot # and expiration date were not provided). The vaccination was recommended to the patient by a pharmacist. No information regarding the patient's concomitant therapies was reported. On an unspecified date in the middle of January 2015 (reported as since she received ZOSTAVAX, the patient experienced "not feeling well afterwards". On an unspecified date, the patient experienced "redness and arm swelling" at the injection site of ZOSTAVAX with lasted few weeks. The patient did not seek medical attention at this time but took TYLENOL (unspecified dosage, lot #, expiration date and manufacturer) as treatment for the arm swelling. On an unknown date, the patient experienced "chills in her legs and pain in the lower part of her legs". This pain was described as "seeing and feeling the veins popping out of her legs". The patient sought medical attention with three unspecified vascular doctors and one cardiologist on unspecified dates. The patient took NEURONTIN (unspecified dosage, lot #, expiration date and manufacturer) for her leg pain, but it "aggravated the symptoms" and she stopped this medication on an unspecified date. On  unknown dates, two studies were performed: a venous Doppler of her legs and an arterial study. Both studies "only showed normal aging results". On an unknown date, the patient broken her toe (case of this injury was  unknown). The outcome of not feeling well, injection site redness and arm swelling was not reported. The outcome of chills in her legs, pain in the lower part of her legs and broken toe was considered as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced nausea and vomiting on an unspecified date after receiving the first vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Fatigue, body ache, muscle tenderness in arm that receive vaccine, stomach cramping, diarrhea, and uterine cramps all within 24 hours  48 hours later there is a red circle at injection site about 1 inch in diameter
L arm became extremely sore at 04:30 PM. At 10:00 PM extremely dizzy and felt like I was going to faint. From 10:00 PM to 12:30 AM of 1/7/2015 had chills and body aches.
mild arm tenderness at injection site, upon waking at 10-11AM the next morning I experienced body aches, chills, and intermittent dizziness.
She experienced dizziness; gastrointestinal symptoms; Symptoms such as nausea; Symptoms such as vomiting; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a day after receiving Shingrix, the patient experienced dizziness, gastrointestinal symptom nos, nausea and vomiting. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the gastrointestinal symptom nos, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the dizziness, gastrointestinal symptom nos, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was unknown as patient could be 60 years or 61 years old at the time of vaccination. The patient refused to provide full demographics and refused to provide healthcare professional information. The reporter wanted to know additional information on symptoms experienced after Shingrix.  The reporter explained that she received Shingrix about 5 and a half months ago approximately in October 2021 (exact date not provided).  The patient stated that she experienced dizziness as well as gastrointestinal symptoms such as nausea and vomiting on the same day after receiving the vaccine and informed that the gastrointestinal symptoms had since resolved but the dizziness was persisting.  The reporter was provided medical advice disclaimer and information on adverse reactions per package insert. The reporter refused to provide health care professional information. The reporter did not consent to follow-up.
VACCINE WAS GIVEN 1 DAY AFTER BEYOND USE DATE, NO ADVERSE EVENTS REPORTED, FOUND ON DOUBLE CHECK OF FORMS.
Under 18 patient had vaccine administered; Sore arm; A spontaneous report was received from a consumer (patient's parent) for a 16-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced under 18 patient had vaccine administered and sore arm.  The patient's medical history was not provided. No concomitant product use was reported.  The reporter stated that her son was under 18 years of age and on 19-FEB-2021 Friday, the patient received their first of two planned doses of mRNA-1273 (Lot number: 02(not sure))L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient was supposed to get Pfizer vaccine, but the pharmacy had Moderna vaccine that day. The pharmacy contacted Moderna and realized that vaccine should not be administered in under 18. The patient also experienced sore arm the day of the vaccination which was recovered the same day. The reporter wanted to know how to continue.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events, under 18 patient had vaccine administered and sore arm was recovered/ resolved.  The reporter did not provide the assessment for the events under 18 patient had vaccine administered and sore arm.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number02(not sure))L20A) with  associated AE reported.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the US, Janssen given as an alternative 9.15.2021
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Jan2021 (Lot number: EL3247) as dose 1, single and administration date 23Feb2021 (Lot number: EL6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". No follow-up attempts are possible. No further information is expected.
Patient was given H1N1 LAIV nasal spray on 10/22/09. On 10/23/09 patient experienced dizzy spells, nausea, and inability to walk unassisted. Patient saw MD and was treated for vertigo. MD told patient that vaccine settled in her ear.
Had severe cramps x 2 days; no fever; had muscle & joint aches; discontinued vax p/2nd capsule;
Patient received both vaccinations with appropriate doses and administration site. patient sat for a moment before getting up to retrieve other documents from pharmacist. Patient then collapsed while standing and hit head on the way down and possibly on the floor. Patient also seemed to be experiencing some convulsions after collapsing.
2-3 days ago fever developed. Temp approx 101. During her bath her mother described ehr back as feeling like she was covered with "grains of sand." Fever resolved. On 05/24/02, pt woke up with pink rash on cheeks, back and chest. Her demeanor is fine. No fever. Discussed MMR with chicken pox. Advised to call doctor.
23DEC96 245PM mom called stating pt went to sleep p/taking bottle-had sz activity lasting <min;t98.7-referred to hosp;
(R) arm had flu vaccine & pneumonia in same arm 9/27/11. Pt here states arm very sore yesterday now warm to touch red & blotchy around arm.
Patient described really bad migraine and blurry vision about 2 hours after vaccination. The next day he reported having difficulty moving due to body aches. Blurry vision resolved after sleeping but still awoke to a headache, body aches resolved about 24 hrs after.