chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; the patient received one dose of ROTATEQ following temperature excursions; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 23-JUL-2019, the patient received one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) following temperature excursion (product storage error), administered orally (dose number was not reported) (lot#: R016790, expiration date: 20-APR-2019) for prophylaxis. No adverse effects were reported.
Post SHINGRIX vaccine after 2 days got extreme joint pain, in everything lasted x 7 days. Still has pain in knees and on the right De Quervain's tendon as of 7/12/18.
12/27/2021 at 9 pm (mild symptoms): headache, body aches and fatigue. 12/28/2021 at 9 am: severe abdominal pain, nausea, lightheaded, blurring vision, ringing in ears, blue lips, almost lost consciousness, tachycardia at rest (HR 150 bpm) and tachypnea (respirations >35). Extreme fatigue and dizziness for several days after 12/28/2021.
21OCT98 pt c/o joint & muscle ache & h/a;23OCT ankles edematous;25OCt severe edema of ankles w/blisters on calves, red raised areas on heels;size of fingernail, ankles red & inflamed;saw MD & was given cortisone & medrol pack;
PT WAS GIVEN VERY DILUTED/ SALINE INJECTION. PT WAS INFORMED AND RESCHDULED TO GET VACCINE AGAIN 3/21
covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; This is a spontaneous report from a contactable unspecified Healthcare professional reporting for himself. This 52-year-old male patient received on 20Dec2020 02:30 PM first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) at single dose intramuscular in the left arm for COVID-19 immunization. No allergies to medications, food, or other products. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Concomitant medications (all started on an unknown date and received within 2 weeks of vaccination) included buspirone hydrochloride (BUSPIRON), atorvastatin (manufacturer unknown) and acetylsalicylic acid (BABY ASPIRIN). On 21Dec2020, 10 hours after getting vaccine the patient had body aches, cold and severe left arm pain. 4 days after getting vaccine again the patient had cold, body aches and sore throat for couple of days. On 28Dec2020, covid 19 test (nasal swab) result came up positive. The patient went to Emergency room. Outcome was recovered on an unknown date. It was unknown if a treatment was performed.; Sender's Comments: The association between the event lack of effect (COVID 19 nasal swab test result came up positive) with BNT162b2 can not be fully excluded.
Flu Vaccine on 11/06/2007, numbness of feet then legs and hands then severe weakness of limbs coming on gradually, starting 1-2 weeks after vaccine, now starting to improve but still symptomatic with weakness numbness and gait imbalance as of 02/14/2008. 1/20/2010 Improved but still weak from Guillian Barre. 02/29/2008 MR received from neurologist for multiple visits 1/2/08 to 2/14/08 with DX:  Guillain-Barre Syndrome. Initially presented 2/1/08 with 2 month hx of numbness in hands and feet and weakness of the legs and hands which has recently been worsening.  PE (+) for moderate hand weakness, mild weakness of dorsiflexors and plantar flexors of the foot and toes, inability to walk on toes or heels, stocking-glove sensory loss, and diminished vibratory sense of the feet and toes. Borderline Romberg's and gait difficulty. Pt later reported band-like numbness around the abdomen and increasing difficulty walking. Tx with plasmapheresis. Possible post vaccinal GBS.  3/31/08 MR received for hospital DOS 1/11-19/2008 with D/C Dx: Demyelinating neuropathy of recent/acute onset.  Barrett esophagitis.  Hx of cholecystitis, s/p recent cholecystectomy.  Hypercholesterolemia. Records also sent for DX of Cholecystitis DOS 12/21-24/2007 and 12/31/07-1/1/08 with c/o Leg and arm numbness and leg weakness.  Pt initially presented 12/31/07 with 6 week hx of numbness of the extremities and unsteady gait. PE (+) for decreased sensation in the feet, brisk DTRs, decreased motor strength, unsteady, staggering gait.   Tx with steroids and D/c to be f/u as an outpt. Pt presented again 1/11/08 with progressive numbness and admitted with DX of Acute Demyelinating Polyneuropathy for plasmapheresis. C/O dyspnea  noted on consult of 1/12/08. D/C to continue rehab as outpt. Pt. is improving in symptoms-this stated in Dr. visit on 3/26/08.
After the first injection, within 10 minutes, I noticed that the tip of my tongue and part of my lips were tingling. It resolved within a few hours and with no intervention. It was unclear if it was associated with the vaccine.
Pain at injection site; insomnia; malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 16:45 as dose 4 (booster), single (Lot number: 6J2524) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (not ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1 MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering", described as "Pain at injection site"; INSOMNIA (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering"; MALAISE (non-serious) with onset 15Sep2022 at 02:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, insomnia, malaise.  Additional Information:  Other medical history: None (as reported). No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No Known allergies. Device date updated as 15Sep2022. Reported about COVID vaccine.  No follow-up attempts are possible. No further information is expected.
I have suffered daily with fatigue. It?s very hard for me to stay awake so I have taken a lot of time off work due to being tired. I have had terrible muscle/body aches and pain at the site where the injection was administered. I started having pain when urinating and diarrhea. I went to the doctor (  ) where I was diagnosed with a bladder infection. I had to take antibiotics ( Bactrim ) which I just finished, starting to feel a little better but still suffering with fatigue. I also had a headache for one week after vaccine and have been taking over the counter pain medicine.
Client states soreness to arms from Hepatitis vaccine injections #1 and #2 continues to current time.  States no swelling or erythema.  No swelling, erythema observed or nodules palpated. States is improving but still present from Feb and March injections.
This patient had 4 cm erythematous lesion with nodule. Allergy vs cellulitis (warm, erythema) being treated with antibiotic and 18 hour follow up.
Onset of fever and chills for one week-then unable to walk-weakness in legs-could not feed myself or go to the bathroom by myself-weakness in hands. To further explain the adverse event of my flu shot----I was diagnosed by three doctors as having Guillain Barre syndrome as a result of the flu shot administered late last year at the drug store. I was diagnosed first of February 2017 and am still sick (five months expected to last at least 6 months or more). I first walked with a walker now with a cane. I am unable to do very much and Have great pain a great deal of the time. I have lost 20 pounds. Often unable to sleep because of pain. Upset stomach. Diarrhea. I have trembling in my hands as well as in my legs. I was in acute rehab care in a hospital for two weeks and am receiving physical therapy. How can you administer a vaccine that can cause such damage? Patient 6-5-17.
Patient received pneumococcal polysaccharide PPV23 on 5/4/16. She reported swelling and redness of left arm. Came to the urgent care dept on 5/5/16 diagnosed with cellulitis and given PO antibiotics and NSAIDS.
Uniformly erythematous, warm rash spreading from the site of the injection and distally down the arm; started 10 days after injection. Clinically consistent with cellulitis however non painful and occasionally pruritic so concerned for allergic component still.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-FEB-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
WE HAVE NO DETAILS OTHER THAN DATE OF COLLECTION OF + COVID TEST    9-28-22 AND DATE OF DEATH 11-20-22
My upper left arm developed a swollen spot that was tender to touch; that was tender to touch.; Now there is a red itchy spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: STELARA taken for immunisation, administration date 13Apr2021. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Not available/provided to reporter at the time of report completion, Administration date Apr2021, Administration time: 02:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: Apr2021, when the patient was 72 years old, for COVID-19 immunization; Smallpox vaccination (It is on my childhood smallpox vaccination scar), for Small Pox Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "My upper left arm developed a swollen spot that was tender to touch"; TENDERNESS (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "that was tender to touch."; RASH MACULAR (non-serious) with onset 28May2021 12:00, outcome "unknown", described as "Now there is a red itchy spot". Therapeutic measures were not taken as a result of peripheral swelling, tenderness, rash macular.  Additional information: Patient was not tested covid positive post vaccination. Patient does not take any other medications in two weeks.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). It was reported that the patient had experienced a case of shingles in the past on unknown date. After the patient was vaccinated with ZOSTAVAX she was diagnosed with a recurrence of shingles. The outcome of the event was reported as recovered/resolved on unknown date. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
35mm 1/2" high inflammation type red, swollen, painful hot reaction; itches the site.
Fever, major headache and nausea, mild cough, shortness of breath, syncope episodes
swollen red face, chest pain, shortness of breath, hives, temp of 103, b/p140/88, light headed
Skin reaction was hot to touch; Hardness around the injection site; Itchiness around the injection site; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Skin reaction was hot to touch), INJECTION SITE INDURATION (Hardness around the injection site), VACCINATION SITE PRURITUS (Itchiness around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Mar-2021, patient got a second reaction larger than first. The original injection site, skin all around the first injection site from the shoulder to wear the arm bend the redness, hardness and itchiness had returned.  No concomitant medication were provided by the reporter.   Patient used Hydrocortisone cream as directed by pharmacy for treatment which helped to dissolve the reaction.
Client returned to clinic 5/11/07; Mom mentioned on 3/17/07 child - T. 101/seizure/rash/bruse at injection site. Child was tx at ER. CT scan, Rx Motrin, D/C.
Client evaluated by EMS not feeling well BP 148/95, P 121 BS134.  Vitals came down to BP 126/86, P104, O2 99, BS 134.  Client left feeling better> No reaction after first dose.
Beginning of Alzheimer; Not feeling well / just not been feeling well; Fatigue; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LOSARTAN, LEVOFLOXACIN (LEVOXIN), DONEPEZIL HYDROCHLORIDE (ARICEPT), PRIMIDONE and VITAMINS NOS for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MALAISE (Not feeling well / just not been feeling well), FATIGUE (Fatigue) and HEADACHE (Head ache). On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer), MALAISE (Not feeling well / just not been feeling well), FATIGUE (Fatigue) and HEADACHE (Head ache) outcome was unknown.     The patient received the booster dose and was not feeling well. The patient just not been feeling well, just the fatigue with the headache. The patient had beginning of Alzheimer.  Company Comment - This case concerns a 79-year-old female patient with no relevant medical history, who experienced the unexpected event of Dementia Alzheimer's Type. The event occurred on approximately around the same month when the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) was given. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 79-year-old female patient with no relevant medical history, who experienced the unexpected event of Dementia Alzheimer's Type. The event occurred on approximately around the same month when the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) was given. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Employee received a concentrated dose of the COVID vaccine booster. She received 0.3mLs of non diluted vaccine. Vial was originally intended as a 6 dose vial.  No adverse effects have been noted yet.
Case number PHEH2012US006274 is an initial spontaneous report received from nurse on 14 Mar 2012. This report refers to an adult female patient. The patient was vaccinated with MENVEO (batch number: A10135B) intramuscularly on 13 Mar 2012. On 14 Mar 2012, patient developed nausea, headache, dizziness and general malaise. The outcome of events was not reported.
his gums became discolored and turned purple/gums (both sides up and down) remain purple/discoloration to the gums in his mouth; his mouth started hurting; feeling hot; Body aches; Fever; Pain to the gums in his mouth; muscle aches; sore throat; neck pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration to right shoulder on 24Dec2020 11:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received vaccine on 24Dec2020. He experienced body aches, fever, and feeling hot with onset of about 3-4 hours after he was administered (24Dec2020). Next day (25Dec2020), his mouth started hurting, his gums became discolored and turned purple. Gums (both sides up and down) remained purple. He will be seeing a dentist. He also reported pain and discoloration to the gums in his mouth on 25Dec2020. He had been experiencing some of the regular side effects such as muscle aches, sore throat, neck pain on an unspecified date in Dec2020. Outcome of the event gum discoloration was not recovered, of the events feeling hot, generelized aching, and fever was recovered on 26Dec2020, of the event gum pain was recovering, and of the remaining events was unknown. He reported seriousness criteria as what he thinks to be medically significant at this point; that they could be medically significant. He is scheduled to receive the second dose of the product which at this point he does not plan to change. Dose change is unknown until he determines cause of these events and on what the doctor and dentist he is going to see recommend. He believes events could be caused by the vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
5/21/2019 noted tickling sensation on the left ear. 5/22/2019 woke up L face droop including forehead. Decreased sensation L face, drooling. Dysphagia because she could not feel the food. Symptoms continued for about 1 week but no improved severity. Saw her GP and she started her on decadron 4mg PO and referred for MRI next morning (5/29). Also had severe pressure sensation on the face.  Saw Dr. on 5/30 continued on 4mg of decadron. Over about 1 1/2 week her facial weakness had improved. Recovered eye closure, drooling stopped. Had persistent numbness on the face side of the face, mouth and tongue extending to forehead and mid skull.   Decreased decadron 6/21/2019 to 2mg Currently on decadron 2mg; since decreasing the dose her she has had partial recurrence of her symptoms.
2 lumps on the neck; Painful to touch; Fever; Pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (2 lumps on the neck), PAIN (Painful to touch), VACCINATION SITE PAIN (Pain in the injection arm) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in the injection arm). On 02-Apr-2021, the patient experienced PYREXIA (Fever). On 03-Apr-2021, the patient experienced NODULE (2 lumps on the neck) and PAIN (Painful to touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NODULE (2 lumps on the neck), PAIN (Painful to touch), VACCINATION SITE PAIN (Pain in the injection arm) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD21-068765 (E2B Linked Report).; Sender's Comments:  MOD21-068765:MOD-2021-066658 1st dose cases
starting 10 days after 2nd dose, raised red rash scant clear discharge at injection sites
Information has been received from an L.P.N. concerning a 13 year old female student with a congenital heart defect and allergy to contrast dye who on the morning of 05-JAN-2007 between approximately 9-11 a.m. was vaccinated in the left upper arm with her second dose of Gardasil (yeast), lot#654389/0961F. In the p.m. of 06-JAN-2007 the patient developed skin tender and some skin "bumps" with pruritis X 2 days. It was reported that on 09-JAN-2007, the patient recovered. No further information is available.