chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756513A, A0756515A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
face & lips swelled;chin swelled called ER advised DPH; a little rash on face cheeks & chin;little rash on cheeks 24AUG98;
his wife has been testing positive for over a week now; his wife has been testing positive for over a week now; fever; coughing; congestions; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious) with onset May2022, outcome "unknown", described as "congestions"; COUGH (non-serious) with onset May2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset May2022, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "his wife has been testing positive for over a week now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: testing positive for over a week now. Clinical course: Caller, 38 year old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer COVID vaccine, then he tested positive for COVID infection on the Friday before reporting, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he was just wondering why the vaccine shots didn't work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash on chest, swelling @ inject site & warm to touch. 1st inject. No known hx of allergy or seizure
and the vial had been refrigerated since 11Aug2021; They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021) and PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered a booster dose of the Moderna Covid-19 Vaccine on 26Nov2021 to a patient from a vial that was 4 days past its expiration date of 22Nov2021) and PRODUCT STORAGE ERROR (and the vial had been refrigerated since 11Aug2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Date the vial was initially stored in the refrigerator was 11-Aug-2021 and the vial did not undergo any temperature excursions.
Fever,severe headache,nausea,muscle soreness and stiffness,extreme fatigue and mild diarrhea
Itching at vaccine area.  Red spot at vaccine site and five small bumps around site with no blister formation.
felt her arm begin to be warm; arm was purple; arm was very swollen; arm was painful; arm the size of a plum; arm really red; rash began to spread down; rash was itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE WARMTH (felt her arm begin to be warm), VACCINATION SITE DISCOLOURATION (arm was purple), INJECTION SITE SWELLING (arm was very swollen), VACCINATION SITE PAIN (arm was painful) and VACCINATION SITE JOINT ERYTHEMA (arm the size of a plum) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Apr-2021, the patient experienced INJECTION SITE WARMTH (felt her arm begin to be warm), VACCINATION SITE DISCOLOURATION (arm was purple), INJECTION SITE SWELLING (arm was very swollen), VACCINATION SITE PAIN (arm was painful), VACCINATION SITE JOINT ERYTHEMA (arm the size of a plum), VACCINATION SITE JOINT ERYTHEMA (arm really red), VACCINATION SITE RASH (rash began to spread down) and RASH PRURITIC (rash was itchy). At the time of the report, INJECTION SITE WARMTH (felt her arm begin to be warm), VACCINATION SITE DISCOLOURATION (arm was purple), INJECTION SITE SWELLING (arm was very swollen), VACCINATION SITE PAIN (arm was painful), VACCINATION SITE JOINT ERYTHEMA (arm the size of a plum), VACCINATION SITE JOINT ERYTHEMA (arm really red), VACCINATION SITE RASH (rash began to spread down) and RASH PRURITIC (rash was itchy) outcome was unknown.            Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.
Swelling and blisters on face, neck & behind head Diagnosed with Shingles and treatment started with antiviral drug
My throat started being scratchy and I had intermittent cough, it was persistent just every once in a while. Started having some achiness which was a few hours later that day. I went home and took some Mucinex and went to bed to try to get to feeling better. Then my fever when I checked it was 99.8. Then I had some chills with it as well. I stayed in bed and tried to eat soup for a day or 2. Nothing happened with my smell or taste, just felt like the flu. I continued to take Mucinex during the day and overnight to try to get my symptoms under control. It started on the 2nd by the night of the 4th I was feeling better but with low grade fever. Occasional cough but no chills. My appetite came back and was able to eat solid foods. From there it was just fatigue, brain fog lingering. On Wednesday my wife complained of getting symptoms with weird musty smell in her noise. So then we went to get tested on the 8th and it was positive for COVID and we quarantined after that. Only lingering thing for me was fatigue and trouble concentrating.
right knee pain; tiredness; fever 100F; body ache; joint pain; she started to feel very bad; she couldn't stand; she has had zikavirus and felt like the same; gum pain; face swollen; feet pain; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain) and SWELLING FACE (face swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, VALSARTAN and OXYBUTYNIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and ARTHRALGIA (joint pain). On 24-Mar-2021, the patient experienced ARTHRALGIA (right knee pain), FATIGUE (tiredness) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, FEELING ABNORMAL (she started to feel very bad), ASTHENIA (she couldn't stand), ZIKA VIRUS INFECTION (she has had zikavirus and felt like the same), GINGIVAL PAIN (gum pain), SWELLING FACE (face swollen), PAIN IN EXTREMITY (feet pain), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (body ache) and PYREXIA (fever 100F) had resolved. At the time of the report, ARTHRALGIA (right knee pain), FATIGUE (tiredness) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection site itchy; Injection site a little swollen; 3 inch red area around the injection site; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (3 inch red area around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia (NOS). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (3 inch red area around the injection site). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (3 inch red area around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used include blood thinner NOS and medicine for her arritmia (arrhythmia). Soreness in her arm lasted 3-4 days. No treatment medications were reported.
Fever (100.6), chills, headache, body aches, fatigue, nausea
Im running 101 fever; This case was reported by a consumer and described the occurrence of fever 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, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced fever (101 degree C) on next day after receiving Shingrix. The reporter asked if would have the same side effects with the 2nd dose of Shingrix. The patient did not usually get side effects with vaccines.
pressure build up behind the eyes for 3-4 days; lethargic; sweating; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT, LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced OCULAR DISCOMFORT, LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT had resolved and LETHARGY, HYPERHIDROSIS, HEADACHE, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
10:30 pm chills, bones cold, body aches 1:30am  vomiting, profuse sweating, inability to stand, all of my body hurts from my head to my toes
Swollen lymph nodes and pain in armpit in injected arm; Swollen lymph nodes and pain in armpit in injected arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient's known allergies were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), ethinylestradiol/ etonogestrel (NUVARING) and atorvastatin calcium (LIPITOR); all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced swollen lymph nodes and pain in armpit in injected arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes and pain in armpit in injected arm were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt. states after receiving 2nd dose of Phizer 04/25/2021, shortly after 04/28/2021 started to experience stroke-like symptoms (facial sag, slurred speech, lost of limb control), ER visit seizure activity (tongue rolled back to throat), screaming.  Was not seen by a Physician/RN. Still continuing to experience symptoms.
Gave immunizations, patient was sitting in chair and mom screamed for someone to come help her. Ran over to her another nurse cracked the ammonia and she came to. Picked her up, layed her down in procedure room. Checked her blood pressure. Had her lay down for a while and gave her water. Completed orthostatic blood pressures to ensure she would not faint. Kept her for 2 hours monitoring her.
Mom called and left a message at 2:16 PM informing me that at approximately 2:15 PM upon leaving our clinic parking lot that her daughter had 2  hives pop up around her mouth.  I was able to call mom back around 3:15 PM, she then stated that patient had gotten hives around her mouth before after certain foods like eggs and dairy, and bell-peppers make her lips swell up.  Mom stated that she would medicate patient once they got home with Benadryl if things got worse as this as helped with her allergic reactions in the past.  I called and spoke with my supervisor regarding what happened at approximately 3:45 PM. I called back and spoke with child's mom regarding her condition at 4:15 pm, she stated that her daughter had a bloody nose but that her hives were getting smaller.  I reminded her to watch for any breathing issues and call 911 if necessary or go to E.R.  Mom stated that patient had a bloody nose earlier today too before being vaccinated, from the dry air she believes.  I then told her to medicate with Benadryl if hives worsen or seek out care at an urgent care clinic this weekend if necessary.  I told mom that I would be filling out a VAERS report for the incident, and to check with her child's pediatrician before vaccinating her again with MMR vaccine.
Headache, Myalgia, Fever, Eye pain, Pain at injection site Narrative:
w/in 24 hrs p/vax pt exp a fever of 102, h/a, chills & an inject site react which included joint swelling, & redness/swelling @ site; seen in office; no tx initiated; sx lasted approx 48 hrs;
Stated she had a stomach ache before going to bed night of 2-1-06 and awakened early am to chills, fever of 103 degrees, achiness, sweats and then the fever broke.  Episode lasted 4 hours. She was tired all day of 2-206 but then felt fine by evening. No other signs and symptoms.  No treatment required.
6 itchy blisters on right hand, arm, wrist, and bicep/ look like large mosquito bite; blister itch; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 14th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th November 2019, 1 days after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in  left deltoid. The patient developed 6 blisters on the right arm (opposite of injection site) on the wrist, arm, bicep and hand. The patient stated, these blister itch and look like large mosquito bites and had not resolved at the time of reporting. The reporter consented to follow up. The reporter was unsure if this was related to Shingrix vaccine.
Itching in Injection Site, Waited 30 Minutes after injection and itching persisted in the same area, was discharged from vaccination clinic waiting area however the itching persisted as time went on then progressed throughout my entire body. Its 11:24pm on 02/14/2021 and my entire body itches extremely bad. The injection site is not raised or red.
received Moderna 1st dose, w/in seconds had Fruity taste smell, within 1-2 min had diffuse red + mild swelling in shoulder and red puffy face + red chest BP 194/110 and developed throat tightness which progressed - given epi IM sx improved in throat + less redness + shoulder swelling quickly + paramedics took to hospital
Patient stated that around 1:30pm she felt shoulder pain up and down her arm. She iced the shoulder. By 3pm she was unable to move her arm, and went to see her doctor. MD gave her a prescription for NORCO 5/325, and a sling for the arm. She was also instructed to not receive the second shot.
Patient reported sore arm on night of vaccination.  Around 36 hours later, started to develop lymph nodes swollen under left arm.  It is causing numbness  in left arm  from elbow to pinky finger.
no additional adverse effects reported; first dose on an unspecified date in 2013; second dose on 05-MAR-2020; This spontaneous report has been received from a pharmacy technician regarding a 25-years-old of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On an unspecified date in 2013 (also reported as 7 years ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 05-MAR-2020, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional adverse effects were reported.
Information has been received from a physician concerning a 2 month old male who was vaccinated with a first 2ml oral dose of Rotateq (human bovine). Concomitant vaccinations included "other vaccines". It was reported that one week after the patient experienced diarrhea. It was noted that the physician did not feel the event was due to Rotateq (human bovine). Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.