chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness on her right arm, shoulder, and her neck; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 (Lot number: FA7484) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset Aug2021, outcome "not recovered", described as "numbness on her right arm, shoulder, and her neck"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "arm was sore". Therapeutic measures were not taken as a result of hypoesthesia.  Additional information: Patient did not receive other products. Patient confirms above details and says at first her arm was sore then a couple days after she got it, maybe 3 days afterwards it was numb and she thought it would go away but it hasn't gone yet, and it has stayed the same. She says she is supposed to get her second dose tomorrow. She says she has done no treatment for the numbness, she hasn't spoken to her doctor, and she doesn't know if she should have the second dose since she still has the numbness.    Follow-up attempts are completed. No further information is expected
2 days following I had a headache for 4 days, then following that I had sore, bleeding gums that became full blisters inside my mouth by the following morning when I woke. I had chills as well but the mouth sores were what sent me to the doctor. I also had gingivitis come about which I have never had.
severe hip joint pain; wasn't able to walk; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 22Feb2021 at 15:15 (Batch/Lot number was not reported; at the age of 82 years old) as dose 1, single for COVID-19 immunisation.  Medical history included chronic back pain and 25-year breast cancer survivor. No known allergies. Concomitant medication included atenolol and unspecified statin medication. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. The patient experienced severe hip joint pain and wasn't able to walk on 23Feb2021 at 09:00 am. It eased off on the third day, and it was gone by the end of the fourth day. The patient did not receive treatment for the events. The patient recovered from the events in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patients received 0.25 ml of the bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients received 0.25 ml of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient was administered with Booster dose.  The patient did not experienced any side effect. Pharmacist does not know if the patient were taking other medication. HCP was not aware of incident.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644253:Patient - Wife Case
Has mild kidney function issues; This spontaneous case was reported by a patient and describes the occurrence of RENAL IMPAIRMENT (Has mild kidney function issues) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL IMPAIRMENT (Has mild kidney function issues) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Has mild kidney function issues) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was asking if he needs to get more than one bivalent booster dose. He stated that his first dose of the Moderna bivalent was on 22-Sep-2022. He stated that he had mild kidney function issues. No further information provided.  Treatment information was not provided. Company comment-This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Renal impairment that occurred in the context of a dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of event was not disclosed. It was reported that patient had mild kidney function issues. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event was available in the report. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Per obituary, patient died at the Hospital on 5/13/2021. SARS CoV2 PCR on 5/12/2021 was negative.
rash classified as Erysipelas; Itching rash in scalp and forehead; red rash in scalp and forehead; Warm to touch; Pustular rash in scalp and forehead; Swelling around forehead and reyes; scarring; open sores; crusted; This case was reported by a other health professional via call center representative and described the occurrence of erysipelas in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date unknown) for prophylaxis.   On 28th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erysipelas (serious criteria GSK medically significant), itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust. On 18th October 2022, the outcome of the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, skin ulcer and crust were recovered/resolved. On an unknown date, the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was medical assistant, reporting on behalf of patient.  The reporter reported that, patient received Shingrix at a pharmacy.  The reporter reported that, patient stated rash appeared a couple of days after receipt of dose.  The reporter reported that, rash was located on the patient's scalp and forehead. The reporter reported that, patient's rash was itchy, red, contained pustules and was warm to the touch.  The reporter reported that, patient experienced swelling around the forehead and eyes.  The reporter reported that, pustules turned into open sores, crusted and left scarring.  The reporter reported that, patient's rash was classified as erysipelas, which was a skin infection involving the dermis layer of the skin.  The reporter reported all symptoms were resolved as of 18th October 2022, at patient's last visit.  The reporter reported that, the patient had scarring remaining from the pustules. The reporter worked at a dermatology office, where patient went to receive treatment for rash. In 2022, less than 2 months after receiving Shingrix, the patient experienced facial swelling, scar, skin ulcer and crust. The patient did not receive Shingrix dose at dermatology office.  The reporter did not have contact information where patient received dose of Shingrix. The reporter consented to follow up.
Vomiting x5, no stooling for 12 hours as of 2:26 PM on 01/03/2017 when seen by doctor.
Pt reports generalized rash when she woke up this morning on breast, chest and abdomen.  +itchy  Pt received 2nd dose of HPV vaccine yesterday  denies SOB, swelling in throat/tongue  tx: hydrocortisone ointment applied after shower
She has had a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low; she started feeling light headed like she is gonna pass out; No energy; This is a spontaneous report from a contactable Nurse(daughter). A 17 year old female patient first dose of received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 05Aug2021 (age at vaccination 17 years) as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported . It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. On 19 Aug2021 the patient had experienced a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low,No energy and feeling light headed like she is gonna pass out. On an unspecified date the patient underwent lab test and procedures which had included Blood test,Holter monitor , had echocardiogram for heart and EKG for her heart with diagnosis of unknown results for all tests. The clinical outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient reports approximately 30 minutes after injection she had severe pain in her legs and her arms, feels awful 1-2 hours later developed headache, chills, achiness - leg pain persists 4 days later.
Patient reported SOB, headache, dizziness, numbness of right arm, soreness of left arm, feeling of fainting and weakness approximately 1 hours post vaccination. Vital signs initialized11:08 AM (HR 130, R 18, BP 121/73, Sat 80%) Instructed to remain calm, encouraged deep breathing exercise, elevated legs, icepack provided on the injection site. Patient is able to talk and swallow. Patient revealed history of fainting and FH of stroke. EMS called, vital signs at 11:31 AM: HR 130, R 18, Bp 144/104, O2 Sat 100%. 3 Lead EKG: Sinus Tachycardia. Able to ambulate to the ambulance, Patient verbalized feeling better and showed no respiratory distress when EMS arrived and was sent to Hospital.
Diarrhea, aches, chills, fatigue, pain at injection, headache, neck ache
12/18 VACCINATION 12/19 WOKE UP, HA, FATIGUE, MUSCLE ACHES.  12/20; HA WORSE, SYMPTOMS WORSE 12/21 FELT BETTER 12/22 VERTIGO, FACE IS RED. URGENT CARE. PRESCRIBED NAUSEA MEDS.
Swollen lymph node in the right neck with pain for 2 days.  Lymph node swollen for 2 weeks with gradual size reduction
Fever 38C, Chills, local pain - lasted less than two days.  Intense lower back pain - lasted about two days. Irregular Bowel movement, abdominal pain - come and goes, not fully recovered at time of writing. There was no constipation (in sense of difficulty to pass stool) but no bowel movement either, only pain.  Treatment: after 24 hours start taking pain killers (Tylenol night, Aleve). Hot bath helped with back pain and abdominal pain. Laxative (Bisacodyle)  helped with Bowel movement, and relieved pain - but took long time and unknown if back to normal. Now on liquid diet (water,clear  soup, tea with sugar)  to allow to rest a bit, seems more comfortable at the moment.
Initial unsolicited report received from a nurse via consumer's spouse on 01 November 2016. This case involves a 64-year-old female patient who was vaccinated with INFLUENZA VACCINE (batch number, expiry date of the product, dose and dose in series, route and site of administration were not reported) on an unspecified date (reported as 'last week'). The patient had a medical history of multiple sclerosis. The patient's concomitant medication included LEMTRADA at a dose of 12 mg daily from 22 August 2016 till 26 August 2016 for 5 days for multiple sclerosis. On an unspecified date and duration following the vaccination (the vaccination was reported as to be administered 'last week'), the patient developed low grade flu symptom. Laboratory data and corrective treatment were not reported. The outcome of the event was not recovered. List of documents held by sender: none.
Anxiety.  Observed 30minutes B/P 130/86@ 10:18AM.  No worsening of condition.
heart rate increased to 100BPM; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EJ1685) via an unspecified route of administration on 18Dec2020 04:30 PM at single dose in left arm for COVID-19 immunisation. Medical history included Asthma, Known allergies: Sulfa, Peanuts, Shell Fish and Peas. Concomitant medications included cetirizine hydrochloride (ALEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLOVENT) and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and Probiotics. The patient previously took Iodine and Erythromycin and experienced known allergies. At 18Dec2020 04:45 PM, her heart rate increased to 100BPM and continued for 45 min, and this result in Emergency room/department or urgent care. The patient underwent lab test and included EKG and heart rate count. Therapeutic measures were taken as a result of event and included treatment with Pepcid, Benadryl, EKG and Monitored her heart rate. Outcome of event was recovered on Dec2020.
Pt was only to have have varicella and HPV vaccines.  Given MMR unecessarilynone
Patient reports that she broke out in hives on the left side of her face and left arm. She states that they are very itchy. Pt advised to take antihistamine and monitor symptoms.
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP.  A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30  Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020.  The action taken was not applicable.
Myocarditis started 4 days after vaccination: chest pain, nausea, exhaustion   Went to ER and admitted to the hospital on 12/1/21 Discharged on 12/2/21
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREES C
Significant CVA landing patient in ICU (hemiparesis).  tPA and and thrombectomy required.
devel a red hard area 5" x 5" @ site of inject on lt thigh; had temp @ 101-102; did not want to walk on it just wanted to lay around; MD said it was a shot react; pt returned to pvt MD x 2 wks for high fever & cough;
numbness and weakness down her right arm; numbness and weakness down her right arm; her index finger turned blue; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 14:00 (Lot number: EW0191) at the age of 59 years as dose 1, single and administered in arm left, administration date 26Jun2021 (Lot number: EW0217) 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: MUSCULAR WEAKNESS (non-serious), HYPOAESTHESIA (non-serious) all with onset 04Jun2021, outcome "recovered" (05Jun2021) and all described as "numbness and weakness down her right arm"; SKIN DISCOLOURATION (non-serious) with onset 04Jun2021, outcome "recovered" (05Jun2021), described as "her index finger turned blue.  Additional information; Pfizer BioNTech Covid Vaccine is a Pfizer product unspecified manufacturer, RA number and Expiry Date of Pfizer BioNTech Covid Vaccine was Unknown.Other Products,Patient History and Investigation Assessment were Not Provided. Reporter stated after the first vaccine, she had numbness and weakness down her right arm and her index finger turned blue, but that was the first vaccine, and only lasted the same day of the vaccine, and next day it was gone. The patient was taking Pfizer BioNTech Covid Vaccine (Verbatim): Thought she may win the million dollars, that the governor of (with held) offered for people that get vaccine.    No follow-up attempts are possible. No further information is expected.
Double vision began 20 minutes after Flu and Pneumo. Had to drive to 2nd location for Zoster vaccine approximately 20 minutes.
01/07/2022:  Patient presents with shortness of breath.  States that her baseline shortness of breath is increased over the last several days, she had been having bilateral lower extremity swelling, cough, and exertional/pleuritic chest discomfort, had an episode of near syncope on Wednesday, 2 days ago, was brought to a HCF at that time, her Covid swab came back positive.  Homeless and She states that she got Covid from someone who was staying at the shelter  01/10/2022: immunosuppressed with lupus therapy -- > s/p monoclonal antibody with Sotrovimab infusion. Continue Decadron for total 10 days
Pt exp sx similar to pts who were dx w/fibroymyalgia; details of these sx @ time of the report were unk;
flu like sx w/swollen hand several days p/vax; treated w/Epi & Medrol dose pak;
Left arm, hand, shoulder, boob, and under arm numb for 3 days. Left shoulder & under arm twitches with shooting, painful tingles down my arm on the 3rd day after vaccination.
Broke out on rash on back, trunk then face. +itching. No fever. Good appetite.  Counseled mom on removing from daycare and calling PMD.
Father received 2nd vaccine and died two days later of heart failure. Was not in critical condition prior to the vaccine.
10MAR spitting up more than usual & fussy;11MAR spitting up frequently, very fussy;12MAR d & v, really fussy; 13MAR seen by MD adm to hosp w/BOM, gastritis, OS conjunctivitis, viral pneumonia, dehydrat; 16MAR severe diarrhea; 18MAR cough
Unknown which RSV vaccine- it was not administered at our hospital1 Patient reports receiving flu and RSV vaccine the morning of 10/5 and that evening developed fever with chills. He later noticed diffuse rash on the left side of back with intense and took 2 doses of OTC Benadryl. Patient decided to visit the ER when symptoms failed to improve (see Item 19). He reports no similar complaints before, and this is his first RSV vaccine.
Pt had a syncopal episode 2mins post vaccination w/ associated dizziness and nausea. Vitals: 101/50, 97, 14, 98% Pt stable and released from the vaccination site.
Immediately had discomfort in my right arm, that feeling of discomfort in my arm never went away, I started experiencing severe arm shoulder & neck pain & stiffness a few days later, I went to the ER at  for my symptoms , I was quickly released with an assumption that I had maybe injured myself pulling out carpet from my home on 3/7.  I was given pain pills, muscle relaxer & predisone. None of those options helped. Scheduled a Drs appointment with same complaint, was scheduled for an MRI of neck. Neck MRI was good, no other options to help me.  I switched providers to  Clinic in search of a 2nd opinion because at this point I was paralyzed in pain from my arm up to my neck and in my right shoulder blade.  I was referred to physical therapy, much of my physical therapy was focused on core exercises as any work or any movement with my arm/neck would send me in a spiral of pain. I started to experience low grade fevers at night time of 99.7, my whole right side of my body felt hot & weak. I had another MRI of my shoulder,  came back clear, I then had another MRI of my brain, came back clear.  I was referred to pain management and was given dose of 5 day Predisone just to try. Predisone took most all pain away, however I still have flair ups of pain.
Breathing issues and high heart rate. Life support 1.5 days layer. Myocardidtis. Cloting issues. Left side weakness. Seizures. Lots of abnormal things that happened. Was on life support 6 wks. Then needed a trach and vent.