chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; swelling; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown.   It was unknown if the reporter considered the pain in arm and swelling to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's spouse. The age at vaccination was not reported. The patient experienced significant arm pain and swelling after receipt of shingrix dose. The reporter consented to follow up.
This spontaneous report as received from a medical assistant and refers to an unspecified patients of unknown age. On an unknown date, an unspecified patient received an improperly stored dose of the following GARDASIL 9 lot # M013636, expiry date:15-FEB-2018 (incorrect product storage). No adverse effect was reported. The outcome of incorrect product storage and no adverse event were unknown. Additional information has been requested.
WIDE SPREAD RASH ON MY FOREARM AROUND THE VACCINE SHOT AREA, ITCHY, SENSITIVE TREATMENT AVEENO CREAM AND TYLENOL LASTED 13 DAYS AND  IS ALMOST GONE BY NOW
Pt seen on 10/13/00 for sinusitis. Pt was given Pneumovax on 10/13/00 with recommendations for flu vaccine, when available. Pt called and was seen on 10/16/00 with temperature 01 101F, chills, nausea, headache and weak. States developed fever within hours of vaccination.
Itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Lumpectomy (Left breast).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at injection site). On 25-Feb-2021, VACCINATION SITE PRURITUS (Itch at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-058335 (Patient Link).
Low blood pressure; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at 16:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medications included duloxetine and ergocalciferol (VIT D). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Extreme fatigue for 5 days with low blood pressure on 21Jan2021 at 12:00 AM. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  Information on the lot/batch number has been requested.
Redness and hard lump at site. One medium pustule sustained and a few smaller bumps appeared and resolved in two days.
5hr p/vax pt began intestinal cramping, vomiting, fever, malaise, h/a, weakness, sleepy;24hr later diarrhea began-all sx persisted for 4-5 days;took pepto bismol w/no relief;
Chills, sweats, rash, headache, nodule under skin, inflamation, nodules on skin, itching, painful, nodule are hard, looks like calcium buildup, all over body. Prescribed steroid ointment and pills.
The patient lied about having received the covid vaccine previously, in order to get a booster shot, so she actually received her 3rd dose from us instead of her first dose.  Her 1st and 2nd dose were given at the Health Dept in Feb 2021 and it was Moderna there.
This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Patient presented to emergency department on 6/4/21 with altered mental status. During workup patient was found to be COVID-19 positive. Patient had fever at time of admission which was believed to be caused by COVID-19 infection. She was admitted for lacunar infarct and acute encephalopathy. She was started on dexamethasone for COVID-19 management, but was stopped as there was no major change in disposition with treatment. During the course of the hospital stay, she was deemed asymptomatic for COVID-19 and her symptoms were more likely to be attributed to other causes.
seen on 18MAY93 recvd DTP/OPV/HIB screaming since 1230PM; unconsolable, t99 ax, cried for 6 hrs; stops crying to feed; MD thought crying r/t sore leg;
mom called-red hot area RLT (1 1/2 "approx X 3/4"), mother was advised to apply ice to area & call ofc if no improvement. Nurse called mon 3:00 pm- site much improved-less redness & doing ok
Fever 101.6 Joint pain, leg cramps, headache, nausea, short of breath, fatigue. 3 days
My arm was extremely swollen and had a reddish pink rash that extended beyond a 3inch square. On Monday 4/19, I contacted my allergy doctor. I was prescribed prednisone. I took that for a week and all symptoms resolved.
first dose: swollen lymph node; first dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at vaccination was 25 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had cancer in her family. The patient's concomitant medications were not reported. The patient previously took prevenar 13 for pneumonia (last vaccine she got 6 months ago they actually they told her that this vaccine might have a chance of lesser mitigated side effects but that was not the case. She said that last one was Prevnar 13 for pneumonia) and flu vaccine (she was surprised because she has never had reactions. She said actually she reacted badly to the flu vaccine. She has not gotten the flu vaccine in 10 years because she reacts badly and she has not gotten the flu in 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient said that the first vaccine was fine, her arm hurt a little. The swollen lymph nodes began after the first vaccine, she got the first dose on 11Jun2021 and maybe on 13Jun2021 she was in the shower and felt the lump and freaked out and began calling doctors and they said she had just got the vaccine and it could be that but she was still going to have it checked out because there was triple negative in her family and her lymph nodes were still swollen now and it has been over a month, they got even bigger with the second dose. They said a very low percentage have the swollen lymph nodes so she wanted to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jul2021 at 18:30 or 19:00 pm (age at vaccination was 25 years) as dose 2, single for COVID-19 immunization. No relevant tests were done. She asked whether there was going to be a third shot, like a booster. She said she just asked because she was dreading it since getting the second shot. The outcome of the event first dose: arm hurt a little was resolved on an unknown date in 2021. The outcome of the event first dose: swollen lymph node was not resolved.
Low fever; achy; pretty bad arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L26A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain). At the time of the report, PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication is not provided. Treatment information include Advil.
Urticaria, skin rashes and mild swelling across the body including back, left and right arm, left and right hands, left and right feet, left and right legs, torso
A spontaneous report, was received from a nurse practioner (patient), a 47 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced numbness in both legs, hands and both arms (hypoaesthesia), tingling pins and needles in both legs, hands and both arms (paraesthesia), felt like cramps in legs (muscle spasms).  The patient's medical history was not provided. Concomitant medications reported included montelukast sodium, levothyroxine, and salbutamol sulfate.   On 28 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A), intramuscularly in the left arm for COVID-19 for infection prophylaxis.  The patient reported that she received the vaccine on 28 Dec 2020 around 2:00 pm. On the same day at around 5:00 pm, she started feeling numbness and tingling pins and needles in legs. She stated that it felt like cramps. The patient reported that she took acetaminophen and leg cramps OTC and was better and able to sleep at night.   On 29 Dec 2020, the patient went to occupational health at her work and reported the incident. She stated that she took acetaminophen and ibuprofen around the clock.   On 31 Dec 2020, the patient experienced numbness and tingling on her hands. She confirmed that it was both legs and both arms that were affected. The patient reported that her primary care doctor was aware.  On 02 Jan 2021, the patient stated that it was then almost a week and the numbness, pain, and tingling were still there. The patient stated that she took ibuprofen at 12:00 pm that day and the cramps were on and off. She reported that she was concerned and would like a follow up call. The patient also gave consent to follow up with her doctor.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, numbness in both legs, hands and both arms, tingling pins and needles in both legs, hands and both arms, and felt like cramps in legs, were considered as not resolved.; Reporter'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.
1 inch rash on left thigh, rash on right thigh size of childs hand. Showed up on 12/15/11. Was instructed to give child BENADRYL & monitor for spreading rash, SOB, discomfort.
myalgia; fatigue; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of myalgia in an unspecified number of female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced myalgia (Verbatim: myalgia) and fatigue (Verbatim: fatigue). The outcome of the myalgia and fatigue were unknown.   It was unknown if the reporter considered the myalgia and fatigue to be related to Arexvy.     It was unknown if the company considered the myalgia and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 It was reported by Health Field Representative on a GlaxoSmithKline Vaccine that a pharmacist stated in the pharmacy on the day of reporting that a few female patients, all over 60 years of age, reported feeling more fatigue and myalgia than normal after receiving the Arexvy Vaccine. The reporter did not have any further information about these events, nor any information about lot/expiry, route of administration, date of administration, or any distinguishing factors for the patients. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023147946:1 of 2 report
Had so much pain last night; It lasted 4 hours or longer but the first 2 hours the pain was unbearable; Pain in the same place the rod is; Tenderness in the same area. It feels kinda tight but there is no pain; It started in the shoulder and went to the back; Headache; It started in the shoulder and went to the back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain) and BACK PAIN (It started in the shoulder and went to the back) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A D and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (had surgery and has titanium on the back).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain), BACK PAIN (It started in the shoulder and went to the back), HEADACHE (Headache) and ARTHRALGIA (It started in the shoulder and went to the back). At the time of the report, PAIN (Had so much pain last night), PAIN (It lasted 4 hours or longer but the first 2 hours the pain was unbearable), PAIN (Pain in the same place the rod is), TENDERNESS (Tenderness in the same area. It feels kinda tight but there is no pain), BACK PAIN (It started in the shoulder and went to the back), HEADACHE (Headache) and ARTHRALGIA (It started in the shoulder and went to the back) outcome was unknown.            Treatment included Tylenol 500   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: NNI
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received
1/27/2022- Presented to ER, complaint of SOB. Temp-101.5. p-90. Chest CT-Coarse interstitial disease with ground-glass opacities. Admit Sepsis/Acute hypoxia secondary to Covid 19 pneumonia. IV decadron, IV Remdesivir, baricitinib, vitamins, ceftriaxone and doxycycline. 1/29/2022-Spo2 stable on RA. Afebrile. 1/30/2022-VSS, discharged to home.
Pain left arm after vaccination.  Developed erythema 3 days after vaccination.  Erythema resolved after 1 week when pt started 10 course of antibiotics with PMD.  Pt still has left arm pain at injection site 1 month after vaccination.
Post vaccination, patient complained of " Intense itchiness/ tingling" at the sight of injection.  Pt denied  any other symptoms and confirmed  only itching tingling at site. about 3X3 area around site.  After examination, no redness/swelling/ hives present. Monitored patient, instructed him to stay for a total of 30 minutes post vaccination.  Patient stated that itchiness dissipated about 10 minutes after vaccination. Reviewed normal side effects of vaccination with client and when to call a health care provider.
Patient given a dose of vaccine that had been sitting at room temperature for longer than the manufacturer recommended timeframe. Patient did not report any signs or symptoms at the time of injection or within the 15 min post injection.
Got H1N1 at 4pm. Feelings  on forehead and side of face tingling  at 5:00PM.        . Care sent to pharmacy at 5:15pm. Stayed for a while feeling after then went home. Called later in evening feeling okay.
Patient is an 86 year old dementia non-verbal patient at the Stadium Place Nursing and Rehabilitation center. She is generally not alert and has a lot of grunting and arm tremors. On January 8, 2021, she received the Pfizer Covid-19 vaccination on her right arm. About an hour later, the patient?s aid reports patient having a minor nosebleed. The nursing home facility staff noted that patient does not normally exhibit such symptoms. Of note, Pt is on 4 liters of oxygen around the clock and has a nasal cannula inserted in her nostrils. Nursing staff believes this nosebleed is possibly related to the covid 19 vaccine. In addition, nursing staff also attempted to take patient blood pressure but due to constant movements and tremors the reading could not be done. She was monitored for next few hours and no other symptoms has presented.
Chest tightness, nonproductive cough, headache, taste is different, but not completely gone. Starting on 9/27/21.
Lethargic for 8 hours; Headache; felt tiredness; Low grade temperature; Muscle and joint pain; Muscle and joint pain; Chills on and off; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature) and MYALGIA (Muscle and joint pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to excipient.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off). At the time of the report, LETHARGY (Lethargic for 8 hours), HEADACHE (Headache), FATIGUE (felt tiredness), PYREXIA (Low grade temperature), MYALGIA (Muscle and joint pain), ARTHRALGIA (Muscle and joint pain) and CHILLS (Chills on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications were reported.
Symptoms: Fever, tiredness, body aches, joint pain, soreness around eyes, and soreness at injection site.  Symptoms started approximately around 7:00 P.M. , which is approximately six hours after receiving the vaccination.
Large area of redness and swelling on outer aspect of R arm. Advised Benadryl as directed and re-check area in 24 hrs (area 7cm x 5cm at recheck-swelling decreased slightly).