chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore skin on his back; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (sore skin on his back) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN OF SKIN (sore skin on his back) and HEADACHE (headache). At the time of the report, PAIN OF SKIN (sore skin on his back) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-333654 (Patient Link).
pain all over her stomach; nausea; Patient threw up for 2 days in a row.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.). At the time of the report, ABDOMINAL PAIN UPPER (pain all over her stomach), NAUSEA (nausea) and VOMITING (Patient threw up for 2 days in a row.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-433382, MOD-2021-433458 (Patient Link).
My left outer bicep has become weak and tender. I have difficulty completing tasks with left arm.  Pain increases when my arm is raised above shoulder.
slight wheezing, asthma  flare up a initially.. premedicated as directed with pepcid and albuterol then by late afternoon/ early evening significant chills but no fever and very sore left arm.
This spontaneous report received from a registered nurse refers to a 12 months old male patient with no illness at time of vaccination. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. His concomitant therapies and historical vaccines were not reported. On 14-SEP-2018, the patient was vaccinated with an improperly stored first dose of M-M-R II, subcutaneously (SC) in the right thigh, lot # N025899 (expiration date: 19-SEP-2019); with an improperly stored first dose of VARIVAX, SC, in the left thigh lot # N035940 (expiration date: 18-DEC-2019); with an improperly stored first dose of VAQTA intramuscularly (IM) in the right thigh, lot # R006210 (expiration date: 22-APR-2019) and with an improperly stored fourth dose of PREVNAR IM, in the left thigh, lot # T94429 (expiration date not reported). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) (product storage error) which occurred at the time of storage in clinical practice. No adverse effect was reported  (conflicting information reported that the patient received an unspecified treatment for the "none" experience). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010598; US-009507513-1901USA002753; US-009507513-1901USA002754; US-009507513-1901USA002755; US-009507513-1901USA002756; US-009507513-1901USA002757; US-009507513-1901USA002758; US-009507513-1901USA002759; US-009507513-1901USA002760; US-009507513-1901USA002762; US-009507513-1901USA002763; US-009507513-1901USA002764; US-009507513-1901USA002765.
Pt has received the first dose of Pfizer and was here for the second and the MA administered Moderna.
Allergic reaction:  swelling from her elbow to fingertips on  left side, swollen eyes, coughing, swollen tongue,  elevated BP, sweating, tired Patient received benadryl 50mg, pepcid 20mg prior to vaccine due to history of allergies.  Patient was sent by ambulance to the ER.
I had extreme soreness in my arm for about 2-3 days.  It went away, but oddly came back after about 6 days.  It was just as sore as the first time and took up to about 7 more days to go away. Not noticeably swollen or red.  After that I had residual pain, tenderness and itchiness for about 2-3 more weeks.  Finally gone.  I had tenderness and pain for a few days after the second vaccine, but it never came back like it did with the first vaccine.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 10:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown., Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: immunization, chills, nausea, headache, pain in extremity and malaise with onset 08Dec2021, outcome recovered. Therapeutic measures were not taken as a result of chills, nausea, headache, pain in extremity, malaise. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not prolonged hospitalization. The events reported as non-serious. The lot number for bnt162b2 was not provided and will be requested during follow up.
arm soreness; 16-year-old received the Moderna vaccine instead of the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine) and PAIN IN EXTREMITY (arm soreness) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine). On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 30-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine instead of the Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter
1 wk after vaccination - moving nerve pain on arms, legs, neck. No loss of function. Pursuing treatment with private physician.
I have been experiencing a very sore/painful arm. I was not able to move it without experiencing high pain level.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 at 16:00 as dose 1, single (Lot number: EL3249), in right arm, on 04Feb2021 at 12:00 as dose 2, single (Lot number: EL9264), in left arm and on 04Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: patient taking  other medications/products within 2 weeks of starting COVID-19 treatment. brand-Paxlovid, treatment start date-08Jun2022 stop date-13Jun2022, product-Acetaminophen 500 mg, start date-08Jun2022 stop date-16Jun2022, Product-Ibuprofen 200 mg start date-08Jun2022 stop date-16Jun2022.
This spontaneous report as received from a female consumer of unknown age reporting on herself. Medical history and concurrent conditions were not provided. On 09-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date, the patient experienced redness at the injection site. The patient did not seek medical attention. The outcome of redness at the injection site was unknown. Relatedness between the therapy with ZOSTAVAX and the redness at the injection site was not reported. Additional information has been requested.
2 days after TD, developed rash, multiple single round or oval papules, 0.25ml, 1 cm diameter, erythematous, mildly raised borders with scaly centers. Greatest cluster L axilla and medial upper arm. 2cm lesion noted left lateral thigh. Not itchy or painful. Given Claritin.
Tinnitus, extreme dizziness to the point that I am barely able to walk, running into walls, vomiting, breaking out into sweats when trying to function at all, like packing a lunch for a child.
About a week after receiving my first shot, I have had hives populate on different areas of my body (legs, thighs, back, stomach) at various times of the day and at different intervals between outbreaks. Each outbreak lasts about 20 minutes before going away on its own. This has been going on for about a week and a half. I have also had a loss of balance at times when walking or standing still and have had a hard time focusing on where my next step will be level. I have stumbled while walking but have not fallen over. This feels like someone is trying to push me over has been going on for about a week. I do not feel dizzy. I was prescribed Cadista by my doctor to try and help the loss of balance.
Narrative: Patient reported at recent PCP visit that she was diagnosed with adis pupil by eye provider. She says the problem occurred after her second COVID vaccination. Went to ER initially as advised by call center. Says was sent to eye provider and says al was ok except for 'reaction to light'. Then went to see Doctor. Says with diagnosis was advised to get eyes checked yearly-says was advised could return to normal or could remain.
This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. Concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with a dose GARDASIL (lot number, expiration date, dose and route were not provided). Concomitant medications were unspecified. On an unknown date, the patient experienced dyskinesia reported as "jerky movement" and syncope reported as "passed out temporarily". The patient did not seek medical attention. The outcome of dyskinesia and loss of consciousness was reported as recovered/resolved on an unspecified date. The reporter did not assess the relatedness of GARDASIL to the events. Additional information has been requested.
cough; This is a spontaneous report from a contactable physician. A 16-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0172), dose 1 via an intramuscular route of administration, administered in Arm Right on 08May2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 16 years). Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced cough on May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (If COVID tested post vaccination: Yes). Therapeutic measures were taken as result of cough included scheduled non-steroidal anti-inflammatory drugs (NSAIDs). The clinical outcome of the event was recovering.    Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Day after received TDAP booster (1st in 2008) she developed a 9 1/2 x 13 1/2 cm red rash with itching at the site of the injection.
Mild fever, muscle aches, headache, fatigue, chills for approximately 18-24 hrs following the shot
Less than 24 hours after receiving vaccine, pt developed bilateral lower extremity paresthesias - reported no feeling in legs and complained of pain as well - neuro exam by MD was consistent with decreased sensation to just below both knees; by 4PM on 10/1/09 at f/u visit, neuro symptoms resolved; pt still had low grade fever. Pt also had fever of 102 for these 3 days.
Pt is 8 YO and received DAPTACEL indicated for 7 and under--no adverse reaction noted.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-SEP-2013 the patient was vaccinated with M-M-R II (lot number and expiration date unknown), dose, route, indication and anatomical location unspecified. Concomitant medications were not reported. On 16-SEP-2013, the patient was administered a dose of M-M-R II that was exposed to 11.5 degrees C for 12 hours which was not supported. No adverse effects were reported. Additional information has been requested.
FEELING DIZZY; SWEATS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 23-AUG-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling dizzy, and sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling dizzy and sweats was not reported. This report was non-serious.
Patient with history of stent placement on 3/8/21 who developed SVT on 3/11/21 and was treated in the ED, Presented for covid vaccination on 3/13/21 as recommended by his cardiologist.  Came back to the hospital ED approximately 9 hours post vaccination with SVT.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Paramedics called due to the patient fainting and they cleared him. Patient felt dehydrated after, drank pedialyte and water and felt better after about 30 minutes.
Information has been received from a registered nurse concerning a 12 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (therapy dose, route and site unknown). The nurse reported that the patient was given the first dose of GARDASIL and within minutes the patient fell asleep. The patient was able to be aroused and she answered questions correctly but then fell right back asleep afterwards. The patient stayed in the office. The nurse states the patient had still not yet awake. Follow-up information has been received from the registered nurse. She reported that the patient had bilateral congenital cholesteatoma and asthma, migraines, motion sickness. The patient had no known drug allergies and did not use tobacco and alcohol. The patient had previously vaccinated influenza virus vaccine (unspecified). On 09-AUG-2010 in the afternoon, at approximately 3:30 pm, the patient was seen at office for White Cell Count ("WCC") and was vaccinated with the first dose of GARDASIL. There was no concomitant medication. After 3 minutes of the vaccination, the patient felt really tired. The patient was lethargized by fatigue and headache. The patient had juice with pretzel. On 09-AUG-2010 the patient presented to the emergency room at 5:40 pm via a wheelchair. Upon arrival she was clam and her headache pain score was assessed at 4/10. Vital signs included body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. All other body systems were normal. The laboratory tests and results as following: body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. Other tests including  Respiratory, Neurological, Eye, Gastrointestinal, genitourinary, gynecological, skin and orthopaedic were all normal. The patient was treated with Ibuprofen 600 mg, po, three times a day. The patient had ability to take food and fluid in emergency department. At 7:20 PM, the patient was awake, pleasant and had ginger ale. The patient was re-examined and then was discharged at 7:30 pm. Clinical impression: headache and pre-syncope. The patient was sent home and was improved. The patient was recovered on 10-AUG-2010. Additional information is not requested.
Pt c/o itching at site of injection and back.  Denied SOB.   Hives, redness at site.  Diphenhydramine 25mg po given at vaccination site.  Transferred by EMT to ER.   At ER, patient given Prednisone 60mg,  additional diphenhydramine 25mg and famodidine 40mg.     Recommended she take Prednisone x 2 days and diphenhydramine x 24hrs. Patient was discharged to home within one hour.
Pruritic rash and fever T max 103 for 1 day, started 9/3/15. Received Varicella vaccination 9 days ago.
Information has been received from a 91 year old female consumer reporting on herself with drug reactions or allergies to morphine and anxiety and osteoporosis who in approximately September 2011 ("last fall") was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported). Concomitant therapy included THYROXIN and DEPLIN. In approximately September 2011 ("last fall"), shortly after receiving ZOSTAVAX (Merck) the patient experienced itching and burning on her right side and buttock. The patient described her skin as brown spots and she had told her doctor about the reaction. Steroid ointment and cream were given as  a treatment for itching and burning on her right side and buttock and her skin described as brown spots. At the time of the report the patient not recovered. Blood tests were performed, results not provided. The patient sought unspecified medical attention. Follow up information has been received from the consumer stating that she had used many products for the itchy brown spots on her buttocks. She advised that she would be seeing her dermatologist regarding this matter. Additional information has been requested.
Left Arm twitching, left eye twitching, right arm pain, focal seizure in left side of body lasting over 48 hours
electrical type zaps all over body. Memory issues, brain fog, exhaustion, balance off. Not feeling like myself. Hard to complete tasks as before getting dose 2. I did not get this feeling from dose 1,  I experienced the first zap about 30 mins after the first dose. This was sharp and direct zap and it was on the tip of my nose. It felt like a current was going through me.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M007963, expiration date 24-DEC-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA003754.
On 4/11/2018 around 2:27pm patient named was given her first dose of SHINGRIX shot. She was given the shot on her left arm (IM). Before giving her the shot I verified her vaccine history with ALERT, and confirmed name, DOB, if she had never gotten this shot before, if she was allergic to anything, had any reactions to any vaccines in the past, and if she was allergic to anything other than PCN. She confirmed her name and answered no to all the questions I asked her. I advised her about SHINGRIX, and told her she needed to sit down at least 15 minutes after getting the vaccine. She said she would wait. I gave her the shot in the left deltoid (with both of us seated), and asked her how she was feeling. She said she was fine, and she also did not display any stress from the injection. She wanted to wait in the waiting room, and so I waited for her to remain seated. I returned to the pharmacy to get a copy of the VIS information, so walked it over to her in the waiting room. I asked her again if she was alright and she said yes. I was working and my tech and I saw her lying down on the floor of the waiting room through the TV monitor. I rushed over to her to see if she was ok. I asked her what was wrong, and she said was feeling dizzy/lightheaded, and nauseous. She said she was feeling hot and sweaty. I asked staff to bring me the emergency kit, and also BP cuff so I could take her BP - her hands were cold to the touch. I asked her if I could check for any hives, and there was none. I asked if she had trouble breathing but she said no, she was fine with breathing. I asked her if she knew where she was, she said pharmacy, and she also knew what day it was. She also told me she had to use the bathroom. I told her, we want her to stay lying down. In the meantime, staff was told to call 911. As I was trying to get her BP - the paramedics came, and I moved aside to let them do their assessment. I provided all the information to the EMTs. Due to her age, and previous history of heart condition, the EMTs decided to take to the hospital for tests. I called the patient around 8 o'clock tonight (4/11/18) at home, and she was at home. She said she was doing much better, and they did all the tests on her. She said the MD thinks it is not an allergic reaction but a vaso-syncope from the immunization. I told her we will call her in a day or so to check on her again.
Patient reported a rash on L biceps, R elbow, L thigh 17 days after receiving smallpox vaccine.  No other systemic or local symptoms.
Nausea, dizziness, weakness, muscle ache, no energy, tired, headache, arm ache.