chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 10th September 2018 03:30, the patient received the 1st dose of SHINGRIX. On 10th September 2018 08:00, 4 hrs 30 min after receiving SHINGRIX, the patient experienced back pain, pain localized and feeling unwell. In September 2018, the patient experienced shingles and rash. The patient was treated with gabapentin and antivirals for systemic use (Antiviral). On 5th October 2018, the outcome of the shingles and rash were recovered/resolved. On an unknown date, the outcome of the back pain, pain localized and feeling unwell were recovered/resolved. It was unknown if the reporter considered the shingles, rash, back pain, pain localized and feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The consumer reported her pharmacy had already called inquiring about the percentage of individuals that acquired shingles after first vaccination, but she was calling with additional questions. By 8pm that night of vaccination the patient was experiencing back and side aches, not feeling well and didn't sleep well due to the pain. The patient noted it lasted through the week. On Friday by 12:30 in the afternoon, 3 days and 21 hours after vaccination, the patient noticed a rash that was confirmed by her physician at an visit on the same day, on 14th September 2018 at 1:30 pm she had shingles. The patient was placed on an antiviral for 7 days and given gabapentin.  The patient stated she had the rash for 3 weeks. The patient on the day of reporting to see if any individuals that had contracted shingles in the study had previously had the live vaccine on the market because she did get it in the past and should she get the second dose of SHINGRIX.  The prescribing information clinical study data for exclusion criteria was reviewed and that in the incidence of SHINGRIX that was after the two doses were received. The patient had been referred to her physician for guidance and she provided her doctor's information for follow-up.
pt recieved vaccine 5/13/19; contacted pharmacy on 5/20/19 reporting 3 spot blotchy rash on upper arm that started on 5/19.  pt stated was not itchy, but was red and warm to touch.  Counseled pt to seek follow up with PCP and contact us back to let us know outcome. Pt saw Doc and said was inconclusive weather or not it was related to vaccine admin. due to presentation and delay in onset. Prescribed pt triamcinolone topical and drew around margins with marker to determine if spreading over the next 48 hours. Pt is instructed to follow up with picture of rash in 2 days.
I hear a High pitched tone heard in both ears. Constant, day or night. No change with head position, or when clearing ears, or when plugging one ear or the other. Very annoying, I hear it with everything I do. I do not think I have any hearing loss. And I may get my hearing checked but unfortunately I don?t have a baseline audio gram to be able to compare.
Information has been received from a pharmacist via a field employee concerning a female patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant medications were not provided. On an unknown date (reported as "in early summer", exact date unspecified), the patient was vaccinated with a dose of ZOSTAVAX, (dose and frequency: 1 injection/once; lot #, expiration date and route not reported). Then the patient traveled to another country. On an unspecified date she developed a rash and returned home with a rash "on her face, hair, and side of head". The outcome of rash was unknown. Additional information has been requested.
TD given instead of DTAP.  Child shoud have received DTAP because of age.
Explosive diarrhea; Migraine; Mild diarrhea; Feeling really tired; Nausea; Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI; Tingling on lips; Buzzing or vibration all over body; Mild tachycardia; Slightly elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia) and BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN), IBUPROFEN (ADVIL [IBUPROFEN]), VITAMINS NOS and ZINC for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure), FATIGUE (Feeling really tired) and NAUSEA (Nausea). On 20-Jan-2021, the patient experienced DIARRHOEA (Mild diarrhea). On 21-Jan-2021, the patient experienced MIGRAINE (Migraine). On 22-Jan-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On 19-Jan-2021, FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) and NAUSEA (Nausea) had resolved. On 20-Jan-2021, DIARRHOEA (Mild diarrhea) and FATIGUE (Feeling really tired) had resolved. On 21-Jan-2021, MIGRAINE (Migraine) had resolved. At the time of the report, DIARRHOEA (Explosive diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a person working in a physician's office concerning an approx 6 yr old male who in June 1999 was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt had a recent mild case of chicken pox that resolved without incident.  Unspecified medical attention was sought.  No product quality complaint was involved. No other information was provided.  Additional information has been requested.
Patient described 2 weeks of bone pain; Headache; Photophobia; Back pain; Fatigue; This is a spontaneous report received from a contactable reporter physician. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was healthy. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced two weeks of bone pain, headache, photophobia, back pain and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment for events. On 05May2021, the patient underwent COVID-19 virus test and the result was pending. The clinical outcome of the events headache, bone pain, photophobia, back pain, and fatigue were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow up (01Aug2021): This follow-up report is being submitted to amend previously reported information: Amendment of reporter data, patient information, Lab data, Vaccination details, Event data and narrative.
Raised red area on arm, warm to touch, growing daily. Noticed at 4 inches long, 9 inches long 2 days later.
had pain in my sternum; my body to lock up from neck, down arms, and thoracic area of back; sick; feel heart palpitations; muscles tightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), (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: BONE PAIN (non-serious), outcome "unknown", described as "had pain in my sternum"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my body to lock up from neck, down arms, and thoracic area of back"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PALPITATIONS (non-serious), outcome "unknown", described as "feel heart palpitations"; MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "muscles tightening". Additional information: Reporter stated, "Your Pfizer vaccines and Omicron booster caused my body to lock up from neck, down arms, and thoracic area of back. My husband could feel my muscles tightening and I could feel heart palpitations and had pain in my sternum. I endured one month of Medrol treatments, plus a trigger point injection in thoracic and epidural for Lumbar. People with autoimmune conditions shouldn't get this. I've been sick since my first vaccine FEBRUARY 2021 and everyone after."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385262 same reporter and product, different dose and event .;US-PFIZER INC-202300385261 same reporter/product, different dose/ event.;
superficial rash like swelling of arms, legs & hips; persisted for 3-5 days & resolved; used a topical cream; may have had a sl fever; primary series ID; last dose in series on 6SEP89;
Arm swelling, red, head started to hurt, started to throw up...had cold chills and ran a fever. Could not drive, felt dizzy. My asthma was awful...hard to breathe. I took aspirin and stayed in bed.  This continued until EXACTLY 5:00 on 12/16/2010.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in 2017 (reported as "earlier this year"), the patient received a first dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for human papilloma virus (HPV) prevention. On an unknown date in 2017 (reported as "day or so" after the administration of the first dose of GARDASIL 9, the patient had developed some jaw and mouth pain. The patient sought medical attention (doctor's appointment) and she was given an unspecified treatment for the adverse events. On an unknown date in 2017, the patient recovered from the events of jaw and mouth pain (also reported as "adverse events improved"). At the time of the report (provided as "at that time"), the patient's mother did not feel that her daughter would continue the vaccination series schedule (which was also reported as "vaccination was not reintroduced"). The causality assessment between the events of jaw and mouth pain and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
I woke up with a lot of chest pressure and heart rate was elevated. My resting heart rate was elevated between 92 and 115 beats per minute. I was lightheaded and feeling general pain when lying on my left side. It was about 24 to 36 hours before I sought care. I went to the emergency room after calling my insurance provider, they recommended that I go to the hospital to ensure it was not a heart related. They gave me aspirin and a saline solution in a large syringe. There was no diagnosis and the doctor asked me to follow up with my PCP since the symptoms have subsided a lot. There is some light pressure still there, but it has been subsiding each they.
Patient came in today and said she received  her 2nd Moderna vaccine on  02/15/2019 and the arm became very sore and red the next day. She went to her primary care physician who advised her to report her adverse effect to the location where she received her COVID -19 vaccine which she did.
Extreme pain in muscles & joints?lack of balance?loss of feeling in some areas?the problem appears to be increasing over time - 07/17/2022
Large red bump: large bruise, hot to touch on LA. Neck swollen. Armpit also red and swollen. Cold compress applied and Benadryl taken.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 17-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose and number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
1st dose Modernal 1/13/2021 without side effects.   Follow 2nd dose Moderna 2/9/2021, on 2/14 she developed hives on left arm where she received the vaccine.   She then developed hives on other areas of her body, her tongue was "broken out", and she had difficulty swallowing   The hives would come and go, breaking out in an area, then resolving, and appearing in another area.  She saw her physician 3 wk following the 2nd injection, who diagnosed "bug bites" and treated her with oral Methylprednisol taper  over the course of 6 days.    She completed the medication and was not better, possibly "worse".  She contacted her physician who referred her to the ER and was treated with an oral medication.  She was provided a referral for a gastroenterologist.  A gastroscopy was performed 3/24/2021 and biopsy results pending.  She has been self treating with Benadryl, with some improvement.  Continues to have hives.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE; PARACETAMOL; SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), SWELLING (little swelling), TINNITUS (humming in ears) and DIZZINESS (swimmy headed) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No  concomitant medications were reported. This case was linked to MOD-2022-524056 (Patient Link).
Swollen upper arm, large red spot below site of injection (~2-3 inches in diameter, hot, raised), swelling in and below armpit into breast and back.  Mostly resolved by 4 days after appearance, with ~2 inch diameter, sparse red rash.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Approximately on an unknown date in 2013 the patients were vaccinated with VAQTA (lot#, expiration date and route not reported) that was improperly stored approximately on an unknown date in March 2013 (reported as over the last month). No adverse effects reported. The medical assistant was unable to confirm the exact number or identities of the patients at the time of this report. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. It was reported by Health Professional that inadvertently administered FLUMIST to a 12 month old child. The outcome of the event of nurse inadvertently administered FLUMIST to a 12 month old child is unknown. The report was considered to be non-serious.
Swollen tongue, diarrhea, throat closing,  numb tongue, numbness on left cheek on face.
Patient described rapid onset sweating and flushing. Said he felt light headed as well. Gave Benadryl 25 mg with continued observation for 30 minutes and he said he felt mostly better, but still tired and weak. Followed up next day and his mother said he was doing better.
13 Y/O received 3rd dose of GARDASIL at 10 am in right arm developed swelling of right hand in the evening.  On exam she had edema of fingers & palm of the hand with no erythema, there was no tenderness on the hand.  No fever good cap refill good radial pulse, sensory intact.  Injection site looked good.  Patient was examined 28 hrs after the vaccine was given.
She had lower leg pain in both legs; a red painful rash developed where she had the pain for both legs; a red painful rash developed where she had the pain for both legs; erythema nodusum; Immune reaction; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (lower leg pain in both legs), ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION (Immune reaction) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION. On an unknown date, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY, ERYTHEMA, RASH, ERYTHEMA NODOSUM, and VACCINATION COMPLICATION (Immune reaction) 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.
Support staff checking in patients outside the building witnessed a patient passing out at the top of the walkway. One person ran inside to get the clinic coordinator.  She immediately asked staff to call EMS and she ran out to assess the situation.  The patient was lying on his side motionless.  She attempted to rouse the patient and assess if CPR was needed.  The patient opened his eyes and looked dazed and confused.  He rolled on his back.  He began to verbally respond and apologized for passing out.  He stated that this happens to him frequently when he gets an immunization or blood drawn.  He had abrasions and a small contusion on the left side of his face in the temple region with a small amount of blood and dirt from hitting the sidewalk. She was joined by NP and NP along with 2 medical assistants. While waiting to EMS to arrive, campus police came on the scene to help direct EMS whenever they arrived.   Vitals were taken BP 140/70  HR 62  2:30 PM .  An ice pack was applied to his head.  Additional information on the patient?s identity was acquired.  Patient was alert and oriented.  Patient had his cellphone and attempted to call his wife with no answer.  He also sent her a text.  EMS arrived on the scene.  Patient?s wife called and she apprised her of the situation as EMS assessed the patient.  After their examination, EMS declined to transport the patient due to the patient's narrative of this situation occurring frequently.  They advised him to follow-up with his MD and left the scene. Clinic staff and campus police stayed on the scene until the patient?s wife arrived.  She was advised to take him immediately to the ED to be assessed for a head injury.  Wife drove patient to hospital.   She called the patient later that evening.  Patient stated he was thoroughly examined for a potential head injury and was cleared.  He was given information on interventions he can try to use to avoid a severe vasovagal incident in the future.  Patient was cleared to get his second dose of COVID-19 vaccine.
p/vax pt had rt sided tonic then tonic-clonic sz;rt arm & rt leg-not conscious x3min;CBC & electrolytes nl;exam nl;no fever;
Large, tender, and erythematous rash present on the left shoulder (immunization site), which started on 3/19. Rash is 12 x 12 cm in size, Pt without other symptoms to include fever, chills, cough, sob, chest pain, seizure, or other neurologic symptoms.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2015 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered) (dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Rec. 1st shingle vax. Started getting dizzy room was spinning and then progressively got worse. Couldn't walk. Attempted to stand up but could not was stumbling. Had to catch breath. sweating profusely. Went to bathroom and was dry heaving. also had Blurry vision. Called MD next day twice and has not gotten response. All symptoms gone just feeling exsaughted.   Rec Flu shot 10/6/20  At workplace Hospital.