chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red (spot is about the size of a silver dollar) area below the injection site; Tender area below the injection site; Swollen area below injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
In 2-3 minutes after injection patent fainted,  she was conscious but dizzy,  she was sweating a lot, her skin was pale and clamy, she felt nauseated and threw up
sick for a night; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received 2nd shot of Shingles vaccine and sick for night. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR084069, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084069:Same reporter
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On 28-AUG-2015, the patient was vaccinated with a dose of GARDASIL injection, intramuscularly, lot # K010215 (exact dose and expiry date were not reported). Then, on 02-SEP-2016, the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly, lot # M018810 (exact dose and expiry date were not reported). It was not reported what caused an interchange of vaccine products. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Resident's first vaccine was July 21, 2021. Second dose was given August 5, 2021. the second Moderna dose was given too early.
Confirmed Outbreak  1st Dose - Moderna - 007M20A 010A21A 2nd Dose - Moderna  017F21A 3rdDose - Moderna  042J1A - 4th Dose - Moderna
12/18/20 4 hrs after injection redness& swelling at site started. 12/19/20 severe fatigue, muscle/ joint aches, severe migraine with nausea, dizziness, started at around 11am at 1pm chills started& lasting through 12/21/20 1450. Headache at a pain level 8
Joints aching; Could barely walk; Felt very weak; Felt very bad; Back to bed and slept; Arm was very sore; Muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of arthralgia (received 1st dose on 25th July 2019 and experienced events, refer case US2020000352) and Flu vaccine with an associated reaction of pain in extremity (received flu vaccine on an unknown date in 1970 and experienced pain in arm).   On 27th September 2019, the patient received the 2nd dose of Shingrix .5 ml. In September 2019, less than a day after receiving Shingrix, the patient experienced joint pain, walking difficulty, pain in arm and muscle weakness. On 28th September 2019, the patient experienced weakness, feeling bad and bedridden. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the joint pain, walking difficulty, weakness, feeling bad, bedridden, pain in arm and muscle weakness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination awoke in the middle of night with every joint aching. The patient could barely walk, in the morning it was still hard to walk. The patient felt very weak and bad, she went back to bed and slept till 2pm. The patient also had arm pain and muscle weakness. The patient stated had not discussed the events with her physician but her mother did and the doctor said he was not aware of the events. This is 1 of the 3 cases reported by same reporter.
tachycardia; Not been able to sleep; Heart beating more than normal; Heart racing all the time; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration administered in arm left on 02Sep2021 at 12:00 AM(Lot Number: 1021) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at time of vaccination. Previously the patient received an unspecified vaccine in 2021 (other vaccine in four weeks) at 31 years for immunisation with no adverse effect. Concomitant medication included an unspecified Pfizer vaccine (lot# fc3181) received on 02Sep2021 (same date of bnt162b2). The patient experienced tachycardia (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, not been able to sleep (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, heart beating more than normal (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered, heart racing all the time (caused hospitalization) on 03Sep2021 13:00 with outcome of not recovered.    No follow-up attempts are possible. No further information is expected.
complaining of mild tightness of chest immediately following vaccination.  Pt stated that tightness  not uncommon with history of asthma and anxiety.  Denied : any itching or allergy related complaints,  any  respiratory difficulty.
I had the flu shot; Initial information regarding an unsolicited valid non-serious social media case received from consumer or non-healthcare professional on 25-Nov-2020.  This case was linked to case 2020SA344141.  This case involved patient (with unknown demographics) who had the flu shot (Influenza) when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1998, it was reported that, the patient had the flu shot (Influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Jul2021 at 11:45 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 14Jul2021, the patient experienced vomiting. The event vomiting did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
right arm pain, swelling, headaches, fever. pt states it was right arm injections. documented in clinic as left deltoid.
minutes after administration, patient reports head feeling strange, so I asked her to remain seated so I can observe her prior to getting up to the observation room. Then she reports feeling nauseous and weak. I asked her what medical conditions she has and she told me she is diabetic and has kidney disease. I asked if she ate breakfast, she said she did not, only had something small before heading out in the morning. I gave her am ice pack to place on the back of her neck which helped relieve her symptoms of head feeling strange and the nausea. Once nurse arrived, we checked her pulse and blood pressure, at this time it was around 11:45 am and her pulse was low at 64 and blood pressure at 94/60, which patient states is her baseline normal blood pressure. We opened the windows so she could get some fresh air since the room was very hot and shortly after we took her pulse and blood pressure she seemed to be feeling better. By 11:50 am the ambulance arrived and paramedics asked if she would like to be taken to the hospital to get checked, she said even though she is feeling a lot better, she would prefer to go just in case.
No additional AE information provided; the patient was administered an improperly stored dose of VAQTA; This initial spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. This report concerns one patient and one combination product.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032055, expiration date: 09-NOV-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse event information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
7 x 7 cm ara of erythema and warmth where DTaP was given.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
After receiving covid19 vaccine (Moderna, 1st dose), patient complained of pressure in right check, and near area of bone graft. No other symptoms. On site EMS were notified and assessed patient and deemed unremarkable. Patient denied offer to transport to ER.
10/22/08 6:30PM c/o eyes itching & burning and hoarse voice 10/23/08 4:30AM c/o headache got up to medication for headache, c/o nausea, became sweaty and skin felt clammy then passed out Reported did not seek medical attention.
This spontaneous report as received from a employee according to the pharmacist and refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The relatedness between shingles and ZOSTAVAX was not reported. The outcome of herpes zoster was unknown. Additional information has been requested.
The pt experienced a fever of 102 and shortness of breath, which started approximately 2 1/2 hours post vax. This resolved spontaneously.
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002451: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
While getting the vaccine, there was a malfunction of the syringe and it seemed to fall apart in the nurses hand. She stated that approx 80 percent of the vaccine was injected and asked if I wanted another dose. I agreed without thinking. Afterwards, i experienced nasuea, body aches, chills and a nosebleed. After discussing it with my coworkers, it was pointed that the vaccine may be unsafe in the quanity I was given. I was hoping to get information on whether I should be worried about a getting nearly twice the recommended dosage.
Description by Physician: Localized reaction at injection site. Diffuse swelling right upper arm.  No erythema. No loss of function of arm/hand. Symptoms began 24hrs after injection. No medical treatment needed.  Advise warm compress to site.
The day after receiving pneumococcal vaccine, pt was seen by PMD for red and swollen arm, with red streaks to wrist and chest wall. Treated with oral steroid and oral antibiotic.
Patient reporting severe pain in shoulder (9 on a 1-10 scale) and innability to raise arm within 2 hours of receiving vaccination.  Patient unable to sleep for 2 days due to pain.  Patient states has been treating with OTC Ibuprofen.  As of today (6 days later), patient reporting increased ability to use arm normally and pain decreased to a 3 on a 1-10 scale.  Patient states pain comes and goes now, not there constantly.
ADMINISTERED PAST THE CURRENT REFIGERATION BEYOND USE DATE AS LISTED BY EUA
65 year old female (DOB: 06/30/1955) received the 2nd dose of the Moderna COVID-19 vaccine at County Fairgrounds on 03/09/2021 @ 11:00. Pt started experiencing body chills, body aches, fever, nausea, and headache on 03/25/2021 evening. Pt was scheduled for an elective surgery, bunion removal on left foot on 03/26/2021 @ 08:30. Pt was declined the elective surgery due to fever. Pt's fever peaked at 101.8F. Pt called primary doctor and doctor recommended pt go to ER. Pt was admitted to ER on 03/26/2021 @ 10:00 and discharged on 03/26/2021 @ 13:00. Pt tested (-) for COVID-19 and ER diagnosed pt with UTI and prescribed Cefalexin (Keflex) 500 mg for treatment. Pt is diagnosed with breast cancer and takes Anastrozole (Arimidex) 1 mg and multivitamins. Pt takes Tylenol for symptoms, but receives mild relief. Pt is still experiencing body chills, body aches, fever, nausea, and headache. Pt asked when should the elective surgery be scheduled. Pt was advised to talk to primary doctor and oncologist regarding the elective surgery and symptom management. SPI was consulted and Dr was notified.
My original diagnosis was hematuria. However, in October 2022 I was urinating a lot of black blood clots and the urine was dark. I had noticed the previous week that my urine was darker than normal I just thought I was dehydrated. The following day it had cleared. I had some clots the next several days between October 8th and 12th, 2022. I have a CT and Scope with urologist in the next two weeks. October 21 and 25, 2022.
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Information has been received from a nurse practitioner concerning a 24 year old female patient with post-traumatic stress disorder and allergy to VALIUM who on 30-SEP-2010, was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot # 666118/159Y). Concomitant therapy included IMPLANON, prazosin, sertraline HCl, carbamazepine, SEROQUEL, TEGRETOL and lorazepam. It was reported that within one hour after administration of the vaccine the patient returned to the clinic with severe abdominal cramping, diarrhea and vomiting. The vomiting was addressed with sublingual ZOFRAN, but it persisted. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. Additional information has been requested.
About 1 week after first injection, swelling and bruising at injection site. Shoulder pain in that shoulder. Sometimes fingers will tingle in left hand. Is not continuous but does still come up. After 3rd dose similar pain in right shoulder.
top of her left arm was swollen; she had pain all down the left side of her body, the whole left side; This is a spontaneous report from a contactable consumer (Patient).  A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 17Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got the shot in her left arm and the top of her left arm was swollen, she had pain all down the left side of her body, the whole left side in Dec2020. The patient only took paracetamol (TYLENOL) for treatment. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Information has been received from a receptionist at the physician's office reporting for the physician concerning a 73 year old male patient without any drug allergy, with chronic renal insufficiency and bladder cancer and a history of renal failure acute who on 26-APR-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # not reported) at a pharmacy (location unknown). Concomitant therapy included Furosemide, amlodipine, metoprolol, HECTOROL, diazepam, simvastatin (manufacturer unknown) and allopurinol. On 27-APR-2012 the patient developed a red raised extending down the back of the right leg to the foot. The patient saw another unspecified physician that same day who noted it was likely shingles. The patient saw the reporting physician on 01-MAY-2012 who confirmed the diagnosis of shingles. No treatment was given to the patient. No lab test was done. At the time of this report, the event outcome was unknown. Information has been received from medical records concerning a 73 year old male with a history of hyperuricaemia, who on 26Apr2012 was given a dose of ZOSTAVAX (Merck) vaccine administered in his right arm (lot # 16581AA, expiration date 21 Jan2013, not validated at this time). There was no perceived difficulty at the time of the injection. By the following day, he had developed a red raised rash extending down the back of his right leg to the foot. The upper edge was the right gluteal fold. The patient did seek medical attention on 27 Apr with a physician who felt it was shingles and that the development was a result of the patient's kidney issue. The patient was not given any medications as he was not having any pain. The patient was not certain if he ever had chickenpox as a child. Throughout there was some hypersensitivity to the area with minimal intermittent itch. Assessment included: adverse effect, NOS due to correct medicinal substance properly administered. The patient continued on his regular medications. Additional information has been requested.