chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 25-JUL-2017, the patient was vaccinated with VARIVAX lot # M042495, expiry date 19-OCT-2018 for prophylaxis. Concomitant therapies included sterile diluent. On 25-JUL-2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
1) 1st severe migraine 6-4-07. 2) 2nd severe migraine on evening July 6, 07 with severe eye pain on the morning of July 7th, hemorrhagic left eye then (hyphema). 3) July 11, saw ophthalmologist - diagnosed hyphema, blood in eye. 4) July 13, sudden onset sore throat/sinus problems/fatigue - sinus duration 6 days. 5) July 25 blood clearing - return to ophthalmologist in 2 weeks.
PROQUAD administered instead of MMR that was ordered. Varicella separate vaccine also administered therefore double dose of Varicella. Low grade fever, fussy. Mild rash, poor oral intake.
Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm.  The patient went to the emergency room for the pain and was released.  The pharmacist stated that the patient is a "hypochondriac" and the nurse did not think her event warranted a visit to the hospital.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # N003980 with expiration date 12-NOV-2018, lot# M043836 with expiration date 17-JUN-2018, for prophylaxis.  No adverse event was reported. The doses of ROTATEQ, were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter; Sender's Comments: US-009507513-1708USA002992: US-009507513-1708USA002993: US-009507513-1708USA002995: US-009507513-1708USA002863:
Moderna vaccine was administered outside of the clinic - reported by patient   EPILEPSY, UNSPECIFIED 3/31/2022 ADENOCARCINOMA METASTATIC TO LIVER  EPILEPSY, UNSPECIFIED 3/31/2022 ADENOCARCINOMA METASTATIC TO LIVER
Abdominal pain, headache, fever, chills, nausea, runny nose, cough, tiredness, facial edema.
bad pain in neck and shot down to shoulder where got the shot; stiff neck; arm hurts; bad pain in neck and shot down to shoulder where got the shot; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot). At the time of the report, NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
body aches, fever, nausea  Swelling of lymph node in armpit of vaccinated arm at day 2.  Swelling and pain lasted 3 days, pain radiated into breast and nipple.
Patient received dose 1 of the Pfizer COVID vaccine (lot ER8735, exp 7/2021) at 1015. At 1020, patient reported to LVN that he felt nauseous and dizzy. Patient was given emesis bag. Patient's sister reported patient had not eaten since the night before. Vital signs: blood pressure 110/60, pulse 90, respirations 16. PHN approached the patient, noting diaphoretic skin. Patient was placed supine in zero-gravity chair and given juice and granola bar. Patient denied allergies, medical conditions, and medications. At 1025, vital signs: blood pressure 112/60, pulse 80, respirations 16. Patient reported symptoms improving, PHN noted patient's skin was no longer diaphoretic. At 1030, vital signs: blood pressure 110/60, pulse 77, respirations 16. Patient finished snack and juice, reported feeling better. Patient reported similar reaction when having blood drawn previously. At 1035, vital signs: blood pressure 114/62, pulse 72, respirations 16. PHN encouraged patient to stay for monitoring for 30min. PHN educated patient about following up with medical provider and when to call 911. At 1040, patient sat up. Vital signs: blood pressure 110/64, pulse 70, respirations 16. At 1045, patient stood up closely monitored by PHN and EMT, reported symptoms had resolved. Vital signs: blood pressure 110/62, pulse 77, respirations 16. Patient drank water. At 1050, vital signs: 112/60, pulse 74, respirations 16. Patient left walking with steady gait at 1052 accompanied by sister to drive him home.
Patient received dose 1 on 12/29/20.  Reported a dime-size red welt at injection site on 1/8/21.  On 1/12/21 the welt had increased in size (quarter), was slightly raised, and red.  Patient did not report a rash at the injection site, and the welt was not itchy.
day 1 erythema, induration, tenderness @ vax site rt arm 4 inch diameter;day 2 petechial rash & erythema rt hand, rhinorrhea, lacrimation, insomnia, arthralgias, myalgias, noc sweats, chills, neck pain & stiffness & back pain, pain costal
chills, body aches, high fevers , severe nausea . Fever spiked to 102.5 - advil and tylenol were taken, neither reduced fever. Fever was over 102 for 5 hours then broke back down to normal. Chills were severe, sweating through clothing and shaking .
1.) POSITIVE for COVID with home antigen test on June 6, 2022.  Began with a sore throat about 5 days prior, then worse chills, low fever, fatigue.  I had a home test and a molecular test on June 3 and was negative at the time.  2.) swollen and painful lymph nodes under axilla of same ar that received vaccine shot (Left).  Had a mammogram a few days after vaccine and very swollen in axilla and breast region.  Radiologist said NO signs of breast cancer but I have to follow up in 6 to 12 weeks with another diagnostic mammogram to make sure the swelling went down.  The radiologist said she sees this often after vaccination.
Acute deep pain in both legs from thighs to knees.  Lasted approximately3 hours.
Visited ER after seeing a sudden, very large, black floater appear in my left eye. Then revisited ER with flashes of light in same eye.
Severe shaking chills lasted 2 hrs Moderate headache, ear ache 2 hr General  body ache 12 hrs
Difficulty breathing began approx 8 days post Vx, progressed to pneumonia after 10 days, deceased at 12 days
Throat started hurting; This is a spontaneous report from a contactable nurse (patient herself). A 36-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was seeking information on the Covid-19 vaccine side effects and mentioned that her throat started hurting for 8-12 hours (h) after receiving the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Shortly after receiving the vaccine I broke out in a rash on my chest and torso. Over the next few weeks it has seemed to get worse covering more surface area. I contacted my Doctor to see what to do and if I should get the second dose.
Received 0.5 ml of Moderna 6mo-5 yr vaccine instead of 2 yr vaccine Moderate Pain at site of injection. No fever
The pt developed a fever of 102-103 deg F and was taken to ER and the child had a seizure in ER. Child is doing well.
Left foot went numb. Prickly numbness creeping up neck and around ears in waves causing near syncope. Also having simultaneous waves of tingling throughout buttocks to anus making the feeling of the need to move bowels. Short, frequent waves followed by short resolution and then it happened again for about 14 hours. Left foot numbness continues to be intermittent. On 11/14/13 the left hand went numb and continues to do so intermittently. Also have multiple areas of intermittent fasciculations, vibrations, muscles spasm to all areas of the body.
Information has been received from a 20 year old female who on 12-MAR-2007 was vaccinated with a dose of Pneumovax 23.  Within 48 hours, on approximately 14-MAR-2007 the patient developed hip and leg pains and on 16-MAR-2007 the symptoms were getting worse and she reported she felt like she had the flu.  She reportedly had flu like symptoms, fever and body aches.  She was instructed to contact her primary care doctor.  Additional information was not available.
product was reconstituted with 0.7ml of sterile water and administered/no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional and physician via call center via Agency (Reference number- 00898208).  This case is linked to case US-SA-2021SA420893(CLUSTER).  This case involves a 2-month-old male patient who received HIB (PRP/T) VACCINE [ActHIB] which was reconstituted with 0.7 ml of sterile water (product preparation error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  On 14-Dec-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot number: UJ636AAA and expiry date: 26-Feb-2023) via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose?"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Uncomplicated herpes zoster rash on right arm along the C5 and C6 dermatomes.
Patient presents today from the vaccine clinic with concerns for tongue swelling. She states she got her first dose of the Pfizer COVID vaccine today and shortly after developed some swelling in her tongue. She was given a dose of 25 mg of benadryl. She feels much better now that she is at the clinic and wonders if her tongue was just dry.
wanted to let someone know my symptoms developed a week and two days after the second Moderna vaccine.  Severe dizziness, vomiting and tired.  I slept for 36 hours straight and did not eat or drink during that time.   My issues are resolving on day five today I only have a slight amount of dizziness.  Thought it was odd it took so long to get the symptoms after the shot.  I had no ear issues and my blood pressure was normal.
Swollen tongue (glossitis) first noticeable around 4:30am on 12/9/2021. Took a full dosage of oral Benadryl at this time. By 6am swelling was bad enough that it prevented speech and eating. Drinking was still manageable, and breathing unhindered. Swelling began to reduce around 7am, and was no longer noticeable by 11am. Some soreness lingered until 7am 12/10/2021.
nauseous; terrible abdominal cramps; indigestion; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization administered in Hospital. Medical history included hypersensitivity, compromised immune status, respiratory disorder. There were no concomitant medications. The patient reported, she got the 1st dose of the vaccine yesterday and woke up today with terrible intestinal cramps, indigestion on 29Jan2021 15:30 and is nauseous on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for nauseous was unknown and for the other events it was not recovered. Follow-up attempts are completed. No further information is expected
developed lethargy 3 days later and found to have acute brainstem infarct on MRI
Scab @ inject site (size of tip of pen); redness 3" x 7: all redness sl raised; observed redness on 5JAN93 in evening;
lightheaded with injections, got vaccine in recliner BP 100/80 P 70 responded well to fluids
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Severe Headache - lasted all day from ~ 7 AM to 9 PM. Took NSAID at 9 PM.
On the night of the day of vaccine patient experienced head ache fever body ache and joint pain  which was treated with Motrin and bed rest.  Patient followed up with Dr next day still didn't feel better that evening and  was taken to the ER because symptoms got worse and was given stronger Motrin and Tylenol and was sent home. Symptoms continued for about a week and a half before he felt better.
15 yo patient received vaccine approved for ages 18 and up.  NO side effects or adverse reaction occurred.
No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.   On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 38 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 18-JAN-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) (route/site: intramuscular/deltoid) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (route/site: subcutaneous/"triage") at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from  the same reporter.; Sender's Comments:  US-009507513-2202USA008508: US-009507513-2202USA008507: US-009507513-2202USA008509:
A bump at the injection site; large round welt appeared at the injection site raised red hot to the touch and sore; large round welt appeared at the injection site raised red hot to the touch and sore; large round welt appeared at the injection site raised red hot to the touch and sore; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 14:00 (age at vaccination: 46 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included giant cell tumour of tendon sheath, PVNS in my right knee, knee arthroplasty and high blood pressure. Concomitant medication(s) included olmesartan. The patient had no known allergies. The patient had covid prior to vaccination. On 02Aug2021 19:00, slightly over 24 hours of receiving the vaccination, the patient started to have a bump at the injection site, large round welt appeared at the injection site raised red hot to the touch and sore. On 03Aug2021 at around 11AM (Tuesday morning) a large round welt appeared at the injection site raised red. The patient did not receive any treatment for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in physician's office visit. The patient was not diagnosed with covi-19 prior to vaccination nor was tested since vaccination. The outcome of all the events was unknown. The device date was 10Aug2021.   The lot number for the vaccine was not provided and will be requested during follow up.
Site: Swelling at Injection Site-Mild, Systemic: Joint Pain-Severe, Additional Details: pain in both knees, described as sharp pain when walking or running; worst first thing in the morning or after sitting for a while, then subsides, but still painful all day; wears copper brace to help with pain and going to see doctor when available appointment
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 at 12:00 as dose 1, single (Lot number: EN6198), in left arm, on 29Jun2021 at 13:00 as dose 2, single (Lot number: ER8732), in left arm and on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3198) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 23Dec2019 (unspecified if ongoing), notes: Considered himself a long hauler. On 23Dec2019, positive for COVID-19 was admitted. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine; Zofran, reaction(s): "known allergies: Zofran", notes: known allergies: Zofran. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2019) Positive. Therapeutic measures were taken as a result of drug ineffective and covid-19 with the treatment of Paxlovid 300 mg, 100 mg dose pack from 28Nov2022 to 03Dec2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300018632 Same reporter, patient; different vaccine dose and events;US-PFIZER INC-202300018630 Same reporter, patient; different vaccine dose and events;