chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 6 year old female with no allergies and medical history who on 08-OCT-2001 was vaccinated SQ with 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 638252/0225L). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). On 15-APR-2007, the patient developed chickenpox with 30 to 40 lesions. It was described as multiple papular vesicular lesions on the trunk, extremities, and scalp. There were also several lesions on patient's palate. The patient also experienced fever. Unspecified medical attention was sought and no lab diagnostic tests were performed. At the time of the report the patient still had chickenpox lesions. A product quality complaint was not involved. Additional information has been requested.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Facility called the morning of 08/03/21 and spoke to staff member on the medical team at Pfizer who gave the same information. Staff member was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
arms are still really sore on day four; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; Redness, swelling, itching at the injection site; severe muscle aches; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 10:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "allergies; Lisinopril". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer unknown), for covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 27Sep2023 at 16:00, outcome "recovering" and all described as "Redness, swelling, itching at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2023 at 16:00, outcome "not recovered", described as "arms are still really sore on day four"; CHILLS (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "chills "; MYALGIA (non-serious) with onset 27Sep2023 at 16:00, outcome "recovering", described as "severe muscle aches ". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema, vaccination site swelling, vaccination site pruritus, myalgia, chills.  Additional information: Facility type vaccine: Pharmacy or Drug Store. The patient had no other vaccine in four weeks and no other medication in two weeks No. The patient reported that this is the worse reaction of the five shots she had. Redness, swelling, itching at the injection site, severe muscle aches and chills and her arms are still really sore on day four.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient reported dizziness while in observation area.  EMS took a blood pressure of 90/58. Blood pressure did not improve and patient continued to feel symptomatic. City Fire Rescue was called for transport.
headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller had the first dose and experienced a headache, she wanted to know if she can take a pain reliever for it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Started feeling heart palpitations (heart pounding sensation) on the date indicated, accompanied by higher than normal blood pressure (132/74).  I exercise 4-5 times per week and my normal blood pressure is around 114/70.  Palpitations were so intense that I was unable to sleep and went to be evaluated at the emergency room.  I was referred to a cardiologist where I am still being evaluated.  Blood pressure normalized after about 5 days, but palpitations remain 3 weeks after their onset.  I am still awaiting the results of a heart monitor study.
Fever, chills, sore arm at injection site, red, raised swollen arm at injection site.
Patient received Moderna booster dose 11/5/21. Reported to have had "sore" arm 11/6/21; "cold like symptoms' 11/7/21 & 11/8/21; during early hours of 11/9/21, patient is said to have awoke during night with "heaviness to chest".
Pt recvd vax & 3 days p/vax exp flu-lke sx which resolved in 24 hrs;
Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
(L) lateral leg redness and swelling; warm at site. 9 1/2 cm X 8 1/2 cm
Legs were feeling warm/Warm sensations; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Legs were feeling warm/Warm sensations) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M0A) for COVID-19 vaccination.     The patient's past medical history included Mumps. Concurrent medical conditions included Blood sugar increased and Blood pressure high. Concomitant products included DILTIAZEM for Blood pressure high, METFORMIN for Sugar blood increased.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING HOT (Legs were feeling warm/Warm sensations). At the time of the report, FEELING HOT (Legs were feeling warm/Warm sensations) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-319681 (Patient Link).
24 hours s/p Hep B vaccine developed local redness and itching and swelling at injection site. Pt reports redness 3 inches. Also reported full body aches but no fever. Had HA. At 48 hours itching and swelling began to subside but red remaining about 3 inches at site of shot. Hard lump at site of shot. 72 hours redness "still there" "lump" resolving.
Mild soreness at injection site, nausea starting next morning and lasting about 2 hours,  achiness starting next morning and lasting about 12 hours, tiredness relieved by 3 hour "nap" about 24 hours after receiving vaccine.
Sour Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for Covid-19 Immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sour Throat". The event "sour throat" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: It was reported that patient did not had covid prior vaccination. Patient tested for covid post vaccination. No Known allergies was reported. No other medical history.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a health care professional on 26/Feb/2008.  A child experienced a seizure after receiving Daptacel.  The patient's recovery status was unknown at the time of the report.  No further information was provided.
Never received her second dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 6 months ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter reported that the patient started her Shingrix vaccine series over 6 months ago. The reporter stated that the patient never received her 2nd dose of Shingrix vaccine. The reporter wanted to know do we had to start over the series. No additional details were available. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
approx 10 of 200 pts exp adverse events p/recvd 1st Engerix-B; events included bronchospasm, conjunctivitis, h/a, muscle aches in arms & shoulders; No further information is abailable; THis case is considered to be invalid;
Patient has a 3" by 2 1/2" reddened/pink/bruised looking area, warm to touch. No fever. Patient had no cold sx when vaccine was given has cold symptoms on 5-19-11.
Patient states he had arm swelling, headache and chills that started roughly 24 hours after his second vaccination.  Forty-eight hours after his vaccine, Patent states he felt "hypothermic, really really cold and then had the sweats." This lasted for approx 12 hours
Mom indicated that just before bed that child developed a slight reddened area on right side of neck, just under his ear. He was scratching at it as well. He also developed right eyelid swelling and some chills. Mom administered Tylenol. In the morning the symptoms had improved but were still there, she gave him some Benadryl at that time.  and sent him to school.
Headache, soreness at the injection site, flu like symptoms, fatigue, loss of taste and smell, edema in foot. Healthcare provider has placed patient on oxygen.
Patient received injection on 10/3 and came into pharmacy today on 10/9 stated she had not had any soreness or redness until yesterday when she was at a scheduled dermatology appointment and showed to her physician during visit at which time the doctor gave her a sample of a topical steroid to try and suggested she come to show us the reaction site the site is red and somewhat fevered and did not appear this way until yesterday she states she does not believe she has been bitten by an insect and it is most likely a delayed reaction to the injection but is not sure
Employee states that she had shortness of breath, asked employee when it started she stated she has been under alot of stress and has had shortness of breath this pass week. Instructed employee to have seat in the breakroom until she was better.
feels just not right/ Foggy Brain; Light headedness; migraine headache; headache; Dizziness; sweating at night; back pain; general malaise; fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), MALAISE (general malaise), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating at night) and MIGRAINE (migraine headache) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dizziness and Night sweat. Concurrent medical conditions included Migraine. Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 04-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced BACK PAIN (back pain), MALAISE (general malaise), HYPERHIDROSIS (sweating at night) and PYREXIA (fever). On 06-Jun-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (headache). On 07-Jun-2021, the patient experienced MIGRAINE (migraine headache). On 08-Jun-2021, the patient experienced FEELING ABNORMAL (feels just not right/ Foggy Brain) and DIZZINESS (Light headedness). The patient was treated with IBUPROFEN on 07-Jun-2021 for Migraine headache, at a dose of 400 mg. At the time of the report, BACK PAIN (back pain), MALAISE (general malaise), DIZZINESS (Dizziness), HYPERHIDROSIS (sweating at night), MIGRAINE (migraine headache), FEELING ABNORMAL (feels just not right/ Foggy Brain), DIZZINESS (Light headedness), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.
Patient's arm became very sore and had radiating pain in her chest. Patient made appt with her PCP.
On January 6, 2021, exactly one week after receiving my first dose of the Moderna vaccine, I woke up to my injection site being red, swollen, hot, and itchy. The area of redness has gotten bigger each day and is still hot and itchy with induration.
Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
pt recv vax 14JUL95 & c/o joint pain, rash, t104 ER visit where mom stated MD has full blown case of measles; mom states had MMR 1 wk a/; MD documented viral vs 5th disease;
No additional AE reported.; one dose of VARlVAX was administered on 08/24/2021 following a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 24-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T027303, expiration date 12-AUG-2022, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis (product storage error ). The vaccine administered experienced temperature excursions of -10.7 degrees Celsius for 192 hours. No additional adverse event reported.
S&S: "not 100%", leg pains, lumbar pain, stiff neck, short-term memory loss; Vital signs were stable; denies vision changes, H/A (nonretractable to meds), balance changes, weakness, speech abnormalities. Tx: Patient educated on post COVID-19 syndrome, Tylenol for pain, pseudoephedrine for congestion, labs for Liver enzymes, discussed possible neurology referral, follow-up w/ PCM on 2/4/2021 (14 days after initial visit).
Vaccine that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 43 years 8 months.  No concomitant medications were reported. It was reported vaccine administrated beyond use date after the thaw process. There  was no adverse reaction noted or reported to us ever regarding these administration. No treatment medications were reported.
Pt is a 55 year old who received his first anthrax vaccination without any local adverse effects. On 2/15th, he received a smallpox vaccination as well "a whole bunch of shots." Approximately three weeks after receiving his vaccinations, while sitting in the "chow" hall after supper, he says, "my whole body started shaking and I felt weak." He was admitted to hospital where he received an EKG and a stress test. He was told that he had "flutters" and was kept overnight. The following morning he was told that both studies were normal and he was discharged. Approximately 1 week after he again experienced several episodes of "shaking and feeling weak," sometimes accompanied by SOB and pressure across his chest (5-6/10 on pain scale). He was seen there by medics and given a NTG that "helped" but did not completely relieve his chest discomfort. These episodes continued and he was airevacuated on 4/27th where a cardiac cath showed a high-grade mid-LAD stenosis. He was to be transferred to another hospital for a stent placement, but he began experiencing additional "left-sided chest pain" (1-2/10) and on 5/6th a PCI and stent of his mid-LAD lesion was performed. A "low-level exercise test" performed 5/8th showed normal hemodynamic response and no EKG changes or symptoms. He was admitted to hospital 5/9/03 and followed by Dr. -minimal amount of redness and swelling.
Systemic: convulsed immediately after getting shot, less than 10 sec, came to in less than 10 sec-Mild, Systemic: Seizure-Mild, Additional Details: he covulsed immediately after injection, staff got him on floor, he awoke in less than 10 sec and was completely aware, knew his name, where he was, and relatively the current time. We had him lay on floor with feet up,  he said he felt fine, had normal blood pressure 142/88 hr 89, when emt arrived he felt lightheaded so they took him to hospital, He said no history of seizures, but said does pass out and do this after injections.
Patient in for Moderna booster 0.25 ml dose. Nurse drew up and gave 0.02ml dose. Patient returned from waiting area and given full 0.25ml dose
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On 29-AUG-2014, an unspecified number of patients had received improperly stored doses of PNEUMOVAX23 (dose, frequency, route and lot # unknown). No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Menstrual cycle has been prolonged & now having spotting & cramps.  My entire life I have always been regular & this is the very 1st time I experience a 12 day cycle and still spotting & having cramps.
ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED  IN ICU  PER DAUGHTER FOUND have 2 ANEURYSMS.
Headaches 1/23-24/2021 Sore Arm 1/22-25/2021 Extreme lower back pain 1/23/2021 Chills and aches 1/23-24/2021
Patient called and said his arm was sore and his hand felt weak. He said the pain started on Saturday morning - he received the vaccine on Friday afternoon.
Five min. after injection: Pulse raced for short period of time (15 sec),  during that time felt pressure in left wrist, later that day experienced large bruise on the on the left wrist,
LMP, 03/02/2021 Miscarriage, 05/2021
headaches, chills right after vaccination. chills resolved but headaches lasted for 4-5 days