chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) had resolved. At the time of the report, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  The refrigeration date was 07-May-2021.   This case was linked to MOD-2021-364649 (Patient Link).
Pt recvd hep B vax;1st 2 doses were Recombivax;3rd dose 21MAR90 was Engerix-B.Test results 01MAY90 were neg for HBSAB.Addt'l dose of Engerix-B given 27MAY90;test results 12JUN90 were pos for HBSAB.
This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of oral, ROTATEQ undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Patient had been seen 2/28/08 for otitis media.  She was seen 3/8/08 for well-child exam, she was afebrile and ear exam normal despite not completing Augmentin.  1 y/o vaccines given.  That evening she developed fever.  On 3/10/08 she had a seizure lasting 6-7 minutes.  She was taken to medical center and diagnosed with febrile seizure.  No labs or imaging done.
Right deltoid 4.5 inch annular area, warm, raised. Uniform in color, reddened. Complain of tenderness, itching and burning. Over the counter Ibuprofen and Ice.
Patient received the flu shot on 8/18 at an offsite clinic. Patient reported to pharmacy on 9/1 stating that she has still been experiencing vaccine-induced shoulder injury which consists of pain and limited range of motion.
4" x 3" area of swelling, hard, red, hot to touch at injection site.  First appeared within 24 hours of injection.  Course of 4 days. Treated with ice packs.
I was hospitalized in April of 2021 with cellulitis and Sepsis. I was under the care of a Cardiologist. I have been hospitalized from 08/12/2021 until 08/18/2021. since I received the first dose of the vaccine. I started to feel heat and swelling in my face about 36 hours after the vaccine. It was like hot flashes and I did not feel well. When I looked in the mirror my face was red and swollen and my throat, mouth and lips were uncomfortable. I was treated with Benadryl and Xanax and released. During the week after that I was skin tested by a doctor and that night my legs and arms started shake and I was feeling hot flashes all over my chest and my arms and legs. On 08/12/2021 I was taken by ambulance to the hospital, and they packed me with ice. I was treated with Benadryl,, Xanax and they did a lot of testing. I was supposed to go back for the follow up on my scratch testing for the skin test, but I was in the hospital. After I was released, I was very depressed and started to have another allergic attack and returned to the hospital on 08/21/2021 and they did cardiac testing. My blood pressure has been under control since this started. I have not received the second dose under advice of my doctor.
The night of the vaccine, patient experienced severe fatigue which she described as similar to coming out of anesthesia. She also felt faint and reports that she had a pulse of 172 when she checked.  She also noticed she had pinpoint  pupils with normal room lighting.
Unexpected menstrual bleeding, light. I do not bleed during my menstrual cycle due to my IUD. The morning after my first pfeizer Covid vaccine, I woke up with spotting. Flow was manageable using a panty liner, and lasted only through the early afternoon. No bleeding the next day.   Initial assumption was that the spotting was due to my IUD nearing its expiration date, but no spotting occurred the next month.   No spotting occurred with the second vaccine shot.
pt recv vax 4AUG95 & MAY97 pt devel chickenpox consisting approx 100 lesions w/a low grade fever;
Approximately 5 minutes after receiving the vaccine the patient began to feel dizzy, felt like she could not breathe and state her throat felt tight.  She was given Adrenaline 0.5ml (0.5mg) IM and Benadryl 50mg IM and 911 was called.  EMS arrived shortly and she was transported to the local Emergency Room.
Headache; soreness in the injection site; chills; soreness on the right side of neck; swollen lymph nodes on right side of neck; nausea; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in left arm on 16Dec2020 16:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included paracetamol (TYLENOL) and birth control pills, multivitamins taken within 2 weeks of vaccination. The patient experienced headache, soreness in the injection site, chills, soreness on the right side of neck, swollen lymph nodes on right side of neck, nausea all on 17Dec2020 08:00 with outcome of not recovered. The patient did not receive treatment.
started not feeling well on Tuesday with a lot of Covid side effects; This is a spontaneous report from a contactable consumer (patient's wife) via a male patient (reporter husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient started not feeling well on Tuesday with a lot of COVID side effects. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
got shingles they both had the vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported as follows: The patient got Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR184272, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR184272:same reporter
Anthrax vaccination to R deltoid. R arm became swollen approximately 1-2 days later and remained swollen and slightly red for 1 week-10 days. No fever, no HA, no N/V.
fever & irritability; adm to ER; poss aseptic meningitis; more details requested;
I was 8 weeks pregnant when I received the Moderna shot. My only symptom was a sore arm the day of the injection. At ten weeks I went to the doctor for an ultrasound. They found that the fetus was measuring at 8 weeks and there was no heartbeat detected.  This is my second pregnancy and there was no issues with pregnancy or delivery previously.
At approximately 2:04pm patient stated she was dizzy and would like to lie on gurney.   Assisted to gurney, VS 90/58 ,p 111- 97%, resp 16 Denies medical issues, DM, takes no medications and mom who is with Pt confirms this.  Rested for 5 min and states feels better and no longer dizzy.  VS 96/60 p 99-97%, Resp 14.  Apple juice provided.  Pt states has hx of "fainting" with blood draws. Advised to  request to lie down when returns for 2nd vaccine.  Pt states feeling better and ambulated with steady gate to car with mom at side.
No other AEs; HCP confirmed this vaccine was administered on 11MAY2023 after the temperature excursion; This spontaneous report was received from a Registered Nurse (R. N.) regarding to a patient of unspecified age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 11-MAY-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 time dose, lot #1938950, expiration date: 31-MAR-2024 (dosage regimen was not provided) administered orally as prophylaxis (product storage error).  The improperly stored vaccine dose underwent temperature excursions of 1.8 degrees Celsius (C) for 0 hours 9 minutes and 0 seconds, 1.3 C for 1 hour 12 minutes and 0 seconds and 1.2 C for 1 hour 58 minutes and 0 seconds without previous excursions. No other adverse events were reported.; Sender's Comments:  US-009507513-2305USA006001:
Developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) outcome was unknown.            Treatment details included Anti-viral medication.   Reporter did not allow further contact
Severe tinnitus, hearing loss, acoustic neuroma. I will forward medical report upon request. Head pain, anxiety, nosebleeds.  Annual follow up on 01/28/04: "Pt did not recover from adverse events. Very severe tinnitus which has made my life a living hell! I am suffering greatly from the severe tinnitus!
February 3rd, I started getting diarrhea and had to take two Imodium, I had blood in my stool and was vomiting up bile as well. I went to the hospital on Friday the 5th of February. They said it was probably a colon infection, they did not know. But it was the first time ever I thought I was going to die. I had straight blood coming out of my rectum and I was sitting on the toilet with the room spinning. They gave me two strong medications; I cannot remember what and after about a week after the medications I was feeling better. I am still achy and tired in my body though. I get wore out faster than I usually would. I have not had any bloody diarrhea since then though. I do not feel myself, don't want to go for walks like I used to or anything like that. Physically I am not as strong since getting the vaccine.
This case was reported by a nurse and described an adult male pt who did not respond to the hep b vaccine recombinant (Engerix B). The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the pt received the third dose of Engerix B (lot ENG5446A4). On an unspecified date approx one to two months later, a hep B surface antibody titer was negative.
Kidney infection Bladder infection UTI Fever of 104.8° Sore arm for months.  Abnormal menstrual cycles Abnormal uterine fluid Abnormal uterine bleeding and hemorrhages Infertility
I had all of the common side effects of getting vaccinated, headache, muscle pain, drowsiness etc. Then around 12hrs later I started having a light allergic reaction. I got hives on the right arm (injection arm) and itchiness around my whole body (top of head, arms, legs) I took a Benadryl and put some Benadryl anti itch cream on the hives and all symptoms stopped.
Patient states started feeling ill on 9/21/21 with chest tightness, dry cough and overall achiness. Tested on 9/24, and positive results on 9/26/21. Patient's husband tested positive on 9/23/21
This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients (husband and wife). This is 2nd of 2 reports. A 74-year-old female patient received the 1st dose of PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included immunocompromised. The concomitant medications were not reported. The patient experienced cancer on an unspecified date with outcome of unknown. The reporter wanted to know the patients should receive a second dose of PREVNAR 13, since  immunocompromised. Information on the batch number has been requested.; Sender's Comments: Cancer is unrelated to the vaccination with PREVNAR 13 representing an intercurrent malignancy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate..,Linked Report(s) : US-PFIZER INC-2018421231 same reporter/product/event, different patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 1, single (Lot number: FJ1614) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing); "childhood bronchitis" (unspecified if ongoing); "regular allergies" (unspecified if ongoing); "Known allergies: sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 cannot be excluded.  This case will be reassessed should additional information become available.
had to have surgery; This spontaneous case was reported by a pharmacist and describes the occurrence of SURGERY (had to have surgery) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-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 SURGERY (had to have surgery). At the time of the report, SURGERY (had to have surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.  The physician did want the patient to get the next dose until after they are healed. Today is the first day the patient can receive the dose, but other patients are scheduled to receive their second dose also. The patient will be outside the 42-day window
9/22/2023 ''I had a flu shot 2 weeks ago, and it was the  most painful shot I ever had. It was painful when she put the needle in and  then when she pushed the plunger it was very painful all the way from my shoulder to my hand.'' Patient states reports the pain as 4/10 constant, more so at night. In addition, ''If I touch at the joint at the top of my shoulder it is painful 4/10 tender.''  States no redness, no swelling, no swollen glands in the axilla. Reports he is  able to move the shoulder normally, but the pain is there and worsens after use during the day. I have tried to call him to f/u but cannot reach him.  Will try again.
This spontaneous report as received from a other health professional (registered nurse) refers to an unspecified patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with VAQTA (dose, route and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient was administered improperly stored VAQTA. No adverse effects reported. Product quality complaint was not reported. Additional information has been requested.
Continual fatigue, gastro intestinal pain, nausea and headaches since 2 April 2021, starting at 11:30 am.
Breakthrough case admission after three vaccines Moderna 1/28/21 Lot# 031L20A;  Moderna 2/24/21 Lot# 016M20A;  Moderna 12/9/21 Lot# 012H21B
Angioedema 6 days after the vaccine pt had swelling on left arm and left side of neck that lasted for 3 days
Pfizer Covid-19 vaccine booster dose administered around 90 minutes beyond syringe expiration time of 11:30am (ie, over 6 hrs after vaccine mixed).
The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date; Received expired 2nd booster vaccine beyond MFG Expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  On 19-MAY-2022, the vial was initially stored in the refrigerator and on same date the vial were administrated to the patient. The vial did not undergo any temperature excursions. The patient received expired 2nd booster vaccine beyond manufacturing expiry date.
injection site warm to the touch; painful injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma (Melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-676548, MOD-2022-676549, MOD-2022-676551 (Patient Link).
High fever between 102f and 104f while taking 400mg of ibuprofen lasting for 24 hours
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that the patient received a first dose of VAQTA on 02-JAN-2014 and a second dose of VAQTA (25/0.5 U/ml) on 31-MAR-2014. No adverse symptoms reported. No PQC involved. Additional information has been requested.
Case number PHEH2012US015559 is an initial spontaneous report received from a nurse on 03 Aug 2012. This report refers to multiple patients whose identifiers were not reported. It was reported that these patients received intramuscular dose of MENVEO (batch number: M11047) that had been exposed to temperatures of minus 2.5 degree C for up to two weeks. No adverse event was reported following the maladministration. No further information was provided.
Upon reviewing documents  - pt statest it was there booster dose - but review shows database has no documentation of 2nd dose.  Only 1st and booster .25 recieved.
blisters; fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (spouse) reported that a male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient developed blisters and fever after having his first dose. He took Valacyclovir for the events. His next supposed dose will be on 26Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.