chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 patients received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported. Date the vial was initially stored in the refrigerator: 13Sep2021 Date(s) of administration of vaccine: 14Oct2021 through the 21Oct2021 included.
Fever; body aches; chills; hives on stomach; itching on hands.  Missed 1 day of work
Headache; chills; muscle aches; fatigue; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Jan2023 at 12:45 as dose 1 (bivalent), single (Lot number: GJ5342), in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "COPD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: TRELEGY.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 03Jan2023 at 12:45, outcome "unknown", described as "Wrong vaccine administered"; HEADACHE (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; CHILLS (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; FATIGUE (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered"; MYALGIA (non-serious) with onset 04Jan2023 at 08:30, outcome "not recovered", described as "muscle aches". Therapeutic measures were not taken as a result of headache, chills, myalgia, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
on 7/12/21 patient noticed swollen gland in right submandibular region, with mild fever off 100F last night. Patient noticed an increase in the size of gland overnight.
A node under my right armpit has swollen. It is about the size of a golf ball. It makes it hard to raise or use my right arm. The pain is in the side of my breast up my armpit and down to my elbow. I am using Ibuprofen and Acetaminophen, Hot compress and resting. Ive also alerted my care team. I am also keeping track of the size to make sure it does not get bigger.
12/19 - onset of abdominal pain which is like her usual chronic necrotizing pancreatitis which she has had off and on for 10 years. This was accompanied by nausea. The pain & nausea last for about 3 hours. 12/20 - nausea and diarrhea. Today 12/21 she reports that she has recurrence of the abdominal pain, nausea, and feels hot. She is at work today. Advised to contact her physician for assessment and treatment as needed. Will follow-up with her
Dose administered was 0.5 ml from a vial of expired MMR. Expiration date was 12/4/2019. Patient was observed for 30 minutes plus and no adverse reactions were noted or reported by patient. Discharged at 4 pm in stable condition with instructions to return to Student Health or go to nearest Emergency Room if any adverse events occur as noted on Vis dated 8/15/19. I contact Merck - spoke with RN - reported incident. He confirmed that Merck internal data supported the potency of the vaccine under the conditions I explained to him & vaccine storage recorded. Merck Case # 01465644 was created by RN. I contacted regional director of Dept. of Health & reported the incident. As of this report, the patient has not returned to report any adverse effects. MMR Vaccine has been pulled & discarded from vaccine supplies. Procedure reviewed in house & additional staff training implemented. Patients IgG titer confirmed measles immunity from 1st dose administered in 1999. No further MMR vaccination recommended.
About 4 and a half hours later, my arm really began to hurt. It lasted for two days. I could barely bend my arm at one point.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Pt had small vaccine 2weeks ago 4/15/03.  Scab fell off 2wks after.  Began rash this am 5/1/03, some of rash has blisters.  Pt states resembles chickenpox, no c/o itchin & has scratched.  Rash on arms, back, legs and face.
Left arm red & swollen. Red area about 4 inches long, 2-3 wide. Rash all chest and breasts to top of belly
Felt like had the flu; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vacination was not reported. The patient stated that, after vaccination with dose of Shingrix, felt like had the flu. The patient asked, if it was ok, that her husband wanted to get Shingrix shot at the same time of his flu shot. The patient stated that, her husband received Pneumovax, 2 weeks ago and said to wait 4 weeks to get Shingix shot.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite of being fully vaccinated with two doses of Pfizer and receiving a booster from Pfizer on 09/20/2021.
Pt got Moderna Booster @ 1:21pm. Pt c/o swelling of tongue . pt stated she had similar reaction to 1 st dose of Moderna. gave Pt Benadryl 25mg @ 1:37- pm . took vital signs @ 1:37pm . pt vitals were BP 174/115 Spo2 94% and pulse rate 112.   I retook vitals signs @ 1:51pm Vitals were BP 151/106 Sp02 95% and Pulse rate 96. after 30 minutes of monitoring pt stated she was feeling better she stated her tongue was feeling better. she was released  and advice to follow up with Primary Physician regarding Hypertension.
Developed bright red rash, on face, legs, buttock and maculopapular rash on chest anter body within minutes after vaccines given. Rash resolved spontaneously in 15-20 min.
Nurse was pulling out needle from vial after dilution for pediatric Pfizer COVID 19 Vaccine (5-11 y/o) and another Nurse noticed the syringe that Nurse 1 used to dilute was a 5 cc syringe not a 3 cc syringe. Therefore, the vaccine was diluted with 1.6 mL NS not 1.3 mL. One vial had previously been diluted with the same syringe in the morning session and 10 vaccines were given. Parents of the children who received the vaccine in AM session will be called and notified. Provider, Supervisor and Nurse Manager were notified. Pfizer and COVID Call Centers were called/consulted; both gave the CDC resources/instructions (COVID-19 Vaccine-Administration Errors and Deviations) that states, for this diluent error/deviations ?do not repeat the 1st dose? and they recommended that children receive their second dose as scheduled. Second vial was wasted with 10 doses.
After getting the vaccine, I had a sore arm; Joints are hurting but that is not due to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After getting the vaccine, I had a sore arm) and ARTHRALGIA (Joints are hurting but that is not due to the vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, METHOTREXATE.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (After getting the vaccine, I had a sore arm) and ARTHRALGIA (Joints are hurting but that is not due to the vaccine). At the time of the report, VACCINATION SITE PAIN (After getting the vaccine, I had a sore arm) and ARTHRALGIA (Joints are hurting but that is not due to the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Prolonged soreness in arm. Her arm is still sore. She also stated that she had a white patchy area over injection site.
body aches, headache, cough, chills, fever and nasal congestion  Advised patient to hydrate, Tylenol for fever body aches
evening of 12SEP t104 was on amoxil till 12SEP for redness several loose stools;had inc occipital nodes;sl macular discrete rash on ears & face confluent rash;eardrums red w/no light reflex;gen macular sl confluent rash;
After an arterial catheterization, a blood clot developed in my forearm, about an hour later.
A male patient (age not reported) complained of "feeling off", muscle aches and a "weird taste" in his mouth since he received FLUZONE SV 2008-2009 (lot number unknown, route/site of administration not reported) a few weeks ago. The patient declined to provide any additional information until he follows up with his physician. At the time of the report, the patient had not recovered. Documents held by sender: None.
Rash on neck and chest; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 67-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 30Jan2021 at 08:00 at 67-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 09Jan2021 at 67-years-old (lot number=EL1284; vaccine location=Left arm; first dose; administration time: 08:00).  On 31Jan2021 at 21:00, the patient experienced rash on neck and chest (non-serious). The clinical outcome of the event, rash on neck and chest, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received, updated reporter details.
From initial info received on 6/28/05 from a physician regarding an adverse event occurring in the USA, it was reported that an 18 year old male pt received his 1st dose of Menactra, lot U1659AA, administered IM in the right deltoid, a dose of Tubersol 5 TU, lot C207AA, administered ID in the left forearm and a dose of hepatitis A vaccine, lot M1090D, administered in the left deltoid on 6/17/05. Eleven days later, on the morning of 6/28/05, the pt developed generalized purpura. The pt was seen by a physician. It is unknown at this time whether the pt recovered from this event.
This spontaneous report as received from a registered nurse refers to a 54 year old female patient. On 15-AUG-2013 the patient was vaccinated with M-M-R II (lot number, dose, site, indication unspecified) by the intramuscular route. "Now" on 23-AUG-2013, the patient felt like she was getting a sinus infection. The outcome of sinus infection was reported as not recovered/not resolved. It was unspecified if the patient had sought medical attention. Additional information has been requested.
I had muscle aches, chills, fatigue, headache. All symptoms were mild. They lasted for about 24 hours after starting, or about 36 hrs after receiving the vaccine.
I had a low-grade fever and fatigue after the vaccine for 24 hours.  On 06/14/2022 I wasn't feeling well with a runny nose, cough and a low-grade fever. I tested positive for COVID-19 with a home test on 06/15/2022. I visited a medical clinic and was prescribed an antibiotic, something for the cough and a nasal spray.
The day after the shot I began having severe abdominal pain, muscle and nerve pain, and shortness of breath. The abdominal, muscle, and nerve pain began at around 10:00am. The shortness of breath began around 2:00-3:00 in the afternoon and lasted for 30-45 mins (longer than the 20mins listed in the attending ER physician's report), at which point my wife called for an ambulance and I was taken to the emergency room of Hospital. I was prescribed diphenhydrAMINE injection 25 mg, droperidoL injection 1.25 mg, ketorolac injection 15 mg, and another pain killer by the paramedics that I do not see listed in the record.   Although not to the same degree, I have continued to have gastrointestinal cramping since the second vaccination. This is a worsening of a condition (IBS) that I had previously, but which had mostly been in remission since beginning Mirtazapine in Fall 2019 subsequent to a heart attack on 8/7/19. I am meeting with my primary physician, Droctor, on 5/10/21 and contacted, my gastroenterologist, on 5/5/21.
First and second doses-sore arm and redness around injection site Second dose-severe headache, fatigue, and weakness for 3 days following vaccination
Had a lump started right after injection, but on 1/28/21 lump grew to baseball size, it is red, warm to the touch, and itchy.
Pt rec'd 1st dose (deltoid) on 22AUG90; W/in less than 24 hrs post vax developed vaginitis yeast infect; Treated w/"anti yeast/fungal cream" & condition resolved p/7 to 10 days; 2nd & third doses are "on hold."
Wrong vaccine administured; No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event). On 02-Dec-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administured).    Concomitant and treatment medications were not reported.  Company Comment: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced non serious unexpected Maternal exposure during pregnancy with No adverse event that occurred in association with second dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine. Additionally, Wrong product administered was also noted as non- serious unexpected event. No further details on Last menstrual period/Expected date of delivery, gestation period, lab test results were available. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.      Reporter did not allow further contact
Swelling, redness, tenderness at injection site; onset 2-4 hours after injection. Persistent 5 cm square reaction on 12/28/07.
Initial and follow-up information has been received from a registered nurse concerning a 23 year old female patient who on 26-SEP-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 659487/1960U) 0.5 mL "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). The patient developed severe local injection site reactions and arm pain. On 03-OCT-2008 the patient developed lymph nodes swollen with pain in arm, elbow and shoulder, which waked her at night. On 13-OCT-2008, the patient developed hives. The patient was given BENADRYL, ZYRTEC and prednisone. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Gradual hair thinning starting the month after Hepatits A booster was given.  Within 4 months she had total hair loss, including eye brows and eyelashes.  Looking back she had been hospitalized for digestive problems (constant diarrhea) that appeared in November of 2008.  This happened a month after her first Hep A vaccine.  She recovered completely from the digestive problems but then after the second shot she ended up with all over body hair loss.  It has been 8 months now and the hair has not returned.  No one in her family has this type of hair loss.  Other than these two health problems she has always been healthy.
The antibodies in my body is just dropping more than half, 50% after six months.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2021 (Lot number: EL3247) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN B COMPLEX. Vaccination history included: Bnt162b2 (Dose:1, Lot/batch: EL0142), administration date: 30Dec2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: DECREASED IMMUNE RESPONSIVENESS (non-serious), outcome "unknown", described as "The antibodies in my body is just dropping more than half, 50% after six months.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was healthy. Patient reported six months ago on 20Jan, she got the second shot from Pfizer and after a couple of weeks, when she got the blood work for her primary care, she tested antibody cells was as coming, that was 298. Thats the number and then after six months like, last week, not even six months, she got back to the routine checkup and she also had test on antibody test, it was about to 127. It was further reported that she used to take vitamin C vitamin B, multi vitamins and Lipitor (not further clarified) thats for her cholesterol 10mg and then after that for couple of month she was not taking any vitamin. On 21Feb2021, she had the antibodies 293 and got the blood work on 17Jun, her antibodies were going down to 127.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Pt developed red warm area in left arm approx 7 x 7cm around vaccine site. Cellulitis vs fat necrosis vs allergic reaction.
Since Monday I have had random heart palpitations and feel like I?m going to pass out. Over the week they have happened less and less. On Monday I had them around 30 times and now it is just a few times a day.
Information has been received form a physician concerning his 33 year old daughter who had been vaccinated with GARDASIL series. During one of the GARDASIL vaccination (unspecified which dose), she developed syncope. She had sought medical attention and had recovered from syncope. No further information is available.
3 days p/vax soreness of arm from fingers to elbow-inc 4-5 days w/extreme pressure & burning all the way to the shoulder-strength reduced by approx 2/3.