chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose 1: 05-Jun-2023 and Dose 2: 10-Jul-2023; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 05-Jun-2023 and Dose 2: 10-Jul-2023) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7647B and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 10-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 05-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On 10-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 05-Jun-2023 and Dose 2: 10-Jul-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 05-Jun-2023 and Dose 2: 10-Jul-2023) 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 WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 05-Jun-2023 and Dose 2: 10-Jul-2023).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
1010 Lightheadness, 1st vaccine reports Hx of HTN did not take meds. BP 160/88,HR 66,sats 99%, Resp 16. 1024 symptoms resolved. States she feels ok to go home refused BP states she will go take her meds. S/S to seek immediate Care for reviewed. She verbalized understanding. Left ambulating for home.
shingles in my right eye/ Suspected vacciantion failure; shingles in my right eye; blurred vision; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 23-JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced blurred vision (Verbatim: blurred vision). On an unknown date, the patient experienced vaccination failure (Verbatim: shingles in my right eye/ Suspected vacciantion failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in my right eye) (serious criteria GSK medically significant). The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and blurred vision were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and blurred vision to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and blurred vision to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-Jun-2023 The case was received from the patient via interactive digital media. The patient stated that had the shingles shot. The patient stated that on the day of reporting, he or she woke up with blurred vision. The patient called his or her ophthalmologist and was seen immediately. The patient was taking an anti viral pill for shingles in his or her right eye. The ophthalmologist will see the patient again in two days. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
8/18/21 Intense pain in upper left back near his shoulder blade, which made it hard to breath. The pain continued for 6+ days with soreness for a full week after that. On the first morning after symptoms started (8/19/21), we took him to get a chest x-ray to check his lungs, which were clear and also took him in to the Pediatrician for evaluation. Pediatrician waited a few days to suggest additional testing, which is recorded below.  8/20/21 High fever of 102.7, tested negative for Covid-19 (tested due to fever)  8/24/21 Urinalysis results were normal except for transitional high Urobilinogen at 2.0 mg/dL.  8/25/21 Blood panel was mostly within normal range except for high inflammation markers (CRP 88mg/L, ESR 53mm/hr).  9/2/21 Repeat Blood panel showed that inflammation markers had dropped to just above normal (CRP 8mg/L, ESR 17mm/hr).  Because inflammation markers dropped and pain had mostly dissipated by that time (9/2/21), the Pediatrician did not order any further testing. Her conclusion was that the inflammation was most likely due to the vaccine.
Patient was given the DTaP vaccine on 10-13-2010 at around 4:00pm. At around 1:00am on 10-14-2010 he woke up with a fever of 103 and the shivers. He also vomited 3 times and had 47 breaths per minute. Due to his fast breathing and his pre-existing asthma the nurse advised to bring him in to emergency where he was seen.
This spontaneous report was received from patient of unknown age and gender reporting on itself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2015, (also reported as "about two and a half years ago") the patient was vaccinated with a primary dose of VAQTA, intramuscularly for prophylaxis (dose, lot number and expiration date were not reported) prior to going on a vacation. It was reported that the patient did not return for booster dose of VAQTA. No adverse reaction reported.
Headache dizziness  Warm  Feverish feeling but never developed. Elevated blood pressure with no history or diagnosis of hypertension. Painful swollen lymph node under arm vaccine was given
FEVER 101, TIRED, RASH NOTICED ON INJECTION SITE 08/10/2015. CLINIC NOTIFIED- MONITORING.
pt recv vax 2JAN96 & pt devel chickenpox w/over 100 lesions;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 2:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 75.93 years. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and at 10:00 PM with temperature 32 degrees Fahrenheit. The vial was initially moved to the fridge on 29-Sep-2021 and 05-Oct-2021 and proposed beyond use date was 29-Oct-2021 and 05-Nov-2021. Product moved to clinic on 27-Oct-2021. 20 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
approximately 48 hours after receiving the first Pfizer Covid vaccine I noticed a small area of redness on my left clavicle near my shoulder, it was red and itchy.  Just thought it was dry skin and used some Eucerin lotion.  Over the next 3-4 days this redness spread across my chest and down toward my breast.  It became more red, itchy and irritated and started spreading up my neck. This went on for a few weeks and just thought it was dry skin irritation.  When the rash became more raised and looked almost like hives I checked in with  our clinic Family Practice doctor as my regular provider was out of the office.  It was about time for my second Pfizer Covid vaccine and I hesitated to get another shot with this rash getting worse.  Dr.  has started me on Mometasone Cream twice daily along with Benadryl and or Zyrtec for the itching.  The rash is fading and tolerable as of 1/21/21 but still remains.
Chicken pox started 4/28/04. Treated for Strep Pharyngitis 4/27/04.
Patient experience a pain in shoulder lasting longer than a week, went to orthopedic doctor and received a steroid shot following an MRI.
Dose 2 01/30/2021  Aoubt 3 months later,  April 22, 2021, Acute low GI didtress, abdominal pain and blooting saw phyician who did intial evaluation ordered CAT scan and order, CBC, Urinalisis, Creatimime and Abdominal Pelvis CT scan then had another visit for followup the following week Cordizal Amyalsc was order Metabolic panel and CBC. Prescription prescibed  Simethicon 80mg every six hours as needed. On Percobet / 5/325mg 1 tablet every eight hours as needed. Was able to be full recovered by 07/01/2021
Parents noticed redness in AM 6/22/11 the size of a dime. It felt warm to the touch and itch. Now 6.5 cm wide x 7.0 cm tall, erythematous & warm. Still itches. No pain.
Skin discoloration; Shingle; Pain on his lower left side close to his torso; Rash on his lower left side close to his torso; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Skin discoloration), HERPES ZOSTER (Shingle), PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discoloration), HERPES ZOSTER (Shingle), PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso). On 27-Mar-2021, PAIN (Pain on his lower left side close to his torso) and RASH (Rash on his lower left side close to his torso) had resolved. On 29-Mar-2021, HERPES ZOSTER (Shingle) had resolved. On 23-Apr-2021, SKIN DISCOLOURATION (Skin discoloration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication included Valtrex.
Numbness in arm within 15 minutes of injection, coldness in fingers on right arm for approximately 1 hour after injection.
I developed high blood pressure of 160/97 on 1/7/22 and went to immediacenter/er.  I received the booster shot on 1/5/22.
Started with general malaise in early evening day of shot, then chills, 101.5 fever, nausea, vomiting, and then next day developed diarrhea. Unable to eat normally until Friday evening without feeling nauseous. Unable to resume normal work duties until Friday and still then not feeling quite right. Still tired on Saturday.
pain; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm and accidental underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Welts; Allergy to vaccine; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) (manufacturer report number: 2019128091).  This case involves adult patient of unknown demographics (174.998 kg) who experienced welts and allergy to vaccine, while he/she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious welts (urticaria) and allergy to vaccine following the administration of TETANUS TOXOID.  No Lab data was reported.  Final diagnosis was allergy to vaccine and welts.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for welts and for allergy to vaccine.  Documents held by the sender: none.
Dizziness & nausea - feeling faint approximately 20 min after vaccination. Several hours later: weakness, fatigue, loss of appetite, severe arm and shoulder muscle pain - swollen. Unable to lift my left arm without severe pain. Moderate fever. fast heartbeat. I did not go to the doctor as I thought symptoms might pass. As of 11/20/2016 most symptoms gone except for fatigue and mild shoulder pain. I can now lift my arm with slight pain. I took Aleve and applied ice pack and then heat to my shoulder. Not much relief from either.  I have never had this kind of reaction from a vaccination. I have not informed my doctor or the pharmacy.
Patient received the incorrect dosage of Jynneos. He received 0.1ml subcutaneously, instead of 0.5ml.  Patient denies any adverse effects or feeling unwell. He was scheduled to return for the corrected injection, but was a no-show for the appointment. Administering RN was retrained and demonstrated back the correct techniuqe and dosage per route.
awoke this morning with ringing in right ear, ear clogging (same ear), minor right side sinus headache,
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Redness swelling (softball size) itching, painful to move, oozing, blistered.
She experienced small, sharp pains in the chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (She experienced small, sharp pains in the chest) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She experienced small, sharp pains in the chest). At the time of the report, CHEST PAIN (She experienced small, sharp pains in the chest) had resolved.            No Concomitant product use was reported.  The patient reported after receiving the Moderna booster dose the patient experienced small, sharp pains in the chest that went away. It was unknown if the IM injection was given into the left or right deltoid.  No treatment information was provided.   This case was linked to MOD-2022-440060 (Patient Link).
6 days after vaccination for Yellow Fever, Hep A, Hep B, and meningitis, patient experienced pre-flu like symptoms, somewhat achy all over, light-headed, looked pale. No fever. Symptoms lasted for about 36 hours.
Mild papular rash across chest which progressed over 4 days before reporting.  also c/o sore throat, fatigue, mild appetite loss. States had similar reaction, only worse, following MMR #1 on 8/1/12, but did not report at that time or before dose 2 was given. States rash progressed to abdomen and back, and lost 5 lbs due to anorexia following that dose.
HEADACHE; ARM SORENESS; FELT ELECTRIFYING; FELT THE MEDICINE GOING INTO THE  MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included fiber myalgia in arms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180525, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 14:40 for prophylactic vaccination on left arm. No concomitant medications were reported. On 19-MAR-2021, the subject experienced felt electrifying. On 19-MAR-2021, the subject experienced felt the medicine going into the muscle. On 21-MAR-2021, the subject experienced arm soreness. On 24-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt electrifying, and felt the medicine going into the muscle on 19-MAR-2021, and had not recovered from headache, and arm soreness. This report was non-serious.
After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had "bumps on the inside of my mouth "and "it took 7-10 days for the cold blisters to go away.; bumps "inside my mouth are still there and the size of kidney beans; After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had "bumps on the inside of my mouth "and "it took 7-10 days for the cold blisters to go away.; This is a spontaneous report from a contactable consumer (the patient). This is one of the 2 report of same patient. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiration date: Unknown), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported "After my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth (oral mucosal blistering and lip blister). I had "bumps on the inside of my mouth" (Aphthous ulcer) and "it took 7-10 days for the cold blisters to go away". He used Abbreva which was expensive." The caller stated the bumps "inside my mouth are still there and the size of kidney beans. The patient received treatment. Outcome of the events oral mucosal blistering and lip blister was recovered on unknown date in 2021 and the event aphthous ulcer was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headache, body aches, fever started 12 hours after the vaccination.  The symptoms last for 36 hours.  I took Tylenol and Advil which helped enough so I could get out of bed and try to eat.
Administered past the 30 day refrigeration time; Temperature changes (in F): 41-42; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Temperature changes (in F): 41-42) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, 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 experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Temperature changes (in F): 41-42). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Temperature changes (in F): 41-42) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
PATIENT STATED THAT SHE IS HAVING PAIN IN SHOULDER. SHE IS GOING TO SEE DOCTOR. THINKS IS DUE TO THE FLU VACCINE.
Client was due for last dose of MMR and first dose of VZV, nurse dispensed and administered VZV and MMRV instead of MMR.