chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature; No adverse event; poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature), POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine from a Medical cooler unmonitored left in 70 degree Fahrenheit room temperature) and POOR QUALITY PRODUCT ADMINISTERED (poor quality vaccine administered).    No concomitant medications was reported. The patient received the Moderna Primary series first dose on 24-Mar-2021 with lot number 031A21A in right arm, received second Moderna primary series dose on 21-Apr-2021 with lot number 047B21A in left arm and Moderna Monovalent booster dose on 8-Mar-2022 with lot number 027L21A in right arm. Expiration date was unknown. No adverse reaction was reported for the vaccine. No treatment drug details was reported.
I could not lift my arm at all.  Now, TWO MONTHS later, while it is better, I still have difficulty lifting my elbow above my shoulder.
Information has been received from a health professional concerning an approximately 12 month old male who on 24-JAN-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot#649817/0728R). Following vaccination the patient experienced a fever as high as 102F that persisted for 1 day with no rash. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED SNACK AND WATER, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
The Moderna vaccine was taken out of the freezer and placed in to the refrigerator on 9/8/2021. The vaccine was administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator. No adverse reaction occurred during the 15 minute waiting period or reported after the clinic date.
allergy; This case was reported by a physician via other manufacturer and described the occurrence of allergy in a 81-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included pregabalin (Lyrica) capsule for neuropathy.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Lyrica (oral) 100 mg twice daily (200 mg daily). On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced allergy (list might be incomplete). The information provided in the source document was not clear. It was unknown whether the reporter gave consent to further follow up or the patient consented to follow up with the reporter.
Loss of conscious (syncope) along with loss of bowel control at time of event, ambulance called and taken to ER
This spontaneous report was received from a nurse refers to a 7 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Pt. In observation area after receiving a Covid vaccine.  Pt. stated "I do not feel well."  Pt. Taken to gurney to lay down at 1841 pulse oximeter applied.  Mother of pt. is a physician and is at bedside for emotional support.  Mother stated that Pt. has anemia.  Pulse was 154 and pt.stated "I felt a jolt in my chest." Heart rate returned to 109-120s with slower breathing and talking through anxiety. Pt asked for juice and drank apple juice. HR then went up to 150-160s again x2 with Pt. Not feeling well again. Oxygen saturation remained 99-100% on RA.  ER contacted to alert arrival of patient for more observation for elevated HR.   Pt. Transferred to ER on campus.
feeling fatigued after the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling fatigued after the second dose of the vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FATIGUE (feeling fatigued after the second dose of the vaccine). At the time of the report, FATIGUE (feeling fatigued after the second dose of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Patient has reported that first vaccine was given to left arm shoulder deltoid and No adverse events  were experienced after the first dose.  Also, she has reported that, her second dose vaccine was administered to her her left arm shoulder deltoid muscle.  Patient ha s confirmed her email address.   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Follow up was received which included no new information.
OU Red, H/A 9/30/13, 10/1/13 sore throat and arm sore at injection site.
This spontaneous report as received from a pharmacist refers to a 72 years old female patient with high blood pressure. The patient was vaccinated with ZOSTAVAX (subcutaneous, dose and lot# were not reported) on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-AUG-2012 the patient developed "an itchy red circle/rash at the site of injection." No treatment information was reported. The outcome of an itchy red circle/rash at the site of injection was reported as recovering/resolving. No lab diagnostics studies performed. The patient sought medical attention via speaking to pharmacist. Additional information has been requested.
Pt. states that after receiving the 3rd dose of Phizer 12/31/2021, started experiencing symptoms 01/03/2022 of pain in the palm of the hand (inflamed vessel) with bruising and right Middle Finger slight bruising with pain. Primary appt. scheduled for 01/07/2021. Previous Covid + 09/2021 with Monoclonal Treatment.
DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of medical conditions and no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, dizziness, weakness, and feeling unwell. This report was non-serious.
2 pts exp local rxn- sever arm pain for 12 hrs p/1st dose of Engerix-B; following 2nd dose of vax exp severe rt upper arm pain;
PAPULES/ BLISTERS ON RIGHT ARM AND SWELLING/ REDNESS LEFT ARM
Starting Day 3, I had a severe headache that remained constant for about 1.5 days. I experienced pain in my arm, anything from touch to movement, and a large, hot, itchy knot in my arm at the injection site. I became very nauseous starting in the morning on Sept. 3rd, and began vomiting by midday. I vomited a total of 6 times, and felt very weak and ill. I began to feel better by the next evening, with all symptom gone a day after that.   However today (day 10), my injection site felt itchy, which was when I noticed it was a large red knot that is very hot to the touch. I am feeling weak and lethargic today, and the pain in my arm is radiating about an inch around the red lump. It is approximately 2 inches in diameter all around.
Swelling in left arm that has not gone away since vaccination. Location at bottom of bicep. tender and sore
Provider ordered INFANRIX, but LPN gave HAVRIX in error. No adverse reaction identified. Parent made aware when error was found; 5 days later. Parents were notified.
it was rpt a pt w/history of chickenpox was exposed to daughter who on 5/11/98 was vax. in 5/98 pt exp secondary transmission. approx 3wks p/ daughter vax pt devel crusty lesions. dx w/shingles by her MD
Patient passed out and fell on his back. Paramedics were called to site and determined patient was fine
Headache and light fever. Headache has persisted to an almost daily occurrence since the first covid 19 vaccine, which I have never had occurrences so often in my life before.
p/vax pt devel an inj site rxn characterized by a half-dollar size area of swelling & pain;self medicated w/advil & APAP;pt recovered w/in 48hr;
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received Influenza vaccine. Previously administered products included seasonal flu vaccine with no reaction on previous exposure (annually for many years). On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced pain in arm and mobility decreased. The patient was treated with SOLUMEDROL. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Influenza vaccine. Additional information was provided: The patient experienced severe pain in the upper arm that has not resolved for months. The physician reported that the patient had limited use of the arm, and continued to avoid using his arm at all. The physician conducted all the usual assessments and tests (all WNL), and had also administered SOLUMEDROL IM to the area which did not change the pain level.
Information has been received from a registered nurse concerning a 76 year old patient with a medical history of skin cancer, who on 11-JUL-2007 was vaccinated with a dose of PROQUAD (Lot # 657536/0475U) instead of zoster vaccine live (Oka/Merck). On 14-AUG-2007 the patient was administered zoster vaccine live (Oka/Merck) (Lot # 656859/0357U). The site reported that this was not product confusion. No adverse experience was related to this event. No further information was available. No product quality complaint was involved. Additional information has been requested. Follow-up received from a registered nurse stated that they have been very busy and have someone pull the vaccines for them. Normally the vaccines are checked twice but because it was so busy, it was not. The patient received zoster vaccine live (Oka/Merck) on 14-AUG-2007 and it was reported that "she was fine". There was nothing further to report. Additional is not expected.
Incredibly sore/painful muscles, very painful joints, chest pain, back pain, neck pain, head congestion, eye strain, severe fatigue, mildly impaired cognitive function, severe pain at injection site, random shooting pains through various parts of my torso (including ribs, groin and abdomen) and extremities.
PATIENT REPORTED THAT AFTER RETURNING TO HER CAR THAT SHE SUSPECTED AN ADVERSE REACTION. SHE EXPERIENCED CHEST PAIN, PAIN IN HER BACK NEAR COCCYX BONE, AND ALSO PAIN IN HER LEFT ARM. SHE FLAGGED DOWN ANOTHER PATIENT TO ALERT US. I WAS THE ONE WHO RESPONDED TO THE PATIENT AND CHECKED FOR AN ANAPHYLACTIC REACTION WHICH WAS NEGATIVE. I THEN INSTRUCTED STAFF TO CALL 911 AND FROM THERE SHE WAS TRANSPORTED TO THE HOSPITAL WHEN HER BLOOD PRESSURE WAS VERY ELEVATED, (SHE SAYS THIS IS TYPICAL IF SHE IS UP MOVING AROUND HOWEVER). AFTER BEING SEEN AT THE HOSPITAL AND HAVING NUMEROUS TESTS, THE PATIENT WAS RELEASED AND WAS TOLD BY THE PHYSICIAN THAT SHE MUST HAVE JUST HAD A "STRONG REACTION" AFTER HAVING THE VACCINE.
I experienced a high fever, body aches, fatigue, tiredness and I was in bed for 3 days. Usually I am able to sleep at night and be productive in my day but now I am always exhausted sometimes I even take a shower and get out the shower and be so tired to make it to bed. I also have a lot of recurring infections and now I am taking a antibiotic.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021 at 4:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Nov-2021 at 4:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was unknown whether patient was ever diagnosed with Covid-19.The information about acute illnesses, chronic or long standing health conditions, information about other medications at the time of vaccination or at time of reporting were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19 Nov 2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Tested postive with Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested postive with Covid-19) in a 22-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested postive with Covid-19). At the time of the report, COVID-19 (Tested postive with Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No relevant concomitant medications were provided.  No treatment information was provided.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F-Time Frame: 5 minutes) dose of ROTATEQ (lot # L013202 and expiration date: 27-JAN-2017, orally). No concomitant therapies were reported. NO adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient complaining of right biceps muscle hurting when she uses her arm since day after receiving her Td shot in the right deltoid on 11/3/08. patient made Worcester County Health Dept aware of this on 12/2/08. Patient declines to see a doctor to be evaluated for this. Encouraged patient to be evaluated. Deep aching in midarm below where shot was given (mid underarm) starting about a day after shot was given getting worse over the weeks. After 6 weeks it has lessened to minimal. No problem at injection site.
Pt was given Flucelvax vaccine instead of high-dose Fluad for 65+. No adverse effects were noted and error was discussed with pt. Provider contacted manufacturer and Flucelvax is approved for patients ages 6months and older and should not cause harm to the patient.
This case was reported by a healthcare professional and described the occurrence of a female subject of unspecified age not responding to therapy following vaccination with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On unspecified dates the subject completed a full series of hepatitis B vaccine (unknown) and did not respond.  She then received a second full series on unspecified dates.  At an unspecified time after completion of the second series of hepatitis B vaccine, serological testing determined that the subject was not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Rash starting behind ears and spreading down to stomach and back. Began 10d after vaccines given lasted 3 days. No fever, +produce fussiness 1-2d
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Benadryl self-administered. Patient reports taking 3 doses since vaccine administration.
inflamed; secondary rash like a thin line from the arm to her wrist; very itchy; The actual injection site was red; threw up 3 times; large round rash,almost 3 quarters of the left arm; wasn't really itchy; hot to touch; whole left arm was swollen down to the left hand; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed) and RASH (large round rash,almost 3 quarters of the left arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Anxiety, Allergy and Heartburn. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZIRTEK) for Allergy, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression and Anxiety, OMEPRAZOLE for Heartburn, LISINOPRIL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), RASH (large round rash,almost 3 quarters of the left arm) and VOMITING (threw up 3 times). On 30-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red) and RASH (secondary rash like a thin line from the arm to her wrist). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg once a day. At the time of the report, RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed), RASH (large round rash,almost 3 quarters of the left arm), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red), VOMITING (threw up 3 times) and RASH (secondary rash like a thin line from the arm to her wrist) outcome was unknown.        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.
Persistent high fever (103) for 4-5 days with no other signs of illness. Fever was generally controllable with Tylenol. No swelling at injection site. No symptoms of viral infection other than fever.