chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  HCP reported about temperature excursions with freezer in the facility. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.   The vails were stored in Frozen state.  Treatment medications were not reported.   This case was linked to MOD-2022-591989.
experienced shingles after vaccine/ suspected vaccination failure; shingles; This case was reported by a nurse via sales rep 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 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 Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The nurse practitioner reported to a field representative that a patient experienced shingles while taking Nucala. The patient did receive the shingles vaccine, but it was not specified which one.  No further information was provided. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked with US2023031990 reported by same reporter. Note: The suspect Nucala was not captured in the case as separate case was created for the same.; Sender's Comments:  US-GSK-US2023031990:same reporter
Pt is here for Johnson and Johnson vaccine, received at 1745. At 1746, while still at vaccination table, PT reported that he didn?t feel well and presented with diaphoresis, pallor, a sensation of being hot and light-headed, reported that his vision was dimming/everything was getting darker. No LOC noted. PT provided ice pack at 1747, applied to back of neck. PT reports that this has happened to him before with blood draws and that he had severe phobia r/t needles. PT also reported it had been about 6 hours since he?d eaten, but he declined the juice offered before his vaccination. He also reports that he has lost 35 LBS in 3 months r/t a diet. VS at 1746: HR 56, SPO2 98% %A. At 1755: BP sitting is 90/60, HR is 76, SPO2 is 98%. At 1800, BP sitting is 118/80, HR is 84, SPO2 98% and PT is reported he feels ?100% better.?. At 1803, PT continued with diaphoresis, but color had improved. PT accepted apple juice. At 1808, PT stood from chair unassisted with steady gait. Pt denied SOB, respiratory distress, itching. At 1828, PT exited facility with steady gait, stable and able to walk on his own, denying dizziness and reporting that he ?feels good.?.
a 32 year old female here for covid vaccine. Administered vaccine; patient tolerated well. Approximately seven minutes later patient fainted for less than 30 seconds. Incident occurred at 1550. VS at time incident: BP: 74/40, HR:58, Sp02:100%. Water and coke was given to patient. Patient drank approximately 120ml of water and 60ml of Coke. At 1556 VS: Blood pressure: 98/64, HR: 60, Sp02: 100%. At 1600 VS: BP: 102/62, HR: 64, Sp02:100%. Patient stated she felt better and no longer had any symptoms. Patient discharged; medically stable.
Flu like symptoms. Entire body was sore, joints, muscles, neck, head, legs, shoulders, arms, feet. I was constantly cold the entire day and evening.
Patient age 17 was administered Moderna at Store.  Age limit for Moderna is 18.
Patient received full 0.5 ml dose of Moderna in error after previously receiving doses of Pfizer on 2/6/21 and 2/27/21 and a Moderna Booster (0.25ml) on 11/26/21  No known adverse reaction.
Headache, feverish scratchy eyes, aches - 2nd day dizziness.
A consumer report has been received. The report concerns a female consumer, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 02-Nov-2015. The patient experienced NASAL CONGESTION which started on 04-Nov-2015 and STIFF NECK which started on 03-Nov-2015. The outcome of the event of STIFF NECK and NASAL CONGESTION is unknown. The reporter's description of the event (s) was as follows: see attachment. The report was considered to be non-serious.
Approximately 2 hours after receiving the vaccine the patient reported tingling down her arm.  Md told her the tingling was probably from her tensing her muscle.
The following morning post vax, the pt developed a reddened area around injection site, hard nodule at injection site as well. Reddened area was warm and pt complained of pain when palpated.
Didn't get second dose - almost 6 months; Rash the size of half a dollar below her breast and above her waist; Left side of face went numb; Numbness including lips; "Tick" where her left eyelid is; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips), ARTHROPOD BITE ("Tick" where her left eyelid is), PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months) and RASH (Rash the size of half a dollar below her breast and above her waist) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips), ARTHROPOD BITE ("Tick" where her left eyelid is) and RASH (Rash the size of half a dollar below her breast and above her waist). On 09-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months). At the time of the report, HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips) and ARTHROPOD BITE ("Tick" where her left eyelid is) had resolved and PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months) and RASH (Rash the size of half a dollar below her breast and above her waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information provided included natural herbs.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received 27-JUL-2021 contains NNI. Patient declined  for further follow up.
This spontaneous report as received from a pharmacist refers to an unspecified nunber of patients of unknown age and gender. On an unknown date the patients were vaccinated subcutaneously with 0.65 ml single dose of ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) that were improperly stored. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2008, the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported) in the vaccination series. On an unspecified date in January 2016, the patient was vaccinated with a second dose of GARDASIL 9 lot# M024261, expiration date 30-JUL-2018 (dose and route of administration were not reported) and then he/she received a third dose of GARDASIL 9 on 09-JAN-2017. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Hives began within about 6 hours and continued to spread over the next 2 days. Treated with po zyrtec and benadryl.
Father tested positive 4/28 in AM, have previously been in state for the past 7 days, had little to no contact with him the next day, though he was not wearing a mask around the house. Started feeling symptomatic that afternoon, tested negative on 4/29, tested positive on 5/1.
sz, head arched back, limb stretched out + 101-102 w/in 24hr of vax;
Pain and soreness in arm where shot was administered. Pain lasted for 24 hours. It was also hard to lift my arm in certain directions or sleep in it.
1 week after tetanus injection pt states arm difficult to raise up head and pain at site. Injection site warm and hard to touch, painful and has white (purulent) head at site. Made appt for pt to see physician at urgent care but pt refused. Told to use warm compresses TID and clean with soap and water. Keep clean. Refused medical attention.
This spontaneous report as received from a physician refers to 10 patients of unknown age. The patients were vaccinated with ZOSTAVAX (lot#not provide). No other co-suspects were reported. No concomitant medications were reported. The physician stated that since December 2011 to 23-JUL-2012, there had been 10 patients who received ZOSTAVAX stored between -3C to 1C. Physician was still doing research to determine length of time ZOSTAVAX were stored this way before given to patients. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. Additional information is not expected.
Fever to 103.1 F rectally. 3 red, raised, hot bumps to vaccine site where varicella and hepatitis a were given. Fussiness. Saw MD 10/8/10 - Amoxicillin x 10 days prescribed.
1010 to MD started shivering, fever 102, came on w/shaking & gritting of teeth, breathing rapidly; As soon as fever came down improved; later that evening temp to 104; no further sz activity;
itching. PT reports generalized itching x 10 days no rash present. reports onset 3 days after 1st moderna vaccine. 75-year-old female with whole body pruritis.  At this time she has no visible rash, jaundice or mucosal lesions.  Electrolytes, LFTs and renal function are normal, making renal insufficiency and liver dysfunction unlikely as the cause of her itching.  Her CBC shows an isolated mild eosinophilia, but is otherwise normal.  Will place patient on Allegra to see if this helps with the itching and have her follow-up with her primary care.
Elevated heart rate / tachycardia  . BP increased from 110/70 (which is my normal) to 145/86.   Tremors Uncontrollable shaking, not cold.  Went to the Emergency Department via ambulance. The very next morning heart went into tachycardia again with increased BP.    Throughout the week, for about 7-8 days, BP was high.
10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; The patients are all adults the patients have not reported other side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) outcome was unknown.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received Moderna vaccine that had thawed out and then refroze. The patient did not report other side effects.  Treatment information was not provided.  This case contains information for the 3rd patient out of 10 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
5 minutes post vax, the pt requested to lie down. Color pale, decreased responsiveness, ammonia inhalant given and pt was observed for 15 minutes. Discharged home with mother.
On 5/4/00, the pt developed a fever. On 5/5/00, he broke out in a rash. On 5/6/00, pt was taken to physician who dx measles rash secondary to vaccine adminstration.
Fainted about 7 minutes after receiving the vaccine. Came up to consciousness again after 1-2 minutes, but felt lightheaded and nauseas. Vomited 45 minutes after receiving the vaccine.
sore scratchy throat-nasal area stuffy, laryngitis, chest congestion, coughs, body aches & pains, dry mouth, loss of appetite;call in to MD;
Weakness on right side of body, numbness in hands; nausea & light headiness. Weakness & numbness outside upper left & right legs & knees/numbness in fingers. On Sept. 28, 2017 got a Flu Shot another shot (not sure if it was a ZOSTAVAX shot) from Clinic. As of Feb. 24, 2018 Still have some numbness in fingers and some weakness left & right knees.
Patient came to the pharmacy on 11/18/2013 and reported that she is experiencing rash and redness in her right eye. Rxm referred the patient to the PCP.
Extremely tired for several days after booster. Within 4-5 days I noticed back of throat, gums & roof of mouth feeling irritated. Few more days & it hurt to eat. I had developed sores in my mouth. Went to my ENT doctor who diagnosed many canker sores in my mouth & stated it was because the booster had over stimulated my immune system. Much better but on last recheck 3 weeks ago I still have a few sores but they are healing.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M037248, expiry date 24-FEB-2019 and lot# M044032, expiry date 03-JUL-2019) intramuscular (strength, dosing details, anatomical location were unknown) for prophylaxis. The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003783.
client complained of dizziness after receiving 1st dose Pfizer Covid Vaccine. RN responded with EMT. PHN arrived shortly. Upon arrival client sitting in chair, pale, alert and oriented x4. EMT was taking vitals. Client stated feeling dizzy and nauseous 5 mins after receiving vaccine. Vitals at 1526: blood pressure 124/80, pulse 81, oxygen 99%. Client denied blurry vision, headache, shortness of breath, chest pain. 1530 client able to stand and transfer to anti-gravity chair. Client stated feeling more dizzy after getting up. PHN gave client water and instructed to drink slowly. Per client no relevant medical history, current medication or allergies. Vitals at 1532: blood pressure 124/65, pulse 83, oxygen 95%. Client stated was on a diet and last time she ate was 6 AM. At 1533 client stated nausea and dizziness improving. Skin color normal for ethnicity. Client given juice and snack. Vitals at 1546: blood pressure 123/71, pulse 72. oxygen 99%. Per client dizziness improving, nausea subsided. Client denied blurry vision or headache. Client advised to eat prior to vaccine and follow up with provider. Last vitals at 1556: blood pressure 122/64, pulse 79, oxygen 97%. Client stated symptoms had resolved. Was not driving home, friend here with here and would take public transportation. ER precautions given. Client able to stand from chair with no complaint of dizziness. Client left facility with steady gait at 1558.
2 hours after receiving vaccine, Left upper arm began to be painful. Rated 8-10 on 0-10 scale.  Aggravated by movement/reaching with Left arm.  First seen in Employee Health on 11/5/09.  No redness or swelling noted in area.  L deltoid area painful to touch.  Afebrile.  Warm compresses and Ibuprofen recommended.  At recheck on 11/10/09, states much improved.  Pain less severe; 4/10 only with movement of L arm.
PT RECIEVED PFIZER BOOSTER ON 12/1/21 @ THE PHARMACY. PT STATED THAT BY THE NEXT DAY, THEY NOTICED THEIR  LEFT SIDE OF NECK GETTING WARM & EXTREMELY SORE & SWOLLEN & TENDER, RAISED KNOT OF THE SIZE OF A PEA. IT OCCURRED WITHIN 24 HRS..... PT IS "STILL" FEELING/EXPERIENCING  THE ADR. PT WAS CONCERNED & WANTED SOMEONE TO KNOW WHAT HAS TAKEN PLACE SINCE AFTER THEIR .  PT WOUL;D LIKE FOR PFIZER TO GIVE THEM A CALL  - TO FURTHER DISCUSS THE MATTER. I, DID ENCOURAGE THEM TO CONTACT THE PHARMACY & LE T THEM KNOW OF THEIR ADR. ALSO ENCOURAGED PATIENT TO MONITOR THE LUMP & IN THE MEANTIME TAKE TYLENOL
Pain across chest; Burning sensation on tongue; Red tongue; Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain across chest), TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST PAIN (Pain across chest), TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever). On 11-Mar-2021, CHEST PAIN (Pain across chest) had resolved. At the time of the report, TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Abnormal behavior, gagging/chocking, tongue thrust, temp 100.8 deg. F, "brief seizure," EEG-pending; return to baseline 3/2 to present.
vaccinated on Sept 12 2020 / second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2020, batch number 5KM49, expiry date 26th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021152856 and US2021152861, reported by same reporter for different patients. The VAERS details were provided for 1st dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152861:Same reporter US-GLAXOSMITHKLINE-US2021152856:Same reporter
Breakthrough case admission after 3 vaccines Pfizer 3/5/21 lot# EN6206;  Pfizer 3/26/21 lot# ER8732;  Moderna 12/26/21 lot# 068H21A
BLURRED VISION FOR THREE DAYS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 193 pounds, and height was 64 inches. The patient's concurrent conditions included seizure disorder, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced blurred vision for three days. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision for three days on APR-2021, and headache, and tiredness on 12-APR-2021. This report was non-serious.