chrisvoncsefalvay/vaers-outcomes huggingface dataset:
usually have a space between the frozen liquid and the vial stopper, but with this one, she; 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 PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) 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 PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she). At the time of the report, PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.
Felt very nauseous and began to vomit 3 to 4 times, also felt like I couldn't wake up very drogy lasted about 15 hr this all started about 4am on the 14th
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.11. Concomitant products were not provided. On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 34 and 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
I always got sick after taking the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 14-Dec-2020.  This case involves a patient of unknown demographics who always got sick (sickness) after taking the shot, while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient stated that he/she always got sick (sickness) unspecified days after the patient got the shot.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Left upper arm red, swollen and feverish. Area started at approx one inch above elbow up to approx 1 1/2 inches below. No decrease in ROM.
Hot to touch 5" local swelling, redness, pain at site of injection. Also pain & tenderness & large swelling under rt. arm which lasted until 5-2-2011. Very uncomfortable.
Arm soreness/My arm hurt really bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad). At the time of the report, VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX  lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
pt reported exp rxn to vax w/in 1/2hr of vax;rt arm swelled, devel a red, splotchy rash & was very itchy;pt has been taking DPH & used ice for swelling;pt thinks the itching is letting up today 20OCT97
The Moderna Bivalent Vaccine had expired on 5-19-2023. The inmate had no signs and symptoms. No adverse outcome to this date.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. It was unknown if the patient had any allergies (medications, food and other products). It was also unknown if the patient ever had COVID positive test or diagnosis. It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication of the patient was not reported. The events did not cause the patient to seek medical care (office visit, urgent care, ER, hospitalized). No treatment information was provided by the reporter. This case was linked to MOD-2022-545402, MOD-2022-545418 (Patient Link). Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up information included no new information.
None stated. This adverse event was made in error.  There was no adverse event to report.  We were trying to correct a vaccine entry not report an event.  Please void.
Fever, chills myalgias within 5 hours of receiving vaccine. 2 prior vaccines for HPV no problem.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L046897, expiration date 23-FEB-2017 (dose and route of administration were not reported). The vaccine was exposed to 9 degrees Fahrenheit for 4 minutes. A data logger was not used to log temperatures. No adverse effects were reported. Additional information has been requested.
Paresthesia in all extremities. Beginning in left arm (injection site) 14 days after vaccination. In the following  days numbness/tingling occurred in all 4 extremities, coming and going. Still occurring as of report date. Went to Emergency Department on 10/2/23 (14 days after vaccination) when symptoms were only in left arm. Went to primary care provider 10/10 - labs were all normal including inflammatory markers, calcium was slightly elevated (will be retested). MRI of brain scheduled for 10/19.
Extreme tiredness Headache Muscle pain Chills Nausea Feeling unwell
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapy was not reported. On an unknown date after patient received the vaccine there was blood in the injection site. The outcome of injection site bleeding was unknown. Additional information has been requested.
checked my B/P and it was 165/99/ blood pressure measurement: staying elevated in 140's ever since; his blood pressure was 168/99, and it has been fluctuating ever since; HA/had a really bad headache; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EL8982), via an unspecified route of administration in arm left on 31Jan2021 14:00 as 2nd dose, single for COVID-19 immunisation. Medical history included, cardiac pacemaker insertion from 12Mar2019 to an unknown date, blood pressure abnormal, anticoagulant therapy, blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium taken for blood pressure abnormal from an unspecified start date and ongoing, hydrochlorothiazide taken for blood pressure abnormal, start and stop date were not reported, aspirin taken for anticoagulant therapy and ezetimibe taken for blood cholesterol abnormal from an unspecified start date and ongoing. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had events reported as "checked my b/p and it was 165/99" then at 10:00am it was 148/84 and it had been staying elevated in 140's ever since/he took his blood pressure, and it was 165/99. it has been in the 130 to 140 ever since then, had a really bad headache, his blood pressure was 168/99, and it has been fluctuating ever since on 01Feb2021. The patient's blood pressure was recorded as 165/99 on 01Feb2021, 130/71 on 02Feb2021, 168/99 on 03Feb2021, 123/69 on 04Feb2021. On unknown dates, the patient underwent blood pressure measurement and results were reported as 148/84; staying elevated in 140's; 168/99; fluctuating ever since; it has been in the 130 to 140 ever since then. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Description of complaint: Consumer reporting an AE for the second dose of the Pfizer COVID 19 vaccine, while providing concomitant products caller mentions he used to take a statin called Atorvastatin before he switched to Ezetimibe three years ago. He does not have any product or information to provide NDC, lot or expiration date for Atorvastatin he used to take. The outcome for the events was reported as recovered for events Blood Pressure increased and headache. Outcome of the event blood pressure fluctuation was reported as unknown.  Follow-up attempts are completed. No further information is expected.
toothache; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). An 88-year-old (reported as 88) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 26Feb2021 as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported receiving her vaccine the day before the present report (26Feb2021) and she had a slight toothache, but she stated she know this was not from the shot (and reiterated this multiple times). She stated her friend told her she heard on the television that paracetamol (TYLENOL) and ibuprofen were not supposed to be taken with the vaccine. She asked if she was able to take this. Seriousness criteria reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. From 05-SEP-2017, through 20-SEP-2017, the patients were vaccinated with improperly stored ROTATEQ orally, lot # N000175 with expiration date on 20-SEP-2018, (dose was not reported) for prophylaxis. The doses of ROTATEQ were exposed to a temperature excursion of 10.4 degrees Celsius (°C) during a time frame of 50 minutes which was detected by the data logger. Previous temperature excursion was reported as 13.9°C for 173 minutes. There was no adverse events were reported. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA010722: US-009507513-1709USA010723.
She received her first dose of GARDASIL 9 about 3 years ago and did not receive the second dose yet.; No additional AEs were reported; This spontaneous report as received from a pharmacist, referring to a currently 27 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   In 2020 (reported as about 3 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (1 dose (1 dosage form), route, strength, lot number and expiration date were unknown) for prophylaxis. She did not receive the second dose yet (inappropriate schedule of product administration). No additional adverse event was reported. No further information provided.
Fever, chills, and diarhea...self-treated with Tylenol and plenty of fluids. Effects lasted for 2 days.
Initial report received from healthcare professional on 20 October 2014. A 50-year-old male patient, had medical history of diabetes, hypertension, hypercholesterolemia, sleep apnea and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI159AA, expiry date 30 Jun 2015 and dose number was not reported) in to the deltoid right on 13 October 2014. The patient had experienced joint pain and fever to 101.6 F on 15 October 2014. Lab investigations were not reported and corrective treatments included ADVIL. It was reported that the pain and joint pain resolved on an unspecified date. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies prednisone and sulfa drugs and birth defects were reported. At the time of this report outcome of pain was resolved and fever was unknown. List of documents held by sender: none.
Feeling asthmatic during the beginning of strenuous exercise and having difficulty breathing, never had this issue before. Becoming faint, dizzy, sleepy in the middle of the day often 2 hours after eating. Feeling a rapid heart beat.
On 06/25/2021, chest pain. I went to the ER, Hospital, they admitted me because I was having a heart attack. Within an hour, at 1:16pm I had a series of blood test, the 2nd series of blood test, it showed the cardiac enzyme were at 16000. They did an Emergency catherization. They called it NSTEMI Heart attack. They told me I was lucky because I had no heart damage, they could not do anything to repair it. Treatment: Aspirin 80 mg, Lipitor 40 mg. I just had to rest. A small artery that suddenly broke as though somebody came and cut with some scissors. The doctor monitors me to take my heart pressure. This morning I took it 4 times and it was bad. I have a follow up with the doctor, Dr., on 09/20/2021. I look fine, but there are days my blood pressure is bad, but I feel fine.
This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patient was vaccinated with improperly stored doses of ROTATEQ orally, lot number M041184, expiration date: 31-MAY-2018 (dose and dose number were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested.; Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001646: US-009507513-1805USA001647: US-009507513-1710USA011550:
I took Moderna booster on 2/11/2022, I feel palpitation, heartbeat from 78  to 110/min suddenly sometimes from 2/13/2022, this symptoms have not been relieved so far. I found white rash on the  arms and BLE, no itch on 2/19/2022, white rash more and more, and changed to the red, and more and more itch. I took Loratadine 10mg 3 days, the medication doesn't work. I visited the PCP and is requested to take cetirizine 10mg qd 2 weeks. The itching is relieved but not complete controlled.
My uppper arm is red, swollen, itchy and hot, with sharp pains every now and then, it's painful/uncomfortable to have any clothing on it. Treated with antihistimine and pain reliever.
CENTRAL NERVOUS SYSTEM DISORDER; This spontaneous report received from a patient via other manufacturer (Novavax) concerned an elderly female. The patient's weight, height, and medical history were not reported. The patient had a polyethyleneglycol allergy (macrogol 4000). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number series 1) (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 01-APR-2021, the patient experienced affected eyes. On an unspecified date, patient experienced felt like it was inducing a pro-inflammatory cytokine response (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin not reported, batch number: 211021A expiry: UNKNOWN) dose was not reported, 1 total administered on 18-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. No concomitant medications were reported. On an unspecified date, the patient experienced central nervous system disorder (Dose number series 2). On an unspecified date in 2022, Laboratory data included: Antibody test 1000 neutralizing antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of central nervous system disorder was not reported. This report was non-serious. This case, involving the same patient is linked to 20211011757 (primary dose case).
Covid arm; Covid arm was terribly itchy; Covid arm was burning; Covid arm had redness; Covid arm had swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Development of shingles a aprox. 2 weeks after 2nd dose of covid-19 vaccination.