chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to ED with numb and paralyzed right side of the face. Little hard to talk. Focal weakness during neuroreview of systems. Patient has a history of Bell's Palsy with the previous incident on 09/04/2010.
Vaccine administered after more than 1 temperature excursion; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:45 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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 (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.   Age of patient was reported as 49.72 for dose administered on 27-Feb-2021 and 49.80 for dose administered on 27-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit at 09:00 AM, 35-degree Fahrenheit at 11:00 AM to 02:00 PM, 34-degree Fahrenheit at 03:00 PM to 04:00 PM and 35 degree Fahrenheit at 05:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Pt presented tearful and complaining of tingling to bilateral upper extremities approximately 3 mins following vaccination. Vitals taken and heart rate was 133 and patient skin appeared flush. We added another 15 minutes on to her monitoring time, verbally calmed her and gave her a bottle of water. Her heart rate began to decrease to a normal rate range of 76-88 beats per minute. She stated she was starting to feel better. Within the 30 minute observation she complained of feeling "funny". Her vitals were normal however she was very tearful and stated she had feeling of something bad about to happen. The patient was transferred to the exam room and lost conciouness according to the nurse caring for her. I observed the patient very groggy. Oxygen was applied and RN and RN administered Solumedrol and Epi intramuscularly. The patient was transported to the hospital via ambulance. The patient returned to the facility to pick up her car and stated she feels better and she received fluids at the hospital.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) 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 assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). No concomitant medication were reported.   The nurse reported that for the past month, a total of 19 patients received the half doses of Bivalent on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022, instead of 0.5 ml. No treatment information was provided by the reporter.
Patient has developed cellulitis @ the injection site. It is being treated with Septra for 7 days red swollen and tender 2 cm.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Bloody Stool-Severe, Additional Details: Ptx stated night of or morning after vaccination on 05/06/21, experienced abdominal pain and had a bowel movement that contained blood in stool (blood filled toilet bowl and could not see stool). Ptx stated arm was sore. No reports of bruising, red sports on skin, severe headache nor swelling in arms or legs. Recommended ptx to contact PCP right away.
Information was received from a registered nurse, who reported that on multiple unspecified dates, multiple unspecified patients were administered improperly stored ROTATEQ (lot #M031650, expiration date 16-MAR-2018) (dosage and route of administration not provided). No adverse effects reported. No additional information provided. Temperature/Time frame: > 46°F but < 77°F for 1.5 hours. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA012015: US-009507513-1702USA012014: US-009507513-1702USA009271:
About 5 minutes after receiving the shot, patient complained of being light headed, hot, patchy vision, loss of hearing, pale color and almost passed out at the pharmacy contour. He had been helped to have a seat and drink some water, about 5 minutes later he felt much better but only experienced tingling in his fingertips. He stayed for another 20 minutes in pharmacy and mentioned he felt totally alright before leaving the pharmacy area.
Patient received dose of unknown vaccine day prior to ED visit and patient presented with extreme AMS and delirium
11/17/06 5pm None. Toddler given adult dose of Fluarix mistakingly given as pediatric vaccine.
Felt herself weak; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt herself weak), HEADACHE (Headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included RIVAROXABAN (XARELTO), CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and POTASSIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (Felt herself weak). On 13-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, ASTHENIA (Felt herself weak) had not resolved.            The patient did not receive any treatment for the symptoms.
Severe pain in my left arm and shoulder. Could hardly move it and used a heating pad. The doctor  could not see me till 4/27/22. My orthopedic doctor gave me a cortezone shot. He also took an xray. He saw minor arthritis. He said he could not get further info unless he did an MRI. I cannot get and MRI because of my Artificial Aortic Heart Valve. It is still aching. Not quite as bad. I am dealing with the pain by taking Tylenol Arthitis  650 mg/6 a day.
Zostavax was inadvertently given instead of Varivax.  No adverse effects noted.
32 day after vaccination I developed Bell's Palsy.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158; Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24Apr2021 13:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included diabetes. Patient had known allergies to penicillin. Concomitant medication included metformin. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: unknown, Formulation: solution for injection), via an unspecified route of administration, administered in arm right on 03Apr2021 at 13:15 as single dose for covid-19 immunisation with no adverse effect. Patient developed bell's palsy 32 day after vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received metformin within 2 weeks of vaccination. Patient developed bell's palsy 32 day after vaccination. These adverse event result in emergency room/department or urgent care. Patient was treated with anti viral prescription. Patient was not diagnosed with covid-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered.    Follow up needed, further information has been requested.
pt exp T102 & diarrhea on 10FEB98;11FEB98 pt afeb, well hydrated & nl PE;pt recv vax & devel fever;17FEB98 pt unresponsive @ 9AM taken to ER found to be dead on arrival autopsy performed dx SIDS;
Adult vaccine was administered to patient (age 6), on site to receive second dose of Moderna.
This spontaneous prospective pregnancy report as received from a female patient of unknown age and demographics. On 04-JUN-2014 the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (dose, route, lot# and expiry date were not reported). The consumer stated that she tested positive for pregnancy three weeks after receiving an unspecified chicken pox vaccine," which is other-than-indicated in the Prescribing Information. No adverse effects were reported. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. Additional information is not expected because there is no contact information with the reporter.
Extreme fatigue followed by chills, headache and fever to 101.5 F. Soreness at injection site.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 7th March 2019, the patient received Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX (intramuscular). On 8th March 2019, 1 days after receiving Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX, the patient experienced fever, chills and headache. On 12th March 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever, chills and headache to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. Additional details were provided as follows: The patient experienced fever, chills and headache after receiving Flu vaccine and SHINGRIX vaccine. The patient always experiences the events after receiving Flu vaccine. All the events resolved except headache which was worsening and the patient finds it debilitating. The headache started at the back of her eye going down the back of her head to her neck. The patient felt nauseous due to the large amount of pain medication she was taking for the headache. This case is linked to case US2019GSK052355, same patient.
minor aches and pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 59-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number) via an unspecified route of administration on an unspecified date (at the age of 59 year) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number)  via an unspecified route of administration on an unspecified date (at the age of 59 year) as dose 1, single for COVID-19 immunisation. The patient  received tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, Strength 11 mg), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at a dose of 11 mg for an unspecified indication. The patient medical history was no reported and concomitant medication were not reported. It was reported that the patient bought relief factor to relieve of minor aches and pain. Action taken with tofacitinib citrate was unknown. The outcome of event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
myocarditis; This is a spontaneous report from a non-contactable other HCP via a Pfizer sales representative. A 28-year-old patient of an unspecified gender received second dose of BNT162B2 (Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Unknown if diagnosed with COVID-19 prior vaccination, and unknown if COVID-19 tested post vaccination. The patient was diagnosed with myocarditis following second dose vaccine on unknown date. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was seen at a Medical Center for treatment and diagnosis. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of Myocarditis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temepratures:34F (1.111 Celsius degrees) for 64 hours and 33 F (0.555 Celsius degrees) for 16 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 3:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 3:22 PM, 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 31.45.  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-MAY-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45 and 4 PM: 44.  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 Fisher brand 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.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received 2 doses of Janssen COVID vaccine erroneously. First Dose on 6/23/21 and second dose on 7/1/21  No known side effects.
Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Developed a rash five days after vaccine and was diagnosed with shingles six days after vaccination. Took Enbrel and methotrexate two days after vaccination.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown) (lot number not reported, expired date 27-APR-2012) on 27-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Severe shivering during the night after the injection with temperature of 97.1 intermittent fatigue, dizziness, and sleepiness continuing for 5 days after the injection. Headache for 4 days after the injection.
Large swollen painful lymph node udder the right arm and left arm also impacted to a lesser extent
12hr p/vax became pale, somewhat limp for estimated 102min;lips lost color color returned w/o any intervention;also had harsh whiny cry prior to event;
Onset of symptoms noted by mom over 24 hrs after vaccines administered-c/o headache and swollen arm (L)-red area size of grapefruit and elevated area size of quarter-TYLENOL given & heat applied. Recovering well 48hrs after vaccines.
After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 006B21A and 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.). At the time of the report, EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.) outcome was unknown.            Treatment information for dose 3 event was not provided. Reporter states lot number of the Moderna COVID-19 booster vaccine: 059H21A but she says it may also be 054H21A.   This case was linked to MOD-2021-435946.
I have been sick for 3 days; runny nose; Diarrhoea now; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick for 3 days), RHINORRHOEA (runny nose) and DIARRHOEA (Diarrhoea now) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (I have been sick for 3 days), RHINORRHOEA (runny nose) and DIARRHOEA (Diarrhoea now). At the time of the report, ILLNESS (I have been sick for 3 days) and RHINORRHOEA (runny nose) outcome was unknown and DIARRHOEA (Diarrhoea now) had not resolved.            No concomitant medication were reported. The treatment information were unknown.
The second dose was given early on 8/3/2021. It should have been given 08/12/2021. No complications.
Received Pfizer vaccines on 1/18/21, 2/8/21; tested positive for COVID-19 by PCR on 7/12/21; known exposure to COVID, beginning 7/6/21 had New sore throat, New cough, New shortness of breath, New headache, New loss of smell; received monoclonal antibodies on 7/14/21.
Pain in arm; unable to lift arm at all.  Ice, acetaminophen.  Still taking acetaminophen 09/27/15 & still unable to lift arm over her head.
My daughter explained she had a lump under her arm pits. Doctor told us to put hot towel under arm. The lump is still there just does not hurt as bad.