chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:26 AM, 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 (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.27.  No concomitant medications were reported.  Batch number 025L20A administered on 07-Jan-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-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 traceable temperature monitor at every hour.  No treatment medications were reported.
Tremoring distonic movements associated with hypotension, abnormal movements persisted after hypotension resolved. Pt was sent to hospital by ambulance.
urticaria-widespread-Lg welt like hives arms and legs worst areas Dry mouth, feels tongue feels thick onset 2 hr after injection for 48 hrs then improved
Mom states pt recvd vax w/o problem, but began persistant crying x 2.5 hrs; no other problems noted;  MD was called, but visit to MD not necessary; Pt fine p/crying episode over;
08/27/22 presents to  ED for "generalized weakness". PMHx of "Anemia, Dyslipidemia (high LDL; low HDL), CABG, Hyperlipidemia, Hypertension, Kidney disease, and Osteoporosis"
8 hours post injection Patient reported pain in chest, feeling like her heart was working extra hard. Checked her fit bit in the morning and her normal heart rate is 60 but dropped down to 40bpm during episode. Also felt flushed.
Patient reported feeling a bit of chest pain after receiving her covid Pfizer vaccine. Did not report any trouble breathing or redness/ itching.
Pt recvd vax on 13AUG92 & next day devel nausea & weakness; 15AUG92 vomit x 2 & diarrhea & sharp epigastric pains; 16AUG92 devel t101, generalized body aches, felt weak all over; 17AUG92 fever remitted; extreme weakness, s/nausea;
Information has been received from a physician concerning an infant who on an unknown date, was vaccinated with a dose of ROTATEQ, oral (dose, lot number not reported). On an unknown date, the patient had a bloody stool and was hospitalized. Therapy with ROTATEQ was discontinued. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Five minutes after getting the shot, I felt a wave of dizziness descend over me, my heart began to pound very hard and fast, and a sensation of heat came over me along with flushing into my face. It lasted about 60 seconds, but I did not lose consciousness and it didn?t progress to anything more. It then began to subside. I felt a couple more small surges of dizziness in the following 20- 30 minutes.
No adverse event; Bivalent doses administered after the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD).    No concomitant medications were reported.  It was reported that, the patient received bivalent doses after the beyond use-by date.  No treatment medications were reported.
My son felt light headed, had loss of hearing and vision and passed out. Came to and passed out again. This happened 3 times and lasted for 30 minutes.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received BOOSTRIX (batch number Z9Z4Y, expiry date 2nd July 2018). On 29th February 2016, the patient received BOOSTRIX (intramuscular). On 2nd March 2016, 2 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX in left arm and experienced injection site pain. On 17th May 2016, the patient presented back to the pharmacist and indicated that the arm pain was existing and it became worse with stretching of the arm. The patient inquired the pharmacist how long the pain would last.
I developed a rash all over my body but not on the face,  about three weeks ago, like pimple sized, they itch a lot even in the night. The hospital didn't even know what it was from. I was given an antibiotic shot for the rash and I put lotion on it each day. I also have a congestion in my lungs since the rash began.
dose administered after 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported 2nd dose was stored on the refrigerator since 10 Aug 2021. No concomitant medications details were reported. No treatment information details were reported.
Nausea, welts on right upper arm with pruritic rash that spreads down to right wrist.
arm pain in left shoulder blade; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date: unknown), via an unspecified route of administration, administered in left arm on 17May2021 (at the age of 21 years old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced arm pain in left shoulder blade (which was reported as worsened) on 18May2021. Patient had tried to treat the pain with Ice and Tylenol, but nothing was really getting rid of the pain. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large local inflammatory reaction on left upper extremity, warm to touch, pink color, pruritic.
Unknown exactly which Influenza vaccine was administered at the pharmacy. Patient reports that within 2-3 hours of vaccine administration that his eyes were throbbing and there was pressure around his eyes, he reports an onset of double vision that worsened upon standing and ambulating. Patient reports symptoms persisted  in the morning with double vision only, throbbing and pressure had improved, but double vision is significant.
Admitted 1/7/22 to 1/9/22 to Hospital for acute ITP in setting of MMR + Varivax vaccines on 12/22/21 and Viral URI (pos for RSV) Presented with petechiae, purpura, ecchymosis and platelet count of 2 thousand.
First dose administered 1357, 08/09/21 Second dose administered  1733, 08/09/21 Med error
Immediately following the vaccination, I was sick -- extreme fatigue, fever, brain fog. In June, I had a cerebral infarct, which is a stroke.
Patient has a episode of syncope with incontinence following her vaccines. Syncope occurred within 10 min after receiving her vaccines. She also experienced a blood pressure decrease and pallor. She gradually regained normal activity after taken to exam room for rest.
Pt was given the covid-19 vaccine for ages 6 mo - 5 yr that was approved for 1st and 2nd dose as the 3rd dose on 2/16/23 in stead of the bivalent covid-19 vaccine that is now approved for the 3rd dose.  No adverse effects to the patient.  This vaccine previously approved for the 3rd dose in the series until the Bivalent vaccine replaced it.
DIZZINESS; BODY ACHE; CHILLS; HEADACHE; FEVER; PAIN RADIATED TO THE BACK; STINGING SENSATION; FELT TERRIBLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,  expiry: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 17-MAR-2021, the subject experienced stinging sensation. On 17-MAR-2021, the subject experienced felt terrible. On 17-MAR-2021, the subject experienced pain radiated to the back. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging sensation on 23-MAR-2021, and felt terrible, dizziness, body ache, pain radiated to the back, chills, headache, and fever. This report was non-serious.
Patient started having rapid heart rate and heaviness. She requested water, and she was given 25 mg liquid Benadryl. Her heart rate was 180/100. She was taken to the er at children?s hospital, checked by a physician, then transported to the adult er.
FELT UPSET; FELT DEPRESSED; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced felt upset, felt depressed, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt upset, felt depressed and suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220301169.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
pt recv vax & became preg LMP 9/19/97;expected date of delivery is 6/26/98;mom delivered a nl healthy male on 6/26/98 birth weight was 8lb 1oz mom had cesarean section delivery for failure to progress & cephalopelvic disproportion;
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment drug information was not given.
pt presented to pharmacy 3/23/21 with a half dollar sized hard mass. Pt complained about itching at the site the day after vaccination, site still was red to pink 15 days after injection, injection site was extremely sore but has improved and pt has more arm mobility...pt refused to go to dr, ..pt was concerned that everyone else he knows has improved and his arm is still sore
Moderna 7/14/21, 8/17/21, 2/21/22. Positive on 12/22/22
Emp presented 20 minutes following flu shot complaining of chest tightness, facial flushing, throat constriction and profuse sweating. Escorted employee to the ER for further evaluation. Due to history of cardiac disease, Cardiologist consulted in ED and took employee to Cath Lab. Provider notes indicate that cath was clear and that "this episode of angina is not related to his coronary artery disease. Cannot rule out that this was a reaction to the recent influenza vaccination he received." No rash was present. No epinephrine administered. Symptoms resolved same day.
Pt presented to the Immunizations clinic with a noticeable rash.  Pt states he woke up with the rash all over his body. Denies using or trying anything new. Did not have any other symptoms at the time he presented to the clinic.
No additional AEs; Temperature excursion for VARIVAX. Product was administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX), injection, that had suffered a temperature excursion (product storage issue) (lot number W025277 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date has been established as 10-AUG-2024), administered for prophylaxis (strength, and route of administration were not provided).
Took the 1st shot around 10:30am, I fainted and possible seizure at 8pm.  By the time I received the 2nd shot I noticed a bump on my chest growing more than like a bite or pimple.
Patient received his second dose 7 days from the first Pfizer dose, he was supposed to have 21 days in between.
Patient did not have any adverse effects or symptoms after receiving the ROTATEQ; a dose of ROTATEQ was given after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 11-APR-2022, the patient received a dose of rotavirus vaccine, live, oral, pentavalent therapy (ROTATEQ) 2 milliliter once, orally as prophylaxis (lot # 1707502 with expiry date 31-MAR-2022) after its expiration date (Expired product administered). The patient did not have any adverse effects or symptoms after receiving the rotavirus vaccine, live, oral, pentavalent therapy (ROTATEQ) (no adverse event).
Started feeling bad 12/17/2022; severe headache body ach;cough; fever and fatigue.
88-year-old female with H/O HTN, COPD, CAD, AFib on Coumadin, COVID 19 positive few days ago, brought into the ED C/O fever and shortness of breath.
This case was reported by a consumer and described the occurrence of pneumonia in an adult male subject who was vaccinated with influenza virus vaccine (unknown manufacturer) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza virus vaccine (unknown). At an unspecified time after vaccination with Influenza virus vaccine, the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Fever (39.7 degrees Centigrade); This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 17Apr2021 at 11:30 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 10:00, after about 18 hours after vaccination, the patient developed fever (39.7 degrees centigrade) that lasted about two days. On the second day, fever and temperature was much reduced. After two days, the fever was completely cleared. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever (39.7 degrees centigrade) was recovered on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown demograpgic patient who was vaccinated with a dose of vaccine PENTACEL which had been left outside of refrigeration for one week (lot UJ082AAA) Exp. Date, route and administration site not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Onset of chills approximately 3-4 hours after injection. Duration = 6 hours.
No additional adverse events reported; the patient was administered a dose of VARIVAX on 12/30/2019, that had been improperly stored; This spontaneous report was received from an office manager and refers to patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (lot # S021926, expiry date: 15-JUL-2021; exact dose, dose number, route and site of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date and route of administration were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes. There were no previous excursions related. Data logger was involved.
Pt developed SOB, presented to the ED and tested positive for COVID 19.  She was admitted to inpatient care, non ICU.
Case number PHEH2014US003635 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. IT was reported that this patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Pt devel high fever p/recving Tetanus Toxoid Adsorbed; 2 wks later, pt was admitted to hosp w/lower back pain & creatinine increased to 4.8mg/dl; renal biopsy showed tubular interstitial nephritis; rx: steroids & Motrin; fully recovered;