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 PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021 ) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021 ) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 03-Apr-2021 at 9:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:13 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, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021 ) 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 58.20 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 3-Apr-2021 with temperature range of 34 Degree Fahrenheit from 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. Product moved to clinic on 3-Apr-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
CHILLS AND SHIVERS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced chills and shivers. On 26-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the chills and shivers and fever was not reported. This report was non-serious.
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
Muscle aches; Nausea; Mild fever; vaccination site pain; Headache started 24 hours later after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MYALGIA (Muscle aches), HEADACHE (Headache started 24 hours later after second shot), NAUSEA (Nausea) and PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included DULOXETINE, BUPROPION, EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL and EXENATIDE (BYDUREON) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Headache started 24 hours later after second shot). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 02-Apr-2021, the patient experienced MYALGIA (Muscle aches), NAUSEA (Nausea) and PYREXIA (Mild fever). On 02-Mar-2021, HEADACHE (Headache started 24 hours later after second shot) had resolved. On 01-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 03-Apr-2021, NAUSEA (Nausea) and PYREXIA (Mild fever) had resolved. On 04-Apr-2021, MYALGIA (Muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol to help side effects after the second dose.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on 23-Jan-2013. It was reported that the patient was administered expired FLUMIST. The outcome of the event of EXPIRED FLUMIST ADMINISTERED is unknown. The report was considered to be non-serious. Corrected report 02-Apr-2014: The field new valid case is ticked as No.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX23 (dose, unit and route not reported, lot # L014458 and expiration date 11-FEB-2017). The vaccines were exposed to 34F for 30 minutes, previous temperature excursion included 55F for 16 hours and 34F for 2 hours. No adverse symptoms were reported. This is one of several reports receive from the same reporter. Additional information has been requested.
I had no symptoms at all until the next morning when I woke up with a horrible backache. For all that day and the next day I was lethargic,  just wanted to sleep, had mild bodyaches, and a very slight headache.  not bad at all, especially compared to COVID-19!
Burning and very painful. Arm got stiff. Started having hives. Ran temperature was delirious on Friday night and half on Saturday.
experiencing headaches in the last 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), when the patient was 44 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experiencing headaches in the last 2 days".  Additional information: The patient stated he just had second his Pfizer shot on Saturday and has been experiencing headaches and Wanted to know if this is normal. The patient was asking whether he could take Tylenol or Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 12 hrs of vax pt became lethargic, limp, lips white, irregular breathing; observed in ER for 12 hrs improved condition discharged home; apparent SIDS w/in 12 hrs; prev hx of SIDS in half sib @ 6 wks of age; t98 @ time of vax-no temp;
This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was unknown. On 13-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot number: J009827 with expiry date of 10-AUG-2014) (0.5 ml) intramuscularly. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Starting at 11:30pm started feeling queezy; then got chilled. The chills turned into shivering & body shaking & teeth chattering. Neck muscles & jaw muscles hurt. Dressed in polar fleece jammies, socks, flannel bed-sheets, two heavy duvets & couldn't get warm nor stop the shaking. Tried standing to walk it off but legs were like jelly.  Tried bio-feedback to relax & stop the shivering but it just continued in wave after wave. My chest tingled and my heart felt like it was working hard. It subsided around 4:30a.m. The next day felt 'punk' muscles still jelly like & jaw really ached from chattering. The 2nd day was fine.
12 hours after receiving vaccine, pt got a total body rash.  A little while later she experienced uncontrolled shaking.  Patient went to the Emergency room and was prescribed steroids for her rash.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 27-SEP-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose and route not reported) (lot # L036851 and expiration date 23-SEP-2017) for prophylaxis. There were no adverse events.
I smell smoke, like a cigarette type of smoke, but no one smokes in my house. This started happening about 4 hours after I took the 2nd dose. Two days later and I still smell it. It very persistent.
ACUTE RESPIRATORY FAILURE 12/31/2022 HX OF HIP PATHOLOGICAL FX
Client states on Saturday, 2/20/2021 started itching all over back and arms and developed a rash, bumps on left side. Symptoms started about 24-36 hours after 2nd covid vaccine received.
Within 15 minutes of the Janssen injection, I felted light headed and dizzy which became much worse with disordered speech, confused thinking, uncontrollable laughter and hallucinations.     I walked down my road singing and laughing just total delirium.    Maybe  bad choice of word but I don't know how to completely describe the disorientation.    My son, helped me get back home in which I laid down on the grass and just stared at the sky. My son, assisted me in to my home in which I slept several hours and woke up about 8:30 pm.      I feel embarrassed of my behavior although I know for a fact it is correlated to the vaccine shot.
Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completio of Paxlovid tested negative.; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 03Sep2022, outcome "unknown", described as "Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completio of Paxlovid tested negative.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Aug2022) Negative, notes: Two days after completion of Paxlovid tested negative; (03Sep2022) Positive, notes: Rebound of covid by home test 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical Course:Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completion of Paxlovid tested negative.Known allergies No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given the flu shot Firday, September 11, 2020 and immediately noticed some discomfort. He has not been able to move much of his arm after cold compresses, ice, and multiple pain medications. Patient called the pharmacy Wednesday, September 16, 2020 to tell us about the incident. I asked them to come to the pharmacy. After seeing the location of the injection, I advised the patient to see his primary care doctor.
CHILLS, NAUSEA, HEADACHE, RIGHT ARM HURTS REALLY BAD
This spontaneous report has received from a pharmacist referring to a currently 66 year old patient of unknown gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not reported. The patient received PNEUMOVAX 23 (dose, route, strength, batch/lot # and expiration date were not reported) on an unspecified date in 2014 for prophylaxis, PREVNAR 13 (dose, route, strength, batch/lot # and expiration date were not reported) on an unspecified date in 2017 and PNEUMOVAX 23 (dose, route and strength were not reported; lot # N029303, expiration date 21-APR-2019) on 04-SEP-2018 for prophylaxis. No adverse effects were reported.
Twenty days, post vax, pt developed a pruritic varicella-like rash with scattered vesicles on her extremities, thorax and mid back. Pt also experienced a fever of 99.2F.
Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021.  Pt pain became worse despite treatment and then started to have lower ext wkness and numbess and unable to walk.  Pt also had loss of hearing Diagnosed with Guillain Barre syndrome while in the hospital by a neurologist
15 min p/vax pt became dizzy & began to shake; was brought to infirmary & told to rest; pt went back to work & became dizzy again & fainted; was OK for 1 hr, then dizzy, fainted, began to shake again; nauseated; brought to infirmary;
Patient states that shortly after being vaccinated with COVID19 vaccine, she developed an itchy feeling all over her body. She states that today the itching is now only to her hands.
Patient had severe pain at site of injection that has not resolved since vaccine administration. Guest unable to sleep.
sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 22-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for deafness neurosensory was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The deafness neurosensory was a disabling event according to the reporter.  Upon internal review, the deafness neurosensory was considered a medically significant event.
This case was considered medically important. Information regarding PREVNAR 13 was received from a nurse regarding a 5-year-old male patient who experienced anaphylactic reaction. At 5 years of age, the patient received a dose in Jun-2010. The patient also received a dose of PROQUAD (Merck & Co Inc) in Jun-2010. The patient experienced anaphylactic reaction on an unknown date in Jun-2010. He returned to the office shortly after the vaccination. He was treated with an "EPI-PEN" and oxygen; 911 was called and the child was transported to the Emergency Room. Three more injections of epinephrine were administered. It is unknown if the child was admitted to the hospital. Anaphylactic reaction resolved on an unknown date. No additional information was available at the time of this report.
Redness and burning in eyes, followed by shaking chills and fever with headache and fatigue.  Lasted 24 hours
mom called 2JUL92 & stated pt has red, swollen hot area on lt upper arm, increasing in size x last 5 days; state pt is fussy; seen by MD 1JUL92 who stated looks like rxn to vax; mom advised to consult w/MD for eval;
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY
itchy; vaccination site is very red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (vaccination site is very red) and VACCINATION SITE PRURITUS (itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site is very red) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site is very red) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Case number PHEH2013US016359, is an initial spontaneous report received from a nurse on 30 Jul 2013. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced cellulitis. The outcome was reported as unknown. The seriousness and causality of the event were not reported.
I am pre-menopausal but began getting my period again-period  continued every month for 4months muscle aches, joint pain, insomnia and vision issues- tired and blurry
Generalized itching; Generalized hives; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Generalized itching) and URTICARIA (Generalized hives) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 012A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PRURITUS (Generalized itching) and URTICARIA (Generalized hives). At the time of the report, PRURITUS (Generalized itching) and URTICARIA (Generalized hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were given.  Patient was trying to find out whether hives are possible reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received included non significant information. On 17-Nov-2021: Follow up received included patient demographics, vaccine details, concomitant medication and events start dates.
Systemic: Seizure-Severe, Additional Details: Pt had vaccine at 12p and 3 hours later at a family gathering, stated she was talking to others and then awoke to paramedics. She was informed she had had a seizure and was convulsing. She states she is recovered and is unsure if vaccine was the cause. She did have tumor removed years ago but hadnt had seizure since.
Saturday night (vaccine given Saturday) patient experience flushing. Then her arm turned red and had spots around it and was bruised. Advised to treat with BENADRYL and ibuprofen.
COVID-19 INFECTION; INFLUENZA B INFECTION; This spontaneous report received from a patient concerned a 61 year old female. 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 and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced covid-19 infection. On 31-MAR-2021, the subject experienced influenza b infection.  Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE, and Influenza B virus test (NR: not provided) POSITIVE. Treatment medications (dates unspecified) included: ascorbic acid, azithromycin, colecalciferol, and oseltamivir phosphate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection, and influenza b infection. This report was non-serious. The case was associated with a product quality complaint number: 90000175465; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sudden appearance of chills/shivering which lasted for approximately 30 minutes.  In the night, around 2 am, during and after a bathroom visit a feeling of lack of muscle strength/use in both arms and legs which seemed to last for about an hour.  General lethergy throughout the following day.  Treatment - 2 aspirin, rest.  Outcome - now 4 days later and no sign of any problems.
stomach pain, stomach feels hot, chills, watering @ mouth like needs to vomit;
PATIENT HAS REPORTED FEVER, CHILLS/SHAKING, NAUSEA/VOMITING AND MISSED WORK FRIDAY THRU MONDAY DUE TO REACTION. LEFT ARM DECREASED FUNCTIONING DUE TO PAIN/SWELLING/REDNESS.