chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:53 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 70.41.  No concomitant medication was reported by reporter.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 11:00 AM and 29 degrees Fahrenheit at 9AM . This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time 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 by using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Red area on right leg, swollen with 3-4 small blisters around injection site, per mom. Applied cool wash cloth to area. No fever noted, per mom.
This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 36-years-old) as single dose for COVID-19 immunisation. The medical history includes RSD (Reflex sympathetic dystrophy). The patient is Allergic to soy, nuts (not extreme allergy). Concomitant medications were not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021, as a single dose for COVID-19 immunisation. On 17Mar2021. the patient experienced Pain in whole upper arm which received the shot. Feels like a rock or inflated balloon. The clinical outcome of the Pain in whole upper arm which Felt like a rock or inflated balloon was unknown.  No follow-up attempts are possible. No further information is expected.  Amendment (15Jun2021): This follow-up report is being submitted to amend previously reported information which includes: protect confidentiality checked since reporter is the patient self, for relevant med history#01 the verbatim were updated, for historical vaccine with BNT162B2 1st dose: age/units captured as 36 years per vaccination date and DOB, "known_allergies: soy, nuts (not extreme allergy)" was added as relevant med history.
Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 18-OCT-2016, at age 66, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
I had a breakthrough COVID Case: 01/05/2022 I was positive for two weeks. I went to the emergency room, and they did X -rays and found that I did develop Pneumonia. I was given Zithromax and Prednisone for six days.  I had an oxygen concentrative, and I had to wear a nasal canulae for a week. I am still having congestion and breathing trouble.
watery eyes itching redness in both eyes; watery eyes itching redness in both eyes; watery eyes itching redness in both eyes; blurred vision; This is a spontaneous report received from a contactable consumer (patient's spouse) for a male patient of unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Mar2021 the patient experienced watery eyes itching redness in both eyes, and blurred vision. Patient started with eye drops and by Tuesday vision was restored to normal. The outcome of the event blurred vision was recovered on an unspecified date, and other events was unknown.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324852 Same reporter/ drug /AE, different patient
Patient presented to pharmacy today 11/28 complaining of muscle spasms and joint pain since receiving her flu vaccine in October.
Rash on left arm-starting at injection site and going down entire arm. Itching and irritation noted.
pt recvd vax 10AUG93 & immed following vax pt became cold & clammy, weak & very faint, p/lying down for 10 mins stood up & exp the same sx; fifty mins later pt felt well enough to leave MD's office, BP nl;
Pt came back after about 25 mins from injection stating she did not feel well. Symptoms included flushing, nausea, and general not feeling well. When ask if she had symptoms like this before, pt said yes it is on and off. Patient admits that she feels like when she has not eaten. Pt admitted to not eating today before shot and it was likely due to that.
Hives, rash, fever daily. Been put on hydrocortisone cream and cetirizine. Was tested for mycoplasma which came back negative. The hives and rash spread all over his body and last 3-4 hours and then go away for about 8 - 10 hours and then repeat.
pt recvd vax & had fever x 5 days; inc 103.7; rash x 2 wks; poor apetite; irritable;
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Swelling in arm, redness previously, Chest pains on the 29th , and this morning had problem with breathing and temp 103.9.
RESTLESSNESS; TROUBLE KEEPING EYES OPEN; LACK OF FOCUS; MOTOR SKILLS WERE AFFECTED; MUSCLE SPASM NEAR LYMPH NODE; LYMPH NODES SWELL; SHIVERING; WEAKNESS; BEDRIDDEN; DIFFICULT TO LIFT ARM; FAST HEART BEAT; PAIN IN ARM; COULD BARELY MOVE; NAUSEA; CHANGE IN SMELL; CHANGE IN TASTE; DISORIENTATION; DIZZINESS; JOINT PAIN; CHILLS; FEVER; MUSLCE PAIN; HEADACHE; FATIGUE; INJECTION SITE PAIN; TINGLING; STINGING; FEELING NOT RIGHT; DIFFICULTY DRIVING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tingling. On 12-MAR-2021, the subject experienced stinging. On 12-MAR-2021, the subject experienced feeling not right. On 12-MAR-2021, the subject experienced difficulty driving. On 12-MAR-2021, the subject experienced injection site pain. On 13-MAR-2021, the subject experienced change in smell. On 13-MAR-2021, the subject experienced change in taste. On 13-MAR-2021, the subject experienced disorientation. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced muslce pain. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021 18:00, the subject experienced pain in arm. On 13-MAR-2021 18:00, the subject experienced could barely move. On 13-MAR-2021 18:00, the subject experienced nausea. On 14-MAR-2021, the subject experienced fast heart beat. On an unspecified date, the subject experienced restlessness, trouble keeping eyes open, lack of focus, motor skills were affected, muscle spasm near lymph node, lymph nodes swell, shivering, weakness, bedridden, and difficult to lift arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling, difficulty driving, chills, fever, and headache, and nausea on 13-MAR-2021, was recovering from fatigue, disorientation, dizziness, injection site pain, muslce pain, and joint pain, had not recovered from fast heart beat, and change in smell, and the outcome of stinging, feeling not right, pain in arm, could barely move, restlessness, trouble keeping eyes open, lack of focus, motor skills were affected, muscle spasm near lymph node, lymph nodes swell, shivering, weakness, bedridden, difficult to lift arm and change in taste was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000173045. The suspected product quality complaint has been confirmed to be void (does not meet criteria) based on the PQC evaluation/investigation performed.
Patient received H1N1 Vaccination at mass clinic run by the Health Department. Onset following day post vaccination, of pain in upper left arm. Painful to lift arm, extremity is weak and unable to lay on arm when sleeping. Symptoms still persisting 1/13/2010 when contacted VAERS reporter. States can only raise arm approx 45 degrees without pain. Has taken periodic pain relief medication but symptoms still persist. Advised by VAERS reporter to contact family physician for evaluation on 1/13/2010.
Aches /all night I had aches; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Cardiac problems and irritability, arrhythmia-type.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills). In April 2021, PAIN (Aches /all night I had aches), PYREXIA (Fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 104 (High) 104. In April 2021, Heart rate: irregular (abnormal) Some kind of irritability that was irregular beating of the heart. Did not continue the next day..         Concomitant medications were  not provided.  It was reported that the patient had bad reaction after the second dose. She experienced aches, fever and chills. All night she had aches. She experienced some kind of irritability that was irregular beating of heart , arrhythmia type at that night and she could only lie there and sleep because the fever and chills were so bad. The cardiac stuff did not continue the next day. Within a couple of days, she was fine.  Treatment information was not provided.
During a mass flu clinic for adults and children, a child received Fluarix, meant for adults 18 years old and older, by mistake.  No known adverse events. No adverse event occured.
Pt noticed itching and redness to injection site, bigger than 50 cent, on 10/23/04 at around 8:30AM. Pt called today and advised to take Benadryl 25  ever 5 hours no SOB or any resp distress, no fever. Advised to call all if symptoms worsens. Treatment just started today (10/25/04)
2-3 weeks after vaccination patient started with weakness in both legs, general fatigue, progressive weakness in both arms, progressive dysarthria, and fasciculations in both upper arms. Patient followed up with neurologist but did not improve. Patient now has pending appointment with Neurology.
a little swelling in the arm; her arm was a little sore afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single and administered in arm right, administration date 15Apr2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: 2018 (ongoing); "Mitral valve replacement", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "a little swelling in the arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was a little sore afterwards".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner concerning a 22 year old female who on 13-MAY-2008 was vaccinated with a first dose of GARDASIL IM. On 13-MAY-2008 the patient experienced a seizure after receiving GARDASIL. The patient was found on the floor, in the fetal position with her hands drawn up to her chest, was shaking and bit her tongue after receiving GARDASIL. The same thing occurred when the patient was at the dentist. The nurse practitioner suggested that the patient go to the emergency room (ER), but declined. The patient was fine before leaving the office and drove home. At the time of reporting the patient had recovered on an unspecified date. Upon internal review seizure is considered to be an other medical event. Additional information has been requested.
I suffered some type of allergic reaction in which the glands in my throat swelled, which resulted in difficulty swallowing and labored breathing. Although the swelling decreased after a day, I still have difficulty swallowing and experience occasional shallow breath. This has made use of my CPAP for sleep apnea incredibly difficult. I need to keep the CPAP on its highest setting, but this causes my nasal passages to dry out to a point where swallowing becomes impossible. When this has happens, I have awake in a panic until my ability to swallow resumes.
about 13 hours after getting vaccine, pt woke up shivering/shaking violently--reported as "almost felt like convulsions" lasting more than 1 hour.  he almost called 911 ----pt was extremely nauseous and took pepto-bismol.  never vomited.  also had a massive headache.  felt like he had a fever, but took no temp.  went back to bed.  did not sleep well.  reported every muscle in his body being very sore, from head to toe for the next few days.
Patient came into the clinic to receive the Moderna Bivalent but was inadvertently given the Moderna pediatric 0.5 mL dose. Health Department, CDC and Moderna Helpline were notified this same day for guidance. Patient was notified same day of the error.
No additional AE.; Patient was administered improperly stored PROQUAD on 03/12/2021.; This spontaneous report has been received from a nurse, concerning a 4 years old patient of unknown gender.  The patient's past medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 12-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA) (PROQUAD) (product storage error) (strength, dosage, anatomical location or route of administration were not provided) lot # T025221 with expiration date on 19-JAN-2022, for prophylaxis. The storage temperature was -12°C for a time frame of 6 hours and 30 minutes. There was no previous temperature excursion. No additional adverse event (AE) was reported. Digital data logger was involved. The outcome of product storage error was unknown.  This is one of several reports received from the same reporter.
Tired, groggy, weak. Went away in about 8-12 hours.
I have filler (Voluma) in my cheeks and Jevederm Ultra in my lips. My cheeks have been swollen for 3 days. They feel a bit numb and hurt when I smile. I started taking Benadryl yesterday and it has not done anything. My lips are slightly swollen but they are not bothersome. My cheeks are more swollen than when I had the procedure done in June 2020.  I noticed the swelling on Friday 4/16/2021, a week and a half after my shot.
2 days after vaccines pt began crying on and off for a period of 10 days. No further problems after that. Mom says she has been crying for 10 days constantly.
Leg fatigue (felt like I had run a half marathon) first in the evening. Severe headache began overnight and lasted until 24 hours from injection. Treated with Tylenol, 2 pills, every 6 hours
Hypotonic-hyporesponsive, pallor episode, lasting minutes, within one hours of vaccines.
Headache, Myalgia, NauseaVomiting, "arm pain"
chill; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chill) and PYREXIA (fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chill) and PYREXIA (fever). At the time of the report, CHILLS (chill) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
The patient did not experience an adverse event in relation to receiving the COVID-19 vaccine. The patient was age 11 years 7 months at the time vaccine was administered, as her documentation form was filled out incorrectly and guardian had verbalized patient was twelve years of age.
A 1 1/2" x 1/4 in indent is located on the pt's (L) thigh. Parent noticed it for the first time 6-14/10. Saw PCP today. He believes it may be due to H1N1 vaccine dose #2. Thinks the vaccine deteriorated the muscle tissue. Pt. has no decrease in movement or pain.
Employee reported feeling both hot and cold, shivering, sweating, and lightheaded approx. 1 hr after vaccine was given. No treatment was provided as employee was at home at the time of the reaction. The employee states that the symptoms lasted about 7 hours.
Tremors in upper body, lasting <1 minute (occurred on 01/05/2012). No treatment. Decreased appetite (began 01/04/2012, continues to date) No treatment. Extreme fussiness/prolonged crying (>3 h) began 01/05/2012, continues to date.  Cries high pitched, short, sharp cries as if in pain, though no external source of pain or discomfort can be found.  Treating at home with touch, massage, frequent contact, and other reassuring measures.  No medical treatment yet.
Myalgia Loss of smell, generalized weakness Narrative:  Received COVID-19 VACCINE on 12/23/2020. 24 hours after receiving the vaccine I had body aches, loss of smell and general weakness. All symptoms are gone except I still have loss of smell and easily get tired. Other than that I am feeling ok (12/282020).
Case number PHEH2012US020831, is an initial spontaneous report received from a physician on 10 Oct 2012. This report refers to patient of unknown age and gender. The patient was vaccinated with MENVEO (batch number: unknown) intramuscular into the left arm, on 06 Oct 2012. On the same day has begun swelling in the arm. Event outcome, seriousness and causality assessment was not reported.