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 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 8:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:38 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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.   Patient age was reported as 62.07. No concomitant medication was reported by reporter. Batch number 025C21A underwent temperature excursion on 24-May-2021 with temperature 35 degrees Fahrenheit at 08:00 AM and 35 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 03-May-2021 and beyond use date for the vial was reported as 02-Jun-2021. Product moved to clinic on 24-May-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 Fisherbrand 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
chest tightness shortness of breath fatigue sore at site of injection abdominal pain lose stool nausea
Sore arm; 100.6 fever; Chills; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route in the right arm on 13Apr2021 at 13:30 (at the age of 45-year-old) as single dose for COVID-19 immunisation. Medical history included HPV (human papilloma virus) oncogenic type 16/18 and severe dysplasia in pelvic areas. Concomitant medications included paracetamol (TYLENOL EXTRA STRENGTH), dextrin (BENEFIBER) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route in the right arm on 19Mar2021 at 13:30 (at the age of 45-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 13Apr2021 at 20:30 hours, the patient experienced sore arm, 100.6 fever, chills and sweats. The events 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 events. The clinical outcome of the events of sore arm, 100.6 fever, chills and sweats were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
"Moderna COVID-19 Vaccine EUA".   Fever - 101.4, chills, headache, nausea, aches.  Arm extremely sore.  Fever lasted a few hours, other symptoms lasted over 2 days from start.
Swelling in my sinuses as well as swelling along the roof of my mouth and the back of my throat. Extreme soreness in left arm radiating across shoulder blade as well as up the left side of my neck. Nausea/vomiting after eating.
The pt's father described limpness, eyes rolling up, clenching of hands and feet. Took to doctor and given meds; Naproxene suppositories for fever. On 05/10/2002, afebrile, throat, ears injected active.
5/9 Cellulitis left arm s/p Tdap placed on Keflex per clinic & now doing well.
I experienced after my vaccination arthritic pain, muscle pain, headaches. I went to see my doctor because the pain became intense. I also had left arm pain, fatigue and pain in my joints. I did not receive treatment right away and the doctor told me to take my regular chronic prescription medications. They did take away vitamin B12 completely and I am only taking vitamin B1 and B6. I had lab work down and urine analysis. They did a stool exam to check for cancer. They also did thyroid levels, kidney levels, they checked for tuberculosis and all exams were negative. They also did a mammogram and ultrasound of the right breast due to a nodule. I have a biopsy pending due to my nodule in my right breast. My glucose is controlled. I still have left arm pain that comes and goes, continue with headaches daily. I do stretching exercises and walk three times a week.
Hi,  I have a very regular menstrual cycle. My previous cycle of periods end on 4/10/21, which was the day of my 1st vaccine. I had the PSM on around 5/4/21. Since I took the vaccine on 5/7/21 my PSM feeling had gone and I didn?t have menstrual bleeding too. I am a bit concerned as something like this never happened. A few days after PSM I have my regular periods. I am definitely not pregnant too.
This spontaneous report as received from a pharmacist via field employee refers to 2 patients of unknown age and gender.  Information regarding the patients current condition and medical history was not provided. On an unknown date (a while ago) the patients were vaccinated with ZOSTAVAX, vial, dose, lot number unspecified. On an unknown date the patients experienced shingles. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was reported as recovered/resolved. The causality assessment was not provided. This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.
8-12hr post vaccine -> night sweats, 2 days post vaccine -> rash.
Began experiencing chills; Began experiencing fever; Muscle pain in back; Joint pain in back; Very weak; Tired; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on an unknown date in May2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications which were unknown within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on an unknown date in Apr2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10May2021, roughly 12 hours after the second dose, the patient experienced chills, fever, muscle joint pain in the back and felt very weak and tired. The patient took a hot bath and ibuprofen (ADVIL) and fell asleep. The patient reported that the symptoms resolved within four hours of onset. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with hot bath and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events fever, chills, muscle pain in back, joint pain in back, very weak and tired were resolved on an unspecified date in May2021.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
THE PATIENT RECEIVED 0.25 ML OF THE MODERNA BIVALENT VACCINE INSTEAD OF 0.5 ML ON 9-6-2022.
I had my vaccination on 11/25/2022. On 04/06/2023 I started to have a scratchy throat with a cough. I had shortness of breath. I went home and started to feel really achy. I tested COVID-19 Positive on 04/06/2023. I lost my taste and smell on 04/07/2023. I had fatigue exhaustion with sneezing as well. I was not given a prescription but advised lots of rest and hydration. I am still having shortness of breath cough congestion and fatigue on 05/30/2023. I am now using a Nebulizer for 6 weeks.
Initial misuse report received from a healthcare professional on 28 October 2013 and on 21 March 2014. A patient of unknown age and gender had received unstable FLUZONE HD vaccine on unknown date. It was reported that FLUZONE HD order was shipped on 18 October 2013 and arrived on 21 October 2013 which was outside of time frame for shipping. The office was closed on weekend. Three doses were given. No adverse event was reported. The list of documents held by sender: None.
I sat down for 15 min, but after the first minute I started to feel flush and like I was about to pass out. The worker had me to lay down and took my BP, which was 158/90 and I'm usually 108/60. I remained in that position for about 15 min. My entire body was shaking uncontrollably. My BP came down and they gave me Benadryl before sending me to the ER. Within an hour post Benadryl, I felt drowsy, but back to myself.
I woke up with leg pain and very tired / Same reaction with 2nd vaccine; I woke up with leg pain and very tired / Same reaction with 2nd vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. don't have card on me at this time, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 09Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "I woke up with leg pain and very tired / Same reaction with 2nd vaccine".  Additional information: Patient Age group: Adult (18-64 Years). There were no other vaccine in four weeks and no Other medications in two weeks. The patient received the 1st booster on 20May at 4pm at her local drug store she was fine until 3am she woke up with leg pain and very tired. Went back to sleep throughout saturday she slept most of the day. Same reaction with 2nd vaccine. Late saturday after noon the back of her head became itchy and then itchy behind her ears. She took a antihistamine n put cream on. Sunday same thing happened. Monday at 4 am work up to a rash and itchy areas to her neck n chest. It was driving me crazy. She took another antihistamine and added more cream like she did on Saturday and Sunday. Monday called Dr. was seen at 330 pm yes allergic reaction. Never in her life have she had an allergic reaction and or rash. Dr. put her on steriod, Pepcid for her stomach because of steriods, Benedryl and cream. Have to see an allergist earliest appointment is Jul12. Again never a reaction to anything in her life. She have pictures from Monday morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200751697 similar report from same reporter
Employees were to receive Fluzone, but received high-dose vaccine in error from occupational health nurse.  Occupational health nurse received incorrect product from inpatient pharmacy.  Friday, Oct 2, approx 5:19pm, Occupational Health Manager received a call from Occupational Health nurse administering flu vaccine to employees at Hospital. OccHealth nurse stated she went to inpatient pharmacy and requested Fluzone preservative free influenza vaccine for Occupational(Employee) Health to administer to employees. Stated the pharmacy tech handed her the doses from a refrigerator without pharmacist checking before dispensed. After 4th dose adminsitered, nurse noted on the box it was high dose influenza vaccine and returned them to pharmacy. States doses were administered between approximately 1:30pm-2:30pm, Oct 2. OccHealth Manager contacted pharmacy director, Clinical Occupational Health Director, and Occupational Health Medical Director of the incident between 6pm-7pm Oct 2.
rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn; he still has itching on his back; peeling some what on arms; feeling chilled all day and fatigue; feeling chilled all day and fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), PRURITUS (he still has itching on his back), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]), ATORVASTATIN, VITAMIN D NOS, METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), AMLODIPINE and METHOTREXATE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), PRURITUS (he still has itching on his back), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue). At the time of the report, RASH (rash all over his body(excluding the palms of his hands or soles of his feet) which was red like a sunburn), SKIN EXFOLIATION (peeling some what on arms), CHILLS (feeling chilled all day and fatigue) and FATIGUE (feeling chilled all day and fatigue) outcome was unknown and PRURITUS (he still has itching on his back) had not resolved. Not Provided          Treatment: Benadryl, Vistaril, Nivea lotion, Keri lotion.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Approximately 2 hours after shot, I began to feel dizzy and kinda weak.  Sat down.  Finally laid down to see if dizziness would car up (missed class).  Approximately 7 hours later the dizziness was clearing and returned to normal shortly thereafter.
Kept getting hot/sweaty then chilled the day after the shot. I started with  night sweats the 2nd night.  I have  continued to have multiple "hot flashes" EVERY day and night since my first Covid vaccine shot. They start with a warm firey sensation in my torso then spread out from there.  I never experienced these symptoms prior to March 14.  It seems similar to hot flashes described for menopause but I had not hit menopause yet.
Hospitalization; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273  (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criteria hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment information provided.  No concomitant medications reported.; Sender's Comments: Limited information regarding the hospitalization has been provided at this time and a causal relationship cannot be excluded
S: pt vaccinated with small pox c/o rash with eruption 15 days after vaccination. Pt also received other shots as mentioned in 13. Rash on right elbows and right hip/leg, mildly pruritic. A/P erythema multiforme. Treatment Allegra and Benadryl.
A report was received from a health care professional on 13OCT2003 who is a 43 year old female vaccinee who experienced severe body aches, myalgias, arthralgias and fever on the same day as receiving Fluvirin vaccine on 9SEPT2003. On 9SEPT2003, the vaccine experienced severe body aches, myalgias, arthralgias and fever with temperature spikes as high as 103 degrees Fahrenheit. The vaccinee was administered 800 mg ibuprofen every 6 hours and 325 mg acetaminophen every 4 hours. The vaccinees symptoms persisted through most of 10SEPT2003 until 22:00 hours, at which time her fever and other associated symptoms resolved. Since 10 SEPT2003, and up to the time of the report the vaccinees symptoms have not returned. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Muscle pain, pain in arm of injection, trouble raising injection arm, chills/ sweating, fatigue, tightness all over ( muscles, jaw, chest, etc) , irritability, headache, trouble concentrating/ disoriented
Pt recv vax on 12/10/98; 2 hr post vax pt exp local erythema/ induration of Lt Leg; tx=ice & Allegra
Case number PHEH2014US025079, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 10 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter  Treatment information was not provided
Numbness, tingling and twitching in my face, which spread throughout my body; Numbness, tingling and twitching in my face, which spread throughout my body; Numbness, tingling and twitching in my face, which spread throughout my body/ primarily twitching; Cramping throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 25Jul2021 at 12:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medication included armodafinil (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) for an unknown indication and experienced drug allergy. On 03Aug2021 at 14:45, the patient experienced numbness, tingling and twitching in his face, which had spread throughout his body. It started approximately 2 weeks after receiving the vaccine. At that point it was primarily twitching and cramping throughout his body. He had been seen by 3 neurologists now and they still did not have a diagnosis (at the time of this report). His next neurology follow-up was on 18Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness, tingling and twitching in his face, which spread throughout his body/ primarily twitching and cramping throughout his body was not resolved at the time of this report.
Shortness of breath, several abnormally large lymph nodes. 1st CT scan was to image the lymph node that showed up and it spotted haziness in the lungs. 2nd CT scan confirmed issue in lungs
Patient calls center reporting she felt increased heart rate immediately after but heart rate later normalized. At about 8pm, she had headache, tiredness and temp of 99.7F, took 1tab of 500mg extra strength with no help and has since been taking the tylenol every 8hrs. Pt currently complaining of abdominal cramping, dizziness and tiredness. Pt advised to go to ED
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with advisory organizations to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.
10 MINUTES AFTER VACCINATION PATIENT COMPAINED ABOUT FULL BLOWN DIARREAR AND VOMITING AND FEELING WEAK.