chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm/hand numbness; This is a spontaneous report received from contactable nurse. This is the second of two reports. A 36-year-old adult [non-pregnant] female received the second dose of intramuscular BNT162B2 (solution for injection; Lot EL9764 expiry not provided) as a single dose in the left deltoid on 16Feb2021 (at 36-years-old), for COVID-19 immunization. Relevant medical history included known allergy to coconut, obesity (BMI 32), and former smoker. Concomitant medications included ascorbic acid/ dexpanthenol/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine hydrochloride/ tocopheryl acetate (MVI), and levonorgestrel (MIRENA). The patient previously received COVID-19 immunization with intramuscular BNT162B2 (Lot EJ1685) in the right deltoid on 05Jan2021 at 13:00 (at 36-years-old) and experienced sensation change (pins and needles) in left arm and tested positive for COVID. The patient was not pregnant at the time of vaccination. The patient did not receive any immunomodulating or immunosuppressing medications or any other vaccinations around the time of the vaccination. The patient tested positive for COVID via oropharynx PCR on 23Jan2021. On an unspecified date in 2021 the patient experienced Left arm/hand numbness which required hospitalization. Treatment for the event included aspirin (81mg) for thirty days. The outcome of the event Left arm/hand numbness was recovering.   The reporting nurse was unsure if the event was related to the use of the Pfizer product.; Sender's Comments: Based on temporal association, the causal association between the reported event numbness and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) :PFIZER INC-2021105933 PFIZER (Same reporter/patient/product, different event)
immediate chills, shaking, low BP (82/60), low grade fever (99.8) when covered with blanket in following 48 hrs - fever 102.7 before meds. chills, shaking, severe diarrhea, abdominal cramping, nausea
PATIENT CONTACTED THE HEALTH DEPARTMENT ABOUT AN HOUR AFTER HER APPOINTMENT.  SHE STATED THAT SHE HAD STARTED TO FEEL LIKE HER VISION WAS BLURRING, AND THAT SHE WAS BURNING FROM THE INSIDE, HER CHEST WAS TIGHT AS WELL. HER CLIENT THAT WAS WITH HER STATED SHE WAS ACTING LIKE SHE WAS HAVINGA SEIZER WHILE THEY WERE DRIVING. THIS RN SUGGESTED THAT SHE HAVE SOMEONE DRIVE HER TO THE ER.  RN CONTACTED PATIENT AT THE END OF THE DAY ~4PM, PATIENT STATED SHE WAS SEEN AT THE ERAND THE DOCTOR TOLD HER SHE HAD AN ALLERGIC REACTION. PATIENT ALSO STATED SHORTLY AFTER SHE CALLED THE CLINIC THAT HER THROAT FELT LIKE IT WAS SWELLING UP, HER LIPS WERE BALLOONING OUT, AS WELL.  PATIENT STATED THE DOCTOR TOLD HER THE VACINE WAS INTERACTING WITH ONE OF HER PSYCHOTROPIC MEDICATIONS.
5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the couch - socks, boots, leggings, sweatshirt, 2 blankets - and napped. 9:00pm; finally felt warm. Back and shoulder muscles were very sore. Temp had risen to 100.3F. Took 400mg ibuprofen and went to bed. Awoke the next morning feeling great. No residual effects.
Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him.  He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea.  This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure.  This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered.  The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.
Booster; Woke up confused; Unable to stop Shaking; spinal meningitis; Broke the blood brain barrier and infected him; He progressively Got worse; He had lost all motor skills; infected him; incoherent speech; This is a spontaneous report from a contactable consumer (reporters father).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (booster) for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162B2, dose 1 and then dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. A few days after the booster, the patient woke up confused and unable to stop shaking, he was admitted to Hospital. The patient progressively got worse, he had no idea where he was and he had lost all motor skills except speech but he was incoherent. After a few nights fearing the worst the antivirals he was given began to work and he stabilized and regressed several times. After a week he was diagnosed with spinal meningitis. The booster broke the blood brain barrier and infected him. The patient was not recovered from the events confusion and shaking while the outcome of the other events was unknown.   The patient underwent lab tests and procedures which included investigation: spinal meningitis was diagnosed on an unspecified date.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Current: COVID arm- small patch around injection site became red on day 8, Feb.11. It is not Feb.15, and the red itchy patch has grown to 2 1/2 " by 2 1/2".  For the first 2-3 days, I had headaches, chills, extreme fatigue and had difficulty breathing. I had chest pressure the first day.
GM brought pt to HB Pt R arm is swollen and firm about 1 1/2 inch around shot site, Area is red. GM said pt said it itches. First her to cont Tylenol or Motrin every 4-6 HR today and tomorrow and apply cool cloth to area.
I do not know the individuals medical hx or illness/complications. Due to new information circulating related to mRNA vaccines and myocarditis/pericarditis and being made aware that this person had suffered cardiac arrest after being admit to the hospital following complications with their health it warrants being reported regardless of prior health conditions.
Patient states he felt lightheaded, extremely weak, diaphoretic, nausea, chills and had one episode of vomiting while on site. Patient contacted today by phone by myself. Advised patient to follow up with PCP when eligible for booster vaccine to have administered in controlled setting (PCP office or hospital) secondary to CDC since he vomited within 15 minutes of having vaccination. Patient verbalized understanding and is in agreement with assessment.
By 11:30 pm I was feeling body aches, chills, pain at the injection site,  and headache.  By 7 am I felt whole body weakness, fever and body ache.  24 hours after the injection I still had a 101.3 fever.   36 hours after injection, the injection site was red, hot, and had redness had increased x3.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported
10 min after injection -noted migraine-hard to concentrate, abnormal taste, hair feels "heavy", photosensitivity.  These are her normal headache symptomology.  She also experienced same with first Moderna does on March  2021
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 1:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 1:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened. Date the vial was initially stored in the refrigerator: 29 Oct 2021, 02 Nov 2021, 03 Nov 2021, 04 Nov 2021, 05 Nov 2021, 16 Nov 2021, 19 Nov 2021, 23 Nov 2021 and 30 Nov 2021. Date vial(s) moved from freezer to refrigerator, if applicable 19 Nov 2021 is when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Patient received vaccination  and within a minute was turning red and having trouble breathing. Technician grabbed a 0.3mg Epipen and the pharmacist. Tried to inject one epipen and the needle bent trying to administer through pants. They proceeded to roll up pants and administered 2nd epipen in the thigh. 911 was called.
low grade temperature; headache; chills; fatigue; nausea; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021 04:30, the patient received Bexsero. On 13th September 2021, the patient started Bexsero Pre-Filled Syringe Device. On 13th September 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, headache, chills, fatigue and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, chills, fatigue and nausea were unknown.   It was unknown if the reporter considered the fever, headache, chills, fatigue and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was reporter's son. The age at vaccination was not reported. The patient received Bexsero shot and he started having a low grade temperature of 100.5 degree F with Tylenol onboard for an hour. The patient also experienced headache, chills, fatigue and nausea.  The reporter asked if these were common side effects. The reporter further stated according to information some was common side effects.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
I got the Moderna vaccine, lot#060H21A, at Pharmacy. It was the winter of 2021 I think. This vaccine put my brain into severe pain. No medicine would help with this pain for 3 days. This vaccine is magnetic.
ED to Hosp-Admission Current  9/11/2021 - present (4 days) l  DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission COPD exacerbation (CMS/HCC) [J44.1] COVID-19 virus infection [U07.1] HPI    Pt is an 71 y.o. female. with  Past medical COPD, chronic respiratory failure on 3 L of oxygen, seizure, A. fib, not anticoagulation due to hematuria, came to emergency room due to generalized weakness and hypoxia.  As per patient and daughter over the phone, patient had Covid positive family members visiting on Monday, today when daughter checked patient oxygen it was in low 80s, then patient was on 3 L, oxygen was increased to 4 L, was improvement to low 90s.  Given patient significant history of COPD, she was brought to emergency room.  Lab work in the emergency room unremarkable, no significant changes from previous values.  Urine significant for hematuria, negative procalcitonin.  Vital tests positive for COVID-19   Patient seen and examined bedside, in mild respiratory distress.   Hospital Course   Patient was admitted to med surgical floor with acute on chronic hypoxic respiratory failure secondary to COVID-19 infection.  Her oxygen requirement at home is 3 L she was requiring up to 4 L with diffuse wheezing bilaterally.  She was started on remdesivir as well as Decadron.  Her oxygenation requirement came down to 3 L.  She is back to her baseline and will be discharged home today.  She has completed 5 doses of remdesivir   Discharge instructions Patient strictly follow with her primary care provider in 1 week She will take 5 more days of dexamethasone 6 mg and then she can go back to her prednisone 10 mg daily
VACCINE POURED DOWN THE ARM  WHEN NEEDLE REMOVED; PULLED OUT THE NEEDLE THE VACCINE POURED OUT STREAMING DOWN  HER ARM; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine poured down the arm when needle removed, and pulled out the needle the vaccine poured out streaming down her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine poured down the arm when needle removed and pulled out the needle the vaccine poured out streaming down her arm was not reported. This report was non-serious.
She reports that she immediately felt itching and a tightness in her throat.  She presents here complaining of the same symptoms.  She reports itching affecting the left arm only.  She denies any pain.  She reports that she is able to breathe easily, but feels like her throat is tight.  Patient reports history of allergic reaction to vaccinations when she was a young child, but cannot remember any specifics about the events because of her age at that time.  She has no other complaints at this time. Presents here with chief complaint of possible allergic reaction to Covid vaccination.  Patient does not have any urticaria, oropharynx is patent, there is no perioral or periorbital swelling, oxygen saturation is good and breath sounds are equal bilaterally.  I do not feel that anaphylactic reaction is occurring and do not feel that epinephrine treatment was necessary during emergency department visit today.   Patient is treated with prednisone in the emergency department today.  She reports improvement of her symptoms after medication is administered.   Patient will be discharged home with instructions to use Benadryl as needed for continued symptoms.
his sister and The lady that vaccinated him said they also had blurry vision with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine). At the time of the report, VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided
nurse reported that it was heard that another nurse who was vaxed w/Hep B vax & exp chest pain; No further details were provided;
headache; scratchy dry nose; feeling tired; arm pain; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, scratching dry nose, feeling tired and arm pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot #unknown) intramuscularly for of COVID-19 infection.   On 28 Dec 2020, the reporter stated that her co-worker received the vaccine last Wednesday. Her coworker reported headache, scratching dry nose, feeling tired and arm pain. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, arm pain, was resolved. The outcome of events, headache, scratching dry nose and feeling tired were not reported.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a non-serious unexpected event of nasal dryness and non-serious expected events of headache, fatigue and vaccination site pain. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
C/O leg/arm muscle pain and weakness ongoing since flu vaccine. Woke up with symptoms the morning following the flu vaccine. Seen 2/26 - Rx ibuprofen tid x 7 days.
pt recv vax 7AUG96 & 16AUG96 pt devel rash consisting of 12 lesions;17AUG96 pt vomited;
2 inch Area around injection site turned red and was very itchy on first and second day. Tuesday and Wednesday By the 3rd day area had turned pink and was not as itchy. Thursday By day 4 area was clear and not itchy. Friday
pt recvd flu vax & devel a red, bumpy, spreading over total body rash, sparing face, but accompanied by itching; pt was seen by MD & had 2 biopsies done;
Pt experienced bruising, redness, swelling and painful are at injection site.  Pt complained of burning and stinging after injection. Pt was referred to doctor.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022 at 7:46 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Feb-2022 at 7:46 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received vaccine past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No concomitant medications were reported.  No treatment information was reported.