chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA. Received first COVID vaccination Fri., Jan. 22 at 1:56pm. I was not anxious about the shot at all and was playing solitaire on my cell phone when  around 2:15pm it was like a switch turned on and I felt my heart racing and pressure on my chest. I notified the nurse and she took my blood pressure and it was 200/90, HR 98, Oxy 100%. At 2:25pm it was 140/80, HR 96, Oxy 96%. And at 2:39pm it was 132/88 and the nurse felt it was OK to return home. My chest felt better at home around 4:15pm that same day.  I definitely had no anxiousness about taking the COVID vaccine, and was not worried about a reaction at all. Having that high of a blood pressure was a surprise because my blood pressure is usually around 117/74, and I don't get anxious about allergy shots or vaccinations. I have been taking allergy shots for over 15 years every month. I had taken my allergy shots in both arms 2 days prior to the COVID vaccination that was ok'd by my clinic.
Flu like symptoms; Fatigue; Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Ongoing. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Discontinued. In 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira for the event(s) of fatigue and flu like symptoms was not provided. Also, causality for the event of hidradenitis suppurativa flare up with humira(adalimumab) was a reasonable possibility.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
onset of rheumatoid autoimmune symptoms; suspected internal bleeding from clotting; brain fog; numbness in feet/legs; high inflammation; persistent daily headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches). At the time of the report, RHEUMATIC DISORDER (onset of rheumatoid autoimmune symptoms), INTERNAL HAEMORRHAGE (suspected internal bleeding from clotting), FEELING ABNORMAL (brain fog), HYPOAESTHESIA (numbness in feet/legs), INFLAMMATION (high inflammation) and HEADACHE (persistent daily headaches) outcome was unknown.            Patient went hiking the day before and was perfectly healthy. No concomitant medications were reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
I will state that I do NOT know for sure if this was connnected! However I began having issues with my breathing in the first week of April. I went to an urgent care as I thought it was a muscular injury. Prescribe muscle relaxers actually made things worse. Next stop was an ER the next day where an abnormal D-dimmer level led to a CT and diagnosis of possible pleurisy. Sent home with pain management and antibiotics. Returned again the following day and admitted for 2 days. Pain management, antibiotics, Corticosteroids and testing followed along with administration of oxygen. Some improvement, but not great amounts. Sent home still incredibly short of breath and difficulty breathing. Managed for most of a week before an appointment with a lung doctor. No real improvement though. Administered increased amounts of cortico steroid, more pain management, and advair inhaler. Began to finally help symptoms! Then went in on 4/20 for my second dose of Covid vaccine. The question had been asked if the issue was possibly related to the vaccine, but due to the length of more than seven days between vaccine and onset was advised it was unlikely. I was advised to do the second dose. Within 24 hours the tightness in chest returned and difficulty in breathing got worse. Thankfully this time it began to relax within 48 hours without increase in medication or return to specialists.
C/O soreness/discomfort evening following injection awakened by next day with c/o arm hurting and warmth redness ~ 3cm around injection site. Progressed that day with increased redness and warmth of upper arm including red streaks descending down arm painful neck and shoulder. Seen by PMD 8/9 and given Rx for Beadryl and Tylenol #3.
pain in opposite arm; Fatigue; Chills; Pain in arm; Difficult to lift arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm,), LIMB DISCOMFORT (Difficult to lift arm), PAIN IN EXTREMITY (pain in opposite arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm,), LIMB DISCOMFORT (Difficult to lift arm), FATIGUE (Fatigue) and CHILLS (Chills). On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in opposite arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm,), LIMB DISCOMFORT (Difficult to lift arm), PAIN IN EXTREMITY (pain in opposite arm), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
brief faint <1min with both hands stiffness, staring eyes, Her conscious  was back <1min. After fainting spell, everything came back normal. No other treatment.
I had chills, aches and headache. My arm is itchy with a red rash and a knot on it. Arm is very sore also
Patient is a diabetic pt with an indication for a pneumovax 23 vaccination. According to her IMZ consent form she is allergic to codeine and has functional neurological disorder. She takes no medication for her functional neurological disorder. She received the vaccine Saturday evening November 2nd. She called me Thursday morning to notify me that she did have an allergic reaction to the vaccine. She called her doc with symptoms of tingling and numbness in her lip, chin and cheek on her left side. He notified her it was an allergic rxn to the vaccine and advised her to take Benadryl. She stated the redness did go away,but the numbness still existed in some areas on her face. I advised her not to wait and reach at out to the same provider. We did receive an rx for a medrol dose pack a few hours later. She also had some dental work including an extraction on the same left side of her face but she stated that was 3 weeks ago. I will continue to followup with her if her symptoms have resolved.
Fever 100.2. sore arm, headache, muscle pain, vomiting ( once), no appetite/nausea, sore throat, severe coughing , short of breathe , runny nose
hives under left eye arm selling & bruise where injected slight numbness left cheek right after shot sneezed several times  about 30 min after headache funny taste in mouth for couple days fever 100 degrees for 2 days nausea itchy rash left hand  itchy rash  near injection site 2 weeks later large bruises right arm, right knee smaller bruises on arms, legs 2 purpura spots right arm heart fluttering & shortness of breath 1st week fatigue feeling off ~ 7-10 days  1st five days were à nightmare
Diarrhea; fatigue; muscle weakness; Fever; breastfeeding toddler (13 months); breastfeeding toddler (13 months); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 15:30 (Lot number: Unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE IN UNAPPROVED INDICATION (non-serious) all with onset 21Sep2021, outcome "unknown" and all described as "breastfeeding toddler (13 months)"; DIARRHOEA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Diarrhea"; FATIGUE (non-serious) with onset 22Sep2021, outcome "unknown", described as "fatigue"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021, outcome "unknown", described as "muscle weakness"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of diarrhoea, fatigue, muscular weakness, pyrexia.  Additional information: No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  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 physician concerning a 9 year old female patient who on 29-JAN-2010 was vaccinated with the third dose of VARIVAX due to a computer records error. It was stated that the patient reported feeling dizzy. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Caller and his wife received the booster dose of the Comirnaty vaccine on on 27Sep.; Shoulder discomfort; This is a spontaneous report received from a contactable consumer or other non- healthcare professional (patient reported for himself). A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 27Sep2021 (at the age of 73-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date (Both at the age of 73-years-old) for COVID-19 Immunsation and patient did not had any problems after the first two doses of the vaccine. On an unspecified date of 2021 the patient experienced shoulder discomfort. The outcome of events shoulder discomfort was recovered on an unspecified date of 2021.    Follow-up (12Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
redness spreading diagonally; red area was slightly raised; redness below where shot was given; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), ERYTHEMA (redness below where shot was given), ERYTHEMA (redness spreading diagonally) and MASS (red area was slightly raised) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 24-Apr-2021, the patient experienced ERYTHEMA (redness below where shot was given). On 25-Apr-2021, the patient experienced ERYTHEMA (redness spreading diagonally) and MASS (red area was slightly raised). On 15-Apr-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 29-Apr-2021, ERYTHEMA (redness below where shot was given), ERYTHEMA (redness spreading diagonally) and MASS (red area was slightly raised) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient is an 82-year-old ESRD on dialysis Monday Wednesday Friday completed dialysis today when he spiked a temperature at the facility.  The facility did administer 1 g of vancomycin per their dialysis protocol as well as an amp of D50 for his blood sugar that was reading in the 50s.  He states that for the past 3 days he has been having nasal congestion and productive cough.  He also has been having generalized weakness for the past day as well.  Denies any sick contacts.  Denies any chest pain or difficulty breathing.  Denies any pedal edema.  Denies any abdominal pain nausea vomiting or diarrhea.  Denies any hematuria dysuria melena hematochezia.  Denies any numbness weakness or paresthesias in any of his extremities
EDD 12/15/18 Seen in office for prenatal visit on 10/16/18. Given weekly MAKENA injection (hx of preterm labor). Also given Tdap as patient is in third trimester. Patient returns to office the following day (10/17/18) reporting itching and rash that began shortly after her appointment on 10/16/18.
really tired; very cold; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.  A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced really tired (fatigue) and very cold (nasopharyngitis) on an unspecified date. Clinical course of events includes; she stated that it didn't start right away but that lately she's been really tired and very cold every second day. She will feel fine the next back but then back to being tired and cold the following day. She relayed, "I feel so cold and I cant do anything, I wasn't this way before." She would like to know if this is due to the vaccine. The outcome for the event was unknown.  Information on the lot/ batch number has been requested.
I didn?t have any allergic reaction on the first 2 doses of Covid vaccines but the 3rd dose.   I got the first allergic reaction on 11/25/2021.  I had rashes/hives on my stomach area, my legs, my arms, and some on my butt.  I took Benadryl for a day but it didn?t clear it up so I called pharmacy where I got the 3rd Covid vaccine, they told me to take Zirtec.  I took Zirtec and it cleared the rashes off after 2-3 days.
Information has been received from a health professional concerning a female patient who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced redness, swelling at the injection site and low grade fever. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to multiple unspecified number of patients of an unknown age and gender. There was no information about the patients pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of PNEUMOVAX23 lot number M029681, expiration date 22-JAN-2018 (strength, dose, frequency, route of administration, and anatomical location were not provided) were administered to a multiple unspecified number of patients for prophylaxis. The vaccine was exposed to a temperature of 67 Fahrenheit degrees for 16 hours. There was no previous temperature excursion, and the call was not because of a data logger. No adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same soured. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004337: US-009507513-1706USA004336: US-009507513-1706USA004335: US-009507513-1705USA015783:
Swelling to right side of neck and lymph nodes- hospice practitioner notified.  No new orders received.
Weight loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss). At the time of the report, WEIGHT DECREASED (Weight loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medication were reported.
On 9/12/2021 in the morning I felt very tired, chills, fever off and on. By the next day 9/13/2021 I felts body aches, chills , fever, headache, and my right hand/ legs/ feet were swollen. I also had a nose bleed! All these symptoms plus throwing up/ nausea continues into the week. I also broke out with a rash on my face and eyelids. I also had a baseball size lump on my underarm and a lemon sized lump on the injection site. I was bed ridden for about four days
Patient with 3 COVID vaccines who admitted to hospital with COVID detected PCR and complications r/t COVID.  Provider d/c note:  "Summary of Hospitalization: 89-year-old female with past medical history of COPD, chronic pain on chronic opiates, CKD 3, dementia, hypothyroid, and PVD.  Patient was admitted 09/16 for COVID-19 pneumonia after presenting with symptoms of altered mental status which dramatically improved prior to discharge per granddaughter .  This may be related to decreasing gabapentin versus treating her hypoxia/COVID.  Patient was hypoxic on presentation requiring supplemental O2.  She has been started remdesivir and Decadron at and completed 5 days remdesivir prior to discharge.  She was weaned off oxygen 24 hours prior to discharge.  She may have some chronic hypoxia as her primary care physician had prescribed in the past but she was not compliant with it.  She had a mild AKI and hyperkalemia which resolved.  She did have some hematuria I would recommend repeating UA as outpatient."
Information has been received from a physician concerning a 10 year old white female student with no pre-existing medical conditions who on 06/20/1997 was vaccinated once subcutaneously in the left arm with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck) (lot#617355/0567D).  There was no concomitant medication.  It was noted the patient had no illness at the time of the vaccination.  On 03/26/2004 the patient developed chickenpox described as a varicella eruption of the skin and mucous membranes with 150-200 lesions (also reported as 50-100 lesions at time patient seen in the office).  It was also noted that she had fever and cervical adenopathy.  The physician reported that no treatment was required for the adverse event and no laboratory tests were performed.  It was noted the therapy was discontinued.  It was also reported that the patient's chickenpox abated and she recovered.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
No additional adverse events reported; improperly stored doses of GARDASIL 9 was administered; This case was previously considered as non-valid due to lack of patient's identifiers, but upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  This spontaneous report was received from a medical assistant and refers to a 11 years old female patient. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 01-MAR-2021, the patients were vaccinated with improperly stored dosed of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (the third dose; 0.5 milliliter, lot # T007024, expiration date 23-APR-2022) intramuscularly in left arm for prophylaxis (product storage error). The administered doses were exposed to the temperature of 10.13 degrees Celsius (C) for 1 hour. There were previous temperature excursions reported as 9.17 C for 15 minutes and 8.59 C for 15 minutes. The call was because of a digital data logger. No additional adverse event was reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007465: US-009507513-2104USA008178:
Immunizations given on 10/18 father brought son in on 10/19, left arm, deltoid area was swollen, red, warm to touch, child says it was sore and itchy.  Father said redness started this am (10/19) and school RN was concerned.  Father instructed to use cool compress on arm, f/u on 10/22 - arm better, no rash or swelling