chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart condition now, had a heart attack; Heart condition now; circulation problems in my spine; constant pain; loss of sensation in limbs; arthritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (disability, life threatening) with onset 18Apr2022, outcome "not recovered", described as "Heart condition now"; MYOCARDIAL INFARCTION (disability, life threatening) with onset 18Apr2022, outcome "not recovered", described as "Heart condition now, had a heart attack"; ARTHRITIS (disability, life threatening) with onset 18Apr2022, outcome "not recovered"; SPINAL VASCULAR DISORDER (disability, life threatening) with onset 18Apr2022, outcome "not recovered", described as "circulation problems in my spine"; PAIN (disability, life threatening) with onset 18Apr2022, outcome "not recovered", described as "constant pain"; SENSORY LOSS (disability, life threatening) with onset 18Apr2022, outcome "not recovered", described as "loss of sensation in limbs". The events "heart condition now, had a heart attack", "heart condition now", "circulation problems in my spine", "constant pain", "loss of sensation in limbs" and "arthritis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of myocardial infarction, cardiac disorder, spinal vascular disorder, pain, sensory loss, arthritis. Clinical course: Patient had vaccine at Doctor's office/urgent care. No Other vaccine in four weeks. Heart condition now, had a heart attack, circulation problems in my spine, constant pain and loss of sensation in limbs, arthritis, not overweight, was very healthy before any of this. Treatment for adverse event: Blood pressure medication, physical therapy, etc. Patient was not tested for covid post vaccination. There was no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Myocardial infarction , Cardiac disorder, Spinal vascular disorder, Pain , Sensory loss, Arthritis. and the use of suspect product comirnaty cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Tinnitus; General malaise; Mend nebular nose; Runny nose; Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 031L20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Upper respiratory disorder, Hypertension (amlodipine, losartan was used as concomitant) and Diabetes (Tresiba insulin). Concomitant products included INSULIN DEGLUDEC (TRESIBA) for Diabetes, AMLODIPINE and LOSARTAN for Hypertension, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) outcome was unknown.            This case was linked to MOD-2021-324030 (Patient Link).
Arm felt like it had been punched lasted 4 days. Left side of chest hurt unable to isolate lasted 3 days. Severe headache lasted 2 days. Vision blurred started clearing on 5th day. E.D. still on going.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 50-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, headache and general body pain. On an unknown date, the outcome of the fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, headache and general body pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient, who was a pharmacist. The patient said that SHINGRIX had been the worst immunization the patient had received as far as it related to side effects. The patient experienced fever, chills, headache and body pain, after vaccination. The patient was in excellent medical and physical condition and being a pharmacist he or she would be very reluctant to offer and administered SHINGRIX to other patient population because of the severe side effects that experienced self by the patient. Most of their population were older than 50 years and in worse physical health than the patient with underlying comorbidities. For tolerance effect after 2nd dose, please refer case US2018GSK108193.
8/10/02-Hard red lump formed, mom treated with cool compresses, with no relief noted... 8/11-15/02 area increasing in size with black area in center surrounded by a red ring.  mom gave tylenol allergy med. 08/20/02 mom states a rash moving down arm to wrist...applied hct cream with some relief. will take child to her pmd.
Swollen lymph nodes under arm that received the injection. Mildly swollen under opposite arm. Joint pain, body aches and chills.
Vaccination was the 2011-2012 Fluzone Preservative free vaccine.  Started as what seem to be a sore neck that was attributed the aches and pains that could follow, then because a full on neck spasm and sensitive to the touch. Went to the ER for hours and prescribed pain meds.  Since that time, nerve pain has extended to shoulders (7 days later) wrists, thumbs, and elbows.  All have swelling of nerves and joints.  Inability to move joints.  Tylenol does not work nor does heat/cold.
pain at injection site; chills; muscle fatigue; decreased strenght in bilaterl arms esp right; This is a spontaneous report from a contactable Nurse. A 51-year-old non-pregnant female Nurse received the second dose of BNT162B2 (PFIZER COVID-19 Vaccine; Lot Number: EL3246), via unspecified route in the left arm on 28Jan2021 (Age at the time of vaccination: 51-year-old) as a single dose for COVID-19 immunization. Medical history included TRIPLE NEG BREAST CANCER, GERD, allergy to NOTREL and BACTRIM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included SYNTHROID, PROTONIX and PEPCID (manufacturer unknown). Historical Vaccine included first dose of BNT162B2 (PFIZER COVID-19 Vaccine; Lot number: EK9231) via intramuscular route in left arm on 08Jan2021 at 07:30 as a single dose for covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at 16:45, patient experienced pain at injection site, chills, muscle fatigue and decreased strength in bilateral arms esp. right. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
2 weeks after my 1st booster - pneumonia 2 weeks after my 2nd booster Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "2 weeks after my 1st booster - pneumonia 2 weeks after my 2nd booster Pneumonia".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mother states that patient's face became swollen and itchy, and eyes became inflammed and she was upable to open them at 1900 last night. She took 1 Benadryl with no symptom relief. Began having labored breathing and mother took her to ED at 2100. Per mother's report, Vistaril 25 mg was given in ED, and a presciption was given but not yet filled. Patient has not taken any medication since that time. Today 0900 her face and eyes are once again inflammed and she is having pain at the injection site. Mother reported that she is not having any breathing problems today. Advised mother to take her back to the ED right away if breathing problems start again. Called NP. She suggested that patient take Benadryl q 4-6 hours x 1 week. Instructed mother to fill presciption right away. Public health nurse will follow up with mother today.
4 HOURS AFTER DTP/MEASLES VAX, BECAME VERY IRRITABLE, THEN UNRESPONSIVE AND CYANOTIC. AFTER 1 MUN, BREATHING SEEMED TO RESUME,CONSCIOUSNESS GRADUALLY RETURNED NORM OVER SEV HRS.HOSPLZD: ABNORMAL WBC, PLATELETS AND SERUM SODIUM,FEBRILE 18HRS
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 14-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 100-101 (High) High. On an unknown date, Body temperature: 101-106 (High) High. No concomitant medications reported.
7/28/13 tingling/itch in back then 7/31/13 pain and then 8/1/13 breaking out with blisters.
Patient had intractable coughing, and complained of chest tightness starting about 20 minutes after administration. Vital signs remained stable. EMS was called and she was transported to the Emergency Department. No medications were given onsite.
Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control; Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021). In March 2022, the patient experienced PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control). At the time of the report, PSORIASIS (Psoriasis flare-up / Symptoms got worse and flared up / Plaque covered whole scalp and spread in forhead, ears / Psoriasis was out of Control) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine 1st dose on 15-Aug-2021 and 2nd dose on 05-Sep-2021) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in COVID-19 vaccine trial. Primary reporter did not have the lot information because the packaging was discarded.
Clinical reviewer APRN advised me that patient should not have received anymore COVID vaccines after J&J & Pfizer booster regardless of immunocompromised status. Clinic manager & I did not realize patients who received J&J as their first dose could not receive up to 4 doses for immunocompromised status.
On 3/23/21.  Pt admitted w/R sided, pulsatile HA associated w/vomiting. Patient was found to have occlusive dural venous sinus thrombosis involving the dominant R transverse and sigmoid sinuses, extending into upper jugular vein. He received his second COVID-19 vaccination 5 days prior to onset of HA.  Report this for record keeping.
Autoimmune hemolytic anemia, infusion are ineffective,  treatment options TBD. Idiopathic orthostatic hypotension. Treatment options are TBD pending results of a lumbar puncture
Redness at injections site, nausea,  tired, low grade fever,  dirreria
Killer headaches; Dizziness; Nausea; Has been experiencing "killer" headaches. She states that this morning it is "really bad"; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EW0162) via an unspecified route of administration, administered in right arm on 23Apr2021 morning at 9:30 (at the age of 50-years-old) as dose 1, single dose for covid-19 immunization. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported but patient stated took small dose of medication for high blood pressure. On an unspecified date, the patient experienced killer headaches, this morning it is really bad and stated that she is also having dizziness and nausea. Patient received the first dose yesterday but she is experiencing a severe headache. She already took Ibuprofen orally one last night and one this morning, took one 800 mg tablet it's the prescription that she had last year for something else but it helped little but today it got worse. Patient concerned that she had a headache yesterday and this morning it's getting worse, and she took Ibuprofen last night but today it's not helping. She would like to know if it is safe to take Excedrin to treat her symptoms, as she is worried about a potential interaction between it and the vaccine. Response received as there is no information regarding a potential interaction between the vaccine and Excedrin. Spoke from the attached document to let caller know about CDCs considerations that medications used to reduce pain can be taken after vaccination to treat symptoms, but let caller know that it does not specify Excedrin. Referred caller to HCP for further guidance. Unaddressed medical questions referred or forwarded to medical Information. Therapeutic measures were taken as a result of all the events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Woke up weak and unable to sit/stand/walk, slurred  sounds, somewhat disoriented.  (***Note: *** When covid Pfizer vaccine 1 and 2 were give in March 2021 he encountered similar adverse reactions.   After 24-48 hours he was better and more himself).
Large, red painful lump at injection site.  Raised and approximately 5" by 3".  This is day 3 and it's just beginning to lessen in pain and color.  Also itchy
bypass surgery after the first dose; Second dose past 36 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR GRAFT (bypass surgery after the first dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass graft on 16-Mar-2021. Concomitant products included METFORMIN, CLOPIDOGREL BISULFATE (PLAVIX), ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VASCULAR GRAFT (bypass surgery after the first dose) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose past 36 days after first dose). At the time of the report, VASCULAR GRAFT (bypass surgery after the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose past 36 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mother brought child experienced tense, redness, swelling left arm with warmth, no fever/chills, child otherwise well; given antihistamine with improvement.
Patient reports itching at vaccine site, followed by swelling of tongue and eyes. Itching started in the evening after vaccination. Swelling of tongue and eyes occurred while patient was sleeping.
mildly sore arm; Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker (smoked 35 years), Open heart surgery and Triple vessel bypass graft. Concurrent medical conditions included Amputee, Diabetes and High cholesterol.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19). At the time of the report, PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         She did not experience any side effects except for a mildly sore arm.  She recently tested positive for COVID-19 but was completely asymptomatic.  She attributed her lack of problems from COVID-19 to vaccine.  No concomitant medications were reported.  No treatment information was reported.; Sender's Comments: This report concerns a 62 year old female patient with relevant medical history of open heart surgery, diabetes and a past history of smoking who experienced unexpected non-serious events of pain in extremity and COVID-19. It was reported that the patient tested positive for COVID-19, however was asymptomatic. The events occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient reported hearing loss after vaccination, that has persisted and not resolved; This is a spontaneous report from a contactable consumer (Pfizer employee) received regulatory authority.  A female patient of an unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported hearing loss after vaccination, that has persisted on an unspecified date with outcome of not recovered. The event required doctor or other healthcare professional office/clinic visit.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Patient was administered first dose of Johnson and Johnson vaccine. She actively carries an epi pen and was directed to self time for 30 minutes of observation. The paramedics were onsite and in charge of observation of the patients. At the end of the 30 minute observation period, she reported shortness of breath and an itchy back to the paramedics. No visible distress noted. At that time, the paramedics assisted her to the ambulance outside. Per paramedics" pt vital signs where stable and intacted, pt had mild inspiratory wheezes bilateraly in bases. pt had a hx of  asthma and anxiety. pt was coached to control breathing pt felt better. pt transported at 1212 to The hospital. placed in bed and turned over care to facility rn without incident. all safety precautions taken."
Myalgia, Fever, Diarrhea, chills, fatigue, arm pain Reports fever of 102, normalizing within 24 hours, also reports COVID-19 exposure, so will proceed to be tested; called again to also report events above, states she did not follow up with PCP..tested 12/30/2020, negative for COVID-19.
By 10pm on 1/23/21,  I was experiencing chills, fatigue, and swollen lymph node in my right armpit as well as soreness at the injection site  (which started hours earlier).  On 1/24/20, chills and extreme fatigue continued along with dull headache, lack of appetite, and general feeling of unwellness.  Temperature at 3:30pm was 101.2F.